2022.01.17 CS 192 of 2022 13.01.2022 With Annexures

IN THE COURT OF CIVIL JUDGE (SENIOR DIVISION) , GURUGRAM
CIVIL SUIT NO. 192 OF 2022
IN THE MATTER OF:

Lt Col (Veteran) Sarvadaman Singh Oberoi ... Applicant/ Petitioner-in-person
Versus
Union of India through Secretary, Ministry of Ayush, Government of India, Ayush Bhawan,
B-Block, GPO Complex, INA, New Delhi 110023, India Tel: +91-11-2465-1950 Fax: +91-
11-2465-1937 Email: secy-ayush@nic.in & others
... Defendants
Connected to CS 79/2022 NDOH: 17.01.2022
SUIT FOR PERMANENT INJUNCTION UNDER THE SPECIFIC RELIEF ACT,

1963 READ WITH CUSTOMARY INTERNATIONAL LAW DUE TO GRAVE
URGENCY OF PROTECTION OF INTEGRITY OF BODY AND SOUL, CRIMES
AGAINST HUMANITY ULTERIOR FORM OF CONSTRAINT TO VACCINATE
UNDER ACT 30 OF 2019 QUA THE BIAS OF INVASION/ VACCINATION BY
EMERGENCY USE LICENSE (EUL) VACCINES AGAINST THE CAM SYSTEMS
SPECIAL (LATER) LAW IN FORCE VIDE ACTS 14 OF 2020 & 15 OF 2020 WHILE
MAKING FREE MOVEMENT WITHIN INDIA
Place: Gurugram
Date: 13.01.2022
Applicant/Petitioner-in-person
Sarvadaman Singh Oberoi
1102, Tower 1, Uniworld Garden I, Sector 47, Gurugram 122018
Mob: 9818768349, Email: manioberoi@gmail.com
1
IN THE MATTER OF:

Versus
... Defendants
INDEX
SR
PARTICULARS DATE PAGE
NO
1. Memo of Parties 13.01.22 5
2. Court Fees INR 50 PLUS P.F. – INR 50 (TOTAL INR 100) 13.01.22 6
Suit for Temporary and Permanent Injunction read with Customary
3. 13.01.22 7-10
International Law with affidavit.
Application for exemption under Section 80 (2) & 80 (3) CPC with
4. 13.01.22 11-14
affidavit
ANNEXURE P 1: P-1 1940.03.15 Secretary of State v. Mask & Co.,
5. 15.03.40 15-21
[1940] 132 [P.C.] MANU-PR-0022-1940
ANNEXURE P 2: P-2 1979.01.17 State of Kerala v. Roshana, (1979)
6. 17.01.79 22-40
1 SCC 572 19pp
ANNEXURE P 3: P-3 2001.07.01 Legal Status of Traditional
7. Medicine and Complementary-Alternative Medicine, A Worldwide 01.07.07 41-239
Review, WHO 2001 199pp.
ANNEXURE P 4: P-4 2005.12.16 Right to a Remedy and Reparations
8. 16.12.05 240-246
in Gross Violations of Customary International Law 7pp
ANNEXURE P 5: P-5 2009.01.01 Safety issues in the preparation of
9. 01.01.09 247-309
homeopathic medicines, WHO, 2009 63pp
ANNEXURE P 6: P-6 2011.02.22 Russell Bruesewitz et al v. Wyeth
10. 22.02.11 310-366
LLC et al USSC Case No. 09-152 57pp. Unavoidably Unsafe
ANNEXURE P 7: P-7 2012.04.30 Abdullahi v. Pfizer Second Circuit
11. 30.04.12 367-381
Finds a Non-consensual Medical Claim Actionable under ATS 15pp.
ANNEXURE P 8: P-8 2017.01.04 AEFI Survellance Programme-
12. 04.01.17 382-383
Quality Policy and Objectives 04.01.2017 2pp
ANNEXURE P 9: P-9 2013.03.31 AYUSH Annual Report Extracts
13. 31.03.13 384-397
2012-2013 14pp
ANNEXURE P 10: P-10 2013.07.01 Communication Guidelines for
14. 01.07.13 398-453
Building Vaccine Confidence around AEFI 56pp
ANNEXURE P 11: P-11 2016.08.04 Second Schedule under Rule 3
15. 04.08.16 454-468
of AOB Rules, Allocation of Business, Govt of India Extracts 15pp
2
ANNEXURE P 12: P-12 2017.01.31 Allocation of Business Rules of

16. 31.01.17 469-483
the Government of India, 2017 Extracts 15pp
ANNEXURE P 13: P-13 2017.04.05 Kalpana Mehta and Ors. v.
17. 484-511
Union of India and Ors., (2017) 7 SCC 295 28pp 03.12.21
ANNEXURE P 14: P-14 2017.05.08 Gaurav Kumar Bansal v. Union
18. 24.12.21 512-515
of India (2017) 6 SCC 730 4pp
ANNEXURE P 15: P-15 2017.05.19 President endorses Modi's
19. 27.12.21 516-517
homeopathy line 2pp
ANNEXURE P 16: P-16 2018.01.01 Extracts Art. 226 DD Basu
20. 518-524
Commentary, Vol. 10, 9th Ed., 2018 pages 10630-10633 7pp 01.01.22
ANNEXURE P 17: P-17 2018.01.01 Extracts Art. 300-A DD Basu
21. 01.01.22 525-535
Commentary, Vol. 13, 9th Ed., 2018 pages 13804-13811 11pp
ANNEXURE P 18: P-18 2018.05.09 Kalpana Mehta and Ors v. Union
22. 05.01.22 536-726
of India and Ors, (2018) 7 SCC 1 191pp
ANNEXURE P 19: P-19 2019.02.05 Government of India Allocation
23. 20.02.05 727-738
of Business Rules,. 1961 Extracts 12pp.
ANNEXURE P 20: P-20 2019.04.06 Human Rights Court Orders
24. 19.07.47 739-745
Haryana 7pp.
ANNEXURE P 21: P-21 2019.08.08 The National Medical
25. 02.06.48 746-773
Commission Act, 2019 30 of 2019 28pp.
ANNEXURE P 22: P-22 2020.01.16 Causality assessment report of
26. 17.01.79 774-784
608 reported Serious AEFI 17.06.2019 11pp
ANNEXURE P 23: P-23 2020.03.05 The Pharmacy Council of India
27. 22.02.11 785-807
v. Dr SK Toshniwal MANU-SC-0531-2020 3J SPECIALIBUS 23pp.
ANNEXURE P 24: P-24 2020.03.09 Covid-19 is sign of an ecological
28. crisis, Shyam Saran (Retd Foreign Secy), Padma Bhushan, formerly 04.03.12 808
Prime Minister's Special Envoy for Climate Change 1p.
ANNEXURE P 25: P-25 2020.04.22 The Corona Crisis in Light of
29. the Law as Culture Paradigm, International Law and Covid-19 08.05.17 809-812
Jurisprudence, Baxi 4pp.
ANNEXURE P 26: P-26 2020.04.23 COVID-19 A harbinger for
30. 30.06.21 813-817
climate action 5pp.
ANNEXURE P 27: P-27 2020.04.30 ICMR SOP Template EC
31. 28.07.21 818-819
COVID19 2pp.
ANNEXURE P 28: P-28 2020.05.29 Ministry of AYUSH, Govt. of
32. 11.09.21 820-831
India Homeopathy Guidelines for COVID-19 12pp.
ANNEXURE P 29: P-29 2020.09.06 Ethics Committees Guidance
33. 17.09.21 832-848
COVID19 06.09.2020 17pp.
ANNEXURE P 30: P-30 2020.09.15 Medical education of Indian
34. System of Medicine and Homoeopathy PIB Press Release 15.09.2020 29.10.21 849
1p
ANNEXURE P 31: P-31 2020.09.20 The National Commission for
35. 850-875
Homoeopathy Act, 2020 15 of 2020 26pp. 03.12.21
ANNEXURE P 32: P-32 2020.09.20 The National Commission for
36. 24.12.21 876-904
Indian System of Medicine Act, 2020 14 of 2020 29pp.
ANNEXURE P 33: P-33 2021.02.17 WP Civil 7313 of 2020 Prashant
37. 27.12.21 905-907
Reddy T v. DGCI ORDER High Court of Delhi 17.02.2021 3pp
3
ANNEXURE P 34: P-34 2021.02.22 Hon'ble High Court of Delhi

38. Order W.P. C. 5315 of 2020 Master Arnesh Shaw v. UOI Duchenne 908-911
22.02.21
Muscular Dystrophy 4pp.
ANNEXURE P 35: P-35 2021.03.09 R-3 RTI Reply वैक्सीन अननवार्य
39. 09.03.21 912-913
नही 2pp.
ANNEXURE P 36: P-36 2021.04.25 Implementation Framework 914-918
40. 25.04.21
Annx MoHFW DO no Z.28015-85-2021-DM Cell dt 25.04.2021 5pp.
ANNEXURE P 37: P-37 2021.05.17 Israeli People’s Committee
41. 17.05.21 918-923
Releases Report ... COVID Injections , Covid Call To Humanity 5pp.
ANNEXURE P 38: P-38 2021.05.20 Hon'ble High Court of Delhi
42. 20.05.21 924-930
Order W.P. C. 5315 of 2020 Master Arnesh Shaw v. UOI 7pp.
ANNEXURE P 39: P-39 2021.05.22 Doctor's message about low
43. 22.05.21 931-939
pediatric deaths from COVID blocked by Facebook 9pp
ANNEXURE P 40: P-40 2021.05.25 Baba Ramdev fires 25 questions
44. at IMA, asks 'is there any allopathic medicine to turn cruel person kind 25.05.21 940-944
5pp.
ANNEXURE P 41: P-41 2021.05.25 The 25 Questions to IMA in
45. 25.05.21 945-946
Hindi with English translation 2pp.
ANNEXURE P 42: P-42 2021.07.23 WP Civil 7313 of 2020 Prashant
46. 23.07.21 947-948
Reddy T v. DGCI ORDER High Court of Delhi 23.07.2021 2pp
ANNEXURE P 43: P-43 2021.07.27 FAO 153 of 2021 Dr. J.A.
47. 27.07.21 949-957
Jayalal v. Rohit Jha JUDGEMENT 27.07.2021 9pp.
ANNEXURE P 44: P-44 2021.07.28 In re Kohima, Nagaland 2021
48. 28.07.21 958-960
SCC OnLine Gau 1560 3pp
ANNEXURE P 45: P-45 2021.08.10 Ratul Mahanta v. Nirmalendu
49. 10.08.21 961-969
Sana, 2021 (3) RCR (Civil) 815, MANU-SC-0519-2021 9pp.
ANNEXURE P 46: P-46 2021.09.02 Top FDA vaccine officials
50. RESIGN to avoid prosecution for Crimes Against Humanity, Natural 02.09.21 970-973
News 4pp.
ANNEXURE P 47: P-47 2021.09.11 Second Notice Section 80 CPC
51. and Crimes against Humanity Ulterior Form of Constraint to 11.09.21 974-1119
Vaccinate 146pp
ANNEXURE P 48: P-48 2021.09.12 Boys more at risk from Pfizer 1120-
52. 12.09.21
jab side-effect than Covid, suggests study, The Guardian 1123
ANNEXURE P 49: P-49 2021.09.17 Pankaj Arjunbhai Koli v. The 1124-
53.
State of Maharashtra MANU-OT-0099-2021 4pp 17.09.21 1127
ANNEXURE P 50: P-50 2021.10.29 Global COVID Summit 1128-
54. 29.10.21
Declaration and documents in support 18 pp 1145
ANNEXURE P 51: P-51 2021.11.05 Causality assessment report of 1146-
55. 05.11.21
22 reported Serious AEFI 18.10.2021 3pp 1148
ANNEXURE P 52: P-52 2021.12.01 Causality assessment report of 1149-
56. 01.12.21
178 reported Serious AEFI 22.11.2912 7pp 1155
ANNEXURE P 53: P-53 2021.12.27 Ministry of Home Affairs No. 1156-
57. 27.12.21
40-3-2020-DM-I(A) 6pp 1161
ANNEXURE P 54: P-54 2022.01.11 Omicron gastric origin mid 1162-
58. 11.01.22
November 2021 in Canada 11.01.2022 2pp 1163
4
IANNEXURE P 55: P-55 2022.01.11 Union of India Application 1164-

59. I 1.01.22
under 07 Rl 1 and S. 71 DM Act, 2005 in CS 79 of 2022 4pp. 1167
60.
IANNEXURE P 56: P-56 2022.01.12 CS 79 of 2022 Rejoinder to 1168-
!application of MoH&FW under 07 RI I 8pp 12.01.22
1175
61. IANNEXURE P 57: P-57 History of Homoeopathy in India, 1839-2013 12.01.22 1176-
1178
Place: Gurugram
Date: 13.01.2022
5
IN THE COURT OF CIVIL JUDGE (SENIOR DIVISION), GURUGRAM
CIVIL SUIT NO. OF 2022
11'1' THE MATTER OF:

Versus
U nion of India through Secretary, Ministry of Ayush, Government of India, Ayush Bhawan,
1 J-2465-1937 Email: secy-ayush@nic.in & others
... Defendants
MEMO OF PARTIES
Lt Col (Veteran) Sarvadaman Singh Oberoi, aged 73 years, s/o late Capt H.S. Oberoi r/o
1102, Tower 1, Uniworld Garden, Sector 47, Gurugram 122018, Mob: 9818768349, Email:
manioberoi@gmail.com .. .Petitioner-in-person
Versus
1. Union of India through Secretary, Ministry of Ayush, Government of India, Ayush

Bhawan, B-Block, GPO Complex, INA, New Delhi 110023, India Tel: +91-11-2465-1950
Fax: +91-11-2465-1937 Email: secy-ayush@nic.in & others
2. The Cabinet Secretary, Government of India, Rashtrapati Bhawan, New Delhi 110004,
India Fax: +91-11-2301-1241 Email: cabinetsy@nic.in
3. The Secretary, Ministry of Health & Family Welfare, Government of India, Nirman
Bhavan, New Delhi 110011, India Fax: +91-11-2306-3221 Email: secyhfw@nic.in
4. National Disaster Management Authority through its Member Secretary, NOMA Bhawan,
A-1, Safdarjung Enclave, New Delhi 110029, India Tel: +91-11- 2670-1728 Fax:
+91-11- 2670-1729 Email: controlroom@ndma.gov.in
.......Defendants
Place: Gurugram
Date: 13.01.2022
. Q..
t/P..
App11can
lf .
et1t10ner-m-person
1102, Tower 1, Uniworld Garden I, Sector 4 7, Gurugram 122018
6
IN THE MATTER OF:

Versus
... Defendants
--
. . . -.~ ....,-.....
COURT FEES
,.,... . . ........ .__ .... ,. - ... - .. . . . ........... ,.. .. . .
'\.. \,. '-
Place: Gurugram
Date: 13.01.2022
7
IN THE MATTER OF:

Versus
... Defendants
SUIT FOR PERMANENT INJUNCTION UNDER THE SPECIFIC RELIEF ACT,

1963 READ WITH CUSTOMARY INTERNATIONAL LAW DUE TO GRAVE
URGENCY OF PROTECTION OF INTEGRITY OF BODY AND SOUL
Most respectfully submitted
1. That the applicant/ petitioner in this SECOND Suit for Permanent Injunction under
the Specific Relief Act, 1963 read with Customary International Law (CIL
hereinafter) rights in a matter of the greatest complexity, enticement/ forcible
persuasion in breach of informed voluntary consent by resort to overarching
restrictions virtually and literally constituting a mandate on freedom of persons not
wanting to subject their person/ body (protected under right to privacy - Justice K. S.
Puttaswamy (Retd.) v. Union of India, (2017) 10 SCC 1 - 9 JUDGES BENCH) to
invasion by emergency use license (EUL hereinafter) vaccines ( experimental i.e. not
fully proven yet to be effective and inherently designedly unsafe as per US Supreme
Court - ANNEXURE P-6) some of which are mRNA based hence potentially DNA
altering vaccines (my DNA is protected under right to privacy) whereas CAM
(Complementary & Alternative Medicine) systems of medicine recognised
universally by WHO (See ANNEXURE P-3) and by two special acts of Parliament
(See ANNEXURE P-31 & ANNEXURE P-32) override or at the least supplant, at
the option of a citizen using CAM systems the earlier Act which may have
emphasized vaccination, namely ANNEXURE P-21 is now redundant for persons
using CAM systems of medicine. For the logic on later special law supervening
earlier special law reference may be had to ANNEXURE P-23.
8
2. Complex jurisdictional facts arise and hence matter is not amenable to writ i.e. Art.
32/226; furthermore not amenable to Section 30 of Act 10 of 1994 till the 28 year
hiatus in Section 31 is rectified; exclusion of criminal law of India vide List III Item
1 (Art. 246); bars constitutional remedy concerning human rights offence; attracts
mischief of Articles 2.3 & 14.1 ICCPR, 1966,Only this civil remedy of specific relief
of injunction is immediately available in this emergent fact and law situation. (See
ANNEXURE P-1 & ANNEXURE P-45 read with ANNEXURE P-20)
3. Emphasising on the art of "judicial creativity" which gives shape to judicial remedies
of novel nomenclature, Justice Krishna Iyer observed in the case of State of Kerala
v. Roshana, (1979) 1 SCC 572 at SCC p.586 at para 34 and SCC p.588 at para 39:
" 34. Law is not unimaginative, ........ where responsive (and responsible) justice is
the goal; courts cannot adopt a rigid attitude of negativity, allowing people and the
State, as such, to run into darkness; rule of law must come for rescue with courts
providing innovative judicial remedies which are capable of meeting the needs of the
time. ..... After all, law is not a brooding omnipresence in the sky but an operational
art in society....39. After all, the Court system belongs to the people and must
promote constructive justice ; and all institutions, including the Governments.......
likewise belong to the people. This commitment is the whetstone for doing justice in
the wider context of social good.". [ANNEXURE P-2]
4. That documents in ANNEXURES P 1 to P 57 are submitted herewith for admission

/ denial by the respondents so as to decide the matter of injunction against offending
bias of vaccination against CAM systems under the Specific Relief Act, 1963 read
with CIL (including Second Notice, 09.11.2021 Section 80 CPC and Crimes against
Humanity Ulterior Form of Constraint to Vaccinate 146pp.UPDATED) qua the bias
of vaccination against CAM systems. That it is clear from a reading of the
judgements at ANNEXURES P-13 & P-18 that vaccinations are purely voluntary
basis informed choice/ consent and are not to be enticed/ harshly persuaded or
forced with near penal/ penal or harmful administrative measures, usually with
a tinge of big business profit interest of MNCs engaged in pushing untested
vaccines bordering on “crime against humanity” which can cause grave mental
anguish and feelings of loss of dignity as we no longer live in a monarchical or
9
sovereign era but in a free, liberal and democratic society which respects the
beliefs and views of all sections of society.
5. That separate application for waiver ofrequirement Section 80 CPC (1) in view of
grave urgency and for temporary injunction till final disposal of this suit for specific
relief against offending paragraphs ("II. COVID-19 Vaccination") which are nothing
but enticement/ forcible persuasion in breach of informed voluntary consent by resort
to overarching restrictions on free movement of persons hesitant to subject their
person/ body (protected under right to privacy - Justice K. S. Puttaswamy (Retd.)
v. Union of India, (2017) 10 SCC 1 ) to invasion by emergency use license (EUL
hereinafter) vaccines qua the bias of vaccination against CAM systems is separately
preferred.
PRAYER
It is most respectfully prayed to grant:
(a) Permanent injunction against invasion by emergency use license (EUL hereinafter)
vaccines under Act 30 of 2019 qua the bias of vaccination against CAM systems in
force vide Acts 14 of 2020 & 15 of 2020 and
(b) Permanent injunction against any similar acts or omissions which amount to
overarching restrictions on free movement ofpersons hesitant to subject their person/
body (protected under right to privacy - Justice K. S. Puttaswamy (Retd.) v. Union
of India, ) to invasion by emergency use license vaccines, medications and the like,
and
(c) Any other prayer that this learned court may pass in the interests of justice, in the
peculiar facts and circumstances of this matter.
Gurugram
13.01.2022
~~
Lt Col (Veteran) Sarvadaman Singh Oberoi
I 102, Tower 1, Uniworld Garden I, Sector 47, Gurugram 122018
10
IN THE COURT OF CIVIL JUDGE (SENIOR DIVISION), GURUGRAM
IN THE MATTER OF:

Versus
Union of India through Secretary, Ministry of Ayush, Government oflndia, Ayush Bhawan,
... Defendants
AFFIDAVIT
I, Sarvadaman Singh Oberoi, S/o Late Capt. H.S Oberoi, aged about 73 years, Rio
1102/Tower 1 Uniworld Garden I, Sector 4 7 Gurugram, Haryana~ do hereby solemnly affirm
and declare as under:-
I. That applicant is petitioner in the instant suit for injunction under the Specific Relief
Act, 1963 read with customary international law and i s competent to swear this
affidavit on his own behalf.
-·
.,;c \-. ,, . ._,
. 2•. \ That the accompanying petition, with Annexures 'Pl' to 'P 57' has been drafted by
-- '
, {I-
me and the contents of the same are true and correct to my know ledge and belief and
.·, ..{
submissions are based upon information believed to be true.
·, c, ·· ·
DEPONENT
VERIFICATION:
Verified, at Gurugram, on this thirteenth day of January 2022 that, to the best of my
knowledge, the contents of the aforesaid affidavit are true and correct and nothing material
has been concealed therefrom.
DEPONENT
-~ f ~
l .
t -~ f~ -
t•tnd"·
tn~,·•
- -
., . .. . Oath c.-;1n, r;•: :::1nn&t

a.,. ~,;o...,·~ r:;i.;ruQi.-~
;i /3 • I- ?-'2--
S\g; :cC:/tt~ . .-1,>_; r~•· .; .. •~
-w~~ P~r1 j~ ,. fl•\·H
11
IN THE MATTER OF:

Versus
... Defendants
Connected to APP 35/2021 NDOH: 24.01.2022
EXEMPTION UNDER SECTION 80(2) CPC IN SUIT FOR PERMANENT

INJUNCTION UNDER THE SPECIFIC RELIEF ACT, 1963 READ WITH
CUSTOMARY INTERNATIONAL LAW DUE TO GRAVE URGENCY OF
PROTECTION OF INTEGRITY OF BODY AND SOUL
1. That the applicant/ petitioner in this application under Section 80(2) CPC in
SECOND Suit for Permanent Injunction under the Specific Relief Act, 1963 read
with Customary International Law (CIL hereinafter) rights in a matter of the greatest
complexity, enticement/ forcible persuasion in breach of informed voluntary consent
by resort to overarching restrictions virtually and literally constituting a mandate on
freedom of persons not wanting to subject their person/ body (protected under right
to privacy - Justice K. S. Puttaswamy (Retd.) v. Union of India, (2017) 10 SCC 1 - 9
JUDGES BENCH) to invasion by emergency use license (EUL hereinafter) vaccines
( experimental i.e. not fully proven yet to be effective and inherently designedly
unsafe as per US Supreme Court - ANNEXURE P-6) some of which are mRNA
based hence potentially DNA altering vaccines (my DNA is protected under right to
privacy) whereas CAM (Complementary & Alternative Medicine) systems of
medicine recognised universally by WHO (See ANNEXURE P-3) and by two
special acts of Parliament (See ANNEXURE P-31 & ANNEXURE P-32) override
or at the least supplant, at the option of a citizen using CAM systems the earlier Act
which may have emphasized vaccination, namely ANNEXURE P-21 is now
redundant for persons using CAM systems of medicine. For the logic on later special
law supervening earlier special law reference may be had to ANNEXURE P-23.
12
2. Complex jurisdictional facts arise and hence matter is not amenable to writ i.e. Art.
32/226; furthermore not amenable to Section 30 of Act 10 of 1994 till the 28 year
hiatus in Section 31 is rectified; exclusion of criminal law of India vide List III Item
1 (Art. 246); bars constitutional remedy concerning human rights offence; attracts
mischief of Articles 2.3 & 14.1 ICCPR, 1966,Only this civil remedy of specific relief
of injunction is immediately available in this emergent fact and law situation. (See
ANNEXURE P-1 & ANNEXURE P-45 read with ANNEXURE P-20)
3. Emphasising on the art of "judicial creativity" which gives shape to judicial remedies
of novel nomenclature, Justice Krishna Iyer observed in the case of State of Kerala
v. Roshana, (1979) 1 SCC 572 at SCC p.586 at para 34 and SCC p.588 at para 39:
" 34. Law is not unimaginative, ........ where responsive (and responsible) justice is
the goal; courts cannot adopt a rigid attitude of negativity, allowing people and the
State, as such, to run into darkness; rule of law must come for rescue with courts
providing innovative judicial remedies which are capable of meeting the needs of the
time. ..... After all, law is not a brooding omnipresence in the sky but an operational
art in society....39. After all, the Court system belongs to the people and must
promote constructive justice ; and all institutions, including the Governments.......
likewise belong to the people. This commitment is the whetstone for doing justice in
the wider context of social good.". [ANNEXURE P-2]
4. That documents in ANNEXURES P 1 to P 57 are submitted herewith for admission

/ denial by the respondents so as to decide the matter of Section 80 CPC urgency in
the matter of injunction against offending bias of vaccination against CAM systems
under the Specific Relief Act, 1963 read with CIL (including Second Notice,
09.11.2021 Section 80 CPC and Crimes against Humanity Ulterior Form of
Constraint to Vaccinate 146pp., ANNEXURE P-47) qua the bias of vaccination
against CAM systems. That it is clear from a reading of the judgements at
ANNEXURES P-13 & P-18 that vaccinations are purely voluntary basis
informed choice/ consent and are not to be enticed/ harshly persuaded or forced
with near penal/ penal or harmful administrative measures, usually with a tinge
of big business profit interest of MNCs engaged in pushing untested vaccines
bordering on “crime against humanity” which can cause grave mental anguish
13
and feelings of loss of dignity as we no longer live in a monarchical or sovereign

era but in a free, liberal and democratic society which respects the beliefs and
views of all sections of society.
PRAYER
It is most respectfully prayed to grant:
(a) Waiver of the rigours of Section 80 (1) CPC in view of grave urgency caused by
invasion by emergency use license (EUL hereinafter) vaccines under Act 30 of2019
qua the bias of vaccination against CAM systems in force vide Acts 14 of 2020 & 15
of2020,and
(b) Grant the exemption under Section 80 (2) read with Section 80 (3) as matter has been
agitated at the level of the Union and State Governments which would imply
substantial compliance even as the Respondents No. 1 & 3 are authorities under the
overall supervision of Respondents No. 2 & 4 respectively (others have been served
a notice ANNEXURE P-47), and
(c) Any other prayer that this learned court may pass in the interests of justice, in the
peculiar facts and circumstances of this matter.
Gurugram
~
13.01.2022
Lt Col (Veteran) Sarvadaman Singh Oberoi
1102, Tower 1, Uniworld Garden I, Sector 47, Gurugrarn 122018
Mob: 9818768349, Email: manioberoi@ gmail.com
14
IN THE MATTER OF:

Versus
... Defendants
AFFIDAVIT
I, Sarvadaman Singh Oberoi, S/o Late Capt. H.S Oberoi, aged about 73 years, Rio
1102/Tower 1 Uniworld Garden I, Sector 4 7 Gurugram, Haryana, do hereby solemnly affirm
and declare as under:-
1. That applicant is seeking exemption under Section 80 CPC being the petitioner in
the instant suit for temporary and permanent injunction under the Specific Relief Act,
1963 read with customary international law and is competent to swear this affidavit
on his own behalf.

.,~l-M~ '. That the accompanying petition, with Annexures ' Pl' to ' P 57' has been drafted by
me and the contents of the same are true and correct to my knowledge and belief and
~ ' >;\
',JfJRU ... - submissions are based upon information believed to be true.

' .-,:~
DEPONENT
VERIFICATION:
Verified, at Gurugram, on this thirteenth day of January 2022 that, to the best of my
knowledge, the contents of the aforesaid affidavit are true and correct and nothing material
has been concealed therefrom.
DEPONENT
·, -,., :c who
. . ·:" ~k.i,d &. ..
Source : Allahabad Weekly Reporter
15
ANNEXURE P-1
132 [P. C.] SECRET.ARY OF STATE v. MASK & Co. [1940
the jurisdiction of Civil Court was barred to enter-

tain a challenge of the merits of that decision,
[P, 137, c. l]
A IR 1938 Mad. 608, Revet'sed.
B.-Jurisdiction-Ex.lusion of-Must be clear-
ly implied-Even if jurisdiction of (;fril Court
excluded it may examine cases where provisions
of Act not complied with or statutory tribunal has
not acted in accordance to principles of ;udicial
procedure.
The exclusion of the jurisdiction of the Civil
Court& is not to be readily inferred but suc\.i exclu-
sion must either be explic1tly expres,ed or clearly
implied. Even if jurisdiction is so excluded, the
Civil Courts have jurisdiction to examine into cases
where the provisions or the Act have not been com-
plie i with, or the statutory tribunal has not acted in
conformity with the fundamental principles of judi-
cial procedure. [P.136, c. 2; P. 137, c. l]
C.-Government of India Act, 1925, S. 32-
LORD THANKERTON, SIR GEORGE Section does not render Ss. 188 and 191, Sea
RANKrN AND MR. ]AYAKAR. Customs Act ultra vlres o/ Indian Lstislature.
Privy Council Appeal No. 23 of 1939, Section 32 does not affect the validity of an Act
(Madras Appeal No. 179 of 1937), against of tt,e Indian Legislature which creates an obliga-
the decision dated February 2, 1938 of the tion and provides an exclusive Code for its determr-
High Court ~•f J11dicature at Madras, nati,m; such an obligation is not covered by sub-S.
reported m A IR 1938 Mad. 608. (2) of Section 32, An exclusion of the subject's
[Decided on March 15, 1940]. right of resort to Civil Courts by Ss. 1118 and 191
Sea Customs Act, is not ultra vires of the Indian
SECRETARY OF STATE Legislature. [P. 138, c. 1]
v. »-Interpretation of statute-Doubt to J,'l'oper
MASK&Co .. construction of new sect1on-Pret:io1,s law to be
consider.ed.
A.-Sea Customs Act, 1878, Ss. 188, 191-
Sections 188 and 191 J,rCXJide 1elf contained Code Where there is any doubt as to the proper co11s-
of ap~al-Orde1 of Collector of Customs confirm• truction of a new section in an Act, it "ou Id be
ed by Govt. of ltedia-Jurisdiction of Cfoil Court legitimate to consider the previous law \\ hich 1t
to entertain a ch,zllente of tlie merits of decision was c-onsolidat'ng and amending. [P. IS6, 1:. 1:
barred. H. H. Willink and W.W. K . for Appellant.
W. Wallach for Respondent.
BySs. 188 and 191 a precise and self-contained
code of appeal is provided in regard to obligations LORD THANKERTON.-The sole ques•
whkh are created by he statute itself, and it en- tion for detenmination in this appeal
ables the appeal to be carried to the supreme head is as to the jurisdiction of the Civil
of the executive Government. It is difficult to con- Courts to entertain the suit. The
ceive what further challenge of the order was in- appeal is taken from a judgment and
tended to be excluded other than a challenge in the order of the High Court of Judicature at
Civil Courts. Madras, dated 2nd FJbruary, 1938, which
set aside a decree of the Subordinate
Where the Collector of Customs dismissed an Judge at Cuddalore, dated 30th March,
appeal under S. 188 from the order of Assistant Col- 1937, (which had dismissed the respon•
lector of Castoms and his order was upheld and dents' suit on the ground of want of
confirmed by the, Government of India, hsld, that jurisdiction), and directed the Subordinate
2022-01-11 (Page 1 of 7) MANU/PR/0022/1940 SARVADAMAN OBEROI

16
A. W.R.] SECRETARY OF STAT& v. MASK & Co. [P. C.] 133

Judge to restore the suit to the file and advalorem duty to come into effect at the
to dispose of it on the merits. The beginning of 1933, they requested a
respondents are a firm of merchants, telegraphic reply, which they received on
having their head office at Panruti ir. the 29th December, 1932, saying :
Province cf Madras, and, in the course of 'Ir you desire impo rt before January first you
their business, they import betel-nuts must imp;)TI gc)\>ds and cle posit duly ca\cu\Med on
from Java into British India. The facts higher tariff value lnsre,1ur will at time of taking
deposit and passing goods take sealed sample• for
in the present suit, which was filed by the test and will at,o deliver to you other sealed
respondents on 10th April, 1934, are not sample~ to enable you appeal if necessary."
materially in dispute. The suit relates The respondents thereupon imported
to two consignmenti of betel-nuts, 1000 bags on 31st December 1932, and
imported by the respondents in December, paid the higher duty under protest to the
1932, from Java to Pondicherry by £ea, Assistant Inspector of Customs at
and thereafter by rail to Panruti. These Pondicherry Railway Chauki, samples
consignments, which originally consisted being du\y taken. Afttr examination of
of 3927 bags in all, were re-packed at the samples, the Assistant Collector of
the Port of Pondicherry, owing to damage Customs Madras, wrote to the respon•
to the g•mnies, into 4063 bags, before dents on 28th February, 1933, as
importation into British India. The
follows:
consignments were imported into the
Province of Madras by rail and carts from "l have to state that on examination of !he
samples from the con1ignm , nt in question, it has
Pondicherry to Panruti by various instal- been found that tht: betel-nuts imported • are
ments, the first of which consisted of 1000 "boiled." Tile 1000 bags c leared on illst Des;em·
bags imported through the Customs ber, 1932, are therefore assessable at !\7l per cent
Station at Pondicherry on 31st December, on a tariff valuation of Rs. 2S per cwt. and the
remaining bags, if cleared, will be liable to duty
1932. The remaining bags were imported at 45 per cent, on a tariff value of Rs. 16 per
in several instalments in the months of cwt."
February, March and November, 1933, An appeal by the respondents against
through the Customs Stations at this decision was dismissed by the Collec-
Pondicherry and Madalapet. tor of Customs on 20th June, 1932. The
It appears that prior to this occasion, matter was taken to the Government of
the respondents had been in the habit of India. in revision, but by their order dated
importing their betel-nuts at the port of 13th August, 1933, the Government of
Cuddalore in the Province of Madras, India confirmed the Collector's decision.
but, in the beginning of the year 1932, The present suit was fi.led on 10th April,
the Customs Collector at that port had 1934. In the suit the respondents seek
assessed a similar consignment of 3605 to recover the excess amount collected
bags as boiled betel-nuts subject to duty from them by levying duty upon a tariff
on a tariff value, contrary to the respon• value of Rs. 23 per cwt. upon 1000 bags
dents' contention that they should be and of Rs. 16 per cwt. upon the remain·
assessed as raw betel-nuts, subject to duty der, viz., 3063 bags instead of levying
ad valorem. Ih the hope that they might duty upon the invoice value of Rs.
achieve an assessment in accordance with 10-9-1 per cwt. In para 14 of the plaint,
their contention, the respondents altered they state that the cause of action arose
their pla:::e of importation in the case of on 18th August, 1933, when their petition
the consignments here in question but for revision to the Government of India
their disappointment in that respect has was thrown out. Various issues were
given rise to the present suit, in which framed by the Subordinate Judge, but it
they seek to challenge the adverse decision was decided to determine in the first
in a civil suit. On the arrival of the instance issue 3 :
consignments at Pondicherry, the respon- "Has this Court no jurisdiction to entertain thia
dents wrote on 27th December, 1932, to snit and i~ the suit barred by the provisions of
the Collector of Customs, Madras, asking the Sea Customs Act 1"
to_ be allowed to import the goods as raw By a judgment delivered on 30th
sliced betel-nuts and not as boiled. As March, 1937, the Subordinate Judge held
they anticipated au increase in the that the Court had no jurisdiction to

17
134 [P. C.J SECRETARY OF STATE v. MASH & Co. [1~)40

entertain the snit and dismissed the suit. if desirous of appealing against such deci1tion or
An appeal was allowed by the High ~rder shalf, ~ndlng the appeal, deposit in the
Court on 2nd February, 1938, and the hands of the Cintoms-Co!lector al the port where
the dispuk arises the amount demanded !J.y the
Subordinate Judge was dire:ted to pro- oifi~er passing such decision or order.
ceed to dispose of the suit on the merits. \Vhcn delivery of such goods to the owner there-
This appeal is from that decision. While of is v1tliheld merely by reason of such amount
the imposition of the duties here in ques- nut oeing paid, the Cllstoms-Collector shall upnn
tion is regulated by the Land Customs such <kpos1t 1:Jeiog made, cause s1tch g ,ods t<> !Je
dt:livered to such owner.
Act (Act 19 of 1924), the matter in issue
arises under certain provisions of the Sea lf upon any snch appeal it is decided that the
whole or any portion of such amount \\'as not
Customs Act (Act 8 of 1878) which are leviabJe in respect of such goods, the CustQ_rns-
incorporated subject to the necessary C ,1tector s11al! return such amount or portion (as
verbal modifications by S. 9, Land Cus- the case m ,y be) to tl1e owner or such goods on
toms Act, and the schedule to the Act. dt'm,md by such owner.
The Sections of the Sea Customs Act 190. If upon consideration of the circumstances
under which any penalty, increased rate of duty
which are material are contained in or confiscation has been adjudged under this Act
Chap. 17 of the Act which is headed by an Oflker of Customs, the Chief Authority is of
"Procedure relating to offe:1ces, appeals, opinion that such penalty, increased rate or con~
etc." and which includes Ss. 169 to 193. fisc;ition ought to be remitted in whole or iu part,
01 cummuted, such authority may remit the same or
The material Sections are as follows : any portion thereof or may with the consent of the
"182. In every case, e11-:ept those meutioned in owner of any goods ordered to be confiscated,
S. 1-67, Nos. 26, 72 and 74 to 76 O<Jlh inclusive, in commute the order of confiscation to a penally
which under this Act anything is liable to not exceeding the value of such goods
confiscation or to increase rate& of duty ;
191. The Local Government may on the appH-
or any person is li able to a penalty, catio11 ol a, ,y person aggrieved by au y decision or
such confiscation, incre,1sed rate o i d11ty or order passed under thi• Act by any Officer of Cus-
penalty m3y be adju<l ged- toms or Ci1ief Customs-Authority and from whi~fl
no appe.11 lies, reverse or modify such decision.
(a) without lirpit by a Deputy Commissi oner or
Deputy Collect,)r ol Cus:oms, or a Customs- 193. When a pena lty or increased ra te of
Collector ;" duty is adjudged aga rnst any person under this Act
such officer if such penalty or incn:,.,sed rate be not
• • • • paid, may levy the same by sale 01 a ny goods oi
"186. The ,lward of any confiscation, penally the said person which may be in his charge or in
or increased rate of duty under this Act hy an the charge of any other officer of Customs .•• "
Officer of Customs sha 11 not prevent the inflicti on
of any puni~hment to which the person affected Under S. 9, Land Customs Act, re-
therehy is liable under any other la w. ferences to a Chief Customs Officer in the
188. Any p,:rson deeming himself aggrieved Sea Customs Act are to be deemed to
by any decision or order passed by an Q,ficer of refer to a Collector of Land Customs.
Customs under this Ad ma y within three months
from the da te of such dec ision or .-order, a ppea l references to a Customs Collector to a.
therefrom 111 the Chief Customs Authority, or in Land Customs Officer ,and references
1uch cases as the Loca l Guvernment directs to any to Officers of Customs to Collectors
Officer of Custo1ns not inferior in rank to a Cus. of Land Customs or land Customs
toms-Collector and empowered in tha t behalf b
name or in virtue of his office by the Local Gov.:rn- Officers. Further, by S. 4, Central
ment. Board of Revenue Act (Act 4
Such authority or oflker may thereupon make of 1924), the Governor-General in
such further enquiry and pass such order as he Council was substituted for the Local
thinks fit, confirming, altering or annulling the Government in S. 191, Sea Customs
decision or order appealed against : Act.
Provided that no such order in appeal shall haYe
the effect of subjecting any per.on to any greater At the hearing before the Board, the
confiscation, penalty or rate of duty than has beenappellant maintained that the decision
adiudged against him in the original dedsiun or
of the Assistant Collector of Customs,
order.
dated 28th February, 1933, was a.
Every order passed in appeal under this Section
"decision or order passed by an Officer
shall, subject to the power of revision conferred by
Section 191 be fina I. of Customs" within the meaning of S.
188, Sea Customs Act, and that the deci-
189. Where the decision or order appealed
against relates to any duty or penalty leviable in sion of the Collector of Customs on
respect of ~ny goods, the owner of such .goods, ,appeal therefrom, datei 20th June. 1933,

18
A, W.R.] SECRETARY OF ST.A.TE v. MASK & Co. [P, C.] 13S

which had been confirmed on revision and his judgment does not suggest any
under S. 191 was final, and excluded the doubt of the applicability of S. 188.
jurisdiction of the Civil Courts. He But it was raised in the High Court, who
maintained that the only right of chal- decided it in favour of the appellant.
lenge of a decision or order by an officer Their Lordships are of opinion that the
of Customs was by an appeal under S. H.igh Court were right in deciding
188 and that the jurisdiction of the Civil that S. 188 is applicable. The words
Courts was excluded. Alternatively, he "decision or order" are wide words,
maintained that the right of appeal con- and they appear to be of a more general
ferred by S. 188 constituted a procedure nature than the adjudications referred to
which was alternative to procedure in the in S. 182, which are also referred to as
Civil Courts and that as the respondents, awards in S. 136. The difference of
in their option, had chosca to proceed language in Sections which are in such
under S. 188 they were bound by that close juxtaposition primarily sugge!lts an
election and were thus excluded from intention to cover a wider area in S. 188.
resort to the Civil Courts. It is suggested that the heading of the
There can be little doubt that adjudi- Chapter-Procedure relating to Offences,
cations as to confiscations, increased Appeals, etc." -rather indicates that the
rates of duty or penalties made under appeals are co-related with the offences.
the power conferred by S. 182 are deci- Their Lordships are unable to draw any
sions or orders within the meaning of such inference. The chapter is one
S. 188 and the appellant submitted in the relating to procedure and not a chapter
first place that the decision of the Assis- relating to offences ; indeed, it might
tant CoUector in the present case was an be suggested that if the p1ov1s1ons
adjudication as to increased rate of duty as to appeals were merely pirt of the
under S. 182. In their Lordships' opinion procedure relating to offences, there
this contention is untenable, as would be no occasion for a separate
the decision was as to the normal mention of appeals in the heading. But,
rate of duty, whereas an increased in their Lordships' opinion the heading of
rate of duty connotes something the chapter is of no material assistance
in the nature of a penalty an illustration in the construction of S. 188.
of which is to be found in S. 167, No. 35 , In the next place the proviso in S.
where goods in excess of the manifest 188, which is limited to adjudications
or not corresponding with the specifica• under S. 182, does not, in the opinion of
tion are liable to confiscation or to be their Lordships, necessarily involve the
charged with such increased rates of narrower construction of the opening
duty as the Chief Officer of Customs words of the section. If the latter had
directs. expressly referred to any decision or order
The appellant next maintained that under S. 182 or any other Section in the
the decision or order referred to in S. 188 Act, the proviso would have been drawn
was not confined to adjudications under in exactly the same terms. But S. 189
S. 182, but included decis ions by an ases terms naturally applicable to any
officer of Customs as to the rate of duty leviable under any part of the Act.
duty applicable to particular goods, Their Lordships agree with the High
which necessarily involved the determina- Court that there is no reason for limiting
tion of the particular category in the the words "any decision or order passed
tariff classification into which the goods ...... under this Act'' in S. 188 to decisions
fell, and that, accordingly the decision or orders passed under S. 182. Their
of the Assistant Collector in this case Lordships are unable to agree with the
was a decision or order within the somewhat tentative opinion expressed by
rneaning of S. 188. The respondents on Sir Charles Innes in Hari Bhanji v.
the other hand, maintained that the Secretary of State(}), at p. 353, which is
decisions or orders referred to in S. I 88 referred to by the High Court. That
related only to adjudications under S. 182. opinion was not relevant to the case be-
This argument of the respondents was fore the learned Jud{le, which related to
not mentioned by the Subordinate judge, '(1882) ~ Mad. SH,

19
136 [P. C.J SECRETARY OF STATE v. MASK & Co. [1940

an iIIegal levy of duty under the Act of Government. It shall thereupon be lawful for euc!J
1863. The Sea Customs Act, 1878, was authority or superior o'ncer to m.i.ke such further
passed to consolidate and amend the law e,iquiry, 11nd ta pass such order as he shall think
proper, confirming, altering or annulling the ori-
relating to the levy of Sea Customs duties ginal award. Provided that no such order in appeal
which was then regulated by the Con- shall have the effect of subjecting any person to
solidated Customs Act (Act 6 of I8fr3), any greater confiscation, penalty, or rates of duty
than shal I have been adjudged against him in the
which was repealed by the Act of 1878. If original award.
there were any doubt as to the proper
construction of S. 188 of the I 878 Act, CCXXI. The award ol any confiscation, penalty
or increased rates of duty under this Act by ao
it would undoubtedly be legitimate to con- Officer oi Customs shall 1,ot interfere with any
sider the previous law which it was punishment to which the person affected thereby
consolidating and amending, and their s:1,1l1 be liable under any other law.
Lordships desire to add that their view CCXXlll. If, upon consideration of the circum.
already expressed as to the construction of stances under which any pen~lty or confiscation
S. 188 is confirmed by a consideration of has been adjudged under this Act, by an Officer of
the provisions of the Act of 1853. The Customs or by a Magistrate, the- Chief Custo:ns
Authority of the Presidency or place shall be of
material provi,ions of the latter Act are opinion that such penalty or confiscation ought to
as follows: be reimtted in whole or in part, or commuted,
such Chi,~f Customs Authority may remit the same
"VI. If any dispute shall arise between any or any porti~n thereof, or may commute any order
officer of customs and any master or comm:mder of contisc~tion to a penalty not exceeding the value
of a vessel, or importer, exporter, ow11er, or of the goods ordered to be confiscated "
c,1nsignee of goods, or agent, or other person,
in respect to any matter (not specially provided for
by any law for the time bei11g i11 force) relating Section 6 appears under the beading
lo the importation, exportation, or warehousing of "General Rules;" S. 184 under
of any goad's, or to the tevy of any dilly or penalty "Miscellaneous Provisions;" and the other
thereon, or to auy seizure or rorftiture thereof, four Sections under "Offences and
the Chief Customs Anthority of t11e Presidency or
place in which su,;IKljsputes shall have a~1se11 sh.ill Penalties." In their Lordships' opinion, it
settle the same subject to an appeal to the Loe,,! is clear that the provisions of S. 6 and of
Government, acting under the general instructiuns S. 220 are both now incorporated in S.
ol the Governor-G.'t:neral of India in Council." 188 of the later Act, the subject matter
°CLXXXIV. If any dispute shall arise as to of the a vpeal being altered from an
the proper rate of duty payable in respect of any
goods imported into, or exported from, any port in "award" to a "decision or order," and
British India. the importer, exporter, owner, or con- the ht:ading of the chapter being altered
signee ot such go,Jds, or his agent, sha 11 devosit to "Procedure relating to Offences.
in the hands of the officer in charge of the Custom Appeals, etc." S. 184 of the 1863 Act,
House at the port of importation or exportation
respectively, the amoullt of duty demanded by such is reproduced in S. 189, while S. 221
officer, pending the dedsion of the Chief Customs is reproduced as S. 186 of the 1878
Authority, Upon payment of such deposit and Act, before S. 188 and S. 223 reappears
compliance with the pruvi~i ons ol th is Act relatiug as S. 190 of the later Act. The decision
to the entry ol such goods, the officer in charge of the Assistant Collector therefore
of the Custom H()uSe shall cause the goods to be
deliver~d to such importer, exporter, owner, nr falls within the terms of S. 188, Sea
consignee, or his agent. Customs Act of 1878, and the respon-
CCXVlll. 111 evo:ry case in which, under
dents in fact acted on that view, and
this Act, any vessel, <.an, or other mt an, of con- exercised the right of appeal conferred by
veyance, or :my !1orse or other animal is liable to that section and by S. 191. It is now ne-
confiscation; or a.ny goods are liaole lo confiscation cessary to determine whether the order of
or to increased rates of duty; or any person in the Collector of Customs, dated 20th June,
charge of or ow~ing a vessel, or landing or ship-
ping goods, or passmg them through the Custom 1933, which dismissed the appeal under
House, is liable to a penalty, an officer in charge of S. 188, and which was confirmed by the
a Custom House may, unless it be othdwise pro- Governor-General in Council on an
vided in this or any other Act relating to the cus.. application under S. 191, excludes the
toms, adjudge such confiscation, penalty, or in-
creased ratn of duty. jurisdiction of the Civil Courts to
entertain a challenge of the merits of
CCXX. In any case adjudicated by an officer of that decision. It is settled law that the
customs any party aggrie"ed by the award may
appeal to the Chief Customs Authority of the Pre- exclusion of the jurisdiction of the Civil
sidency or place, or to any superior offict:r of Courts is .not to be·readily inferred, but
~ustoms empowt:red m that behalf by the Loc<1l that such exclusion must either be

20
A. W.R.] SECRETARY OF STATE v. MASK & Co. [P. c.] 137

explicitly expressed or clearly implied. Courts. Their Lordships are unable to
It is also well settled that even if juris- agree with this distinction. Their U>rd·
diction is so excluded, the Livil Courts ships are of opinion that in this case
have jurisdiction to examine into cases the jurisdiction on the Civil Courts is
where the provisions of the Act have excluded by the order of the Collector of
not been complied with, or the statutory Customs on the appeal under S. 188,
tribunal has not acted in conformity with and it is unnecessary to consider whether,
the fundamental principles of judicia 1 prior to taking such appeal under S. 188
procedure, Many of the cases rderred the respondents would have been entitled
to in the judgments below are of this to resort to the Civil Courts, or whether
nature, and are not relevant to the they would have been confined to the
present case, in which ther-e are no right of appeal under S~ 188.
allegatians of that nature. S. 188 The determination of- this question
provides that must rest on the terms of the particular
"every order passed in appeal under this Section statute which is under consideration, and
-ahall, subject t,) the power of revision conferred decisions on other statutory provisions
by S. 191, be final." are not of material assistance, except
By Ss. 188 and 191 a precise and in so far as general principles of construc-
self-contained code of appeal is provided tion are laid down. The ma_aprinciples
in regard to cbligations which are created to be observed in the present't:ase are to
by the statute itself, and it enables the be found in the well-known judgment of
appeal to be carried to the supreme head Willes J. in Wolverhampton New Water-
of the executive Government. It is works Co. v. Hawkesford(2), at p. 356,
difficult to conceive what further which was approved of in the House of
challenge of the order was intended to Lords in Neville v. London Express News-
be excluded other than a challenge in paper Limited(3). The question is whe¢er
the Civil Courts. Further, it is to be the present case falls under the third chss
noted that the same finality clause stated by Willes J., viz.:
applies equally to appeals against "Where the statute creates a liability not
adjudications under S. 182 and to appeals existing at common law, and gives a1!10 a particular
a~ainst decisions or ordeti; as to the rate remedy for en ' orcing it ...... With respect to that
of duty levia.ble under the tariff ; their class it has at-vays been held that . the part'Y must
ad ,pt tht: form of remedy given by the statute."
Lordships are unable to construe this
clause differently according as it applies It has been held that the jurisdiction
to these two classes of appeals, as of the Civil Courts is excluded in three
apparently the High Court. were prepared cases in which an appeal under S. 188
to do. In their judgment the High Court had been taken-C. S. No. 747 of 1920,
refer with approval to the unreported already reforred to, Bhiwandiwala and
decision of Coutts-Trotter J., in C. S. Co. v. Secretary of State (4), which is
No. 747 of 1920, in which he held that referred to by the High Court, and Thil!-
the suit, which challenged the adjudica- Yien v. Secretary of State(5). Each of
tion of a fine under S. 182, was barred by these cases related to an appeal against
S. 1-88, and the learned Judges add : an adjudication under S. 182. • In the case
"We think that the decision in that case is, if we referred to in 71 M. L. J. Notes of Recent
ma'Y sa'Y so, not open to exception and it does not Cases, p. 40, Varadachariar J., held that
help the Government in this case, because the act of jurisdiction was not excluded in circum•
the Cu,tums Authorities in that case was an stances similar to the present case, except
adjudication " that there had been no appeal under
Later the learned Judges rejected the S. 188, and for the reasons already ex•
argument that S. 188 only applies to plained, their lordships do not find it
decisions or orders passed by Customs
Authorities when acting under S. 182, and • (1859) 6 CB (NS) 336 : 28 L J C P 2!2:
held that the opening words of S. 188 7 WR 464.
were not so limited. Nevertheless, they 9 (1919) AC 368 : 120 LT 299: S5 TL R 167.
held, as regards the present case, that 4 A I R 1937 Mad 536.
the finality clause was not so worded as 11 A I R 1939 Cal 763 : I L R 1939 Cal 2/i7 : '3
to exclude the jurisdiction of the Civil CWN H5.

21
138 [P. C.] SULEMA.N HAJI v. ABDULLA HAJI [1940

necessary to consider the question. Simi-
larly, in Vacuum Oil Co. v. Secretary of
State (6), and Ford Motor Co. of India
Ltd. v. Secretary of State (7), no appeal
bad been taken under S. 188; the question
of jurisdiction was not in issue, though
in the former case an issue had been
framed, but it was abandoned by the
Advocate General. It was submitted on
behalf of the respondents that an exclu-
sion of the sub_ject's right of resort to the
Civil Courts would be ultra vires of the
Indian Legislature in view of the provi'.•
sions of S. 32, Government.of India Act,
1915, which re-enacted S. 65, Govern-
ment of India A.ct of 1858, and reference
was made to Secretary oj State v.
Moment, J. (8), which was a caseof tor-
tious treSij/;\~S on land. But, in their
Lordship's •opinion, neither Sec. 32 nor
the principle involved in the de::ision in
Secretary of State v. Mmient, J. (8), attect
the validity of an Act of the Indian Le.;:is-
lature which creates an obligation and
provides an exclusive Cade for its deter-
mination; such an obligation is not
covered by sub-S. (2) of Section 32.
On the whole matter, their Lordships
are of opinion that the decision of the
Subordinate Judge was correct, and they
will humbly advise His Majesty that the
appeal should be allowed, that the order
of the High Court should be set aside and
that the decree of the Subordinate
Judge should be restored. The appellant
will have the costs of the appeal, and
also his costs in the High Court.
Appeal allowed.
Solicitors :-India Office for Appellant;
Lambert and White for Respondents.
e A l R 1932 P C l i;s : 1\9 I A 2f>8 : li6 Bom 313
(P • .fl 1 R 19l\8 PC 15: 1938 AW R (P C) 23: 65

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ANNEXURE P-2
572 SUPREME COURT OABES (1979) 1 sec

is only one year. The appellant is a young man and comes from a
respectable family and had made a very candid confession before the
Court in pleading guilty. In these circumstances, we therefore do not
think that any deterrent sentence is called for. We would, therefore,
uphold the conviction of the appellant under Section 28 but give the
sentence till the rising of the Court which he has already undergone.
The appellant will now be released forthwith. The sentence of a fine
of Rs . 200 will be maintained under Section 28 and not under Section
27(a)(i). The fine, if not paid, shall be paid within a month from today.
Accordingly, the appeal is allowed in part.
(1979) 1 Supreme Court Cases 572

(BEFORE V. R. KRISHNA lYEK AND R. s. PATHAK, JJ .)
Civil Appeal No. 2297 of 1978t
STATE OF KERALA Appellant ;
Versus
KUMARI T. P. ROSHANA AND ANOTHER Respondents.
AND
Writ Petition (Civil) No. 4705 of 1978-1:
M. SALEENA Petitioner :
Versus
STATE OF KERALA AND ANOTHER Respondents.
Civil Appeal No. 2297 of 1978 and Writ Petition No. 4705 of 1978,
decided on January 17, 1979
Constitution of India - Artide 1.,4 - Minor differentiation not
covered - Admission to professional courses - Selection based on com-
parison of marks obtained by candidates in the qualifying examination
conducted by different Universities with different ~ards, question papers
and set of examiners, held, not so discriminatory as to violate Article 14 -
No pronounced inequality is produced between Umvel'Sities in the saae
State to justify invocation of Article 14 - Minute and microcosmic classifica-
tions to be avoided
The question was whether there was any discrimination involved in
attributing parity to marks of examinees in the pre-degree and degree
courses of the Calicut University with those of the Kerala University for
the purposes of the combined selection for admission to the four medical
colleges affiliated to these Universities. The High Court upheld the plea
of discrimination. On appeal by the State, the Supreme Court
Held:
Fleeting factors or ephemeral differences cannot be the solid foundation
for a substantial differentiation which is the necessary pre-condition for
4;-i.\ppcal by Special Leave from the Judgment and Order daterl '.'lovember 13, 1978 of
the Kerala High-Court in 0 . P. 3239_of _1978.
+Under Article 32 of the Constltutton.
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STATE OF KERALA V. T. P. R.OSHANA 573
quashing an executive or legislative act as too discriminat ory to satisfy the

egalitarian essence of Article 14. (Para 17)
T~ere is no such substantial difference in the pre-degree courses and
evaluation between the sister universities within the same State that the
breach of Arti~le 14 by equ~l tr~~tment of the marks unequally secured
by e~anun~s m . t~e two umvers1ttes may be spelt out. Every inconse-
quential differentiat ion between two things does not constitute the vice
of _discrimina~ion, if law clubs them together ignoring venial variances.
Article 14 ts not a voodoo which visits with invalidatio n every
e:xecutive or legislative fusion of things or categories where there are
no pronounced . inequalities . Mathemati cal equality is not the touchstone
of constitution ality. (Para 15)
State of Jammu a1td Kas/imir v. Trilolci Nat/i Khosa, (1974) l SCC 19, 42: 1974 SCC (L & S)
49, followed
The present case does not show factual disparities to reach the result
of substantial difference in the syllabi, in the pattern of examinatio ns,
in the marking systems or in the choice of the examiners so as to
warrant invalidatio n on account of equal regard being accorded to the
marks secured by the examinees from the two universities . The vagarious
element in marking and moderation of marks may be a fact of life, but
too marginal to qualify for substantial difference unless otherwise made
out. (Paras 15 and l 7)
Constitution of India - Articles 14 and 15(4) - University-wise
allocation of seats in admission to medical colleges within the State is
non-discriminatory - However, relating such allocation to the number of:
candidates registered in the qualifying courses in the different universities,
held, would put backwBl'd areas at a disadvanta ge and therefore violate
Article 14
Constitution of India - Articles 32, 136 and 226 - Courts on finding
illegality should -not only strike down the impugned action but also give
suitable remedial directions - Events which have already taken place however
not to be ignored - Practice and procedure (Paras 3, 14, 37 and 43)
Constitution of India - Articles 32 and 226 - Benefit of reliefs
gnmted by Court may be extended to those affected persons who did not
move the Court (Para 42)
While long term measures to bring parity between the courses and
marking at the Calicut and Kerala Universitie s were being planned, as a
short term measure the Governmen t devised a scheme of university-wise
allocation of seats, subject however to the ratio of the candidates registered
for the pre-degree and B . Sc. course in the two universities. This affected
students of Calicut University since because of the educationa l backwardn ess
of the Malabar area the number of colleges was less and the enrolment
poor. The High Court found such a scheme discriminat ory. Upholding
that verdict the Supreme Court
Held:
There is no nexus between the registered student-stre ngth and the
seats to be allotted. The fewer the colleges, the fewer the pre-degree
or degree students. And so, the linkage of t~e d_ivisio~ of se~ts with
the registered student-stre ngth would make an irrational mroad mto the
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574 SUPREME COURT CASES (1979) 1 sec
university-w ise allocation. Such a formula would be a punishmen t for

backwardn ess, not a promotion of their advanceme nt. (Para 28)
D. N. Cha,u;hala v. State of Mysar,, (1971) 2 SCC 293, followed
Chitra Ghosh v. Union of India, (1969) 2 SCC 228: (1970) I SCR 413, r,ferr,d to
The Calicut University has been deprived a quota of 30 admissions.
The State Governmen t is directed to admit 30 more students from Calicut
University who fulfil the prescribed qualifications, without affecting the
extra admissions made of Kerala University students. The benefit wil!
extend even to students not party to these proceeding s before the
Court. (Paras 41 and 42)
(The Court also directed the Universitie s to complete within a fixed
date the unification of syllabi and methodolog y of examinatio ns.) (Para 44)
Constitutio n of India - Articles 14 and 32 - Disabninatioo must

be founded on hard facts and not surmises (Paras 15 and 17)
Constitutio n of India - Article 15(4) - Reservation based on
geographical dassification of backward regions is pennissible under -
Reservation in respect of Malabar area in the State of Kerala, dJerefOl'e,
permissl"ble (PBl'R 11)
State of Kera/a v . Rafla Rahim, 1!)78 KLT 369 and State of Kera/a v. R. Jacob Mathew , 1964
KLT 298 : AIR 1964 Ker 316, app,ov,d
M/4183/C
Advocates who appear,d in this cos, :
.M. M. Abdul Khader, Advocate General of Kerala (V. J. Francis and Mustafa K. Rowt,r,
Advocates, with him), for the Appellant in C. A. 2297 of 1978 and Respondents in W. P.
4705 of 1978;
P. V. Govindan Nair, Senior Advocate (.N. su,hakaran and Mrs. Baby Krishnan, Advocates,
with him), for the Petitioner in W. P. 4705 of 1978 and Respondent I in C. A. 2297 of
1978;
Dr. V. A. Styid Muhammad, Senior Advocate (S. K. Mehta, P. K. Shamsiuddin, P. N. Puri and
E. M. Sadrul, Advocates, with him), for the lnterveners;
A. S. Nambiar, Advocate, for Respondent 3 in C. A. 2297 of 1978.
The Judgment of the Court was delivered by

Krishna Iyer, J.-The dynamics of the writ jurisdiction and the
potential for affirmative court action, as part of remedial jurispruden ce.
constitute the key thought which animates the ultimate decision and
direction we give in this couple of cases which have come up by Special
Leave and under Article 32 to this Court, aware as we are of a host
of like proceeding s which pend in the High Court.
2. The State of Kerala is the appellant in the civil appeal and

respondent 1 in the writ petition, but the collective litigation springs from
a traditional type of action and typical kind of relief granted in exercise
of its writ iurisdiction by the High Court striking down a transitory scheme
of admission to the medical colleges of the State evolved by the Govern-
ment but invalidated by the High Court on the ground of discriminat ion
in the distribution of seats among the eligible students drawn from two
disparate regions of the State. Of course, the instant repercussio n of
the decision is apt to be confusion in the admission to the academic courses
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STA.TE OF K.ERALA. v. T. P. R.OSHANA. (Krishna lye,-, J.) 575
which have hardly commenced and this desperate situation has driven the
Government to this Court seeking reversal of the Judgment under appeal.
Law promotes order, not anomie.
3. Any incisive study of the exercise of the writ power in India
may reveal that it limits its action to quashing or nullifying orders pro-
ceeding on a violation of law, but stops short of a reconstruction whereby
a valid scheme may replace a void project. This is no reflection on
the High Court's ruling but is symptomatic of an obsolescent aspect of
the judicial process, its remedial shortcomings in practice and the need
to innovate the means, to widen the base and to organise the reliefs so
that the court actualises social justice even as it inhibits injustice. This
community perspective of the Justice System explains why we have resorted
to certain unusual directions and have shaped the ultimate complex of
orders in these proceedings in a self-acting package. With this exordium
we proceed to narrate briefly the necessary facts and developments revelatorv
of the course of events and the cau·se of action, the impact of the High
Court's judgment and the compul,;ions which have brought the State in
appeal to this Court.
4. The Kerala State, notwithstandinJ? its strikin~ demographic, cultural,
linguistic and political integralitv and educational advance, has certain
historical hangovers of academic disparity and developmental maldistribution
which have survived for two decades as this case testifies. We are not
concerned with the etiological enquiry into this ma1adv but recognic;e it
as a reality since the authentic materials from Commission reports and
prior rulings of the Hi,rh Court concurrently so establish. Broadly speak-
ing. this 'composite' State may be dichotomised as Travancore-Cochin
and Malabar regions woven into one fabric by the States Reorganisation
Act. 1956. Gaping disparities of development cannot be wished away
by political fusion into one State and determined efforts at equalisation of
human condtions, economic and cultur;al, alone lend living validity to
geo-political homogeneity. Malabar being admittedly laggard in the
educational field, the State endeavoured to wipe out this weakness bv
startinj! or supporting new colleges in this neglected segment ; and one
such institution was the medical collel!:e at Calicut. Indeed, the drive
to upgrade the educational status of this backward region persuaded the
State to set up the Calicut University to which were affiliated all the
colleges in that Cinderella area. including the Calicut Medical College.
An adjoining district, Trichur, was also tacked on, for convenience, maybe.
S. The cynosure of attention in this litij!ation is the scheme of
admission to medical colleges in the State ; and so we may adjust the
forensic lens to focus on the struggle for s~ats in the four medical coJleges
in the State - all run by Government but providing for five hundred
and odd students, as against several thousands of applicants. This
'musical chair' situation naturally led to many qualified claimants being
reiected and litigative adventures being inaugurated on grounds of dis-
crimination. One such writ petition having been allowed, the State has,
by special ]eave, come up in appeal . The points raised in the writ
petition under Article 32 are identical.
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6. A sensitive appreciation of the grievance successfully ventilated
by the· writ petitioners in the High Court is possible only if we unfold
a fuller conspectus of the facts. Cognizance of some essential circumstances
is necessitous as the first step. There are three Universities in the State
but we are concerned only with two - the Kerala and the Calicut
Universities - to which the four medical colleges are affiliated, three of
which are under the jurisdiction of the first and the fourth under the
latter. Broadly speaking, the latter caters to the academic requirements
of the Malabar segment plus a neighbouring district and the former to the
rest of the State.
7. The Malabar area bas been regarded as notoriously backward

from the point of view of collegiate education, so much so, the number
of colleges which provide pre-degree courses necessary by way of qualifica-
tion for entrance into the medical colleges, are relatively fewer and, on the
contrary, the remaining part of the State, thanks to many factors, has
been on a higher level. with colleges more numerous and pre-degree students
more prolific. Geographic justice, a component of social justice, has to take
note of these comparative imbalances. Righly, therefore, the State
Government, based on certain reports of Commissions, considered the two
territorial divisions as separate units and regulated seat allocations to
medical colleges in the State on an equitable basis. The social thrust
of the classification, based on geographical dissimilarities, was the core
factor in formulation of that scheme of admissions. This principle found
favour with the High Court in its Full Bench ruling in Rafia Rahim's
case• . While, over the years, amelioration produced by State Plans has
reduced the degree of backwardness, the fact remains that substantial
efJualisation of opportunities between the two areas is a "consummation
devoutly to be wished". We agree with the High Court that
in considering- the question of the educational backwardnes~ of
a particular class of people, or a particular tract of territory of this
State, we cannot forget that the evolution of human society and
its march from backwardness to progress must essentially be a slow
and gradual process. It is not as if, by a Governmental or executive
fiat , a class of people or a bit of territory bas been condemned to
backwardness, and with the lifting of the ban by efflux of time or
otherwise, they automatically spring back into a progressive or forward
class of people or tract. It is useful to recall the observations made
by this Court in State of Kerala v. Jacob Mathew 2 :
9. In these regions of human life and values the clear-
cut distinctions of cause and effect merge into each other. Social
backwardness contributes to educational backwardness ; educa-
tional backwardness perpetuates social backwardness, and botb
are often no more than the inevitable corrolaries of the extremes of
poverty and the deadening weight of custom and tradition. 2 •
8. If we may add, chronic social disability cannot be amenable to
1. State of Kerala v, Rafla Rahim, 1978 2. 1964 KLT 298: AIR 1964 Ker 316
KLT 369 2a. 1978 KLT 369, 387
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STATE OF KERALA v. T. P. ROSHANA (Krishna Iyer, J.) 577
instant administrative surgery and law shall not bury its head,, o'itrich
fashion, in the sands of fiction and assume equality where the opposite
is the reality.
9. The rule of law runs close to the rule of life and where societal
life, as between one part of the State and another, is the victim of die-
hard disparities the constitutional mandate of equal justice under the law
responds to it pragmatically and permits classification geared to eventual
equalisation. We, therefore, agree with the High Court that current con-
ditions warrant the classification of the student community on the zonal
basis - not as a legitimation of endless perpetuation but as a transient
panacea for a geo-human handicap which the State must actively strive
to undo.
10. In Kerala, as in some other States, reservation policies of
Governments and 'eaual protection' pronouncements of courts have chased
each other. A happy harmony among: the great instrumentalities for
accomplishment of constitutional goals by complementary action is the
desideratum for developing countries. if we may say so respectfully.
11. The principle of reservation with weil!htal!:e for the geol!Taphical
area of the Malabar District bas our approval in endorsement of the view
of the High Court. An earlier decisio~ of the Kerala Hij!h Court8 j!&Ve
rise to a Commission appointed to recommend which sections of the
people required specia! treatment under Article 15(4) of the Constitu-
tion, having regard to their social and educational conditions. That
Commission, inter alia ' accel:>ted the educational backwardness of the
Malabar area and recommended eauitable allocation of seats on that footing.
Substantially foundinl!: itself on these recpmmendations but modifving them
in same measure. Government hammered out a formula, a basic feature
of which was poolinl!: toQ:ether the applications for admission to the four
medical colle1:?;es in the State in one consolidated list and selecting students
for medical courses l'trictlv acco:-din!Z to the marks secured - of course,
making allowance for seats reserved for a limited percentaQ'e of students
from outside 311d the customarv bonus of reservation of seats for Schednled
Castes, Scheduled Tribes and backward classes. This part of the 'selection
calculus' is bevond cavil before us, a,;; the nation with all its social encineer-
ing boasts and all its tumultuous bungling, is di<:tances awav from human
justice through human ,law. The ·rough and tumble of academic life,
based on the Pooling System seemed to run smooth for some' vears, when
a new attack was mounted on it in the Hfoh Court with com:titutional
artillery from the inexhaustible armourv of Article 14. A Full Bench
hit the scheme fatallv this time. not with the familiar but fruitless archery
of ~e~phical discrimination but with the weaponry of 'reverse dis-
crimination' in a different manifestation.
12. The strategv of attack was neatly expressed by the. learned
Single Jud_Q'e whose iud!!ment on this point was endorsed. bv the Full
Bench. Discrimination was discovered by the Court in attributing parity
3. State of Kerala v. Jacob Mathew, 1964 KLT 298: AIR 1964 Ker 316
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578 SUPREME· COUR.T CASES (1979) 1 sec
to the marks of examinees in pre-degree and degree courses of the Calicut

University with those of the candidates of the Kerala University. The
Full Bench framed the question, tell-tale fashion :
The question is not whether one University is superior to the
other or maintains higher standards in the matter of syllabus, examina-
tion and evaluation than the other, but whether the operation of
different Universities with varying standards of their own is productive
of inequality.'
13. The descriptive presentation of this discriminatory facet was

given by -the learned Single Judge in the same case:
To compare the marks obtained by students of two different
Universities valued by different examiners on answer papers or.
different patterns may not be the pro0er mode of determining com~
parative merit. Even in the case of candidates appearing for the
same examination in the same university there may be a cause for
complaint in the matter of marks awarded to the candidates. Quite
often revaluation has shown that at least in some cases there is
justification for the plea for such revaluation. Different examiners
value the answer papers and though there is a Chief Examiner bis
role is quite limited. But these are inevitable and the marginal errors
may have to be ignored. By and large the comparative merits of the
candidates will be reflected in the marks they obtain in the examina-
tion to which all candidates are uniformly subjected. But the
same could not be said in the case of examinations conducted by
two or more Universities. It is well-known that sometimes question
papers are tough and sometimes valuation is liberal. Quite often
valuation is midf"d by ~he percentage of pass expected in an examina-
tion. Moderation is also resorted to. While all these may work
uniformly on all the candidates appearing for the same examination
in the same Univer~ity that could not be the case with regard to the
candidates a-ppearing for the same qualifving examination from another
University writing different papers, which are valued by a different
set of examiners. When comparison is betweeu two candidates
passing out from two Universities taking respective examinations or.
the Univer,;ities the education of candidates in matters where near-
accuracy is called for becomes difficult. Maybe the examinations are
similar and the valuation also is similar, but the other factors cannot
be ruled out. If admissions to courses like medicine and en~neer-
ing are to be on the basis that the best talent is to be preferred,
where students from more than one University passing the qualifying
examination have to compete, some method other than comparing
their marks should be devised to determine their comparative talent.•
The Full Bench agreed with this anathematization of equal treatment of
'unequals' and voided the Selection Process. The Court, with helpful
realism, concluded by adding a positive guideline to the declaration of
4. 1978 KLT 369, 375 5. Ibid. 371-72

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nullidcation:
As a result of our discussion, we are of the opm1on, that the
scheme of selection of admission to the Medical Colleges on an
assessment of merit of students drawn from different Universities with
no uniformity of standards is objectionable and violative of Article 14
of the Constitution. We grant a declaration to the writ-petitioner
to that effect. We deny effective relief to the writ-petitioner on account
of non-joinder of the selected candidates, and the futility and
ineffectiveness of upsetting the selections and directing fresh admission
at this stage. We consider that the best scheme of selection in the
circumstances would be the method of selection of candidates by
holding a uniform Entrance Examination to secure uniformity of
standards, as recommended. by the Indian Medical Council - vido
Bxs. PS and PS - and as endorsed by the University authorities
(vide Ex. P7) We direct the State Government to forthwith devise
a scheme of selection by holding such an Entrance Examination and
publish the same within three months from today, so that the candidates
wishing to apply for selection to the Medical Colleges of this State
for the next academic year, have due notice of the scheme of selection.
The object being to secure uniformity of standards for assessment
and evahiation of students drawn from different Universities, our
direction should not be lHlderstood ac.; unalterably and inelastically
fixing the limits for Governmental action. Methods for securing
uniformity of syllabus, pattern of examination, and mode of evaluation
in the different Universities, would well be within the province of
the Government to undertake. We allow this writ appeal to the
limited extent inrucated above. 8
14. ln the end, the writ-petitioner won the battle but lost the war,
for she got an abstract declaration that her exclusion was invalid but
was denied the concrete direction to be admitted into the college.
15. We are not impressed much with the surmise which colours the
reasoning of the Full Bench and the learned Sinele Judge that there is
such substantial difference in the pre-degree courses and evaluations between
the sister universitie~ within the same State that the breach of Article 14
by eoua] treatment of the marks unequallv secnred by examinees in the
two universities mav be spelt out. Tt is trite faw that every inconseauential
differentiation between two thin{tS does not constitute the vice of discrimina-
tion, if law clubs them together ignorine; venial variances. Article 14
is not a voodoo which visits with invalidation every executive or Je2Mative
fusion. of things or cate!!ories where there are no pronounced ineaua1ities.
Mathematical equality i!: not the touchstone of constitutionality. This Court
in Triloki Nath Khosn 7 cautioned:
Mini-classlfications based on micr(}-distinctions are false to our
egalitarian faith and only substantial and stra1ghtforward classifications
6. 1978 KLT S82

7, Stll.u of J. and K. \'. Trilolti Nath l'ihou1 , (19'741 l SCC' l~ . 42 · J<i74 ~CC' (I &S) 49
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580 SUPREME COURT OASES (1979) 1 see
plainly promoting relevant goals can have constitutional validity.

To overdo classification is to undo equality.
In the same ruling there was a caveat entered by Chandrachud, J. (as he
then was) against "a charter for making minute and microcosmic classifica-
tions". What is more, a large latitude is allowed in this area to the
State to classify or declassify based on diverse considerations of relevant
pragmatism, and the judiciary should not "rush in" where the executive
warily treads. The core question is whether there is such substantial
differentiation between the two universities in regard to the pre-degree or degree
courses and syst~m of examinations as too glaring to imperil the equal
protection clause. The presumption is in favour of the vires of legislative
and executive action where Article 14 is the basis of challenge. We see
no factual disparities disclosed in the Full Bench ruling to reach the
result of substantial diffetence in the syllabi, in the pattern of examinations,
in the marking systems or in the choice of the examiners so as to
warrant invalidation on account of equal regard being accorded to the
marks secured by the examinees from the two universities. We cannot
forget that many colleges are run by the State or institutional managements
where pre-degree or degree courses are undertaken. The teachers move
from one university jurisdiction to the other the teaching material is
inevitably of a like nature ; the subiects taught must ordinarily be alike.
The examiners are usually drawn from within the State or neighbouring
States. Even the composition of the academic bodies in the two universities
may have common members. The Universitv Acts themselves are substan-
tially similar. To surmise discrimination from possibilities is alien to
the forensic process in the absence of hard facts .• We are aware that
there are Universities and Universities, that gross divergences among them
exist affecting the quality of the teaching and the marking, the anomalies
of grading and the absurdity of equating the end products on the blind
ass.umption that the same marks mean the same excellence. But not glib
surmises but solid facts supply the sinews of discriminatory inequality or
equality. Going by vague reports, some backward universities and colleges
have degenerated into degree-dealers bringing rapid discredit to Indian
academic status.
16. The Indian Medical Council Act, 1956 has constituted the
Medical Council of India as an expert body to control the minimum standards
of medical education and to regulate their observance. Obviously, this
hi~h-powered Council has power to prescribe the minimum standards c:I.
medical education. It has imolicit power to supervise the qualifications
or eligibility stanaards for admission into medical institutions. Thus there
is an overall invi!rllation by the Medical Council to prevent sub-standard
entrance qualifications for medical courses.
17. The va1mrious element in marking and moderation of marks
mav be a fact of life. but too manrinal to qualify for substantial difference
unless otherwise made out. Indeed, there mav be differences among the
colleges under the same Universitv, among the examiners in the same
university. Such fleeting factors or eohemeral differences cannot be the
solid foundation for a substantial differentiatiE>n which is the necessacy
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STATE OF KERALA i•. T . P, ROSHANA (Krishna Iyer, J.) 581

pre-condition for quashing an executive or legislative act as too discriminatory
to satisfy the egalitarian essence of Article 14. The functional validation
of the writ jurisdiction is an appropriate examination of the substantiality
of the alleged disparity. We do not, however, proceed finally to pronounce
011 this point with reference to the two universities since nothing is available
before us, or, for. that matter, was before the High Court to warrant
a fair conclusion on the issue. We are persuaded to make these observa-
tions for future guidance, so that academic schemes may not be struck
down as arbitrary or irrational save where some sound basis has been laid.
18. We get back to where we left off before this divagation into
the Full Bench decision's ratio on discrimination as between the two
universities. The sole question that survives is of allocation of seats on
a university-wise classification. Following upon the Full Bench decision
which struck down the pool scheme of selection, a constitutionally viable
process had to be evolved. Government, therefore, appointed a fresh
expert committee to examine and report the quo modo of admissions
to medical colleges in the light of the directives contained in the Full
Bench decision. Two solutions were seriously considered by the Com-
mittee, namely (1) a common entrance examination such as is in vogue
in many States and has the approval of the Medical Council of India ;
and (2) the standardization of the syllabi uniformly for the two universities
and the elimination of different yardsticks in regard to the setting of
questio~ papers, marking systems and the like. The first one, though
the better, was given up as productive of public and student resistance.
However wise a measure may be, its viability depends on its acceptance
by the consumers, namely, the student community and the parent com-
munity. Agitational opposition or determined deadlocking may make it
unwise to inflict it on an unwilling constituency. Of course, by a gradual
process of enlightenment the wisdom of such a measure may dawn. What
is rejected to-day may be greeted tomorrow. The Committee jettisoned
the first proposal of a common entrance examination partly scared of its
impr-acticability at the moment. So it opted for the second, namely
uniformity of standards, from the formulation of syllabi up to assignment
of marks at the examinations. Surely either of the proposals is an effective
answer to Article 14. Even so, when the Committee's recommendations
were placed before the Government it reflected carefully on the pragmatics
of implementation and reached the conclusion that it would take some
time to fulfil the prerequisites to give effect to that formula. Time
runs, university applications rush in, admissions must begin, courses must
start and administrative paralysis in decision-making is no alibi. Imple-
mentational dilatoriness cannot stall the flow of medical education.
Caught in this crisis, ~used in part by the court ruling, Government
fabricated a quick scheme of admission to the four medical colleges, .which,
again, has now· been struck down by the High Court resulting in the appeal
before us.
19. The cornerstone of classification adopted for medical admissions

by the Government this time was 1 miversity-wise allocation. By itself,
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582 SUPREME COUR.T GASES (1979) 1 sec

this approach had constitutional sanction, having regard to the ratio
in ClumdlBla's case8 •
20. The ratio in Cbanchala concludes the dispute in this case. Tho
discriminatory vice, if university-wise classification and consequential alloca-
tion of seats were resorted to, was pressed but repelled. Shelat, J. speaking
for the court, formufated the contention thus 9 : (SCC p. 299, para 19)
The next contention was that rule 9(1), which prescribes university-
wise distribution of seats resU1ts in discr.imination for it lays down a
classmcauon which is neither based on any intelligible differentia,
nor has a rational nexus with the object of the rules. The argument
was that a!thougn there is one selecuon committee for all the Gove.m-
ment medlcal colleges in all the three uruversities and for the said
59 seats in pnvate colleges, students passing from colleges affil;ated
to a particU1ar univerSity are first admitted in Govem,ment medical
co.Lleges atti11ated to that um vcrsity and only seats up to 20% in each
of such mec11cal colleges can be allotted to outsiders in the discretion
of the COlllDllttee. 1.he result is that a student having hig.ber marks
than the iast admitted student is deprived of a seat onJ.y for the
reason that he had passed lus P . U . C. examination from a college
atn.uated to another uruversity. According to counsel, such a classifi.ca..
tion has no rauonal baSIS and has no reasonable nexus with and
is in fact inconsIStent w1th the very Object of estabLi.sbment ol.
Government medlcal colleges, namely, to train in medicine the most
menronous amongst the candidates seekmg admission.
The fundamental educational realities and resultant resolution of the legal
imt>roguo are l.llStructively presented in Cbanchala case, which have special
reievance to our case because the social facts, constitutional confrontatl.OJJa
and ac1mm1strauve answers in the K.erala and Karnataka litigatiom are
simllar. S.he1at, J. observed 10 : (SCC pp. 301-02, para 22)
The three universities were set up in three different places pr&-
sumably for the purpose of catering to the educational and academic
needs of those areas. Obviously one university for the whole of the
State could neither have been adequate nor feasible to satisfy those
ne.ecls. Since it would not be possible to admit all candid.a.tea in
the medical colleges run by the Government, some basis for screen-
ing the candidates had to be set up. There can be no manner ol.
doubt, and it is now fairly well-settled, that the Govcrnmen4 as alio
other private agencies, who found such centres for medical training.
have the right to frame rules for admi~ion so long as those rules
are not inconsistent with the university statutes and regulations and
do not suffer from infirmities, constitutional or otherwise. Since the
universities are set up for satisfying the educational needs of different
areas where they are set up and medical colleges are established in
those areas, it can safely be presumed that they also were so set
8. D . N . Chandra/a v. Stt1te of 1lfysMe, !J. Ibid SGR pp. 617-18: sec p. 299
(1971} 2 sec 293: AIR 1971 SC 1762 : 10. Ibid SOR pp . 619-21: sec pp. 301-02
1971 Supp SCR608
True Prinf -----------------------------------------------------------------------------------------------------------------------------------------------------------
ST.It.ff op KE.It.ALA v. T. P, ROSHANA (Krishna iJ·er, J.) 583
up to satisfy the needs for medical training of those attached to those

universities. In our view, there is nothing undesirable in ensuring
that those attached to such universities have their ambitions to have
training in specialised subjects, like medicine, satisfied through colleges,
affilated to their own universities. Such a basis for selection baa
not the disadvantage of districtwise or unitwise selection as any student
from any part of the State can pass the qualifying examination in
any of the three universities irrespective of the place of his birth or
residence. Further10 the rules confer a discretion on the selection
committee to admit outsiders up to 20 % of the total available acats
in any one of these colleges, -i.e. those who have passed the equivalent
examination held by any other university not only in the State but
also elsewhere in India . . . . "The fact that a candidate ha\ling
lesser marks might obtain admission at the cost of another having
higher marks from another university does not necessarily mean that
a less meritorious candidate gets advantage over a more nieritorious
one. As is well-known, different universities have different standards
in the examinations held by them. A preference to one attached to
one univ~rsity in its owl! institutions for post-graduate or technical
training is not uncommon . . . . Further, the Government which
bears the financial burden on running the Government colleges is
entitled to Jay down criteria for admission in its own colleges and
to decide the sources from which admission would be made- provided
of course, such classification is not arbitrary and has a rational basis
and a reasonable connection with the object of the rules. So long
as there is no discrimination within each of such sources, the validity
of the rules laying down such sources cannot be successfully challenged.
(See Cbitra Ghosh v. Union of lndia11). In our view, the rules lay
down a valid classification. Candidates passing through the qualify-
ing examinations held by a university form a class by themselves u
distinguished from those passing through such ex.amination from the
other two universities. Such a classification has a reasonable nexus with
the object of the rules, namely, to cater to the needs of candidates who
would naturally look to their own university to advance their training
in technical studies, such as medical studies. In our opinion, the
rules cannot justly be attacked on the ground of hostile discrimination
or as being otherwise in breach of Article 14.
21. We do not mean to lay down, as an inflexible dogma of universal
ii.pplication, that under utterly different social and educational environs
university-based grouping of. candidates for specialised courses will, willy-
llilly, be valid. But the basic identity of pertinent circumstaqces bearing
:>n the university-centred discrimen in Chanchala and here constitutionalize
the scheme of selection adopted by Government. grouping all eligibles
1rom colleges affiliated to each University as separate units. The High
Court's perspective in this regard is impeccable.
22. It is an interesting sidelight that in Chanchala as much as 20%
:,f the total seats were thrown open to 'outsiders• i.e. 'those who have
. I. (1969) 2 sec 228: (1970) l SCR 413,418
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584 SUPREY,E COURT CAU.S (1979) 1 sec

passed the equivalent examination held by any other university not only
in the State but also elsewhere in India. The underlying unity of syllabus
and broad agreement on evaluation are assumed in this pool system, confined
to 20% but open to several universities.
23. Having held in the earlier Full Bench case that university-wise
categorisation for seats allocation was good the High Court, in the impugned
judgment, still struck down the new scheme as discriminatory. The vice
was traced to a certain feature w hlch went beyond mere university-wise
alJ.ocation and made further modifications govern~ by the proportion of
the number of students presented by the two universitres for the pre-degree
and B.Sc. f!xaminauons. 'Ay, there's the rub'.
24. The Committee s long range proposal of uniformity between the

two universities was unexceptionable and, if adopted, would end appre-
henswns ot mjustice stemming from dissimilarities flowing from divergent
syllabi and exammation methodology. Indeed, Government has accepted
it as the long-term somtion and ng.ntly. The relevant G.O. dated July 14,
1918, sums up the Committee's urufication solution thus:
As a long-term solution, Government may move the Universi.tie&
of Kera.ta and Ca11cut to unify the curricwum and courses of study
for pre-deg(ee course and form Inter-University Board for the conduct
of examination. When such a scheme is establi.shed pre-degree will
be the only qualifymg exammation for selection to all courses in the
medlcal co~ges. Tne Committee has pomted out that unification of
the sy11atms, course of study and exammatJ.on in the four disciplines
of .B.Sc., VlZ., Physics, Chemistry, Zoology and Botany would be
impossible and thus tne reservation now given to graduate candidates
for se1ecuon to med!cal and dental coheges will have to be abolished.
And the decision of Govemm.ent is in these terms :
Government . . . have accepted the recommendation of the
conumttee to have unified c~ulwn and course of study, and oomm.on
board for conduct of exammauons for the Kerala and Calicut
Umversities. But Government consider that unifi.cation of syllabua
and method of exammatJ.on should be made also at degree level in
respect of the 4 d1SC1phnes of Physics, Chemistry, Zoology and Botany
and that the reservation now given to the graduates for admission to
the medlcaJ. and dental colleges should be continued. The Uni-
versiues concerned are being requested to take further action in the
matter.
But the modus operandi for unifi.cation of syllabi and what not are
incapable of instant execution by unilateral declaration, since it is the
bUSllless of the Universities. And Universities are self-consciously auto-
nomous and often politicised, with the result that the writ of Government
may not run there. Moreover, administrative slow-motion is the genius
of governmental and university processes. Universities, with plural bodies.
many voices and contradictory cerebrations, may meet and debate, appoint
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STATE OF KERA.LA v. T. P. ROSHANA (Krishna Iyer, J.) 585
sub-committees and discuss their reports, await reactions of other organs

and hold joint meetings to consider academic issues in all their dimensions
and act generally only after leisurely reflection. Academics cannot be
bustled and often hasten slowly. Meanwhile, the year rolls on, students
stagnate and medical education grinds to a halt.
25. These painful realities apparently induced the Government to

fabricate in its secretariat foundry a transitory strategy for the current year.
26. This short-run project adopted each University as a unit which,

as we have earlier explained, was good so far as it went. But a dubious
rider was added which invited the judicial Waterloo. That is the bone
of contention and so we excerpt the relevant portion :
After considering the proposal in all its aspects Government have
decided that the seats available for MBBS course after deducting
the seats for mandatory admission may be distributed for the students
of the two Universities in the ratio of the candidates registered fer
the pre-degree and B . Sc. course in the two Universities, taking the
average of the number of candidates registered for the pre-degree
and B.Sc. degree courses with eligibility for admission to Medical
Colleges for the last three years as the basis.
This operated as a cut back on the total 'Calicut' seats as wholly available
for the Calicut University students and, indeed, as urged by counsel for
the respondent, subtly subverted the criterion of 'Malabar' backwardness.
27. The Calicut Medical College and the Calicut University were
created as the purpose-oriented mechanisms for progressive elimination of
educational backwardness in that territory. This objective would be
fulfilled if the entire number of seats of the Calicut Medical College
were exclusively made the entitlement for eligible students from colleges
affiliated to that University. A further slice knifed out of the cake would
spell reversal of policy.
28. We agree with the High Court that the injection of the university-
wise student-strength is drawing the red-herring across the trail - an
irrelevance that invalidates the scheme. We cannot see the nexus between
the registered student-strength and the seats to be allotted. The fewer
the colleges, the fewer the pre-degree or degree students. And so, the
linkage of the division of seats with the registered student-strength would
make an irratiop.al inroad into the university-wise allocation. Such a
formula would be a punishment for backwardness, not a promotion of their
advancement. We cannot uphold the discriminatory paring down based
on unreason.
29. Once this premise is reached the calculus is non-controversial.
30. The three medical colleges affiliated to the Kerala University

have a total strength of 345 students and the only college affiliated to the
Calicut University has a student strength of 180. On these basic figures,
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36
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586 SUPREME COUR.T CASES (1979) l SOC
the arithmetic worked out on the principles of deduction is beyond con-

troversy. Forty-two students form the reserved quota and have to "
apportioned between the two universities in the ratio of their student
strength. Making available of seats for candidates from other universities
is also common ground. Both sides agree that the net number of seats
available to be filled up, if we proceed solely on th~ principle of university-
wise allocation, will be 166 for the Calicut University students and 34 7 (sic 317)
for the Kerala Univ,ersity students. The admissions, even on these agreed
figures, will be subject to the die-hard rule of communal reservation. The
further division of seats in the ratio of 60: 40 as between the graduates
and pre-degree candidates also has to be maintained. No question of
complicating the numbers by any further injection of the population ratio
between Malabar and Travancore•Cochin arises because the new formula
takes care of the backwardness of Malabar and there cannot be double
benefits.
31. Decoding the rules in simplex form, what we get in arithmetical
terms is that the Calicut University students who have now b~n allotted
under the Governm~nt formula 136 seats will be entitled to an extra
30 seats.
32. If we rigidly direct that these additional seats be assigned to
the students emerging from the colleges under the Calicut University an
equal number may have to be expelled from the students already admittea
from out of the Kerala University quota. This consequence becomes
compulsive since the total strength sanctioned for the four medical colleges
J4_ed by the two Universities and approved by the Medical Council of.
India is 525 seats.
33. Here comes the play of processual realism in moulding the
relief in the given milieu. The rule of law should not petrify life or be
inflexibly mulish. It is tempered by experience, mellowed by principled
compromise, informed by the anxiety to avoid injustice and softens the
blow within the marginal limits of legality. That is the kanma of the law.
34. Nor is law unimaginative. especially in the writ jurisdiction
where responsible justice is the goal. The court cannot adopt a rigid
attitude of negativity and sit back after striking down the scheme of
Government, leaving it to the helpless Government caught in a crisis
to make-do as best as it may, or throwing the situation open to agitational
chaos to find a solution by demonstrations in the streets and worse. We
are, therefore, unable to stop with merely declaring that the scheme of
admission accepted by Government is ultra vires and granting the relief
to the petitioner of adD1IBsion to the medical college. The need for con-
trolling its repercussions calls for judicial response. After all, law is not
a brooding omnipresence in the sky but an Operational art in society.
35. The High Court's ultimate direction is "We allow this writ
petition and quash Ex. P2 G. 0. to the extent to which it accepts alternative
proposal of the committee referred to in Ex. Pl " . The Court also observed:
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Sl'Al'& oF K.ERAL"' v. T. P . RO!IHANA (Krishna I.1er~ J.) 587
"We think it will be unfair in the circumstances to deny effective relief to

the writ-petitioner' . . The relief claimed was admission to the
medical college.
36. The upshot of the judgment, in terms of student impact,
government policy, college admissions and potential for agitation, may
be envisioned for a while. We may also take note of the gregarious
trend of one writ petition being followed by many when the grievance is
common and the first case is in essence a test case and class action.
What is granted to the petitioner has to be granted to others who follow
her, In terms of numbers several candidates may have to be admitted
into the medical colleges. More than that is the chaotic consequence
of the pro tempore project of the Government being struck down with no
alternative methodology of selection. Governments have no magic remedies
to tide over sudden crises. Their processes are notoriously slow and the
temper of the student community is notoriously inflammable. Thus
the negative stroke of voiding the G. O. and granting relief to the petitioner
is to throw out a number of students already undergoing their course and
to incite unwittingly student Ulll'est of magnitude, apart trom leaving the
academic algebra for admissions in a state of vacuum. One thing is
certain. If the syndrome of campus chaos is to be obviated, the court
should come to the assistance of tile Keraia University students already
admitted and undergoing their medical course, who might otherwise have
to be jettisoned. We, therefore, do not think it right to force into the
medical colleges any student who may be qualified for admission by virtue
of our order at the expense of another who has already been admitted
and is undergoing the medical course, This means that 30 students from
the colleges affiliated to the Calicut Univetsity will have to be provided for
ab extra. But how to find accommodation for 30 more students?
37. The Universities concerned have the power to increase the strength
ad hoc when gripped by a crisis such as has occurred here. The Medical
Council of India has an overall control in this field, being the statutory
body created under the Indian Medical Council Act, 1956. Thus, the
concurrence of the Calicut and the Kerala Universities and the Medical
Council of India becomes necessary for working out effective reliefs in
terms of adding to the strength on a temporary footing, with a sense of
equity and anxiety to do justice to the eJtisting entrants.
38. Unfortunately, nather the Universities concerned nor the students
affected are parties. The presence of the Medical Council of. India also
has to be secured. Confroilted by this situation, we directed, as a measure
of emergency, issuance of notice to the two Universities and made the}ll
party to the record. A similar step was taken in the case of the Medical
Council of. India. At short notice, all the three parties entered appearance.
Although Shri A. S. Nambiar, appearing for the University, expressed
inability to consent to any course of addition of strength, he agreed that
the concerned academic bodies were likely to meet shortly and the
.Universities themselve~ would abide by any directions this Court issued
in the interests of justice. The learned Advocate-General had earlier
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38
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588 StJPltEME COURT CASES (1979) 1 soc

represented that the Universities were likely to agree to a temporary
addition of strength, provided the Medical Council of India would also
approve of the course. We need hardly say that the writ of this Court
binds the parties on record and all the three bodies are before us and
must abide by the directions we issue necessitated by the exigency of
the situation and the need to do justice.
39. After all, the Court system belongs to the people and must
promote constructive justice ; and all institutions, including the Govern-
ments and Universities, likewise belong to the people. This commitment
is the whetstone for doing justice in the wider context of social good.
The Universities, as we gather from counsel representing all the parties,
may not find it difficult to accommodate 30 students more, apportioned
among the four medical colleges of the State. This addition is compelled
by the critical condition set out above. This need will not survive this
academic year and, in that sense, no long-term trauma for academic standards
will be inflicted by each of the colleges. accommodating a few more students
for their courses this year. After all, not much time has passed since
the teaching session began. Compared to their existing strength, the
additions are negligible. The Medical Council of India, through the
learned Additional Solicitor-General, has expressed that it has no objection
to this proposal for a miniscule addition confined to this academic year.
We see no ground for either University to plead inability to help the
cause of justice. The insistence on standards, measured by marks, is
not being relaxed, so much so the quality of the admission of the additional
students does not suffer. A marginal strain in the matter of teaching and
perhaps extra burden in regard to the practicals may have to be endured.
We are, therefore, sure that the Universities, the colleges concerned, the
teaching community and the alumni themselves will appreciate the goal
and cooperate in the success of the direction we make.
40. Had we left the judgment of the High Court in the conventional
form of merely quashing the formula of admission the remedy would have
aggravated the malady - confusion, agitation, paralysis. The root of
the grievance and the fruit of the writ are not individual but collective
and while the 'adversary system' makes the Judge a mere umpire, traditionally
speaking, the community orientation of the judicial function, so desirable
in the Third World remedial jwisprudence, transforms the court's power
into affirmative structuring of redress so as to make it personally meaningful
and socially relevant. Frustration of invalidity is part of the judicial
duty; fulfilment of legality is complementary. This principle of affirmative
action is within our jurisdiction under Article 136 and Article 32 and
we think the present cases deserve its exercise.
41. We direct the State Government to admit 30 more willing

students who are qualified under the rules and who are students from the
colleges affiliated to the Calicut University - in order of the marks
secured. They will be distributed by the Selection Committee among th'e
four medical colleges of Government in an equitable way and their decision
will be final. The Kerala and the Calicut Universities will be bound to
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STATE OP' KERALA v. T. P. ROSHANA (Krishna I.1er, J.) 589
expand the strength of the medical colleges concerned for this year in
obedience to this direction of the Court and the respective bodies under
the Universities will act accordingly.
42. The selection of these 30 students will not be confined to those
who have moved this Court or the High Court by way of writ proceed-
ings or appeal. The measure is academic excellence, not litigative
persistence. It will be thrown open to the first 30, strictly according to
merit measured by marks secured. The apportionment as between
graduates and pre-degree students and the application of the communal
reservation will apply to these 30 to be selected. The Selection Com-
mittee will make its decision on or before January 31, 1979. The
Universities concerned will convey their approval to the Government for
the necessary addition to the student strength in obedience to the direction
of this Court on or before January 27, 1979.
43. We direct the State Government, for the coming academic year,
1979-80, to allot 166 seats for the students from tlie colleges affiliated
to the Calicut University and 347(sic 317) seats to the students from
the colleges affiliated to the Kerala University, the formula regarding every
other aspect being as indicated in this judgment such as for the manda-
tory admissions, the apportionment between pre-degree students and the
degree holders and other reservations.
44. Another imperative step we cast on the two Universities, which

are parties before us and are. therefore, bound by this Order deserves to
be clearly expressed. Having regard to the utter confusion in medical
studies that may be produced by keeping the unification of syllabi and
methodology of examinations in a flux we think it absolutely essential to
fix a time target for the University bodies to act. Government will issue
necessary directions to its representatives on these bodies to accelerate
the pace. We expect both the Universities to implement the proposal made
by the Committee and accepted by the Government regarding the uniform
curricula and common examination system and allied matters in such
manner that there will be no inequality as between students emerging from
one University and the other within the State. This process shall be
completed on or before May 31, 1979.
4S. We are aware that these various directions and orders call for
high pressure activisation. Perhaps, we may emphasise the need for
guarding against the slow march of bureaucratie movement embodied in
Lord Curzon's lament respecting the administration of his time, a state
of affairs wholly opposed to the dynamic fulfilment of the imperatives cast
by the Constitution upon the nation and its institutions. Said Lord Curzon
in a despatch to the Secretary of State :
Your despatch of August 5 arrived. It goes to Foreign Depart-

ment. Thereupon Clerk No. 1 paraphrases and comments upon it
over 41 folio pages of print of his own composition, dealing -solely
with the Khyber suggestions in it. Then comes Clerk No. 2 with
True Prinf -----------------------------------------------------------------------------------------------------------------------------------------------------------
590 BUPREME COUllT CASPJI (1979) 1 sec
31 more pages upon Clerk No. l . Then we get to the region ~

Asst. Secretaries, Dy. Secretaries and Secretaries. All these gentle-
men state their worthless views at ecgual length. Finally we get to-
the top of the '\Cale and we find the Viceroy and Military Member,
with a proper regard for their dignity, expanding themselves over a
proportionate space of print. Then these papers wander about from
Department to Department and amid the various Members of Council
I am grappling with this vile system in my own department, but
it has seated itself 1ike the Old Man of the Sea upon the shoulders
of the Indian Government and every man accept~ while deploring
the burden. u
Hopefully, we part with this case ·with the thought that there will be
no occasion for any party to move for extern;ion of time or to prove that
the curse Lord Curzon spelt out still haunts the wheels of admini5tration.
The appeal is allowed : so also the writ petition -- in the manner and
to the extent we have directed. The oartics will bear their costs. The
decisional guidelines herein given will, we dare say, so help dispose c:A.
the many writ petition~ pending in the High Court. The journey to the
Supreme Court is not atway5 necessitous for final justice.
ORDER
46. While there is agreement that thirty seats more have to be added
as bas been indicated in the jodgment making the total number c:A. scats
allocable to the students of the Calicut University to 166, there is some
dispute regarding the number of seats available for the students belonging
to the Kerala University. We have mentioned in the judgment that it
is 317. It is open to the State Government or to the concerned Universitiea
to bring it to the notice of the Court in case there is any clarification necessary.
(1979) 1 Supreme Court Ca11es 590

(BDOllE V. R. KJltSHNA Iv:ER, jA..'lWANT StNOH AND \ . D. KosHAL. JJ.)
G. T. LAD AND OTIIBRS Appellant&;
Versus
CHEMICAL AND FIBRES OF INDIA LID. Respondent.
Civil Appeal No. 1 J88(NL) of 1976*, decided on December 5/6, 1978
Labom' and Services - "Abandonment of service" - Nature and
meaning of - Circumstances in which it can be assmned that the wodc·
men had vohmtarily abandoned serritt - Absence by employees becaue
of sfrike for enforcement of their demands does not amount to abandon-
ment of service - Termination of service in soch circmmt~ not autho-
rised by the Standing Orders amounted to change In conditions of senlee
entitling them to complain nnder Section 33A of tbe lnclusufal Disputes
12. Culled from David Dikr : Cu,zon in India
*Appeal by Special Leave from the Award dated Februarv 27, J(J76 of the lnduatrial
Triburtal, Maharashtra in Complaints (I. T.) 48-53 and 55-63 of 19n in Reference (I. T.)
376 of 1972 published in the Mahara~htra Government Cautte, Part J-L, dated ]\tne 3,
1976.
41
ANNEXURE P-3
Legal Status of Traditional Medicine and

Complementary/Alternative Medicine:
A Worldwide Review
42
© World Health Organization 2001
This document is not a formal publication of the World Health Organization (WHO), and all rights
are reserved by the Organization. The document may, however, be freely reviewed, abstracted,
reproduced and translated, in part or in whole, but not for sale or for use in conjunction with
commercial purposes.
The views expressed in this documents by named authors are solely the responsibility of those
authors.
43
Acknowledgements
The World Health Organization (WHO) acknowledges its indebtedness

to our Member States, regional offices, and WHO Member State
representative offices for actively providing data on the practice and
legal status of traditional and complementary/alternative medicine in
their countries and regions. Thanks is also expressed to those
international professional organizations, such as the World Federation
of Acupuncture and Moxibustion Societies, World Federation of
Chiropractic, World Chiropractic Alliance, and Liga Medicorum
Homeopathica Internationalis, who provided valuable information
specific to their relevant therapies. We especially thank Mr Neil
Cummings (Canada), Mr Josh Gagne (USA), Ms Sophie Lasseur
(France), Ms Yong Li (China), Mr Stefano Maddalena (Switzerland), Ms
Magali Ramillien (France), Ms Valerie Truong (Canada), and Mr
Guoliang Zhang (China) for drafting and revising the document and Ms
Kathleen Sheridan (Netherlands) and Ms Diane Whitney (USA) for
editing the final draft.
Appreciation is extended to the Norwegian Royal Ministry of Health

and Social Affairs for providing the financial support to print this
review.
44
Contents
45
Contents
Acknowledgements.....................................................................................iii
Foreword.................................................................................................. ix
Introduction ............................................................................................... 1
Terminology ........................................................................................... 1
Widespread systems of traditional and
complementary/alternative medicine ....................................................... 2
The situation in the use of traditional and
complementary/alternative medicine ....................................................... 3
Africa ....................................................................................................... 5
Angola .................................................................................................. 5
Benin .................................................................................................... 5
Botswana .............................................................................................. 6
Burkina Faso .......................................................................................... 7
Burundi ................................................................................................. 9
Cameroon .............................................................................................. 9
Cape Verde .......................................................................................... 10
Central African Republic......................................................................... 10
Chad................................................................................................... 11
Comoros.............................................................................................. 11
Congo ................................................................................................. 11
Côte d’Ivoire ........................................................................................ 13
Democratic Republic of the Congo ........................................................... 13
Equatorial Guinea .................................................................................. 13
Ethiopia ............................................................................................... 14
Gabon ................................................................................................. 15
Gambia ............................................................................................... 15
Ghana ................................................................................................. 16
Guinea ................................................................................................ 18
Guinea-Bissau....................................................................................... 19
Kenya ................................................................................................. 19
Lesotho ............................................................................................... 19
Liberia ................................................................................................. 20
Madagascar ......................................................................................... 21
Malawi ................................................................................................ 22
Mali .................................................................................................... 22
Mauritania ........................................................................................... 25
Mauritius ............................................................................................. 26
Mozambique ........................................................................................ 26
Namibia............................................................................................... 27
Niger................................................................................................... 28
Nigeria ................................................................................................ 29
v
Legal Status of Traditional Medicine and Complementary/Alternative Medicine: A Worldwide Review
46
Rwanda............................................................................................... 31
Sao Tome and Principe .......................................................................... 31
Senegal ............................................................................................... 31
Seychelles ........................................................................................... 32
Sierra Leone ......................................................................................... 32
South Africa......................................................................................... 33
Swaziland ............................................................................................ 36
Togo ................................................................................................... 36
Uganda ............................................................................................... 36
United Republic of Tanzania.................................................................... 37
Zambia................................................................................................ 38
Zimbabwe............................................................................................ 39
The Americas........................................................................................... 43
Argentina............................................................................................. 43
Bolivia ................................................................................................. 43
Brazil .................................................................................................. 44
Canada................................................................................................ 45
Chile ................................................................................................... 52
Colombia ............................................................................................. 53
Costa Rica ........................................................................................... 53
Cuba................................................................................................... 54
Dominican Republic ............................................................................... 55
Ecuador............................................................................................... 56
Guatemala ........................................................................................... 57
Honduras............................................................................................. 58
Jamaica............................................................................................... 59
Mexico ................................................................................................ 60
Nicaragua ............................................................................................ 61
Panama ............................................................................................... 62
Peru.................................................................................................... 64
United States of America ....................................................................... 65
Venezuela............................................................................................ 71
Eastern Mediterranean ............................................................................... 73

Algeria ................................................................................................ 73
Cyprus ................................................................................................ 73
Djibouti ............................................................................................... 74
Egypt .................................................................................................. 75
Islamic Republic of Iran .......................................................................... 75
Jordan ................................................................................................ 77
Kuwait ................................................................................................ 77
Pakistan .............................................................................................. 78
Saudi Arabia ........................................................................................ 81
Sudan ................................................................................................. 82
Syrian Arab Republic ............................................................................. 82
United Arab Emirates............................................................................. 83
Europe .................................................................................................... 85
Austria ................................................................................................ 85
Belgium ............................................................................................... 86
Denmark.............................................................................................. 89
vi
Contents
47
Finland ................................................................................................ 91
France................................................................................................. 93
Germany.............................................................................................. 95
Hungary .............................................................................................. 98
Ireland............................................................................................... 100
Italy .................................................................................................. 101
Latvia................................................................................................ 103
Liechtenstein...................................................................................... 104
Luxembourg ....................................................................................... 105
Malta ................................................................................................ 106
Netherlands........................................................................................ 108
Norway ............................................................................................. 110
Russian Federation .............................................................................. 113
Spain ................................................................................................ 114
Sweden............................................................................................. 117
Switzerland........................................................................................ 119
Ukraine ............................................................................................. 123
United Kingdom of Great Britain and Northern Ireland ............................... 125
South-East Asia...................................................................................... 129

Bangladesh ........................................................................................ 129
Bhutan .............................................................................................. 129
Democratic People’s Republic of Korea................................................... 131
India ................................................................................................. 131
Indonesia........................................................................................... 134
Myanmar ........................................................................................... 135
Nepal ................................................................................................ 137
Sri Lanka ........................................................................................... 138
Thailand ............................................................................................ 141
Western Pacific ...................................................................................... 145

Australia............................................................................................ 145
Cambodia .......................................................................................... 148
China ................................................................................................ 148
Hong Kong Special Administrative Region of China .................................. 152
Fiji .................................................................................................... 154
Japan................................................................................................ 155
Kiribati .............................................................................................. 159
Lao People’s Democratic Republic ......................................................... 159
Malaysia............................................................................................ 160
Mongolia ........................................................................................... 163
New Zealand ...................................................................................... 164
Papua New Guinea.............................................................................. 165
Philippines ......................................................................................... 165
Republic of Korea................................................................................ 166
Samoa .............................................................................................. 169
Singapore .......................................................................................... 169
Solomon Islands ................................................................................. 170
Vanuatu ............................................................................................ 171
Viet Nam ........................................................................................... 171
References ............................................................................................ 175
vii
48
Annex I. The European Union ................................................................... 187
General principles................................................................................ 187
Directives on homeopathic products ...................................................... 187
Free movement of patients and practitioners and insurance coverage of
complementary/alternative medicine products and treatments................. 188
viii
Foreword
49
Foreword
National policies are the basis for defining the role of traditional and
complementary/alternative medicine in national health care programmes, ensuring
that the necessary regulatory and legal mechanisms are created for promoting and
maintaining good practice; assuring authenticity, safety and efficacy of traditional and
complementary/alternative therapies; and providing equitable access to health care
resources and information about those resources.
As seen in this review, national recognition and regulation of traditional and

complementary/alternative medicine vary considerably. The World Health
Organization works with countries to develop policies most appropriate for their
situations. This document provides information on the legal status of traditional and
complementary/alternative medicine in a number of countries. It is intended to
facilitate the development of legal frameworks and the sharing of experiences between
countries by introducing what some countries have done in terms of regulating
traditional and complementary/alternative medicine. This information will be
beneficial not only to policy-makers, but also to researchers, universities, the public,
insurance companies and pharmaceutical industries.
The preparation of this document took almost 10 years, largely because of a lack of
financial resources. Not only was it difficult to obtain accurate, precise information on
the policies of all of the World Health Organization’s 191 Member States, but because
of the constant work of policy-makers on health-related issues, it was impossible for
us to collect current data and keep it current throughout the preparation and
publication process. Although we have worked tirelessly to collect data and keep it as
up to date as possible, new policies have made some information included here
obsolete and basic information for many countries is still lacking. Regrettably, we
were only able to include 123 countries in this review. Some countries are not included
as we were unable to find sufficient information and, for some countries that are
included, we may have mistakenly provided inaccurate or misleading information.
We deeply apologize for any omissions or errors.
In this regard, we would sincerely appreciate countries and organizations providing

necessary corrections and keeping us updated as their policies change, so that our next
edition of this important document will be as accurate and complete as possible.
Thank you!
Dr Xiaorui Zhang
Acting Coordinator
Traditional Medicine
World Health Organization
Geneva, Switzerland
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50
Introduction
51
Introduction
Terminology
In this document, medical providers and practices are generally described as

traditional, complementary/alternative, or allopathic. “Provider” and “practitioner”
are used interchangeably. In a few cases, particularly in the European section, the
cumbersome term “non-allopathic physician” is used to refer to medical practitioners
who are either not allopathic practitioners or who are allopathic providers but not
physicians.
Allopathic medicine
Allopathic medicine, in this document, refers to the broad category of medical practice
that is sometimes called Western medicine, biomedicine, scientific medicine, or
modern medicine. This term has been used solely for convenience and does not refer
to the treatment principles of any form of medicine described in this document.
Complementary/Alternative medicine
The terms “complementary medicine” and “alternative medicine” are used inter-
changeably with “traditional medicine” in some countries. Complementary/alter-
native medicine often refers to traditional medicine that is practised in a country but is
not part of the country’s own traditions. As the terms “complementary” and
“alternative” suggest, they are sometimes used to refer to health care that is
considered supplementary to allopathic medicine. However, this can be misleading. In
some countries, the legal standing of complementary/alternative medicine is
equivalent to that of allopathic medicine, many practitioners are certified in both
complementary/alternative medicine and allopathic medicine, and the primary care
provider for many patients is a complementary/alternative practitioner.
Herbal preparations and products

Herbal preparations are produced by subjecting herbal materials to extraction,
fractionation, purification, concentration, or other physical or biological processes.
They may be produced for immediate consumption or as the basis for herbal products.
Herbal products may contain excipients, or inert ingredients, in addition to the active
ingredients. They are generally produced in larger quantities for the purpose of retail
sale (1).
Traditional medicine
Traditional medicine includes a diversity of health practices, approaches, knowledge,
and beliefs incorporating plant, animal, and/or mineral-based medicines; spiritual
1
52
therapies; manual techniques; and exercises, applied singly or in combination to
maintain well-being, as well as to treat, diagnose, or prevent illness.
The comprehensiveness of the term “traditional medicine” and the wide range of
practices it encompasses make it difficult to define or describe, especially in a global
context. Traditional medical knowledge may be passed on orally from generation to
generation, in some cases with families specializing in specific treatments, or it may be
taught in officially recognized universities. Sometimes its practice is quite restricted
geographically, and it may also be found in diverse regions of the world (see the
section on complementary/alternative medicine, above). However, in most cases, a
medical system is called “traditional” when it is practised within the country of origin.
Widespread systems of traditional and

complementary/alternative medicine
Ayurveda
Ayurveda originated in the 10th century BC, but its current form took shape between
the 5th century BC and the 5th century AD. In Sanskrit, ayurveda means “science of life”.
Ayurvedic philosophy is attached to sacred texts, the Vedas, and based on the theory
of Panchmahabhutas — all objects and living bodies are composed of the five basic
elements: earth, water, fire, air, and sky (2). Similarly, there is a fundamental harmony
between the environment and individuals, which is perceived as a macrocosm and
microcosm relationship. As such, acting on one influences the other. Ayurveda is not
only a system of medicine, but also a way of living. It is used to both prevent and cure
diseases. Ayurvedic medicine includes herbal medicines and medicinal baths. It is
widely practised in South Asia, especially in Bangladesh, India, Nepal, Pakistan, and
Sri Lanka.
Chinese traditional medicine

The earliest records of traditional Chinese medicine date back to the 8th century BC (3).
Diagnosis and treatment are based on a holistic view of the patient and the patient’s
symptoms, expressed in terms of the balance of yin and yang. Yin represents the earth,
cold, and femininity. Yang represents the sky, heat, and masculinity. The actions of
yin and yang influence the interactions of the five elements composing the universe:
metal, wood, water, fire, and earth. Practitioners of Chinese traditional medicine seek
to control the levels of yin and yang through 12 meridians, which bring energy to the
body. Chinese traditional medicine can be used for promoting health as well as
preventing and curing diseases. Chinese traditional medicine encompasses a range of
practices, including acupuncture, moxibustion, herbal medicines, manual therapies,
exercises, breathing techniques, and diets (4). Surgery is rarely used. Chinese
medicine, particularly acupuncture, is the most widely used traditional medicine. It is
practised in every region of the world.
2
Introduction
53
Chiropractic
Chiropractic was founded at the end of the 19th century by Daniel David Palmer, a
magnetic therapist practising in Iowa, USA. Chiropractic is based on an association
between the spine and the nervous system and on the self-healing properties of the
human body. It is practised in every region of the world. Chiropractic training
programmes are recognized by the World Federation of Chiropractic if they adopt
international standards of education and require a minimum of four years of full-time
university-level education following entrance requirements.
Homeopathy
Homeopathy was first mentioned by Hippocrates (462–377 BC), but it was a German
physician, Hahnemann (1755–1843), who established homeopathy’s basic principles:
law of similarity, direction of cure, principle of single remedy, the theory of minimum
diluted dose, and the theory of chronic disease (2). In homeopathy, diseases are
treated with remedies that in a healthy person would produce symptoms similar to
those of the disease. Rather than fighting the disease directly, medicines are intended
to stimulate the body to fight the disease. By the latter half of the 19th century,
homeopathy was practised throughout Europe as well as in Asia and North America.
Homeopathy has been integrated into the national health care systems of many
countries, including India, Mexico, Pakistan, Sri Lanka, and the United Kingdom.
Unani
Unani is based on Hippocrates’ (462–377 BC) theory of the four bodily humours:
blood, phlegm, yellow bile, and black bile. Galen (131–210 AD), Rhazes (850–925 AD),
and Avicenna (980–1037 AD) heavily influenced unani’s foundation and formed its
structure. Unani draws from the traditional systems of medicine of China, Egypt,
India, Iraq, Persia, and the Syrian Arab Republic (5). It is also called Arabic medicine.
The situation in the use of traditional and

Traditional and complementary/alternative medicine is widely used in the preven-

tion, diagnosis, and treatment of an extensive range of ailments. There are numerous
factors that have led to the widespread and increasing appeal of traditional and
complementary/alternative medicine throughout the world, particularly in the past 20
years. In some regions, traditional and complementary/alternative medicine is more
accessible. In fact, one-third of the world’s population and over half of the populations
of the poorest parts of Asia and Africa do not have regular access to essential drugs.
However, the most commonly reported reasons for using traditional and
complementary/alternative medicine are that it is more affordable, more closely
corresponds to the patient’s ideology, and is less paternalistic than allopathic
medicine. Regardless of why an individual uses it, traditional and complemen-
tary/alternative medicine provides an important health care service to persons both
with and without geographic or financial access to allopathic medicine.
3
54
Traditional and complementary/alternative medicine has demonstrated efficacy in
areas such as mental health, disease prevention, treatment of non-communicable
diseases, and improvement of the quality of life for persons living with chronic
diseases as well as for the ageing population. Although further research, clinical trials,
and evaluations are needed, traditional and complementary/alternative medicine has
shown great potential to meet a broad spectrum of health care needs.
Recognizing the widespread use of traditional and complementary/alternative

medicine and the tremendous expansion of international markets for herbal products,
it is all the more important to ensure that the health care provided by traditional and
complementary/alternative medicine is safe and reliable; that standards for the safety,
efficacy, and quality control of herbal products and traditional and complemen-
tary/alternative therapies are established and upheld; that practitioners have the
qualifications they profess; and that the claims made for products and practices are
valid. These issues have become important concerns for both health authorities and
the public. National policies are a key part of addressing these concerns.
Each year the World Health Organization receives an increasing number of requests to
provide standards, technical guidance, and informational support to Member States
elaborating national policies on traditional and complementary/alternative medicine.
The World Health Organization encourages and supports Member States to integrate
traditional and complementary/alternative medicine into national health care systems
and to ensure their rational use. Facilitating the exchange of information between
Member States through regional meetings and the publication of documents, the
World Health Organization assists countries in sharing and learning from one
another’s experiences in forming national policies on traditional and complemen-
tary/alternative medicine and developing appropriate innovative approaches to
integrated health care.
In 1998, the World Health Organization Traditional Medicine Team issued the
publication Regulatory situation of Herbal Medicines: A Worldwide Review. Although it
only includes information concerning the regulation of herbal medicines, this
document attracted the attention of the national health authorities of World Health
Organization Member States as well as of the general public.
Legal Status of Traditional Medicine and Complementary/Alternative Medicine: A Worldwide

Review is much more comprehensive. Both an update and an expansion of the 1998
document, it includes information on the regulation and registration of herbal medi-
cines as well as of non-medication therapies and traditional and complement-
ary/alternative medical practitioners. It is an easy reference, providing summaries of
the policies enacted in different countries and indications of the variety of models of
integration adopted by national policy-makers. Through country-specific sections on
Background information, Statistics, Regulatory situation, Education and training, and
Insurance coverage, it is designed to facilitate the sharing of information between
nations as they elaborate policies regulating traditional medicine and comple-
mentary/alternative medicine and as they develop integrated national health care
systems.
4
Africa
55
Africa
Angola
Regulatory situation
Although there is a registry of traditional health practitioners, there are no official
legislative or regulatory texts governing the practice of traditional medicine, no
licensing procedures for traditional medicine practitioners, no system for the official
approval of traditional medical practices and remedies, and no local or national
councils in charge of reviewing any problems concerning traditional medicine (6).
Traditional medicine practitioners are not involved in Angola’s primary health care
programme at the local or national level (6).
Education and training

Angola does not have any official training facilities or programmes for traditional
medicine (6).
Benin
Background information
Widespread reliance on traditional medicines can be partially attributed to the high
cost of allopathic pharmaceuticals, particularly after the devaluation of the Central
African franc (7). Numerous persons from other countries use Beninese traditional
medicine (7).
Statistics
Eighty per cent of the population relies on traditional medicine (7).
In the Regular Budget 1998–1999, US$ 14 000 was allocated to traditional medicine (8).
There is a licensing process and a registry of traditional medicine practitioners in
Benin (6). Local officials are allowed to authorize the practice of traditional medicine
in their administrative and/or health subdivisions. Some traditional medicine
practitioners are involved in the primary health care programme in Benin (6). There
are national as well as provincial intersectoral councils and groups in charge of
reviewing problems concerning traditional medicine (6).
5
56
Section 3 of Code 3.4, Quality of Health Care and Health Technology (9), relates to
traditional medicine. One objective under this section is the promotion of traditional
pharmacopoeia through the following:
♦ updating and distributing a national list of traditional medicine practitioners by

field of speciality—US$ 5000 is set aside for this task;
♦ developing and distributing a guide for the rational use of traditional

pharmacopoeia—US$ 9000 is allocated for this task.
The Ministry of Health perceives obstacles to the promotion of traditional medicine in

Benin to include the following (7):
♦ lack of means to evaluate the quality, safety, and efficacy of traditional medicine
products;
♦ lack of training in proper sanitation techniques for practitioners of traditional

medicine, leading to unfavourable conditions in the practice of traditional
medicine.
In consideration of these obstacles and in order to protect consumers, the Government

has prioritized the following projects (7):
♦ a census of non-governmental organizations operating in the field of traditional

medicine;
♦ a census of practitioners of traditional medicine;
♦ evaluation of the possibilities of integrating traditional medicine into the national

health care system, particularly into health centres at the sub-prefecture level;
♦ training traditional medicine practitioners to refer serious cases of certain illnesses,

such as malaria and HIV/AIDS, to allopathic health centres.
The Government envisions many opportunities for traditional medicine in Benin;

these projects are just the first steps in a long process (7).
Botswana
Practitioners of traditional medicine provided the only health care services available in
most of Botswana until the first part of the decade following independence in 1966.
The recent introduction of allopathic services throughout the country appears to have
reduced the influence and activities of traditional medicine practitioners, but only to a
limited extent and mainly with respect to younger and more formally educated
population groups. Traditional health practitioners are well respected and influential
6
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57
in rural areas and remain central figures in the everyday lives of the majority of the
rural population.
Statistics
There are about 3100 traditional health practitioners in Botswana, approximately 95%
of whom reside in rural areas (10).
The first reference to the official acceptance of traditional medicine practitioners in
Botswana appears in Section 14.86 of the National Development Plan of 1976–1981:
Although not part of the modern health care system the traditional healer (ngaka)
performs a significant role in Botswana, especially in the rural areas. . . . The policy
of the Ministry is to evaluate further the contribution of traditional healers to the
health care system of the country and possibly then to seek ways of closer
cooperation and consultation.
Similarly, Section 13.28 of Chapter 13 of the National Development Plan of 1979–1984

(10, 11) reads:
There are a large number of traditional practitioners of various types who are
frequently consulted on health and personal matters. The Ministry of Health will
continue its policy of gradually strengthening links with traditional practitioners —
both diviners, herbalists, and faith healers. The emphasis will be put on improving
mutual understanding, especially about the practices and techniques of the
traditional practitioners. No full-scale integration is envisaged, but referrals between
modern health care services and traditional practitioners will be encouraged where
appropriate.
The Medical, Dental, and Pharmacy (Amendment) Act of 1987 (12) outlines
registration requirements for chiropractors, osteopaths, naturopaths, acupuncturists,
and other complementary/alternative medical professionals in Botswana.
Burkina Faso
Under colonialism, traditional medical practices were outlawed as harmful and
dangerous. Only after independence did the Government promote traditional
medicine and begin to restore esteem to traditional medical practices. However, due to
a lack of political initiative and significant mistrust between allopathic practitioners
and traditional medicine practitioners, it was not until the 1980s that noticeable efforts
were made. In 1983, the Government encouraged the formation of associations of
traditional medicine practitioners as well as pharmacopoeia units within decentralized
sanitary structures of the health system.
7
58
According to the Burkina Faso Government, traditional medicine will always remain
an important source of health care for the majority of the population since traditional
medicine is part of African sociocultural foundations.
Statistics
More than 80% of the population in Burkina Faso use traditional medicine.
The Natural Substances Research Institute and a Health Ministry service were created
in 1978 to promote traditional medicine and pharmacopoeia. In 1979, traditional
medicine practitioners were officially recognized in Burkina Faso. Title IV of the
Public Health Code of 28 December 1970 (13) pertains to traditional medicine. Section
49 states:
The practice of traditional medicine by persons of known repute shall be

provisionally tolerated; such persons shall remain responsible, under civil and penal
law, for the acts which they perform.
Subsequent items of legislation shall define the practice of this form of medicine and
the status of persons engaged therein.
A medical and scientific commission appointed by the Minister responsible for

Public Health shall conduct a study of the practice of traditional medicine and shall
undertake investigations, notably in respect to traditional therapeutics, in order to
identify the mode of action and posology of the drugs involved.
The Practice and Organization of Traditional Medicine, Chapter IV of Law

23/94/ADP of 19 May 1994 (14), promulgates the Public Health Code. This chapter
defines traditional medicine and traditional medicine practitioners and reiterates their
official recognition in Burkina Faso.
In July 1996, the Government approved the National Pharmaceutical Policy. In 1997,
the National Pharmaceutical Directive Plan was adopted to define the global
objectives of the National Pharmaceutical Policy in concrete terms. One of the aims, as
designated by the Ministry of Health, was the development and promotion of
traditional medicine and traditional pharmacopoeia within the official Burkina Faso
health care system in order to improve the health care delivered to the population. The
Plan will be taken into consideration in the development of the National Sanitary
Policies, which will cover the years 2001–2010.
Decrees on the following issues are currently being elaborated: the modalities of
private practice of traditional medicine, the creation of and assignments to the
National Commission of Traditional Medicine and Traditional Pharmacopoeia, and an
inventory of improved traditional medications. In an effort to balance conservation of
natural resources and the development of traditional medicines, the Government is
also in the process of developing regulations on the exploitation of traditional
8
Africa
59
pharmacopoeia products with the collaboration of national and international partners,
such as the World Health Organization.
Burkina Faso has local and national intersectoral councils in charge of reviewing
problems related to traditional medicine (6). Local officials in Burkina Faso are
allowed to authorize the practice of traditional medicine in their administrative
and/or health subdivisions. Some practitioners of traditional medicine are involved in
the primary health care programme (6).

There is no official recognition for the qualifications of traditional health practitioners.
However, there is a formal training programme in traditional medicine (6).
Burundi
There are no procedures for the official approval of traditional medical practices or
remedies. Traditional health practitioners are not licensed, and local officials are not
allowed to authorize the practice of traditional medicine in their administrative
and/or health subdivisions, nor are traditional medicine practitioners involved in
primary health care programmes at the local or national level in Burundi. Burundi
does not have any official or legislative texts regulating traditional medicine (6).
However, in Burundi’s Public Health Code of 1982 (15), which limits medical licences
to those persons with formal training in tropical medicine, it is stated that practitioners
currently treating patients by means of traditional medicine may continue to practise
under the conditions and in accordance with the detailed regulations laid down by the
Minister responsible for public health.

Burundi does not have any official training facilities or programmes for traditional
medicine (6).
Cameroon
Law 81/12 of 27 November 1981 approved the Fifth Five-Year Social, Economic, and
Political Development Plan (1981–1986) of Cameroon (16). Section 16-1.3.1.5 states the
following:
During the Fifth Plan, measures will be taken to lay down a joint strategy and
method to effectively integrate traditional medicine into the national health plan by
implementing a program on traditional medicine in conjunction with some of our
neighbouring countries.
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60
Under this plan, Cameroon created the Traditional Medicine Service within the Unit of
Community Medicine in the Yaounde Central Hospital and set up the Office of
Traditional Medicine in the Ministry of Public Health. A number of research projects
on traditional medicine and training programmes for traditional medicine
practitioners have also taken place (17).
Local officials are allowed to authorize the practice of traditional medicine in their
administrative and/or health subdivisions, and some traditional medicine practi-
tioners are involved in Cameroon’s primary health care programme (6).
Cape Verde
Cape Verde does not have any official legislative or regulatory texts governing the
practice of traditional medicine. There are no licensing procedures for traditional
medicine practitioners, nor are there any procedures for the official approval of
traditional medical practices and remedies. Traditional medicine practitioners are not
involved in Cape Verde’s primary health care programme at either the local or
national level (6).

Cape Verde does not have any official training facilities or programmes for traditional
medicine (6).
Central African Republic
The Central African Republic has local intersectoral councils for traditional medicine
and a registry of traditional health practitioners. However, there are no official
legislative or regulatory texts governing the practice of traditional medicine. There are
no licensing procedures for traditional medicine practitioners, nor are there any
procedures for the official approval of traditional medical practices and remedies.
Traditional medicine practitioners are not involved in the Central African Republic’s
primary health care programme at the local or national level (6).

The Central African Republic does not have official training facilities or programmes
for traditional medicine (6).
10
Africa
61
Chad
Although traditional medicine practitioners are involved in Chad’s primary health
care programme, Chad does not have any official legislative or regulatory texts
governing the practice of traditional medicine. There is no licensing process for
traditional medicine practitioners, nor are there procedures for the official approval of
traditional medical practices and remedies (6).

Chad has no official training facilities or programmes for traditional medicine (6).
Comoros
Comoros does not have official legislative or regulatory texts governing the practice of
traditional medicine. There is no licensing process for traditional health practitioners,
nor are there procedures for the official approval of traditional medical practices and
remedies. Traditional medicine practitioners are not involved in the primary health
care programme in Comoros at either the local or national level (6).

Comoros does not have official training facilities or programmes for traditional
medicine (6).
Congo
In rural areas, herbalists and spiritualists are the two most common practitioners of
traditional medicine. In urban areas, acupuncturists and natural medicine providers
— medical practitioners who treat with mineral and animal products — are more
common.
Through scientific analysis, independent researchers have confirmed the efficacy of a

number of Congolese traditional medical products — such as manadiar, antougine,
meyamium, and diazostimul — leading to their distribution throughout Africa.
Statistics
For the treatment of pathologies of the reproductive system, 59.9% of Congolese
women use traditional medicine. Of these women, 38.2% report having experienced
complications or side effects after using these medicines.
11
62
The traditional medicine branch of the Ministry of Health and Social Affairs was
created in 1974 to develop a national herbarium and determine the number of
traditional medicine practitioners in the country. In 1980, the National Union of Tradi-
Therapists of Congo was founded. In 1982, the traditional medicine branch was
expanded, becoming the Traditional Medicine Service. The Service, led by a
pharmacist, was charged with conducting research, enriching the national herbarium,
gathering medicinal formulas, popularizing traditional medicine, and integrating
traditional and allopathic medicine.
In 1987, the National Centre of Traditional Medicine was established to promote

research, manufacture traditional medical products, exchange information with other
traditional medicine institutions, train allopathic doctors and students in traditional
medicine, and teach techniques for the aseptic preparation of medicines to practi-
tioners of traditional medicine. Failure to collaborate with traditional medicine
practitioners and a poor relationship between traditional medicine practitioners and
allopathic practitioners proved to be obstacles to the Centre’s work.
Congo has official legislative/regulatory texts governing the practice of traditional

medicine. It also has local and national intersectoral councils for traditional medicine.
Local officials in Congo are allowed to authorize the practice of traditional medicine in
their administrative and/or health subdivisions. Some traditional medicine practi-
tioners are also involved in the primary health care programme of Congo; however, in
certain centres this integration is very weak (6).
There is a licensing process, a national association, and a registry of traditional health

practitioners. The Management of Health Services of the Ministry of Health, the
National Union of Tradi-Therapists, and other professional traditional medicine
associations review the qualifications of traditional medicine practitioners, although
there are no set criteria for these qualifications.
Traditional medicine practitioners are recognized by the Government and are well
tolerated. In 1996, legislation on the recognition of traditional medicine and
complementary/alternative medicine was drafted, but it has not yet been finalized
because of the 1997–1999 armed conflict. Under current regulations, only herbalists are
permitted to practise in the official health care system.

No training in traditional medicine is integrated into the university medical
curriculum.
Insurance coverage
An attempt has been made to standardize the fees of traditional medicine practitioners
in Congo, although no patient reimbursement exists for such fees (6).
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Africa
63
Côte d’Ivoire
Côte d’Ivoire has neither official legislative nor regulatory texts governing traditional
medicine. There is no licensing process for traditional health practitioners, nor are
there procedures for the official approval of traditional practices or remedies.
Traditional medicine practitioners are not involved with primary health care in Côte
d’Ivoire on either the local or national level (6).

Côte d’Ivoire does not have official training facilities or programmes for traditional
medicine (6).
Democratic Republic of the Congo
The Democratic Republic of the Congo retains health care legislation from the colonial
era, including the Decree of 19 March 1952 on the practice of medicine, as amended
(18, 19). The Decree grants exemplary status for traditional medicine practitioners, but
also places limitations on their practice. Section 15 states the following:
The provisions of this Decree shall not be applicable to nationals of the Belgian
Congo or of neighbouring African territories who, in population groups where such
customs prevail, carry out treatments and administer drugs in accordance with the
usage custom provided they do not constitute a breach of public order.
The Second Ordinary Congress of the Popular Revolutionary Movement in Zaire

adopted a resolution in November 1977 (20) encouraging research into the rehabilita-
tion and recognition of traditional medicine as a complement to allopathic medicine
and urging the establishment of a division dedicated to traditional medicine within
the Department of Health.
Equatorial Guinea
Equatorial Guinea has official legislative/regulatory texts governing the practice of
traditional medicine. There is a licensing process and a registry of traditional health
practitioners. However, Equatorial Guinea does not have procedures for the official
approval of traditional medical practices or remedies. Local officials in Equatorial
Guinea are not allowed to authorize the practice of traditional medicine in their
administrative and/or health subdivisions. Traditional medicine practitioners are not
involved in Equatorial Guinea’s primary health care programme (6).
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Equatorial Guinea has training facilities and programmes in traditional medicine for
both health providers and lay persons (6).
Insurance coverage
An attempt has been made to standardize the fees of traditional medicine practitioners
in Equatorial Guinea, although no patient reimbursement exists for such fees (6).
Ethiopia
Traditional medicine in Ethiopia includes medicinal preparations from plant, animal,
and mineral substances, as well as spiritual healing, traditional midwifery,
hydrotherapy, massage, cupping, counter-irritation, surgery, and bonesetting. Tradi-
tional medical practices and remedies are recorded in oral tradition and in early
medico-religious manuscripts and traditional pharmacopoeias, which, according to
the estimates of some historians, date back to the 15th century AD.
Traditional medicine is largely practised by traditional medicine practitioners,

although, particularly for certain common health problems, it is also practised at home
by the elderly and by mothers.
The Ethiopian Traditional Healers Association was organized to review the qualifi-
cations of practitioners where no regulations exist.
Statistics
Over 80% of the Ethiopian population rely on traditional medicine (21). This
represents the majority of the rural population and sectors of the urban population
where there is little or no access to allopathic health care.
In 1986, over 6000 practitioners of traditional medicine were registered with the
Ethiopian Ministry of Health (22).
Proclamation 100 of 1948, Penal Code 512/1957, and Civil Code 8/1987 all state
conditions for the practice of traditional medicine and the importance of the
development and use of traditional remedies. The 1974 change of government in
Ethiopia was followed by official attention to the promotion and development of
traditional medicine, particularly after the adoption of the Primary Health Care
Strategy in 1978. In November 1979, the Office for the Coordination of Traditional
Medicine (21, 23), which is now a full-fledged department directly under the Vice-
Minister of Health, was established to organize, train, and register traditional
medicine practitioners, and to identify, describe, and register those traditional
medicines with actual or potential efficacy. The Ministry of Health also incorporated
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traditional medicine into the National Ten-Year Perspective Plan 1984–1994 (24),
which called for the organization, training, and supervised use of traditional medicine
practitioners in strengthening and expanding primary health care services.
The Health Policy and the Drug Policy of 1993 both emphasize the need to develop the
beneficial aspects of traditional medicine through research and through its use in the
official health delivery services. Proclamation 1999 was issued based on the National
Drug Policy. In Article 6, Sub-Article 8 of the Proclamation, it is stated that the Drug
Administration and Control Authority shall prepare standards of safety, efficacy, and
quality of traditional medicines and shall evaluate laboratory and clinical studies in
order to ensure that these standards are met. The Authority shall also issue licences for
the use of traditional medicines in the official health services.

No officially recognized education is provided in traditional or complementary/alter-
native medicine.
Insurance coverage
There is no national health care insurance or private insurance covering traditional
medicine.
Gabon
Practitioners of traditional medicine in Gabon are involved in the country’s primary
health care programme. However, Gabon does not have official legislative or
regulatory texts governing the practice of traditional medicine. There are no licensing
procedures for traditional health practitioners, nor are there procedures for the official
approval of traditional medical practices and remedies (6).

Gabon does not have any official training facilities or programmes for traditional
medicine (6).
Gambia
Gambia has official legislative/regulatory texts governing the practice of traditional
medicine. There is a licensing process for traditional health practitioners and some
traditional medicine practitioners are involved in Gambia’s primary health care
programme (6).
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Gambia has a training programme in traditional medicine for health workers (6).
Ghana
Missionaries introduced allopathic medicine to Ghana during the colonial period.
After independence in 1957, the Government initiated a number of medical projects,
promoting allopathic medicine as Ghana’s official medical system (25). However,
successive governments have recognized both traditional and comple-
mentary/alternative medicine, including acupuncture, homeopathy, naturopathy,
osteopathy, and hydropathy.
Traditional medicine practitioners use herbs, spiritual beliefs, and local wisdom in
providing health care.
There are a number of associations of traditional medicine practitioners, including the

Ghana Psychic and Traditional Medicine Practitioners’ Association, which was formed
in 1961 (26). In 1999, the Government brought all the traditional medicine associations
together under one umbrella organization, the Ghana Federation of Traditional
Medicine Practitioners’ Associations (25).
Statistics
In Ghana, about 70% of the population depend exclusively on traditional medicine for
their health care. There is approximately one traditional medicine practitioner for
every 400 people, compared to one allopathic doctor for every 12 000 people (27). With
over 100 000 traditional medicine practitioners uniformly distributed nationally, they
are not only more accessible to the public, but also the backbone of the health care
delivery system (28).
Restrictions contained in the Poisons Order 1952 limit the use of the substances listed
in the Order to registered medical practitioners.
The Medical and Dental Decree of 1972 and the Nurses and Midwives Decree of 1972
allow indigenous inhabitants of Ghana to practise traditional medicine, provided they
do not practice life-endangering procedures.
The Centre for Scientific Research into Plant Medicine was established in 1975. In
addition to its research capacity, the Centre operates a hospital providing both
traditional and allopathic medicine.
Until the passage of the Traditional Medicine Practice Act, the Government worked
with the Ghana Psychic and Traditional Medicine Practitioners’ Association to license
and register traditional medicine practitioners and to ensure a standard of care (29,
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30). The Traditional Medicine Practice Act 595 was drafted by traditional medical
practitioners, placed before the Parliament in 1999, and passed on 23 February 2000.
The Act establishes a council to regulate the practice of traditional medicine, register
practitioners and license them to practice and to regulate the preparation and sale of
herbal medicines.
The Act defines traditional medicine as “practice based on beliefs and ideas
recognized by the community to provide health care by using herbs and other
naturally occurring substances” and herbal medicines as “any finished labelled
medicinal products that contain as active ingredients aerial or underground parts of
plants or other plant materials or the combination of them whether in crude state or
plant preparation” (31). The Act is divided into four parts (26).
Part I concerns the Traditional Medicine Practice Council, including its establishment;
function; membership; tenure of members; meetings; the appointment of committees
such as Finance, General Purposes, Research, Training, Ethics, and Professional
Standards; granting of allowances to members; and the establishment of regional and
district offices.
Part II covers the registration of traditional medical practitioners. Clause 9 states that
no person shall operate or own a practice or produce herbal medicines for sale unless
registered under this act. The qualifications for registration are given in Clause 10.
Clause 11 provides for the temporary registration of foreigners who have a work
permit, satisfy the requirements for registration under this act, and have a good
working knowledge of English or a Ghanaian language. The rest of Part II deals with
matters concerning renewal of the certificate of registration, suspension of registration
of practitioners, cancellation of registration, and representation to the Council. In
Clause 13, it is provided that the Minister of Health, on the recommendation of the
Council in consultation with recognized associations of traditional medicine
practitioners, may regulate the titles used by traditional medicine practitioners based
on the types of services rendered and the qualifications of the practitioners.
Part III covers matters concerning the licensing of practices: mandatory licensing;
method of application and conditions for licensing; issuance and renewal of licences;
acquisition and display of licences; ownership and operation of a practice by a foreign
practitioner; revocation, suspension, and refusal to renew a licence and
representations to the Council by aggrieved persons; powers of entry and inspection
by an authorized inspector; and notification of death to a coroner.
Part IV concerns staff for the Traditional Medicine Practice Council as well as financial
and miscellaneous provisions, such as the appointment of a registrar, the provision of
the Register of Traditional Medicine Practitioners, offences, and regulations. Clause 41
states categorically that the Act shall not derogate from the provisions of the Food and
Drugs Board Law PNDCL 305B.
The Traditional Medicine Unit (26, 31) under Ghana’s Ministry of Health was created
in 1991. In 1999, this was upgraded to the status of a directorate. The Ministry, in
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collaboration with the Ghana Federation of Traditional Medicine Practitioners’
Associations and other stakeholders, has developed a five-year strategic plan for
traditional medicine, which outlines activities to be carried out from 2000 to 2004. It
proposes, among other things, the development of a comprehensive training
programme in traditional medicine from basic to tertiary levels.
Volume 1 of the Ghana Herbal Pharmacopoeia (31) contains scientific information on 50

medicinal plants. A second volume is currently in preparation. Efforts are being made
to integrate traditional medicine into the official public health system. It is expected
that by the year 2004, certified efficacious herbal medicines will be prescribed and
dispensed in hospitals and pharmacies.
administrative and/or health subdivisions (6).
The Government of Ghana has set aside the third week of March every year as
Traditional Medicine Week, starting from the year 2000 (31).

Training by apprenticeship is required, accepted, and promoted for practitioners of
traditional medicine. The Ministry of Health is working towards including traditional
medicine in the curricula of allopathic medical schools and towards the introduction
of a diploma course in traditional medicine at the postgraduate level. As a step in this
direction, in the year 2000, the Ministry is planning to assess the training needs for
traditional medicine practitioners (25). There are official training programmes for
traditional birth attendants (30).
Guinea
In Guinea, Ordinance 189 PRG of 18 September 1984 (32) states that the profession of
physician can only be practised by persons with a Guinean diploma of Doctor of
Medicine, a foreign diploma granting equivalent status, or a foreign diploma that
entitles its holder to practise medicine in his or her country of origin. Various activities
that constitute the unlawful practice of medicine are set out in Section 9. However,
traditional medicine seems relatively unaffected by this ordinance.
Guinea has official, applied, legislative/regulatory texts governing the practice of

traditional medicine. There is a licensing process and a registry of traditional health
practitioners as well as local and national intersectoral councils for traditional
medicine (6). Local officials are allowed to authorize the practice of traditional
medicine in their administrative and/or health subdivisions, and some traditional
medicine practitioners are involved in Guinea’s primary health care programme (6).
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Guinea-Bissau
Guinea-Bissau has local and national intersectoral councils for traditional medicine.
However, Guinea-Bissau does not have any official legislative or regulatory texts
governing the practice of traditional medicine and there is no licensing process for
traditional health practitioners. Local officials are not allowed to authorize the practice
of traditional medicine in their administrative and/or health subdivisions and
traditional medicine practitioners are not involved with Guinea-Bissau’s primary
health care programme (6).
Kenya
Statistics
Traditional birth attendants deliver most of the babies born in Kenya — up to 75% in
some regions (33).
Traditional medicine started being incorporated into Kenya’s national health policy
framework in the late 1970s. Kenya’s Development Plan 1989–1993 (34) recognized
traditional medicine and made a commitment to promoting the welfare of traditional
medicine practitioners. The Ministry of Health and provincial authorities require the
registration of traditional medicine practitioners.
In 1999, Kenya’s patent law was revised to include protection for traditional
medicines.

Traditional birth attendants participate in official training programmes in some
districts.
Lesotho
Lesotho has two statutes that regulate the practice of traditional medicine and limit it
to registered practitioners. Section 2 of the Natural Therapeutic Practitioners Act of
1976 (35) defines natural therapeutics as the provision of services for the purpose of
preventing, healing, or alleviating sickness or disease or alleviating, preventing, or
curing pain “by any means other than those normally recognized by the medical
profession”. Natural therapeutics includes methods commonly employed by
homeopaths, naturopaths, osteopaths, chiropractors, and acupuncturists. Section 3
prohibits non-registered persons from practising as natural therapeutic practitioners.
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Applicants for registration must be at least 21 years of age, citizens of Lesotho, and
recommended as qualified by the Natural Therapeutic Practitioners Association of
Lesotho. The Registrar of the register of natural therapeutics must be satisfied that it is
in the public interest to permit the applicant to practise. Persons who were practising
prior to the date of commencement of the Act are deemed to be qualified. Authorised
persons under the Act are prohibited from carrying out certain procedures, including
performing operations or administering injections, practising midwifery, withdrawing
blood, treating or offering to treat cancer, performing internal examinations, or
claiming to be or leading people to infer that the individual is an allopathic physician.
The Act also prohibits preventing any person from being treated by an allopathic
physician or improperly influencing any person to abstain from such treatment.
The Lesotho Universal Medicinemen and Herbalists Council Act of 1978 (36) followed
the Act of 1976. It provides for the establishment of the Universal Medicinemen and
Herbalists Council. Section 5 states the objectives of the Council: to promote and
control the activities of traditional medicine practitioners, to provide facilities for the
improvement of skills of traditional medicine practitioners, and to bring together all
traditional medicine practitioners into one associated group. The Council is required
to do all that is necessary to attain these objectives and to ensure that every traditional
medicine practitioner has a valid licence to practise as such. The Council must also
keep a register of all its members. Membership is open to every traditional medicine
practitioner who pays the prescribed fee. It is an offence to form or encourage the
formation of any other association of traditional medicine practitioners.

Lesotho has a training programme in traditional medicine for health workers (6).
Liberia
Liberia has official legislative/regulatory texts governing the practice of traditional
medicine. There is a registry of traditional health practitioners and there are local and
national councils for traditional medicine. Local officials are allowed to authorize the
practice of traditional medicine in their administrative and/or health subdivisions,
and some traditional medicine practitioners are involved in Liberia’s primary health
care programme. However, Liberia does not have licensing procedures for traditional
health practitioners or procedures for the official approval of traditional medical
practices and remedies (6).

Liberia has a training programme in traditional medicine for health workers (6).
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Madagascar
The National Centre of Applied Pharmaceutical Research (NCAPR), founded in 1976,
is composed of five technical departments: ethnobotanical and botanical, chemistry,
pharmacodynamics, galenic pharmacy, and experimental clinics. NCAPR has the
capacity to analyse herbal medicines from their ethnobotanical form to their
manufactured form.
NCAPR received financial support from the United Nations Development Programme
in 1984 to undertake several projects. In 1985, NCAPR and the World Health
Organization agreed to a four-year collaborative project on research into traditional
medicines. The main objectives were to establish an inventory of medicinal plants and
their indications, investigate the therapeutic and toxic effects of the registered plants,
and undertake research standardizing and improving the presentation of traditional
medicines.
In 1995, NCAPR began reviewing the practice of traditional medicine as a whole by

analysing the role of traditional medicine practitioners in the primary health care
system.
The National Tradi-Therapist Association of Madagascar was formed in 1997.
Statistics
Serving a population of 12.3 million, there are 4500 allopathic physicians, 220
pharmacists, 360 dentists, 1635 midwives, 3124 nurses, 1282 sanitary aides, and more
than 10 000 practitioners of traditional medicine.
Traditional medicine practitioners are involved in Madagascar’s primary health care
programme (6).
In 1992, Madagascar had no legislative/regulatory texts governing the practice of

traditional medicine, no licensing process for traditional health practitioners, and no
procedures for the official approval of traditional medical practices or remedies (6). In
1996, a commission was created to study the legal aspects of traditional medicine with
the intention of regulating its practice. In 1998, a project to grant official legal
recognition to traditional medical practice was launched. In the same year, a census of
traditional medicine practitioners was conducted, and, in addition, a project in the
eastern and northern parts of Madagascar began integrating traditional medicine
practitioners into the official health system. In 1999, regulations for herbal medicines
were drafted. These were approved by Parliament in 2000.

Madagascar does not have any official training facilities or programmes for traditional
medicine for either health workers or lay persons (6).
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Malawi
The Malawi Medical Practitioners and Dentists Act of 1987 (37) makes detailed
provisions for the registration, licensing, and training of allopathic physicians and
dentists. Regarding traditional medicine practitioners, Section 61 reads:
Nothing contained in this act will be construed to prohibit or prevent the practice of
any African system of therapeutics by such persons in Malawi, provided that
nothing in this section shall be construed to authorize performance by a person
practising any African system of therapeutics of any act which is dangerous to life.
Some traditional medicine practitioners are involved in Malawi’s primary health care
programme (6).

Malawi has a training programme in traditional medicine for health workers (6).
Mali
Statistics
Seventy-five per cent of the population of Mali uses traditional medicine. There is
approximately one traditional medicine practitioner for every 500 inhabitants. Around
180 Herbalist Cards, 200 Therapist Cards, and 1000 Collaboration with the Traditional
Medicine Department Certificates have been issued. There are 32 associations for
practitioners of traditional medicine in the country.
The Department of Traditional Medicine and the National Research Institute of
Medicine and Traditional Medicine were created in 1973. They were designated to
demonstrate the value of traditional medicine resources through scientific research
and to differentiate the roles of herbalists from those of other traditional medicine
practitioners, which included defining their respective status, regulations, and code of
ethics.
The Department of Traditional Medicine is mandated to inventory medicinal plants

and their indications, verify the therapeutic and toxic effects of the recorded plants,
undertake studies to improve and standardize the forms of presentation of traditional
medicines, train researchers in the fields of traditional medicine and traditional
pharmacopoeia, involve traditional medicine practitioners in the politics of primary
health care, write technical notices related to traditional medicine, and set up expert
advisory missions for national and international institutions interested in traditional
medicine in Mali.
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In order to fulfil this mandate, the Department has planned the following: a census of
traditional medical practitioners; an umbrella association to bring together the 32
traditional medicine practitioner associations; the production of improved traditional
medicines, some of which have status as essential medicine in Mali and are indexed in
the National Therapeutic List; the set up of phytochemical analyses as well as
pharmacological and clinical tests of medicinal plants; the training of national and
foreign researchers; and participation in symposiums, seminars, and workshops.
An order issued by the Minister of Public Health and Social Affairs on 16 May 1980
(38, 39) established a Scientific and Technical Committee to work in conjunction with
the National Research Institute of Medicine and Traditional Medicine. The Committee,
whose functions are defined in relation to the overall health care needs of the country,
has drawn up draft regulations on the practice of traditional medicine.
By Decree 94/282/P-RM of 15 August 1994, the Government of Mali regulated the

opening of private consultation clinics for traditional medicine, medicinal herbs stores,
and improved production units for traditional medicine. According to the Decree,
private consultation clinics for traditional medicine are establishments that provide
traditional medical care to patients. Medicinal herbs stores are airy and clean
premises, which possess shelves and a counter and are run by a chartered person. The
only purpose of the stores is to sell medicinal plants or medicines made from plants.
However, conventional pharmacists are also allowed to sell herbs. Improved
production units for traditional medicine are semi-industrial or industrial units that
transform raw materials into herbal preparations and herbal products.
Decree 95/1319/MSS-PA/SG of 22 June 1995 establishes organizational and functional

rules for the private consultation clinics, medicinal herbs stores, and improved
production units. Under this decree, membership in a registered and recognized
traditional health practitioner association facilitates one’s ability to obtain a certificate
of notoriety and morality. Chartered traditional medical practitioners, medical staff,
and retired traditional medicine paramedical staff may open private traditional
medicine consultation clinics. Chartered medicinal plant sellers, graduates from the
Katibougou Rural Polytechnic Institute (which specializes in water and forests) or its
equivalent, and graduates from the Superior Normal School (which specializes in
biology) or its equivalent are allowed to open medicinal herbs stores. Industrial
exploitation of medicinal plants is authorized only when it involves herbs, leaves,
stems, barks, and/or fruits and is permitted only when the plants are cultivated.
Collection of wild plants for industrial exploitation is not permitted. Improved
traditional medicine production units must be supervised by a pharmacist, and a
pharmacist, chemical engineer, or biologist must monitor the control procedures.
Article 8 of Decree 95/009/P-RM of January 1995, establishing permits for

pharmaceutical products, outlines special rules for requests involving traditional
medicines made from plants. These requests should include the name and address of
the person in charge of putting the product on the market, and if the latter is not the
manufacturer, the name and address of the manufacturer; a summary of the product’s
characteristics (name, form, pharmacological properties, therapeutic indications,
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posologies, and administration); chemical and pharmaceutical files; toxicological and
pharmacological files; a clinical file; 10 samples of the product; and a receipt for the
registration fee.
administrative and/or health subdivisions. Some traditional medicine practitioners
are involved in Mali’s primary health care programme (6).

Created in 1996, the Faculty of Medicine, Pharmacy, and Odonto-Stomatology of the
University of Mali is responsible for training allopathic physicians and pharmacists.
Among the requirements for students and researchers are courses directly related to
traditional medicine and traditional pharmacopoeia, such as Botany, Pharmacognosy,
Vegetal Substances, Chemistry, Pharmaceutical Legislation, and Public Health. Other
schools, faculties, and institutes that collaborate with the Department of Traditional
Medicine on training and research in traditional medicine include the Rural
Polytechnic Institute, the Superior School of Health, the Central School of Commerce
and Industry, the Rural Economy School, the Faculty of Science and Technology, and
the Faculty of Arts, Languages, and Human Sciences.
Universities, organizations, and international and foreign research centres — such as

universities in Burkina Faso, Côte d’Ivoire, France, Italy, Norway, and Senegal; the
Centers for Disease Control and the National Institutes of Health, both in the United
States; and ACCT, CAMES, and the World Health Organization — collaborate
together on postgraduate training, research, thesis supervision, and examination
boards.
Periodic meetings, seminars, and workshops have been organized with traditional
medicine practitioners, sometimes through their associations. The main points of
national health programmes on AIDS, mental health, and family health have been
presented with the intention that traditional medicine practitioners act as
intermediaries, informing the public, and in recognition of the fact that traditional
medicine practitioners are involved in patient care. The Department of Traditional
Medicine organizes and supervises exploratory meetings and missions between
associations of traditional medicine practitioners and their foreign partners.
Each year the Department of Traditional Medicine organizes open houses on health
information, education, and communication in traditional medicine. Radio and
television programmes on traditional medicine with independent traditional medicine
practitioners, representatives of associations, or persons in charge of technical services
are regularly transmitted on public and private stations.
Insurance coverage
National health insurance covers allopathic medical care for only 500 000 to 1 000 000
of Mali’s 11 000 000 inhabitants. It does not cover traditional or complementary/alter-
native medical care.
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Mauritania
Adopted in 1981, Decision 1831 (40) established a working group to examine problems
concerning traditional medicine and traditional pharmacopoeia. Section 2 of the
Decision reads:
The task of the working group shall be to determine the situation of traditional
medicine and the traditional pharmacopoeia in Mauritania and, in particular:
♦ To examine the most appropriate and realistic ways and means of establishing an
honest dialogue between the official health services and traditional practitioners
in the spirit of the objective of health for all by the year 2000 through primary
health care; and
♦ To propose the most appropriate mechanisms for identifying traditional

practitioners who are amenable to such dialogue in order to determine and
acknowledge the part that they can play in the system of comprehensive health
care (health promotion, prevention of disease and disability, diagnosis and early
treatment of disease, and rehabilitation).
Section 56 of Ordinance 83–136 (41) on the practice of medical professions states that
the Ordinance does not apply to traditional medicine and traditional pharmacopoeia,
as they are to be covered by separate legislation.
However, as of 1992 (6), Mauritania did not have official legislative/regulatory texts
governing the practice of traditional medicine, any licensing process for traditional
practitioners, or procedures for the official approval of traditional medical practices
and remedies. Traditional medicine practitioners are not involved in Mauritania’s
primary health care programme.

Mauritania does not have any official training facilities or programmes for traditional
medicine (6).
Mauritius
The Ayurvedic and Other Traditional Medicines Act of 1989 (42) governs traditional
medicine in Mauritius. In this Act, traditional medicine is defined as “the practice of
systems of therapeutics according to homeopathy, Ayurvedic, and Chinese methods”.
The central provisions of the legislation include the establishment of a regulatory
body, the Traditional Medicine Board, and a registration system that requires
practitioners to obtain a diploma in traditional medicine.
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The Traditional Medicine Board, established in Section 3 of the Act, is composed of
Government officials, medical practitioners, persons knowledgeable in traditional
medicine, and laypersons. The Board’s functions, set out in Section 8, include
disciplinary responsibilities, publication of a code of practice governing standards of
professional conduct and ethics, and compilation of an annual list of traditional
medicine practitioners.
The registration system for traditional Chinese medicine practitioners requires

applicants to hold a diploma in traditional medicine. Under Section 24, non-registered
persons are not entitled to practise any act of traditional medicine for gain, unless
exempted from registration. However, no exemptions are listed in the Act.
Unregistered persons are also prohibited from presenting themselves as registered
practitioners. The Minister responsible for health has the power to make regulations,
set out the basic qualifications required for studying traditional medicine, and
establish the terms and conditions under which it may be practised. The Minister also
has the power to impose restrictions on the practice of any aspect of traditional
medicine.
administrative and/or health subdivisions in Mauritius (6). There is no chiropractic
law.
Mozambique
Mozambique does not have official legislative/regulatory texts governing the practice
of traditional medicine, any licensing process for traditional health practitioners, or
procedures for the official approval of traditional medical practices and remedies (6).
However, in 1991, a proposal was put forward for a three-year programme to establish
a foundation for collaboration between the National Health Service and the
practitioners of traditional medicine in Mozambique. The proposal suggested that
traditional medicine practitioners constitute a separate, parallel, and self-regulating
health service that collaborates with the Mozambique Government in the realization of
specific public health goals. In this regard, the three-year programme would do the
following:
♦ establish workshops to train traditional medicine practitioners in the treatment of

priority diseases;
♦ establish a research-derived information base about traditional beliefs and

practices;
♦ educate Government health workers at all levels in traditional beliefs and

practices;
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♦ coordinate research in traditional medicines, although, due to a tight budget, this
research would not be funded by the Government itself.
Collaborative programmes with traditional medicine practitioners also take place

under the umbrella of the Department of Health. In addition, there are a number of
programmes sponsored by non-governmental organizations, most of which
collaborate with either district or provincial health authorities (43).
Namibia
Before independence, health services were fragmented along racial lines, and tradi-
tional medicine was outlawed. After Namibia’s independence in 1990, traditional
medicine was legalised. Since then, the Ministry of Health and Social Services has
adopted the primary health care approach to the delivery of health services, and major
restructuring has been undertaken. The Namibia Eagle Traditional Healers
Association was created in 1990.
Statistics
According to the 1994 Lumpkin Report (44), there is at least one traditional medicine
practitioner per 500 people in the Kavango and Owambo regions. In the Caprivi
region, there is about one traditional medicine practitioner per 300 people. In
Windhoek (Katutura), the ratio is one traditional medicine practitioner per 1000
people. There are three chiropractors practising in Namibia (45).
A joint study by the Ministry of Health and Social Services and World Health
Organization in 1997 reported that traditional medicine practitioners in Namibia can
be classified as herbalists, faith-herbalists, diviner-herbalists, diviners, faith healers,
and traditional birth attendants.
The Official National Primary Health Care/Community-based Health Care Guidelines
were launched in 1992.
In 1994, Lumpkin carried out a preliminary survey on the use of traditional medicine
in the country. The resulting report, Traditional Healers and Community Use of
Traditional Medicine in Namibia, was submitted to the Ministry of Health and Social
Services (44). Also in 1994, the Namibian Parliament passed an act requiring all health
workers, including traditional medicine practitioners, to become legally registered.
The act delegated each professional group to elect a board to facilitate the registration
process. In 1996, the Namibian Traditional Medical Practitioners Board was created.
In 1997, the Ministry of Health and Social Services and the World Health Organization
jointly undertook a study entitled Scientific Evaluation, Standardization, and Regulation of
Traditional Medical Practices in Namibia. The findings of this study guided the
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development of the 1998 draft Traditional Healers Bill. They were also used to
prioritize activities and to inform the planning process for the 2000–2002 programme
on the regulation and integration of traditional medicine.
The Traditional Healers Bill will establish the Traditional Healers Council to oversee
the registration and regulation of the practice of traditional medicine providers. The
Council will be given the task of supervising and controlling the practice of traditional
medicine practitioners, fostering research into traditional medicines, and making loans
or grants available to traditional health practitioners. Traditional medicine
practitioners in Namibia, many of whom come from other African countries, are not
currently registered and operate without any guidelines from the Ministry of Health
and Social Services. The aim of the Bill is to protect the public from dangerous and
opportunistic practices as well as to promote acceptable aspects of traditional
medicine in Namibia.
Once legislation is in place, the Government intends to include traditional medicine

practitioners in community-based health care programmes and incorporate the
traditional medical system into the country’s official health services referral system.
The Allied Health Service Professions Act of 1993 (46) permits the relevant Minister to
create a professional board to regulate the chiropractic profession. The objectives of
the board, stated in Section 2, shall be to assist in promoting health, oversee
professional training, and control the practice of chiropractic.

According to the joint study by the Ministry of Health and Social Services and World
Health Organization in 1997, all traditional medicine practitioners, except traditional
birth attendants, undergo apprenticeships ranging from one to three years.
Niger
In Niger, candidates for the licence to practise traditional medicine are assigned to the
National Hospital in Niamey (47), where they practice under the supervision of the
Chief Physician. Once satisfied with the skills of the traditional medicine practitioner,
the Chief Physician then recommends that the Ministry of Public Health and Social
Affairs issue a licence.
A 1989 order established the Committee for Studies on Traditional Medicine and
Traditional Pharmacopoeia (48). The Committee’s tasks include formulating the basic
premises for a national policy on traditional medicine, preparing statutes for a
national institution to be responsible for improving and developing the regulation of
traditional medicine, and drafting legislation governing the practice of traditional
medicine.
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Nigeria
There has been a rapid expansion of allopathic health care in Nigeria over the last
three decades, including an increase in the number of allopathic health care providers.
At the same time, because the majority of Nigerians use traditional medicine, the
Government of Nigeria has shown appreciation for the importance of traditional
medicine in the delivery of health care.
Though informal interaction between the Government and traditional medicine
practitioners can be traced back to the 19th century, formal legislation promoting
traditional medicine dates to 1966 when the Ministry of Health authorized the
University of Ibadan to conduct research into the medicinal properties of local herbs.
Efforts to promote traditional medicine continued throughout the 1970s in the form of
conferences and training programmes. In the 1980s, policies were established to
accredit and register traditional medicine practitioners and regulate the practice of
traditional medicine. In 1984, the Federal Ministry of Health established the National
Investigative Committee on Traditional and Alternative Medicine. A committee to
research and develop traditional and complementary/alternative medicine was
formed by the Federal Ministry of Science and Technology in 1988 (49).
The Nigerian Medical and Dental Practitioners Act of 1988 (50) forbids the practice of
medicine or dentistry by unregistered practitioners, specifically the issuance of death
certificates, performance of post-mortems, or certification of leprosy or mental
disability. However, traditional medical activities are protected by a provision in
Section 17.6, which reads as follows:
Where any person is acknowledged by the members generally of the community to

which he belongs as having been trained in a system of therapeutics traditionally in
use in that community, nothing in [the provisions of the Act dealing with offences]
shall be construed as making it an offence for that person to practise or hold himself
out to practise that system; but the exemption conferred by this subsection shall not
extend to any activity (other than circumcision) involving an incision in human
tissue or to administering, supplying, or recommending the use of any dangerous
drug within the meaning of Part V of the Dangerous Drugs Act.
Registration requirements for chiropractors and osteopaths are outlined in the Medical
Rehabilitation Therapists (Registration, etc.) Decree of 1988 (51).
A 1992 decree (52) created the National Primary Health Care Development Agency
with a broad mandate concerning health matters, including the endorsement of
traditional birth attendants. Among other things, the Agency is responsible for
supporting village health care systems by
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♦ paying special attention to and providing maximum support for the training,
development, logistic support, and supervision of village health workers and
traditional birth assistants, along with the relationship between those workers and
their communities and the mechanisms that link those workers to other levels of
the health system;
♦ paying special attention to the involvement of women and grassroots organization

of women in the village health system.
In 1994, all state health ministries were mandated to set up boards of traditional
medicine in order to enhance the contribution of traditional medicine to the nation’s
official health care delivery system (49).
The National Traditional Medicine Development Programme was established in 1997.

Since then, the Federal Ministry of Health has been instituting measures to formally
recognize and enhance the practice of traditional medicine. These measures include
the constitution and inauguration of the National Technical Working Group on
Traditional Medicine; development of policy documents on traditional medicine,
including the National Policy on Traditional Medicine, National Code of Ethics for the
Practice of Traditional Medicine, the Federal Traditional Medicine Board Decree, and
Minimum Standards for Traditional Medicine Practice in Nigeria; and advocacy for
traditional medicine at all levels and in relevant forums, such as the National Council
on Health (since 1997), Consultative Meetings of the Honourable Minister of Health
with State Commissioners for Health and Local Government Chairmen (in 1999), and
the Presidential Think Tank Forum (in 1999).
In 2000, the Traditional Medicine Council of Nigeria Act was proposed. The functions
of the Council include facilitating the practice and development of traditional
medicine; establishing guidelines for the regulation of traditional medical practice to
protect the population from quackery, fraud, and incompetence; liaising with state
boards of traditional medicine to ensure adherence to the policies and guidelines
outlined in the Federal Traditional Medicine Board Act; establishing model traditional
medicine clinics, herbal farms, botanical gardens, and traditional medicine
manufacturing units in the geopolitical zones of the country; and collaborating with
organizations with similar objectives within and outside Nigeria. The Nigeria Medical
Council is contemplating integrating homeopathy into the country’s health care
delivery system (53).
Rwanda
Rwanda has local and national intersectoral councils for traditional medicine and a
registry of traditional health practitioners. However, Rwanda does not have official
legislative/regulatory texts governing the practice of traditional medicine, a licensing
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process for traditional health practitioners, or procedures for the official approval of
traditional medical practices and remedies (6).

Rwanda has traditional medicine training facilities for lay persons (6).
Sao Tome and Principe
Sao Tome and Principe has local and national intersectoral councils for traditional
medicine. However, there are no official legislative/regulatory texts governing the
practice of traditional medicine, no licensing process for traditional health
practitioners, and no procedures for the official approval of traditional medical
practices or remedies. Traditional medicine practitioners are not involved in Sao Tome
and Principe’s primary health care programme (6).

Sao Tome and Principe does not have any official training facilities or programmes for
traditional medicine (6).
Senegal
Despite repressive laws against the practice of traditional medicine during the colonial
period, almost every village in Senegal has a traditional medicine practitioner (54).
The Experimental Centre for Traditional Medicine was established in Senegal in 1987.
It now has an active patient roster of over 30 000 persons and is made up of a
professional staff of both allopathic and traditional medicine practitioners (55).
Whether or not spiritualists should be considered as traditional medicine practitioners

is currently being debated in Senegal.
Traditional medicine was officially recognized by the Government of Senegal in 1985
(55). Senegal has a registry of traditional health practitioners (6). The Health Ministry
advocates the promotion and rehabilitation of traditional medicine and traditional
pharmacopoeia. There are official strategies and activities to encourage collaboration
between traditional and allopathic medical practitioners.

Senegal has traditional medicine training facilities for lay persons (6).
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Seychelles
Seychelles does not have official legislative/regulatory texts governing the practice of
traditional medicine, a licensing process for traditional health practitioners, or
procedures for the official approval of traditional medical practices and remedies.
Practitioners of traditional medicine are not involved in Seychelles’ primary health
care programme (6).

Seychelles has no official training facilities or programmes in traditional medicine (6).
Sierra Leone
In Sierra Leone, the Medical and Dental Surgeons Act of 1966 (56) states that nothing
in the Act is to be construed as prohibiting or preventing the practice of “customary
systems of therapeutics”, provided that such systems are not dangerous to life or
health. The Medical Practitioners and Dental Surgeons Decree of 1994 (57) repeals the
Medical and Dental Surgeons Act of 1966. However, it retains exemptions for
traditional medical practitioners. Section 43 reads as follows:
Nothing in this Decree shall be construed to prohibit or prevent the practice of

customary systems of therapeutics or the practice of druggists authorized by any
law; but nothing in this Decree shall be construed to authorize the practice of any
customary system of therapeutics which is dangerous to life or health.
In Sierra Leone, some traditional medicine practitioners are involved with the primary
health care programme (6).
The Traditional Medicine Act of 1996 regulates the profession of traditional medicine
and controls the supply, manufacture, storage, and transportation of herbal medicines.
The Act establishes the Scientific and Technical Board on Traditional Medicine and
two committees under it: the Disciplinary Committee to advise the Board on matters
relating to the professional conduct of traditional medicine practitioners and the
Drugs Committee to advise the Board on the classification and standardization of
traditional medicines.
The Scientific and Technical Board is charged with securing the highest practicable
standards in the provision of traditional medicine in Sierra Leone by promoting the
proper training and examination of students of traditional medicine, controlling the
registration of traditional health practitioners, and regulating the premises where
traditional medicine is practised.
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It is provided in the Traditional Medicine Act that the Board shall have a registrar who
shall make and keep the Register of Traditional Medical Practitioners. Anyone whose
name is entered in this Register shall be regarded as a member of the Sierra Leone
Traditional Healers Association. Cancellation and suspension of registration, annual
publication of the list of registered traditional medicine practitioners, restriction on
use of the title “Traditional Medical Practitioner”, and the provision of medical aid by
traditional medicine practitioners are also covered by the law. Part IV of the Act
contains a list of the diseases for which traditional medical providers may not
advertise treatments.

Sierra Leone has no official training facilities or programmes in traditional medicine
(6).
South Africa
Traditional healers — in South Africa known as inyangas, sangomas, and witchdoctors
— have a crucial role in providing health care to the majority of South Africans. They
are deeply interwoven into the fabric of cultural and spiritual life. In 1980, the
Traditional Healers’ Organization was created.
The National Department of Arts, Culture, Science, and Technology funds consortium
research projects into traditional medicines (58).
Statistics
Traditional healers are present in almost every community. They are the first health
providers to be consulted in up to 80% of cases, especially in rural areas (59). There are
over 200 000 traditional healers in South Africa and only 27 000 allopathic medical
practitioners. The Traditional Healers’ Organization currently represents more than
180 000 traditional healers from South Africa and a number of neighbouring countries,
including Swaziland, Zambia, and Zimbabwe (60). There are approximately 200
chiropractors practising in South Africa (45).
Every year 1500 tons of traditional medicines are sold in medicine markets in Durban
alone. The traditional medicine industry is worth up to 2 300 000 South African rand
per year.
South Africa regulates general traditional healers, herbalists, chiropractors,
homeopaths, osteopaths, and naturopaths under the Associated Health Service
Professions Act of 1982, as amended (61). This Act sets up a registration and licensing
scheme for various professions. Registration entitles medical providers to practise for
gain and call themselves members of that profession. Practice for gain by a non-
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84
registered person is an offence punishable by a fine and/or imprisonment of up to one
year.
To qualify as a traditional healer, one has to serve an apprenticeship of between one

and five years and must be well known within the community one serves and
amongst other traditional healers. Qualified traditional healers register with the
Traditional Healers’ Organization and are given a book to certify that they are
qualified healers. The qualifications are valid in Africa, Asia, Latin America, Europe,
and Australia (60). However, Section 41 of the Associated Health Service Professions
Act of 1982 states that the provisions of the Act shall not be read to “derogate from the
right which a medicine man or herbalist contemplated in the Code of Zulu Law may
have to practise his profession”. The South African law also imposes restrictions on
the professional nomenclature that can be adopted by traditional healers. Use of the
title “Medical Practitioner”, or a title suggesting that its holder is qualified as an
allopathic medical practitioner, is prohibited.
Applicants for registration as chiropractors must show they hold a degree, diploma, or
certificate demonstrating sufficient proficiency in chiropractic. Such qualifications are
not, in contrast, required for the registration of an osteopath or naturopath. The
Associated Health Service Professions Board may, on an individual basis, impose
restrictions on the kind of work that can be carried out by chiropractors or require
applicants for registration to obtain further practical experience, on terms stipulated
by the Board.
Chiropractors and osteopaths are prohibited from performing operations,

administering injections (other than intramuscular or hypodermic injections),
practising obstetrics, and taking or analysing blood samples. Additionally,
chiropractors and osteopaths may not “treat or offer to treat cancer or prescribe a
remedy for cancer or pretend that any article, apparatus, or substance will or may be
of value for the alleviation of the effects or for the curing or treatment of cancer“.
There is also a prohibition against preventing or improperly discouraging a person
from obtaining treatment by an allopathic physician or health care professional.
Osteopaths are subject to further restrictions, which, among other things, bar them
from performing internal examinations or reading or interpreting Roentgen plates as
part of a clinical diagnostic procedure.
In August 1998, the South African Parliament decided to enlist the help of traditional
healers in achieving major goals in primary health care. However, whether traditional
healers should become part of the Department of Health itself or belong to their own
association in affiliation with the Department of Health remains controversial (59).
The National Department of Agriculture governs traditional medicines via the

National Plant Genetic Resource Committee, of which a traditional healer is a
member. The National Department of Health produced the National Drug Policy. For
the purpose of implementing the National Drug Policy with respect to traditional
medicines, the National Department of Health established the National Reference
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85
Centre for Traditional Medicines. Traditional medicines are included in the Drug
Policy section of the Government’s Reconstruction and Development Programme.
The goals of the Traditional Medicines Programme of the Department of Pharma-

cology, University of Cape Town (62, 63), are to promote the use of safe, effective, and
high-quality essential traditional medicines; to promote the documentation and
scientific validation of traditional medicines; to contribute to primary health care by
providing appropriate information to traditional healers and other health pro-
fessionals; to support industrial development in this sector; and to contribute to the
training of traditional healers. In 1994, the Programme participated in formulating an
outline proposal on the registration and control of traditional medicines.
In 1998, the Parliament passed Act 132, the South African Medicines and Medical
Devices Regulatory Authority Bill (64), covering the registration and regulation of
traditional medicines and changing the regulation of medicines in the country. The Bill
establishes the South African Medicines and Medical Devices Regulatory Authority to
replace the Medicines Control Council, which was set up in 1965. The Medicines
Control Council held allopathic, traditional, and complementary/alternative
medicines to the same set of standards and procedures. The South African Medicines
and Medical Devices Regulatory Authority Bill, in contrast, makes provisions for
different procedures to be applied when registering allopathic medicines and
traditional and complementary/alternative medicines. This is done by establishing
separate expert committees for the two major types of medicine. In the case of
traditional medicines, issues of safety and quality take precedence over
demonstrations of efficacy. The aim is to regulate and not to prevent access to what
many people use in preference to allopathic medicines.

In the 1960s, due to pressure from the South African Medical Council, non-allopathic
medical colleges were closed. Those practising at the time were ‘grandfathered’ into a
closed register. Allopathic medical doctors retained the right to practise homeopathy
regardless of their level of homeopathic education. The Homeopathic Association of
South Africa is currently working to gain recognition for homeopathic education as a
pre-graduate and postgraduate university subject. The long-term vision is a chair of
homeopathy at one of the universities. As a first step, there are overtures to the South
African College of Medicine for accreditation and application for registration of a
South African Faculty of Homeopathy (53). There are two institutions offering six-year
chiropractic programmes leading to a Master’s degree (65).
Swaziland
In Swaziland, the Control of Natural Therapeutic Practitioners Regulations of 1978
(66) limits the definition of “natural therapeutic practitioner” to persons practising
chiropractic, homeopathy, naturopathy, or electropathy. The prohibitions on pro-
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86
fessional practice are similar to those in force in Lesotho. Some traditional medicine
practitioners are involved with Swaziland’s primary health care programme (6).

Swaziland has no official training facilities or programmes in traditional medicine (6).
Togo
Togo’s law on health practitioners holds exemptions in favour of providers of
traditional medicine. In the first paragraph of Section 68 of the Criminal Code of 1980
(67), the definition of the illegal practice of medicine very closely reflects Article L 372
of the French Code of Public Health. However, the second paragraph of Section 68,
states the following: “The above provisions do not apply to medical practitioners who
practise according to traditional methods.”
Togo has a registry of traditional health practitioners. Some traditional medicine

practitioners are involved with Togo’s primary health care programme (6).
Uganda
Practitioners of traditional medicine vastly outnumber allopathic doctors in Uganda
(68). The National Traditional Healers and Herbalists Association has recently put
forth a proposal to establish a hospital in Mengo, Kampala, where traditional health
care will be offered. This proposed 20-bed hospital would operate with facilities worth
US$ 8.9 million (69).
Traditional and Modern Health Practitioners Together against AIDS and other
diseases (THETA) (68) is an indigenous non-governmental organization dedicated to
improving mutually respectful collaboration between traditional and allopathic health
practitioners in Uganda. THETA is working with traditional medicine practitioners in
education, counselling, and improved clinical care for people with sexually
transmitted diseases, including HIV/AIDS.
The Medical Practitioners and Dental Surgeons Act 10 of 1968 prohibits unlicensed
persons from practising medicine, dentistry, or surgery. However, Section 36 allows
the practise of any system of therapeutics by persons recognized to be duly trained in
such practice by the community to which they belong, provided the practice is limited
to that person and that community. In Uganda, the Ministry of Health presides over
allopathic practitioners, while the Ministry of Women in Development, Culture, and
Youth presides over traditional medicine practitioners.
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The Government of Uganda has expressed interest in recognizing traditional health
systems and has set up, under the Ministry of Health, the Natural Chemotherapeutics
Research Laboratory to study the therapeutic potential of natural products (69). The
intention is eventually to include in the National Health Service those products
deemed efficacious. Research is conducted jointly with traditional medicine
practitioners.
The Government of Uganda is in the process of developing a health policy

emphasizing primary health care. The Health Review Commission (69) recommended
that the Ministry of Health work closely with traditional medicine practitioners to
achieve the objectives of health for all by the year 2000. The Commission specifically
recommended including traditional health practitioners as members of community
health teams and welcoming them to participate in primary health care.

THETA (68) organizes training programmes for traditional medicine practitioners and
is establishing and managing a resource and training centre to facilitate the collection
and dissemination of information on traditional medicine.
United Republic of Tanzania
Traditional medicine has been practised separately from allopathic medicine since the
colonial period. The practice of traditional medicine is threatened by a lack of written
documentation on traditional medical practices, which has made its promotion
difficult, and by a decline in biodiversity, including traditional medicinal resources, in
certain localities. There has also been a decline in the number of practitioners of
traditional medicine (70).
Beginning in the 1990s, complementary/alternative systems of health care have

emerged in Tanzania. These new medical options include magnetic therapy,
homeopathic medicine, massage, and traditional Chinese, Korean, and Indian
medicines.
The Medical Practitioners and Dentists Ordinance (71), which was constituted before
Tanzania’s independence and is still in operation, holds exemplary status for
traditional practitioners. Chapter 92.20 (72) states the following:
Nothing contained in this ordinance shall be construed to prohibit or prevent the

practice of systems of therapeutics according to native methods by persons
recognized by the community to which they belong to be duly trained in such
practice.
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88
Provided that nothing in this section shall be construed to authorize any person to
practise native systems of therapeutics except amongst the community to which he
belongs, or the performance of an act on the part of any persons practising any such
system which is dangerous to life.
In an effort to promote and standardize traditional medicine, the Government

established the Traditional Medicine Research Unit in 1974 as part of the University of
Dar es Salaam and the Muhimbili Medical Centre (73). In 1985, the Government of
Tanzania was in the process of developing a law to register and license traditional
practitioners.
In 1989, governance of traditional health services was shifted from the ministry
responsible for culture to the Ministry of Health, which has established a Traditional
Health Services Unit (70). This Unit is working to unify traditional health practitioners
and mobilize them to form their own association. The Unit is also involved in the
formation of a traditional medicine policy, the overall goal of which is to improve the
health status of the people through the use of effective and safe elements of traditional
health care. Traditional health services are officially recognized in the National Health
Policy of 1990 (73).

There has been no attempt to introduce or incorporate traditional medicine into the
training curricula of allopathic medical students.
Zambia
During the colonial period, traditional medicine was denigrated. After independence
in 1964, the Zambian Government did not enact legislation to regulate traditional
medicine, nor was a clear policy on the practice of traditional medicine postulated.
Nevertheless, traditional medicine continued to be practised and was tolerated by the
authorities (74). Currently, herbal medicine, naturopathy, traditional Chinese medi-
cine, reflexology, spiritualism, and other forms of medicine are practised in Zambia.
Both Zambians and foreign nationals practise traditional and complementary/alterna-
tive medicine.
Statistics
At least 70% of Zambians use traditional medicine. Traditional and complemen-
tary/alternative medicine is used and accepted by a great majority of the population,
regardless of ethnic, religious, or social background. There are more than 35 000
members of the Traditional Health Practitioners’ Association of Zambia, founded in
1978, and thousands of non-members (74).
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The Government recognizes traditional and complementary/alternative medicine and
there are national policies on traditional and complementary/alternative medicine.
The Traditional Health Practitioners’ Association reviews and registers traditional
practitioners for licensing. Although there are no official regulatory measures for
recognizing the qualifications of practitioners, plans are under way to develop such
regulations.
Traditional medicine and complementary/alternative medicine are neither integrated

with allopathic medicine nor into the national health system. However, Traditional
Birth Attendants and Community Health Care Workers practise at the level of pri-
mary health care.
The National Drug Policy has a chapter on traditional medicines, which discusses the
materia medica but not the practice of traditional medicine (74).

There is no formal training in traditional or complementary/alternative medicine at
any allopathic training institutions.
Insurance coverage
Traditional and complementary/alternative medicine are not covered by insurance in
Zambia.
Zimbabwe
During the colonial period, although huge amounts of funds were allocated to the
allopathic medical sector, no budgetary provisions were made for the traditional
medical sector. Zimbabwe’s independence in 1980 marked a turning point in the long
antagonistic relationship between allopathic and traditional medicine (75). The
Zimbabwe National Traditional Healers Association (ZINATHA) was formed the
same year (76, 77), having been proposed at a meeting of 100 prominent traditional
medical practitioners and Government officials organized by the then Minister of
Health, Dr H. Ushewokunze.
The goals of ZINATHA (76) are to promote traditional medicine and practice, promote
research into traditional medicine and methods of healing, promote training in the art
of herbal and spiritual healing, supervise the practice of traditional medicine and
prevent abuse and quackery, and cooperate with the Ministry of Health to establish
better working relations between traditional and allopathic practitioners.
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Statistics
In 1994, there were 11 000 workers in the allopathic health system in Zimbabwe. At the
same time, ZINATHA had 24 000 qualified members (69). There are now over 55 000
traditional medicine practitioners registered with ZINATHA (75). There are four
chiropractors practising in Zimbabwe (45).
In Zimbabwe, the Minister of Health presides over both allopathic and traditional
health sectors. In 1981, two significant statutes on the practice of traditional medicine
were enacted in Zimbabwe. The comprehensive scope of these acts provides a sharp
contrast to the general legalisation on the practice of traditional medicine adopted in
other jurisdictions. The Natural Therapists Act of 1981 (78) regulates the organization
and registration of natural therapists, a term that includes homeopaths, naturopaths,
and osteopaths. It is an offence for an unregistered person to engage in the practice of
these professions for gain or to claim to be a registered natural therapist. Licensing
legislation regulates the educational standards and practice of chiropractic (81).
The Traditional Medical Practitioners Council Act of 1981 (79) is one of the most
comprehensive pieces of legislation on the practice of traditional medicine that has
been enacted anywhere in the world. Under the terms of the Act, the practice of
traditional medicine includes every act the object of which is to treat, identify, analyse,
or diagnose, without the application of operative surgery, any illness of the body or
mind by traditional methods. The Traditional Medical Practitioners Council Act
recognizes ZINATHA as the association for traditional medicine practitioners in
Zimbabwe (80). This legislation also created the Traditional Medical Practitioners
Council.
The objectives of the Traditional Medical Practitioners Council are to supervise the
control and practice of traditional medical practitioners, promote the practice of
traditional medical practitioners, foster research into traditional medical practice,
develop knowledge of traditional medical practice, hold inquiries for the purpose of
the Traditional Medical Practitioners Council Act, and make grants or loans to
associations or persons where the Council considers this necessary or desirable for, or
incidental to, the attainment of the purposes of the Council.
The Minister of Health is to appoint a registrar to establish a register of traditional

medicine practitioners. The Traditional Medical Practitioners Council is to grant an
application for registration if it is satisfied that the applicant possesses sufficient skill
and ability to practise traditional medicine and is of good character. Where
appropriate, the Council may grant the applicant a qualification as a spirit medium.
The Minister of Health may also grant registration as an honorary traditional medical
practitioner, with or without qualification as a spirit medium, to traditional
practitioners of special standing. Registered practitioners may use the title “Registered
Traditional Medical Practitioner” or “Registered Spirit Medium”.
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An unregistered person commits an offence punishable by up to two years
imprisonment and/or a fine if he or she practises or carries on business for gain as a
traditional medical practitioner, whether or not purporting to be registered; pretends,
or by any means whatsoever holds himself or herself out to be a registered traditional
medical practitioner; or uses the title “Registered Traditional Medical Practitioner” or
any name, title, description, or symbol indicating or calculated to lead persons to infer
that he or she is registered as a traditional medical practitioner. Falsely claiming to be
a registered spirit medium constitutes a similar offence.
The Council has the authority to make by-laws to define “improper and disgraceful
conduct” in the case of registered traditional medical practitioners. A registered
practitioner who is found guilty of such conduct or who is grossly incompetent is
liable to disciplinary measures, which include cancellation or temporary suspension of
registration.
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The Americas
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The Americas
Argentina
Statistics
In Argentina, an estimated 3000 physicians and 500 pharmacists practise homeopathic
medicine (53). There are three practising chiropractors (45). Some kinesiologists are
also members of the chiropractic association (82).
Traditional medicine is regulated by Article 75-17 of the Constitution, Ley 23.302,
Decreto 1269-96, and Resolution 83-94 (82). Only professionally qualified doctors who
have graduated from recognized medical schools may legally practise homeopathy. In
November 1997, the Chamber of Deputies of Cordoba Province regulated the
prescription of homeopathic medications (53). There is no chiropractic law.

There are seven homeopathic schools offering regular three-year degree programmes
as well as intensive programmes (53). A chiropractic college is being established (82).
Bolivia
The principal specialities of traditional medicine practitioners are coca qawiri,
midwifery, aysiri, materos, qulliri, milluris, qaquidores, paqos, layqiri, and rezadores (83).
Statistics
In Bolivia, where 50.5% of the population is indigenous, the proportion of the
population with access to allopathic medicine ranges from 11% to 70%, depending on
the region (83). There is a strong preference for traditional medicine. In southern
Cochabamba, over 55% of the population prefer to use traditional medicine (83).
There are an estimated 5000 practising traditional health providers (83). There is one
practising chiropractor (45).
In 1985, the practice of traditional medicine was legally recognized (84). Laws
governing traditional medicine in Bolivia include Traditional Medicine Practice
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94
Regulation 198771-1984, Resolución Suprema 198771-84, and Personería Juridica de la
Sociedad Boliviana de Medicina Tradicional (82). In order to practice traditional
medicine in Bolivia, it is necessary to have an official licence granted by the Ministry
of Human Development. However, only an estimated 500 traditional medicine
practitioners have this permit (82). Revalidation of one’s Doctor of Chiropractic degree
is required to practice chiropractic.
The National Division of Maternal and Child Health (85) was established in 1982 with
regulations on the conduct of family health activities. This division is authorized to
regulate traditional birth attendants.
There is no official programme linking traditional medicine with allopathic medicine

(83). There is no formal registry of traditional medicine practitioners.
In 1982, the Ministry of Health established regulations on herbal medicines (84), and
as of January 2001, all homeopathic medicines must be registered (84).

In 1982, the Ministry of Health set up a training programme for traditional
practitioners at allopathic medical schools (84). KUSKA (a civil organization devoted
to multi-disciplinary research in health, education, agriculture, ecology, and eco-
tourism) has two schools of traditional medicine: INKARI in Cochabamba and the
Kallawaya Institute in La Paz. At these schools, experienced traditional health
practitioners offer seminars, workshops, lectures, meetings, and trimester courses, as
well as opportunities for students to observe and practice consultations and
treatments.
Formal courses, workshops, and seminars in traditional medicine are also available
through the official health sector. Workshops, principally sponsored by the Catholic
Church, are offered for nurses and health promoters (83). Traditional medical
knowledge may also be acquired through personal revelations and inspiration. In
Rahay Pampa, traditional medicine is frequently taught to successive generations
within a family.
Brazil
Statistics
In Brazil, there are an estimated 12 000 homeopathic physicians, 200 homeopathic
veterinarians, 100 homeopathic dentists, 1300 homeopathic pharmacists, and six
homeopathic laboratories (53). There is a chiropractic association in Brazil.
Regulations governing traditional medicine in Brazil include La Política de Atención
Integral a la Salud Indígena de FUNASA, which promotes respect for the traditional
systems of health of indigenous communities (82). In 1980, the Brazilian Medical
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95
Association recognized homeopathy as a medical speciality. In 1988, the Government
recognized homeopathy and included it in the National Health System (86). Since
1995, the Federal Council of Pharmacy has recognized and standardized the title of
“Specialist in Homeopathic Pharmacy” (53).

As of 1991, physicians seeking homeopathic specialization must complete a 1200-hour
course: 450 hours of theory, 450 hours of practice, and 300 hours of monographs. The
Feevale Central University and University of Anhembi Morumbi offer chiropractic
programmes recognized by the World Federation of Chiropractic.
Canada
In Canada, complementary/alternative and traditional medicines are known as
natural health products and are subject to food and drug regulations. Natural health
products include herbal medicines; traditional Chinese, ayurvedic, and native North
American medicines; homeopathic preparations; and vitamin and mineral
supplements.
There are a number of associations of complementary/alternative medical

practitioners. In 1983, the Chinese Medicine and Acupuncture Association of Canada
(CMAAC) was established as a national organization (87). CMAAC works to unite
practitioners and to lobby the Government for the regulation of traditional Chinese
medicine and acupuncture. In 1987, the World Federation of Acupuncture and
Moxibustion Societies was formed with the support of the World Health Organization.
In 1996, allopathic physicians interested in traditional and complementary/alternative
medicine in Canada created the Canadian Complementary Medical Association (88).
Statistics
Several reports from the late 1990s found that between 15% and 70% of the Canadian
population had used complementary/alternative medicine in the proceeding six to 12
months (89, 90, 91). A 1999 study, for example, reported 70% of Canadians had used
one or more natural health products in the preceding six months, but only 24%
consulted one or more complementary/alternative health practitioners (92).
The use of complementary/alternative medicine is increasing in Canada (92, 93). The

following chart represents findings of the 1999 Berger Monitor survey on the six-
month use of complementary/alternative health practitioners in 1993 and 1999 (92).
According to a study by the Fraser Institute (92), of the Canadians who have used
complementary/alternative medicine, 36% have consulted a chiropractor, 23% have
used relaxation techniques, 23% massage, 21% prayer, 17% herbal therapies, 12%
special diet, 12% folk remedies, 12% acupuncture, 10% yoga, 8% self-help groups, 8%
lifestyle diets, and 8% homeopathy.
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96
Respondents who had consulted a
practitioner of
Complementary/Alternative medicine 1993 1999
Chiropractors 9% 12%
Massage/masseuses 4% 10%
Herbalists 1% 3%
Acupuncturists 1% 2%
Homeopaths 1% 2%
Reflexologists 1% 2%
A significant proportion of Canadians report spending 30 Canadian dollars or more

per month on complementary/alternative health services or natural health products.
From 1996 to 1997, a total of 3.8 billion Canadian dollars was spent on complemen-
tary/alternative health care in Canada (92). The amount spent on vitamins and food
supplements is rising by 20% a year (88).
In general, the use of complementary/alternative health care in Canada (94) is higher

at younger ages, among women, among people with higher formal education and
higher incomes, and in the West. Canadian users of complementary/alternative
medicine have more good health habits and better overall health. However, these
differences are partly minimized when adjusted for age, education, and household
income. Users of complementary/alternative medicine make fewer visits than non-
users to both allopathic general practitioners and specialists.
The most common reasons for which patients consult complementary/alternative

practitioners are problems of the musculoskeletal system and connective tissue. These
complaints account for 56% of consultations. Other problems include respiratory
diseases, injuries, poisonings, ill-defined conditions, and special investigations.
Complementary/alternative practitioners provide most complementary/alternative

treatments. However, allopathic physicians are increasingly involved in the provision
of complementary/alternative medicine. There are approximately 4500 chiropractors
practising in Canada (45).
Canadian physicians choosing to provide alternative treatments must comply with
guidelines set by the relevant province’s College of Physicians and Surgeons. The
Federal Food and Drug Act does not recognize traditional Chinese doctors,
naturopaths, homeopaths, or herbalists. However, the recent Federal Report (supra)
noted that access to quality health care is tied to the education, training, and licensing
of practitioners and products. As such, it seems likely that Canada will soon give
formal recognition to more complementary/alternative practitioners.
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Most of the health care legislation, such as the Canada Health Act, focuses on
allopathic medical practitioners. However, the regulation of professionals is a
provincial matter, and many provinces have become tolerant of non-allopathic health
care providers. Ontario’s Regulated Health Professions Act, S.O. 1991, c.18 is an
example of the more inclusive legislation adopted by a number of provinces.
On 26 March 1999, the Federal Government accepted all 53 recommendations made by

the Standing Committee on Health in their report, Natural Health Products: A New
Vision. While the Health Minister’s formal acceptance of these recommendations will
not immediately change the status of natural health products in Canada, the policy
direction has been set. A transition team was created and it is now working to
implement these recommendations. One of the recommendations led to the creation of
the Office of Natural Health Products, which regulates the safety, quality, and proper
labelling of these products. It is also responsible for supporting epidemiological and
social science research and for the dissemination of information to Canadian
consumers to enable them to make informed self-care decisions.
Beginning in the spring of 2000, the Office of Natural Health Products invited
comments and suggestions from a wide range of interested Canadians — including
manufacturers, distributors, and retailers of natural health products — on the
formation of a regulatory framework for natural health products, covering their
production, import, sale, and use in Canada (95). In March 2001, the Proposed
Regulatory Framework for Natural Health Products was drafted. The Framework
contains provisions for natural products sold in Canada (96), including licensing of
products and sites, good manufacturing practices, labelling and packaging, and
reporting of adverse reactions. The intent is to address consumers’ concerns for safety
and product quality without being unduly restrictive of the natural health product
industry.
The Expert Advisory Committee on Complementary Medicines was recently formed

to provide scientific advice to the Therapeutic Products Programme of Health Canada
on issues regarding the safety, quality, and efficacy of natural health products (97).
Traditional Native North American medicine

In the Yukon Territory, the Health Act of 1990 (98) endorses traditional native North
American medical practices. Section 5 includes provisions to secure “aboriginal
control over traditional aboriginal nutritional and healing practices and to protect
these healing practices as a viable alternative for seekers of health and healing
services”. The Minister of Health also “promote(s) mutual understanding, knowledge,
and respect between providers of health and social services offered within the health
and social service system and the providers of aboriginal nutrition and healing”.
In Ontario (99), traditional birth attendants providing midwifery services to aboriginal

persons or members of an aboriginal community are exempt from the general rule that
restricts “managing labour or conducting the delivery of a baby” to allopathic
physicians, nurses, and midwives. Traditional birth attendants can adopt the title
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98
“Aboriginal Midwife” as a professional designation and portray themselves as
qualified to practise in Ontario.
Manipulative therapy
In at least nine Canadian provinces, special statutes restrict the practice of
manipulative therapy to persons who fulfil specific requirements and have been
registered and/or licensed (100). All provinces have laws regulating the practice of
chiropractic. In Ontario, manipulative therapy is regulated under the Regulated
Health Professions Act of 1991 (101) and the Chiropractic Act of 1991 (101). The Health
Professions Act states that it is an offence for a person to “move the joints of the spine
beyond the individual’s usual physiological range of motion using a fast, low-
amplitude thrust” unless the person is authorized by one of the listed health
profession acts, such as the Chiropractic Act. The Chiropractic Act limits the practice
of chiropractic to members of the College of Chiropractors. The legislation permits the
use of the title “Doctor” by members of the College of Chiropractors of Ontario.
No offence is committed under the Health Professions Act when an otherwise

impermissible joint movement is performed in the course of “treating a person by
prayer or spiritual means in accordance with the tenets of the religion of the person
giving the treatment” or where the treatment is performed by an aboriginal medical
practitioner providing traditional medicine services to aboriginal persons or members
of an aboriginal community.
Chiropractors have professional status in Alberta (102). In 1994, Alberta introduced

requirements for the continuing education of licensed chiropractors (103). Practi-
tioners must acquire 75 hours of continuing education every three years as a condition
for renewal of their annual licence. Full credit is given for participation in programmes
accredited with listed professional bodies. Credit may also be given for other
educational activities with an emphasis in chiropractic, such as research or university
studies.
In Saskatchewan, the Chiropractic Act of 1994 (104) repeals the 1978 Act on the same
subject and prohibits anyone other than a member of the Chiropractors’ Association
from using the titles “Chiropractor”, “Doctor of Chiropractic”, or “any word, title or
designation, abbreviated or otherwise, to imply that the person is engaged in or
qualified to engage in the practice of chiropractic.” Section 22 of the Act lays out the
restrictions on and exemptions to the practice of chiropractic in Saskatchewan:
1. No person other than a practising member shall engage, for fee or reward, in the
practice of chiropractic.
2. Subsection 1 does not apply to a person providing first aid or temporary

assistance in cases of emergency.
3. Nothing in this Act extends to or interferes with the privileges conferred on any
person who practices a profession, trade or calling that the person is licensed or
authorized to practise pursuant to any other Act.
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Traditional Chinese medicine and acupuncture
Health Canada, through the Therapeutic Products Programme, is actively pursuing
the National Initiative on Traditional Chinese Medicine (97). British Columbia,
Alberta, and Quebec include acupuncture among their regulated health professions.
Saskatchewan and the Yukon Territory have guidelines on the practice of
acupuncture.
A 1993 report by the British Columbia Health Professions Council (105) recommended
the designation of acupuncture as a health profession with three limitations:
acupuncture should not be used in the treatment of serious illnesses, such as cancer;
acupuncture should not be used as anaesthesia during surgery, unless supervised by a
physician or dentist; and the patient must be told to consult an allopathic physician,
dentist, or naturopath if acupuncture fails to improve the patient’s condition within
two months.
The Ministry of Health in British Columbia has agreed that traditional Chinese
medicine and acupuncture should be regulated. In April 1998, the British Columbia
Health Professions Council (106) recommended designating “the profession of
traditional Chinese medicine as a health profession under the Health Professions Act.”
The Council also recommended that a college be established to govern both
practitioners of acupuncture and practitioners of traditional Chinese medicine. This
college will ensure that practitioners complete adequate training based on
Government standards.
The Health Disciplines Act of 1980 (107) sets out a framework for the recognition and
regulation of health disciplines in Alberta. Acupuncture is governed by the
accompanying Acupuncture Regulation. In order to be registered as a member of the
acupuncture health profession, an applicant, who need not be an allopathic physician,
must complete both an approved programme of study and an examination.
Competence in English must also be demonstrated. However, this requirement may
be waived where the applicant practices under the supervision of an English-speaking
acupuncturist.
Before acupuncture treatment is administered in Alberta, the patient must have

consulted with an allopathic physician or dentist and informed the acupuncturist of
this. Acupuncturists are prohibited from implying to patients that acupuncture cures
diseases or advising patients to discontinue treatment recommended by an allopathic
physician or dentist. If an improvement in the patient’s condition does not occur
within six months, the patient must be referred to an allopathic physician or dentist.
In Alberta, permissible technical modes of practice are restricted to needle

acupuncture, electro-acupuncture, moxibustion, cupping, and acupressure. Only non-
invasive measuring equipment may be used in patient examinations. The
Acupuncture Regulation also lists a number of procedures that cannot be delegated to
non-acupuncturists, including taking patients’ medical histories, using diagnostic
instruments or therapeutic devices on patients, and inserting or removing
acupuncture needles.
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100
The Quebec Medical Act of 1973 (108) required the Bureau of the Ordre des Médecins
to enact rules for the training, practice, and annual registration of allopathic physicians
practising acupuncture. Rules were also introduced concerning the practice of
acupuncture by non-physicians (109). Non-physician practitioners must hold a
recognized college diploma and pass an acupuncture exam set by the Quebec medical
regulatory body. Detailed patient records must be kept covering matters such as
diagnoses made, treatments rendered, and details of patient consultations with other
medical professionals, including allopathic physicians.
Under Section 44 of the Medical Act of Quebec, no person can claim to be an

acupuncturist unless he or she is a registered non-physician or allopathic physician
who has undergone the required training in acupuncture. Moreover, non-physician
practitioners are precluded from using the title “Doctor” or any title that may infer
that status unless they have a doctorate in acupuncture, in which case they may use
the title “Doctor of Acupuncture”.
A number of medical professional regulatory bodies in Canada have published

guidelines relating to acupuncture. In Saskatchewan, such guidelines were drawn up
by the College of Physicians and Surgeons (110). These permit the practice of
acupuncture by allopathic physicians who hold a recognized diploma. The guidelines
do not mention the practice of acupuncture by non-physicians.
Guidelines issued by the Yukon Medical Council (111), however, state that
acupuncture is a medical procedure that should only be performed by allopathic
physicians or dentists with an appropriate level of training. The guidelines do not
permit physicians to delegate acupuncture procedures to others, such as
physiotherapists, “except in an approved institutional setting such as a public
hospital”. The reasoning behind this is that the Yukon guidelines acknowledge that
acupuncture has a “valid role” in patient management but warn that, based on current
knowledge, “it does not have a curative effect on the fundamental disease process”.
The guidelines strongly endorse two training programmes recognized by the College
of Physicians and Surgeons in British Columbia, but stop short of requiring
completion of a programme of study.
Naturopathy
Naturopathy is regulated in Alberta, Manitoba, and Saskatchewan (112). In each of
these three provinces, naturopaths must meet specified educational requirements and
be registered in order to practise naturopathy or use the title of “Naturopath”.
Educational requirements include the completion of a four-year college programme.
Manitoba and Saskatchewan also require an examination in anatomy, physiology,
chemistry, general diagnosis, and the principles of naturopathy. In all provinces,
naturopaths are prohibited from performing certain health care activities, such as the
prescription and administration of allopathic drugs, obstetrical practice, and surgery.
In Alberta, two corresponding provisions in the Chiropractic Profession Act of 1984

(113) forbid dual registration as a naturopath and chiropractor. One states that
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registered chiropractors cannot practise naturopathy and the other that practising
naturopaths cannot be registered as chiropractors.

Complementary/alternative training programmes are provided by private institutes,
universities, and community colleges, but there is no universal system of accrediting
and validating programmes (92). Though there is no standardized complemen-
tary/alternative component in allopathic curricula, most medical schools offer some
form of training in complementary/alternative medicine to their students of allopathic
medicine (114), but this usually takes the form of a two-hour to four-hour lecture. The
1998 Standing Committee Report states that there is increasing interest in having more
training programmes and more standardized training curricula in
complementary/alternative medicine for both complementary/alternative and
allopathic providers.
In 1985, the Institute of Chinese Medicine and Acupuncture (87) was established to
promote the training standards of the Chinese Medicine and Acupuncture Association
of Canada. Students interested in entering the four-year programme offered by the
Institute are required to have first completed three years of coursework in the sciences
at a recognized university. There are two chiropractic colleges in Canada recognized
by the World Federation of Chiropractic (81).
Insurance coverage
Coverage of complementary/alternative therapies by provincial health insurance
plans and workers’ compensation boards is selective and minimal. Some provincial
health insurance plans cover chiropractic (Alberta, British Columbia, Manitoba,
Ontario, Saskatchewan, and New Brunswick only for seniors who purchase extended
coverage), and one covers naturopathy (British Columbia) (92). Osteopathy is covered
in Alberta (115).
Workers’ compensation boards cover chiropractic in all provinces and territories.

Workers’ compensation boards in British Columbia, Newfoundland, Ontario, Prince
Edward Island, Quebec, and the Yukon Territory cover acupuncture on a case-by-case
basis or on prescription by an allopathic physician (92, 116). The Alberta Health Care
Insurance Plan discontinued its coverage of acupuncture on 1 March 1994. Patients are
now solely responsible for the cost of acupuncture treatment (117).
About 96% of the private health insurance coverage in Canada is group policies
purchased primarily by employers. This insurance is a non-taxable benefit so long as,
among other things, reimbursement is only provided for qualified medical
practitioners, which include chiropractors, osteopaths, naturopaths, therapists,
acupuncturists, and dieticians (92).
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Chile
The Mapuche Community Hospital (118) offers traditional and allopathic treatment
options. Practising at the hospital are traditional medical providers, bonesetters, and
two allopathic doctors. The hospital is affiliated with Mapuche University. Both the
hospital and the university receive financial support from the Ministry of Health.
Statistics
In Chile, 10% to 12% of the population is indigenous (118). Seventy-one per cent of the
population uses complementary/alternative medicine (82). There are between 2000
and 10 000 traditional health practitioners in Chile. Principal traditional medical
specialities are herbalism, spiritualism, traditional birth attendance, aromatherapy,
bach flowers, acupuncture, bonesetting, and chiropractic (83).
National policies emphasize equal treatment for traditional and allopathic medicine
(118). Homeopathy and the Homeopathic Pharmacopoeia are legally recognized. The
Public Health Institute recognizes homeopathic remedies (53). Traditional and
complementary/alternative medicine are regulated by Ley 19.253 of October 1993,
which takes into consideration their role in public health (62).
The Ministry of Health oversees the Unit of Traditional Medicine, which also governs
complementary/alternative medicine, and the Unit of Indigenous Community Health.
The Unit of Traditional Medicine was established in August 1992 (119). Its objectives
are to set standards for the safety and efficacy of traditional medicines and to
encourage the use of proven traditional medicines, including incorporating them into
allopathic health programmes (83). The Unit of Indigenous Community Health
develops the primary health care system at the community level (118).
The Health Ministry issues licences for the practice of traditional medicine, but very
few traditional medicine practitioners are licensed. Unlicensed traditional health
practitioners risk fines or the closure of their offices (83). There is no official registry of
traditional medicine practitioners.

Mapuche University (118) offers programmes in traditional knowledge leading to
Bachelor’s, Master’s, and Doctorate degrees. Students of these programmes may
choose to specialize in traditional medicine. The university also cultivates medicinal
plants and conducts research on traditional medicine. Most students of traditional
medicine learn through apprenticeships with experienced providers. In some cases,
these are family members. Some practitioners receive medical insight through
personal revelations.
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Traditional medical training for official allopathic health personnel is not very
extensive and consists of occasional informative events that may or may not be
included in official training programmes (83).
The Government has recognized homeopathy as a medical system, but there are no
officially recognized training programmes or examinations (86). A chiropractic college
is being established (81).
Colombia
Traditional medicine is widely practised in Colombia (120).
Statistics
Forty per cent of the population has used complementary/alternative medicine (82).
There are six chiropractors practising in Colombia (45).
The Congress of Deputies officially recognized homeopathy as a system of medicine in
1905. In 1914, the Government standardized training requirements for homeopathic
doctors and established a system of title protection (86). Only allopathic physicians
may practice homeopathy. The Institute of Medicaments and Food regulates the
manufacturing of homeopathic remedies. Integration of homeopathy into the Public
Health Services is planned (53). Chiropractors are not permitted to use X-ray
equipment. However, chiropractors may request radiologists to provide X-ray services
for their patients.

Homeopathy is taught in three schools authorized by the Ministry of Education. The
regular three-year courses are limited to licensed allopathic physicians (53).
Costa Rica
There are no associations of traditional medicine practitioners in Costa Rica. Women
do not practice traditional medicine (83).
Statistics
There are at least 19 practitioners practising indigenous traditional medicine (83).
There are two chiropractors practising in Costa Rica (45).
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Though the production of traditional medications is regulated, the practice of
traditional medicine is ignored in official health laws. There is no registry of
traditional health practitioners in Costa Rica. Traditional medicine practitioners are
not licensed, nor are they sanctioned for practising medicine. This may soon change,
however, as the Legislative Assembly is currently considering a bill that would
regulate traditional medicine.
There are no official programmes linking traditional medicine with allopathic

medicine (83).
The College of Physicians and Surgeons recognized homeopathy as a medical

speciality in 1994. By a pronouncement of the Sala de Jurisdicción Constitucional of
the Supreme Court on 9 January 1998, allopathic medical doctors can be accredited
postgraduate homeopathic studies under the Medical Speciality Regulations.
Homeopathy is thereby treated as a branch of allopathic medicine and governed by
the same regulations as other allopathic specialities (53). A chiropractic law is
pending.
In 1996, a multidisciplinary committee composed of representatives from the Ministry

of Health and colleges of pharmacy in Costa Rican universities convened to formulate
regulations on herbal medicines (121). In 1998, the committee published Decree 26782S
regulating the industrialization, registration, commercialization, and publication of
herbal preparations and herbal products.

There are no institutions officially responsible for teaching traditional medicine (83).
Postgraduate homeopathic studies are available through an institution recognized by
the College of Physicians and Surgeons (53).
Cuba
Statistics
Sixty per cent of the population use traditional or complementary/alternative
medicine (122). Sixty per cent of allopathic physicians are trained in traditional or
complementary/alternative medicine (122). There are 579 registered herbal products
made in Cuba. An additional 295 registered herbal products are imported (122).
Following the 1959 revolution, Cuban health authorities forbade the practice of
traditional medicine by anyone except traditional birth attendants. Traditional birth
attendants were slowly integrated into Cuba’s health services as ancillary staff (123).
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The 1983 Cuban Public Health Law (124) puts forth strict requirements for the
qualification of health care workers. Traditional medicine practitioners are not granted
exemplary status. Section 90 states the following:
Medical, dental, and pharmaceutical activities and other health professions shall be
practised by persons who have followed special courses and hold a qualification
conferred by a centre of higher education in Cuba (or an equivalent foreign
qualification); the activities of health technicians, qualified staff, and other health
workers shall be practised by persons who have followed special courses and hold a
qualification granted by an institute, school, polytechnic, or centre for technical
training in health.
A 1988 decree (125), which contains regulations for the implementation of the Public
Health Law, prohibits the practice of medicine by persons who do not meet these
qualification criteria.
In 1992, the Ministry of Health officially recognized homeopathy (53). National and
international homeopathic congresses were scheduled during 1997 and 1998, and there
are an increasing number of physicians using homeopathic remedies. Homeopathic
dispensaries are spread all over the country. A standard good manufacturing practice
for the manufacture of homeopathic remedies has been accepted. In 1992, acupuncture
was integrated into the Cuban health care system (122).
In 1995, the Traditional Medicine Programme (122) was instituted, prioritizing the
cultivation of medicinal plants, the education of practitioners, research into traditional
medicine, and the integration of traditional medicine into the national health care
system.

Courses on introductory and advanced homeopathy are given at the medical and
pharmaceutical schools.
Dominican Republic
The principal traditional medical specialities are vodun, ensalmadorismo, and herbalism
(83).
Statistics
There are between 2000 and 3000 practitioners practising traditional health in the
Dominican Republic (83).
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Although there is an official programme linking traditional medicine with allopathic
medicine, there is no official registry of traditional health practitioners, and traditional
medicine practitioners are not licensed in the Dominican Republic (83).

The Ministry of Health and Social Welfare offers training programmes for traditional
birth attendants in hospitals and health centres throughout the Dominican Republic.
The Pan American Health Organization assisted in revising these programmes in 1973
(120, 126). There are no other institutions that teach traditional medicine. Instead,
traditional medicine is taught through apprenticeships with experienced practitioners.
Traditional medical knowledge may also be transmitted through dreams and personal
revelations. There are no official training programmes in traditional medicine for
allopathic health personnel (83).
Ecuador
In Ecuador, there are associations of traditional medicine practitioners that work at
regional and local levels. Some of these associations were created by indigenous
organizations and others by state initiatives (83).
Statistics
There are nine chiropractors practising in Ecuador (45).
Section 174 of the Ecuadorian Health Code of 1971 (127) limited the practice of
physicians, pharmacists, dentists, midwives, and other health practitioners to persons
holding qualifications “granted or validated by the University of Ecuador”. Under
Section 179, health authorities were responsible for the detection and suppression of
the illegal practice of medicine and allied professions “without prejudice to normal
judicial proceedings”. By Section 180, “It shall be automatically assumed that a person
is illegally practising [medicine] . . . if, without holding a legally conferred qualifica-
tion, diploma, or certificate, he possesses equipment or materials for such practice.”
In the beginning of 1998, indigenous peoples proposed a bill to regulate traditional

medicine (83). This bill was passed in June and came into force in August 1998. Based
on this bill, the Constitutional Assembly included two articles in the Constitution that
stipulate principles on which the practice of traditional medicine must be based.
Chapter 4, Section 4, Article 44 reads as follows:
The State will formulate national health policy and will monitor its application. It
will control the operation of the entities of this sector. It will acknowledge, respect
and promote the development of traditional and alternative medicine, the practice of
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which will be regulated by law and will promote scientific and technological
advancement in the health area subject to bio-ethical principles.
The Constitution of the Republic, Chapter 5, Article 84, Numeral 12 establishes

collective rights:
to the systems, knowledge and practice of Traditional Medicine, including the right
to the protection of ritual and sacred places, plants, animals, minerals and
ecosystems of interest to the State from the point of view of traditional medicine.
There is no registry of traditional medicine practitioners in Ecuador and no licensing

procedure for practitioners of traditional medicine. There is no official institution in
charge of regulating traditional medical practice (83). There is, however, the National
Division of Indigenous Health, which was created by a ministerial resolution to
promote the development of traditional medicine (82).
In Ecuador, there are no specific programmes linking traditional medicine with

allopathic medicine. But, with increasing interest in traditional medicine, particularly
Quichua medicine, the State is focusing more attention on official linkages. Some
efforts have been made to coordinate with institutions and organizations affiliated
with traditional medicine in Ecuador (83).
In 1983, the Government recognized homeopathy as a medical practice (86). The

Ecuadorian Medical Federation began officially recognizing homeopathy as a medical
speciality in 1988. It is also recognized in the Constitution of the National Assembly
(53). There is no chiropractic law.

Universidad Andina Simón Bolívar, a private Andean university in the city of Quito, is
responsible for teaching traditional medicine in Ecuador. Offerings include certificate
programmes, seminars, workshops, and meetings.
The Ministry of Public Health established training courses for traditional birth
attendants in 1974 with the aim of incorporating them into the health services of rural
areas (120, 128). There is no official training in traditional medicine offered to
allopathic health personnel (83).
Guatemala
The principal traditional medicine specialists in Guatemala are traditional birth
attendants, bonesetters, herbalists, spiritualists, chupadores, massage therapists, and
practitioners who specialize in muscle tears (83). A 1977 order established the
Guatemalan Association of Acupuncture (130). The Association promotes the
knowledge and the study of acupuncture and facilitates professional contacts with
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108
acupuncturists in other countries. Membership in this association does not license
individuals to practise acupuncture.
The University of San Carlos is undertaking research on medicinal plants (129).
Statistics
There are approximately three traditional health practitioners per municipality. About
250 traditional health practitioners are registered with the TOTO-Integrado
Association (83).
The laws regulating traditional medicine in Guatemala include Acuerdos de Paz, the
Political Constitution, the Health Code, and Regulations for the Quality Control of
Herbal Products (82, 129). The Health Code defines, classifies, and outlines
registration and licensing requirements for all medicines. The Regulations for the
Quality Control of Herbal Products classifies herbal products and registration
procedures for them (129).
Although there is no official licence to practise traditional medicine, 10% of traditional

medicine practitioners have a permit to practise. These permits are issued upon
completion of a training course organized by the Public Health Ministry and local
health centres. The permits are not available throughout the country. Traditional
medicine practitioners without permits may practise within their own communities,
but they are rejected by institutions and risk being sued for malpractice (83). A registry
of traditional health practitioners is currently being developed.
The programme of the Integral Healthcare System links traditional and allopathic
medicine (83).

Courses in traditional medicine are available through the Public Health Ministry.
Additionally, CDRO in Totonicapan, Barefoot Doctors in Chinique, and Quiche
Guatemala offer technical studies, seminars, informal presentations, and workshops
that include instruction in traditional medicine. Traditional medicine is also learned
through apprenticeships, which may include practice, observation, readings,
workshops, and videos. How to treat a particular illness is sometimes learned as a
result of having suffered from it oneself.
Personnel in the official health services do not receive training in traditional medicine
(83).
Honduras
Section 130 of the Honduran Health Code of 1966 (131) states the following:
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The practice of naturopathy, homeopathy, empiricism, and other occupations
considered to be harmful or useless by the Secretariat for Public Health and Social
Welfare shall be prohibited in the country.
Practitioners of traditional medicine are not granted exemplary status. There is no

chiropractic law.
Jamaica
Statistics
More than 8000 medicinal products, including 610 vitamins, 90 minerals, and 60
herbal remedies, were registered and licensed in Jamaica between 1975 and 2000. Of
the 403 medicinal products registered in 1999, 9.5% were of herbal origin (132). Herbal
products are a multi-million dollar industry in Jamaica (133).
In 2000, the Parliament considered revisions to the Food and Drugs Act of 1964 and
the Food and Drugs Regulations of 1974. The revisions (134) were aimed at ensuring
the safety, efficacy, and quality control of herbal products. In 2001, the Parliament
approved the revisions, under which the following applied:
♦ Products are subject to approval, requirements for which are similar to, but not as
elaborate as, those for pharmaceuticals. The onus is on manufacturers to
substantiate quality, efficacy, and safety.
♦ Products containing vitamins and minerals in less than three times the
recommended daily amount are classified as foods and do not require formal
registration.
♦ Vitamins containing more than three times the recommended daily amount are
classified as drugs.
♦ Herbal products require registration if they contain substances used for conditions
that normally need medical intervention.
♦ Herbal products containing substances used for self-limiting conditions that do not
normally require medical intervention do not require registration.
♦ Registered products, like drugs, require a permit for importation.
♦ Products that are not registered do not require a permit for importation; however,
proof of quality is required annually or such other time, as deemed necessary.
The revisions define an herbal medicine as “a medicinal product consisting of a

substance produced by subjecting a plant or plants to drying, crushing, or any other
process or of a mixture whose sole ingredients are two or more substances so
produced or of a mixture whose sole ingredients are one or more substances so
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produced and water or some other inert substance”. This definition is adapted from
Section 132 of the United Kingdom’s Medicines Act of 1968.
There is no chiropractic law. Chiropractors are recognized as medical practitioners but

prohibited from providing physical therapy services and from using the title of
“Doctor”.
Mexico
The principal traditional medical specialists are traditional birth attendants, herbalists,
bonesetters, curanderos, snake culebreros, shamans, spiritualists, and sobadores (83, 135).
Statistics
Traditional birth attendants preside over more than two-thirds of childbirths in
Mexico. There are 55 to 60 chiropractors practising in Mexico (45). There are about
3000 homeopathic physicians (53).
In 1980, the Mexican Institute of Social Security created a unit to study traditional
medicine and medicinal plants. Later, a programme was introduced to foster the
integration of traditional and allopathic systems of medicine. The programme was
designed to involve traditional practitioners in the health activities of 3500 rural
medical units within the Social Security System (135). The Mexican Institute of Social
Security is also working with the national plan for depressed zones and marginalized
groups (Coplamar) to integrate allopathic and traditional medicine (83).
Mexico’s registry of traditional medicine practitioners is kept by the National Indi-

genous Institute and the Mexican Institute of Social Security.
Traditional medicine forms an integral part of the health care delivery system.
Although there is no official licence for the practice of traditional medicine, other than
for traditional birth attendants, the authorities are currently working on creating such
a licence. Proposals for a bill to regulate traditional medical practice, aside from that of
traditional birth attendants, have been made since 1989 (83).
The Regulations of 20 October 1976 (136) established a distinct sector of the health
field for qualified traditional birth attendants. Section 2 of the Regulations define
qualified traditional birth attendants as persons who have been attending deliveries
without training and are licensed and qualified under the Regulations. Licences are
issued by health centres following the completion of a training course. Section 9 states
that entry to the course is restricted to persons who have attained majority, are literate,
and are recognized by the communities in which they work as carrying out obstetric
activities. Section 13 specifies that traditional birth attendants may attend women in
their community during normal pregnancy, delivery, and the puerperium provided
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that they notify a health centre. They may also prescribe appropriate medications in
accordance with the instructions of the Secretariat for Health and Welfare.
There is a proposal to add provisions to the General Health Law that would regulate
the quality control of medical activities, establishments, products, and services.
Chapter 4 of these proposed changes covers herbal medicines.
Homeopathy has been accepted and integrated into the national health system in
Mexico. In 1895, a presidential decree was issued to establish a national homeopathic
school; to regulate training requirements for homeopathic doctors, including title
protection; and to establish a national homeopathic hospital. In 1996, the Government
recognized homeopathy as a medical speciality (86). Licensing legislation regulates
chiropractic educational standards and practice (81). Chiropractors have been licensed
since 1988. Credentials must be periodically revalidated (65).

The National Indigenous Institute has a unit dedicated to the organization,
coordination, and instruction of traditional medicine. In some states, the Institute
coordinates with associations of traditional medicine practitioners to provide
workshops, courses, and other activities where practitioners can gather and share their
knowledge. Traditional medicine is taught through apprentice programmes, including
practice, observation, and workshops. In some cases, families are known for a
particular speciality.
The Mexican Institute of Social Security offers informal presentations and workshops
on traditional medicine, medical anthropology, and community work techniques to
personnel working in the official health services (83).
There are several schools and hospitals teaching homeopathy. Homeopatia de Mexico,
an association for homeopathic practitioners, obtained official recognition for its
postgraduate school in 1996 (53). A chiropractic college is presently being established
(81).
Nicaragua
Statistics
There are 2500 persons registered in the registry of traditional medical practitioners.
The principal traditional medical specialities are traditional birth attendance,
herbalism, spiritualism, and massage (83).
The Department of Traditional and Popular Medicine of the Ministry of Health
regulates traditional medicine in Nicaragua (82). No licence is required to practice
traditional medicine. While there are no restrictions or legal barriers that limit its
practice, the Nicaraguan Academy of Homeopathic Medicine is working towards
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gaining official status for homeopathy. The National Council of Universities supports
homeopathy and accepts its practice by allopathic doctors (53).
A regulation on the use of plant medicines (83) is currently being developed and will
eventually be under the responsibility of the Department of Drugstores of the Ministry
of Health according to the General Law of Medication and Drugstores.

In 1989, the Ministry of Health established the National Centre of Popular and
Traditional Medicine (62) with the objective of training health promoters and
allopathic medical and paramedical persons in these fields. In 1991, courses in
traditional medicine were introduced into allopathic nursing schools, and allopathic
nurses began being trained in basic plant therapy and medical anthropology. After the
change of government in the same year, the Centre became a non-profit foundation
independent from the Ministry of Health. Along with the National Autonomous
University of Nicaragua and several institutions under the leadership of the Ministry
of Health, the Centre forms a part of the National Commission for Essential
Investigation.
Cecalli, Soynica, the School of Agriculture, UNAN, Real Nicaraguense de Sistemas

Traditionales, and MINSA also offer training in traditional medicine. Though
allopathic health personnel may follow these courses, training in traditional medicine
is not offered through the official health services (83).
Panama
The Government of Panama has made considerable efforts to register and train tradi-
tional birth attendants and to integrate them into the country’s health care system
(137).
Statistics
Although there is only one chiropractor practising in Panama, both the United States
and Canada have been sending chiropractic missions to Panama since 1997 (65).
Law 4376 of August 1999 created the Area of Traditional Medicine under the National
Directorate of Health Promotion. The Area is charged with developing a strategy of
action for the incorporation of traditional medicine into primary health care, including
research on medicinal plants.
The Carta Organica Administrativa de la Comarca (138), following Executive Decree

194 of 26 August 1999, governs traditional medicine in the Ngöbe-Buglé region.
Article 258 of the Carta classifies traditional medical specialities, the services they
offer, and their legal status regarding diagnosing ailments and dispensing medicines.
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This same article recommends that traditional and allopathic medical practitioners
cooperate and collaborate together.
Article 257 creates the Special Medical and Technical Commission to bring together
traditional medicine and allopathic medicine. Articles 261 and 262 refer to the
organization of botanical gardens for the scientific study of medicinal plants and
propose the publication of texts and health manuals.
Article 266 defines the functions of the Special Medical and Technical Commission,
including the following:
♦ coordinating with the national health system;
♦ certifying traditional health practitioners;
♦ organizing the methodology for a study of traditional medical practice;
♦ educating the public about scientific investigations into the methods, uses, and
effects of traditional medicine;
♦ preparing a health infrastructure plan for the community;
♦ studying the medical history of the Ngöbe-Buglé.
In recognition of the existence, contribution, and importance of traditional medicine to

the health of indigenous communities, Article 3 of Law 36 of 3 October 2000 (138), a
nationally applicable law, created an autonomous institute of indigenous traditional
medicine. The institute recognizes, protects, and promotes traditional knowledge
related to the medicinal properties of plants, access to genetic resources in indigenous
regions, and the return and distribution of benefits from the commercial application of
this knowledge.
In Article 4 of Law 36, it is stated that at the institute there will be one representative
of each indigenous community, one representative of traditional medicine practi-
tioners, the Minister of Health or designate, and one representative of the Panamanian
Medical Association.
Article 7 establishes traditional medicine as the patrimony of the communities from

which it comes and advances the conservation and promotion of traditional medicine
in indigenous areas. It also states that allopathic medicine should not be forced upon
these communities. Article 8 recognizes traditional health systems in indigenous
communities. Article 10 mandates indigenous authorities to mount a campaign of
protection, promotion, and conservation of traditional medical practices.
Article 21 orders the establishment of a Faculty of Medicine and a Faculty of Pharmacy

of indigenous materia medica and their use in the treatment of sickness. The rest of the
articles of Law 36 refer to access to resources, benefit sharing, intellectual property,
and the commercialization of medicinal plants.
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Licensing legislation regulates chiropractic educational standards and practice (81). A
chiropractic law was adopted in 1967, permitting chiropractors to “examine, analyse
and diagnose the human body by way of any method physical, chemical, electrical, or
the use of x-ray” and provides for “the adjusting, manipulation and treating of the
human body” (65).
Peru
The principal traditional medical specialities are herbalism, traditional birth
attendance, and bonesetting (83). The National Institute of Traditional Medicine has 17
branches throughout the country. It disseminates information and conducts research
on traditional medicine. In particular, the Institute is responsible for a research
programme in traditional medicine known as the General Direction of Research and
Technology (83). This programme is responsible for carrying out clinical research,
conducting medical anthropological research, gathering demographic statistics, and
facilitating the integration of traditional and allopathic medicine. It is also charged
with promoting the protection, control, and cultivation of medicinal plants.
Traditional medicine was officially prohibited in Peru in 1969, but the prohibition was
not enforced (120). The National Institute of Traditional Medicine is the official
institution working on the regulation of traditional medicine (83). The Congress of the
Republic is discussing potential laws and statutes for the regulation of traditional
medicine (83). A bill on traditional medicine was proposed in 1999, but has not yet
been passed.
Although there is no official licence in Peru for the practice of traditional medicine, the
Ministry of Health issues practice permits. A registry of traditional medicine
practitioners is currently being developed in Peru.
The Ministerial Decree for the Creation of Rural and Urban Peripheral Health Services
places priority on the investigation and preservation of traditional medicine (82).
Section 4 of the Supreme Decree 010-97-SA of 1997 (139) regulates plant medicines and
natural resources of medicinal value. It defines and classifies plant medicines and
natural resources of medicinal value, outlines procedures and requirements for their
registration, and details the requirements that must be met for the manufacture and
sale of plant medicines.

Students of traditional medicine learn via apprenticeships involving practice,
observation, and videos as well as from personal experiences, revelations, and dreams.
In some cases, medical skills are passed down within families. The National Institute
of Traditional Medicine provides official training programmes in traditional medicine.
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In addition, some universities and non-governmental organizations registered with
the Ministry of Health offer programmes in traditional medicine for traditional
medicine practitioners. Some universities offer seminars, workshops, meetings, and
conferences in traditional medicine for students studying allopathic medicine.
Courses, workshops, and informal presentations are also offered to official health
personnel (83).
United States of America
Complementary/alternative medicine has a substantial presence in the United States
health care system. Both public and professional interest in these therapies is
increasing. The College of Physicians and Surgeons at Columbia University and the
Falk Institute of Pittsburgh University have research projects devoted to assigning an
integrative role in the health care system to complementary/alternative therapies.
In 1991, Congress established the Office of Alternative Medicine within the National
Institutes of Health to encourage scientific research in the field. The National Institutes
of Health Revitalization Act of June 1993 (140) was a landmark. It expanded the Office
of Alternative Medicine within the National Institutes of Health from a staff of six to a
staff of 12. The Office’s objectives include the facilitation and evaluation of “alternative
medical treatment modalities, including acupuncture and Oriental medicine,
homeopathic medicine, and physical manipulative therapies”. The Office is mandated
to set up an advisory council, establish an information clearinghouse to exchange
information on traditional medicine, support research and training, and provide
biennial reports on the Office’s activities to the Director of the National Institutes of
Health. These reports are then included in biennial reports to the President and
Congress.
Statistics
A 1997 national survey (141) estimated that in the previous year 42.1% of the adult
population in the United States had used at least one of the complementary/alter-
native therapies included in the survey. This is an increase from 33.8% in 1990. The
therapies included in the survey were relaxation techniques, herbal medicines,
massage, chiropractic, spiritual healing by others, megavitamins, self-help groups,
imagery, commercial diets, folk remedies, lifestyle diets, energy healing, homeopathy,
hypnosis, biofeedback, and acupuncture. Rates of use of complementary/alternative
therapies in 1997 ranged from 32% to 54% in the socio-demographic groups examined.
The therapies with the greatest increases in use included herbal medicines, massage,
megavitamins, self-help groups, folk remedies, energy healing, and homeopathy.
Visits to chiropractors and massage therapists accounted for nearly half of all visits to
complementary/alternative medical practitioners in 1997.
The probability of patients visiting a complementary/alternative medical practitioner

increased from 36.3% to 46.3% between 1990 and 1997. The total number of visits to
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complementary/alternative medicine practitioners increased from 427 million in 1990
to 629 million in 1997, thereby exceeding total visits to all primary care allopathic
physicians.
Estimated expenditures for professional complementary/alternative medical services

increased 45.2% between 1990 and 1997. For 1997, these expenditures are
conservatively estimated at $21.2 billion with at least $12.2 billion of this paid out-of-
pocket. Total 1997 out-of-pocket expenditures relating to complementary/alternative
therapies are conservatively estimated at $27 billion, which is comparable with the
projected 1997 out-of-pocket expenditures for all physician services. Just over half of
patients (64% in 1990 and 58.3% in 1997) of complementary/alternative medical
practitioners pay entirely out-of-pocket for the services.
Approximately 3000 allopathic physicians and other health care practitioners currently
use homeopathy (142).
In 1993, more than 45 000 licensed chiropractors and 32 000 Doctors of Osteopathy
were practising in the United States. More than 60% of osteopathic physicians are
involved in primary care. The profession is responsible for approximately 10% of the
total health care delivered in the United States. Chiropractors currently see 10% to 15%
of the population of the United States (143). There are about 6000 acupuncture
practitioners in the United States. An estimated 3000 allopathic physicians have taken
courses in acupuncture with the intention of incorporating it into their medical
practices (143). There are over 1000 licensed naturopathic doctors in the United States.
There are approximately 50 000 biofield practitioners providing 18 million sessions
annually. There are approximately 50 000 qualified massage therapists in the United
States, providing 45 million one-hour massage sessions per year. There are 10
ayurvedic clinics in North America, including one hospital-based clinic that served
25 000 patients between 1985 and 1994 (143).
In the United States, regulatory controls surrounding complementary/alternative
medicine involve six related areas of law: licensing, scope of practice, malpractice,
professional discipline, third-party reimbursement, and access to treatments. State
laws dominate the first five areas. Federal laws, particularly food and drug laws,
largely control the sixth. In each of these areas, legal rules aim to safeguard consumers
against fraud and to ensure patient protection against dangerous practices and
practitioners. Because allopathic medicine has historically dominated licensing,
accreditation, reimbursement, and other regulatory structures, however, existing legal
rules governing complementary/alternative therapies and providers arguably favour
allopathic medicine and paternalism at the expense of concerns for patient choice and
autonomy.
Licensing laws in each state provide that the unlicensed practice of medicine is a
crime, with medicine being broadly defined to include such matters as diagnosis and
treatment of disease or any human condition. Both non-licensed providers of comple-
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mentary/alternative care (such as non-allopathic physician homeopaths, herbalists,
iridologists, nutritionists, and spiritualists not practising within the tenets of a specific
recognized religion) and licensed complementary/alternative care providers (such as
chiropractors and, in many states, acupuncturists, massage therapists, and
naturopaths) who exceed their legislatively authorized scope of practice risk
prosecution for unlicensed medical practice.
Under malpractice rules, practitioners are liable when their professional practices
deviate from standards of care applicable to their locale and speciality and when
patient injury results. This is problematic since complementary/alternative care by
definition deviates from allopathic standards of care. Professional disciplinary cases
are frequently brought against allopathic providers integrating complementary/alter-
native practices, often in tandem with civil malpractice lawsuits. Third-party
reimbursement is regularly denied to patients receiving such treatments because the
third parties consider the treatments to be experimental and/or not medically
necessary. Patients find access to complementary/alternative treatments restricted
further on the grounds that the medicinal substances used to diagnose, cure, or
mitigate disease are classified under federal law as new drugs and are thus subject to
extensive premarketing approval to show safety and efficacy before they may be used.
Although more and more complementary/alternative medical providers are being

licensed in the United States, legal rules must continue to evolve to accommodate
widespread consumer and provider use of therapies that have historically fallen
outside the scope of allopathic medicine (144).
Traditional Native North American medicine

Traditional Native North American medicine in the United States is regulated under
the Self-Determination Act (82).
Homeopathy
Arizona, Connecticut, and Nevada have specific licensing boards for homeopathic
physicians.
The market for homeopathic medicine in the United States is a multi-million dollar
industry. Homeopathic remedies are recognized and regulated by the Food and Drug
Administration and are manufactured by pharmaceutical companies under strict
guidelines.
Manipulative therapy
Statutes regulating the practice of manipulative therapy exist in every state of the
United States (145). Practice is restricted to persons who fulfil certain requirements
and have been registered and/or licensed. In many cases, practising without a licence
is an offence.
Licensing legislation regulates chiropractic educational standards (81). An example of

such legislation is found in Sections 6551–6556 of Book 16 of the Consolidated Laws of
New York (146, 147). The New York statute states that chiropractors may not treat
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specified diseases; perform operations; reduce fractures or dislocations; or prescribe,
administer, dispense, or otherwise use medicines or medicaments in their practice.
Only licensed persons may practice chiropractic and use the title of “Chiropractor”. To
be eligible for a professional licence, an applicant must have completed two years of
pre-professional college study and a four-year chiropractic resident programme as
well as obtaining satisfactory experience and passing the licensing examinations.
In the United States, practitioners of manipulative therapy are sometimes considered

on the same professional level as allopathic physicians. Part 59 of Title 57 of the United
States Code of Federal Regulations (148) includes osteopathic general practice in the
definition of allopathic family medicine. However, with the exceptions of South
Carolina and Arizona, all states require chiropractors to add an accompanying
qualifying reference to chiropractic following the use of the title “Doctor” or
“Physician” (149).
Acupuncture
Section 355 of the Federal Food, Drug, and Cosmetic Act (150) covers the labelling of
medicines and devices, including acupuncture needles and equipment. In 1973,
acupuncture was declared by the Food and Drug Administration to be a method of
treatment for investigational use by licensed practitioners only until “substantial
scientific evidence is obtained by valid research studies supporting the safety and
therapeutic usefulness of acupuncture devices”. The Food and Drug Administration at
that time published a notice calling for labelling requirements for such devices,
including the following warning: “Caution: experimental device limited to
investigational use by or under the direct supervision of a medical or dental
practitioner.”
States have an array of provisions regarding the practice of acupuncture. In New York,
legislation (151) was passed in 1974 on the recommendation of the State Commission
on Acupuncture. The legislation allowed state boards responsible for medicine and
dentistry to formulate rules and regulations governing the provision of acupuncture
and to establish licensing procedures for its practice in New York. The main
prerequisites for a licence were that the applicant had practised acupuncture for at
least 10 years and had a licence as “a doctor of acupuncture, herb physician, or doctor
of traditional Chinese medicine duly issued by the licensing board of any foreign
country”.
A 1991 statute (146) altered the above position by substituting licensing rules; creating
a board of acupuncture made up of acupuncturists, licensed allopathic physicians, and
members of the public; and obliging licensed acupuncturists to advise patients about
the importance of consulting a licensed allopathic physician concerning their
prognosis, and keep a record of the dispensation of this advice.
To qualify for a licence to practice acupuncture, applicants must satisfy a pre-

professional education requirement of at least 60 hours in an approved university or
college, including a minimum of nine hours in the biosciences. They must then
complete a professional programme, lasting a minimum of 450 hours, which involves
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classroom instruction in the biosciences and acupuncture and supervised clinical
acupuncture experience. Applicants must pass a licensing exam set by the National
Commission for the Certification of Acupuncturists or other approved body. Finally,
applicants must be at least 21 years of age. Section 8216 permits the enactment of rules
for the certification of allopathic physicians and dentists as acupuncturists. Limited
permits for applicants who meet the requirements for admission to the licensing exam
can be issued. However, practice under a limited permit must be under the
supervision of a licensed acupuncturist.
During the 1970s, the legislatures of several other states established conditions for the
licensing of acupuncturists who were not allopathic physicians. As of 1981, non-
allopathic physicians have been permitted to practise acupuncture under various
conditions in at least 15 states (152).
Under a 1978 act in Rhode Island (153):
[No treatment by acupuncture] shall be performed unless within a period of 12

months preceding the treatment the patient shall have undergone a diagnostic
examination by a duly licensed and registered physician with regard to his illness or
malady. The doctor of acupuncture [as defined in the act] or the licensed
acupuncture assistant [likewise defined] shall first . . . be familiar with the results of
the said diagnostic examination.
The act provides for the establishment of the State Board of Acupuncture and also
defines the conditions under which the Board may issue licences to practise
acupuncture or to perform as an acupuncture assistant. The conditions for the issue of
a licence in Rhode Island are as follows: the applicant must have successfully
completed a course of study of 36 months in acupuncture at a college in the Hong
Kong Special Administrative Region of China or have qualifications considered
equivalent by the State Board of Acupuncture, the applicant must have practised
acupuncture for 10 years, and the applicant must have passed examinations set by the
Board.
In Florida (154), only persons certified by the Department of Professional Regulation

may practise acupuncture. Some of the conditions for certification are that the
applicant must be at least 18 years of age, have undertaken two years of education in
acupuncture at a school or college approved by the Department (experience may be
substituted for a part of this training), and pass an examination. It is a misdemeanour
to practise acupuncture without a valid certificate in Florida.
California’s Business and Professions Code (155) lays down an extensive set of
provisions regulating the acupuncture profession. California has appointed an
Acupuncture Board, which consists of nine members. By law, four of these members
must be acupuncturists with at least five years of experience who are not also
allopathic surgeons or physicians, one must be an allopathic physician or surgeon
with two years of experience in acupuncture, the remaining four must be members of
the public who are neither acupuncturists nor allopathic physicians or surgeons.
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In California, in order to receive a licence to practise, applicants must be at least 18
years of age, have completed an approved course in acupuncture or a tutorial
programme in the practice of acupuncture, passed an examination administered by
the appropriate Board, and completed a clinical internship programme of up to nine
months. The length of the internship depends on the applicant’s examination results
and prior clinical training. Internship requirements are waived for applicants who
have previously completed 800 hours of clinical training. Practising acupuncture
without a licence is a misdemeanour. A previous requirement that acupuncture
treatments cannot be performed on a patient without a prior diagnosis or referral from
a licensed physician, surgeon, dentist, podiatrist, or chiropractor has been removed
from the legislation. The completion of 30 hours of continuing education every two
years is required for renewal of the annual practising licence.
Naturopathy
Naturopathy remains relatively marginalized in the United States. Few states license
naturopaths (156). Although legislation on naturopathy varies between states, a
number of general regulations do exist. Under state licensing procedures, naturopaths
have a limited range of treatment options. The use of electricity, heat, water, vibration,
and muscular articulation are permitted as therapeutic modalities, but the general
practice of medicine and surgery are prohibited. The administration of toxic drugs is
similarly prohibited (145).
Hypnosis
Treatment involving the use of hypnosis is characterized as the practice of medicine
and surgery and is therefore subject to licensing requirements.
Biofield therapy
No state has licensing requirements for biofield practitioners. Since legal constraints in
many states restrict the use of the terms “patient” and “treatment”, most biofield
practitioners use the terms “receiver” and “session” in describing their work.

The majority of allopathic medical schools in the United States now offer courses on
complementary/alternative medicine (141). Beginning in 1997, primary care allopathic
physicians have been able to take courses designed to introduce them to homeopathy
and to encourage them to incorporate homeopathy in their practices (53).
The United States has the largest number of chiropractic colleges of any country.
Sixteen colleges are recognized by the World Federation of Chiropractic and
accredited by the Council on Chiropractic Education, the United States accrediting
agency for the chiropractic profession. The Council on Chiropractic Education
establishes minimum standards and assesses institutional compliance with these
standards as well as overall effectiveness (81).
With only a few states licensing naturopaths (156), all except two naturopathic
colleges have closed. Entry to these colleges is conditional on two years of pre-
professional coursework. The programmes are four years in length.
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Insurance coverage
Complementary/alternative therapies are infrequently included in benefit packages,
although the number of insurers and managed care organizations offering coverage is
increasing (141). When complementary/alternative therapies are covered, they tend to
have high deductibles and co-payments that are subject to stringent limits on the
number of visits or total dollar coverage.
Chiropractic care is the exception (116). In many states, chiropractic is covered in full
or in part by Medicaid, Medicare, and other Social Security programmes as well as
private health insurance. The cost of chiropractic treatment can also be reclaimed
under workers’ compensation legislation designed to reimburse, at least in part,
medical expenses incurred by injured workers.
Venezuela
Statistics
The Liga Medicorum Homeopathica Internationalis has 41 members in Venezuela (86).
There are approximately 10 chiropractors practising in Venezuela (116).
In Venezuela, health care is restricted to formally educated medical professionals.
Section 13 of the 1975 Venezuelan law on the practice of medicine (157) states that
persons who perform any act that is restricted to medical practitioners, without
having fulfilled the requirements of the law, are deemed to be practising medicine
illegally. Only traditional birth attendants who have received a ministerial permit are
exempted. Allopathic physicians may practise homeopathic medicine after completing
specialized postgraduate studies. There is no chiropractic law, although the practice of
chiropractic is permitted under common law by officially recognized health care
providers.

The School of Homeopathic Medicine of the Venezuelan Homeopathic Medical
Association is responsible for training allopathic physicians specializing in
homeopathy (53).
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Algeria
The Algerian Public Health Code of 23 October 1976 (158) rendered the practice of
medicine without a licence an offence. Apart from Section 364 on the practice of
herbalists, no exceptions were made for the practice of traditional medicine. Section 47
(159) explicitly prohibited medical auxiliaries from using “secret or occult
procedures”.
This monopoly on the practice of medicine was retained and fortified in Law 85-05 of
16 February 1985 (160) relating to health protection and promotion, which repealed
the 1976 Code, among other things. Under Section 197, in order to practise as an
allopathic physician or dentist, a person must be licensed and hold an Algerian
diploma of Doctor of Medicine or Dentistry or a recognized foreign equivalent. The
exclusion of traditional medicine is underscored by the broad language of provisions
contained in Section 214 that define the activities constituting the illegal practice of
medicine or dentistry. These include acting as a physician or dentist without a licence
and further circumscribe the activities of
Persons who habitually take part, whether for consideration or not, even in the
presence of a physician or dentist, in making a diagnosis or in treating diseases or
surgical or dental conditions, congenital or acquired, real or supposed, by personal
acts, oral or written advice, or by any other means whatsoever, without fulfilling the
conditions prescribed in Sections 197 or 198 [governing the mandatory qualifications
for medical and dental specialists].
Section 225 includes provisions prohibiting medical auxiliaries from “announcing or

applying technical procedures other than those that are taught in national training
programs”. Despite these restrictions, traditional medicine practitioners seem to be
tolerated.
Cyprus
Written records, especially from monasteries, record different types of traditional
medicine and herbal preparations that were practised from the Middle Ages through
the 19th century in Cyprus. Most traditional forms of medicine involve mixing herbs
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and abiding by certain behavioural rules promoting healthy diets and habits. Since
British colonization, allopathic doctors have provided health services.
Statistics
Although most patients use allopathic medicine, some consult homeopaths and other
complementary/alternative medical practitioners. Only a few allopathic doctors practice
homeopathy, acupuncture, or other forms of complementary/alternative medicine.
There are fewer than 10 complementary/alternative medical practitioners who are not
also allopathic doctors. These practitioners offer curative courses focused on using
relaxation techniques or herbs to alleviate stress or stop smoking.
Only allopathic doctors can provide medical treatment in Cyprus. It is a criminal offence
for others to practise medicine or give medications. There is no official recognition of
any kind of traditional or complementary/alternative medicine other than
chiropractic. Again except for chiropractic, there are no national policies regulating
traditional or complementary/alternative medicine, nor have traditional or
complementary/alternative medicine been integrated with allopathic medicine.
A compulsory registration scheme for chiropractors was introduced in Cyprus in 1991

(161). Registration is limited to persons holding a recognized degree, diploma, or
certificate. It is a criminal offence to practise chiropractic without being registered.

There are no official training courses in traditional or complementary/alternative
medicine.
Insurance coverage
No national or private health care insurance covers traditional or complemen-
tary/alternative medicine. Traditional medicine is not included in the proposed
National Health Insurance Scheme.
Djibouti
Traditional medicine practitioners include cheiks, medical providers who use the
Koran or other Islamic scriptures to treat patients, and herbalists. Some practitioners
combine both methods.
With the exception of traditional birth attendants, the Government tolerates, but does
not officially recognize, traditional medicine. Lacking legal status in Djibouti, no clear
regulations control its practice. A 1999 law advocating the necessity to legislate
traditional medicine may lead to changes in this regard.
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Only one category of traditional health practitioner has been integrated into the public
health system: traditional birth attendants. Traditional birth attendants work under
the supervision of public health staff in the rural structure of the primary health care
system.
Egypt
Statistics
The practice of traditional medicine in Egypt is limited to a very few traditional
medical providers (162). There is one chiropractor practising in Egypt (45).
The National Drug Policy was promulgated at the beginning of 1999 as an essential part
of the National Health Policy. Within the framework of the National Drug Policy,
reforms have been carried out in the following five areas: rational use of drugs, issues
related to the drug industry, quality assurance and quality control, management of drug
supplies, and human resource development.
In Egypt, all herbal preparations and herbal products must meet the same standards as
manufactured chemical preparations, according to the law on practising pharmacy.
Herbal preparations and herbal products must be manufactured in a licensed
pharmaceutical plant according to local and international good manufacturing practices.
They must also be registered with the Central Administration of Pharmaceutical Affairs.
The National Organization for Drug Control and Research analyses medicinal plants
and inspects herbal preparations and herbal products to ensure their safety. Herbal
preparations and herbal products are priced according to the law and are distributed
only to pharmacies.
There is no chiropractic law.
Islamic Republic of Iran
Traditional medicine and Islamic medicine are practised in Iran through hokama who
have small shops where they not only recommend medicines, but also prepare and
sell them. With the expansion of allopathic medicine and services, however, the
number of hokama has diminished greatly.
The Shaheed Beheshti University of Medical Sciences (163) has done a lot of research
on medicinal plants. It has also organized an international congress on traditional
medicine and materia medica. Most of the research done on medicinal plants has been
pre-clinical. In Iran, there is no specific hospital for conducting clinical trials of herbal
medicines (163).
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Statistics
Over the last 10 years, the Government has undertaken an inventory of medicinal
plants (163). So far, 2500 flora of Iran’s 8000 medicinal plants have been inventoried
and recorded in 20 volumes of 125 herbs each. One hundred fifty certificates for herbal
medicine have been issued. Eighty-four herbal products have undergone clinical trials
and been licensed. These are included in Iran’s list of essential drugs. By the end of
2004, the Government intends to have issued licences for 300 herbal products (163).
Seven faculties of pharmacy are conducting research on medicinal plants in seven

provinces (163). There are 30 pharmaceutical companies producing herbal medicines,
20 of which produce herbal products and 10 produce herbal preparations (163). There
are also many small herbal shops that supply herbal materials and spices for medicinal
use (163).
There are 14 chiropractors practising in Iran (45).
Traditional medicine practitioners are neither supported nor banned by the
Government, provided patients are not harmed (162). A chiropractic law is pending.
Currently, chiropractors may practice in conjunction with allopathic physicians.
The Government of Iran is very interested in traditional medicines and has initiated a
number of programmes related to them. Since 1991, the Food and Drug Control
Agency has been working in the field of herbal medicines.
In 1991, the National Academy of Traditional Medicine in Iran and Islam (163) was
established. It is mandated to support research on herbal medicines; to study the
history of Iranian traditional medicine; to preserve Iranian traditional medicine; to
investigate education in traditional medicine and recommend an education plan to the
Ministry of Health and Medical Education, including the incorporation of traditional
medicine training and research into allopathic medical programmes; to educate the
public on the rational use of traditional medicine; and to republish famous Iranian
books on traditional medicine. In 2001, the Academy recommended that the Ministry
of Health and Medical Education officially begin training allopathic medical students
in Iranian traditional medicine.
In 1996, the Ministry of Health and Medical Education established the Council
Committee of Medicinal Herbs and Products (163). The Committee consists of a panel
of experts charged with evaluating the safety and efficacy of herbs and herbal
products and issuing rules and regulations for the packaging of herbal medicines.
In order to make allopathic drugs affordable, the Government subsidizes the

pharmaceutical industry’s importation of raw materials. As the Government does not
subsidize herbal products or locally produced herbal raw materials, herbal products
are often more expensive than generic drugs.
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There is no national patent office and no national patent law in Iran. In 2000, a draft
patent law was submitted to the Parliament, but it has not yet been approved (163).

All pharmacy students must study pharmacognosy. In the Universities of Tehran and
Isfahan, pharmacy students are required to write a thesis on research related to a
medicinal plant (163).
Insurance coverage
The Government health insurance covers 90% of the Iranian population, but only a
few registered herbal products are covered by the insurance (163).
Jordan
Traditional medicine is deeply rooted in the history and culture of Jordan. Traditional
medical practitioners and remedies ensure equitable access to primary health care,
particularly where a large portion of the population relies on it. Over the last decade,
there has been a growing interest in traditional and complementary/alternative
medicine, including Chinese traditional medicine, acupuncture, phytotherapy,
homeopathy, and chiropractic. Traditional medicine is practised by herbalists,
practitioners of traditional medicine, and allopathic doctors and other health
professionals.
Statistics
There is one chiropractor practising in Jordan (45).
There are no national policies recognizing traditional or complementary/alternative
medicine. Traditional and complementary/alternative medicine are not integrated
into allopathic medicine or into the national health system. However, some traditional
and complementary/alternative medicine doctors and health professionals have been
approved to practise in primary health care. A chiropractic law is pending.
Kuwait
Laws in Kuwait prohibit traditional medicine providers from practising medicine.
However, herbal medicines are not banned. The use of medicinal plants in the official
health sector began in 1978. Supplementing a ministerial resolution on the registration
of all drugs, a document and guidelines were issued on the safety and quality
assurance of herbal medicines. This document describes the main principles that
should be observed when registering herbal medicines, particularly in regard to
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safety, efficacy, and consistency. This document categorizes medicinal plants into
three groups: plants used on a daily basis, plants subject to large-scale scientific
studies and registered in pharmacopoeias, and new plants that need to be studied. For
each of these plant types, there are specific registration requirements intended to
encourage people to use plants that do not cause adverse reactions or require
allopathic medical advice, as well as to protect people from plants with toxic elements
and about which there are no published studies. Following the document and
guidelines, the Minister of Health issued a ministerial resolution organizing the
handling and registration of herbal medicines in Kuwait.
A ministerial decree, based on World Health Organization recommendations,

established the Centre for Islamic Medicine to undertake the registration of herbal
medicines and to introduce the use of medicinal plants in the treatment of some
diseases. Among its various tasks, the Centre
♦ provides therapeutic services;
♦ undertakes the registration of herbal medicines imported into Kuwait, as decreed

by the relevant ministerial decision;
♦ analyses and tests the efficacy and suitability of all medicinal plants that enter into
the country for human consumption;
♦ undertakes the importation of medicinal plants necessary for the preparation of

drugs used in the treatment of some diseases;
♦ studies and evaluates the best pharmaceutical rendering of each herbal

preparation and herbal product;
♦ carries out various studies on each plant, preparation, and product so as to

identify the stability, efficacy, and safety of the active substances therein.
In 1986, together with the Islamic Organization for Medical Sciences and the World
Health Organization Eastern Mediterranean Regional Office, Kuwait worked to
establish regional standards for herbal medicines (164). Kuwait’s registration policy
was reviewed and endorsed by the Ministers of Health of the World Health
Organization Eastern Mediterranean Region Member States and has become a
reference and basis for the registration of herbal medicines throughout the region. The
Council of Arab Ministers of Health and the Council of Health Ministers of the Gulf
also endorsed the registration policy.
Pakistan
Pakistan’s traditional unani and ayurvedic systems of medicine came to the United
India via Arab physicians. However, the unani medicine currently practised in
Pakistan is vastly different from its Greek roots.
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Most Pakistanis rely on unani medicine, finding it efficacious, safe, and cost effective.
The use of herbal medicines and homeopathy is also widespread. The National
Institute for Health has established a section on traditional medicine (tibb).
Statistics
Unani medicine is widely used throughout the country. About 70% of the population,
particularly in rural areas, use traditional and complementary/alternative medicine.
Approximately 52 600 registered unani medical practitioners serve the nation through
both the public and private sectors in urban and rural areas.
About 360 tibb dispensaries and clinics provide free medication to the public under the
control of the health departments of provincial governments. About 95 dispensaries
have been established under provincial departments of Local Bodies and Rural
Development, and one tibb clinic is working under the Provincial Department of
Auqaf. A separate Directorate of Hakims has also been established under the Federal
Ministry of Population Welfare Programme, and 16 000 diploma-holding unani
physicians of traditional medicine have been involved in the National Population
Welfare Programme. About 40 000 homeopathic physicians are registered with the
National Council for Homeopathy (53).
Unani, tibb, ayurveda, and homeopathy have been accepted and integrated into the
national health system in Pakistan.
Ordinance 65 of 7 June 1962 (165) was issued “to prevent the misuse of the allopathic
system”. It provided that only registered medical practitioners were entitled to use the
title “Doctor”, to perform surgery, or to prescribe any specially listed antibiotics or
dangerous drugs. These prohibitions were also applicable to practitioners of
traditional medicine, it being prescribed that “no person practising the allopathic,
homeopathic, ayurvedic, etc., system of medicine may use the title of ‘doctor’, unless
he is a registered practitioner”.
Subsequently, the Unani, Ayurvedic and Homeopathic Practitioners Act of 1965 (166)
was passed to regulate qualifications and to provide for the registration of
practitioners of the unani and ayurvedic systems of medicine. The Act applied to
tabibs, practitioners of unani medicine, and to voids, practitioners of ayurvedic
medicine, both being prohibited from using the title “Doctor”. Under the Act, the
Board of Unani and Ayurvedic Systems of Medicine was established in order to
arrange for the registration of qualified persons, to maintain adequate standards at
recognized institutions, to conduct research, and to perform other activities.
Requirements for the registration of practitioners were laid down, and training at
recognized institutions was fixed at four years.
The Act established that the following persons might apply for registration: persons
passing the qualifying examinations for the award of a diploma in the unani and
ayurvedic systems; any tabib or void with not less than seven years of practice; any
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tabib or void with five to seven years of practice, who either satisfied the Board as to his
or her knowledge or skill or passed, within a specified period, an approved test in the
theory and practice of the unani and ayurvedic systems; and any person who passed a
written and practical examination in the subject of the “old system” of medicine.
The Government thereafter issued the Unani, Ayurvedic and Homeopathic Systems of
Medicine Rules of 1965 (167), which included implementing provisions on the
registration of practitioners, elections to the boards, and recognition of teaching
institutions. The Act introduced the title of “Homeopathic Doctor” for registered
homeopaths, although the use of analogous titles was forbidden to practitioners of
ayurvedic and unani medicine. Under this Act, courses in homeopathy provided by
recognized institutions must be four years in duration, culminating in a qualifying
examination. Persons who have passed this examination, persons holding
qualifications from an approved homeopathic institution, and certain practitioners of
long standing, “possessing the requisite knowledge and skill”, are eligible for
registration as homeopathic doctors. The Board of Homeopathic Systems of Medicine
was established in order, inter alia, to maintain adequate standards in recognized
institutions and to make arrangements for the registration of duly qualified persons.
The legislation referred to above was also applicable in what was then known as East
Pakistan, now Bangladesh.
The Ministry of Health, through the National Council for Tibb oversees the
qualifications of practitioners. After successful completion of tibb qualifications,
candidates are registered with the National Council for Tibb, allowing them to practise
traditional medicine lawfully.

Tibbia colleges, Pakistan’s unani teaching institutions, are recognized by the
Government and are under the direct control of the National Council for Tibb,
Ministry of Health, which is responsible for maintaining standards of education in
recognized teaching institutions, revising/modifying curricula and syllabuses, and
holding annual examinations. Twenty-six colleges in the private sector and one college
in the public sector offer four-year diploma courses in Pakistani traditional unani and
ayurvedic systems of medicine that follow the prescribed curriculum and conditions
laid down in the regulations.
Hamdard University has recently introduced a five-year programme to follow

intermediate (FSc) training. About 5000 students are enrolled in its Faculty of Unani
Medicine. Annually about 950 persons graduate from the programme. Seventy-six
colleges of homeopathic medicine offer officially recognized programmes for the four-
year Diploma of Homeopathic Medical Science. Several hospitals, outpatient clinics,
and dispensaries are attached to the homeopathic medical colleges (53).
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Saudi Arabia
Traditional medicine in Saudi Arabia is based on herbal remedies and spiritual
healing. There is hardly a city or village in the country where traditional medicines are
not used or sold. They are also commonly used in home remedies for certain ailments.
In 1940, allopathic medicine began being used in large cities. Since then, the health
authorities have taken all possible measures to develop highly sophisticated allopathic
hospitals. The population of Saudi Arabia today enjoys very good health facilities.
There was official resistance to complementary/alternative medicine until the 1990s
when more Saudi Arabians demanded access to complementary/alternative medicine,
and some professionals who had been trained abroad began to practise. The most
popular therapies are acupuncture; herbal, nutritional, and health food products; and
homeopathy.
A scientific research project on the merits and demerits of Saudi Arabian traditional
medicines was undertaken as a precursor to drafting a regulatory framework and
statutory provisions for the practice of Saudi Arabian traditional medicine and the sale
and manufacture of the medicines used in it.
An act governing the practice of pharmacy and trade in medicines and medical
products was issued by Royal Decree M/18 dated 18/3/1398 H (equivalent to 26
February 1978). Articles 44 and 50 of this act prohibit the handling of locally produced
or imported products prior to their registration with the Ministry of Health. Paragraph
13A of the special provisions on registration regulations for pharmaceutical companies
and their products, which was amended through Ministerial Resolution 1214/20
dated 17/6/1409 H (equivalent to 25 January 1989) (168), requires the registration of
medicines and all products having medical claims, including herbal preparations
containing active ingredients that possess medicinal effects.
The License Committee established under the Ministry of Health is responsible for
approving or disapproving, mainly on the basis of safety and efficacy, the marketing
and use of herbal preparations and herbal products, health food products, and natural
health products, including items for cosmetic use. The Ministry of Health has
approved guidelines restricting licences to practice acupuncture to those persons who
have at least 200 hours of training, are anaesthetists, rheumatologists, or
orthopaedists, and who comply with hygienic standards. Licensing legislation also
regulates chiropractic educational standards and practice (81).

No formal education exists in traditional or complementary/alternative medicine in
Saudi Arabia; interested allopathic physicians go abroad to receive such training.
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Insurance coverage
Traditional medicine is not covered by the health insurance system; however, some
traditional medicine practitioners, especially spiritualists, practise free of charge.
Sudan
Traditional medicine in Sudan has roots in Islamic and West African medicine. People
in many areas of the country depend on herbal medicines, which are an integral part
of the health care system. There is wide experience with the use of herbs in medical
treatment. Many families specialize in herbal medicines and this knowledge is passed
on from one generation to another. Patients travel from the capital to rural regions to
consult herbalists, especially for difficult diseases.
The Medicinal and Aromatic Herbs Research Institute was created 25 years ago and
has trained a considerable number of specialists in different fields required for
research in medicinal plants.
Statistics
The Sudan Atlas of Medicinal Plants records the scientific name of more than 2000
medicinal herbs collected from different parts of the country, many native to Sudan.
All of these herbs are in current use in traditional medicine.
There is legislation for the registration of herbal preparations and herbal products.
Syrian Arab Republic
No licences are issued to providers of herbal medicine; such practices are limited to
specialists.
In 1997, the Ministry of Health issued decisions on the technical prerequisites

necessary for the establishment of laboratories for herbal medicine. In 1998, the
Ministry issued decisions on the manufacture and distribution of herbal medicines
and on a system of controls. The manufacture of herbal medicines has been included
in the national drug policy. Both public and private laboratories have been active in
processing medicinal herbs, and the Ministry of Health has given preliminary
approval for the establishment of laboratories that would manufacture herbal
medicines. A file concerning the manufacturing of herbal medicines has been
developed in preparation for their registration.
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Three draft laws covering herbal medicine have been prepared. One concerns herbal
medicines that would be used in primary health care.

A syllabus on treatment with herbal medicines has been recommended for inclusion in
the curricula of faculties of medicine.
A syllabus on medicinal plants and herbal medicines has been introduced into the
curricula of pharmacy faculties and at health institutes for technical assistant
pharmacists.
United Arab Emirates
In 1989, the Ministry of Health’s Zayed Centre for Herbal Research and Traditional
Medicine was established in Abu Dhabi to conduct research on medicinal plants and
traditional medicine practitioners. Similar research is conducted by the Desert Section
of the Desert Marine Environment Research Centre, the Department of Pharmacology
at the Faculty of Medicine of the University of Al-Ain, the Society of National Culture,
and the History and Culture Centre.
There is high consumer demand for herbal preparations and herbal products in the
United Arab Emirates.
Section 1 of Federal Law 7 of 1975 (169) put in place licensing and registration
requirements for the practice of medicine. Only an allopathic physician who holds a
medical degree may apply for a licence to practise medicine. Under Section 2, non-
citizens who seek to practise as general practitioners must complete an additional two
years of post-internship medical practice.
In the United Arab Emirates, birth attendants are designated as medical professionals
by Federal Law 5/1984 (170), the practice of which is open to physicians, pharmacists,
and other licensed individuals. By Section 3, the Minister of Health is to publish
licensing qualifications and outline the powers and duties of licensees.
In order to provide a legal framework to ensure that their benefits could be enjoyed
without unnecessary risks, registration criteria (171) for herbal medicines were
published in January 1998. These criteria were established by a committee of
allopathic physicians and personnel from the Zayed Centre and Emirates University.
The registration criteria include the following:
♦ documentation, including detailed monographs, for the herb;
♦ reference sample of the active ingredient of the herb;
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♦ laboratory analysis for identity, purity, and quantity.
Priority in registration is given to single-ingredient products. Products containing

more than one herb must have a logical justification for the combination based on the
uses of the finished product. Therapeutic claims beyond traditional uses are not
accepted unless scientifically justified.
As of April 1999 (171), 27 applications had been received. Seven of the applications
were completed and approved, seven had completed the laboratory screening process,
and 13 were waiting for laboratory analysis. These 27 applications had come from
companies located in a number of countries, including Germany, Switzerland, Austria,
India, Indonesia, and China.
A 1999 report (171) outlined several problems with the criteria. Companies had
difficulty fulfilling the documentary requirements, especially relating to stability data,
and many companies wanted to register traditional products with more than 10 active
ingredients, such as ayurvedic medicines. Analysis of the active ingredients in the
final products proved technically difficult because of both qualitative and quantitative
interference in the assays. Enforcing the law has also posed challenges.
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Europe
Austria
Statistics
The chart below lists the distribution of allopathic physicians practising
complementary/alternative medicine in Vienna in 1997 (172).
Number of Practising
Complementary/Alternative Medicine Allopathic Physicians
Acupuncture 100
Homeopathy 87
Neuraltherapy 87
Bioresonance 40
Other 200
In 2000, the Liga Medicorum Homeopathica Internationalis had 670 members in

Austria (86). While there are no homeopathic hospitals, homeopathic consultation
takes place regularly in five allopathic hospitals in Vienna and in one allopathic
hospital in Klagenfurt (53). Austria has one academy of holistic medicine.
Only legally qualified and authorized medical professionals may practice medicine in
Austria (172). Under Section 1.2 of the Federal Medical Law, medical acts are defined
as “all activities based on medico-scientific knowledge carried out directly or
indirectly on human beings” performed for the purposes of diagnosis, treatment, and
prophylaxis. Under the Law on Physicians of 1984 (173, 174), medical acts that are not
provided by authorized medical professionals, such as midwives, medical-technical
assistants, and nurses, are reserved for allopathic physicians. Article 184 of the Penal
Code states that unskilled persons who practise medical acts or activities reserved for
allopathic physicians risk a fine or imprisonment of up to three months. However, the
courts have been tolerant with regard to complementary/alternative medical
practitioners and charges of charlatanism. In practice, Article 184 is enforced only
when practitioners use methods that do not have any scientific support, such as mystic
water treatment.
According to the Law on Health Services, only scientifically recognized medical care
can be provided in hospitals. Acupuncture, neuraltherapy, and chiropractic are
recognized, but not homeopathy. However, homeopathy is recognized by the National
Committee of Medicals (53). Nonetheless, and despite the fact that there are neither
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specific legal or paralegal regulations nor draft regulations on the use of
complementary/alternative medicine in the country, allopathic physicians are
implicitly permitted to use any medical technique they deem appropriate, provided
they obtain the consent of their patients. Under their own responsibility, therefore,
allopathic physicians may use complementary/alternative medicine in their treatment
regimes.

The Council of the Order of Physicians (172) issues diplomas officially recognized as
medical qualifications in acupuncture, homeopathy, manual therapy, and
neuraltherapy. Training courses for these diplomas last between two and three years
(from 140 to 350 hours). Neuraltherapy and chiropractic are taught in universities.
The National Medical Association recognizes the examination and title of

“Homeopathic Doctor” (86). A three-year postgraduate homeopathic curriculum is
available and leads to a diploma awarded by the official Medical Society of Austria.
Advanced training is offered through seminars, lectures, and conferences with
Austrian and international scholars (53). There are activities and associations for
students interested in homeopathy at universities in Vienna, Graz, and Innsbruck.
As of 1 August 1996, the creation of a new educational institution of complemen-

tary/alternative medicine is punishable by imprisonment (174).
Insurance coverage
Public insurance funds (172) have the following reimbursement criteria for medical
treatments: scientific proof of effectiveness, cost-effectiveness, and appropriateness.
Complementary/alternative medicine is generally not covered. Exceptions are made,
however, for homeopathy and, for purposes of pain relief, massage, balneotherapy,
and electrotherapy. Exceptions are also made when allopathic treatments are
unsuccessful and relatively recognized complementary/alternative treatments are the
last resort. The Oberösterreichische Gebietskrankenkasse partially reimburses
acupuncture treatments.
Some private insurance companies cover complementary/alternative medicine (172).
Belgium
Statistics
According to a 1998 poll (172), almost 40% of the Belgian population — women more
than men — have used complementary/alternative medicine at least once. Of these
persons, 77% were satisfied with their treatment. While the general public is in favour
of the Ministry of Health giving official recognition to homeopathy, acupuncture,
osteopathy, and chiropractic, allopathic physicians are evenly divided: 43% are in
favour and 43% are opposed to such recognition.
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The most widely consulted complementary/alternative therapies in Belgium (172) are
homeopathy, accounting for 81% of complementary/alternative consultations;
acupuncture, accounting for 38%; osteopathy, 27%; phytotherapy, 25%; and chiro-
practic, 21%. One allopathic physician out of four believes that these therapies should
be reimbursed. Fifty-nine per cent of patients who use complementary/alternative
medicine and 36% of patients who do not use complementary/alternative medicine
are willing to pay higher premiums to cover this reimbursement.
Most providers of complementary/alternative treatments are allopathic doctors or

physiotherapists (172). One allopathic physician out of four provides
complementary/alternative treatments; these are mostly general practitioners. The
most commonly practised forms of complementary/alternative medicine are
homeopathy, practised by 59% of providers of complementary/alternative medicine;
acupuncture, practised by 40%; and phytotherapy, 28%. Thirty-three per cent of
manipulative treatments are provided by physiotherapists and 34% by non-allopathic
practitioners.
There are three homeopathic organizations for allopathic physicians and pharmacists
and two for patients. The Union of Acupuncturists Physicians was created in 1981.
A monopoly on the practice of medicine was introduced by the Practice of Medicine
Act of 1967 (172). Under this act, the practice of medicine, which includes diagnosis,
treatment, prescriptions, surgery, and preventive medicine, was the exclusive domain
of legally qualified allopathic physicians. After the intervention of the European
Commission with regard to the (non)enforcement of European Directives on
homeopathic products, the Government of Belgium asked the Federal Department of
Public Health to draft legislation on complementary/alternative medicine. On 29
April 1999, the new law was adopted by the Belgian Parliament (175). In November
1999, the Government enacted bylaws to ensure enforcement of the law.
Article 2 of the new law introduces provisions for homeopathy, chiropractic, osteo-
pathy, and acupuncture and provides for the recognition of other complemen-
tary/alternative techniques.
Article 3 establishes a commission to advise the Government on the practice of

complementary/alternative medicine, particularly registration of practitioners,
membership in recognized professional organizations, insurance for professionals,
regulation of advertising, and restrictions on medical acts. In order to register,
practitioners must demonstrate that they provide high-quality and accessible care that
has a positive influence on their patients’ health.
Article 6, Paragraph 1 requires the commission to be composed of five allopathic

practitioners (with at least one being a general practitioner), nominated by faculties of
medicine, and five complementary/alternative practitioners, nominated by recognized
professional organizations. The commission, in Article 6, Paragraph 2, is also
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designated to advise the Government on organizing a peer-review system and a code
of professional ethics.
By Article 8, the practice of a registered complementary/alternative form of medicine

is allowed only when the practitioner is licensed for that practice by the Ministry of
Social Affairs, Public Health, and Environment.
In Article 9, complementary/alternative practitioners are required to maintain medical

records for each patient. Complementary/alternative practitioners who are not also
allopathic physicians must obtain a recent allopathic physician’s diagnosis from their
patient prior to commencing treatment. If patients choose not to consult an allopathic
physician before seeing a complementary/alternative practitioner, they must put their
wishes in writing. Registered complementary/alternative practitioners must take
precautions to ensure that patients are not deprived of allopathic treatment. As a
result, complementary/alternative practitioners who are not also allopathic physicians
must keep allopathic physicians informed of the health of their patients. With patient
consent, complementary/alternative practitioners are permitted to seek the advice of
other complementary/alternative practitioners who are not allopathic physicians.
Infringement of the law — in particular, practising complementary/alternative

medicine without a licence or treating a patient without having obtained an allopathic
physician’s diagnosis or without having the patient’s desire to avoid such diagnosis in
writing — risks a fine (under Article 11) or the suspension or withdrawal of the
provider’s licence to practice (under Article 8).

Complementary/alternative medicine is not taught in Belgian medical schools;
however, the Belgian Medical Faculty of Homeopathy offers courses for allopathic
physicians, surgeons, dentists, pharmacists, and veterinarians. These courses comply
with standards set by the European Committee for Homeopathy (172).
The Belgian Acupuncture Federation is authorized by the Belgian Government to train

acupuncturists to practise under the new licensing law (172). In order to be permitted
to practise acupuncture, a provider must be certified as an allopathic medical doctor,
dentist, physiotherapist, nurse, or midwife, as well as having completed at least 750
hours of acupuncture training — 250 hours of basic theoretical principles of traditional
Chinese medicine, 250 hours of traditional Chinese medicine pathology, and 250 hours
of clinical practice — and having written a thesis. There are two associations of
acupuncturists offering three-year training programmes; however, most practitioners
using acupuncture are trained in East Asia or France.
Insurance coverage
The Belgian social security system (172) does not officially reimburse complemen-
tary/alternative treatments, regardless of whether they are provided by allopathic
physicians or not. Practically speaking, however, allopathic physicians using comple-
mentary/alternative medicine may assure their patients that at least part of their fees
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will be reimbursed. Osteopathic treatments are reimbursed so long as physiotherapists
use a classic designation to prescribe them.
In March 1997, the Socialist Mutual Insurance of Tournai-Ath (172) was the first
company to partially reimburse specific complementary/alternative treatments. They
reimburse 25% of homeopathic remedies up to a maximum cost of 6000 Belgian francs
per year and per beneficiary. They also reimburse 400 Belgian francs for each
osteopathic treatment with a maximum of six treatments, but only if they have been
provided by an allopathic physician, nurse, or physiotherapist. The list of reimbursed
homeopathic remedies is adapted from the European Union Directive on homeopathic
products. Reimbursement may soon be extended to other techniques, such as
acupuncture and phytotherapy.
Private insurance companies (172) reimburse chiropractic care and, partially,

acupuncture treatments.
Denmark
Statistics
The complementary/alternative treatments most used by the Danish population are
reflexology, acupuncture, massage, natural medicine, homeopathy, natural healing,
kinesiology, and chiropractic (172).
A 1994 study (172) reported that 33% of the adult population of Denmark had used
complementary/alternative medicine during the previous year, women used it more
frequently than men, and the average age of patients of complementary/alternative
medicine decreased in the period from 1970 to 1994. The study also found that of those
who used complementary/alternative treatments, 77% considered themselves cured,
17% experienced no effect from the therapy, and 1% considered their health problems
to have worsened as a result of their treatment. People most often sought
complementary/alternative therapies for joint and muscular problems.
Approximately 700 physicians are members of the Danish Society for Medical
Acupuncture; 116 of these are newly certified (172). There are 265 chiropractors
practising in Denmark (45). The Danish Chiropractic Association has 300 members.
There are 16 000 allopathic medical doctors in Denmark. There are also several
associations of non-allopathic physician providers.
In Denmark, allopathic physicians holding an academic degree in medicine, having
taken the Hippocratic oath before a faculty of medicine, and authorized by the
National Health Service are not restricted as to the medical techniques they may use.
The title of “Physician” is protected and only licensed allopathic physicians may call
themselves such. Public-sector medical positions are reserved for authorized doctors
(172).
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Two laws (172) regulate the practice of complementary/alternative medicine. The
Medicine Act legislates the making and marketing of natural remedies and includes
criteria for packaging, providing information to patients, and advertising. The Practice
of Medicine Act of 1970 permits non-allopathic physicians to practise medicine
regardless of their training and without previous authorization. However, non-
allopathic physicians are not recognized as official health care providers, their titles
are not protected, and they are not integrated into the national health care system.
By Articles 23–26 of Order 426 of the Practice of Medicine Act of 1976, issued by the
Minister of the Interior on 19 August 1976, non-physicians may not perform specific
medical acts that are reserved for licensed allopathic physicians, nor are they
permitted to use needles except under the supervision of an allopathic physician. The
medical acts reserved for licensed physicians are the following: treating persons for
venereal diseases, tuberculosis, or any other infectious disease; performing surgery;
administering general or local anaesthetics; providing obstetric aid; applying
medicines that may be dispensed only with a physician’s prescription; using X-ray or
radium treatments; or practising therapies using electric machines. Violation of this
limited monopoly is punishable by up to 12 months in prison. However, non-
allopathic practitioners are only prosecuted for selling harmful products, otherwise
exposing patients to a provable danger, or causing the serious deterioration or death
of their patients. Sentencing is particularly severe in cases where the patient is
mentally ill or handicapped, under 18 years of age, or considered incapable of
managing his/her own affairs. Ancillary staff, by contrast, may practice complemen-
tary/alternative medicine without restriction.
Chiropractors are the exception to this law. They are regulated by a 1992 law (65).
Whenever patients consult a chiropractor without an allopathic physician’s referral,
the chiropractor must inform the patient’s practitioner of the diagnosis and treatment,
whether the practitioner is an allopathic physician or not.
A Danish study on complementary/alternative treatments concluded that current

legislation in this field is sufficient and further regulations are not necessary.

The Danish Society for Medical Acupuncture offers a 120-hour diploma course in
acupuncture for allopathic physicians (172). The Danish Chiropractic Association (172)
provides training for non-allopathic physicians. Membership in the Danish
Chiropractic Association is restricted to those persons trained at a college accredited
by the American Council on Chiropractic Education who have completed a six-month
apprenticeship with a member of the Association and have passed the Association
exam.
Insurance coverage
The Danish Chiropractic Association (172) is working to obtain official recognition and
full social insurance reimbursement for chiropractic treatments. In the meantime,
reimbursement is determined by a 1975 agreement between public insurance schemes
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and chiropractors. Under this agreement, public insurance covers one-third of the
costs of up to five chiropractic consultations and one X-ray examination per year, on
the condition that these are provided by chiropractors recognized by the Danish
Chiropractic Council. When patients are referred by licensed allopathic physicians,
some acupuncture and osteopathic treatments are also reimbursed (172).
Finland
The Ministry of Social Affairs and Health recognizes the increasing contribution of
complementary/alternative therapies to the Finnish Health Care System (172). Among
older rural Finns, massage, bonesetting, and cupping are popular; among younger
urban Finns, natural medicine, manipulation, acupuncture, and hypnosis are popular
(172).
Statistics
About 50% of the adult Finnish population have used complementary/alternative
medicine at least once (172). There are 30 chiropractors practising in Finland (45). In
1987, there were 200 local health centres providing acupuncture treatment (172).
Act 559 of 28 June 1994 (176) regulates the licensing of medical practitioners. By Article
4, the right to practise as an independent allopathic medical doctor can be granted to
practitioners who have completed basic medical training and who have additional
training in primary health care or special training in an allopathic medical speciality.
Professional allopathic medical providers who fulfil the required conditions have a
number of rights, including the right to use a protected occupational title.
Only allopathic doctors and, by Decree 564/1994 (172), registered chiropractors,

naprapaths, and osteopaths are recognized health practitioners and allowed to
practise medicine — specifically, to diagnose patients and charge fees. However,
according to Act 559, other medical practitioners may treat patients if they do not
practise within public services and do not pretend to be health care professionals. As a
result, only allopathic doctors and registered chiropractors, naprapaths, and
osteopaths are supervised by the medical authorities in practising complemen-
tary/alternative medicine. Other medical practitioners are not supervised, nor is their
licensing regulated.
While anyone can use an unqualified title, such as “Chiropractor”, by Act 559 only
registered chiropractors, naprapaths, and osteopaths may use the descriptor “Trained”
in describing themselves. Act 559 also confers title protection to allopathic physicians.
Articles 34 and 35 of Act 559 relate to the illegal practice of medicine, punishable by
fine or up to six months in prison, although prosecution is rare. The objective of these
articles is to protect patients and medical professionals working within public services.
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A licence is necessary to market homeopathic products with a degree of dilution less
than one million.

Since 1975, acupuncture has been an accepted part of allopathic medical practice, and
training in acupuncture is a component of the medical curriculum of allopathic
physicians (172).
Chiropractors, naprapaths, and osteopaths must complete at least four consecutive

years of training approved by the National Board of Medico-Legal Affairs. Chiro-
practors generally train in the United States. Other complementary/alternative
therapists often attend schools in Sweden (172).
Insurance coverage
When provided by an allopathic physician, acupuncture is covered by the Social
Insurance Institution (SII) (172). In general, other complementary/alternative
therapies are also reimbursed by the SII, provided they are given by medically
qualified allopathic doctors during their normal sessions and provided the doctors do
not specify which treatment they used. The SII covers treatments given by recognized
chiropractors, naprapaths, and osteopaths when the following conditions are met:
♦ Patients can show that they first obtained a diagnosis and statement of required
treatment from a licensed allopathic physician.
♦ Patients are referred to the complementary/alternative therapist by a licensed

allopathic physician.
♦ The complementary/alternative therapist works in an institution led by a

physiotherapist or an allopathic physician.
Complementary/alternative medications, however, are not covered by the SII.
In Finland, no private insurance companies (172) reimburse complementary/alterna-

tive medicine except in some cases of chiropractic treatment, where reimbursement
follows the same criteria used by the SII.
France
Homeopathic and herbal health care products are very popular in France. The most
popular forms of complementary/alternative medicine are, in order of popularity,
homeopathy, acupuncture, herbal medicines, water cures, chiropractic, thalasso-
therapy, osteopathy, and iridology (172).
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Statistics
A 1987 survey found that 36% of allopathic doctors, mostly general practitioners, used
at least one complementary/alternative technique in their medical practices. Among
allopathic physicians using complementary/alternative medicine, 5.4% used it
exclusively; 20.7%, often; and 72.8%, occasionally. The social security system qualifies
allopathic physicians using complementary/alternative medicines as “doctors with a
particular type of practice (MEP)”. Any doctor can be so designated. In 1993,
physicians who were registered as MEPs represented 6.2% of the whole medical
corpus. Thirty per cent of MEPs provide acupuncture treatments. Twenty per cent
provide homeopathic therapies (172).
An additional 50 000 non-allopathic practitioners provide complementary/alternative

therapy in France (172). There are approximately 390 chiropractors practising in
France (65). There are between 2000 and 4000 kinesiotherapists (172).
One survey (172) found 49% of the people questioned — 53% of the women surveyed
and 44% of the men — had used complementary/alternative medicine at least once,
16% during the previous year. Complementary/alternative medicine is most popular
among people between the ages of 35 and 45, 59% of persons in this age group having
reported using complementary/alternative medicine. Sixty-eight per cent of
executives and academics had used complementary/alternative medicine, compared
to 60% of middle managers and intermediate professionals and 40% of farmers, the
least likely group to use complementary/alternative medicine. Those surveyed
reported using a complementary/alternative medicine for minor diseases (49%),
chronic symptoms (54%), serious illnesses (3%), and the prevention of disease and
promotion of a healthy lifestyle (17%).
Seventy per cent of patients of complementary/alternative medicine considered it

effective for minor diseases; 65%, for chronic diseases; and 9%, for serious illnesses.
Only 11% of patients considered these therapies ineffective for minor diseases; 15%,
for chronic diseases; and 38%, for serious illnesses (172).
France has many organizations for practitioners and patients of complementary/alter-

native medicine.
Under Articles L 372 through L 376 of the Code of Public Health (172), persons other
than licensed allopathic physicians who habitually or continuously diagnose or treat
illnesses, real or supposed, or who perform activities constituting medical procedures
are illegally practising medicine. Persons wishing to obtain a licence to practise
medicine must possess a State certificate; hold French, Tunisian, Moroccan, or
European Union citizenship; and be registered by the professional society of
physicians.
Despite prosecution, non-allopathic practitioners — particularly physiotherapists

using complementary/alternative methods such as chiropractic and osteopathy —
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continue to practise, and the number of allopathic physicians using complemen-
tary/alternative medicine is increasing. Allopathic physicians providing comple-
mentary/alternative treatments either assist persons practising medicine illegally or
practice complementary/alternative medicine themselves. In both cases, they risk
being tried for penal and disciplinary infractions. Recent decisions, however, suggest
that the courts are becoming more tolerant towards the practice of complemen-
tary/alternative medicine.

Teaching complementary/alternative medicine (172) to non-allopathic physicians is
permitted. The number of schools and courses in complementary/alternative
medicine has recently increased, although they vary widely in quality. Private schools,
however, may not issue diplomas to their graduates. According to Article 4 of the Act
of 18 March 1880, only the State has this power.
Despite the allopathic medical establishment’s opposition to the recognition of

chiropractic, the Decree of 11 February 1953 provides for the incorporation of
chiropractic into medical schools. However, the Decree has not been applied and
chiropractic has never been taught in French medical schools. In fact, the practice of
chiropractic is illegal in France. Nonetheless, there is a school of chiropractic (65).
The University of Bobigny (172) established the Department of Natural Medicines in

1982. Since then, diplomas have been awarded in acupuncture, homeopathy, phyto-
therapy, osteopathy, auriculotherapy, naturopathy, oligotherapy, and mesotherapy.
In 1990, the University Diploma in Natural Medicines (172) — training leading to an

inter-university certification recognized by the French National Order of Physicians —
was created for acupuncture and osteopathy. Recognition of a certification in
homeopathy is under consideration. Phytotherapy is already incorporated into
training in pharmacy. However, these therapies are not considered medical
specialities. In order to obtain recognition as a medical speciality, the discipline must
be taught according to the criteria followed for an allopathic speciality, i.e., the
training should be full-time and include periods of clinical practice.
Some non-allopathic practitioners receive their training at foreign schools. For

example, kinesiotherapists/physiotherapists who also provide chiropractic treatments
are usually trained in the United Kingdom or Germany (172).
Insurance coverage
In France, social security and private insurance (172) reimburse some forms of
complementary/alternative medicine so long as an allopathic medical practitioner
provides them.
Social security reimburses homeopathic prescriptions written by authorized

physicians and specific medical activities and products, including chiropractic,
medical phytotherapy consultations, and complementary/alternative technical
sessions with an approved kinesiotherapist. Acupuncture treatments given by MEP
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physicians are also reimbursed, provided that the physicians observe regulations
regarding allopathic consultations.
Germany
In 1992, the Federal German Ministry of Research and Technology initiated an
extensive research programme on complementary/alternative medicine coordinated
by the University of Written/Herdecke (172).
Statistics
Three-fourths of allopathic physicians use complementary/alternative medicine and
77% of pain clinics provide acupuncture treatments (172).
In 1994, there were between 10 000 and 13 000 practitioners of complementary/alter-

native medicine, or Heilpraktikers, 8000 of whom were members of professional
associations (172). There are approximately 40 chiropractors practising in Germany.
There were 20 million patient contacts with complementary/alternative medicine in

1992. The most frequently sought complementary/alternative therapies are, in order
of popularity, homeopathy (accounting for 27.4% of patient contacts), acupuncture
(15.4%), procaine injection therapy, chiropractic, ozone and oxygen therapy, herbal
medicines, humoural pathology, massage, and cell therapy (172).
According to a 1992 poll (172), between 20% and 30% of the population had used
complementary/alternative medicine, with 5% to 12% having used it during the
previous year. Complementary/alternative therapies are more popular with women
than men. Most complementary/alternative patients are between the ages of 18 and 65
and have a relatively high level of education. In most cases, patients have first sought
treatment with allopathic medicine.
There are many organizations for practitioners and patients of complementary/alter-

native medicine.
In Germany, there is no legal monopoly on the practice of medicine (172). Thus,
licensed non-allopathic physicians may practice medicine, and all licensed medical
practitioners are allowed to use complementary/alternative medicine.
There are, however, some restrictions on the performance of particular medical acts.
Only allopathic physicians and dentists are allowed to practise dentistry. Only
allopathic physicians are allowed to treat sexual diseases, treat communicable and
epidemic diseases, deliver specific medications, give or provide anaesthetics and
narcotics, practise obstetrics and gynaecology, take X-rays, perform autopsies, and
deliver death certificates. Infringement may result in penal punishment. In order to
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obtain a title as an allopathic physician, a person must have an academic degree in
medicine, practical experience, a licence from public authorities, and a medical
certificate confirming that there are no indications of physical or mental disability or
addiction to drugs.
Licensed Heilpraktikers (172) may practise medicine with the exclusion of these specific
medical acts. To qualify for a Heilpraktiker’s licence, a candidate must be at least 25
years old, have German or European Union citizenship, have completed primary
school, have a good reputation in order to guarantee a normal professional practice,
have a medical certificate confirming that there are no indications of physical or
mental disability or addiction to drugs, and pass an examination before a health
commission proving that the candidate has sufficient knowledge and ability to
practise as a Heilpraktiker and that the candidate’s treatments do not negatively affect
public health. The exam verifies the candidate’s basic knowledge of anatomy,
physiology, hygiene, pathology, sterilization, disinfecting, diagnosis, and health
regulations, particularly the epidemic law. However, the questions are required to be
basic and understandable.
Chiropractors must obtain a Heilpraktiker licence regardless of whether or not they

have a degree from an accredited institution (65).

As part of the standard curriculum, allopathic medical schools are required to test
students on their knowledge of complementary/alternative medicine. Students may
also select a postgraduate specialization in complementary/alternative medicine (172).
Heilpraktiker candidates do not have to follow standardized training in order to pass
the licensing exam, which has resulted in a wide variety of teaching methods as well
as variations in the length and quality of training. According to a recent poll, only 10%
of Heilpraktikers did not have any form of training, while 88% had from one to four
years of training (172).
The German Federal Association of Heilpraktikers organizes training in 29 cities for

persons who desire to obtain a Heilpraktiker licence. Some of this training lasts three
years or 350 hours (172).
In Germany, the title “Homeopathic Physician” is legally protected. The Medical

Chamber bestows this title after a three-year training programme (86). Advanced
obligatory training courses for homeopathic professors are given on a regular basis.
Official homeopathic teaching contracts exist with the medical faculties in Berlin,
Dusseldorf, Hannover, Heidelberg, and Freiburg (53). Chiropractors holding a degree
from a regionally accredited institution may use the title “Doctor of Chiropractic” (65).
Insurance coverage
In Germany, public and private insurance (172) provides the same kind of coverage.
Both currently reimburse some complementary/alternative treatments and are
moving towards broadening this coverage. Even though there is no constitutional
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right to obtain reimbursement, the following criteria have been established to deter-
mine the coverage of complementary/alternative medicine by both social insurance
and private insurance:
♦ If no allopathic treatment is available to treat a specific illness or to reduce its pain

or if the aetiology is unknown — for example, for multiple sclerosis or certain
forms of cancer — the use of complementary/alternative medicine is reimbursed
provided the treatment has a minimum chance of success whether or not the
method of treatment is generally scientifically recognized.
♦ If the aetiology is known, but no allopathic treatment is available, the recourse to

complementary/alternative medicine is allowed, provided there is a minimum
chance of success according to the aetiology. The same allowance is given when a
previous allopathic treatment has been unsuccessful.
♦ When an allopathic treatment and a complementary/alternative treatment are

both available but the allopathic treatment has side effects or risks for the patient,
in general or in particular, the use of complementary/alternative medicine is
reimbursed. However, in this case, it is necessary to balance the risks and the cost-
effectiveness of the treatment.
♦ If there are safe allopathic and non-allopathic treatments at a patient’s disposal,

he/she may choose the less expensive treatment.
Anthroposophic, phytotherapeutic, and homeopathic products are reimbursed. By

Articles 92 al. 1 and 135 al. 1 Sozialgestezbuch, in order to be reimbursed, experi-
mental treatments have to be recognized, in broad terms, as useful and safe.
Some private insurance companies also reimburse treatments not scientifically

recognized if they are provided by Heilpraktikers and if their effectiveness is not
completely rejected.
Hungary
Statistics
The Hungarian Homeopathic Medical Association has 340 members (172). There are
three practising chiropractors in Hungary (65).
Although allopathic physicians are the most common providers of complemen-
tary/alternative medicine, non-allopathic physicians and non-allopathic practitioners
may provide specific complementary/alternative treatments. In February 1997, the
Hungarian legislature passed two pieces of comprehensive legislation on natural
medicine: Government Decree 40/1997 (IV 5) Korm. r. on natural medicine and the
Decree of the Minister of Welfare 11/1997 (V 28) on some aspects of the practice of
natural medicine (172). These two decrees clearly and officially integrate allopathic
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and non-allopathic physicians who practise complementary/alternative medicine into
the national health care system. The Decrees came into force on 1 July 1997.
The Decrees outline precise rules regarding the curriculum of complementary/alter-

native medical training as well as its practice. Each complementary/alternative
discipline has its own training requirements and State exam. Within a legal
framework, non-allopathic physicians are allowed to use complementary/alternative
medicine once they have passed the exam.
Articles 1 through 7 of the Decrees regulate conditions for practising complemen-

tary/alternative medicine. Annexes 1 through 4 list the specific requirements for each
form of complementary/alternative medicine.
Article 1 identifies three categories of authorized medical practitioners: allopathic

physicians, practitioners with a non-academic higher medical qualification, and other
non-allopathic practitioners. Natural doctors are authorized practitioners who have
passed the required exams and are permitted to use complementary/alternative
medicine.
Article 1 also contains restrictions on the use of complementary/alternative medicine.

Only allopathic physicians may practise homeopathy, Chinese and Tibetan medicine
(including acupuncture), biologic dentistry, therapies using oxygenation, neural-
therapy, anthroposophy, and magnetic bioresonance. Both allopathic physicians and
medical practitioners with a non-academic higher health qualification may provide
manual therapies. Practitioners who do not hold a higher health qualification may
provide acupressure, massage therapy, lifestyle counselling, reflexotherapy, bio-
energy, phytotherapy, and auriculotherapy.
Article 2 clarifies the legal framework in which natural doctors are allowed to practise.
Paragraph 1 of Article 2 states that allopathic physicians are in charge of diagnosis,
therapy planning, and patient follow-up. Other practitioners who have the necessary
qualifications may participate in patient care at the request of the patient or through
an allopathic physician’s referral. Natural doctors who are non-allopathic physicians
are allowed either to practise under the supervision of an allopathic physician or,
more independently, to provide care after an allopathic physician has made a
diagnosis. Consulting allopathic physicians may not oppose a patient’s choice to seek
treatment from a natural doctor.
Article 2 Paragraph 2 delineates medical acts that may not be performed by non-
allopathic physicians. If a patient is under the treatment of an allopathic physician,
natural doctors must consult the patient’s allopathic physician.
Article 2 Paragraph 3 stipulates that only qualified psychologists or allopathic

physicians with a qualification as psychotherapists are allowed to provide
psychotherapeutic care based on natural medicine.
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By Article 3, natural doctors must submit to the same directives as other medical
practitioners, such as respecting obligations, abiding by ethical rules, and keeping
patient records.
Article 4 permits the use of all regular drugs under the provision of complemen-
tary/alternative medicine. Homeopathic products not registered in Hungary can be
used if the registration procedure is in process.
Article 5 gives the Institute of Health, under the authority of the Ministry of Social
Welfare, the responsibility of regulating the training and examination of natural
doctors.
Under Article 7, allopathic physicians with an academic degree in medicine may ask
for a licence to practise as natural doctors without being required to take another
exam. They are also allowed to use the title of “Natural Doctor”, but to use the title of
specialists in particular therapies, they must take the exam. Allopathic physicians are
the only practitioners who do not have to pass the exams to practice complemen-
tary/alternative medicine. Psychologists with higher health qualifications and other
practitioners must take a specific examination in natural medicine before they may use
the title of “Natural Doctor”. Natural doctors are registered and supervised by a
special commission.
Annex 1 contains a complete list of authorized complementary/alternative treatments

and of the medical practitioners who are allowed to provide them.
Annex 2 outlines the information that natural doctors must record, such as patient
histories and a description of the current treatment.
Annex 4 gives the theoretical and practical requirements for examinations in

acupuncture, massage techniques, lifestyle counselling, reflexology, physiotherapy,
bioenergy, and auriculotherapy. For each therapy, the Annex lists the definition of the
technique, practical and theoretical requirements, rules on ethics, and specific topics
for examination.
In 1977, the Government recognized homeopathy as a medical method, but there is no

officially recognized training programme or examination (86). Chiropractic is regu-
lated, but not defined, by law. The Ministry of Education recognizes the Doctor of
Chiropractic degree (65).
Ireland
Statistics
There are 55 chiropractors practising in Ireland (45). There are numerous associations
of professional complementary/alternative practitioners.
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As in the United Kingdom, the Medical Council (172) is the statutory body that
regulates the medical profession. In order to practise medicine as an allopathic
physician, a provider must possess a certificate of qualification from a medical school
and be registered with the Medical Council. Although allopathic physicians do not
have a legal monopoly on medical practice, registered allopathic practitioners have
some exclusive rights. Only those who are registered as doctors are permitted to treat
venereal diseases, practise obstetrics, certify death, issue medical certificates for
official purposes, prescribe a wide range of controlled drugs, give advice in court on
specific issues, supply services to police for alcohol-linked traffic offences, and
administer anaesthetics. All medical positions in State services, the army, civil service,
or private industry are restricted to registered allopathic medical practitioners.
Persons without an allopathic medical degree are tolerated by law to practice

complementary/alternative medicine; however, only medical practitioners with a
university degree in allopathic medicine are recognized. Under Section 61 of Part V,
Fitness to Practise, of the Medical Practitioners Act of 1978 (172), it is an offence for
non-registered practitioners to provide medical treatment under the pretence of being
a registered practitioner. People who make false declarations for the purpose of
obtaining registration are punishable by a fine and/or imprisonment.
There is no chiropractic law, although the practice of chiropractic is permitted under

common law. Chiropractors may obtain a licence to operate X-ray equipment (65).

There is no postgraduate training for allopathic physicians in complementary/alter-
native medicine.
Insurance coverage
When a registered allopathic doctor provides complementary/alternative treatment, it
is not distinguished from other medical care and is covered by the General Medical
Services (172).
Italy
The private sector ensures the availability of complementary/alternative medicine
(172). The Societa Italiana di Omeopatia, founded in 1947, links the different societies
and schools of homeopathy (172).
Statistics
Of Italy’s 250 000 allopathic physicians, 5000 use complementary/alternative
techniques. Of those using complementary/alternative techniques, around 1300
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practise acupuncture (172). There are approximately 200 chiropractors practising in
Italy (65).
Twenty-four per cent of adults have used complementary/alternative medicine at

least once. Women, particularly those between 25 and 50 years of age, are the most
likely to use complementary/alternative medicine (172). In order of popularity,
homeopathy, acupuncture, herbal remedies, prana therapy, anthroposophic medicine,
and chiropractic are the most popular complementary/alternative therapies (172).
More than three million people, 5.25% of the population, use homeopathy. Ninety-two
per cent of these patients are female, 79% are adults, and 69% are middle class. There
are about 5000 homeopathic doctors, 7000 pharmacies selling homeopathic products,
and 20 companies that produce or distribute homeopathic medicines. The market for
homeopathic products in Italy grew from 10 billion lira in 1982 to 120 billion lira in
1994 (177). In September 1996, a petition enclosing 300 000 signatures of patients of
homeopathic medicine asked the Italian Parliament to give official recognition to
homeopathy (172).
In order to practice as an allopathic physician (172), a person must have a degree in
medicine or surgery, must have passed the corresponding State exam, and must be
registered in a professional register. Paramedics are specifically excluded from
practicing complementary/alternative medicine. According to a decision by the
Criminal Supreme Court of Appeals in Perugia, only registered allopathic physicians
may practice complementary/alternative medicine. Allopathic physicians using com-
plementary/alternative, rather than allopathic, techniques are responsible for any
consequences to their patients. Allopathic physicians are not permitted to aid or
cooperate with non-allopathic practitioners to illegally provide medical care of any
kind.
However, the courts have also ruled that chiropractic is a profession, even though it is
not licensed (65). Chiropractors are considered medical auxiliaries rather than medical
specialists and must work under the supervision of an allopathic doctor.
Complementary/alternative practitioners who are not also allopathic physicians can

be prosecuted under Article 348 of the Italian Penal Code, although this rarely occurs
(172). Indeed, the Criminal Supreme Court of Appeals in Perugia’s decision noted that
even if acupuncture is taught in Italian universities, only physicians and surgeons are
allowed to practise it. The Court considers medical and/or surgical expertise
necessary to establish an exact diagnosis and avoid prejudicial consequences to
patients.
Law 175 of 5 February 1992 (172) expressly prohibits the use of titles that are not
recognized by the State. No forms of complementary/alternative medicine are
recognized as medical specialities under this law.
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Specific regulations on complementary/alternative medicine currently cover only
homeopathy and anthroposophic medicine (177). Homeopathy has a long history in
Italy; attempts to regulate it began in the middle of the nineteenth century. On 17
March 1995, legislative Decree 185 was adopted, executing Directive 92/73/CEE,
which regulates the marketing and registration of homeopathic and anthroposophic
products.

Acupuncture training (172) is available for both allopathic physicians and non-
allopathic physicians. Some anaesthesiology programmes include specialities in
acupuncture. The University of Catania, Sicily, offers a postgraduate programme in
acupuncture. The Society of Italian Acupuncturists and the Paracelse Institute also
offer training. The latter is a member of the World Federation of Acupuncturists and
Moxibustion Society. However, training programmes in complementary/alternative
medicine, even when offered at the university level, are not legally recognized.
Insurance coverage
Each Italian region has its own regulations on the reimbursement of health care (172).
In Lombardy, for example, there is a co-payment of 70 000 Italian lira for
complementary/alternative medicine. The National Health Service pays the
remainder. When provided by an allopathic doctor holding a university medical
degree, acupuncture, hypnosis, antalgic lasertherapy, pressing massotherapy,
lymphatic drainage, reflexive massotherapy, biofeedback, and vertebral manipulation
and other articulation massage are reimbursed.
Since the Italian Government is working to reduce National Health Service expenses,
this information is likely to change soon (172).
Not all private insurance programmes (172) reimburse complementary/alternative

medicine services. Those that do vary in the amount they reimburse and they
generally require treatments to be provided by allopathic physicians, except in the
case of articulation manipulation. Insurance premiums vary according to the age, sex,
and health status of the patient. They are approximately 500 000 Italian lira annually
for a child and 1 500 000 Italian lira annually for an adult.
Latvia
Several methods of complementary/alternative medicine are integrated into the social
welfare system of Latvia (172).
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Statistics
Homeopathy and acupuncture are the most popular types of complementary/alter-
native medicine. Most complementary/alternative practitioners are allopathic
physicians (172). There are several complementary/alternative medical associations.
The Council of Ministers of the Republic of Latvia has delegated the power to regulate
and supervise all medical specialities to the Medical Society of the Republic of Latvia.
The Cabinet of Ministers’ Regulations on the Certification of Health Professionals of
1995 (172) provides procedures for licensing medical professionals.
In order to practise legally as a recognized physician, a candidate must have

graduated from a local medical academy or from any other medical college delivering
a recognized diploma. Candidates must also obtain authorization according to local
legislation. Before allopathic physicians can legally practice complementary/alterna-
tive medicine, they must complete the requisite course and exam for the State licence,
which is valid for five years. In order to renew a licence, a practitioner must complete
a new course and examination. Allopathic physicians providing complemen-
tary/alternative treatments — such as acupuncture, homeopathy, auriculotherapy,
iridology, magnetotherapy, osteoreflexotherapy, phytotherapy, naturopathy, laser-
therapy, biofeedback, Ci-Gun, and Su-Jok — are supervised by a commission of
experts that includes members of medical associations and the Medical Society of the
Republic of Latvia.
Acupuncture and homeopathy have the same clinical speciality status as allopathic
specialities (172).
Local laws regulate complementary/alternative medicine (172).
The Administrative Codex (172) prohibits non-allopathic practitioners from practising

medicine of any kind. However, patient lawsuits are uncommon except in cases of
serious harm to their health.

Since 1990, over 300 physicians from the Scandinavian and Baltic States of Latvia,
Estonia, and Lithuania have completed training in acupuncture and traditional
Chinese medicine (172).
There are a few special programmes (172) for non-allopathic physicians intended to
give them basic medical knowledge. These programmes consist of between one and
two years of medical courses at a medical school. Qualification courses in the Reiki
method and medical astrology are also offered.
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Insurance coverage
Complementary/alternative treatments are generally not covered by the compulsory
health insurance (172). Acupuncture and homeopathy are exceptions: in 1994 they
were included in the list of medical specialities reimbursable by social insurance.
In September 1998, two insurance companies, Balta and Parex, began coverage of
legally provided complementary/alternative medicine. They cover two-thirds of
expenses for consultations and treatments by acupuncture, homeopathy, Dr R. Voll
electropuncture, iridodiagnosis, and bioresonance when are provided by authorized
allopathic physicians. Treatments given by non-physicians are not covered (172).
Liechtenstein
Statistics
There are three chiropractors practising in Liechtenstein (45).
According to Order I and Article 49 of the Health Law (172), to practise medicine in
Liechtenstein, a candidate must be a citizen of Liechtenstein; live in Liechtenstein; be a
graduate of a Swiss, German, or Austrian school of medicine; have the necessary
capacity, reputation, and hygienic knowledge; respect the duties of a general
physician; and obtain a licence to practise. The right to work as an independent
allopathic general practitioner and the right to use a specialist title require
postgraduate studies followed by an internship.
According to Article 22 of the Health Law, chiropractors are considered medical

professionals.
The practice of complementary/alternative medicine by allopathic physicians is not

regulated. Allopathic physicians may use complementary/alternative therapies
without having to pass a supplementary exam. However, Article 9 of Order I states
that “physicians have to practise only in their speciality and according to their
knowledge, with the exception of emergencies”. Paramedics are also permitted to
provide complementary/alternative medicine.
By Article 24 Paragraph A Lit. I of the Health Law of 18 December 1985 (178, 179, 180),
complementary/alternative practitioners may provide health care so long as they
refrain from those acts reserved for allopathic physicians. Although there are no court
rulings on this point, none of the medical acts included in Article 24 Paragraph A Lit. I
are considered to be reserved for allopathic physicians (in particular those related to
natural medicine). Therefore complementary/alternative providers only need a
business licence to provide treatment legally, even though they are not allowed to
provide care in the national health care system. A new medical department is in
charge of issuing licences and controlling conditions of practice.
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Although complementary/alternative practitioners have yet to be subject to
prosecution, Article 184 of the Penal Code (172) specifies that an unqualified person
who performs medical acts that are legally reserved for allopathic physicians — such
as surgery, treatment of infectious diseases, or prescription of controlled medications
— can be punished with a fine or a prison sentence of up to three months.
The State health authorities perceive a contradiction between Article 24 Paragraph A

Lit. I of the Health Law and Article 184 of the Penal Code. They are considering two
ways of resolving it: either introducing a law to cover practitioners of natural
medicine or abolishing Article 24 Lit. I of the Health Law. There is currently a
controversial draft Law on Natural Medicine that, if passed, would resolve the
contradiction by loosening the restrictions on the right to perform medical acts.

Complementary/alternative practitioners are generally trained in foreign countries.
Insurance coverage
Complementary/alternative treatments are not covered by compulsory social
insurance (172). To obtain reimbursement for such services, it is necessary to have
complementary/alternative medical insurance. Coverage under this insurance is
limited to 500–1500 Swiss francs per year.
Luxembourg
In order to practise medicine as a physician, a candidate must hold a university
certificate, obtain authorization from the Minister of Health, and have the consent of
the Medical College. Treatment, diagnosis, and prevention of disease are restricted to
members of the allopathic medical corpus. Article 7 of the Law of 29 April 1983 (172)
stipulates that persons without the required qualifications who practise or participate
in the diagnosis or treatment of real or supposed pathological disorders through
personal acts, verbal or written consultations, or other methods, can be prosecuted.
Non-allopathic practitioners using complementary/alternative medicine are regularly
prosecuted.
Though not legally binding, the Code of Professional Ethics (172) states that it is
unethical for allopathic physicians to recommend, to either their patients or
acquaintances, therapies that are based on illusory methods or which are not
scientifically proven.
The Medical College (172) is unequivocally opposed to the practice of

complementary/alternative medicine in Luxembourg. It considers practitioners of
complementary/alternative medicine to be quacks and crooks. Nevertheless, members
of Parliament are in favour of granting official recognition to complemen-
tary/alternative practitioners and techniques.
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There is no officially recognized complementary/alternative medical training in
Luxembourg (172).
Insurance coverage
Reimbursed at 80% of fees, homeopathy is the only officially covered complemen-
tary/alternative practice. In the case of other complementary/alternative therapies,
there is no specific reimbursement rate in the list of publicly covered medical acts and
services, meaning that theoretically, they are not covered by public health insurance.
However, when they are legally provided by a recognized allopathic health care
professional, complementary/alternative treatments are unofficially reimbursed in the
context of a normal consultation. Approved allopathic physicians are thereby free to
choose the treatment they provide (172).
There are no private insurance companies offering coverage for complementary/alter-

native medicine (172).
Malta
Traditional Chinese medicine, chiropractic, and osteopathy are widely practised (172).
Statistics
There are no established professional organizations or self-regulating bodies for
complementary/alternative practitioners in Malta (172).
The medical professions are regulated by Part II of the Medical and Kindred
Professions Ordinance (Chapter 31 of the Laws of Malta) and Part IV of the
Department of Health Ordinance (Chapter 94 of the Laws of Malta) (172). Only
registered allopathic medical professionals are allowed to practise medicine. In order
to practise, a candidate must have a licence issued by the President of Malta and be
registered in the Medical Register. To obtain this licence, the candidate must have
successfully completed a university programme leading to a degree as an allopathic
medical doctor or the equivalent. Allopathic physicians may practice complemen-
tary/alternative medicine.
Non-allopathic practitioners are not legally recognized in Malta, and at present, there
is no registration system for such practitioners. As stipulated in Chapter 31 of the
Laws of Malta, non-allopathic practitioners are not allowed to perform procedures
reserved for recognized allopathic medical professionals such as physiotherapists,
physicians, and pharmacists. However, they are not prohibited from practising
medicine.
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Although there are no legal sanctions on complementary/alternative practitioners
themselves, a breach of the regulations outlined in Chapter 31 usually constitutes a
criminal offence and is punishable by a fine, imprisonment, or both, according to the
specific article breached. There are also restrictions on advertising treatments and
clinics. The court exercises its discretion when determining appropriate punishment.
By Section 98 of Chapter 31 of the Laws of Malta, the only forms of comple-

mentary/alternative medicine licensed by the Ministry of Health are acupuncture,
moxibustion, and traditional Chinese medicine. Conditions of licensing are imposed
by the Ministry of Health as deemed fit.
Article 3 of the provisions requires clinics for traditional Chinese medicine to provide
only traditional Chinese medicine. It further stipulates that patients diagnosed with an
infectious disease must be referred to a registered allopathic medical practitioner for
treatment and that no treatment for infectious diseases can be given at the clinics.
Article 6 of the provisions outlines hygienic standards for the clinics, and Article 7
states that all persons treated by traditional Chinese medicine, including acupuncture,
must be referred by an allopathic doctor registered to practise in Malta. The Public
Health Department must be informed of the name and qualifications of every person
employed under licence. The Department is also responsible for carrying out
inspections.
Acupuncture is not registered as a profession in Malta (172). Acupuncture licences are

conditional upon proof of adequate training and experience. The licensee must renew
the licence annually via a written application. Acupuncturists employed by the
Mediterranean Centre for Traditional Chinese Medicine are usually qualified allo-
pathic doctors as well as acupuncturists.
Malta is considering allowing specific complementary/alternative providers,

particularly chiropractors and osteopaths, to be registered by the local Board of
Professions Supplementary to Medicine alongside allopathic professions (172).

Bonesetters are usually taught through family training. Some chiropractors and
osteopaths are certified by overseas teaching institutions. As there is no local
registration of these practitioners, there are no standardized qualifications to practice
(172).
Insurance coverage
The State runs acupuncture clinics within the public health services. Treatment at
these clinics is provided free of charge. Private acupuncture clinics provide their
treatment on a fee-for-service basis. The costs of acupuncture and other com-
plementary/alternative medical services obtained privately are not reimbursed (172).
Private insurance does not cover complementary/alternative care (172).
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Netherlands
The Dutch Association of Homeopathic Doctors was established in 1898 (172).
Statistics
According to a 1985 study, 18% of the population has used complementary/alter-
native medicine at least once — 6% to 7% during the previous 12 months. In 1990, over
900 000 people consulted a complementary/alternative practitioner other than their
own allopathic general practitioner (172). More women than men use
complementary/alternative medicine, especially those between the ages of 35 to 50.
Most patients treated with herbal medicines and by paranormal healing have little
formal education; most patients of other forms of complementary/alternative
medicine are executives and professionals (172).
The 1985 survey reported more than 4000 complementary/alternative practitioners in

the Netherlands: 735 naturopaths, 300 paranormal healers, 220 homeopaths, 475
anthroposophical professionals (either allopathic doctors or other professionals, such
as anthroposophical nurses), 945 acupuncturists, and 1450 manual therapists. There
are 125 chiropractors practising in the Netherlands (45). In addition to these providers,
according to a 1992 survey, almost half of Dutch general practitioners have provided
complementary/alternative treatment at least once — 40% have used homeopathy, 9%
manipulative medicine, 4% acupuncture, and 4% naturopathy (172).
The most popular forms of complementary/alternative medicine are, in order of

popularity: homeopathy, herbal medicine, manual therapies, paranormal healing,
acupuncture, diet therapy, naturopathy, and anthroposophical medicine (172). The
most common conditions presented to complementary/alternative practitioners are
musculoskeletal pain and complaints of nervous origin (172). Patients most often
report that they use complementary/alternative therapy because allopathic methods
are ineffective for their chronic disorders. Only 14% of patients seek complemen-
tary/alternative care without having first consulted an allopathic practitioner. In one
survey of patients treated with complementary/alternative medicine, 56% said that
their health condition improved quite a lot, 22% felt that some improvement had
occurred, and 22% saw no improvement at all.
According to a consumer survey, about 80% of the Dutch population would like to
have complete freedom of choice over their medical treatments; specifically, they
would like health insurance schemes to recognize complementary/alternative
medicine. Sixty per cent of the Dutch population is ready to pay higher insurance
premiums in order to have this choice.
Since 1993, when the Medical Practice Act of 1865 was replaced by the Individual
Health Care Professionals Act (172), non-allopathic providers have been allowed to
practice medicine in the Netherlands. The new act came into force on 1 December
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1997, bringing the legal status of non-allopathic practitioners in line with that of
allopathic paramedics: they may practise medicine provided they do not perform
specific medical acts reserved for allopathic physicians, except under the orders of an
allopathic physician. Violation of this limited monopoly can be prosecuted. The
medical acts reserved for physicians are surgical procedures, obstetric procedures,
catheterizations and endoscopies, punctures and injections, general anaesthesia,
procedures involving the use of radioactive substances and ionizing radiation,
cardioversion, defibrillation, electroconvulsive therapy, lithotripsy, and artificial
insemination.
The Individual Health Care Professions Act also introduces a system to protect the
titles of a limited number of professional groups, with the possibility of creating new
medical specialities under specific conditions. It also defines the training requirements
necessary for registration as one of these medical professionals. The eight professions
regulated are allopathic medical doctor, dentist, pharmaceutical chemist, health care
psychologist, psychotherapist, physiotherapist, midwife, and nurse. While non-
allopathic practitioners are not allowed to use these titles or to work in the national
health services, procedures are now in place for them to obtain recognition for their
speciality, including a protected title.
There are also legal registers in which qualified medical practitioners of homeopathy,
herbal medicine, manual therapies (such as chiropractic and osteopathy), paranormal
healing, acupuncture, diet therapy, naturopathy, and anthroposophical medicine are
entitled to be registered once they satisfy specific legal requirements. This registration
gives them the right to practice under a protected title, with the aim of insuring they
are qualified in a specific field of health care (172).

According to the Dutch Health Council, complementary/alternative medical
institutions have organized a number of training courses, taken steps to develop
standards of training and professionalism, and established national registration
systems (172).
About 60% of the members of complementary/alternative professional organizations

have undergone training in a field of allopathic medicine, often as a physician,
physical therapist, or nurse (172). Introductory courses on complementary/alternative
medicine are included in the curriculum of several Dutch medical schools (172).
Allopathic doctors wishing to be trained in anthroposophical medicine, acupuncture,
homeopathy, or manipulative therapy can attend part-time courses for one to four
years. There are also postgraduate programmes for physical therapists, most of whom
study acupuncture or manipulative therapy.
Without allopathic medical or paramedical training, individuals may register in one of

the three academies for naturopathy offering full-time courses of three to four years
(172). Students completing the three-year basic course in homeopathy earn the
designation “Homeopathic Physician” (53). Registration must be renewed every five
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years, based on proof of participation in compulsory continuing-education courses. A
disciplinary committee monitors and penalizes homeopathic malpractice.
Insurance coverage
Officially, only homeopathic and anthroposophic medicines are reimbursed by social
insurance (172). However, private health insurance reimburses all care given by
allopathic general practitioners, whether allopathic or complementary/alternative.
Two-thirds of the population have private health insurance.
In 1988, all large private insurance companies (172) began covering homeopathy,
acupuncture, and manipulative therapy as part of their standard or supplementary
packages. In addition to the legally defined standard package, which is the same for
all 45 health insurance funds, the funds also offer a supplementary package to which
their clients can voluntarily subscribe. Under the supplementary coverage, 26 of the 45
health insurance funds reimburse some kinds of complementary/alternative medicine
if provided by an allopathic physician or a physiotherapist, usually homeopathy,
acupuncture, and anthroposophical treatments. In many cases, reimbursement was
given only when care was provided by allopathic physicians or physical therapists
who were members of a professional organization.
In 1991, in response to consumer demand, many packages were expanded to cover

more types of complementary/alternative medicine and to cover care provided by
non-allopathic practitioners. As of 1998, 47 private insurance companies cover
between 25% and 100% of complementary/alternative treatments provided by
allopathic physicians or members of professional organizations — to a maximum of
300 to 2500 Dutch florins per year. This coverage generally includes homeopathy,
anthroposophy, acupuncture, manual therapies, chiropractic, naturopathy, and
neuraltherapy.
Norway
Although some authorised allopathic doctors and other health personnel in Norway
have integrated acupuncture and/or homeopathy into their practice, most usually do
not use complementary/alternative therapies. Some persons with authorization to
practice as health personnel, such as nurses, have complementary/alternative
medicine practices (172).
Statistics
A 1994 poll (172) reported that 23% of men and 30% of women had used
complementary/alternative medicine at least once. Most respondents in this group
were middle-aged persons living in towns. The most popular therapies are
acupuncture, accounting for 35% of consultations for complementary/alternative
treatments; homeopathy, accounting for 33%; reflexology, 29%; natural medicine, 29%;
chiropractic, 16%; kinesiology, 7%; natural healing, 3%; and iridology, 3% (172).
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The Norwegian Association of Chiropractors has about 100 members (172).
In principle, everyone in Norway is allowed to treat patients, regardless of training or
profession. However, only allopathic physicians, and to some extent dentists and
persons assisting physicians and under the guidance of a physician, are allowed to use
the title “Doctor of Medicine”, use a title indicating a speciality in a specific illness, or
advertise (172) — although anyone can place an announcement in the press that
contains only a name, address, consultation hours, and general information on
services provided. Specific medical acts are similarly restricted. These include the use
of controlled medications in treatment, surgical procedures, injections, general or local
anaesthesia, diagnostic or therapeutic methods restricted to physicians, treatment of
cancer, diabetes, dangerous anaemia, struma/goitre with sticky forms, and some
contagious/infectious diseases mentioned in Act 55 of 5 August 1994 on
contagious/infectious diseases (such as venereal diseases, tuberculosis, infectious
hepatitis, HIV, poliomyelitis, and infectious meningitis), as well as practising in an
itinerant way. To receive authorization to practice as an allopathic medical doctor, a
candidate must possess a medical degree from a Norwegian or other recognized
university and have undergone an 18-month internship.
Norway has the oldest regulations in Europe on the practice of medicine by non-
allopathic physicians (172). The first legislation of this kind in Norway dates back to
1619. A new law was adopted in 1871. The Act of 1871 was to some extent less
restrictive than the current Act 9 of 19 June 1936 on the limitations of the right of
persons who are not allopathic physicians or dentists to undertake treatment of ill
persons. Act 9 was used as a model for legislation in Sweden and Denmark.
Aside from allopathic physicians or dentists, anyone who wants to practise

complementary/alternative medicine is subject to Act 9 of 19 June 1936 (172). Under
the law, non-physicians and non-dentists who treat patients are subject to a jail
sentence of up to three months if the patient’s life or health is exposed to serious
danger either by the treatment or because the patient did not seek a health care
provider who could have prevented the danger. Anyone sentenced to prison for such
violations can no longer practise medicine. Except in the most serious cases, criminal
sanctions are rarely used.
Allopathic practitioners are restricted from using complementary/alternative

therapies unless the therapies are considered to be responsible practice within the
practitioner’s profession, the patient is informed about the method and its status, and
the patient agrees to the treatment (172).
The insertion of acupuncture needles is considered a surgical intervention and can

only be performed by allopathic physicians, dentists, or persons delegated by
physicians (172).
Since 1990, chiropractors have been officially recognized as health care professionals
(172). Only licensed chiropractors are permitted to use the title of “Chiropractor”. To
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be licensed, a candidate must have completed a training programme and passed
examinations at an approved institution; undertaken additional training in Norwegian
health law and chiropractic disciplines; completed one year of practical training; and
not be in a position that would lead to withdrawal of the authorization — for instance,
the candidate must not be found unsuitable for practising chiropractic due to old age,
illness, alcohol/drug abuse, or other circumstances. To become a member of the
Norwegian Association of Chiropractors, chiropractors must have completed a course
approved by the American Council on Chiropractic Education and undergone three
months of clinical training.
With some exceptions, homeopathic medicines may only be sold from pharmacies
(172). A licence is necessary to market homeopathic products when the degree of
dilution is less than one million.
In June 1995, the Storting (parliament) examined the place of complementary/alter-

native medicine in the Norwegian health service. Among other things, the Storting
decided to consider introducing certification of the various types of training and
education available for complementary/alternative medical professions. In 1997, with
the intention of revising the 1936 law, the Ministry of Health appointed a committee to
write a report on complementary/alternative medicine. The report was delivered to
the Ministry in December 1998. It describes the situation of complementary/alter-
native medicine in Norway and includes a discussion of the clinical effects of
treatments, possible legal measures, and means of communicating research results and
other information to the public. The Government has not yet decided how to follow
up on the report.
In Beijing on 6 April 1999, the Ministers of Health of Norway and China signed a
memorandum of understanding on Chinese/Norwegian cooperation in the field of
health to increase the knowledge and understanding of traditional Chinese medicine
among Norwegian health personnel (181).

The 1990 chiropractic law regulates the training of chiropractors; however, there are
no recognized schools of chiropractic in the country (172). There are two schools of
homeopathy in Norway (53). One offers courses to all persons with some education in
allopathic medicine. Beginning with the basics, it is a five-year programme with
classes taught one weekend each month. The other school only offers courses to
persons who have the minimum qualifications to practice allopathic nursing.
Insurance coverage
Public reimbursement is not available for what is regarded in Norway as comple-
mentary/alternative medicine. Coverage for homeopathic treatments, for example, is
not included under the official health care system (53). However, by the regulations
governing the national insurance scheme, partial reimbursement is available for
chiropractic treatment provided the chiropractor is authorized as a health care
professional (although not necessarily a member of the Norwegian Association on
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Chiropractic) and the patient was referred to the chiropractor by an allopathic
physician. This coverage is limited to a maximum of between 10 and 14 consultations
per year (172).
In Norway, Norsk Helseforsikring (172), which is connected to International Health

Insurance Denmark AS, is the only private insurance company offering partial
reimbursement for complementary/alternative medicine. The insurance covers
chiropractic and, when performed by a licensed allopathic physician as part of
medical treatment, acupuncture.
Russian Federation
Statistics
There are one or two chiropractors practising in the Russian Federation (65).
The Russian Federation provides a striking example of a change in policy towards
complementary/alternative medicine that may be followed in other former socialist
countries. Section 34 of the Fundamental Principles of the Health Legislation of the
Union of the Soviet Socialist Republics and of the Union Republics required physicians
to use only those diagnostic, prophylactic, and therapeutic methods and
pharmaceutical products authorized by the Ministry of Health. Neither homeopathy
nor homeopathic medicines were authorized.
By contrast, the right to practise the art of healing by “popular” medicine is protected
by Section 57 of the Russian Federation legislation governing health care (182). It
remains to be seen how this provision will be interpreted, but its general open-ended
language suggests that it is likely that complementary/alternative practitioners will
have wide powers to practise.
A 1995 decree refers to homeopathy in the Russian Federation. It permits the use of
homeopathy in every clinic and hospital, giving it official recognition. There is no law
specifically regulating chiropractic, although some chiropractors have been permitted
to practise.

The State Scientific and Practical Centre of Traditional Medicine and Homeopathy of
the Ministry of Public Health of the Russian Federation was created in 1999. The
Centre’s goals include organizing and conducting scientific research and coordinating
and realizing educational activities in complementary/alternative medicine.
A standard Government education programme in homeopathy has been developed by

the Committee for Homeopathy of Russia and approved by the Ministry of Health
(53). Homeopathy has also been introduced at the Russian Medical Academy as a
postgraduate speciality (86).
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Spain
Homeopathy was introduced into Spain in the beginning of the 19th century (172). The
first Spanish homeopathic hospital, the Fundacion Instituto Homeopatico y Hospital
de San Jose in Madrid, was founded in 1878. The Academia Medico Homeopatica de
Barcelona was founded in 1890. There is an outpatient homeopathic clinic at the
Hospital del Nen Deu of Barcelona (53). The Spanish Society of Homeopathic
Medicine was founded in 1996. It represents all homeopathic associations (172).
In addition to homeopathy, popular complementary/alternative therapies include

acupuncture, auriculotherapy, neuraltherapy, and biological medicine. However, until
1987, complementary/alternative medicine (with the exception of homeopathy) had
only a minor role in the Spanish health care system (172).
There are several associations linked to complementary/alternative medicine in Spain.

Since 1996, the Spanish Medical Council has supported complementary/alternative
medicine, provided it is practised by licensed physicians (172).
Statistics
There are 50 chiropractors practising in Spain (45).
In Spain, the practice of medicine is the exclusive right of allopathic doctors (172). In
order to obtain the right to practise medicine, a candidate must hold an academic
degree in medicine, have authorization from a medical college, pledge professional
secrecy, be current in his or her taxes, and as outlined in the Statutes of the Collegial
Medical Organization, respect the Spanish Code of Professional Ethics of 1990. Natural
medicine, by the Royal Decree of 27 March 1926, may only be practised by licensed
allopathic physicians.
On 16 June 1997, the Code of Medical Professional Ethics (172) was adopted in
Catalonia. Article 44 of this code stipulates that doctors using complementary/alterna-
tive medicine must inform their patients of the importance of continuing necessary
allopathic treatments and of the non-conventional character of the complemen-
tary/alternative therapy. Furthermore, doctors must coordinate their supplementary
therapy with the allopathic physician in charge of the patient’s basic treatment. Article
44 forbids using methods that have not been scientifically validated to make a
diagnosis or treat a patient.
Royal Decree 127/1984 does not include branches of complementary/alternative

medicine as medical specialities (172). Opposing this, professional associations
registered with the Ministry of the Interior are seeking recognition from the Spanish
Government for graduate practitioners using complementary/alternative medical
techniques. The Council of Medical Colleges of Catalonia wants to make homeopathy,
acupuncture, and natural medicine official.
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Under Article 62 of Royal Decree 3166/1966 of 23 December 1966, licensed paramedics
are allowed to perform medical acts only under the supervision of an allopathic
physician (172). The three categories of paramedic professions are practitioners of
odontology, psychologists, and university graduates in nursing, which include, for
example, physiotherapists. Some paramedics illegally practice complementary/alter-
native medicine.
The illegal practice of medicine is regulated by Article 403 of the Penal Code,
approved on 23 November 1995 (172). This article states that if persons without
relevant academic certificates practise acts specific to a profession, they risk
imprisonment for a period of up to 12 months. This includes all intrusions made by
non-allopathic physicians in the field of medicine.
State authorities are relatively tolerant with private allopathic doctors and non-
allopathic practitioners using complementary/alternative medicine. On 23 January
1984, in response to a case regarding acupuncture and reflexology, the Spanish
Supreme Court declared that it is not necessary to have a degree in medicine in order
to practise medicine (172). However, only approved medical professionals may make
a diagnosis, give a clinical or medical examination, or decide to apply a specific
therapy.
On 19 June 1989, in a Supreme Court decision, a non-allopathic practitioner of

acupuncture-moxibustion was found not guilty of intrusion into the field of medicine
on the basis of two points (172): first, the practitioner had several foreign certificates
and was a member of the Latin American Association of Research on Acupuncture-
Moxibustion; second, as complementary/alternative medicine is not taught within
Spanish medical faculties and as there is no official certificate authorizing and
legitimizing complementary/alternative medical practice, it does not legally exist.
Consequently, it does not correspond to any legally determined profession and
therefore its practice cannot be the object of intrusion.
In January 1993, the Supreme Court released a non-physician acupuncturist (172). The
argument was the same: complementary/alternative medicine is not included within
the official list of medical specialities and therefore practising complementary/alter-
native medicine is not an intrusion into the field of medicine.
Similarly, the Spanish Association of Physiotherapists denounced certain chiro-

practors for intrusion into the field of medicine. However, in an 18 March 1997
decision, the regional Court of Valencia stated that chiropractors and other practi-
tioners using complementary/alternative medicine are not committing intrusion.
Article 54 of the Law on Medicaments 25/1990 of 20 December 1990 and Royal Decree
2208/1994 of 16 November 1994 regulate homeopathic remedies and the commerciali-
zation of homeopathic products (53).
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The medical universities of Madrid, Sevilla, Murcia, Zaragoza, Valladolid, Barcelona,
and Santiago offer certificate courses in homeopathy, naturist medicine, and
acupuncture to allopathic physicians. The universities of Barcelona, Sevilla,
Valladolid, and Murcia offer postgraduate training in homeopathy for physicians (53).
For pharmacists and veterinarians, some universities offer basic and advanced
homeopathic training programmes as well as other courses and certificates.
Sociedad Española Acupunctura and Sociedad Española de Medicos Acupunctores in

Madrid offer two-week introductory courses, three 90-day training courses, and a
complete three-year training programme. With the sponsorship of the Council of
Europe and the World Health Organization, the Teaching Centre of Traditional
Chinese Medicine in Spain provides comprehensive training for both physicians and
non-physicians in acupuncture with the intention of gaining professional status for
acupuncture. Other professional organizations also provide courses in complemen-
tary/alternative medicine (172).
Insurance coverage
Two public hospitals, Hospital del Nen Deu in Barcelona and Fundacion Instituto
Homeopatico y Hospital de San Jose in Madrid, provide homeopathic care to
outpatients on a fee-for-service basis. Under Article 94 of Law 26/1990 of 20 December
1990, there is no justification for homeopathic products to be financed through the
State insurance system, INSALUD. Efforts by the Homeopathic Physicians Charter of
the State of Spain to gain social security coverage for homeopathic medications have
been unsuccessful (172).
In Spain, only a few private insurance companies provide coverage for any comple-
mentary/alternative medicines (172).
Sweden
Statistics
In a 1989 survey (172), 20% of adults reported having received complementary/alter-
native medical treatment. Forty per cent of patients of complementary/alternative
medicine stated they had chosen these treatments because they were not satisfied with
the National Health Service. Seventy per cent stated that through their
complementary/alternative treatment their health had improved or they had been
cured of their illness; 1% stated their health had deteriorated.
Chiropractic is the most commonly consulted complementary/alternative medicine in

Sweden. Thirteen per cent of the population has consulted one of the 130 practising
chiropractors at least once (45). The next most popular form of complementary/alter-
native medicine is homeopathy, accounting for 4% of consultations, followed by
acupuncture, naturopathy, and herbal medicine.
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In Sweden, the National Board of Health and Welfare (172) maintains a registry of
public health and medical personnel. Practitioners who are not included in the
Supervision of Health and Medical Personnel list of medical practitioners (which
includes only allopathic doctors, dentists, nurses, midwives, and physiotherapists)
may not be registered. Thus, officially only recognized medical practitioners are under
public scrutiny.
The requirements for practising medicine are included in the Act on Competence 542
of 1984 and the Medical Care Act 786 of 1996 (172). Although non-registered persons
may treat patients, specific medical acts are restricted to allopathic physicians. The
specific treatments reserved for physicians are outlined in the Quackery Act — Law
409 of 1960 (172), modified in 1982. Only a physician is allowed to act as a doctor in
medicine; practise general or local anaesthesia; provide care with radiological
methods; practise in an itinerant way; treat specific contagious diseases; treat cancer,
diabetes, epilepsy, or pathological conditions associated with pregnancy or childbirth;
treat a child who is younger than eight years old; issue written recommendations or
instructions for the treatment of patients who are not personally examined by them;
provide acupuncture; and test or supply contact lenses. The violation of these
restrictions is an offence and may be prosecuted.
Non-allopathic practitioners who damage a person’s health by using inappropriate

therapies may be charged with charlatanism constituting a danger to health. Practi-
tioners found guilty of this charge are punishable under the penal law and may be
prohibited from working in the health care field.
In 1989, Sweden granted recognition to chiropractors satisfying the standards of the

Council of Chiropractic Education. By Government Bill 1988/89:96 (172), those
chiropractors completing studies as doctors of chiropractic have the right to obtain a
licence and to be registered under the National Health Service. However, no Swedish
training programme has so far been certified as meeting the appropriate standards.
Currently, all registered practitioners have been trained abroad. Chiropractors trained
at the Scandinavian College of Chiropractic in Stockholm are working to be included
among the recognized practitioners.
Homeopathic remedies are legal and are manufactured according to good

manufacturing practices (53).
In 1994, official recognition was extended to naturopaths. The Swedish Commission

on Competence (172) does not intend to amend the rules of authorization for them.
Osteopaths remain unrecognised and the Swedish Commission on Competence does
not have any proposals regarding osteopathy.
The Swedish Commission on Competence was delegated to undertake a

comprehensive review of the principles governing authorization and competence and,
in the light of this review, to put forward proposals concerning, for example, rules of
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authorization and competence for various categories of professional medical care,
including the Quackery Act.
The Swedish Parliament mandated the Commission on Alternative Medicine (172) to

examine issues concerning the position of complementary/alternative medicine in
Swedish society. The recommendations of the Commission on Alternative Medicine
(1989) and the proposals of the Swedish Commission on Competence (1996) can be
summarized as follows:
♦ create an association of non-allopathic practitioners who have had at least one year
of training and are registered by the National Board of Health and Welfare;
♦ create a State register of all non-allopathic practitioners who have passed their
exams;
♦ create professional titles;
♦ uphold the law reserving specific medical acts for allopathic physicians;
♦ introduce some types of complementary/alternative medicine into the National

Health Service and incorporate complementary/alternative practitioners into the
National Health Service, provided specific conditions are fulfilled;
♦ strictly control the advertising of natural remedies;
♦ plan scientific studies on the effectiveness of complementary/alternative medicine.

Most of the increasing numbers of homeopaths working in Sweden today have been
educated at private institutions. This education corresponds to that of allopathic
physicians in many ways. There are three private schools providing homeopathic
training. There is also a four-year basic medicine course taught by professors from the
University of Upssala (53). No Swedish chiropractic training programme is officially
recognized.
Insurance coverage
While non-allopathic practitioners may treat patients in Sweden, their care is not
reimbursed by the health care system (172). Only acupuncture provided by an
allopathic physician is reimbursed by social insurance, and then only partially. The
Commission on Complementary/Alternative Medicine did not propose the
reimbursement of treatments obtained from practitioners of complementary/alterna-
tive medicine.
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Switzerland
Patients of complementary/alternative medicine who are ill report that they use
complementary/alternative medicine because the therapies do not involve treatment
with drugs or chemicals, there are no side effects, and allopathic medicine was
unsuccessful in treating their illness. Patients of complementary/alternative medicine
who are not ill report that they use complementary/alternative medicine to improve
their well-being and to keep from falling ill (172).
Statistics
A 1992–1993 study (172) showed that the use of complementary/alternative medicine
within the previous 12 months was closely related to whether or not a patient had
complementary/alternative health insurance:
♦ Of those surveyed who had insurance covering complementary/alternative

medicine, 20.7% did not use complementary/alternative medicine; 18.9% used one
form of complementary/alternative medicine; 21.5%, two forms; and 39.0%, three
or more forms.
♦ Those without insurance covering complementary/alternative medicine reported

the following: 56.4% did not use complementary/alternative medicine; 20.5% used
one form of complementary/alternative medicine; 13.4%, two forms; and 9.7%,
three or more forms.
Persons living in the German-speaking and French-speaking parts of the country used
complementary/alternative medicine more extensively than those living in the Italian-
speaking region. Women and persons with higher levels of formal education were
more likely to consult a complementary/alternative medical practitioner than were
men and persons with lower levels of formal education. The most commonly
consulted forms of complementary/alternative medicine are shown in the chart
below.
Type of Complementary/Alternative Patients with Patients without

Medicine Consulted insurance coverageª insurance coverageª
Homeopathy 63% 26%
Alternative massage therapies 41% 19%
Phytotherapy 27% 14%
Nutrition therapy 22% 9%
Acupuncture 18% 4%
Anthroposophic medicine 13% 3%
Magnetotherapy 8% 3%
ª The percentages are the proportion of respondents who consulted a complementary/alternative
practitioner, not the total number of people surveyed.
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There are approximately 180 chiropractors practising in Switzerland (45).
Complementary/alternative therapies are provided by allopathic physicians, natural
doctors, non-allopathic practitioners, pharmacists, and patients themselves (172).
There are many organizations linked to complementary/alternative medicine in the
country.
In Switzerland, cantons (similar to states or provinces) make their own public health
regulations, including the regulation of local medical practice (172). Nonetheless, some
degree programmes and professions, such as allopathic physicians or chiropractors,
are recognized throughout the country, and the titles of some professions, including
“Medical Doctor” and “Chiropractor”, are protected. The cantons allowing only
allopathic physicians to practice medicine are Appenzell internal Rhodes, Jura,
Nidwalden, Uri, and, with the provisions noted, the following:
♦ Aargau: a licence is not required to provide care to healthy persons (when treating
nervousness, stress, sleeplessness, or phobias, for example).
♦ Basel Stadt: authorized physiotherapists and masseurs are permitted to use

reflexology.
♦ Bern: the practice of acupuncture by non-allopathic practitioners is tolerated when

provided under the orders of an allopathic physician.
♦ Fribourg: the Department of Health may issue licences to practise complemen-

tary/alternative medicine on condition that practitioners do not use methods and
techniques restricted to authorized health care professionals.
♦ Geneva: recently, the authorities have been relatively tolerant of non-allopathic

practitioners.
♦ Glarus: reflexology, acupressure, and other similar forms of massage may be freely
provided.
♦ Schwyz: non-physicians may obtain a licence to practise acupuncture.
♦ Solthurn: a draft law would enable the practice of complementary/alternative

medicine as a self-employed profession.
♦ Vaud: recently, the authorities have been relatively tolerant of non-allopathic

practitioners.
♦ Zug: under the supervision of the health authority, reflexology, sport massage,
acupressure, and health advising may be freely provided. Acupuncture may be
provided by persons who have completed three years of training, including
comprehensive theoretical and practical courses, and who have passed a cantonal
exam.
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♦ Zürich: magnetism is not considered a form of medicine and, therefore, its practice
does not require official authorization.
Although the law in these cantons is typically monopolistic, the authorities are
relatively tolerant with regard to non-allopathic practitioners.
In order to be allowed to practice in German-speaking cantons (Appenzell external

Rhodes, Basel Landschaft, Graubünden, Luzern, Obwalden, St. Gallen, Shaffhausen,
and Thurgau), non-allopathic providers must pass the State exam and obtain a licence
from State authorities. In most German-speaking cantons, there are specific medical
acts that are reserved for physicians.
In non-German-speaking cantons, the situation is slightly different. In the canton of

Neuchâtel, since the introduction of a 1995 law, non-allopathic practitioners are
permitted to provide non-dangerous complementary/alternative therapies. While a
licence to practice is not required, complementary/alternative medical providers may
not advertise their services. In Valais, the same restrictions apply, with two additional
requirements: complementary/alternative providers must clearly inform their patients
that they do not have any allopathic education and they must have a licence from the
health department. In the canton of Ticino, non-allopathic practitioners may practise
medicine without a licence; however, they must clearly inform their patients that they
do not have an allopathic education. And, they are not permitted to advertise; use
optical, mechanical, electrical, or ionizing equipment; or prescribe medications or
drugs.
Homeopathy is among the most frequently practised complementary/alternative

therapies in Switzerland. All persons legally providing health care may apply
homeopathy according to the standards of good medical practice. In some cantons,
those not medically qualified may practice homeopathy as well (53). In 1998, the Na-
tional Medical Association recognized homeopathy as a medical sub-speciality (86).
Chiropractic is considered an independent medical profession that is federally

regulated and recognized throughout the country (172). There are several
requirements that must be met to be allowed to practise as a chiropractor, including
limited competence in medical diagnosis and treatment. To practice chiropractic, a
person must have Swiss citizenship, hold a diploma giving access to a university, have
studied at least four years in a chiropractic college recognized by the American
Council on Chiropractic Education, have passed the American commission exam, have
passed the Swiss intercantonal exam, have passed the Swiss federal exam to be
allowed to X-ray, and have completed at least a one-year internship with a Swiss-
authorized chiropractor.

The universities of Zürich and Bern include an introductory course on
complementary/alternative medicine in the standard curriculum for allopathic
physicians. In Bern there are also more extensive courses on homeopathy,
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neuraltherapy, traditional Chinese medicine, phytotherapy, anthroposophic medicine,
hydrotherapy, and bio-resonance (172).
The Swiss Medical Association (172) has been aware of the need to establish
complementary/alternative medical specialities. In 1999 and 2000, it set up a new
training programme for allopathic physicians. Homeopathy, Chinese medicine,
acupuncture, anthroposophic medicine, and neural therapy are now granted speciality
titles for allopathic physicians. Training for these techniques, as with allopathic
specialities such as cardiology or rheumatology, lasts between eight and 10 years.
Students who are not allopathic practitioners may study at any one of several private
institutions offering training programmes in complementary/alternative medicine,
♦ Swiss Association of Natural Doctors: the programme, which lasts six semesters
and is provided on weekends, includes introductions to anatomy, physiology, and
biochemistry; seminars in physiology and pathology; and seminars on diagnostic
and treatment techniques.
♦ School for Natural Medicine in Zürich: two training options are available, both
include basic courses in anatomy, physiology, and pathology. Students then
specialize either in homeopathy and traditional Chinese medicine or in several
forms of complementary/alternative massage. The programme lasts four years.
♦ Academy for Natural Medicine in Basel: the school offers a basic common course
in anatomy, physiology, pathology, psychiatry, neurology, and physical diagnosis.
After completing this common course, students choose from among three
specializations: homeopathy, phytotherapy and natural medicine; traditional
Chinese medicine; or acupuncture. The programme lasts four years plus a required
four-month internship.
♦ Swiss School for Osteopathy of Belmont/Lausanne: this school is working to

obtain official recognition equivalent to a university faculty. It offers a five-year
diploma and a six-year doctorate programme.
Although chiropractic is a recognized profession in Switzerland, there are no

recognized chiropractic schools in the country. Practitioners must train abroad.
Some cantons — Appenzell external Rhodes, Basel Landschaft, Graubünden,

Obwalden, St. Gallen, Shaffhausen, and Thurgau — have specific rules concerning the
exam that candidates must pass to be allowed to practise complementary/alternative
medicine (172).
Insurance coverage
There are several levels of health care protection in Switzerland (172). Insured persons
are free to choose between minimum basic coverage and extensive coverage provided
through policies that provide coverage for complementary/alternative health care and
medications.
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Since July 1999, five commonly used complementary/alternative therapies —
homeopathy, Chinese medicine, anthroposophic medicine, neural therapy, and
phytotherapy — have been reimbursed by compulsory social insurance when they are
provided by an allopathic physician with a postgraduate education recognized by the
Swiss Medical Association. Treatments provided by non-allopathic physicians are not
reimbursed. Except for acupuncture, in order for these therapies to continue to be
reimbursable after 2005, their efficacy and cost-effectiveness have to be proven by that
year.
The complementary/alternative medicine policies of private insurance companies

influenced the Swiss Government’s decision to cover the most commonly used
therapies (172). Private insurance companies, such as Caisse Vaudoise, generally offer
complementary/alternative health care policies covering acupuncture, acupressure,
Alexander technique, anthroposophy (when provided by a physician), audiopsycho-
phonology, auriculotherapy, lymphatic drainage, etiopathy, curative eurythmy,
eutony, homeopathy, postural integration, iridology, colonic irrigation, Kneipp
therapy, kinesiology, anthroposophic medicine, mesotherapy, naturopathy,
osteopathy, polarity, energetic balancing, reflexology, relaxation, breathing
techniques, shiatsu, sophrology, and sympathicotherapy. The supplementary fee for
complementary/alternative policies varies between 10 and 20 Swiss francs per month.
Reimbursement varies between 30 and 100 Swiss francs per consultation; three to 10
consultations are covered per year.
Ukraine
Statistics
There are no hospitals in Ukraine in which only complementary/alternative therapies
are used (172).
Though allopathic physicians may use allopathic or complementary/alternative
therapies, only allopathic physicians and registered non-allopathic practitioners
working under physicians are allowed to provide medical treatments (172). The
Ministry of Health authorizes licences for physicians. It requires an authenticated copy
of documents attesting to the level of education and necessary qualifications for the
practice of medicine, such as a medical diploma or a certificate of specialization, a
letter of reference issued by a former employer, and approval from the designated
local authority.
Complementary/alternative medicine is covered under general regulations (172). In

order to be registered as a legal non-allopathic practitioner, it is necessary to complete
a special programme given by the Academy of Physicians Postgraduate Education or
by the Ukrainian National Medicine Association, which is under the supervision of the
Ukrainian Ministry of Public Health. Some specific branches of
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complementary/alternative medicine, such as reflexotherapy, have their own code of
speciality (172).
Steps are being taken to introduce an official specialization in homeopathy for

allopathic physicians (53).
Homeopathic remedies are officially recognized by the Decree on Medicines of the

Ministry of Health. Quality control of homeopathic remedies is based on the German
Pharmacopoeia (172). The Ukrainian Ministry of Public Health regulates the production
of homeopathic medicines, and the Comission of the Pharmacological Committee on
Homeopatic Medicines under the supervision of the Ukrainian Office for Public
Health is responsible for delivering licences for their sale. Specialised homeopathic
chemist shops exist in Ukraine. People can also buy homeopathic medicines from
Germany and Austria.

The Academy of Physicians Postgraduate Education and the Ukrainian National
Medicine Association offer special courses for non-allopathic practitioners in
homeopathy, iridology, reflexotherapy, aromatherapy, and phytotherapy (172).
Insurance coverage
There is no public or private reimbursement of complementary/alternative medicine
(172). Patients seeking complementary/alternative treatment must pay for the care
themselves.
United Kingdom of Great Britain and Northern Ireland
Successive governments have ensured that as long as patients require complemen-
tary/alternative treatment, access to it will be guaranteed. As a result, the United
Kingdom is the only country in the European Union with public-sector hospitals for
complementary/alternative medicine. Indeed, there are National Health Service
homeopathic hospitals in London, Glasgow, Liverpool, Bristol, and Tunbridge Wells
(53). At Saint Mary’s Hospital, where relaxation, dietetic, yoga, and meditation
therapies are available, allopathic physicians work closely with non-physicians.
Homeopathy provided by allopathic physicians is included in the National Health
Service (86).
Complementary/alternative medications, homeopathic products, and other natural

remedies are becoming increasingly popular and are now widely available in health
food stores and pharmacies (172).
In response to the increased use of complementary/alternative medicine by the public

and the Government’s concern over its effectiveness, the British Research Council on
Complementary Medicines was formed in 1982. Among other things, it noticed the
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major role of complementary/alternative medicine in reducing the costs of the health
care system (172).
In general, in order to become a member of a professional organization, non-allopathic

practitioners must be covered by insurance and adhere to the Code of Professional
Ethics (172).
Statistics
During the past 20 years, interest in complementary/alternative medicine has
increased (172). Seventy per cent of the public is in favour of complementary/alterna-
tive medicine becoming widely available in the National Health Service — particularly
osteopathy, acupuncture, chiropractic, and homeopathy.
One-eighth of the British population has tried complementary/alternative medicine,

and 90% of these people are ready to use it again. Complementary/alternative
medicine is most popular with middle-aged, middle-class women. The complemen-
tary/alternative therapies most used are herbal medicines, osteopathy, homeopathy,
acupuncture, hypnotherapy, and spiritual healing. Much complementary/alternative
medical practice centres on treating chronic diseases. Most patients of
complementary/alternative medicine are also patients of allopathic medicine (172).
Complementary/alternative practitioners without an academic degree provide the

largest proportion of complementary/alternative medicine. In 1987, there were about
2000 non-allopathic medical practitioners. In 1999, there were 50 000 complemen-
tary/alternative medical providers. Approximately 10 000 of these are officially
registered health professionals. In 1998, up to five million patients consulted a comple-
mentary/alternative practitioner. Patients spend about 1.6 billion pounds sterling each
year on complementary/alternative medicine (183).
There are approximately 1300 chiropractors practising in the United Kingdom (45).
There are several professional associations of complementary/alternative practi-
tioners.
Although complementary/alternative medical practitioners without an allopathic
medical degree are tolerated by law, only medical providers holding a university
degree in allopathic medicine are officially recognized (172): to practise medicine as a
physician, a person must posses a certificate or qualification from the faculty of
medicine of a university and complete one year of general clinical training. During the
clinical training period, a physician candidate has provisional registration. After
satisfactorily completing the training, the candidate may obtain full registration. Being
a registered medical practitioner confers privileges and responsibilities, including the
right to use the title or describe oneself as a registered practitioner, to be recognized by
law as a physician or surgeon, to recover fees for medical attendance or advice in a
court of law, to hold specific posts, to provide general medical services in the National
Health Service, and to give some statutory certificates. The General Medical Council, a
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statutory body that regulates the medical profession, maintains the register of
qualified allopathic doctors.
Although registration, for which specific training is required, provides certain

privileges to non-allopathic practitioners as well, the right to practise medicine
without formal recognition is established in British Common Law (172). This right
protects an individual’s freedom to carry out medical activities not specifically
prohibited by an act of Parliament. As a result, given some restrictions and provided
they do not breach the Medical Act of 1983, non-allopathic providers can practise
medicine regardless of their training. In principle, non-registered persons are even
allowed to perform surgical acts with the consent of patients. If such acts result in
maltreatment, however, non-allopathic practitioners may be prosecuted under the
penal law and the tort-based common law of negligence. And if a patient dies, the
practitioner may be prosecuted for involuntary homicide. Registered physicians
cannot be so prosecuted.
Under the terms of the Venereal Disease Act of 1917 and Section 4 of the Cancer Act of
1939 (172), there are some limitations on the rights of non-allopathic practitioners.
Non-allopathic practitioners may not perform certain medical acts, practice specific
professions, or use particular titles. Only registered allopathic doctors may treat
cancer, diabetes, epilepsy, glaucoma, and tuberculosis; prescribe controlled drugs;
perform specific medical acts such as abortion; or treat venereal diseases. Unqualified
practitioners may not claim to be or practise as pharmacists, midwives, or dentists, or
imply that they are State-registered allopathic practitioners whose legal status is
regulated by the Professions Supplementary to Medicine Act of 1960. This Act
regulates dieticians, medical laboratory technicians, occupational therapists,
physiotherapists, radiographers, and orthopaedists. Further, commercial use of the
term “health care centre” in relation to any premises where no allopathic doctors and
nurses are employed is prohibited.
Allopathic physicians referring patients to non-allopathic practitioners for treatment

retain clinical responsibility for their patients. The Medical Act of 1983 (172) does not
regulate which forms of therapy may be practised by registered physicians. Thus,
there is no restriction on registered allopathic physicians using complementary/alter-
native medicine if they have the requisite skills and/or qualifications. Further, the
agreement of 1 April 1990 between allopathic general practitioners and the Family
Health Service Authorities does not define the staff that may work with an allopathic
physician. Thus, a physician’s staff may include physiotherapists, chiropractors, and
dieticians.
In 1950, the Government gave official recognition to homeopathy in the Faculty of

Homeopathy Act. The Government regulates osteopathy and chiropractic through the
quite similar Osteopath and Chiropractor Acts of 1993 and 1994 (172). While registered
practitioners of these two professions have special rights, including title protection,
they, like other non-allopathic practitioners, are not recognized as official health care
providers and may not work in National Health Service hospitals. Nonetheless, these
two acts are considered to be important developments in complementary/alternative
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medicine. Other practitioners, including acupuncturists, homeopaths, and herbalists,
are now pursuing the same level of recognition.
The regulation of chiropractors and osteopaths, as with all health care professionals, is
based upon a register. The right to use the title of “Chiropractor” or “Osteopath” is
restricted to registered chiropractors and osteopaths, and registration depends on
having recognized qualifications, although there are transitional provisions for
experienced practitioners.
The General Chiropractic Council, which includes a significant number of non-

chiropractors, is publishing its own Code of Professional Ethics. Under the Osteopath
and Chiropractor Acts of 1993 and 1994, the principal criteria for disciplinary action
are professional incompetence, conduct that falls short of the standards required of a
registered osteopath or chiropractor, conviction of a criminal offence, and serious
health impairment affecting the ability to work as an osteopath or chiropractor. Under
this Code, practitioners facing disciplinary action from the Committee may be
admonished, suspended, or dismissed. The right to practise is initially granted for a
period of up to three years, then for periods of two to three years. However, this is not
yet in effect.
Homeopathic and other natural remedies are sold by many independent pharmacies.
The European Directive on Homeopathic Products regulates the making and
marketing of homeopathic products in the United Kingdom (172). The licensing of
other medicines is regulated by the Medicines Act of 1968 (172). Applications for drug
registration must be accompanied by details of relevant research and clinical trials.
Requirements are less stringent if the medicines do not contain a new chemical
substance or if they are herbal preparations.
The Health Act of 1999 (183) provides two options for achieving statutory regulation
for a profession or therapy. The first option allows associations representing a
profession to apply for statutory regulation. The second option allows professions to
join the Health Professions Council; membership in the Council confers title
protection.

The British Medical Association recommends incorporating complementary/alterna-
tive medicine into the undergraduate curriculum of medical schools and making
accredited postgraduate training available (172).
While most non-allopathic practitioners have good training, the quality of comple-
mentary/alternative medical programmes varies. The Institute of Complemen-
tary/Alternative Medicines is working with the Training Desk to establish national
standards of training acceptable to both the public and the Government (172).
There are 54 professional associations representing complementary/alternative

practitioners and offering comprehensive full-time courses in anthroposophy,
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chiropractic, homeopathy, phytotherapy, naturopathy, and osteopathy, lasting for a
minimum of three years (172).
The Faculty of Homeopathy Act empowers the Faculty of Homeopathy to train,

examine, and confer diplomas in homeopathy to allopathic physicians and other
statutorily recognized health professionals (172). There are four schools of chiropractic
in the United Kingdom (65).
Insurance coverage
With some exceptions, fees for complementary/alternative therapies are not
reimbursed by the social security system (172). Exceptions are made for treatments
available within National Health Service hospitals, which are provided free of charge,
and occasionally for acupuncture, osteopathy, and chiropractic treatments. An
allopathic general practitioner may claim reimbursement for a wide range of staff,
including physiotherapists, chiropractors, and dieticians; however, the authorities
have the freedom to reimburse all, part, or none of these costs.
Some private insurance programmes (172) reimburse the five most popular forms of
complementary/alternative therapy — homeopathy, osteopathy, herbalism, acupunc-
ture, and naturopathy — when they are provided by allopathic physicians.
The services of chiropractors and osteopaths are reimbursed by trade bodies and by
several associations, such as industrial and veterans’ associations.
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South-East Asia
Bangladesh
Ayurvedic medicine is widely practised in Bangladesh.
When Bangladesh constituted the eastern part of Pakistan, the Pakistani Board of
Unani and Ayurvedic Systems of Medicine was operative in the country. Following
independence, the Bangladesh Unani and Ayurvedic Practitioners Ordinance of 1972
restructured this body as the Board of Unani and Ayurvedic Systems of Medicine,
Bangladesh (184). The Board is responsible for maintaining educational standards at
teaching institutions, arranging for the registration of duly qualified persons (including
appointing a registrar), and arranging for the standardization of unani and ayurvedic
systems of medicine. A research institute has been functioning under the Board since
1976.
The Bangladesh Unani and Ayurvedic Practitioners Ordinance of 1983 (185) prohibits
the practice of unani and ayurvedic systems of medicine by unregistered persons. A
significant feature of the Ordinance is the deliberate omission of a provision contained
in preceding legislation that made it an offence for an ayurvedic or unani practitioner to
sign birth, medical, and physical-fitness certificates.

Control over the teaching of unani and ayurvedic medicine rests with the Board of
Unani and Ayurvedic Systems of Medicine (186). There are nine teaching institutions
under the Board, five for unani medicine and four for ayurvedic medicine. They offer
diplomas upon completion of a four-year programme. The Registrar of the Board also
serves as the Controller of Examinations.
Bhutan
What is now classified as Bhutanese traditional medicine was introduced into Bhutan
in the beginning of the 16th century by Lam Shabdrung Ngawang Namgyal (187). This
medical system has roots in Buddhism and Tibetan traditional medicine. During its
early practice in Bhutan, providers of traditional medicine were trained in Tibet.
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In addition to medications, Bhutanese traditional medicine includes acupressure,
acupuncture, moxibustion, cupping, cauterization, medicated oil massage, herbal and
steam baths, and the application of cold and warm poultices to the body (187).
In 1988, a research unit was established in the Institute of Traditional Medicine

Services (187). This unit conducts research for further quality control of raw materials
and finished products for traditional medicines as well as developing new products. It
also ensures the sustainability of traditional medicine services and looks for ways to
increase the cost-effectiveness of traditional medicine.
Statistics
There is a hospital for traditional medicine in Thimphy, the capital city of Bhutan. An
additional 15 traditional medicine units across the country provide services to about
60% of the country’s population. The Government plans to establish more units, to
cover all 20 districts in the country (187).
There are more than 2990 different medicinal plants used in Bhutanese traditional
medicines (187). About 130 traditionally used formularies are made from 110 different
herbal preparations. About 70% of the raw materials used in these preparations are
available in the country, both as wild and cultivated stocks. The remaining 30% are
imported from India. There are more than 300 herbal products produced in Bhutan.
Most are compound forms, with three to 90 ingredients (187).
In 1967, in an effort to promote and preserve traditional medicine, it was formally
recognized and institutionalized as an integral part of the national health system of
Bhutan (187). In 1979, the Institute of Traditional Medicine Services (187) was founded.
It is housed in an allopathic hospital in order to encourage the integration of
traditional and allopathic medicine, particularly mutual consultation, treatment, and
referrals, and to enable patients to have greater access to a range of health care choices.
Bhutan’s Institute of Traditional Medicine Services is charged with establishing a

traditional medicine system that is scientifically sound and technologically
appropriate, and which meets the needs of the population. To fulfil this mandate, the
Institute works to provide access to traditional medicine for the entire population; to
attain self-reliance in raw materials for the production of traditional medicines,
including the conservation, cultivation, rotational collection, and preservation of rare
and endangered species of medicinal plants; to improve the quality of traditional
medical services through training practitioners; and to increase the production of
traditional medicines for export. Profits from exporting traditional medicines are to be
used to strengthen traditional medicine within Bhutan.
Small-scale mechanised production of traditional medicines started in 1982 with the

assistance of the World Health Organization; previously, all medicines had been
prepared manually (187). All herbal products are now produced mechanically
following good manufacturing practices, with an emphasis on quality control. Herbal
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products take the form of pills, tablets, medicated ointments, syrups, and capsules and
are purely natural — no artificial chemicals are used.

Officially recognized formal training of traditional medical doctors (drungtsho) began
in 1971 with the establishment of a five-year drungtsho programme. In 1978, the
training curriculum was standardized. In 1979, the programme became part of the
National Institute of Traditional Medicine (187). The course now consists of five years
of institutional training followed by a six-month internship: three months in an
allopathic hospital and three months in the traditional medicine hospital and a
traditional medicine unit. During the three-month internship in the allopathic hospital,
interns are introduced to allopathic medicine and the health sciences (187).
Democratic People’s Republic of Korea
In the Democratic People’s Republic of Korea, traditional medicine is integrated into
the official health care system. This policy of integration is reflected in a number of
policy declarations since 1947. It was a prominent feature of the Government’s 1967
political programme and was reiterated in a 1980 public health law (188). Under
Article 15 of this law, with a view to preserving national therapeutic traditions, the
State is required to combine traditional medical practices with allopathic diagnosis in
medical establishments.
India
For centuries, ayurveda, siddha, and unani systems of medicine have coexisted with
yoga, naturopathy, and homeopathy (2). (See the Introduction for descriptions of
ayurveda, unani, and homeopathy.)
Siddha (2) is one of the oldest systems of medicine in India. In Tamil, siddha means
“perfection” and a siddha was a saintly figure who practised medicine. Siddha has
close similarities to ayurveda, the difference between these two systems being more
linguistic — Tamil versus Sanskrit — than doctrinal. In siddha, as in ayurveda, all
objects in the universe, including the human body, are composed of the five basic
elements: earth, water, fire, air, and sky.
Yoga (2) was propounded by Patanjali and is based upon observance of austerity,
physical postures, breathing exercises, restraining of sense organs, contemplation,
meditation, and samadhi.
Naturopathy (2) is a system of drugless treatment and a way of life. It is very close to
ayurveda.
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The introduction of allopathic medicine during the colonial period led to the Govern-
ment’s neglect of traditional medical systems. Now, however, ayurveda, unani,
siddha, naturopathy, homeopathy, and yoga are well integrated into the national
health care system (2). There are State hospitals and dispensaries for both traditional
medicine and homeopathy; however, traditional medicine and homeopathy are not
always well integrated with allopathic medicine, particularly in allopathic hospitals.
Statistics
Traditional medicine is widely used in India, especially in rural areas where 70% of
the Indian population lives.
There are 2860 hospitals, with a total of 45 720 beds, providing traditional Indian
systems of medicine and homeopathy in India. In 1998, more than 75% of these beds
were occupied by patients receiving ayurvedic treatment, which is by far the most
commonly practised form of traditional medicine in India. There are 22 100 dispensa-
ries of traditional medicine (2). There are 587 536 registered traditional medicine
practitioners and homeopaths, who are both institutionally and non-institutionally
qualified (2).
Ayurveda, unani, siddha, naturopathy, homeopathy, and yoga are all recognized by
the Government of India. The first step in granting this recognition was the creation of
the Central Council of Indian Medicine Act of 1970 (2). The main mandates of the
Central Council are as follows:
♦ to standardize training by prescribing minimum standards of education in

traditional medicine, although not all traditional medicine practitioners and
homeopaths need be institutionally trained to practice;
♦ to advise the central Government in matters relating to recognition/withdrawal of

medical qualifications in traditional medicine in India;
♦ to maintain the central register of Indian medicine, revise the register from time to
time, prescribe standards of professional conduct and etiquette, and develop a
code of ethics to be observed by practitioners of traditional medicine in India. All
traditional medicine practitioners and homeopaths must be registered to practice.
The Central Council of Homeopathy (2), constituted in 1973, has the same mandates.
The Indian Government created the Department of Indian Systems of Medicine &
Homeopathy in March 1995 (2). The primary areas of work for the Department are
education, standardization of medicines, enhancement of availability of raw materials,
research and development, information dissemination, communication, and the
involvement of traditional medicine and homeopathy in national health care. More
than 4000 personnel work in these areas.
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The Indian Government seeks the active and positive use of traditional medicine and
homeopathy in national health programmes, family welfare programmes, and
primary health care (2).

Through the Central Council of Indian Medicine and the Central Council of
Homeopathy, the Indian Government is working to standardize the training of
traditional medicine practitioners and homeopaths (2). In support of this, seven
national institutes are under the control of the Department of Indian Systems of
Medicine & Homeopathy:
♦ National Institute of Ayurveda: established in 1976, located in Jaïpur, offers a PhD

MD in ayurveda;
♦ National Institute of Homeopathy: established in 1975, located in Calcutta, offers

Bachelor’s and MD degrees in homeopathy;
♦ National Institute of Naturopathy: established in 1984, located in Pune, offers talks

in Hindi and Marathi and programmes for teachers and doctors;
♦ National Institute of Unani Medicine: established in 1984, located in Bangalore,

offers postgraduate research opportunities in unani;
♦ National Institute of Postgraduate Teaching and Research in Ayurveda: located in

New Delhi, offers PhD and MD degrees in ayurveda;
♦ National Academy of Ayurveda: established in 1988, located in New Delhi, offers a

Degree of Membership Certificate in ayurveda;
♦ National Institute of Yoga: established in 1976, located in New Delhi, offers a one-
year diploma in yoga.
An institution for siddha medicine is planned.
In addition to these national institutes, there are a number of facilities for medical
education under the Department of Indian Systems of Medicine & Homeopathy (2):
Facilities Ayurveda Unani Siddha Homeopathy Total

Undergraduate
154 32 2 118 305
Colleges
Admission
6117 1239 155 4318 11829
Capacity
Postgraduate
33 3 1 10 47
Colleges
Admission
462 55 35 69 621
Capacity
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The health authorities review the qualifications of practitioners through the Central
Council of Indian Medicine and the Central Council of Homeopathy, which can both
determine whether these colleges and universities may continue to admit students.
Insurance coverage
Few people besides State employees have medical insurance, although this insurance
does cover traditional medicine.
Indonesia
Indonesian practitioners of traditional medicine may be divided into four groups:
herbalists; skilled practitioners, including traditional birth attendants, circumcisers,
bonesetters, masseuses, and traditional dentists; spiritualists; and supernaturalists
(189).
Statistics
The use of traditional medicine is increasing each year. Traditional medicine provides
an important resource for self-care within the health services and through traditional
medicine practitioners (189). Forty per cent of Indonesia’s population uses traditional
medicine, 70% in rural areas.
A 1995 Ministry of Health survey reported 281 492 practitioners of traditional

medicine practising in Indonesia, a significant increase over the 112 974 reported in
1990 (189, 190). Of these practitioners, 96.2% use traditional Indonesian methods of
treatment. The rest use medical treatments, such as acupuncture, that belong to the
traditions of other countries (189). Among the 281 492 traditional medicine
practitioners in Indonesia, 122 944 are traditional birth attendants, 51 383 are general
traditional medicine practitioners, 25 077 are masseuses, 18 456 are circumcisers,
18 237 are tukang jamu gendong, 14 000 are herbalists, 12 496 are spiritualists, 10 118 are
supernaturalists, and 8781 are bonesetters (189).
Traditional birth attendants are an important feature of Indonesian health care.

According to national figures for the period 1983 to 1987, allopathic providers
attended only 43% of childbirths. The remainder were either unattended or attended
by traditional birth attendants (191). At least 91 427 traditional birth attendants have
completed a training programme offered by the Ministry of Health.
At the end of 1999, there were 723 manufacturers of traditional medicines in Indo-
nesia, 92 of which were large-scale industries. These companies produce thousands of
registered traditional medicines (189).
Article 1 of Indonesia’s Health Law Act 23-1992 (189) places traditional medicine as an
integral part of curative and nursing care. Article 2 emphasizes the need for
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supervision of traditional medicine to ensure its safety and efficacy. Article 3 supports
further development and improvement of forms of traditional medicine deemed safe
and efficacious in order to fulfil the goal of optimal health for the community. The
Health Law Act classifies traditional medicines (jamu) into two groups:
♦ The first group consists of traditional medicines produced by individual persons

or by home industries. These medicines need not be registered. They are made by
traditional medicine practitioners for use by their own patients. They may not be
labelled or marked except with the empirical name. The Minister of Health is
responsible for helping the producers of these medicines ensure the quality of their
products. To this end, the Ministry permits the use of only 54 species of plants in
these medicines. The safety of all 54 species is known through traditional
experience.
♦ The second group consists of traditional medicines produced and packed on a

commercial scale, whether large or small. These medicines must be registered and
licensed before they may be sold. In order to be registered, jamu (and traditional
medicines not indigenous to Indonesia) must have undergone scientific study,
including microbiological testing. These studies are to ensure the safety and
efficacy, composition and rationality of the composition, dosage form, and claimed
indications for the medicines. For use in formal health services, clinical trials must
be carried out. The Ministry of Health of Indonesia has produced a publication,
Guidance for Clinical Trial of Traditional Drug, to help manufacturers fulfil these
requirements.
In accordance with the 1993 General Guidelines, health efforts, including those for
traditional medicine, have been strengthened within the framework of the national
health care legislation (192).
Traditional birth attendants are permitted to practise without registration or a licence

(193). Allopathic physicians with appropriate training in acupuncture are able to
practice acupuncture in public hospitals.

The Centre for Traditional Medicine Research, under the Ministry of Health and Social
Welfare, provides training in traditional medicine. The Directorate of Selected
Community Health Development, also under the Ministry of Health and Social
Welfare, offers training programmes in primary health care for traditional practi-
tioners of acupressure.
Myanmar
Traditional medicine in Myanmar is based on ayurvedic concepts and influenced by
Buddhist philosophy. From 1885, the beginning of the colonial period in Myanmar,
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until the Second World War, allopathic medicine was promoted over traditional
medicine. During the Second World War, however, allopathic medicines were scarce
and traditional medicine regained prominence.
Statistics
The Department of Indigenous Medicine was established in August 1989. It houses
more than 4000 ancient palm-leaf and parchment writings and books on traditional
Myanmar medicine. Since the promulgation of the Traditional Medicine Law in 1996,
a total of 3962 medicinal items have been registered and 632 manufacturers have been
issued production licences.
Over 8000 practitioners of traditional medicine are registered in Myanmar.
There is one 50-bed hospital for traditional medicine in Mandalay, one 25-bed hospital
in Yangon, and three 16-bed hospitals in other parts of the country. There are 194
township-level traditional medicine departments, each with its own outpatient clinic.
Prior to the Second World War, several national committees recommended that the
Government recognize traditional medicine, but no action resulted.
Four years after Myanmar’s independence in 1948, the Myanmar Indigenous Medical
Committee was formed. The Committee drafted the Indigenous Myanmar Medical
Practitioners Board Act 74, which was passed in 1953 and amended in 1955, 1962, and
1987. The Act established the Indigenous Myanmar Medical Practitioners Board,
which advises the Government on the revival and development of traditional
Myanmar medicine, related research, and the promotion of public health, among other
things. Section 11 specifies “suppression of charlatans or quacks who are earning their
living by means of indigenous Myanmar medicine” as a particular function of the
Board. Subject to the sanction of the Head of State, the Board is also empowered to
prescribe topics for examination in traditional Myanmar medicine, register
practitioners, and remove practitioners from the register if a defect in character or
undesirable conduct is established. Section 24 of the Act prescribes that subject to the
provisions of Section 23 of the Myanmar Medical Act, practitioners of traditional
medicine must be registered in order to sign medical certificates, which by law must
be signed by a medical practitioner. Similarly, unless he or she has obtained the prior
sanction of the Head of State, an indigenous medical practitioner who is not registered
may not hold certain specified appointments in publicly supported hospitals or other
health facilities.
Section 7 of the Indigenous Myanmar Medical Practitioners Board Rules of 1955 (194)
provides for the registration of traditional medicine practitioners under six categories.
The system of classification is essentially based on the division of Myanmar medicine
into four branches: dhatu, ayurveda, astrology, and witchcraft. In Section 9 of the
Rules, details are given of the knowledge required for registration in each specific
category. Provision is made, in Section 10, for authors of works on indigenous
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medicine to be registered in one of three groups. Section 10 also prohibits the
registration of monks as medical practitioners.
Under Section 12 of the Rules, the Board is mandated to find ways to consolidate the
four branches of medicine currently practised into a single system. The Board is also
mandated to conduct research and advise the authorities on standardizing methods of
treatment provided in Government-operated dispensaries.
The Indigenous Myanmar Medical Practitioners Board Amendment Act 48 of 1962

introduced Sections 22-A and 28-A empowering the Chairman of the Revolutionary
Council of Myanmar to cancel the registration of indigenous medical practitioners,
prescribe qualifications for registration, and terminate the services of any or all of the
members of the Board and appoint new members in their place. Under these powers, a
new Board was appointed to initiate the re-registration of practitioners.
In 1996, the Government promulgated the Traditional Medicine Law in order to control
the production and sale of traditional medicines. The Ministry of Health has updated
and revised the Indigenous Myanmar Medical Practitioners Board Amendment Act and
renamed it the Traditional Medical Council Law. It is now in the process of receiving
State approval.

The Ministry of Health established an educational institution known as the Institute of
Indigenous Medicine in 1976 (195). It offers a three-year training programme followed
by a one-year internship. The Institute also conducts a one-year course in primary health
care for traditional medicine practitioners who have no certificate or licence to treat
patients. Those who are successful in the course receive a licence to practise traditional
medicine.
Nepal
The use of medicinal herbs in Nepal’s traditional medical system dates back to at least
500 AD. In Nepal, traditional medicine, although low profile, has been an integral part
of the national health system. Parallel to the allopathic system, traditional medicine is
encouraged in all spheres because of its efficacy, availability, safety, and affordability
when compared to allopathic drugs (196).
Statistics
Ayurvedic medicine is widely practised in Nepal. It is the national medical system.
More than 75% of the population use traditional medicine, mainly that based on the
ayurvedic system. There are 141 ayurvedic dispensaries, 14 zonal dispensaries, 15
district ayurvedic health centres, and two ayurvedic hospitals. One of these hospitals
is centrally located in Naradevi, Kathmandu, and the other is regionally located in
Dang. They have 50 and 15 beds, respectively.
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There are 623 institutionally qualified practitioners of traditional medicine and about
4000 traditionally trained practitioners. Homeopathy has been recently introduced
into Nepal (53).
The policy of the Government (197), based on five-year plans, involves a system of
integrated health services in which both allopathic and ayurvedic medicine are
practised. Ayurvedic clinics are considered to be part of the basic health services, and
there is a section responsible for ayurvedic medicine in the Office of the Director
General of Health Services. The programmes for health services included in the Fifth
Five-Year Plan make provision for four ayurvedic hospitals, one in each of the four
development regions. The Ayurvedic Governmental Pharmaceutical Unit works to
provide inexpensive medicaments.
The Ayurvedic Medical Council was created through legislation passed in 1988 (198).
Section 2.1 of this Act gives the Council’s mandate as, among other things, steering the
ayurvedic medical system efficiently and registering suitably qualified physicians to
practise ayurvedic medicine. In Section 4, the legislation sets out highly detailed
provisions for registration that classify applicant practitioners into four groups
according to their qualifications and experience in ayurvedic science. By Section 5.2.2,
membership in a particular group fixes the range of ayurvedic medicines that a
practitioner is permitted to prescribe. Registered practitioners enjoy a monopoly over
the practice of ayurvedic medicine: direct or indirect practice of ayurvedic medicine by
other medical practitioners is forbidden by Section 5.1.1. Section 5 of the Act enables
registered ayurvedic practitioners to issue birth and death certificates as well as
certificates concerning the ayurvedic medical system and patients’ physical and mental
fitness.

Formal education in the ayurvedic system is under the supervision of the Institute of
Medicine of Tribhuvon University (197). The Auxiliary Ayurveda Worker training
programme is run from the Department of Ayurveda under the Council for Technical
Training and Vocational Education (199).
Sri Lanka
Traditional medicine forms an integral part of the health care delivery system in Sri
Lanka. Traditional and natural medicine founded on the concept of three humours has
a long anecdotal history of effective diagnosis and treatment. Unfortunately, there is a
lack of scientific research to support this history.
Ayurvedic medicine is widely practised in Sri Lanka.
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Statistics
In Sri Lanka, 60% to 70% of the rural population relies on traditional and natural
medicine for their primary health care.
The popularity of traditional medicine led to the promulgation of the Indigenous
Medicine Ordinance in 1941. This Ordinance provided for the establishment of the
Board of Indigenous Medicine, whose duties include the registration of traditional
medicine practitioners, and oversight of the College of Indigenous Medicine and the
Hospital of Indigenous Medicine.
The establishment of the Department of Ayurveda within the Ministry of Health by

Ayurveda Act 31 of 1961 (200) constituted a landmark in the modern history of
ayurveda. Ayurveda, as defined in the Act, encompasses all medical systems
indigenous to Asia, including siddha and unani.
The Act defined the Department’s objectives as provision of establishments and

services necessary for the treatment of disease and the preservation and promotion of
the health of the people through ayurveda; encouraging the study of, and research
into, ayurveda via scholarships and other facilities to persons employed, or proposed
to be employed, in the Department and by the grant of financial aid and other
assistance to institutions providing courses of study or engaging in research into
ayurveda; and taking, developing, or encouraging measures for the investigation of
disease and the improvement of public health through ayurveda.
The Ayurveda Act 31 of 1961 also specified the duties of the Ayurvedic Medical
Council, which include registration of ayurvedic practitioners, pharmacists, and
nurses and regulation of their professional conduct as well as authority over the
Ayurvedic College and Hospital Board and the Ayurvedic Research Committee.
The Ayurvedic Physicians Professional Conduct Rules of 1971 (201) were made by the
Ayurvedic Medical Council under Section 18 of the 1961 Act and approved by the
Ministry of Health. They establish a code of ethics for ayurvedic physicians.
Professional misconduct includes procuring or attempting to procure an abortion or
miscarriage; issuing any certificate regarding the efficacy of any ayurvedic medicine or
any ayurvedic pharmaceutical product containing statements that the practitioner
knows to be untrue or misleading; conviction of an offence under the Poisons, Opium
and Dangerous Drugs Ordinance that was committed in the practitioner’s professional
capacity; selling to the public, either directly or indirectly, any ayurvedic
pharmaceutical product for which the prior sanction of the Ayurvedic Formulary
Committee has not been obtained; and exhibiting or displaying any medical degree or
medical diploma that has not been approved by the Ayurvedic Medical Council.
In early 1980, the Ministry of Indigenous Medicine was established as a separate

department to be led by a senior parliamentarian — who is an ayurvedic practitioner
by profession (202). Responsibility for the Department of Ayurveda was transferred to
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the Ministry. A central feature of the Ministry’s operation has been the establishment
of traditional medical dispensaries and hospitals that provide medical care at no cost.
The Cabinet Ministry for Indigenous Medicine was established in 1994; there was
previously a State Minister for Indigenous Medicine. Research and development
activities are undertaken on behalf of these ministerial offices by the Department of
Ayurveda and the Bandaranaike Memorial Ayurvedic Research Institute, founded
June 1962.
The Homeopathy Act of 1970 (203) recognized homeopathy as a system of medicine

and established the Homeopathic Council appointed by the Minister of Health in 1979
(53). The Homeopathic Council is responsible for regulating and controlling the
practice of homeopathic medicine and maintaining the Homeopathic Medical College.
The 1970 Act exempted persons practising homeopathic medicine, pharmacy, or
nursing from the provisions of the Medical Ordinance and empowered the relevant
Minister to make regulations for the control of professional conduct and other matters.
In particular, the Council is empowered to register and recognize homeopathic
medical practitioners; recognize homeopathic teaching institutes, dispensaries, and
hospitals; hold examinations and award degrees in homeopathic medicine; and
arrange for postgraduate study in homeopathy (86). The Council also maintains a
register of homeopathic practitioners. With some exceptions, qualification following a
course of study of not less than four years is a prerequisite for registration. Only
registered practitioners may practise homeopathy for gain and use the title
“Registered Homeopathic Practitioner”. Such practitioners are also entitled to issue
certificates or other documents required to be issued by medical practitioners; hold
posts as medical officers in public medical institutions; and sign birth or death
certificates, medical certificates, and certificates of physical fitness.

A World Health Organization/United Nations Development Programme project for
the development of traditional medicine in Sri Lanka (SRL/84/020) was implemented
in the 1980s. Phase I began in October 1985 and ended in May 1988. Phase II
(SRL/87/029) began in 1989. The importance of human resource development in the
traditional and natural medicine sector was highlighted in this project. The project
enhanced the teaching capability of eight instructors of traditional medical practice
and the professional capability of 1217 general practitioners of traditional medicine to
provide advice at the community level on the preventive and promotive aspects of
primary health care and treating common ailments.
The same project provided incentives to establish the National Institute of Traditional
Medicine, which carries out educational and training programmes for traditional and
ayurvedic practitioners, school children, and the general public. The Institute does not
offer opportunities for advanced training or postgraduate education, so in 1993 the
Department of Ayurveda began to provide alternative resources for Ayurvedic
Medical Officers to obtain postgraduate qualifications through the Institute of
Indigenous Medicine at the University of Colombo, Rajagiriya.
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Thailand
Thai traditional medicine draws from Indian and Chinese systems of traditional
medicine (204). It encompasses a holistic philosophy and is based principally on
plants, including the use of herbal saunas, herbal medicines, herbal steam baths, and
hot compresses; traditional massage; acupressure; and reflexology. Practitioners of
traditional medicine represent an important resource for the Thai health care system.
Traditional Thai medicine is also practised in Cambodia, Lao, and Myanmar.
Statistics
In 1998, Thailand imported more than 35% of its allopathic medicines and about 30%
of its traditional medicines (204).
Official policy towards traditional medicine in Thailand has a well-recorded history:
♦ 1182–1186: 102 hospitals were established, and at least 30 kinds of herbs were used
in treatments.
♦ 1504: traditional medicine formularies received official endorsement.
♦ 1767: Thai traditional medicine and allopathic medicine were separated for the
first time since the introduction of allopathic medicine.
♦ 1782–1809: herbal medicine formularies were inscribed on the wall of the temple
Wat Potharam.
♦ 1824–1851: protocols for diagnosis and treatment were inscribed on the wall of the
temple (205).
♦ Allopathic medicine was reintroduced by missionaries who used quinine to treat

malaria.
♦ 1888: the Siriraj Hospital, which combined both allopathic and traditional
medicine, was established.
♦ 1913: Thai traditional medicine and allopathic medicine were separated for the
second time by the discontinuation of formal education in traditional medicine.
♦ 1929: a law classifying medical practitioners increased the separation between

traditional and allopathic medicine: “Traditional medicine practitioners were
defined as those who practice medicine based on their observations and
experiences that were passed on by word and in traditional textbooks but were not
based on scientific grounds” (204).
♦ 1941: the production and sale of 10 traditional medicine formulas by the

Government dispensary were stopped.
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In the last few decades, particularly following the Alma-Ata Declaration and a World
Health Organization conference on traditional medicine, Thai traditional medicine has
received renewed interest. The National Institute of Thai Traditional Medicine was
established on 24 March 1993 as a division of the Department of Medical Services. The
Institute is charged with facilitating the integration of Thai traditional medicine into
the public health services.
In 1987, an amendment to a royal decree enabled the Ministry of Public Health to

integrate ayurvedic doctors into the medical work force of both State-run hospitals
and private clinics. Ayurvedic doctors and Thai traditional practitioners are allowed to
use some basic allopathic medical tools in their practice, such as the thermometer and
sphygmomanometer, but are not allowed to prescribe allopathic medicines.
The Government is currently working on developing the use of herbal medicines. The
goals of the Eighth Public Health Development Plan 1997–2001 (204) are to increase
the use of allopathic medicine, increase the use of traditional medicine, curb the use of
extravagant medical and pharmaceutical technology, and promote traditional
treatments within the national public health care system. Included in this policy is the
development of research into medicinal herbs, training of traditional medicine
practitioners, and use of medicinal herbs and traditional medicine practitioners in an
official capacity. Specific objectives are as follows:
♦ support and promote Thai traditional medicine in the national health care system
as a means to improve health through self-reliance at the personal, family,
community, and national levels;
♦ upgrade the standard of Thai traditional medicine for acceptance and integration
into the national health system;
♦ support the basis of Thai traditional medicine by developing a comprehensive

system and strategy for its official use, including academic development,
integration of administrative services into the national health care system,
production of medicinal herbs and Thai traditional medicines, dissemination of
information, and promotion of the use of Thai traditional medicine;
♦ support organizations and agencies that deal with Thai traditional medicine in
both the Government and private sectors;
♦ increase the use of medicinal herbs by supporting the production of plants,

developing the pharmacopoeia, and collaborating with traditional medicine
practitioners.
By 1999, Thai traditional medicine was integrated into the facilities of 1120 health
centres. Most of these health centres are health stations at the sub-district level, which
represent more than 75% of health facilities (204).
All types of traditional medicine practitioners are registered with the Medical
Registration of the Ministry of Public Health.
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The first school for Thai traditional medicine was established in 1957 at Wat Po. Since
1962, graduates from such schools have been licensed to practice general traditional
medicine. In December 1997, the Ministry of Health’s National Institute of Thai
Traditional Medicine established the Thai Traditional Medicine Training Centre,
where programmes in pharmacy, Thai traditional healing, Thai traditional massage,
and reflexology are offered. For people who do not have the opportunity to attend a
university, the National Institute of Thai Traditional Medicine, in collaboration with
the Department of Non-Formal Education, offers courses in Thai traditional medicine
at non-formal education centres at the primary and secondary school levels.
An ayurved-vidyalaya college was established in 1982 by the Foundation for the

Promotion of Thai Traditional Medicine, a private organization supported by the
Government. During its three-year programme, students study not only aspects of
Thai traditional medicine, but also basic science and allopathic diagnostics. This later
training is intended to facilitate their ability to communicate with other health care
professionals.
Students of allopathic medicine receive no training in traditional medicine. Act 7 of 30

December 1966, however, enables allopathic physicians, pharmacists, nurses, and
midwives who want to practice Thai traditional medicine to do so. To be eligible to
practice traditional medicine, allopathic practitioners are required to follow a three-
year course of training and instruction with a registered and licensed traditional
medicine practitioner and to pass an examination set by the Commission for the
Control of the Practice of the Art of Healing.
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Western Pacific
195
Western Pacific
Australia
Traditional Chinese medicine has been practised in Australia since the influx of
Chinese migrants to the Australian gold fields in the 19th century. Its popularity is
growing, as reflected by the proliferation of traditional Chinese medicine practitioners,
training courses, and professional associations during the last decade.
Statistics
Approximately one billion Australian dollars are spent on complementary/alternative
medicine each year (206). A 1996 study reported that 48% of the population has used
complementary/alternative medicine at least once. There are approximately 2500
chiropractors practising in Australia (45).
In December 1995, the Victorian Department of Human Services commissioned a

study on the practice of traditional Chinese medicine. The study found that traditional
Chinese medicine accounts for an increasing percentage of total health care services.
There are at least 2.8 million consultations each year, representing an annual turnover
of over 84 million Australian dollars. In 1995, over 1500 primary practitioners reported
their principal health occupation as traditional Chinese medicine. This number was
expected to almost double by the year 2000, with the graduation of over 1100 students
from qualifying programmes for traditional Chinese medicine. There are 23
professional associations representing different segments of traditional Chinese
medicine.
Traditional Chinese medicine is provided to patients of all ages, including infants.

Two out of three patients are female, 50% have a tertiary education, and over 80%
have English as their first language. Although 44% of cases are rheumatological or
neurological in origin, traditional Chinese medicine treats a broad range of
complaints. Over 75% of patients are treated for a recurrent problem of at least three
months’ duration.
Seven Australian territories — Capital Territory, Northern Territory, Territory of
Christmas Island, Territory of the Cogos (Keeling) Islands, Norfolk Island, South
Australia, and Western Australia — grant allopathic physicians an exclusive
monopoly on medical care by prohibiting the practice of medicine by unregistered or
unqualified persons (207). No provisions directly govern the practice of traditional
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Chinese medicine, although practitioners are regulated in part by various state and/or
federal regulations and guidelines.
In New South Wales, Queensland, Tasmania, and Victoria, there is general freedom to
practise medicine or surgery, but it is tempered by a number of restrictions. For
instance, unqualified persons may not recover fees or treat venereal diseases. In
addition, New South Wales makes it an offence to treat cancer (a similar prohibition
exists in Victoria), tuberculosis, poliomyelitis, epilepsy, diabetes, and other specific
diseases.
In Australia, there is a long history of efforts by associations of chiropractors and

osteopaths to obtain statutory recognition for their professions. This is reflected in the
laws regulating chiropractic and osteopathy. In certain Australian states, chiropractors
are specifically exempted from the allopathic physicians’ monopoly to practice
medicine. For instance, the Medical Act 1894–1968 of Western Australia prohibits
persons other than allopathic medical practitioners from practising medicine or
surgery, “provided that this paragraph shall not apply to a person practising as a . . .
chiropractor who gives . . . chiropractic advice or service” (208). Chiropractic and
osteopathy are the subject of specific legislation in South Australia, Capital Territory,
Victoria, and New South Wales (208). In Victoria, chiropractors and osteopaths must
hold an approved degree or diploma in order to be registered by the territorial board.
Although registration is not compulsory, only registered persons and allopathic
medical practitioners are permitted to recover fees or charge for their professional
services.
In 1974, the Australian Parliament set up the Committee of Inquiry into Chiropractic,
Osteopathy, Homeopathy, and Naturopathy. The Committee published an extensive
report in 1977 (209).
In New South Wales, the re-enactment of the Medical Practitioners Act 1938 as the
Medical Practice Act 1992 (210) resulted in several amendments to the 1938 text. The
growing acceptance of traditional medicine was at the root of changes to a number of
prohibitions on the cures and treatments offered of by non-allopathic practitioners.
In 1998, the Therapeutic Goods Act was established with the objective of providing a
national framework for the regulation of therapeutic goods in Australia, particularly
to ensure their quality, safety, efficacy, and timely availability. Most products claiming
therapeutic benefit must be registered with the Australian Register of Therapeutic
Goods before being sold in Australia. The Therapeutic Goods Administration is
responsible for administering the Act (211).
In 2000, the Therapeutic Goods Administration developed the Guidelines for Levels and
Kinds of Evidence to Support Claims for Therapeutic Goods (1). The Complementary
Medicines Evaluation Committee recognizes two types of evidence to support claims on
therapeutic goods: scientific evidence and traditional use. The extent of required
evidence depends on the claims made for the product. For the Committee, traditional
use refers to written or orally recorded evidence that a substance has been used for three
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or more generations for specific health-related or medicinal purposes. Some exceptions
to this requirement are made for homeopathy. The regulations include clauses for the
use of medicines as one component of a multifaceted treatment, the use of treatments
that combine a number of traditions, and the use of treatments that are recent
modifications of traditional therapies. Traditional therapies are considered to include
traditional Chinese medicine, traditional ayurvedic medicine, traditional European
herbal medicine, traditional homeopathic medicine, aromatherapy, and other traditional
medicines.

The number of traditional Chinese medicine programmes offered by universities and
private colleges is growing. Programmes, some of which lead to diplomas, range from
50 hours to over 300 hours. There are also traditional Chinese medicine programmes
available for qualified allopathic practitioners. These range from 50 to 250 hours. The
Royal Melbourne Institute of Technology, the University of Technology at Sydney,
and the Victoria University of Technology have degree programmes in traditional
Chinese medicine. These programmes are offered within the schools of Applied
Science or Health Science.
Acupuncture was first offered as a formal education programme in Sydney in 1969

with the founding of the privately owned school, Acupuncture Colleges, Australia
(212). This programme subsequently formed the basis of the Diploma of Applied
Science (Acupuncture) accredited by the New South Wales Higher Education Board in
1987 and the four-year Bachelor of Applied Science (Acupuncture) accredited by the
New South Wales Higher Education Unit in 1992. Following the same programme, the
Victoria University of Technology began offering a Bachelor of Health Science
(Acupuncture) in 1992. The Royal Melbourne Institute of Technology, the University
of Technology at Sydney, and the Victoria University of Technology also offer
Master’s degrees and graduate diplomas in acupuncture (213).
With growing acceptance of acupuncture by the public and by allopathic practitioners,

graduates are able to play a larger part in the public-health sector of the community,
working in allopathic hospitals, community health centres, and in areas of specialized
health services. The Bachelor of Health Sciences in Acupuncture prepares graduates
for this role in general health care (213).
Training in homeopathy has been from the level of the FHom of London (53). There
are two chiropractic colleges recognized by the World Federation of Chiropractic (81).
Naturopathy, European herbalism, homeopathy, and nutrition are taught at the
Southern Cross University in New South Wales (213).
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Cambodia
The Ministry of Health has established the Centre for Traditional Medicine, which is
limited to basic work in a few botanical medicines and has little input into
pharmaceutical issues. Much of the knowledge available on botanical specimens is
based on their use in neighbouring countries. Shops throughout the country sell
traditional medicines from around the world.
A law on the organization of traditional therapeutics and traditional pharmacopoeia
was enacted in 1964 (214). This law defines traditional therapeutics as treatment and
care using traditional methods, excluding surgical and obstetrical procedures, dental
surgery, and electrical, chemical, or bacteriological methods of therapy and analysis.
To practice, traditional medicine practitioners must be at least 25 years old, have
completed a three-year apprenticeship, and possess a licence issued by the Minister of
Health. Traditional medicine may not be practised on the premises of allopathic health
care establishments (215).
The National Drug Policy (216), developed with technical collaboration from the
World Health Organization, is intended to increase the importance of traditional
medicine and encourage traditional medical practice as a complement to allopathic
medicine. The Policy states that fundamental and applied research on traditional
remedies will be pursued and diseases that can be treated effectively with traditional
medicines will be identified. The Law on the Management of Pharmaceuticals was
adopted on 9 May 1996 (216), replacing relevant existing legislation. Following the
adoption of this law by the National Assembly, a draft decree pertaining to the
manufacture, importation, exportation, and supply of traditional medicines was
submitted by the Ministry of Health to the Council of Ministers.

There is no officially recognized curriculum incorporating the use of traditional
medicines.
China
Over the last century, traditional Chinese medicine has co-existed with allopathic
medicine (217). (See the Introduction for a description of traditional Chinese
medicine.)
Statistics
There are 350 000 staff working at more than 2500 hospitals of traditional medicine in
China. In addition, 95% of general hospitals have units for traditional medicine and 50%
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of rural doctors are able to provide both traditional and allopathic medicine (213). In
1949, there were 276 000 practitioners of traditional medicine in China. The figure
increased to 393 000 in 1965 and 525 000 in 1995. Among these traditional medicine
practitioners are 257 000 traditional medical doctors who graduated from traditional
medical universities with a knowledge of both traditional and allopathic medicine,
10 000 allopathic medical doctors retrained in traditional medicine, 83 000 pharmacists
who are specialists in herbal medicines and who have graduated from traditional
medicine universities, 72 000 assistant traditional medicine doctors, and 55 000
assistant herbal pharmacists trained in traditional medicine secondary schools (219).
In China, traditional medicines account for 30% to 50% of total consumption (218).
There are 800 manufacturers of herbal products, with a total annual output worth
US$ 1800 million. There are over 600 manufacturing bases and 13 000 central farms
specialized in the production of materials for traditional medicines. There are 340 000
farmers who cultivate medicinal plants. The total planting area for medicinal herbs is
348 000 acres (219).
There are 170 research institutions across the country with perhaps the most prestigious
being the Academy of Traditional Medicine in Beijing.
In China, the integration of traditional medicine into the national health care system
and the integrated training of health practitioners are both officially promoted (219).
The Government of China has reinforced its commitment to the integration of
traditional and allopathic medicine on a number of occasions. Adopted in 1982, Article
21 of the Constitution of the People’s Republic of China promotes both allopathic and
traditional Chinese medicine. The Bureau of Traditional Medicine was set up as part of
the Central Health Administration in 1984. In 1986, the State Administration of
Traditional Chinese Medicine was established (4). In 1988, the Central Secretariat of
the Chinese Communist Party stated the following (220):
Traditional Chinese medicine and Western medicine should be given equal

importance. On the one hand, our unique successes in public health and hygiene can
be attributed to traditional Chinese medicine. Hence, traditional medicine should
not be abandoned. Instead, it is to be well preserved and developed further. On the
other hand, traditional Chinese medicine must make full active use of advanced
science and technology to ensure its further development. The policy of integration
of traditional Chinese medicine and Western medicine should persist. Both systems
should cooperate with each other, learning from each other’s merit to make up their
own shortcomings. Both should strive for the full play of their own predominance.
Again in 1997, the Government reiterated that one of its guiding principles in the field
of health care is equality in policies related to traditional and allopathic medicine. The
integrated nature of the Chinese medical system is underscored by the fact that
traditional and allopathic medicine are practised alongside each other at every level of
the health care system (221):
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Western-style and traditional Chinese doctors work together at the [township]
centre according to the policy of integrating the two systems of medicine. Patients
may see either type of doctor.
The 1985 Management Stipulations for Physicians and Assistants of Traditional

Chinese Medicine requires traditional medicine practitioners to learn and make use of
innovations in allopathic medical technology (213).
The criteria for qualification as a traditional Chinese medical physician or assistant are
also set out in the Management Stipulations (222). Qualification as a traditional
medical physician can be achieved through a number of routes, typically combining
post-secondary academic studies and one to two years of practising, teaching, or
researching traditional medicine. By Article 5 of the Stipulations, the academic
component can be undertaken at a university or college devoted to traditional
medicine, within a department of traditional medicine at a school of allopathic
medicine, or by completion of a State-approved diploma or certificate. Under Article 7,
a similar, but less demanding, combination of academic studies and one year of
practical involvement in traditional medicine is typically needed for qualification as a
traditional medicine assistant.
Under a 1985 circular (223) issued by the Chinese Ministry of Public Health’s Depart-
ment of Traditional Chinese Medicine, persons who studied under the former appren-
ticeship system — in place before the 1960s when formal examinations were not
required — may take the formal examinations leading to qualification as a traditional
medical physician or assistant. The examinations follow the completion of courses
administered by private institutions with Government recognition. The courses may be
taken as correspondence courses, night classes, or at workers’ universities. Candidates
who fail these tests, or persons who decide not to take them, must pass a unified
examination offered by the Health Department before their qualifications to practise as
traditional Chinese medicine assistants or physicians will be recognized. For
assistants, the examination is based on information taught at the secondary school
level. There is a more demanding unified exam based on a three-year post-secondary
education for those in the apprenticeship system who wish to convert their existing
status to the level of pharmacist or physician of traditional medicine.
In addition to physicians and assistants, a third tier of health professional exists in

traditional Chinese medicine: individuals examined and officially recognized as
proficient in a particular branch of traditional medicine. However, the absence of a
uniform method of assessment for these practitioners has led to some unqualified
individuals being able to obtain official recognition, according to a 1989 circular issued
by the State Administration of Traditional Chinese Medicine (224). Motivated by a
desire to protect the integrity of traditional medicine and to safeguard patients’
interests, the response of the State Administration has been to introduce annual testing
of practitioners in this third tier. Tests are administered by a group of senior
traditional medicine practitioners. The annual testing involves both a theoretical
component and a clinical examination. Successful completion of the annual testing
leads to a certificate, which details the candidate’s specific skills and the range of
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diseases that can be treated. Failing the annual test results in cancellation of the
candidate’s certificate and right to practise, pending re-examination.
Released in 1988, a series of Provisional Management Stipulations (225) regulates

private health care offered by traditional Chinese medical physicians within the State-
sponsored socialist health-care system. Article 4 of the Stipulations endorses an official
policy favouring preventive care and instructs private-sector physicians to undertake
primary health care as designated by the local health authority. The right to practise
traditional Chinese medicine privately is restricted to those who have passed the
unified examination and technical assessment or who have met the Ministry of Public
Health’s requirements for regulation as a health professional and have practised
medicine in State-owned or collective medical institutions for three years. A licence
must be obtained to open a private practice and the licence holder “shall strictly
observe the approved practice, place, range of service and business limits to the
practice”.
Under 1989 regulations (226), traditional Chinese medical assistants are only
permitted to open their own practice in rural towns, which include county-level
townships and villages. In small towns and cities, they may only serve in private
physicians’ clinics. Under Article 2, persons with a certified proficiency in a particular
branch of traditional Chinese medicine, subject to annual retesting, are only permitted
to open a practice at the local county or district level.
Prompted by a desire to protect patients from abuse and deception, regulations

concerning medical qigong were enacted in China in 1989 (227). Qigong is described in
the preamble to the regulations as “a self-cultivation approach to keep fit through
dredging meridians, adjusting the mind, and balancing yin, yang, qi, and blood to get
rid of diseases”. The regulations provide that practitioners of qigong must obtain
approval from the local health authority to teach qigong in public places. By Article 1,
teaching must be based on scientific approaches. Under Article 2, qigong practitioners
working in medical institutions must possess medical qigong skills and be qualified as
traditional Chinese medical physicians or assistants under the Management
Stipulations described above. According to Article 4, those who intend to treat
patients with emitted qi (energy) must have their methodology and the claimed
curative effect approved by the city health authority. If the curative effect is shown to
be tenable, based on a study of 30 cases of the same type of illness by a designated
medical institution, a licence will be issued. Article 6 prohibits non-medical
institutions, including the army, from rendering medical treatment.

Traditional Chinese medicine used to be taught through apprenticeships (217). Now,
there are 57 secondary schools teaching traditional Chinese medicine, with an
enrolment of 29 000 students. These schools train medical personnel for rural and
basic units. There are also 28 universities and colleges of Chinese traditional medicine
and pharmacology, with a total enrolment of 46 000 students, including 2800
undergraduates. Together, these universities and colleges provide 14 professional
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undergraduate programmes along with programmes for Master’s and Doctorate
degrees (4). A chiropractic college is presently being established (81).
To qualify as a physician of traditional Chinese medicine, a candidate must typically

complete five years of study. Admissions standards to colleges or universities
generally require completion of middle school (seven grades), but there is some
flexibility: in some colleges, a primary school education (four grades) is sufficient
(191).
As mentioned above, medical education is integrated in China (228). Although there

are more allopathic medical schools in China than traditional medical schools, every
allopathic medical school contains a department of traditional medicine and every
traditional medical school contains a department of allopathic medicine. Between 10%
and 20% of the teaching in allopathic medical schools is allocated to traditional medicine
(229). A somewhat greater emphasis is placed on allopathic medicine in colleges of
traditional medicine. The Division of Traditional Medicine in the Ministry of Public
Health suggests orienting 30% of teaching in these schools to allopathic medicine.
Insurance coverage
Health insurance covers both allopathic and traditional medicine (218).
Hong Kong Special Administrative Region of China
Although traditional Chinese medicine is widely used, allopathic medicine has been
the focus of the health care system in the Hong Kong Special Administrative Region of
China (Hong Kong SAR) (230).
Statistics
In a general household survey conducted by the Census and Statistics Department of
the Government of Hong Kong SAR in 1996, it was reported that traditional Chinese
medicine practitioners provide 10.5% of medical consultations. An earlier survey
showed that up to 60% of Hong Kong SAR’s population had used traditional Chinese
medicine either for treatment of disease or maintenance of health. According to the
1996 survey, there are 6890 traditional Chinese medicine practitioners in Hong Kong
SAR, of whom 66% are full-time practitioners. There are 37 chiropractors practising in
Hong Kong SAR (45).
There are approximately 2000 types of Chinese medicinal herbs for sale in Hong Kong
SAR. About 3300 brands of proprietary traditional Chinese medicines are available, of
which 500 brands are manufactured locally. Information provided by the Govern-
ment‘s Census and Statistics Department showed that in 1998, 500 trading
organizations were involved in the import/export, wholesale distribution, and retail
sales of traditional Chinese medicines.
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Until recently, there was no specific legal control or recognition of traditional Chinese
medicine in Hong Kong SAR. Regulations fell under the Public Health and Municipal
Services Ordinance, which controls the sale of drugs unfit for human consumption,
and the Pharmacy and Poisons Ordinance, which prohibits the adulteration of
traditional Chinese medicines with allopathic drugs.
The Basic Law of Hong Kong SAR provides that the Government shall formulate
policies to develop allopathic and traditional Chinese medicine and to improve
medical and health services. In 1989, to promote the proper use and good practice of
traditional Chinese medicine, the Secretary for Health and Welfare set up the Working
Party on Chinese Medicine. The Party was mandated to review the use and practice of
traditional Chinese medicine in Hong Kong SAR. In 1995, the Secretary for Health and
Welfare appointed the Preparatory Committee on Chinese Medicine. In March 1997
and March 1999, the Committee submitted reports on the regulation and development
of traditional Chinese medicine in Hong Kong SAR.
In his 1997 policy address, the Chief Executive of Hong Kong SAR announced that for
the protection of public health, a statutory framework providing legal recognition to
traditional Chinese medicine and appropriate regulation of its practice, use, and trade
would be established. The Chinese Medicine Bill was drawn up in 1998 and was
introduced in the Legislative Council in February 1999.
The Legislative Council passed the Chinese Medicine Ordinance, which is based on
self-regulation, in July 1999. The Chinese Medicine Council — a regulatory body
comprised of traditional Chinese medicine providers, trade professionals, academics,
lay persons, and Government officials — is responsible for implementing the
regulatory measures. The Department of Health will provide administrative support
and enforce the regulations.
A registration system for practitioners of traditional Chinese medicine will be created

in 2000. Likewise, a registration and licensing system to regulate the manufacture and
trade of traditional Chinese medicines will be set up in phases in 2000. The safety,
efficacy, and quality of proprietary traditional Chinese medicines will be assessed
before they are registered. The dispensation, storage, and labelling of traditional
Chinese medicines will also be regulated.

Educational institutions offer refresher courses for providers and dispensers of
traditional Chinese medicine to upgrade their knowledge and skills. Undergraduate
courses in traditional Chinese medicine practice and pharmacy have recently been
introduced at local universities.
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Fiji
In Fiji, both the traditional medicine of the indigenous population and that of Indo-
Fijians who brought with them their own medicinal plants and medicinal plant
knowledge are practised. Rural Fijians are the primary users of traditional medicine,
though its popularity in urban areas is increasing. Traditional medicine practitioners
are often consulted before allopathic medical providers. Many allopathic providers
also practice traditional medicine (231).
Statistics
Founded in 1993, the Women’s Association for Natural Medicinal Therapy, a non-
governmental organization promoting traditional medicine, has begun a survey of
over 2000 practising providers of traditional medicine in 13 of the 14 provinces in Fiji.
In two of these provinces, the surveys have been completed. These surveys and
conversations with local people indicate great faith in allopathic medicine even though
villagers may find traditional medicine to be more effective and cost efficient. The
surveys further suggest that many people, including practitioners of allopathic
medicine, use traditional medicine but hesitate to call it such because traditional
medicine is associated with witchcraft.
Between 60% and 80% of the population use traditional medicine (231). According to
Fiji’s Biodiversity Strategy and Action Plan, the average Fijian household uses US$ 200
worth of medicinal plants annually. If these traditional medicines were replaced by
allopathic medicines, this would amount to a total of US$ 75 million annually.
The Medical and Dental Practitioners Act of 1971 (232) empowers the Minister of Health
to issue regulations governing chiropractic, acupuncture, and chiropody. Such
regulations were issued in 1976 (233).
In 2000, the Cabinet of the Government of Fiji instructed the Minister of Health to
develop a national policy on traditional medicine (231).
In Fiji, the lawful practice of acupuncture is subject to registration by the Permanent

Secretary for Health (233). Applicants for registration must prove either that they are
licensed as acupuncturists in the United Kingdom, Canada, New Zealand, or any of the
states of the United States or that they possess a certificate from the health authorities of
China, the Province of Taiwan, Hong Kong Special Administrative Region of China,
Singapore, or the Philippines to the effect that they have practised acupuncture in any of
those locations for a period of not less than three years.

Most students of traditional medicine receive their training through oral instruction
from established practitioners (231). No great importance is attached to formal
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education in either traditional medicine or complementary/alternative medicine at
universities or medical schools, although some training is done through primary health
care.
The Government and medical associations review the qualifications of practitioners, but
there is no regulatory measure for recognizing the qualifications. Licensing legislation
regulates educational standards for chiropractic (81).
Insurance coverage
Practised outside of the national health care system, traditional medicine is not covered
by insurance.
Japan
In Japan, traditional medicines are classified into two broad groups: kampo medicine
and traditional medicine indigenous to Japan (234). Traditional Chinese medicine,
introduced to Japan between the 3rd and 8th centuries, was modified to meet local
needs and became known as kampo medicine. For about 10 centuries, from the time of
its introduction until it was superseded by allopathic medicine in 1875, kampo
medicine was the mainstream Japanese medicine.
Following the Meiji Restoration in 1886, the newly established Japanese Government
endorsed German allopathic medicine over kampo medicine. After 1885, new doctors
were trained only in allopathic medicine, with the result that kampo medicine almost
disappeared. By 1920, fewer than 100 doctors were practising kampo medicine (235),
but after the Second World War, there was a resurgence of public interest in kampo
medicine and today it is practised extensively.
Acupuncture, moxibustion, Japanese traditional massage/finger pressure, and judo-

therapy are also widely practised in Japan.
Statistics
The 1998 production value of kampo medicines in Japan was 97 708 million yen, or
1.7% of total medicine production. Of this, prescription kampo medicines accounted
for 83.2%; proprietary medicines, for 15.9%; and household distribution, 0.9% (236). A
nationwide survey conducted in October 2000 found that 72% of registered allopathic
doctors currently use kampo medicines in their clinical services (237).
In addition to the 268 611 registered allopathic medical doctors, the number of
registered medical practitioners at the end of 1998 included 69 236 acupuncturists,
67 746 moxacauterists, 94 655 massage practitioners, and 29 087 judotherapists (238).
There were also 125 953 registered pharmacists at the end of 1998 (239).
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Under the Medical Practitioners Law 201 of 1948 (235), only allopathic physicians may
practice medicine, including kampo medicine. However, there are no restrictions on
the types of medical procedures allopathic physicians may use in their practice.
According to the Pharmacists Law 146 of 1960, a person must be qualified as a
pharmacist in order to engage in services related to traditional medicines.
The Subcommittee on Kampo Medicines and Products of Animal and Plant Origin of
the Central Pharmaceutical Affairs Council has developed regulations governing
kampo medicines as proprietary medicines (240). These regulations also apply, with
necessary modifications, to prescription medicines. The Pharmaceutical Affairs Law in
Japan does not distinguish between traditional and allopathic medicines; both types of
preparations are subject to the same regulations.
Kampo medicines are products prepared for use in accordance with kampo medicine
formulae (239), which, according to the principles set out by the Central Pharma-
ceutical Affairs Council, are formulae described in established books on kampo
medicine currently and frequently used in Japan. The formulae include standard
formulae, added or subtracted formulae, and combined formulae. They include
formulae containing vitamins B1, B2, and/or C for nutritional supplementation. The
extracts prepared from kampo medicine formulae should be limited to those that have
previously been used as decoctions. Any ingredient, efficacy, or indication that is not
appropriate for proprietary medicines is not accepted.
Standards for medicinal plant materials are included in Japanese Pharmacopoeia (241),
the Japanese Herbal Medicine Codex (242), and Japanese Standards for Herbal Medicines
(242).
Japanese Pharmacopoeia
First established in 1886 by the Minister of Health and Welfare, and in accor-
dance with Article 41 of the Pharmaceutical Affairs Law 145 of 1960, the Japanese
Pharmacopoeia is an official standard regulating the properties and qualities of
medicines. Some herbal medicines are included in the Japanese Pharmacopoeia. The
14th edition is expected in 2001 (239, 241).
Japanese Herbal Medicine Codex
Standards have been established separately for herbal medicines not included in
the Japanese Pharmacopoeia. Herbal medicines in frequent use, which are not in the
Japanese Pharmacopoeia, are examined according to specific criteria and made
official by inclusion in the Japanese Herbal Medicine Codex (242).
Japanese Standards for Herbal Medicines
Published in 1993, Japanese Standards for Herbal Medicines contains 248 articles: 165
from the Japanese Pharmacopoeia (XII) and 83 from the Japanese Herbal Medicine
Codex. When using substances listed in Japanese Standards for Herbal Medicines as
materials or ingredients of pharmaceutical products to be manufactured in, or
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imported into, Japan, manufacturers and importers should comply with the
provisions in this book (242).
When the Pharmaceutical Affairs Law was amended in April 1993, the Regulations for
Manufacturing Control and Quality Control of Drugs were changed from
manufacturing requirements for drug companies to a prerequisite for licences to
manufacture drugs. The Regulations, including new validation requirements, came
into effect in April 1996. Moreover, good manufacturing practices for investigational
products were adopted via a notice issued by the Director-General of the
Pharmaceutical Affairs Bureau of the Ministry of Health and Welfare in April 1997.
The Japan Pharmacists Education Centre (243) issues a certificate for pharmacists
specializing in kampo medicines and herbal materials in accordance with its own
qualification criteria. Renewal of this certification is required every three years.
In 1990, the Society of Japanese Oriental Medicine (235) started a registration system of
allopathic physicians specializing in kampo medicine. This system requires all
registered specialists to attend authorized meetings of the Society and to present
relevant scientific papers and medical journals at the meetings. This registration
system requires registration as a specialist in kampo medicine to be renewed every
five years, in accordance with the rules set out by the Society.
The Practitioners of Massage, Finger Pressure, Acupuncture and Moxibustion, etc.

Law 217 of 1947 stipulates in Article 1 that anyone other than an allopathic physician
who wishes to practise acupuncture, moxibustion, or massage/finger pressure must
pass the relevant national examination and obtain either a licence in massage/finger
pressure alone or a combination licence in acupuncture, moxibustion, and
massage/finger pressure from the Minister of Health and Welfare.
Article 2 outlines the requirements that must be met in order to take the national
exams: candidates must be eligible to enter a university according to Article 56 of the
School Education Law 26 of 1947; have studied more than three years at a school
recognized by the Minister of Education, Science, and Culture or at a training institu-
tion recognized by the Minister of Health and Welfare; and have obtained the
knowledge and technical skill necessary to be an acupuncturist, moxacauterist, or
massage practitioner, including knowledge of anatomy, physiology, pathology, and
hygiene.
In Article 18.2, an exception to these criteria is made for persons with visual
impairment: persons with visual impairment, as defined by a Ministry of Health and
Welfare ordinance, may take the exams if they are eligible to enter a high school
according to Article 47 of the School Education Law 26 of 1947; have studied at a
school recognized by the Minister of Education, Science, and Culture or at a training
institution recognized by the Minister of Health and Welfare; and have obtained the
knowledge and technical skill necessary to be an acupuncturist, moxacauterist, or
massage practitioner, including at least three years of study in anatomy, physiology,
pathology, and hygiene for certification as a massage practitioner only or five years of
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study in anatomy, physiology, pathology, and hygiene for joint certification as an
acupuncturist, moxacauterist, and massage practitioner.
In 1999, the Japan Society for Acupuncture and Moxibustion (244) began a registration
system for allopathic medical doctors specializing in acupuncture and moxibustion.
The rules for qualification set out by the Society require registration to be renewed
every five years.
Judotherapists are regulated under the Judo Therapists Law 19 of 1970. By Article 3, in
order to become qualified as a judotherapist, a candidate must pass the national
judotherapist examination and obtain a licence from the Minister of Health and Wel-
fare. Under Article 12, candidates must be eligible to enter a university according to
Article 56 of the School Education Law 26 of 1947; have studied more than three years
at a school recognized by the Minister of Education, Science, and Culture or at a
training institution recognized by the Minister of Health and Welfare; and have
obtained the knowledge and technical skill necessary to be a judotherapist, including
knowledge of anatomy, physiology, pathology, and hygiene.

As of 2000, there are 80 medical schools offering six-year allopathic medical
programmes in Japan. Though there is no systematic programme exclusively teaching
kampo medicine, the Toyama Medical and Pharmaceutical University offers a four-
year postgraduate Doctorate programme in kampo medicine as well as the only
officially recognized undergraduate medical curriculum where kampo medicine is
taught alongside allopathic medicine (235).
A 1998 national survey reported that 18 medical schools have either an elective or
required class on complementary/alternative medicine, mainly kampo medicine
and/or acupuncture (245). Beginning in 1998, each year the Japan Society for Oriental
Medicine offers a summer programme in kampo medicine for 60 undergraduate
students of allopathic medical schools (246).
Forty-six colleges and universities across Japan provide four-year undergraduate

programmes in pharmaceutical sciences with traditional medicines as part of the
curriculum, with a new enrolment of 7720 students in these programmes each year
(239). The Research Institute for Natural Medicines (247), established in 1963 as part of
the national Toyama Medical and Pharmaceutical University, is a unique national
research institute in the fields of kampo medicine and pharmaceutical sciences. It
provides undergraduate, two-year Master’s, and four-year Doctorate programmes. In
April 2000, the Japan Pharmacists Education Centre launched a special training course
on kampo medicine and herbal materials in collaboration with the Japanese Society of
Pharmacognosy (243).
Both acupuncturists and moxacauterists must complete a minimum three-year

training programme. Twenty-two schools and training institutions offer three-year
programmes in acupuncture and moxibustion. One university offers a four-year
programme. Eighty-seven schools and training institutions offer joint programmes in
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acupuncture, moxibustion, and Japanese traditional massage/finger pressure. Seven
of these are five-year programmes and 22 are three-year programmes. There are 91
schools and training institutions offering a three-year programme in only Japanese
traditional massage/finger pressure (238). Twenty-five schools and training
institutions offer three-year programmes in judotherapy (238).
For visually impaired persons, 31 schools and training institutions offer three-year
programmes in Japanese traditional massage/finger pressure alone and seven schools
and training institutions offer five-year joint programmes in acupuncture, moxibus-
tion, and Japanese traditional massage/finger pressure (238).
Insurance coverage
As of April 2000, the National Health Insurance Reimbursement List included 147
prescription kampo formulae and 192 herbal materials used in prescription kampo
formulae. Acupuncture, moxibustion, Japanese traditional massage, and judotherapy
are also covered by national health insurance (238).
Kiribati
Kiribati traditional medicine includes bonesetting, herbal medicine, massage, tradi-
tional birth attendance, and word and wind medicine (248). Allopathic medicine was
introduced to Kiribati during the colonial period in the early 1890s. In the 1940s,
traditional medicine was outlawed on the grounds that there was no scientific
evidence as to its efficacy. Despite the prohibition, traditional medicine continued to
be practised (249).
The Medical and Dental Practitioners (Amended) Act of 1981 (250) authorizes some
aspects of traditional medicine in Section 37, which states, “Nothing in the Medical and
Dental Practitioners Ordinance shall affect the right of anyone of Kiribati to practise in a
responsible manner Kiribati traditional healing by means of herbal therapy, bonesetting
and massage, and to demand and recover reasonable charges in respect of such
practice.”
Lao People’s Democratic Republic
The Lao phrase for traditional medicine is ya phurn meung, which translated literally
means “medicine from the foundation of the country”. Lao traditional medicine dates
back to at least the 12th century, when the country was united. With unification,
traditional Buddhist and Indian medical systems were integrated into the society,
quickly influencing traditional Laotian medicine. Allopathic medicine came to the Lao
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People’s Democratic Republic in 1893 when the French invaded the country. Lao
traditional medicine remains an important element in the prevention and treatment of
disease (251).
Statistics
Thirty to forty per cent of both allopathic and traditional medicines are produced
domestically. There are seven factories producing allopathic medicines in Laos. Three
factories in the Vientiane municipality produce traditional medicines. There are
traditional medicine hospitals at all levels (251).
The Lao People’s Democratic Republic has a national programme on traditional
medicine with a five-year work plan.
The third in a series of national seminars on traditional medicine was held in February
1993 to review the use of traditional medicine in primary health care at the provincial
and district levels. A draft national policy on traditional medicine was discussed at a
national workshop on traditional medicine held in December 1995 and thereafter
submitted to the Ministry of Health (252).

In 1996, training courses were held in Sayaboury and Champasack provinces on the
use of traditional medicine in communities (206). The courses were intended to
promote the rational use of traditional medicine.
Malaysia
Traditional medical practices brought by Indian and Chinese traders and migrants
complemented, but did not replace, the indigenous medical system in Malaysia. The
introduction of Islam by Indians and Arabs, on the other hand, led to major changes in
the traditional medical system. Among them was treatment by recitation of verses
from the Koran.
The diversity in medical systems in Malaysia reflects the diverse population of Malay,
Chinese, Indian, and indigenous heritage. In addition to allopathic medicine, the
major systems of medicine practised in Malaysia include ayurveda, siddha, unani,
traditional Chinese medicine, and traditional systems of medicine, such as that
provided by traditional medicine practitioners, spiritualists, bonesetters, traditional
birth attendants, and others who use home remedies. Medical options also include
homeopathy, naturopathy, reflexology, aromatherapy, and chiropractic.
Traditional Malay medical practices can be traced mainly to Indonesia. These medical
practices are especially popular among Malay in rural areas and rely on practical
experience and observation handed down orally and in writing from generation to
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generation. Medical treatment may include reciting incantations over water and
giving it to the patient to drink, administering herbs internally or externally, giving
amulets, and prescribing special baths, with lime flowers or holy water, for example.
More than one of these options may be used and more than one traditional medicine
practitioner may be called upon.
Chinese traditional medicine is believed to have been introduced into Malaysia by

Chinese migrants working in the tin mines. These migrants brought herbal medicines
as well as other forms of treatment, including acupuncture. Chinese medical practi-
tioners hold high status and are known as sinseh. Today, traditional Chinese medicine
is also used in urban centres.
Siddha, ayurveda, and unani — all traditional Indian medical systems — are practised
in Malaysia. The majority of medicines used in these systems are of vegetable, mineral,
and animal origin. Herbal preparations and herbal products are imported from India
as medical tablets, oils, ointments, metals, mineral concoctions, and herbal powders.
Statistics
The 1996 National Health & Morbidity Survey II found that 2.3% of the people
sampled consulted a traditional or complementary/alternative medical practitioner
and 3.8% used both allopathic medicine and traditional Chinese medicine. Although
no statistics are available, traditional medicine is mainly practised by providers of
traditional medicine, whereas allopathic medical providers practise comple-
mentary/alternative medicine as well as allopathic medicine.
In Malaysia, sales of traditional and complementary/alternative medicines are

estimated to be 1000 million Malaysian ringgit annually, compared with a market of
900 million Malaysian ringgit for allopathic pharmaceuticals.
There are 12 chiropractors practising in Malaysia (45).
The official health care system adopted and implemented by the Malaysian
Government is an allopathic one. Subsection 1 of Section 34 of the Medical Act of 1971
contains the following broad general exemption (253):
Subject to the provisions of subsection 2 and regulations made under this Act,
nothing in this Act shall be deemed to affect the right of any person, not being a
person taking or using any name, title, addition or description calculated to induce
any person to believe that he is qualified to practise medicine or surgery according
to modern scientific methods, to practise systems of therapeutics or surgery
according to purely Malay, Chinese, Indian or other native methods, and to demand
and recover reasonable charges in respect of such practice.
Subsection 2 limits the treatment of eye diseases to practitioners of allopathic

medicine. Likewise, the Poisons Ordinance of 1952 restricts the use of certain
substances to practitioners of allopathic medicine.
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The Midwives (Registration) Regulations of 1971 (254) legalize the practice of eligible
traditional birth attendants. Subsection 2 of Section 11 of the Regulations permits
midwifery to be practised by the following:
Any person untrained in the practice of midwifery, who within four years of the
commencement of [the Midwives Act of 1966] satisfies the Registrar that such
person has during a period of two years immediately preceding application for
registration . . . attended to women during childbirth.
There are no other laws affecting traditional medical practice in Malaysia; however,
there are a number of laws that regulate the production and sale of traditional
medicines. These are the Poison Act of 1952, Sale of Drug Act of 1952, Advertisement
and Sale Act of 1956, and the Control of Drugs and Cosmetics Regulations of 1984.
Since 1992, traditional medicine products have been registered (255).
The Drug Control Authority is responsible for product registration, including quality
and safety. Every manufacturer of traditional medicine is required to comply with
good manufacturing practices, and importers are required to comply with good
storage practices. All homeopathic medicines have to be registered with the National
Pharmaceutical and Drug Control Board (53).
In the past, the Government has taken a neutral stand on the practice of traditional
Chinese medicine. However, in recognition of the current and potential contribution
of traditional and complementary/alternative medicine to health care, the
Government is now considering bringing traditional Chinese medicine into the official
health care system (255). The Ministry of Health has set up the Steering Committee on
Complementary Medicine with a multisectoral membership to advise and assist the
Minister in formulating policies and strategies for monitoring the practice of
traditional Chinese medicine in the country.
A national policy is being drafted on traditional Chinese medicine to encourage

established practitioners to form their own self-regulatory bodies. These bodies will
enable a system of official recognition of member-practitioners. To ensure that the
qualifications of practitioners are recognized and can be accredited for formal
registration, the bodies are required to set formal standards, including training, for
their own practices. They are also encouraged to update the skills and knowledge of
their members. The Unit of Traditional Chinese Medicine has been established at the
Primary Health Care Section, Family Health Development Division, Ministry of
Health. It will be responsible for monitoring and facilitating the implementation of the
Ministry’s policies as well as strengthening national and international collaboration.

Recently, the umbrella body for traditional Chinese medicine has issued a Practice
Approval Certificate for practitioners who have taken its courses or courses from a
recognized university. This certificate is needed for a Business License Certificate.
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Homeopathy will be introduced as a discipline at the newly established Faculty of
Biomedicine (53).
Insurance coverage
Neither national healthcare insurance nor private insurance covers traditional Chinese
medicine in Malaysia.
Mongolia
Traditional Mongolian medicine has a known history of more than 2500 years. Rooted
in Tibetan and Indian medicine, traditional Mongolian medicine is part of the broader
cultural heritage of the people and reflects their lifestyle as well as geographic and
climatic conditions.
From the 1930s until the end of the 1980s, traditional medicine was officially ignored.
Socio-economic changes in Mongolia during the 1990s led to the development of the
national culture, including revival of the traditional medical heritage. Traditional
medicine is now more popular and accessible to communities.
Acupuncture and moxibustion have gradually been recognized as clinically effective

in the treatment of disease and in the promotion of health. In 1991, two non-govern-
mental organizations, the Association of Acupuncture and the Association of
Traditional Medicine, were established (256).
Statistics
There is one 100-bed hospital for traditional medicine, 15 small traditional medicine
hospitals with 10 to 20 beds, 19 outpatient clinics for traditional medicine near
Government health centres, and 81 private clinics and units of traditional medicine.
There are also five manufacturing units for traditional medicines (257). Including
those who have taken short-term courses in traditional medicine, there are about 600
— from a total of 5875 — allopathic physicians providing traditional medicine,
acupuncture, and glass-cupping therapy.
The Government of Mongolia considers traditional medicine to be an important health
care resource for the population and is therefore working to incorporate traditional
medical remedies into the official health service (258).
In 1991, the Health Minister issued an order to begin developing traditional medicine
from 1991 to 1995. This led to the establishment of an official structure for traditional
medical care within the overall health system. In 1996, the Ministry of Health and Social
Welfare worked out a development plan for traditional medicine for 1997–2000,
focusing on training new personnel, standardizing training curricula, improving
research, and expanding the manufacture of herbal medicines. A draft policy on the
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development of Mongolian traditional medicine was discussed at the Conference on
National Policy on Traditional Medicine in 1998 and was adopted by the State Great
Khural Parliament on 2 July 1999 (258). This document contains plans for developing
Mongolian traditional medicine over the next 10 to 15 years and covers 19 areas of work,
♦ developing the structure and organization of hospitals of traditional medicine

further;
♦ interrelating the activities of training and re-training of traditional medicine

personnel;
♦ producing safe herbal medicines with naturally extracted herbs, in line with good
manufacturing practices;
♦ providing support to doctors of traditional medicine and to private health

institutions;
♦ exploring possibilities of curing critical diseases with traditional methods;
♦ applying some methods of traditional medicine to ambulance services as well as

primary health care.

Before 1989, there were no formally qualified doctors of traditional medicine. Since
then, 24 to 26 students have been admitted and enrolled each year in the Department
of Traditional Medicine at the national medical university. Many of the teaching
materials, including acupuncture textbooks and facilities, are from neighbouring
countries. In both the three-year programme and the six-year programme, many hours
are allotted to traditional medicine but only a minimal amount of time is set aside for
acupuncture (256).
New Zealand
Statistics
There are 170 chiropractors practising in New Zealand (45).
The Government of New Zealand recognizes homeopathy, osteopathy, and
chiropractic (218). Chiropractic has been regulated by law since 1962, and
chiropractors are permitted to use X-ray equipment (65).

There is one school of chiropractic in New Zealand (45).
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Papua New Guinea
Traditional medicine is widely accepted and practised in rural areas where the
majority of the population lives. The use of traditional plants for curing common
ailments and afflictions in village communities is encouraged by private and non-
governmental organizations on the grounds that it is a sensible option in the face of
the rising costs of allopathic medicine, transport difficulties, and the poor facilities at
aid posts and rural health centres.
Although important for individuals and communities, traditional medicine remains
outside the formal health system. It is expected that a policy in support of the rational
use of traditional medicine will be developed soon and that a role for traditional
medicine will be embodied in the new National Health Plan 2001–2010. Provisions for
the introduction of proven traditional medicines have already been made in the
recently approved National Drug Policy (259).
Philippines
The National Health Care Delivery System in the Philippines is predominantly
allopathic.
Statistics
There are about 250 000 practitioners of traditional medicine in the country.
Approximately five to eight chiropractors are practising in the Philippines (45). There
are no privately owned hospitals providing formal traditional or comple-
mentary/alternative medical services. As of 1999, only a handful of Government
hospitals offered acupuncture services to the general public.
Natural medicines are marketed over the counter in dozens of health food stores and
in a limited number of pharmacies (260).
The Department of Health has developed a national programme on traditional
medicine together with a six-year plan of work. In 1993, a traditional medicine
division was established within the Department of Health to support the integration of
traditional medicine into the national health care system as appropriate, with technical
support from the World Health Organization (261).
The Traditional and Alternative Medicine Act was signed by the President in Decem-
ber 1997. It states that it is the policy of the Government to improve the quality and
delivery of health care services to the Filipino people through the development of
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traditional and complementary/alternative medicine and its integration into the
national health care delivery system. The Act created the Philippine Institute of Tradi-
tional and Complementary/Alternative Health Care (213), which will be established
as an autonomous agency of the Department of Health. The Institute’s mission is to
accelerate the development of traditional and complementary/alternative health care
in the Philippines, provide for a development fund for traditional and complemen-
tary/alternative health care, and support traditional and complementary/alternative
medicine in other ways.
Training in traditional medicine for allopathic practitioners is a priority in the country.

Collaboration on education and research between institutions in the Philippines and
other countries has also been established (213).
In the Philippines, traditional birth attendants may legally work only in areas where
physicians or registered midwives are not available.
The Board of Medicine Resolution 31 of 2 March 1983 (262) recognizes acupuncture as

“a modality of treatment for certain ailments to be practised only by registered
physicians in the Philippines”. The Board is mandated to promulgate rules and
regulations to govern the practice of acupuncture and to evaluate and assess the
annual reports submitted by practitioners “on their experiences and the results of their
clinical treatment of cases” to determine if they may continue to practice legally.

More than 200 Government allopathic physicians have been trained in acupuncture.
Republic of Korea
In the Republic of Korea, the oldest record of traditional medicine, known as oriental
medicine, dates to the Gochosun period, about 4332 years ago. Oriental medicine
flourished until 1894 when the Gab-O Reform abolished the law of oriental medicine,
leading to its decline in favour of allopathic medicine. In 1945, oriental medicine was
revitalised and is very popular today.
Intended to represent oriental medical doctors and foster legal order, the Korean
Oriental Medical Association (KOMA) (263) was organized on 16 December 1952 to
promote health through the development of oriental medical science and by
facilitating cooperation among its members. KOMA has 16 branch offices established
under the National Medical Treatment Law in 1952. These are located in both cities
and provinces.
The establishment of the Korea Institute of Oriental Medicine (264) was initiated on 24
March 1994 by National Act 4758. The Institute opened on 10 October 1994. It employs
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over 30 persons, and in 2000, it had a budget of 5047 million won. Among other
things, the Institute focuses on clinical trials of oriental medicine, research on the
standardization and development of oriental medicines, investigation and analysis of
acupuncture, and research to assist in the development of the oriental medicine
industry. Plans for expanding the Institute are expected to make it a major research
institute for oriental medicine and a worldwide centre for research and study of
traditional and complementary/alternative medicine.
Statistics
There are 107 oriental medical hospitals and 6590 oriental medical clinics. There are
9914 oriental medical doctors (264). Public health doctors of oriental medicine work at
69 provincial Government health centres. Oriental medicine doctors have worked for
the Surgeon General in the army since 1989. There are about 133 acupuncturists, 41
moxibustion practitioners, and 76 acupuncture/moxibustion clinics. Approximately
30 chiropractors are practising in the Republic of Korea (45). The Korean Oriental
Medical Association has about 10 000 members.
According to national medical insurance records, 13 907 000 persons received oriental
medical treatment in 1998. This represents 4.8% of the total number of people
receiving medical treatment.
The Civil Medical Treatment Law, brought into force in 1951, established a dual
system of medical treatment comprised of oriental and allopathic medicine. In 1969,
the Ministry of Public Health and Welfare published a notification permitting
pharmaceutical companies to produce herbal preparations whose formula is described
in the 11 classic books on traditional Korean and Chinese medicine, without first
having to submit clinical or toxicological data (219).
The Medical Affairs Division under the Medical Bureau of the Ministry of Health and
Welfare was in charge of the administrative management of oriental medical
treatment until 1993, when the Oriental Medicine Division was established. In
November 1996, this Division was expanded into the Oriental Medicine Bureau (264),
a major bureau of the Ministry of Health and Welfare, with two of its own divisions.
The Oriental Medicine Bureau works on short-term and long-term policy planning,
research on oriental medical systems, and the administration of oriental medicine. One
project is a programme of cooperation with China involving collaborative scientific
research and the exchange of researchers and research information. Another project,
intended to promote oriental medicine abroad, offers free medical examinations and
treatment by oriental medicine in the World Health Organization Western Pacific
Region Member States. Future plans for the Bureau emphasize the importance of
quality control in manufacturing and distributing oriental medicines, particularly
through licensing. Research will also be carried out to index materials and develop
methods of chemical analysis of oriental medicines.
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In 1993, an advisory council on oriental medical policy was established in the Ministry
of Health and Welfare (264). Oriental medical doctors are allowed to perform medical
acts, including acupuncture and moxibustion. However, they do not have the right to
order X-rays and pathological tests. To get an oriental medical doctor’s licence, one
must graduate from an oriental medical college and pass the national examination for
oriental medical doctors. Under the Medical Treatment Act (265), acupuncture can
only be practised by persons holding a certificate of qualification. The policy of
cultivating acupuncturists was abolished in 1962 and since then only oriental medicine
doctors can practise acupuncture.
Under the Pharmacist Law, which became effective on 1 July 1994, pharmacists must
pass the national oriental medicine exam in order to practise oriental medicine (264).

The education system for oriental medicine in Korea was established in 1964. Oriental
medical studies (263) consist of a preparatory two-year programme and a regular four-
year programme covering the basic subjects of oriental and allopathic medicine. In
1994, there were 3922 students majoring in oriental medical sciences enrolled in six-
year programmes at 11 colleges throughout the country. Every graduate school has a
Master’s and Doctorate programme in oriental medical sciences. In each case there is
an affiliated oriental medicine hospital providing clinical education. In 1996, the
Government approved the establishment of oriental pharmacy departments at several
universities (213).
Insurance coverage
A national medical insurance programme covering oriental medical services has been
in effect since 1 February 1987. Included in the coverage are oriental medical
diagnosis, acupuncture, moxibustion, and 56 kinds of medicines based on herbal
extracts (263). Total medical insurance payments for oriental medicine treatments in
1998 were 315.55 billion won, or 3% of the total medical insurance payments for
medical treatment. Patients treated with unauthorised complementary/alternative
medicine are not covered by the medical insurance scheme.
Samoa
Traditional medical practitioners in Samoa have used medicinal plants and other
forms of non-drug treatment for centuries. This knowledge is typically passed down
within families (266).
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Statistics
The exact number of traditional medicine practitioners in Samoa is unknown, but a
recent survey concerning primary health care workers estimated that there are about
150 full-time practitioners of traditional medicine. Visiting acupuncturists from the
People’s Republic of China have been providing acupuncture treatments in the
country for about 10 years. Approximately 55 000 patients have been treated.
There is no legislation on traditional medicine in Samoa. Although the Medical
Practitioner’s Act states that only registered persons can practise medicine, practi-
tioners of traditional medicine are not considered to be breaking the law. The Health
Sector Reform has included traditional medicine as a sub-component for institutional
strengthening/reform.
Singapore
Singapore’s health services are based on allopathic medicine. However, it is common
practice among the various ethnic groups to consult traditional practitioners for
general ailments. Chinese, Indian, and Malay traditional therapies all have a part in
complementary/alternative health care in Singapore.
Statistics
About 45% of the population have consulted traditional medicine providers.
Traditional Chinese medicine is the most prominent traditional therapy, both in terms
of the number of its practitioners and patients and in its far-reaching appeal (213). A
list published by the local traditional Chinese medicine community in 1997 reported
1807 practitioners of traditional Chinese medicine in Singapore, most of whom were
more than 40 years old. Half of them practised traditional Chinese medicine on a full-
time basis, one-third practised part-time, and the remainder were not practising at the
time of the listing (267). Approximately 10 chiropractors practise in Singapore (45).
Traditional Chinese medical practice is restricted to outpatient services in Singapore.

About 10 000 persons visit traditional Chinese medicine clinics each day, compared to
74 000 persons who visit allopathic clinics.
The health authorities recognize the importance of traditional medicine in the provi-
sion of health care and have initiated efforts to promote and ensure the safe practice of
traditional medicine. A traditional medicine unit was set up in the Ministry of Health
in November 1995 (268).
Act 34, the Traditional Chinese Medicine Practitioners Act of 2000, was passed by
Parliament on 14 November 2000 and assented to by the President on 2 December
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2000. The Act provides for the establishment of the Traditional Chinese Medicine
Practitioner Board to approve or reject applications for registration and to accredit
courses in the practice of traditional Chinese medicine, among other things. This
accreditation is intended to facilitate registration. The Register of Traditional Chinese
Medicine Practitioners shall be kept by the Registrar appointed by the Board. A
registered practitioner who desires to obtain a certificate to practice must make an
application to the Board. Unlawful engagement in prescribed practices of traditional
Chinese medicine is punishable by a fine, imprisonment, or both.
Under the power conferred by the Traditional Chinese Medicine Practitioners Act of
2000, the Minister for Health issued the Traditional Chinese Medicine Practitioners
(Registration of Acupuncturists) Regulations of 2001, which came into effect 23
February 2001. The Traditional Chinese Medicine Practitioners Board, with the
approval of the Minister for Health, issued the Traditional Chinese Medicine
Practitioners (Register and Practising Certificates) Regulations of 2001, which came
into effect on 18 April 2001.

Schools of traditional Chinese medicine have made valuable contributions to the
training of traditional Chinese medicine practitioners in the past. Singapore has
adopted a standardized six-year part-time training programme in traditional Chinese
medicine. National examinations for both acupuncture and traditional Chinese
medicine will soon be required for practitioners (268).
Solomon Islands
There is very little documentation on traditional medicine in the Solomon Islands.
Traditional medicine practitioners regard the medicines they use as their personal
property and conduct their practices under very strict confidence. Many of the natural
materials used to make the traditional medicines can only be collected at specific times
(269).
In 1979, the Government officially recognized and accepted the use of traditional
medicine as a supplement to allopathic medicine in rural communities where the
availability of allopathic drugs is limited. The policy states that traditional medical
practice is not to be institutionalized but, rather, is to remain largely in the hands of
individual practitioners.
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Vanuatu
In Vanuatu, under the Health Practitioners Act of 1984 (270), amended in 1985 (271),
osteopathy and chiropractic are designated as ancillary allopathic medical professions
subject to registration. By Section 5 of the Act, a person is eligible to be registered if, in
the opinion of the Health Practitioners Board, he or she has sufficient training, skill,
and practical experience. At its discretion, the Board can require applicants who do
not meet these criteria to complete a recognized training course. Section 18 makes it an
offence for a non-registered person to practise medicine or claim to be registered to
practise medicine.
Viet Nam
In Viet Nam, traditional medicine can be divided into two categories: Vietnamese
traditional medicine, which is influenced by Chinese traditional medicine, and oriental
medicine. In the countryside and in remote and mountainous areas, Vietnamese
traditional medicine is more commonly used. In the delta, lowlands, and cities,
patients more commonly use a combination of Vietnamese traditional medicine and
oriental medicine.
Both Vietnamese traditional medicine and oriental medicine form an integral part of
the national health care system in Viet Nam and have an important role in promoting
the health of the Vietnamese people, particularly in difficult cases, geriatric diseases,
and primary health care at the commune level. Allopathic doctors who have
graduated from medical universities and who have been trained in traditional medi-
cine have become some of the most outspoken supporters of traditional medicine.
They are actively engaged in promoting the rational use of traditional medicine in
their institutes and hospitals (272).
Statistics
According to Ministry of Health statistics, about 30% of patients receive treatment
with traditional medicine. Treatment is provided by traditional medicine practitioners
(who have not received any formal education) and by traditional medical doctors
(who have graduated from a department of traditional medicine at one of the medical
universities in Hanoi, Ho Chi Minh City, or Haiphong). There are about 1000
traditional medicine practitioners, 5000 traditional medical doctors, 2000 assistant
traditional medical doctors, and 209 traditional medicine pharmacists (272).
Additionally, there are approximately 8000 private practitioners of traditional
medicine. Of this number, about 1400 are acupuncturists.
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The Viet Nam Association of Traditional Medicine Practitioners has 24 000 members.
Of this number, 461 work in public hospitals. The Viet Nam National Association of
Acupuncture has 18 000 members, 4500 of whom work in public hospitals (272).
A Traditional Medicine Hospital of the Ministry of Interior Affairs was inaugurated at

the end of 1996 (273). Additionally, there are 286 departments of traditional medicine
in general hospitals, 45 provincial hospitals of traditional medicine, and four institutes
of traditional medicine in Viet Nam (274). There are three medical colleges that have a
faculty of traditional medicine, two pharmaceutical colleges, two secondary schools of
traditional medicine, two State pharmaceutical companies, two State pharmaceutical
manufacturers of herbal medicine, and three national research institutes for traditional
medicine (219).
An Army Institute of Traditional Medicine was established in 1978, with a staff of 100
doctors and pharmacists. The tasks of the Institute include clinical work, research,
training, and the manufacture of herbal products. It serves about 20 000 outpatients
and 2500 inpatients each year.
The Viet Nam Acupuncture Institute operates under the authority of the Ministry of
Health. The Institute is responsible for giving nationwide guidance on acupuncture
and other medical therapies that reduce or avoid the use of drugs in treatment. It has
350 beds and serves approximately 2500 inpatients and 8500 outpatients each year.
The Government supports public-sector facilities for traditional medicine and encour-
ages people to mobilize resources for the development of traditional medicine,
especially for primary health care. Government programmes include training health
workers at the community level in using traditional medical methods to treat common
and recently defined diseases and encouraging people to plant medicinal vegetables,
ornamental plants, and fruit trees. These three groups of plants are intended for use in
treating common diseases in the community as well as improving family incomes.
This model has become a countrywide programme.
A number of official documents indicate clear support for traditional medicine. There
is official recognition for a number of traditional therapies, including medications
made from plants and animals, massage, acupuncture, acupressure, moxibustion, vital
preservation, cupping, and thread embedding.
Article 39 of the Constitution of the Socialist Republic of Viet Nam outlines State
undertakings to develop and integrate allopathic and traditional medical and
pharmaceutical practices as well as to develop and integrate official health care,
traditional medicine, and private medical care. More detailed provisions on traditional
medicine can be found in a 1989 public health law (275) and 1991 regulations made
under it (276).
Among the objectives of health care, Section 2 of the 1989 law lists the development of
official Vietnamese medicine on the basis of traditional medicine and pharmacy and the
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integration of allopathic and traditional medicine. The promotion of these objectives is
the shared responsibility of the Ministry of Health, the Vietnamese Traditional Medicine
Association, and the Viet Nam General Union of Medicine and Pharmacy. Under
Section 34.1, these organizations are additionally charged with ensuring conditions for
the operation of all major hospitals and institutes of traditional medicine. Section 34.2
provides that the medical services and the people’s committees at all levels are to
consolidate and broaden the health-care network using traditional medicine. Section 35
permits licensed traditional medicine practitioners to practise in any State, collective, or
private health care institution. This includes acupuncturists who have been trained, who
have attended courses in traditional medicine, or whose knowledge of traditional
medicine was passed down to them through their family. Traditional medicine
practitioners may examine and treat patients as well as offer preventive advice.
However, before new treatment methods can be used, they must be approved by the
Ministry of Health or provincial health office and the Traditional Medicine Association.
Superstitious practice is forbidden by Section 36. Private practice of traditional medicine
is subject to management by the Government and the Ministry of Health.
The 1991 regulations specify required qualifications for traditional medicine practi-
tioners as well as the permitted range of procedures practitioners may use. A breach of
any of these rules that results in serious harm to life or health of another person is
punishable under the Criminal Code by imprisonment (277).
The 1993 Vietnamese Ordinance on Private Medical and Pharmaceutical Practice (278)
includes detailed provisions on the private practice of traditional medicine. The
Ordinance permits certified practitioners of traditional medicine to privately practise the
range of activities for which they are certified, provided they have a permit to do so and
subject to State overview. Article 5 lists permitted activities as including practice in a
traditional medical hospital or clinic and providing traditional forms of treatment such
as acupuncture, massage, acupressure, and herbal saunas. Article 7 requires traditional
practitioners to hold a diploma of Doctor of Medicine or Assistant Doctor Specialising in
Traditional Medicine and to have practised traditional medicine for a minimum period
that varies between two and five years.
A number of measures are included in the Ordinance to further safeguard patients’

interests. Under Article 17, practitioners must put up a name board that sets out the
activities they are permitted to practice. Private practitioners must obtain the permission
of the Ministry of Health to use novel treatment techniques or drugs. Superstitious
practices are not permitted according to Article 19. Private practice without a certificate
or practice that exceeds the range of permitted activities is subject to administrative,
disciplinary, or criminal sanctions under Article 34.
The Government entrusts the health service system with issuing licences to traditional
practitioners through an assessing committee. Anyone who has 13 certificates issued
by an assessing committee and the Ministry of Health can privately practise
traditional medicine. In the area of acupuncture, the regulatory qualifications of
practitioners include Professor, Associate Professor, PhD, Acupuncture Speciality
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Doctor Level I, Acupuncture Speciality Doctor Level II, and Acupuncture-Oriented
Doctor.
The Ministry of Health advocates socialization and diversification of traditional

medicine.

There is no college or university of traditional medicine in Viet Nam. Although Hanoi
Medical University has a department of traditional medicine, it does not meet the
needs of developing traditional medicine in Viet Nam. Two secondary schools are the
main seats of learning in traditional medicine. There is strong support for a facility of
higher education in traditional medicine, and the Government is planning to create a
university of traditional medicine to provide programmes for secondary,
undergraduate, and postgraduate study (278, 279).
Insurance coverage
Health insurance covers costs for both allopathic and traditional medicine (218);
however, this is not on an equal basis in all areas because of differential access to care.
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References
225
References
1. General guidelines for methodologies on research and evaluation of traditional medicine. Geneva, World
Health Organization, 2000 (unpublished document WHO/EDM/TRM/2000.1; available on
request from Traditional Medicine, Department of Essential Drugs and Medicines Policy, World
Health Organization, 1211 Geneva 27, Switzerland).
2. Annual report 1998–1999. Ministry of Health and Family Welfare, Government of India.
3. La médecine Chinoise. Paris, Encyclopédie Hachette, 2001.
4. Liu B. The national government policy and efforts on promoting traditional medicine in China. In:
Traditional medicine, its contribution to human health development in the new century: report of an
international symposium, Kobe, Japan, 6 November 1999. Kobe, Japan, World Health Organization
Centre for Health Development, 2000 (unpublished document; available on request from the
WHO Centre for Health Development, I.H.D. Centre Building, 9th Floor, 1-5-1 Wakinohama-
Kaigandori, Chuo-ku Kobe 651-0073, Japan).
5. Unani medicine in India. New Delhi, Central Council for Research in Unani Medicine, Ministry of
Health and Family Welfare, Government of India, 1997.
6. Analysis of questionnaire on traditional medicine. Geneva, World Health Organization, 1992
(unpublished document WHO DOC. 5183A/REV. DOC. 6136A).
7. Massougbodji MA, Tevoedjre A. Communication with WHO. Cotonou, Ministère de la Santé, de
la Protection Sociale, et de la Condition Féminine and Ministère du Plan, de la Restructuration
Economique, et de la Promotion de l’Emploi, République du Bénin, 27 October 1997.
8. Epa K. Communication with WHO. WHO Representative, Benin, 10 November 1997.
9. Plan d’action 1998–1999. Cotonou, République du Bénin, 1997.
10. Staugard F. Traditional medicine in a transitional society: Botswana moving towards the year
2000. Gaborone, Ipelegeng Publishers, 1989.
11. Haram L. Tswana medicine in interaction with biomedicine. Social science and medicine, 1991,
33:167–175.
12. The Medical, Dental, and Pharmacy (Amendment) Act, 1987. International digest of health legislation,
1989, 40:819.
13. Upper Volta, Public Health Code, Part II, Tilte IV: Traditional medicine. International digest of health
legislation, 1973, 24:649.
14. Burkina Faso. Law No. 23/94/ADP of 19 May 1994 promulgating the Public Health Code. Interna-
tional digest of health legislation, 1995, 46:449–454.
15. Decree-Law no. 1/16 of 17 May 1982. International digest of health legislation, 1984, 35:1.
16. Fifth five-year social, economic, and political development plan (1981–1986). Yaounde, Department of
Planning, Ministry of Economic Affairs and Planning, Republic of Cameroon, 1981.
17. Lantum DN. Traditional medicine-men of Cameroon, the case of Bui division: a socio-demographic and
epidemiological profile. Yaounde, Yaounde Public Health Unit, University Centre for Health Sciences
(UCHS/CUSS), University of Yaounde, 1985.
18. Decree of 19 March 1952. Bulletin officiel du Congo Belge, 15 May 1952, Part L: 882–890.
19. Codes et lois du Congo Belge, 1952, 3:616.
20. Traditional medicine in Zaire: present and potential contribution to the health services. Ottawa,
International Development Research Centre, 1980.
21. Bishaw M. Promoting traditional medicine in Ethiopia: a brief historical review of government
policy. Social science and medicine, 1991, 33:193–200.
22. Serto Ader, Yekatit 13:1978 EC (20 February 1986). Ethiopia.
175
226
23. A study regarding the future development of traditional medicine. Addis Ababa, Ministry of Health,
Ethiopia, 1984/1985.
24. Ten-year perspective plan. Addis Ababa, Provisional Military Government of Socialist Ethiopia,
1983/1984.
25. Mensah EN. Traditional medicine in Ghana: situation, policies, development and challenges of the
21st century. Presented at the International Congress on Traditional Medicine, Beijing, China, 22–24
April 2000.
26. Oppong-Boachie K. Strategy for traditional medicine for the African region: the experience of
Ghana. Presented at the WHO consultative meeting on strategy for traditional medicine for the
African region 2001–2010, Harare, Zimbabwe, 13–15 December 1999.
27. Commodore SGO. Welcome address. Presented at Traditional medicine and modern health care:
partnership for the future, a two-day national consensus-building symposium on the policies on
traditional medicine in Ghana, 15–16 March 1995.
28. Mensah MLK, Sarpong K. Training of the traditional medicine practitioners and the preservation
of our medical heritage: options and challenges. Presented at Traditional medicine and modern
health care: partnership for the future, a two-day national consensus-building symposium on the
policies on traditional medicine in Ghana, 15–16 March 1995.
29. Sanders AJGM. Towards the legalisation of African folk therapy. Medicine and the law, 1989, 7:523–
528.
30. Le Grand A, Wondergem P. Herbal medicine and health promotion: a comparative study of herbal
drugs in primary health care. Amsterdam, Royal Tropical Institute, 1990.
31. Bodeker G. Planning for cost-effective traditional health services. In: Traditional medicine, better
science, policy and services for health development: proceedings of a WHO international symposium, Awaji
Island, Hyogo Prefecture, Japan, 11–13 September 2000. WHO Centre for Health Development, Kobe,
2001 (unpublished document; available on request from the WHO Centre for Health
Development, I.H.D. Centre Building, 9th Floor, 1-5-1 Wakinohama-Kaigandori, Chuo-ku Kobe
651-0073, Japan).
32. Ordinance no. 189 PRG of 18 September 1984 on the practice of the medical profession, Sections 1
and 2. International digest of health legislation, 1985, 36:21.
33. Nyamwaya D. African indigenous medicine: an anthropological perspective for policy makers and primary
care managers. Nairobi, African Medical and Research Foundation, 1992.
34. Development plan, 1989–1993. Kenya.
35. Lesotho. Practice of traditional medicine. International digest of health legislation, 1978, 29:160–161.
36. Lesotho. An Act (No. 17 of 1978) to provide for the establishment of a Medicinemen and
Herbalists Council to promote and control the activities of medicinemen and herbalists
association. International digest of health legislation, 1981, 32:402.
37. Malawi. An act (No. 17 of 1987) to provide for the establishment of the Medical Council of Malawi,
the registration and disciplining of medical practitioners and dentists, the licensing of private
practice of medical practitioners and dentists, the regulation of training within Malawi of medical
personnel and generally for the control and regulation of the medical profession and practice in
Malawi and for matters incidental to or connected therewith. International digest of health legislation,
1988, 39:613–616.
38. Koumare M. La médecine traditionnelle au Mali. Bamako, Institut National de Recherches sur la
Pharmacopée et La Médecine Traditionelle, 1980.
39. Sall B. La médecine traditionelle en République du Mali. Revue juridique et politique, indépendance et
coopération, 1981, 35:117.
40. Decision no. 1831 of 9 December 1981. International digest of health legislation, 1983, 34:122.
41. Ordinance no. 83–136 of 6 June 1983. International digest of health legislation, 1983, 34:369.
42. Mauritius. An Act to provide for the practice and control of Ayurvedic and other traditional
systems of therapeutics in Mauritius. International digest of health legislation, 1991, 42:424–426.
43. Clarke E. Traditional medicine in Mozambique. Health systems trust update, October 1998, 37:11.
44. Information provided to WHO by the Ministry of Health and Social Services, Namibia, February
2000.
45. Communication with WHO. Chandler, Arizona, World Chiropractic Alliance, January 2001.
176
References
227
46. Allied Health Service Professions Act, 1993. Act no. 20, 1993. Government Gazette, 2 September
1993, 2:710. Namibia.
47. Ousseini H. Communication with WHO. Chief Physician of the Niamey Hospital, Republic of
Niger, 25 August 1982.
48. Order no. 32/MSP/AS/CF of 31 March 1989 establishing the Committee for Studies on
Traditional Medicine and Traditional Pharmacopoeia. International digest of health legislation, 1990,
41:308.
49. Sule S. Communication with WHO. National Traditional Medicine Development Programme,
Federal Ministry of Health, Nigeria, 11 May 2000.
50. Ajai O. The integration of traditional medicine into the Nigerian health care delivery system: legal
implications and complications. Medicine and the law, 1990, 8:308.
51. The Medical Rehabilitation Therapists (Registration, etc.) Decree 1988. International digest of health
52. The National Primary Health Care Development Agency Decree 1992. International digest of health
53. Liga Medicorum Homeopathica Internationalis, ed. World homeopathy 1998. Selva, Spain, Liga
medicorum homeopathica internationalis, 1998.
54. Baldé S, Sterck C. Traditional healers in Casamance, Senegal. World health forum, 1994, 15:390–392.
55. Floyd VD. Communication with WHO. PROMETRA (Promotion des Médecines Traditionnelles),
Dakar, Republic of Senegal, 21 July 1997.
56. Sierra Leone. Registration of physicians and dentists. International digest of health legislation, 1969,
20:133.
57. Sierra Leone. A Decree (N. P. R. C. Decree No. 12 of 1994) to establish the Medical and Dental
Council, to provide for the registration of medical practitioners and dental surgeons and for other
related matters. International digest of health legislation, 1994, 45:462–463.
58. Mayeng I. Integrating traditional medicine into national health care systems, is it an attainable
objective? Presented at the WHO consultative meeting on strategy for traditional medicine for the
African region 2001–2010, Harare, Zimbabwe, 13–15 December 1999.
59. Clarke E. The collaboration between traditional healers and the department of health. Health
systems trust update, October 1998, 37:5.
60. Hess S. Traditional healers in SA. Health systems trust update, October 1998, 37:6–7.
61. Associated Health Service Professions Act, no. 63 of 1982, as amended by the Associated Health Ser-
vice Professions Amendment Act, no. 108 of 1985 and the Associated Health Service Professions
Amendment Act, no. 10 of 1990. South Africa.
62. Regulatory situation of herbal medicines: a worldwide review. Geneva, World Health Organization,
1998 (unpublished document WHO/TRM/98.1; available on request from Traditional Medicine,
Department of Essential Drugs and Medicines Policy, World Health Organization, 1211 Geneva
27, Switzerland).
63. Felhaber T, Gericke N. TRAMED final narrative report: 1 June 1994–30 April 1996. Traditional
Medicine Programme, University of Capetown, South Africa, 1996 (unpublished document).
64. Gray A. The registration of traditional medicines: a new medicines bill. Health systems trust update,
October 1998, 37:9–10.
65. Communication with WHO. Chandler, Arizona, World Chiropractic Alliance, July 2000.
66. Swaziland. Practice of medicine, dentistry, allied health professions, and traditional medicine.
International digest of health legislation, 1978, 29:818.
67. Law no. 80–1 of 13 August 1980 embodying the criminal code. Journal officiel de la République
Togolaise, 13 August 1980, Special Issue:1. Togo.
68. Clarke E. Traditional medicine in Uganda. Health systems trust update, October 1998, 37:12.
69. Amooti-Kyomya S. Traditional health systems and the conventional system in Uganda. In: Islam
A, Wiltshire R, eds. Traditional health systems and public policy. Ottawa, International Development
Research Centre, 1994.
70. Mhame P. Development of national policy on traditional medicine and strategies for integrating
traditional medicine into health systems. Presented at the WHO consultative meeting on strategy
177
228
for traditional medicine for the African region 2001–2010, Harare, Zimbabwe, 13–15 December
1999.
71. Tanzania laws. Chapter 409, Section 37 and Chapter 416, Section 53. Tanzania.
72. Swantz L. The medicine man among the Zamaro of Dar es Salaam. Uppsala, The Scandinavian Institute
of African Studies in cooperation with Dar es Salaam University Press, 1990.
73. The national traditional and birth attendants implementation policy. Dar es Salaam, Ministry of Health,
United Republic of Tanzania, 1999.
74. Mudondo CM. The role of traditional medicine in the health system: Zambian situation. Presented
at the African forum on the role of traditional medicine in health systems, Harare, Zimbabwe, 16–
18 February 2000.
75. Matondo IN. Traditional medicine in Zimbabwe. Presented at the International congress on
traditional medicine, Beijing, China, 22–24 April 2000.
76. Cavender T. The professionalisation of traditional medicine in Zimbabwe. Human organization,
1988, 47:251–254.
77. Ushewokunze H. An agenda for Zimbabwe. Harare, Zimbabwe, College Press, 1984.
78. Zimbabwe. An Act (No. 31 of 1981) to establish a Natural Therapists Council of Zimbabwe; to
provide for the registration and regulation of the practice of homoeopaths, naturopaths and
osteopaths in Zimbabwe, and to provide for matters incidental to or connected with the foregoing.
International digest of health legislation, 1982, 33:10–12.
79. Zimbabwe. An Act (No. 38 of 1981) to establish a Traditional Medical Practitioners Council; to
provide for the registration and regulation of the practice of traditional medical practitioners; and
to provide for matters incidental to or connected with the foregoing. International digest of health
legislation, 1982, 33:12–14.
80. Chavundka G. ZINATHA: the organization of traditional medicine in Zimbabwe. In: Last M,
Chavundka G, eds. The professionalisation of African medicine. Manchester, Manchester University
Press, 1986.
81. The chiropractic profession: first draft of technical information on the chiropractic profession. Prepared for
the World Health Organization by the World Federation of Chiropractic, 15 January 1999
(unpublished document).
82. Report of the working group of OPS/OMS on traditional, complementary and alternative medicines and
therapies, Washington DC, 15–16 November 1999. Washington DC, Pan American Health
Organization/World Health Organization, 1999.
83. Traditional health systems in Latin America and the Caribbean: baseline information. Washington DC,
Pan American Health Organization/World Health Organization, July 2000 (Technical report of a
project funded by the National Institutes of Health, USA).
84. Alvarez W. Country presentation. Presented at the WHO workshop on traditional and indigenous
medicine in the Americas, Guatemala City, Guatemala, 18–23 March 2001.
85. VI. Family health. Bolivia. Regulation on the conduct of family health activities in Bolivia.
86. Liga Medicorum Homeopathica Internationalis, ed. World homeopathy, 2000. Selva, Spain, Liga
Medicorum Homeopathica Internationalis, 2000.
87. History of the Chinese Medicine and Acupuncture Association of Canada. In: Progress report 1983–
1998. London, Canada, The Chinese Medicine and Acupuncture Association of Canada, 1998.
88. Gray C. Growing popularity of complementary medicine leads to national organization for MDs.
Canadian medical association journal, 1997, 157:186–188.
89. Millar WJ. Use of alternative health care practitioners by Canadians. Canadian journal of public
health, 1997, 88:154–158.
90. Popularity of alternative medicine still growing in the US, Canada, poll finds. Alternative therapies,
1998, 4:29.
91. Natural health products: a new vision. Ottawa, Library of Parliament, 1998.
92. Perspectives on complementary and alternative health care: a collection of papers prepared for Health
Canada. Ottawa, Health Canada, 2001.
93. Natural health products: recent chronology. Ottawa, Health Canada, March 1999.
178
References
229
94. Blais RB, Maiga A, Aboubacar A. How different are users and non-users of alternative medicine?
Canadian journal of public health, 1997, 88:159–162.
95. Workbook, ONHP consultation 2000. Available online at http://www.hc-sc.gc.ca/hpb/onhp
96. Proposed regulatory framework for natural health products. Ottawa, Health Canada, March 2001.
97. Rock A. Presentation by the Health Minister of Canada to the House of Commons Standing
Committee on Health. Reproduced in The Chinese Medicine and Acupuncture Association of Canada,
1998, 6:21.
98. Canada (Yukon Territory). The Health Act. International digest of health legislation, 1993, 44:1–5.
99. Regulated Health Professions Act, 1991, Sections 27 and 35. International digest of health legislation,
1993, 44:204.
100. For the relevant laws of the Canadian provinces, see
Alberta: International digest of health legislation, 1967, 18:275–276 and 1969, 20:195.
British Columbia: International digest of health legislation, 1961, 12:718 and 1969, 20:198.
New Brunswick: International digest of health legislation, 1960, 11:88.
Newfoundland and Labrador: The Chiropractors Act, 1992.
Nova Scotia: International digest of health legislation, 1973, 24:67.
Ontario: Regulated Health Professions Act, 1991, Statutes of Ontario, c.18 and The Chiropractic Act,
1991, c.21.
Prince Edward Island: International digest of health legislation, 1969, 20:422–423.
Quebec: International digest of health legislation, 1975, 26:327–328.
Saskatchewan: Osteopathic Practice Act, c.0-7.
101. Statutes of Ontario, 1991. Ontario, Canada.
102. Chiropractic Profession Act, RSA 1980, c-9.1. Ottawa, Canada.
103. Chiropractic Profession Amendment Regulation (Alberta), Alta. Reg. 82/94, at Section 10.1. The
Alberta gazette, 1994, 90:264.
104. Canada (Saskatchewan). An Act (Chapter C-10.1) respecting chiropractors. International digest of
health legislation, 1997, 48:3–4.
105. Wigod R. Legalize, regulate acupuncture, Health Professions Council says. The Vancouver sun, 26
November 1993:B7.
106. Cheung CK. President’s address. The Chinese Medicine and Acupuncture Association of Canada,
1998, 6:12.
107. Health Disciplines Act (Alberta), Chap. H-3.5, R.S.A., as amended, 1980. Alberta, Canada.
108. Medical Act, 1973, Chapter M-9, as amended. Quebec, Canada.
109. Regulations respecting the practice of acupuncture by persons other than physicians. International
digest of health legislation, 1993, 44:208.
110. Guidelines for the practice of acupuncture in the Province of Saskatchewan. (Undated). Regina, Canada.
111. Directive issuing acupuncture guidelines. Whitehorse, Yukon Territory, Yukon Medical Council, 6
May 1986.
112. For the relevant laws of the Canadian provinces, see the following:
Alberta: Naturopathy Act (Alberta), R.S.A. 1980 c.N-6.
Manitoba: Naturopathic Act (Manitoba), L.R.M. 1987, c.N-80.
Saskatchewan: Naturopathy Act (Saskatchewan), c. N-4.
113. Chiropractic Profession Act (Alberta) c. 91, 1984. Alberta, Canada.
114. Ruedy J. Paper on medical schools’ approach to the demand for AM/CM at the alternative and
complementary medicine conference. Toronto, Institute for International Research, March 1998.
115. The Alberta Health Care Insurance Act. International digest of health legislation, 1993, 44:581.
116. Chapman-Smith D. The chiropractic profession. The chiropractic report, 1993, 7:2.
117. Alberta health bulletin, 26 January 1994, 4:1.
118. Ibacache J, Quidel J, Saez M. Country presentation. Presented at the WHO workshop on
traditional and indigenous medicine in the Americas, Guatemala City, Guatemala, 18–23 March
2001.
119. Medina CE. Medicina tradicional en los sistemas locales de salud, informe de Chile. Santiago, Unidad de
Medicina Tradicional y Otras Prácticas Médicas Alternativas, Ministerio de Salud de Chile, 1994.
179
230
120. Velimirovic B, Velimirovic H. The utilization of traditional medicine and its practitioners in health
services: a global overview. In: Velimirovic B, ed. Modern medicine and medical anthropology in the
United States/Mexico border population. Washington DC, Pan American Health Organization, 1978
(Scientific Publication, No. 359).
121. Martinez S. Encuentro regional sobre aspectos regulatorios de productos a base de hierbas.
Presented at the Regional meeting on regulatory aspects of herbal products, Kingston, Jamaica,
13–16 November 2000.
122. Padron L. Country presentation. Presented at the WHO workshop on traditional and indigenous
medicine in the Americas, Guatemala City, Guatemala, 18–23 March 2001.
123. Cuba’s health care system. In: Djukanovic V, Mach EP, eds. Alternative approaches to meeting basic
health needs in developing countries, a joint UNICEF/WHO study. Geneva, World Health
Organization, 1975.
124. Law no. 41 of 13 July 1983 on public health. International digest of health legislation, 1985, 36:13.
125. Decree no. 139 of 4 February 1988 promulgating regulations for the implementation of the law on
public health. International digest of health legislation, 1989, 40:800.
126. Manual para el adiestramiento de parteras empiricas, revised ed. Santo Domingo, Ministry of Health
and Social Welfare of the Dominican Republic, 1973.
127. Supreme Decree no. 188 of 4 February 1971 embodying the health code. International digest of health
128. Manual de capacitación de parteras empiricas. Quito, Ministry of Health, Ecuador, 1976 (unpublished
document).
129. Regulación y Control de Productos Farmaceuticos y Afines. Direccion General de Regulación,
Vigilancia y Control de la Salud, November 1999. Guatemala.
130. Guatemala. Acupuncture: Guatemalan Acupuncture Association. International digest of health
131. Decree no. 75 of 14 November 1966 promulgating the health code of the Republic of Honduras.
International digest of health legislation, 1967, 18:733.
132. Changes to Food and Drugs Act proposed. Jamaica gleaner, 28 January 2000.
133. Roxborough P. ‘Natural’ medicines a hit: distributors raking in big money. Jamaica gleaner, 23
January 2000.
134. Amendments to the Food and Drugs Act and food and drugs regulations to include herbal
products: draft cabinet submission. Kingston, Jamaica, Ministry of Health, 2 March 1999.
135. Report of the consultation on approaches for policy development for traditional health
practitioners, including traditional birth attendants. Geneva, World Health Organization, 1985
(unpublished document NUR/TRM/85.1; available on request from Traditional Medicine,
Department of Essential Drugs and Medicines Policy, World Health Organization, 1211 Geneva
27, Switzerland).
136. Regulations of 20 October 1976. International digest of health legislation, 1978, 29:606.
137. Stepan J. Traditional and alternative systems of medicine: a comparative review of legislation.
138. Villalba ED. Salud de los pueblos indigenas. El caso de los Ngöbe-Buglé de Panama: informe de
consultoria Organización Panamericana de la Salud. Panama, December 2000 (unpublished
document).
139. Decreto Supremo no. 010-97-SA. Reglamento para el Registro, Control y Vigilancia Sanitaria de
Productos Farmaceuticos y Afines. Ministry of Health, 1997. Peru.
140. Public Law 103-43, 10 June 1993. United States of America.
141. Eisenberg D et al. Trends in alternative medicine use in the US, 1990–1997. Journal of the American
Medical Association, 11 November 1998, 280:1569–1575.
142. Eisenberg D et al. Unconventional medicine in the US: prevalence, costs, and patterns of use.
English journal of medicine, 1993, 323:673.
143. Alternative medicine: expanding medical horizons. A report to the National Institutes of Health on
alternative medical systems and practices in the United States. Washington DC, US Government
Printing Office, 1994.
180
References
231
144. Cohen MH. Legal boundaries and regulatory perspectives. Baltimore, The Johns Hopkins University
Press, 1998.
145. Corpus juris secundum. St. Paul, Minnesota, West Publishing Co., 1987, 70:396.
146. McKinney’s consolidated laws of New York annotated. Book 16. St. Paul, Minn., West Publishing Co.
147. United States of America. Practice of certain health professions: miscellaneous provisions. Interna-
148. United States of America. Grants for establishment of departments of family medicine. Interna-
149. 1993–1994 Official directory: chiropractic licensure and practice statistics. Greeley, Colorado, Federation
of Chiropractic Licensing Boards.
150. Riddle JW. Report of the New York State Commission on Acupuncture (legal considerations). In:
Kao FF, Kao JJ, eds. Recent advances in acupuncture research. Garden City, New York, Institute for
Advanced Research in Asian Science and Medicine, 1979.
151. Unites States of America. Acupuncture. International digest of health legislation, 1975, 26:899–900.
152. Schwartz R. Acupuncture and expertise: a challenge to physician control. The Hastings Centre
report, 1981, 11:5.
153. United States of America. Rhode Island. Acupuncture. International digest of health legislation, 1979,
30:665–666.
154. An act (Chapter 168 of the Laws of 1980) relating to acupuncture clinics. International digest of
health legislation, 1982, 33:252–264.
155. Laws and regulations relating to the practice of acupuncture, 2000. Sacramento, California,
Acupuncture Board, 2000.
156. Wardwell WI. Alternative medicine in the United States. Social science and medicine, 1994, 38:1061.
157. Law of 9 August 1975. International digest of health legislation, 1979, 30:905.
158. Algeria. Protection of public health: Public Health Code. International digest of health legislation,
1978, 29:261–317.
159. Journal officiel de la République Algérienne Démocratique et Populaire, 17 February 1985, 8:122.
160. Law no. 85-05 of 16 February 1985 on health protection and promotion. International digest of health
legislation, 1985, 36:909 (as amended by Law no. 90-17 of 31 July 1990. International digest of health
legislation, 1991, 42:229).
161. The Chiropractors’ Registration Law of 1991 (No. 62 of 1991). Cyprus.
162. Report on the intercountry expert meeting on traditional medicine and primary health care, Cairo, Egypt,
30 November–3 December 1992. Alexandria, WHO Regional Office for the Eastern Mediterranean,
December 1992.
163. Zhang X. Duty travel report. Geneva, World Health Organization, 15 May 2001 (unpublished
document).
164. An act and notes for guidance aiming at ensuring the safety and quality of herbal remedies (The Herbal
Remedies Act). Sulaibekhat, Kuwait, The Islamic Organization for Medical Sciences and the World
Health Organization, 21–23 April 1986.
165. Ordinance no. 65 of 7 June 1962. International digest of health legislation, 1965, 16:168.
166. Pakistan. Practice of traditional medicine. International digest of health legislation, 1967, 18:428.
167. Statutory rules and orders, 1970, V:78–89. Pakistan.
168. Regulations for registration of herbal preparations, health and supplementary food, cosmetics and antiseptics
that have medical claims. Directorate of Pharmaceutical Licences, General Directorate of Medical and
Pharmaceutical Licences, Ministry of Health, Kingdom of Saudi Arabia (undated). Saudi Arabia.
169. Federal Law no. 7 of 1975 on the practice of human medicine. International digest of health
170. Federal Law no. 5/1984 on the practice of certain medical professions by persons other than
physicians and pharmacists, Sections 1 and 2. International digest of health legislation, 1984, 35:745.
171. Galadari M. Herbal drug registration in the UAE. Presented at the Ninth international conference
of drug regulatory authorities, Berlin, Germany, 28 April 1999.
181
232
172. Maddalena S. The legal status of complementary medicines in Europe — a comparative analysis. Bern,
Stämpfli, 1999.
173. Ärztegezetzes 1984. BGBl (Bundesgesetzblätter) no. 373. Austria.
174. BGBl (Bundesgesetzblätter) no. 378/1996. Austria.
175. Loi du 29 avril 1999 relative aux pratiques non conventionnelles dans les domaines de l’art
médical, de l’art pharmaceutique, de la kinésithérapie, de l’art infirmier et des professions
médicales. Moniteur Belge, 24 June 1999, 169. Belgium.
176. The Act Concerning Health Care Professionals 559/1994 of 28 June 1994. Finland.
177. Solimene U. Communication with WHO. Direttore Professor Centro di Ricerche in Bioclimatologia
Medica Biotechnologie – Medicine Naturali, Universita Degli Studi di Milano, Italie (Professor and
Director, Centre of Research in Bioclimatology, Biotechnologies and Natural Medicine, State
University of Milan, Milan, Italy), 1999.
178. Gesetz über das Gesundheitswesen vom 18. Dezember 1985. Liechtensteinisches Landesgestzblatt,
1986, 12.
179. Verordnung über die medizinischen Berufe vom 8. November 1988 (Order I). Liechtensteinisches
Landesgestzblatt, 1988, 51.
180. Verordnung über die andere Berufe der Gesundheitspflege vom 16. März 1989 (Order II).
Liechtensteinisches Landesgestzblatt, 1989, 30.
181. Report of the Chinese-Norwegian health seminar, Oslo, Norway, 20–23 November 2000. Oslo, Norwegian
Ministry of Health and Social Affairs, January 2001.
182. Russian Federation. Principles of the legislation of the Russian Federation on the protection of the
health of citizens. International digest of health legislation, 1994, 45:3–6.
183. Complementary and alternative medicine, 6th report. London, House of Lords Select Committee on
Science and Technology, 21 November 2000.
184. Rahman L, Azizul Islam HH. Development of indigenous systems of medicine in Bangladesh.
Presented at the WHO regional seminar on the Traditional Medicine Programme, Colombo, Sri
Lanka, 1–5 April 1977 (unpublished document SEA/Trad Med/1).
185. II. Health Manpower. Bangladesh. An Ordinance (No. XXXII of 1983) to provide for the regulation
of the qualifications and registration of practitioners of Unani and Ayurvedic systems of medicine.
International digest of health legislation, 1984, 35:565-568.
186. Islam HA. Legislation in the development of traditional medicine in Bangladesh. International
digest of health legislation, 1985, 36:525, 527.
187. Dorji P. Traditional medicine system in Bhutan. In: Traditional medicine, better science, policy and
services for health development: proceedings of a WHO International Symposium, Awaji Island, Hyogo
Prefecture, Japan, 11–13 September 2000. Kobe, Japan, World Health Organization Centre for Health
Development, 2001 (unpublished document; available on request from the WHO Centre for
Health Development, I.H.D. Centre Building, 9th Floor, 1-5-1 Wakinohama-Kaigandori, Chuo-ku
Kobe 651-0073, Japan).
188. Democratic People's Republic of Korea. Health protection and promotion: general provisions.
189. Ritiasa K. Jamu and traditional medicine practices in Indonesia. In: Traditional medicine, better
science, policy and services for health development: proceedings of a WHO International Symposium, Awaji
Island, Hyogo Prefecture, Japan, 11–13 September 2000. Kobe, Japan, World Health Organization
190. Untoro R. Database inventory and registry of biological resources and traditional knowledge.
Presented at the ASEAN workshop on the TRIPS agreement and traditional medicine, Jakarta,
Indonesia, 12–15 February 2001.
191. Roemer MI. National health systems of the world. Vol. 1. New York, Oxford University Press, 1991.
192. Kim-Farley RJ. Communication with WHO. WHO Representative, Indonesia, 22 February 1994.
193. Country review of traditional medicine programme in Indonesia. Presented at the WHO regional
seminar on the Traditional Medicine Programme, Colombo, Sri Lanka, 1–5 April 1977
(unpublished document SEA/Trad Med/1).
182
References
233
194. Rules of 25 August 1955 of the Ministry of Health. Myanmar.
195. Tin U. Traditional medicine of Burma. Presented at the WHO regional seminar on the Traditional
Medicine Programme, Colombo, Sri Lanka, 1–5 April 1977 (unpublished document SEA/Trad
Med/1).
196. Khakurel BK. The regulation of herbal medicines in Nepal. Presented at the Eighth international
conference of drug regulatory authorities, Manama, Bahrain, 11 November 1996.
197. A short account of the ayurvedic activities in Nepal. Presented at the WHO regional seminar on
the Traditional Medicine Programme, Colombo, Sri Lanka, 1–5 April 1977 (unpublished document
SEA/Trad Med/1).
198. The Ayurvedic Medical Council Act, no. 21 of 2045 (1988). International digest of health legislation,
1992, 43:24.
199. Pigott W. Research and development of traditional and natural medicine. WHO representative, Nepal,
13 February 1996 (unpublished document).
200. Country review from Sri Lanka. Presented at the WHO regional seminar on the Traditional
Medicine Programme, Colombo, Sri Lanka, 1–5 April 1977 (unpublished document SEA/Trad
Med/1).
201. The ayurvedic physicians professional conduct rules, 1971. International digest of health legislation,
1974, 25:435.
202. Development, 1931–1981. Colombo, Sri Lanka, Ministry of Plan Implementation, 1981.
203. Ceylon. Homeopathy. International digest of health legislation, 1971, 22:209–210.
204. Herbal medicine practice in Thailand. In: Traditional medicine, its contribution to human health
development in the new century, report of an international symposium, Kobe, Japan, 6 November 1999.
Kobe, Japan, World Health Organization Centre for Health Development, 2000 (unpublished
document; available on request from the WHO Centre for Health Development, I.H.D. Centre
Building, 9th Floor, 1-5-1 Wakinohama-Kaigandori, Chuo-ku Kobe 651-0073, Japan).
205. Thaïlande. In: Grand Larousse Encyclopédique. Paris, Larousse.
206. Memorandum on the draft process report by the Director-General to the Fifty-first world health
assembly on TRM. Manila, Traditional Medicine, WHO Western Pacific Regional Office, 20 March
1997.
207. Australian commentary on Halsbury’s laws of England, 4th ed. Sydney, Butterworths, 1990.
208. For the relevant laws of the Australian states, see the following:
South Australia: The Chiropractors Act 1991 (no. 6 of 1991). International digest of health
Capital Territory: The Chiropractors Registration Ordinance 1983 (no. 28 of 1983). International
digest of health legislation, 1987, 38:456.
Victoria: The Chiropractors and Osteopaths Act 1978, no. 9161.
New South Wales: Chiropractic Act, 1978, no. 132.
209. Chiropractic, osteopathy, homeopathy and naturopathy: report of committee of inquiry. Canberra, The
Acting Commonwealth Government Printer, 1977 (Parliamentary Paper, No. 102/1977).
210. Commonwealth Law bulletin, October 1993, 1362.
211. Overview of the regulatory requirements for the manufacture and supply of medicine in Australia
and for export. Woden, Australia, Therapeutic Goods Administration, November 1999.
212. Acupuncture college handbook 1994. Sydney, Australia, University of Technology, 1994.
213. Technical briefing on traditional medicine. Presented at the Forty-ninth regional committee
meeting, Manila, Philippines, WHO Regional Office for the Western Pacific, 18 September 1998.
214. Cambodia. Practice of unofficial medicine and pharmacy. International digest of health legislation,
1965, 16:40–41.
215. Hiegel JP. The ICRC and traditional Khmer medicine. International review of the Red Cross, 1981,
21:251.
216. Drug registration: mission report in Cambodia 17 January–13 February 1997. Manila, WHO
Regional Office for the Western Pacific, 24 April 1997.
217. Xiaopin W. Review of traditional Chinese medicine practice in China. In: Traditional medicine, better
science, policy and services for health development: proceedings of a WHO International Symposium, Awaji
183
234
Island, Hyogo Prefecture, Japan, 11–13 September 2000. Kobe, Japan, World Health Organization
218. Zhang X. Traditional medicine world-wide review. In: Traditional medicine, better science, policy and
services for health development: proceedings of a WHO International Symposium, Awaji Island, Hyogo
Prefecture, Japan, 11–13 September 2000. Kobe, Japan, World Health Organization Centre for Health
Development, 2001 (unpublished document; available on request from the WHO Centre for
Health Development, I.H.D. Centre Building, 9th Floor, 1-5-1 Wakinohama-Kaigandori, Chuo-ku
Kobe 651-0073, Japan).
219. Zhang X. Integration of traditional medicine into national health care systems. Presented at the
Medicus Mundi Switzerland workshop on the integration of traditional medicine into public
health, Lausanne, Switzerland, 4 April 1998.
220. Jingfeng C. Integration of traditional Chinese medicine with Western medicine — right or wrong?
Social science and medicine, 1988, 27:521–528.
221. Chen PC. Population and health policy in the People’s Republic of China. Washington DC,
Interdisciplinary Communications Programme, Smithsonian Institution, 1976 (Occasional Mono-
graph Series, No. 9).
222. State administration of traditional Chinese medicine, 14 January 1989. Beijing.
223. Department of Traditional Chinese Medicine, Ministry of Public Health and Personnel
Department for the Unified Examination Given to Personnel without Official Education Employed
as Physicians (Assistants) of Traditional Chinese Medicine (Herbs), 31 December 1985. Beijing.
224. Circular of re-check of persons who are proficient in a particular branch of traditional Chinese
medicine. Beijing, State Administration of Traditional Chinese Medicine, 12 August 1989.
225. Provisional management stipulations for privately practising doctors of Western medicine and physicians of
traditional Chinese medicine. Beijing, Ministry of Public Health and State Administration of
Traditional Chinese Medicine, 21 November 1988.
226. Additional regulations to the management stipulations for privately practising personnel of
traditional Chinese medicine. Beijing, State Administration of Traditional Chinese Medicine, 3
May 1989.
227. Some regulations for strengthening the management of medical qigong treatment (trial
implementation). Beijing, State Administration of Traditional Chinese Medicine, 19 October 1989.
228. Roemer MI. Comparative national policies on health care. New York, M Dekker, 1977.
229. Rosenthal MM. Modernization and health care in the People’s Republic of China: the period of
transition. In: Rosenthal MM, ed. Health care systems and their patients: an international perspective.
Boulder, Westview Press, 1992.
230. Leung TH. Traditional medicine in Hong Kong, China. Presented at the Workshop on
development of national policy on traditional medicine, Beijing, China, 11–15 October 1999.
231. Chen K. Fiji national workshop on traditional medicine: mission report 25–31 March 2001. Manila, WHO
Regional Office for the Western Pacific, 10 July 2001.
232. Fiji. Practice of medicine, dentistry, chiropractic, and acupuncture. International digest of health
legislation, 1979, 30:531–533.
233. The Acupuncturists, Chiropractors and Chiropodists (Qualification) Regulations, 1976, and the
Acupuncturists, Chiropractors and Chiropodists Regulations, 1976. International digest of health
234. Yamamura Y. The history of kampo medicine and its development in modern Japan. In: Hosoya E,
Yamamura Y, eds. Recent advances in the pharmacology of kampo (Japanese herbal) medicines. Tokyo,
Excerpta Medica Ltd., 1988 (International Congress Series 854).
235. Terasawa K. The problems that should be resolved in Japanese oriental (kampo) medicine. In:
International forum on Japanese oriental (kampo) medicine in Toyama, Japan, 29–29 July 1990. Toyama,
Japan, Department of Japanese Oriental (Kampo) Medicine, Toyama Medical and Pharmaceutical
University, 1990.
236. Ministry of Health and Welfare. The year book of statistics of production by the pharmaceutical industry,
1998. (original in Japanese). Tokyo, Ministry of Health and Welfare, 1999.
184
References
235
237. Nikkei Medical, October 2000 (Supplement) (original in Japanese).
238. Communication with WHO. The Ministry of Health and Welfare, Government of Japan, August
2000 (original in Japanese).
239. Japanese/English pharmaceutical administration in Japan, 9th ed. Tokyo, Yakuji Nippo, Ltd., 2000.
240. Ministry of Health and Welfare. Traditional medicines in Japan. In: Proceedings of the fourth
international conference of drug regulatory authorities, Tokyo, 6–11 July 1986. Tokyo, Ministry of Health
and Welfare, 1986.
241. Japanese pharmacopoeia, 13th ed. Tokyo, Ministry of Health and Welfare, 1996.
242. The Japanese standards for herbal medicines. Tokyo, Yakuji Nippo, Ltd., 1993.
243. Communication with WHO. Japan Pharmacists Education Centre, August 2000 (original in
Japanese).
244. Communication with WHO. The Japan Society of Acupuncture and Moxibustion, August 2000
(original in Japanese).
245. Tsuruoka K, Tsuruoka Y, Kajii E. Complementary medicine education in Japanese medical
schools: a survey. Complementary therapies in medicine, 2001, 9:28–33.
246. Communication with WHO. The Japan Society for Oriental Medicine, August 2000 (original in
Japanese).
247. General information on the research institute for WAKAN-YAKU. Toyama, Japan, Toyama Medical
and Pharmaceutical University, March 1990 (original in Japanese).
248. Metai A. Traditional medicine practices in Kiribati. Presented at the International congress on
traditional medicine, Beijing, China, 22–24 April 2000.
249. Ekeieta B. Traditional medicine in Kiribati. Presented at the Workshop on development of national
policy on traditional medicine, Beijing, China, 11–15 October 1999.
250. Kiribati. An Act (No. 9 of 1981) to amend the Medical and Dental Practitioners Ordinance (Cap.
55) so as to legalise the practice of traditional healing methods and permit practitioners to charge
for their services. International digest of health legislation, 1982, 33:243.
251. Keola K. Traditional medicine in the Lao People’s Democratic Republic. Presented at the
Workshop on development of national policy on traditional medicine, Beijing, China, 11–15
October 1999.
252. The work of WHO in the Western Pacific Region: proposed programme budget 1991–1993. In:
Diagnostic, therapeutic and rehabilitative technology. Manila, WHO Western Pacific Regional Office,
1993.
253. Malaysia. Registration of physicians and practice of medicine. International digest of health
legislation, 1975, 26:170–172.
254. Malaysia. Registration of midwives. International digest of health legislation, 1975, 26:165–166.
255. National seminar on uses of traditional/alternative medicine in contemporary health care: mission report in
Kuala Lumpur, Malaysia, 21–25 December 1997. Manila, WHO Regional Office for the Western
Pacific, 12 May 1998.
256. Acupuncture and moxibustion for primary medical care: mission report in Ulaanbaatar, Mongolia, 14 June–
14 July 1998. Manila, WHO Regional Office for the Western Pacific, 23 October 1998.
257. Bold S. Country report: Mongolia. Presented at the Workshop on development of national policy
on traditional medicine, Beijing, China, 11–15 October 1999.
258. Research methods on medicinal plants and their role as immunostimulants: mission report in Ulaanbaatar,
Mongolia, 10 September–3 October 1998. Manila, WHO Regional Office for the Western Pacific, 27
November 1998.
259. Ambihaipahar U. Country report: Papua New Guinea. Presented at the Workshop on
development of national policy on traditional medicine, Beijing, China, 11–15 October 1999.
260. Banaynal ET. Country report: Philippines. Presented at the Workshop on development of national
policy on traditional medicine, Beijing, China, 11–15 October 1999.
1995.
262. Official gazette, 28 March 1983, 79:1852. Philippines.
185
236
263. Oriental medicine in Korea. Republic of Korea, Ministry of Health and Social Affairs, 1994.
264. 2000 Health and Welfare Services. Republic of Korea, Ministry of Health and Welfare, 2000.
265. Republic of Korea. The Medical Treatment Act. International digest of health legislation, 1992, 43:14–
15.
266. Ainuu LSP. Traditional medicine in Samoa. Presented at the Workshop on development of
national policy on traditional medicine, Beijing, China, 11–15 October 1999.
267. Chea CHA. The development of national policy on traditional medicine in Singapore. Presented at
the Workshop on development of national policy on traditional medicine, Beijing, China, 11–15
October 1999.
1996.
269. Maenu’u LP. Traditional medicine in Solomon Islands. Presented at the Workshop on develop-
ment of national policy on traditional medicine, Beijing, China, 11–15 October 1999.
270. The Health Practitioners Act no. 5 of 1984. Date of assent: April 20, 1983. Vanuatu.
271. The Health Practitioners (Ancillary Medical Profession) Order no. 32 of 1985. International digest of
health legislation, 1987, 38:31.
272. Developing a national policy and strategic plan for traditional medicine: mission report in Hanoi, Viet Nam,
11–31 October 1997. Manila, WHO Regional Office for the Western Pacific, 29 May 1998.
273. Workshop on the modernisation of traditional medicine: mission report in Hanoi, Viet Nam, 7–11 April
1997. Manila, WHO Regional Office for the Western Pacific, 16 May 1997.
274. Integration of acupuncture with modern rehabilitation medicine: mission report in Hanoi, Viet Nam, 11–28
October 1997. Manila, WHO Regional Office for the Western Pacific, 25 May 1998.
275. Law of 30 June 1989 on the protection of public health. International digest of health legislation, 1990,
41:15.
276. Regulations of 1991 on medical examinations and treatment within the framework of the national
system of traditional medicine. International digest of health legislation, 1993, 44:18.
277. The Criminal Code of the Socialist Republic of Viet Nam, Section 196. International digest of health
278. Ordinance on Private Medical and Pharmaceutical Practice. Hanoi, Vietnam, Permanent Committee of
the Ninth National Assembly of the Socialist Republic of Viet Nam, 13 October 1993.
279. Second national workshop on national policy on traditional medicine: mission report in Hanoi and Ho Chi
Minh City, Viet Nam, 28 June–5 July 1998. Manila, WHO Regional Office for the Western Pacific, 28
September 1998.
280. Baeyens A. Free movement of goods and services in health care: a comment on the court cases
Decker and Kohll from a Belgian point of view. European journal of health law, 1999, 6:373–383.
281. Keller K. Homeopathic medicinal products in Germany and Europe: legal requirements for
registration and marketing authorization. Drug information journal, 1998, 32:803–811.
282. Official Journal EC, 13 October 1992, L 297:8–11, 12–15.
283. Official Journal EC, 22 April 1992, L 102:23–24, 102–155.
186
Annex I. The European Union
237
General principles
The Treaty on the European Union (EU) came into force 1 November 1993. The Treaty
instituting the European Economic Community (EEC) was intended to open a large
market zone without borders, enabling the free movement of persons, goods, services,
and capital. It is Treaty regulations on the movement of persons and goods, in
particular, which affect health services and medications (172, 280, 281).
For the purpose of employment or for activities as a self-employed person, citizens of

the European Union, under Articles 39 to 55 of the Treaty, have the right to move and
take residence freely within the European Union. Some limitations and conditions on
this freedom are outlined in Articles 12 and 39 of the Treaty. Moreover, by Directive
65/221/EEC, individual countries can limit the right of free movement on justified
grounds of public health.
Specific directives ensure the mutual recognition of diplomas of allopathic doctors,

dentists, pharmacists, midwives, and nurses. Similarly, directives based on Article 95
of the Treaty regarding Union-wide harmonization of legislation regulate, among
other things, pharmaceuticals, blood products, medical devices, foodstuffs, dangerous
substances and preparations, cosmetics, safety of products, precursors, tobacco
products, personal protective equipment, and the protection of personal medical data.
Directives on homeopathic products
The first phase of European Union legislative harmonization in homeopathy was the
adoption of two European Directives that came into force on 1 January 1994 (282) —
one on homeopathic products for humans and one on homeopathic veterinary
products. These Directives ensure a single European Market for homeopathic products
and outline provisions regulating their manufacture, inspection, marketing, and
labelling. They also establish a simplified registration procedure for medications
containing less than one part per 10 000 of undiluted tincture or less than 1/100th of
the smallest dose used in allopathic medicine (281). According to the 1995 European
Commission report to the Parliament and the Council on the application of Directives
92/73 and 92/74, however, the existing level of legislative harmonization is
insufficient.
The EEC Directive regulates the marketing of proprietary medicinal products (283).
However, individual countries are free to restrict the licensing of herbal medicines.
187
238
Germany and the United Kingdom have chosen to restrict such licences in order to
protect their populations from the possible carcinogenic effects of pyrolizidine
alkaloids, which occur in a number of medicinal herbs.
Free movement of patients and practitioners and insurance coverage of

complementary/alternative medicine products and treatments
Directives on the free movement of patients and practitioners and on insurance

coverage of complementary/alternative medicine are more difficult to implement.
Although the free movement of persons within the European Union is a cornerstone of
the Treaty of Rome, the diversity of national policies severely limits its applicability to
practitioners of complementary/alternative medicine. Case 61/89 of the European
Court of Justice involved an acupuncturist without allopathic medical qualifications
practising in France. The Court’s decision confirmed the right of individual countries
to make their own legislation on whether or not to reserve the practice of medicine to
allopathic doctors.
As social insurance remains the province of national governments rather than an issue
for European Union consideration, insurance coverage of complementary/alternative
products and treatments is unlikely to become the subject of a European Directive
(280).
Nonetheless, in April 1994, European Deputy Paul Lannoye presented a proposal on

the status of complementary/alternative medicine to the European Parliament
Committee on the Environment, Public Health, and Consumer Protection. He asked
for provisions for complementary/alternative medicine within social security systems,
the incorporation of complementary/alternative medical systems into the European
Pharmacopoeia, an end to prosecutions of non-allopathic practitioners in countries
where the practice of medicine is the exclusive domain of allopathic providers, and a
pan-European system of recognition and regulation of complementary/alternative
medical practitioners along the lines of the British Osteopath and Chiropractor Acts.
He also requested a research budget of 10 million Euros per year for five years. At the
last moment, the European Parliament cancelled the vote on the proposal.
At the end of 1995, the Conference of Presidents of the European Parliament put
forward a report intended to engage the European Commission in the process of
recognizing complementary/alternative medicine (172).
On 27 February 1997 the Committee on the Environment, Public Health, and

Consumer Protection began a study of complementary/alternative medicine. On 29
May 1997 the European Parliament passed a resolution,
4. Call[ing] on the Commission, if the results of the study allow, to start the process
for the recognition of non-conventional medicines and, for this purpose, to take
the necessary steps to encourage the establishment of appropriate committees;
188
239
5. Call[ing] on the Commission to carry out a thorough study on the safety,
effectiveness, scope of application and the complementarity and alternative
nature of all non-conventional medicines, and to prepare a comparative study of
the various national legal models to which non-conventional medical
practitioners are subjected;
6. Call[ing] on the Commission, in formulating European legislation on non-

conventional forms of medicine, to make a clear distinction between non-
conventional medicines which are “complementary” in nature and ones which
are “alternative” in the sense that they replace conventional medicine;
7. Call[ing] on the Council, after completion of the preliminary works referred to in

paragraph 2 above, to encourage the development of research programmes in the
field of non-conventional medicines covering the individual and holistic
approach, the preventive role and the specific characteristics of the non-
conventional medicine;
8. Call[ing] on the Commission to submit a proposal for a Directive on food

supplements which are frequently situated on the boundaries between dietary
and medicinal products. Such legislation should help guarantee good manu-
facturing practices to secure consumer protection without restricting freedom of
access or choice and ensure the freedom of all practitioners to recommend such
products;
9. Call[ing] on the Commission to remove trade barriers between Member States by

giving manufacturers of health products free access to all markets in the EU. . . .
A Resolution of the European Parliament, however, is not a binding act, but a

declaration of policy. Nonetheless, the adoption of the resolution has led several
countries to consider revising their legislation.
The European Commission’s COST (European Cooperation in the Field of Scientific

and Technical Research) programme undertook Project B4, a European initiative for
comprehensive research on complementary/alternative medicine. The Governments
of Belgium, Croatia, Denmark, Finland, Germany, Hungary, Italy, Netherlands,
Norway, Slovenia, Spain, Sweden, Switzerland (the project’s initiator), and the United
Kingdom all participated in the project. The goals of the project were to demonstrate
the possibilities, limitations and significance of complementary/alternative medicine
by establishing a common scientific background, helping to control health care costs,
and harmonizing legislation. The project was completed in 1998.
189
240
ANNEXURE P-4
A/60/49 (Vol. I)
' ' ANNEXURE P-34 PART IV/ 6

RELEVANT EXTRACTS
~ ~ ~,t;t:;_60/Wt
/:t l-6 · Ii-~!
Resolutions
and
Decisions
adopted by the General Assembly

during its sixtieth session
Volume I
Resolutions
13 September - 23 December 2005
General Assembly
Official Records• Sixtieth Session
Supplement No. 49 (A/60/49)
United Nations • New York, 2006

241
V. Resolutions adopted on the reports of the Third Committee
Recalling its resolution 59/179 of20 December 2004, Recalling the adoption of the Basic Principles and
Guidelines on the Right to a Remedy and Reparation for
Affirming the right of all States in the region to live in
Victims of Gross Violations of International Hmnan Rights Law
peace within secure and internationally recognil.ed borders,
and Serious Violations of International Humanitarian Law by
l. Reqffirms the right of the Palestinian people to the Commission on Human Rights in its resolution 2005/35 of
self-detennination, including the right to their independent State 19 April 2005 175 and by the Economic and Social Council in its
of Palestine; resolution 2005/30 of 25 July 2005, in which the Council
recommended to the General Assembly that it adopt the Basic
2. Urges all States and the specializ.ed agencies and
Principles and Guidelines,
organizations of the United Nations system to continue to
support and assist the Palestinian people in the early realization 1. Adopts the Basic Principles and Guidelines on the
oftheir right to self-determination. Right to a Remedy and Reparation for Victims of Gross
Violations of International Human Rights Law and Serious
Violations of International Humanitarian Law annexed to the
RESOLUTION 60/147 present resolution;
Adopted at the 64th plenaiy meeting, on 16 Decemoor 2005, without a vote; oo 2. Recommends that States take the Basic Principles
the recommendation of the Committee (A/60/509/Add.1, para. 23) 171 and Guidelines into account, promote respect thereof and bring
them to the attention of members of the executive bodies of
60/147. Basic Principles and Guidelines on the Right to government, in particular law enforcement officials and militruy
a Remedy and Reparation for Victims of Gross and securi1y forces, legislative bodies, the judiciary, victims and
Violations of International Human !Ughts Law their representatives, human rights defenders and lawyers, the
and Serious Violations of International media and the public in general;
Humanitarian Law
3. Re~sts the Secretruy-General to take steps to
The General. Assembly, ensure the widest possible dissemination of the Basic Principles
and Guidelines in all the official languages of the United
Guided by the Charter of the United Nations, the
Nations, including by transmitting them to Governments and
Universal Declaration of Human Rights, 172 the International intergovernmental and non-governmental organizations and by
Covenants on Human Rights, 173 other relevant human rights including the Basic Principles and Guidelines in the United
instruments and the Vienna Declaration and Programme of Nations publication entitled Human Rights: A Compilation of
Action,114
International. Instruments.
Affirming the importance of addressing the question of
remedies and reparation for victims of gross violations of Annex
international human rights law and serious violations of
BaskJ>rinciples and Guidelines WI the Right to a Remedy
international humanitarian law in a systematic and thorough
and Reparation for Vretims of Gross Violations of
way at the national and international levels,
International Human Rights J,aw and Serious
Recognizing that, in honouring the victims' right to benefit Violations of International Humanitarian Law
from remedies and reparation, the international communi1y
keeps faith with the plight of victims, survivors and future Preamble
human generations and reaffirms international law in the field,
The General. Assembly,
Recal.ling the provisions providing a right to a remedy for
171 victims ofviolations of international human rights law found in
Tiie draft resolution recommended in the report was sponsored in the
Committee by: Albania, Atgentina, Annenia, Austria, A7.erbaijan, Belgium, numerous international instruments, in particular article 8 of the
Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Congo, Costa Universal Declaration of Human Rights,172 article 2 of the
Rica, Croatia, Cyprus, Czech Republic, Demnarlc, Dominican Republic, International Covenant on Civil and Political Rights,173 article 6
Ecuador, Estonia, Finland, France, Georgia, Greece, Guatemala, Haiti, of the International Convention on the Elimination of All Fonns
Honduras, Hungmy, Iceland, Ireland, Italy, Japan, Kenya, Latvia,
Liechtenstein, Liiimania, Luxerubowg, Mexico, Monaco, Netherlands, of Racial Discrimination,176 article 14 of the Convention against
Nigeria, Norway, Panama, Paraguay, Peru, Poland, Portugal, Republic of Torture and Other Cruel, Inhuman or Degrading Treatment or
Moldova, Romania, Sierra Leone, Slovenia, South Africa, Spain, Sweden,
Switzerland, the funner Yugoslav Republic of Macedonia, Timor-Leste,
United Kingdom of Great Britain and Northern Ireland, Uruguay and
Venezuela (Bolivarian Republic of).
1n Reoolution 217 A (III). 115
See Official Records of the &anomic and Social C0101Cit 2005,
173
Resolution2200A(XXI), annex. Supplement No. 3 and corrigendum (E/2005/23 and Corr.I), chap. II, sect.A
174 176
A/CONF.157/24 (Partl), chap. ill. Resolution 2106A (XX), annex.
354
242
Punishment,177 and article 39 of 1he Convention on 1he Rights of such victims, and mandates the Court ''to protect the safety,
of the Child,178 and of international humanitarian law as foood physical and psychological well-being, dignity and privacy of
in article 3 of the Hague Convention respecting the Laws and victims" and to permit the participation of victims at all "stages
Customs ofWar on Land of 18 October 1907 (Convention IV),179 ofthe proceedings determined to be appropriate by the Court'',
article 91 of the Protocol Additional to the Geneva Conventions
Affirming that the Basic Principles and Guidelines
of 12August 1949, and relating to the Protection of Victims of
contained herein are direcied at gross violations of international
International Armed Conflicts (Protocol I) of 8 June 1977, 180
human rights law and serious violations of international
and articles 68 and 75 of the Rome Statute of 1he International
humanitarian law which, by their very grave nature, constitute
Criminal Court,181
an affront to human dignity,
Recalling the provisions providing a right to a remedy for
Emphasizing that the Basic Principles and Guidelines
victims of violations of international human rights found in
contained herein do not entail new international or domestic
regional conventions, in particular article 7 of the African
legal obligations but identify mechanisms, modalities, procedures
Charter on Human and Peoples' Rights, 182 article 25 of the
and methods for the implementation of existing legal obligations
American Convention on Human Rights, 183 and article 13 of
under international human rights law and international
the Convention for the Protection of Human Rights and
humanitarian law which are complementacy though different as
Foodamental Freedoms,184
to their nonns,
Recalling the Declaration ofBasic Principles ofJustice for
Recalling that international law contains the obligation
Victims of Crime and Abuse of Power emanating :from the
to prosecute perpetrators of certain international crimes in
deliberations of the Seventh United Nations Congress on the
accordance with international obligations of States and the
Prevention of Crime and the Treatment of Offenders and
requirements of national law or as provided for in the applicable
General Assembly resolution 40/34 of 29 November 1985 by
statutes of international judicial organs, and that the duty to
which the Assembly adopted the text recommended by the
prosecute reinforces the international legal obligations to be
Congress,
carried out in accordance wi1h national legal requirements and
Reqffirming the principles enoociated in the Declaration of procedures and supports the concept of complementarity,
Basic Principles of Justice for Victims of Crime and Abuse of
Noting that contemporary fonns of victimization, while
Power, including that victims should be treated with
essentially directed against persons, may nevertheless also be
compassion and respect for 1heir dignity, have their right to
directed against groups of persons who are targeted collectively,
access to justice and redress mechanisms fully respected, and
that the establishment, strengthening and expansion of national Recognizing that, in honouring the victims' right to benefit
funds for compensation to victims should be encouraged, :from remedies and reparation, the international commooity
together with the expeditious development of appropriate rights keeps faith with the plight of victims, survivors and future
and remedies for victims, human generations and reaffirms the international legal
principles ofaccountability,justice and the rule oflaw,
Noting that the Rome Statute of the International Criminal
Court requires the establishment of "principles relating to Convinced that, in adopting a victim-oriented perspective,
reparations to, or in respect of, victims, including restitution, the international community affirms its human solidarity with
compensation and rehabilitation", requires the Assembly of victims of violations of international law, including violations of
States Parties to establish a trust fund for the benefit of victims international human rights law and international humanitarian
of crimes within the jurisdiction of the Court, and of the families law, as well as with humanity at large, in accordance with the
following Basic Principles and Guidelines,
Adopts the following Basic Principles and Guidelines:
177
United Nations, Treaty Series, vol. 1465, No. 24841.
178
I. Obligation to respect, ensure resJHlC( for -
Ibid, vol. 1577, No. 27531.
179
'and implement international human~
See Carnegie Endowment fur International Peace, The Hague Conventions and international humanitarian law
and Declarations of 1899 and 1907 (New Yolk, Oxford University Press,
1915). 1. The obligation to respect, ensure respect for and
180
United Nations, Treaty Series, vol. 1125, No. 17512. implement international human rights law and international
181
Qfficial Records of the United Nations Diplomatic Corrference of humanitarian law as provided for under the respective bodies of
Plenipotentiaries on the Establishment ofan International Criminal Court,
Rome, 15.June-17 July 1998, vol.I: Final documents (United Nations law emanates from:
publication, Sales No. E.02.1.5), sect A.
182
(a) Treaties to which a State is a party;
United Nations, Treaty Series, vol. 1520, No. 26363.
183
Ibid., vol 1144, No. 17955. ( b) Customary international law;
184
Ibid., vol. 213, No. 2889.
355
243
(c) The domestic law ofeach State. incorporate or otherwise implement within their domestic law
appropriate provisions for universal jurisdiction. Moreover,
2. lf they have not already done so, States shall, as required where it is so provided for in an applicable treaty or other
under international law, ensure that their domestic law is international legal obligations, States should facilitate
consistent with their international legal obligations by: extradition or surrender offenders to other States and to
(a) Incorporating nonns of international hwnan rights appropriate international judicial bodies and provide judicial
law and international humanitarian law into their domestic law, assistance and other fonns of cooperation in the pursuit of
or otherwise implementing them in their domestic legal system; international justice, including assistance to, and protection ot;
victims and witnesses, consistent with international hwnan
(b) Adopting appropriate and effective legislative and rights legal standards and subject to international legal
administrative procedures and other appropriate measures that requirements such as those relating to the prohibition of torture
provide fair, effective and prompt access to justice; and other forms of cruel, inhuman or degrading treatment or
(c) Making available adequate, effective, prompt and punishment
appropriate remedies, including reparation, as defined below;
Iv. Statutes of limitations
(d) Ensuring that their domestic law provides at least
the same level of protection for victims as that requiredby their 6. Where so provided for in an applicable treaty or contained
lnternatiorial obligations. in other international legal obligations, ~ of limitati~
•h
. hall not apply to gross violations of international human ri
II. Scope of the obligation law an senous vmlations of international humanitarian law
constitute crimes Wlder international law.
3. The obligation to respect, ensure respect for and implement
international human rights law and international humanitarian 7. Domestic statutes of limitations for other types of
law as provided for under the respective bodies of law, includes, violations that do not constitute crimes under international law,
inter alia, the duty to: including those time limitations applicable to civil claims and
other procedures, should not be W1duly restrictive.
(a) Take appropriate legislative and administrative and
other appropriate measures to prevent violations;
V. ,-\lidims of gross violations of international hum!!ll
(b) Investigate violations effectively, promptly, rights law and serious violations of international
thoroughly and impartially and, where appropriate. take action humanitarian law
against those allegedly responsible in accordance with domestic
and international law; 8. For purposes of the present document, victims are persons
who individually or collectively suffered harm, including
(c) Provide those who claim to be victims of a human physical or mental injury, emotional suffering, economic loss or
rights or humanitarian law violation with equal and effective substantial impairment of their fundamental rights, through acts
access to justice, as descn'bed below, irrespective of who may or omissions that constitute gross violations of international
ultimately be the bearer of responsibility for the violation; and human rights law, or serious violations of international
(d) Provide effective remedies to victims, including humanitarian law. Where appropriate, and in accordance with
reparation, as described below. domestic law, the term "victim" also includes the immediate
fiunily or dependants of the direct victim and persons who have
Ill. Gross violations of international human rights law and suffered hann in intervening to assist victims in distress or to
serious violations ofinternational humanitarian law prevent victimiz,ation.
that constitute crimes under international law 9. A person shall be considered. a victim regardless of
4. In cases of gross violations of international human rights whether the perpetrator of the violation is identified,
law and serious violations of international humanitarian law apprehended, prosecuted, or convicted and regardless of the
constituting crimes under international law, States have the duty familial relationship between the perpetrator and the victim.
to investigate and, if there is sufficient evidence, the duty to
submit to prosecution the person allegedly responsible for the VL Treatment of victims
violations and, if found guilty, the duty to punish her or him.
10. , Victims should be treated with humanity and respect_._.for,.____
Moreover, in these cases, States should, in accordance with
their dignity and human rights..and appropriate measures should
international law, cooperate with one another and assist
be lllken to ensure their safety, physical and psychological well-
international judicial organs competent in the investigation and
prosecution of these violations.
being and privacy, as well as those of their families. The State
should ensure that its domestic laws, to the extent possible,
5. To that end, where so provided in an applicable treaty provide that a victim who has suffered violence or trauma
or W1der other international law obligations, States shall should benefit from special consideration and care to avoid his
356
244
or her re-traumatization in the course oflegal and administrative and appropriate international processes in which a person may
procedileS designed to provide Just1ce and reparation. have legal standing a.tJ.d should be without prejudice to any
other domestic remedies.
'a!- Victims' right to remedies
IX. Reparation for harm sutftred-
11. Remedies for gross violations of international human ~
righ1s law and serious violations of international humanitarian 15. fa:Jey:p1ate, efff'rlive and prompt reparation is intended to_
law include the victim's right to the following as provided for promote justice by redressing gross violations of international
under international Jaw: human rlfY!ts Jaw or serious violations of international
humanitarian law. Reparation should be proportional to the~
(a) Equal and effective access to justice; gravity of the violations and the harm suffered. In accordance
(b) Ad~e, effective and prompt reparation for hann with its dom§tjc laws and international legal obligatio~ a
suffered; State shall provide reparation to victims for acts or omissions
which can be attributed to the State and constitute gross
(c) Access to relevant infonnation concerning violations violations of international human righ1s law or serious violations
and reparation mechanisms. of international humanitarian Jaw. In cases where a person, a
1 on, or other . is found liable for re on to a
~ A ~ to justice • sue should rovide to the vi ·
or compensate the State if the State has already provided
12. A victim ofa gross violation of international human righ1s • th • •
lfil¥ orof a serious violation of international hamanimrian Jaw reparation to e victim. -
shall have equal access to an effective 1udicial ~ as 16. States should endeavour to establish national programmes
provided for under international law, Other remedies available for reparation and other assistance to victims in the event that
to the victim include access to administrative and other bodies, the parties liable for the harm suffered are unable or unwilling to
as well as mecbanisn:is, modalities and ~ g s conduc,ts4 meet their obligations.
1
.,_( ~\
in accordance with domestic law. Obligations arising under
f~.:- ~international law to secure the right to access justice and fair and 17· states shall, with respect to claims by victims, enforce
_u:N"IA It- impartial proceedings shall be reflected in domestic laws. To domestic judgements for reparation against individuals or
\ ~ e n d , States should: entities liable for the harm suffered and endeavour to enforce
1/'f"." n valid foreign legal judgements for reparation in accordance with
(a) · Disseminate, through public and private mechanisms, domestic law and international legal obligations. To that end,
information about all available remedies for gross violations of States should provide under their domestic laws effective
international human rights law and serious violations of mechanisms for the enforcement of reparation judgements.
international humanitarian law;
18. In accordance with domestic law and international Jaw,
(b) Take measures to minimize the inconvenience to andtakingaccountofindividualcircumstances, victims of gross
victims and their representatives, protect against unlawful violations of international human rights law and serious
interference with their privacy as appropriate and ensure their violations of international humanitarian law should, as
safety from intimidation and retaliation, as well as that of their appropriate and proportional to the gravity of the violation and
families and witnesses, before, during and after judicial, the circumstances of each case, be provided with full and
administrative, or other proceedings that affect the interests of effective reparation, as laid out in principles 19 to 23, which
1;
1l . Ih,
~<1'
victims; • include the following fonns: restitution, compensatiQD, - ""'
_rehabilitation, satis:fuction and guarantees ofnon-repetitioJ!. ~~
(c) Provide proper assistance to victims seeking access
to justice; 19. _Restituti<JJ1_should, whenever possible, ~re the victim
to the original situation before the gross violations of
(d) Make available all appropriate legal, diplomatic and
international human rights law or serious violations of
consular means to ensure that victims can exercise their rights to
international humanitarian law occurred. Restitution includes, as
remedy for gross violations of international human righ1s Jaw or
appropriate: restoration of liberty, enjoyment of human righ1s,
serious violations ofinternational humanitarian law.
identity, family life and citiz.enship, return to one's place of
13. In addition to individual access to justice, States should residence, restoration ofemployment and return of property.
endeavour to develop procedures to allow groups of victims
20. _Compensation.should be provided for any economically
~ n t claims for reparatjo.n and to receive reparation, as
appropnate. . assessable damage, as appropriate and proportional to the
gravity of the violation and the circumstances of each case,
14. An . oss resulting from gross violations of international human rights ·Iaw
violations o ns and serious violations of international humanitarian law,
of international humanitarian law should include all available such as:
357
245
(a) Physical or mental hann; (c) Strengthening the independence ofthe judiciaiy;
(b) Lost opportunities, including employment, education (d) Protecting persons in the legal, medical· and health-
and social benefits; care professions, the media and other related professions, and
(c) Material damages and loss of earnings, including human rights defenders;
loss of earning potential; (e) Providing, on a priority and continued basis, human
(d) Moral damage; rights and international humanitarian law education to all
sectors of society and training for law enforcement officials as
(e) Costs required for legal or expert assistance, medicine well as militruy and security forces;
and medical services, and psychological and social services.
(f) Promoting the observance of codes of conduct and
21. Rehabilitation should include medical and psychological ethical norms, in particular international standards, by public
as
care well as legal and social services. servants, including law enforcement, correctional, media,
medical, psychological, social service and militruy personnel, as
22. Satiefaction should include, where applicable, any or all of
well as by economic enterprises;
the following:
(g) Promoting mechanisms for preventing and
(a) Effective measures aimed at the cessation of
monitoring social conflicts and 1heir resolution;
continuing violations;
(h) Reviewing and reforming laws contnouting to or
(b) Yerification of1he fuc1s and full and IJ!lblic disc!~
of the truth to the extent that such disclosure does not cause allowing gross violations of international human rights law and
further harm or threaten the safety and interests of the victim. serious violations of international humanitarian law.
the victim's relatives, witnesses, or persons who have intervened
to assist the victim or prevent the occurrence of further X. Access to relevant information concerning violations
violations; and reparation mechanisms
(c) The search for the whereabouts of the disappeared, 24. States should develop means of informing the general
for the identities of the children abducted, and for the bodies of public and, in particular, victims of gross violations of
those killed, and assistance in the recoveiy, identification and international human rights law and serious violations of
reburial of the bodies in accordance with the expressed or international humanitarian law of 1he rights and remedies
presumed wish of the victims, or the cultural practices of the addressed by these Basic Principles and Guidelines and of all
fumilies and communities; available legal, medical, psychological, social, administrative
and all other services to which victims may have a right of
(d) An official declaration or ajudicial decision restorin,: access. Moreover, victims and their representatives should be
.Jbe dignity; the reputation and the rights of the victim and of entitled to seek and obtain information on 1he causes leading to
, persoJ!S closely connected with the victim; their victimization and on the causes and conditions pertaining
(e) Public apology, including acknowledgement of the to the gross violations of international human rights law and
fuels and acceptance of responsibility; serious violations of international humanitarian law and to learn
the truth in regard to these violations.
(f) Judicial and administrative sanctions against persons
liable for the violations; XI. Non-discrimination
(g) Commemorations and tributes to the victims; 25. The application and interpretation of these Basic
(h) Jnclusion of an accurate account of 1he violations_ Principles and Guidelines must be consistent with international
that OCCUJTed in international human rights law and international human rights law and international humanitarian law and be
humanitarian law training and in educational material at all without any discrimination of any kind or on any ground,
levels. without exception.
23. Guarantees of non-repetition, should include, where
applicable, any or all of the following measures, which will also XU. Non-derogation
contribute to prevention: 26. Nothing in these Basic Principles and Guidelines shall be
(a) Ensuring effective civilian control of militruy and
construed as restricting or derogating from any rights or
security forces; obligations arising under domestic and international law. In
particular, it is understood that the present Basic Principles and
(b) Ensuring that all civilian and military proceedings Guidelines are without prejudice to the right to a remedy and
abide by international standards of due process, fairness and reparation for victims of all violations of international human
impartiality; rights law and international humanitarian law. It is further
358
246
understood that these Basic Principles and Guidelines are Recalling further the definition of torture contained in
without prejudice to special rules of international law. article 1 of the Convention against Torture and Other Cruel,
Inhwnan or Degrading Treatment or Punishment, 186
XIlI. Rights of others
Noting that under the Geneva Conventions of 1949 187
27. Nothing in this document is to be construed as derogating torture and inhuman treattnent are a grave breach and that under
from internationally or nationally protected rights of others, the statutes of the International Tribunal for the Former
in particular the right of an accused person to benefit from Yugoslavia and of the International Criminal Tnbunal fur the
applicable standards of due process. Prosecution of Persons Responsible for Genocide and Other
Serious Violations of International Humanitarian Law
Committed in the Territory of Rwanda and Rwandan Citiz.ens
RESOLUTION 60/148 Responsible for Genocide and Other Such Violations Committed
in the Tenitoiy of Neighbouring States between 1 Januaiy and
Adopted at the 64th plenary meeting, on 16 Derember 2005, wilhoul a vote, on
31 December 1994, and the Rome Statute of the International
the recommendation of the Committee (A/60/509/Add.1, para. 23)185
Criminal Court188 acts of torture constitute war crimes and can
constitute crimes against humanity,
60/148. Torture and other cruel, inhuman or degrading
treatment or punishment Commending the persistent efforts by non-governmental
organizations, including the considerable network of centres for
The General Assembly,
the rehabilitation of victims of torture, to combat torture and to
Reaffirming that no one shall be subjected to torture or to alleviate the suffering of victims oftorture,
other cruel, inhuman or degrading treattnent or punishment,
1. Condemns all forms of torture and other cruel,
Recalling that freedom from torture and other cruel, inhuman or degrading treatment or punishment, including
inhuman or degrading treatment or punishment is a non- through intimidation, which are and shall remain prohibited at
derogable right that must be protected under all circumstances, any time and in any place whatsoever and can thus never be
including in times of international or internal anned conflict or justified, and calls upon all States to implement fully the
disturbance, and that the absolute prohibition of torture and absolute prohibition of torture and other crue~ inhuman or
other crue~ inhuman or degrading treatment or punishment is degrading treatment or punishment;
affirmed in relevant international instruments,
2. Emphasizes that States must take persistent,
Recalling also that a number of international, regional and determined and effective measures to prevent and combat
domestic courts, including the International Tnbunal for the torture and other cruel, inhuman or degrading treatment or
Prosecution of Persons Responsible for Serious Violations of punishment, including their gender-based manifestations, and
International Humanitarian Law Committed in the Territory of also emphasizes the importance of taking fully into account the
the Fonner Yugoslavia since 1991, have recognized that the recommendations and conclusions of the relevant treaty bodies
prohibition of torture is a peremptoiy norm of international law and mechanisms, including the Committee against Torture and
and have held that the prohibition of cruel, inhuman or the Special Rapporteur ofthe Commission on Human Rights on
degrading treatment or punishment is customaiy international torture and other cruel, inhuman or degrading treatment or
law, punishment;
3. Condemns any action or attempt by States or public
officials to legalize, authorize or acquiesce in torture and other
cruel, inhuman or degrading treatment or plDlishment under any
circumstances, including on grounds of national security or
185
The draft resolution recommended in the report was sponsored in the through judicial decisions;
Committee by: Albania, Andorra, Atgentina, Armenia, Australia, Austria,
A7.erbaijan, Bangladesh, Belarus, Belgiwn, Benin, Bolivia, Bosnia and 4. Stresses that all allegations of torture or other cruei
Henegovina, Brazil, Bulgaria, Bw1dna Faso, Canada, Central Aftican inhuman or degrading treatment or punishment must be promptly
Republic, Chile, Costa Rica, Croatia, Cyprus, Cz.ech Republic, Denrnruk,
Dominican Republic, Ecuador, El Salvador, Eritrea, Estonia, Finland, France,
and impartially examined by the competent national authority,
Georgia, Gennany, Ghana, Greece, Grenada, Guatemala, Honduras,
Hungary, Iceland, Ireland, Italy, Jordan, Kenya, Kyrgyzstan, Latvia,
Liechtenstein, Lithuania, Luxembourg, Malta, Mexico, Micronesia
(Federated States of), Monaco, Mongolia, Namibia, Netherlands, 186
United Nations, Treaty Series, vol. 1465, No. 2484 I.
New Zealand, Nicaragua, Nigeria, Nmway, Panama, Papua New Guinea, 187
Paraguay, Peru, Poland, Portugal, Republic of Korea, Republic of Moldova, Ibid, vol. 75, Nos. 970-973.
188
Romania, SanMarino, Serbia and Montenegro, Slovakia, Slovenia, South Official Records of the United Nations Diplomatic Coriference of
Aftica, Spain, Sweden, Swiuerland, the fonner Yugoslav Republic of Plenipotentiaries on the Establishment ofan International Criminal Court,
Macedonia, Timor-Leste, Twkey, Ukraine, United Kingdom of Great Rome, 15 June-17 July 1998, vol. I: Final documents (United Nations
Britain and Norlhem Ireland, United States ofAmerica and Uruguay. publication, Sales No. E.021.5), sect A
359
247
ANNEXURE P-5
248
Safety issues in the preparation of

homeopathic medicines
249
WHO Library Cataloguing-in-Publication Data:
Safety issues in the preparation of homeopathic medicines.
1.Homeopathy - standards. 2.Homeopathy - trends. 3.Drug compounding -

standards. 4.Medicine, Herbal. 5.Medicine, Traditional. I.World Health
Organization.
ISBN 978 92 4 159884 2 (NLM classification: WB 930)
© World Health Organization 2009
All rights reserved. Publications of the World Health Organization can be obtained from WHO
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should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail:
permissions@who.int).
The designations employed and the presentation of the material in this publication do not imply the
expression of any opinion whatsoever on the part of the World Health Organization concerning the
legal status of any country, territory, city or area or of its authorities, or concerning the delimitation
of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which
there may not yet be full agreement.
The mention of specific companies or of certain manufacturers’ products does not imply that they
are endorsed or recommended by the World Health Organization in preference to others of a
similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary
products are distinguished by initial capital letters.
All reasonable precautions have been taken by the World Health Organization to verify the
information contained in this publication. However, the published material is being distributed
without warranty of any kind, either expressed or implied. The responsibility for the interpretation
and use of the material lies with the reader. In no event shall the World Health Organization be
liable for damages arising from its use.
Printed in Spain
Contents
250
Contents
Contents .......................................................................................................................... iii
Acknowledgements ........................................................................................................ v
Foreword........................................................................................................................ vii
Preface .............................................................................................................................. ix
1 Introduction ................................................................................................................. 1
2 Challenges for quality control of homeopathic medicines................................. 3

2.1 Homeopathy and homeopathic medicines............................................................ 3
2.2 Potential safety issues............................................................................................... 4
2.3 Quality control challenges ....................................................................................... 5
3 Quality control issues for homeopathic medicines .............................................. 7

3.1 Plant material............................................................................................................. 7
3.2 Animal or human derived source material ........................................................... 9
3.3 Mineral and chemical material.............................................................................. 11
3.4 Mother tincture........................................................................................................ 12
3.5 Finished product ..................................................................................................... 12
3.6 Diluents and excipients .......................................................................................... 12
3.7 Impurities and contaminants ................................................................................ 13
4 Regulation regarding homeopathic medicines ................................................... 15

4.1 Regulations relating to manufacturing and marketing ..................................... 15
4.2 Consumer information ........................................................................................... 16
4.3 Regulatory frameworks.......................................................................................... 16
References....................................................................................................................... 19
Annex 1: List of participants in the WHO consultation on quality of

homeopathic medicines, Milan, Italy, 25-27 June 2007 .......................................... 23
Annex 2: Glossary ......................................................................................................... 25
Annex 3: Points to consider on safety of homeopathic medicines from

biological origin ............................................................................................................ 33
Annex 4: Examples of national labelling requirements for homeopathic

medicines in selected countries.................................................................................. 43
Annex 5: Examples of national regulatory requirements for homeopathic

medicines in selected countries.................................................................................. 47
iii
Key technical issues of quality impacting on the safety of homeopathic medicines 251
iv
Acknowledgements
252
Acknowledgements
The World Health Organization wishes to express its appreciation for the
generous financial support provided by the Regional Government of Lombardy
for the development and publication of this document, including financial
support for the organization of a WHO consultation during the development
process.
WHO further wishes to express its thanks to the Regional Government of

Lombardy and the WHO Collaborating Centre for Traditional Medicine at the
State University of Milan, Italy, for kindly hosting the WHO consultation on
quality of homeopathic medicines held in Milan, Italy, in June 2007.
WHO also acknowledges its indebtedness to approximately 400 reviewers from

more than 105 countries, including experts and national regulatory authorities in
more than 101 countries who provided national information, comments and
advice on the draft texts, members of the WHO Expert Advisory Panel on
Traditional Medicine, members of the WHO Expert Advisory Panel on
International Pharmacopoeia and Pharmaceutical Preparations, and members of
the WHO Collaborating Centres for Traditional Medicine. The preparation of this
document benefited, in addition, from technical support received from relevant
professional organizations and nongovernmental organizations in the field of
homeopathic medicines.
Special acknowledgement for the preparation of the revised draft document, by

reviewing and technically assessing the comments received, is also due to
Professor Tamas Paal, Hungary and, for preparation of the original text, thanks
are due to Dr Hermann Garden, Basel, Switzerland.
Special thanks are also due to participants at the June 2007 WHO consultation on
quality of homeopathic medicines in Milan, Italy, who reviewed and finalized the
draft document (Annex 1).
v
vi
Foreword
254
Foreword
Homeopathy is a system of medicine born in Europe in the last part of the

eighteenth century. The homeopathic doctors use homeopathic medicines, which
are prepared following a well-defined procedure, starting from substances
derived from the mineral, herbal and animal worlds. The techniques of
preparation of these drugs include the dilution of the raw material, in
hydroalcoholic solutions or in other excipients, and the potentization of the
product into different grades. In some cases, the dilution is so high that it is
almost impossible to find one molecule of the original raw material. Of course
this fact has created an intense debate between, on one side, people who have
experienced positive effects from homeopathic therapy and strongly believe in it
and, on the other side, people who criticize these products, as being contrary to
all the requirements of modern pharmacology.
The use of homeopathic medicines has spread more and more, and nowadays it
is widespread not only in the European region but also in south Asian countries
and North and South American countries. With the worldwide increase in the
use of homeopathic medicines and the rapid expansion of the global market, the
safety and the quality of homeopathic medicines has become a major concern for
health authorities, pharmaceutical industries and consumers. The safety of the
homeopathic medicines largely depends on their quality. Requirements and
methods for the quality control of finished homeopathic medicines are far more
complex than for chemical drugs, particularly for the combined or mixed
homeopathic medicines. Furthermore, the quality of the homeopathic medicines
is influenced both by the quality of the procedure used during their production
and the quality of the raw material. Products which meet high quality standards
are needed to allow the patient to make safe use of the homeopathic medicines.
Nowadays, this is more and more important because, as a consequence of market
globalization, many of the raw materials and medicines used in the homeopathic
systems come from different countries.
In the Lombardy region about 20% of the population regularly uses homeopathic
medicines, but almost 60% of the population use them occasionally for their
health and well-being and these numbers are increasing. Moreover, more than
34% of people use homeopathic medicines for self-healing. Of course, these
people need to be guaranteed the same high level of quality and safety that is
offered to the entire Lombardy population. Since 2002, the Social-Health Plan of
the Lombardy Region has supported the principle of freedom of choice among
different options of care.
Faced with the present situation, it is extremely important for the protection of
consumers to assure basic requirements for homeopathic medicines at the
international, national and regional levels. For this reason, the Regional
Government of Lombardy has provided its support and cooperation to WHO to
develop this technical document, in order to ensure that homeopathic medicines
meet minimum standards and to guarantee the high quality of homeopathic
medicines, both in Lombardy and worldwide. In addition, it is our wish that this
vii
technical document be used as a reference to facilitate establishment of regulation

in those countries where no regulations have yet been developed. This document
could also be used for the promotion of citizens' awareness about safety and
quality of homeopathic medicine.
Luciano Bresciani Giulio Boscagli

Regional Minister of Health Regional Minister of Family and Social
Regional Government of Lombardy Solidarity
Regional Government of Lombardy
viii
Preface
256
Preface
Herbal medicines have been increasingly used over the past three decades. For
example, in Europe in 2003, herbal medicine sales were worth 5 billion
US dollars.1 The cost of the traditional Chinese medicines used in China in 2008
was 26 billion US dollars.2 The value of Japan's production of its traditional
medicines, known as kampo medicines, reached almost 1 billion US dollars in
2007.3
Homeopathy is one of the most commonly used forms of herbal medicines.4

There is a large market for homeopathic products around the world. For
example, in 2008, Australia spent 7.3 million US dollars on homeopathic
medicines;5 France spent more than 408 million; Germany 346 million and the
United Kingdom more than 62 million US dollars.6 In the United States, adults
7
spent 2.9 billion US dollars on homeopathic products in 2007.
Given the importance of homeopathic medicines, health authorities – and

consumers - are quite naturally concerned with their safety. Since homeopathic
medicines are typically administered at a very high dilution, and ingredients
may not even be detectable or quantifiable in the final products, homeopathic
medicines are often thought to present no major safety concerns. Still, there are a
few aspects of the production of homeopathic medicines that could constitute
potential safety hazards. Firstly, not all homeopathic medicines are administered
at a high dilution. Sometimes, a homeopathic medicine made from source
material, such as a mother tincture, is administered in the most concentrated
form. Secondly, homeopathic medicines are made from a wide range of natural
or synthetic sources: minerals and chemicals, but also plant materials, including
1
De Smet P. Herbal medicine in Europe – Relaxing regulatory standards. New England
Journal of Medicine, 2005, 352:1176–1178.
2
China Research & Intelligence. Report of traditional medicine industry, 2009. Shanghai,
China Research & Intelligence (http://www.shcri.com/reportdetail.asp?id=275, accessed
15 September 2009).
3
The yearbook of statistics of production by the pharmaceutical industry, 2007 [original in
Japanese]. Tokyo, Ministry of Health and Welfare, 2008
(http://www.mhlw.go.jp/topics/yakuji/2007/nenpo/index.html, accessed 13 August
2009).
4
WHO traditional medicine strategy 2002–2005. Geneva, World Health Organization, 2002.
5
A survey conducted by the Complementary Healthcare Council of Australia, 2008.
6
ECHAMP. Homeopathic and anthroposophic medicine in the United Kingdom: ECHAMP Facts
and Figures, 3rd ed. Brussels, ECHAMP, 4 August 2009 (e-pub ahead of print).
ECHAMP. Homeopathic and anthroposophic medicine in the French Republic: ECHAMP Facts
and Figures, 3rd ed. Brussels, ECHAMP, 4 August 2009 (e-pub ahead of print).
ECHAMP. Homeopathic and anthroposophic medicine in the Federal Republic of Germany:
ECHAMP Facts and Figures, 3rd ed. Brussels, ECHAMP, 4 August, 2009 (e-pub ahead of
print).
7
Nahin NL et al. Costs of complementary and alternative medicine (CAM) and frequency
of visits to CAM practitioners: United States, 2007. National Health Statistics Report, 2009,
18 (http://nccam.nih.gov/news/camstats/costs/nhsrn18.pdf, accessed 15 September
2009).
ix
roots, stems, leaves, flowers, bark, pollen, lichen, moss, ferns and algae;
microorganisms, including fungi, bacteria, viruses and plant parasites; animal
organs, tissues, secretions and cell lines. Human materials may include tissues,
secretions, hormones, and cell lines. Some of these source materials constitute
potential safety hazards, even at high dilutions.
The resolution on traditional medicine adopted by the World Health Assembly

(WHA) in May 2009 (WHA62.13),1 urges Member States to “formulate national
policies, regulations and standards, as part of comprehensive national health
systems, to promote appropriate, safe and effective use of traditional medicine.”
It also requests WHO to "continue providing technical guidance to support
countries in ensuring the safety, efficacy and quality of traditional medicine.”
This applies to homeopathic medicines, and this document is a contribution to
implementing these recommendations, by identifying potential safety issues
related to the production of homeopathic medicines.
At the same time, it attempts to bring some consensus about terminology

harmonize definitions of homeopathic medicines, to recommend safe degrees of
dilutions of homeopathic preparations and to promote the exchange of
information.
In preparing this document, WHO has consulted with more than 400 reviewers
from 105 countries, including experts in the fields of homeopathic medicines,
herbal medicines, biologicals and pharmaceuticals, members of the WHO Expert
Advisory Panel on Traditional Medicine, members of the WHO Expert Advisory
Panel on international pharmacopoeia and pharmaceutical preparations and
WHO Collaborating Centres for Traditional Medicine, as well as relevant
nongovernmental organizations. National regulatory authorities in more than
100 countries have received the drafts of the document for their review and
provided additional information, comments and advice.
The document is intended as a support to national regulatory authorities – and to

manufacturers of homeopathic medicines - in ensuring the safety and quality of
homeopathic medicines. National authorities may want to use it as a reference
when establishing appropriate regulatory requirements. The document provides
definitions of commonly used technical terms in relation to the quality of
homeopathic medicines:. This had been recommended by workshop on
homeopathy at the 10th International Conference of Drug Regulatory Authorities
(ICDRA) in 2002, held in Hong Kong Special Administrative Region of the
People's Republic of China, and should facilitate quality control regulation.
Dr Xiaorui Zhang
Coordinator, Traditional Medicine

Department of Health System Governance and Service Delivery
World Health Organization
1
http://apps.who.int/gb/ebwha/pdf_files/A62/A62_R13-en.pdf
x
Introduction
258
1 Introduction
The term homeopathy is derived from the Greek words ۳μȠȚȠȢ (hómoios: similar)
and ʌȐșȠ䪷 (páthos: suffering, disease). Homeopathy has a holistic approach to
healing, with as its central tenet that “like cures like” (in Latin: similia similibus
curentur). Homeopathy has its own views on illness, and its own diagnostic and
treatment principles, as well as products and practices. Established in 1796 by the
German physician Samuel Christian Hahnemann, it treats patients with heavily
diluted preparations of substances which in their undiluted form are thought to
cause effects similar to the symptoms presented. Homeopathic medicinal
products are also used in other therapeutic approaches with a different
epistemological and methodological status, such as anthroposophic medicine,
homotoxicology/antihomotoxic therapy and isotherapy .
Homeopathy is widely used in all WHO Regions. The national regulatory

framework and the place of homeopathy within the health care system differ
from country to country, but the use of homeopathic medicines, mostly as non-
prescription medicines, is growing in many parts of the world. The exact size of
the homeopathic medicines market in economic terms, is not well known, but
sales data reveal that homeopathic medicines represent a significant part of
medical economies.
Despite the growing use of homeopathic medicines worldwide, few of the WHO
Member States regulate these medicines. It is usually taken for granted that the
safety of homeopathic medicines should not be a major concern as these
medicines are often highly diluted when administered. However, this is not
always the case. Moreover, the variety of materials used (medicinal plants,
animal and human materials, pathogens as well as minerals and chemicals) and
other technical aspects of the production and manufacture of homeopathic
medicines may constitute potential risks to their safety.
Adverse events occurring during homeopathic treatment are rarely attributed to

the homeopathic medicine itself. However, safety assessment should also
consider possible impurities of the source material or contamination and failures
of good manufacturing practice. Furthermore, because many homeopathic
medicines can be purchased as non-prescription medicines in community
pharmacies and health stores, without consultation with a healthcare provider, it
has become increasingly important to provide sufficient and accessible
information on such medicines. Although homeopathic medicines are generally
assumed to be benign, the level of authorization, appropriate labelling and
quality assurance should take into consideration its extensive use, also within
vulnerable populations such as the elderly, pregnant women and children.
In recent years there have been a number of calls on WHO to support efforts to
regulate the safety of homeopathic medicines.
WHO’s Traditional Medicine Strategy 2002-2005, as well as that covering the

period from 2004 to 2007 have both addressed the safety, quality and efficacy of
1
traditional medicine (TM) and complementary and alternative medicine (CAM).

Developing technical guidance regarding the safety and quality control of herbal
medicines and other TM/CAM products was a key element in these Strategies.
The 10th International Conference of Drug Regulatory Authorities (ICDRA) held

in Hong Kong Special Administrative Region of the People's Republic of China in
June 2002, requested WHO to: “Harmonize definitions of homeopathic
medicines; [make] recommendations for safe degrees of dilutions of homeopathic
preparations; promote the exchange of information; and provide guidance to
governments and [nongovernmental organizations] NGOs training of
homeopathic medicines”(1).
Finally, resolution WHA56.31 on traditional medicine, adopted by the 2009

World Health Assembly, requested WHO to provide technical support for
developing methodologies to ensure product quality, efficacy and safety.
This technical document is WHO’s response to these requests and

recommendations, and is a part of the implementation of the WHO Traditional
Medicine Strategy and the WHO Medicines Strategy. It aims to provide guidance
to Member States on technical aspects of the production and manufacture of
homeopathic medicines that potentially have implications for their safety. This is
of relevance for establishing national quality standards and specifications for
homeopathic medicines, as well as for controlling their quality. The document,
however, does not address issues of efficacy or clinical utilization.
Homeopathy uses a specific terminology that is not always used in a consistent

way in the monographs and current editions of pharmacopoeias in official use.
For the purpose of this document it has been necessary to define key terms
unambiguously: without doing so quality control recommendations are difficult
to make. The terms used in this document are defined in Annex 2. These
definitions enjoy considerable consensus, and are broad enough to encompass
homeopathic medicines made and used according to well-established variations
to the original philosophy of Hahnemann (such as reference to complex
homeopathic medicines and those referred to as homeotherapy). The
terminology is used consistently as defined in the annex; this is felt to be
necessary for a uniform and explicit regulation of homeopathic medicines.
The document is structured in three parts. First the specificity of homeopathic

medicines is reviewed, indicating the type of potential safety problems they may
present and the quality control challenges this poses. The next chapter deals
specifically with the safety aspects related to the materials and ingredients used
in the preparation of homeopathic medicines. The last part reviews regulatory
issues related to the manufacturing and marketing processes, and to consumer
information. The body of the document is followed by a glossary of technical
terminology relevant to the subject, and complementary materials.
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Challenges for quality control of homeopathic medicines
260
2 Challenges for quality control of

homeopathic medicines
2.1 Homeopathy and homeopathic medicines

The central tenet of homeopathy is that “like cures like” (in Latin: similia similibus
curentur), in a holistic approach to the totality of the patient’s symptoms.
Homeopathic medicines are based on the principle that high dilutions of
potentially active molecules retain a memory of the original substance. Hence,
the starting materials, the homeopathic stocks and/or mother tinctures are
subjected to a process of serial dilution and succussion in order to potentize the
product with an inert carrier material. Originally, Hahnemann employed this
process to diminish the toxicity of potentially hazardous substances. The name
potentization to characterize this process was given by him later.
From the safety point of view it is important to note first that, although
homeopathic treatments often utilize ultramolecular dilutions of the starting
material (above Avogadro's number), there are also homeopathic medicines of
considerably lower dilution which do contain molecules that may be active in the
biochemical sense. Hence, although homeopathic medicines are in general
considered to be safe when administered appropriately, toxicological aspects
should not be neglected especially when using lower dilutions of unsafe starting
material.
Moreover, the amount of starting material present in homeopathic medicines

may depend on the method of preparation. Safety issues may arise if these
differences in method of preparation are neglected. For example, a comparison of
the "identically" entitled pharmacopoeial monographs on Aconitum napellus in
different pharmacopoeias, e.g. the Pharmacopoeia française (Phf) (2), the German
Homeopathic Pharmacopoeia (GHP) (3), the Homoeopathic Pharmacopeia of the United
States (HPUS) (4) and the Homoeopathic Pharmacopoeia of India (HPI) (5), reveals
considerable differences (Table 1). Aconitum napellus 1X = 1DH prepared
according to the German Homeopathic Pharmacopoeia is closer to Aconitum napellus
mother tincture than to the 1X = 1DH, both prepared to according to the
Pharmacopoeia française. In the case of India the alkaloidal content is not specified
because the members of the Homoeopathic Pharmacopoeia Committee (HPC)
feel that minor variations in the quantity of physiologically active alkaloids in the
end product are of no consequence for the action of the medicine. They consider
it acts qualitatively, at a non-physiological level, and its action is qualitative and
not quantitative (dose-dependent).
3
Table 1. The monographs on Aconitum napellus in four pharmacopoeias
Characteristic Pharmacopoeia German Homoeopathic Homoeopathic

française Homeopathic Pharmacopeia Pharmacopoeia
(Phf) Pharmacopoeia of the United of India
(GHP) States (HPI)
(HPUS)
Alkaloid content 0.02–0.05% 0.08–0.16% 0.025–0.075% Not described

expressed in aconitine (approximately
in the mother tincture 0.03%)
Ratio of mother tincture 1:9 1:4 1:1 Mother
to diluent for obtention Tincture = 1X
of 1X = 1DH
Percentage of the 10% 20% 100% 100%
mother tincture in the
1DH dilution
Resulting alkaloid 0.002–0.005% 0.016–0.032 % 0.025–0.075% N/A
content expressed in
aconitine in 1X = 1DH
2.2 Potential safety issues
There are two major groups of potential hazards: those related to the source
materials, and those related to the procedures used for manufacture of the
finished product.
Homeopathic medicines or their stocks/mother tinctures are prepared from

natural or synthetic sources that are referenced in pharmacopoeial monographs
or other recognized documents. Not considering imponderabilia, the source
materials for homeopathic medicines may consist of the following:
• plant material such as: roots, stems, leaves, flowers, bark, pollen, lichen,
moss, ferns and algae;
• microorganisms such as: fungi, bacteria, viruses and plant parasites;
• animal materials such as: whole animals, animal organs, tissues, secretions,
cell lines, toxins, nosodes, blood products;
• human materials such as: tissues, secretions, cell lines and endogenous
molecules such as hormones;
• minerals and chemicals.
The quality of source materials and of the excipients used in the manufacture of
homeopathic medicines is important. Homeopathic medicines may employ
material from problematic sources, the use of which is restricted in conventional
medicine: nosodes comprise dilutions of pathogenic organs or tissues; causative
agents such as bacteria, fungi, ova, parasites, virus particles, and yeast; disease
products; excretions or secretions. All materials of animal or human origin are at
risk of containing pathogenic agents. Homeopathic medicines may be based on
toxic source materials from animals or plants, while others, particularly in their
fresh form are prone to degradation processes or microbiological contamination.
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Challenges for quality control of homeopathic medicines
262
Plant materials may be contaminated with pesticides and heavy metals. The
content of toxic constituents in plant materials may vary considerably.
Good manufacturing practice (GMP) guidelines covering the manufacturing

process, premises, personnel, packaging and labelling apply to homeopathic
medicines as well as to conventional pharmaceuticals. Failure to apply GMP may
lead to major quality and safety concerns such as misidentification, impurity of
starting material, cross-contamination or incidental contamination.
The unique characteristics of the manufacturing of homeopathic medicines has a

number of specific implications and demand specially qualified and experienced
personnel. These have to handle toxic materials, materials, particularly fresh
ones, that are prone to degradation processes and microbial contamination; and
homeopathic medicines derived from animals or human sources. The properties
of homeopathic medicines can be compromised by accidental or intentional
contamination of source materials, excipients or diluents, or by the vessel or
bottle in which the dilution is made. Because definitions may vary between
pharmacopoeias, and because of the wide range of processing techniques and
manufacturing methods in the various pharmacopoeias, the final homeopathic
products may show marked variability.
2.3 Quality control challenges
Manufacturers of licensed medicines are required to prove that their products

meet basic quality standards and adhere to GMP guidelines. The same goes for
licensed homeopathic medicines. Most established manufacturers of
homeopathic medicines have already adopted relevant measures for quality
assurance procedures and manufacture according to the principles of GMP. This
is not always the case in countries where production of homeopathic medicines is
not subject to licensing. Beyond adherence to GMP guidelines, the distinctive
characteristics of homeopathic medicines have implications for quality control.
First, a number of WHO technical guidelines relating to quality assurance and

control of herbal medicines apply (6, 7, 8–12).
Second, the specific nature of homeopathic medicines have as consequence that

some of the methods for quality control and some test systems that are
mandatory in pharmaceutical regulation, may at times be inapplicable or
irrelevant. These include identification and quantification of active substance and
toxicological testing of the final homeopathic product. Identification and assay of
source materials may not be feasible at high potencies. In such cases the quality
should be demonstrated by complete validation of the manufacturing and
dilution process.
5
6
Quality control issues for homeopathic medicines
264
3 Quality control issues for homeopathic

medicines
Homeopathic medicines are often prepared from natural source materials. Two
issues are decisive for the quality of homeopathic preparations: determining the
authenticity and the origin of the starting materials according to the homeopathic
tradition, and defining the manufacturing procedure. As long as the identity and
purity of starting materials and the reproducibility of the manufacturing process
are given, the natural biological and geographical variation of starting materials
are an integral part of quality of homeopathic medicines. Identity and purity
testing is usually performed with the starting material and with the least diluted
source employed for potentization (e.g. mother tincture). Consistency of product
quality is assured by defining appropriate specifications especially for starting
materials, and by defining the manufacturing procedures standardized according
to official homeopathic pharmacopoeias and other officially recognized
documents, and validated according to GMP.
The diverse origin of the raw materials used in the production of homeopathic
medicines requires a range of approaches to ensure the safety of the final
product. Generally speaking, quality control should perform identification and, if
applicable, quantification of materials before processing; using validated
techniques and relevant analytical tests on source identity, possible contaminants
and toxic constituents. These tests should be of pharmacopoeial or equivalent
status (13 - 15).
Raw material used for homeopathic preparations should be characterized to

determine, where applicable, the origin, the history and the nature of the starting
material:
• if of botanical origin, the scientific name – genus, species,
subspecies/variety, authority and name of family (cross-reference to
general name); other information as appropriate such as ecotype,
chemotype, and phenotype; part employed; the state of material; possible
pharmacologically active or toxic constituents; macroscopic and
microscopic description;
• if of biological origin, by the physical, anatomical and histological state;
and
• if of mineral or chemical origin, by the physical form, structural formula
and relative molecular mass.
3.1 Plant material
Where plant material is used, all matter, including parts of plants, exudates or
processed materials should comply with the relevant national quality standards
and specifications, pharmacopoeial analytical requirements and monographs. In
addition to any pharmacopoeial references on quality control and analytical
7
testing of herbal materials, other relevant guidelines and manuals may also be
considered (6, 7, 8-12, 15-18).
Due to the complex and variable nature of plant material, and its possible
contamination with microbes, insects, pesticides, heavy metals, fumigants,
mycotoxins and radioactivity, adequate control of source material, storage and
processing assume particular importance when plant materials are used in the
manufacture of homeopathic medicines.
Manufacturers are called to follow exemplary standards and provisions

regarding identification of source material, limit tests, and complementary tests.
These are listed in Table 2. A clear description of the following characteristics
should accompany every batch, or its absence should be justified:
• parts/material of plant used; macroscopic description of plant and plant
material;
• microscopic characteristics;
• identity tests;
• purity tests;
• moisture/water content;
• determination of content of toxic constituents (if applicable);
• method for preparation of mother tincture.
Table 2. Provisions regarding quality control of plant material used for the preparation
of homeopathic medicines.
Identification of 1. scientific name;
source material 2. stage of growth;
3. part of plant used;
4. information about whether materials were cultivated or
collected from the wild and the place of cultivation or
collection from the wild;
5. comparison, by the manufacturer or by a recognized
laboratory, with an illustrated description of an authentic
specimen for macroscopic and microscopic characteristics
as well as analytical determination of marker substances
or standard substances (if applicable).
Limit tests: 1. Limit tests should be performed for:
• pesticides (agricultural and veterinary chemicals),
• heavy metals (if appropriate, for metals such as lead,
mercury, arsenic and cadmium),
• fungi, bacteria, mycotoxins (e.g. aflatoxins), and
• any other relevant contamination (e.g. by-products of
manufacture, radiolytic products derived from
sterilization by ionizing radiation, or residues from
other decontamination procedures).
2. Limit tests should be done on representative samples at
an unprocessed or raw stage (if processed matter has to
be used, a sample should be taken before any
potentization is done).
3. Limit tests and ranges should comply with
pharmacopoeial standards, as limits applicable to food
may not be appropriate.
8
266
Complementary Where applicable, tests are performed for:

tests: 1. foreign matter;
2. total ash;
3. water content;
4. bitterness value;
5. loss on drying;
6. radioactive contamination.
3.2 Animal or human derived source material
Homeopathic medicines derived from healthy or diseased animals or human

sources raise concerns about microbiological and viral contamination. These
issues are discussed, particularly with a view of minimizing the risk of exposure
to transmissible spongiform encephalopathy (TSE) transmitting agents. The
Head of Medicines Agencies Homeopathic Medicinal Products Working Group
has reviewed the points to consider on safety of homeopathic medicines of
biological origin (Annex 3).
Adequate and validated procedures such as filtering, pasteurization, sterilization

or precipitation have to be used depending on the individual raw material,
contamination or pathogenic load, especially to establish the first safe
preparation. The dilution process alone is not sufficient to establish microbial,
viral or TSE safety (Box 1). Therefore, effectiveness of the method used to
eliminate pathogenic agents, in addition to dilution, should be assessed and
validated by appropriate limit tests. If homeopathic medicines are prepared from
raw animal (ruminant) products, all possible transmission of pathogenic agents
should be taken into account in the safety procedures. Because animal-derived
organs and secretions have different levels of infectivity, tissues can be grouped
into corresponding categories (19-21). Only first safe preparations may be
distributed as homeopathic medicines or intermediates. These should comply
with the principles of minimization of the risk of transmission of pathogenic
agents (e.g. sterilization), taking into account the species infection potential other
than the homeopathic therapeutic agent. The determination of the “first safe
preparation or dilution” ensures the correct definition of viral studies to be
applied to evaluate putative infectivity. Safety studies, taking both viral and non-
viral adventitious agents into consideration, should be performed at this lowest
level prior to manufacturing further dilutions and/or other homeopathic
preparations.
Box 1: Managing the risk of transmission of TSE

The use of materials derived from animal resources is essential in certain homeopathic
medicines. Currently, there is no evidence that TSE has ever been transmitted by the use
of products of animal origin in medicines including homeopathic medicines. However, in
response to general safety concerns, the possible risks of TSE and related diseases in
animals and humans (e.g. bovine spongiform encephalopathy (BSE), scrapie, Creutzfeld-
Jacob Disease (CJD)) should be addressed. The species of the animal and its age constitute
important information for a risk assessment. This also concerns carrier materials and
excipients, for example, gelatine, collagen, milk and milk-derived products, lecithin,
phospholipids, amino acids and protein hydrolysates, glycerol and stearates. Sufficient
and accessible information is required for the sponsor and the public, backed up by
9
regular inspections, strict legislation on international trade and traceability back to the
slaughterhouse.
To enable the self-assessment of the processes by the manufacturer and/or sponsor and
to minimize the risks of TSE transmission, the following measures should be taken:
• animal species that are not affected by TSE or a non-animal-origin should be
preferred;
• use of highly infective tissues must be considered in the context of actual scientific
data, and, in particular the age of the animals. The use of such material can be
legitimate where adequate documentation on risk assessment is available;
• possible cross-contamination should be avoided through validated cleaning
processes;
• preferably, young animals should be used;
• where concerns exist, samples should be submitted for pre-clearance to a recognized
laboratory;
• a risk–benefit assessment should be done to consider the quantity of animal material
used;
• working procedures and sources of material should be documented to identify
products and enable an immediate response in the case of any unexpected event.
Source materials of animal origin should comply with test systems described
for:
• contamination with viruses pathogenic to humans (e.g. European
Pharmacopoeia 6.0 (22), “Homeopathic preparations” describing handling
of starting materials of animal origin with a clear distinction between
starting materials from healthy animals);
• agents that could transmit animal spongiform encephalopathy (e.g.
European Pharmacopoeia 6.0 (22), “Minimizing the risk of transmitting
animal spongiform encephalopathy agents via human and veterinary
medicinal products”).
A clear description of the following characteristics should accompany every

batch, or its absence needs to be justified:
• identification of the source of the animal material, including information
on whether animals were bred or caught in the wild and the place of
breeding or capture in the wild.;
• parts/material of animal used;
• anatomical description of the animal part;
• histological description of the animal part;
• identity tests;
• purity tests;
• determination of content of toxic constituents (if applicable);
• method for preparation of the initial homeopathic preparation (reference
to general procedure).
Source material of human origin (tissues, blood or fluids) is a potential source of

infection through a variety of known and unknown transmissible agents.
Whenever any blood product is to be used, or contamination of blood is possible,
raw materials should comply with the relevant national or official guidelines (3,
23-25). Since human-derived materials such as pituitary or liver extracts,
albumin, or tonsils may be contaminated by bacteria, virus or CJD transmission,
quality control measures should address these issues.
10
268
Clear documentation on the donor is a prerequisite for ensuring the safety of

homeopathic medicines of human origin. A clear description (from tests and/or
documentation of history of the material) of the following characteristics should
accompany every batch, or its absence needs to be justified:
• identification of the source;
• material used;
• anatomical description;
• histological description;
• identity tests;
• purity tests;
• method for preparing the initial homeopathic preparation (reference to
general procedure).
Nosodes. By definition, nosodes comprise dilutions of pathogenic organs or

tissues; causative agents such as bacteria, fungi, ova, parasites, virus particles,
and yeast; disease products; excretions or secretions. Nosodes are considered as
homeopathic medicines if processed in accordance with a recognized
homeopathic pharmacopoeia in official use, or other officially recognized
documents. Due to their diverse nature, it is recommended that nosodes be
evaluated individually for safety assessment.
Biotechnological source material, i.e. materials derived from biotechnologically

manufactured or processed raw materials (e.g. human, animal or plant cell lines,
microorganisms, genetically modified organisms or products of fermentation)
should comply with relevant guidance (26-29).
3.3 Mineral and chemical material
If minerals or chemicals are used as source materials for the manufacture of

homeopathic medicines, analytical tests should be carried out to determine the
identity and the source or origin; to detect possible contamination with heavy
metals and any other possible toxic constituents. The purification procedure must
be described. For minerals and chemicals data must be presented on source
material; appearance and description of raw materials; identity tests; purity tests;
and determination of content. If these data are absent justification must be
provided.
For the first dilution/trituration, details of the following are required, or their
absence needs to be justified:
• method of preparation;
• description and characteristics;
• identity tests;
• purity tests;
• determination of content;
• determination of toxic constituents.
11
3.4 Mother tincture
Mother tinctures for the production of homeopathic medicines should comply

with pharmacopoeial specifications and quality requirements in official use, or
those of other officially recognized documents.
The following data should be presented, or their absence needs to be justified:

• method of preparation (reference to general procedure);
• appearance and description;
• identity tests;
• purity tests;
• procedure for stability tests;
• determination of content;
• determination of toxic constituents.
3.5 Finished product
Homeopathic dosage forms in the final products should comply with

pharmacopoeial requirements and should be tested to determine the following:
• identity and content (if applicable); normally the test for uniformity of
content is not appropriate either to determine the potency or to
demonstrate that the source material or its characteristic constituents
cannot be detected;
• quality of dosage form (uniformity of mass, hardness and friability for
tablets – test for disintegration can only be omitted when justified); test
for viscosity or rheology (for ointments);
• residual solvents, reagents or incidental contamination as a result of the
manufacturing process (e.g. European Pharmacopoeia 6.0 (22), “Residual
solvents; limiting residual solvent levels in active substances, excipient,
and medicinal products”;
• stability; the stability tests for the dosage form should be the minimum
requirement.
3.6 Diluents and excipients
In addition to the evaluation of active substances, safety evaluation should also

cover the excipients and diluents used in homeopathic medicines. The
manufacturer should ensure that:
• all excipients and diluents included in the final product are listed in the
documentation and, if applicable, on the label if required under national
legislation;
• excipients and diluents comply with a pharmacopoeia in official use or
other officially recognized documents;
• if new excipients and diluents are included, sufficient data on their safety
and quality are provided to national health authorities.
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270
Depending on the pharmacological and toxicological nature of the excipient and

diluents concerned, risk evaluation should take into account their overall
exposure, because any substance might be found potentially toxic after long term
or intensive use. In this context, it should be recognized that additional sources
or routes of administration of the excipient or diluent from food or concomitant
treatments might add to the total daily exposure.
Special attention should be paid to the general labelling and warnings on the
package of the final product. For example, ethanol, glycerol and lactose, often
used in the preparation of homeopathic medicines, are listed in the EU under the
guideline ENTR/F2/BL D (2003) entitled Excipients in the label and package leaflet
of medicinal products for human use (30) and a threshold is given for the individual
substance on a per dose basis.
The Food and Drug Administration of the US (US FDA) has set up “maximum
concentration limits for alcohol as an inactive ingredient in OTC drug products
intended for oral ingestion”. However, it should be recognized that “dose” has to
be defined more precisely, as a single dose and as a maximum daily dose. It is the
actual intake of the excipient or diluent that is relevant, although very low in the
case of homeopathic products, and not its percentage in the final product. On the
other hand, in homeopathy, small quantities can be used several times a day and
such homeopathic medicines may contain high levels of ethanol. In this context,
adequate information including warnings, contraindications and adoption of
monographs is mandatory when remedies are prescribed to children, women
who are pregnant or breastfeeding, or patients with relevant medical histories
including liver failure, brain injury, seizures or alcoholism. Other relevant
warnings as regards sugars also apply to homeopathic medicines.
3.7 Impurities and contaminants
Quality and safety of homeopathic medicines can also be affected by impurities

and incidental constituents, which may be found in the final preparation as a by-
product of manufacturing and storage, contamination or low-quality raw
materials, or may be formed during the production process. Such constituents
include microbial toxins, microorganisms, metals, pesticide residues or
degradation products. These impurities may pose a potential risk to patients and
therefore need to be minimized. Hence, the manufacturer or sponsor should
validate and manage the production, processing and storage practices. Owing to
the large range of potential impurities and contaminants and the varying extent
of exposure to them over time, no comprehensive list of all impurities and their
limits can be presented. However, the manufacturer has an obligation to trace
and minimize the presence of impurities and contaminants. The following
questions should be considered in setting requirements regarding impurities and
incidental constituents:
• what specific impurities and contaminants need to be considered?
• what tests (validated and reproducible limit tests which comply with a
pharmacopoeia in official use or other officially recognized documents
should be applied?
• what limits should be specified? (If possible, pharmacopoeial references
should be used – others have to be justified.)
13
Therefore, quality control has to determine limits of relevant contaminants for

the source material as well as the stock solution or triturate. This aspect is of
particular importance, since storage and manufacture may pose an additional
risk for accidental contamination of the final product. In principle, the legal
standards and limits for the final product should comply with those published in
the pharmacopoeia in official use or other officially recognized documents.
To ensure adequate quality and safety of the final homeopathic product, limit
and product tests, validation checks and process control represent essential
approaches and apply to the source materials, stocks or mother tinctures, starting
materials and excipients. Methods, techniques and apparatus necessary for the
quality control of homeopathic medicines has to be in accordance with a
pharmacopoeia in official use or other officially recognized documents.
14
Regulation regarding homeopathic medicines
272
4 Regulation regarding homeopathic

medicines
The regulatory framework and its requirements for homeopathic medicines

differs from country to country. Homeopathic medicines may be subject to
similar regulatory control to that applicable to conventional pharmaceutical
products, with adaptations to the particular requirements of homeopathic
medicines. In some countries they are subject to separate regulatory frameworks.
A number of regulatory authorities already require quality assurance of

homeopathic medicines. Manufacturers, packagers, labellers, importers and
distributors of finished homeopathic medicines or related raw materials have to
meet the relevant requirements including effective process controls, validated
analytical methods, adequate buildings, and good storage and sanitary
conditions.
4.1 Regulations relating to manufacturing and marketing
The regulatory frameworks expect health authorities to request pre-marketing

proof of quality and safety. Typically, manufacturers of homeopathic medicines
are expected to prepare documentation describing quality assurance in general,
and quality control of specific homeopathic medicines. Raw or source material,
mother tincture, diluent or excipient, and final product must all comply with
quality standards published in an official pharmacopoeia or documentation of
equivalent status and the process of manufacture should conform with the
applicable GMP principles (12).
While GMP guidelines provide general guidance for medicinal products

including homeopathic medicines, they do not necessarily address the special
requirements of homeopathic medicines for guidance on, e.g., process validation
or quality assessment of the starting material. Theoretically, this could lead to
substandard product quality, which may pose a risk to public health and could
result in a comprehensive product recall. The relevant documents that define
basic principles in quality assurance and control, taking into account the unique
characteristics of homeopathic medicines (4, 6 ,10-12, 31-38). These are general
guidance references, and may be adapted to meet individual needs. The
equivalence of alternative approaches to quality assurance should, however, be
validated.
Validation of the manufacturing process is crucial, given the specific nature of

homeopathic medicines. It relies heavily on the compliance with the master
formula which provides the relevant information on the system of potentization
to be adopted (e.g., decimal, Hahnemannian) and the relevant pharmacopoeial
method; processing of raw materials (e.g. maceration or percolation); number of
succussions during each potentization step; duration of trituration; method of
15
impregnation; in-process controls; and procedures to be followed for handling of

the final product1.
4.2 Consumer information
Given the conditions under which homeopathic medicines are used, consumer
information is a critical issue (39). A particular aspect is constituted by the
product label and package leaflet, which represent the first and, in many cases,
the only information received by the consumer, it plays a crucial role in safe and
rational use of the medicine. Hence, it is important, that labels show the required
consumer information about the product. Labelling requirements vary from
country to country and may be very detailed, as is the case in Canada (Annex 4).
The list of labelling requirements in Table 3 may serve as orientation for what is
generally considered useful and realistic. Local regulatory systems may require
additional data, such as lists of contraindications, precautions and side-effects;
also special patient groups, such as pregnant or breastfeeding women, children
and people with allergies should be addressed. Moreover, there may be a
requirement that licensed homeopathic medicines should be sold with a package
insert, similar to that of conventional medicines. Some of the information listed
above might be presented in the package insert, or on the secondary packaging,
according to national provisions.
4.3 Regulatory frameworks
The objectives, scope and approaches of national regulatory frameworks for

homeopathic medicines varies considerably from country to country. Even in
highly regulated health systems, regulation of homeopathic medicines may still
be in an early stage. Annex 5 provides a set of examples from countries with
regulatory systems in place. Most divide homeopathic medicines into two or
more classes, - with limitations on route of administration and minimal dilution,
but also with.simplified authorization procedures for those that are considered
harmless and used for self-limiting conditions and over the counter sales. On the
whole, however, there is still a dearth of information on the occurrence of safety
problems and on whether safety in those counties that have regulatory and
quality control regimes safety is actually improved.
There is a need for better documentation and evidence on actual rather than
potential safety problems. For example, in a number of countries there are
regulatory frameworks that oblige licence holders to report possible adverse
reaction after authorization, including events related to quality defects and
incorrect labelling. Such pharmacovigilance systems yield information on
adverse events. Current global databases, however, document only very few
1
The “first safe preparation or dilution” should be clearly defined. Depending upon
national provisions and legislation, manufacturers or distributors of homeopathic
medicines may face restrictions on their distribution of potencies below “first safe
preparation”. The first safe preparation should be defined on a case-by-case basis and can
be defined at any level of the manufacturing process up to the last removal/inactivation
step introduced in the process.
16
Regulation regarding homeopathic medicines
274
Table 3. Typical labelling requirements for the safe and proper use of homeopathic
medicines
• name and address of manufacturer, packager or distributor (with contact
telephone number or e-mail address, if appropriate);
• manufacturer’s batch number;
• registration number (if applicable);
• net amount (content) of the product in the container;
• common name of dosage form, the traditional homeopathic name commonly
used in the geographical area, if applicable;
• statement that identifies the product as homeopathic – e.g. “homeopathic
medicine” or “homeopathic medicine for anthroposophic use”;
• scientific name of the active substance(s), and/or the traditional homeopathic
name of the active substance(s), as given in recognized pharmacopoeias in
official use or other officially recognized documents; the degree of
dilution/potency; and a reference to the pharmacopoeia that was used for the
method of preparation;
• quantity of the active substance(s) in the dosage form;
• excipients, if required by the national regulatory system;
• directions for use and dosage requirements, if applicable;
• indications, in accordance with the national regulatory system;
• storage conditions;
• warnings about alcohol or lactose, if applicable;
• warning that advises the user to consult a doctor or qualified health care
professional if the symptoms persist or worsen;
• route of administration;
• expiry date (if required by the national regulatory system).
such events. It is presently unknown whether this is due to underreporting or to

a genuine absence of such events.
It is the responsibility of governments to design regulatory frameworks that are

adapted to their specific situation. Nevertheless, they can and should take full
advantage of experience accumulated across the world. National health
authorities that are developing regulatory frameworks may want to adapt WHO
guidelines on safety monitoring of herbal medicines in pharmacovigilance
systems (40) for their frameworks and pharmacovigilance systems. They may
also want to ensure more systematic exchange of experience on the
implementation of effective regulation. This document provides a modest
contribution to such exchange of experience.
17
18
References
276
References
1. Proceedings of the Tenth International Conference of Drug Regulatory

Authorities (ICDRA), Hong Kong, China, 24–27 June 2002. (Available at:
http://apps.who.int/medicinedocs/es/d/Js4923e/2.5.html).
2. Pharmacopée Francaise [French Pharmacopoeia] Vol. 3, 10th ed. Refondue +

Mise A Jour 2003 + Liste Des Plantes Medicinale. Agence Medicame, 2003.
3. German Homeopathic Pharmacopoeia (GHP) Vols 1 and 2. Stuttgart,

Medpharm Scientific Publishers, 2006.
4. Homoeopathic Pharmacopoeia of the United States. Southeastern, PA,

Homeopathic Pharmacopeia Convention of the United States (available by
subscription at http://www.hpus.com/).
5. Homoeopathic pharmacopoeia of India. Delhi, Controller of Publications. 1st

ed. Vol. 1, 1970; 2nd ed. Vol. 2, 1984; 1st ed. Vol. 3, 1978; 1st ed. Vol. 4., 1984; Vol. 5,
1985; Vol. 6, 1991; Vol. 7, 2000; Vol. 8, 2001.
6. WHO guidelines on good manufacturing practices (GMP) for herbal medicines.

World Health Organization, Geneva, 2007.
7. Quality control methods for medicinal plant materials. Geneva, World Health
Organization, 1998.
8. General guidelines for methodologies on research and evaluation of traditional

medicine. Geneva, World Health Organization, 2000.
9. Basic tests for drugs – Pharmaceutical substances, medicinal plant materials and
dosage forms. Geneva, World Health Organization, 1998.
10. WHO Guidelines on good agricultural and collection practices (GACP) for
medicinal plants. Geneva, World Health Organization, 2003.
11. WHO guidelines on assessing quality of herbal medicines with reference to

contaminants and residues. Geneva, World Health Organization, 2007.
12. Quality assurance of pharmaceuticals. A compendium of guidelines and related

materials. Vol. 2, Good manufacturing practices and inspection. 2nd updated ed.
Geneva, World Health Organization, 2007.
13. Health Products and Food Branch Inspectorate Guide, supplementary guidelines
for homeopathic preparations. Ottawa, Health Canada, 1996.
14. EU Guidelines to good manufacturing practice, medicinal products for human

and veterinary use, Vol. 4, Part II. Brussels, European Commission, 2005.
19
15. Homeopathic good manufacturing practices. Southeastern, PA, Homeopathic

Pharmacopeia Convention of the United States, 2007.
16. Guideline on quality of herbal medicinal products/traditional herbal medicinal

products. London, European Medicines Evaluation Agency, 2006.
17. Annex 7. Manufacture of herbal medicinal products. In: EU Guidelines to

good manufacturing practice, medicinal products for human and veterinary use, Part II –
Basic requirements for active substances used as starting materials, vol. 4. Brussels,
European Commission, 2005.
18. Australian regulatory guidelines for complementary medicines, Part III,

Evaluation of complementary medicine substances. Woden, ACT, Australian
Government, Department of Health and Ageing, Therapeutic Goods
Administration, 2005 (available at:
http://www.tga.health.gov.au/docs/html/argcm.htm).
19. WHO guidelines on transmissible spongiform encephalopathies in relation to

biological and pharmaceutical products. Geneva, World Health Organization, 2003
(WHO/BCT/QSD/03.01).
20. EC recommendations on the conditions related to the “BSE negligible risk

(closed) bovine herds”, adopted by the SCC 22/23 July 1999.
21. European Pharmacopoeia. Minimizing the risk of transmitting animal

spongiform encephalopathy agents via human and animal medicinal products and
Homeopathy preparations
22. Council of Europe. European pharmacopoeia, 6th ed. Strasbourg, Directorate

for the Quality of Medicines of the Council of Europe, 2006.
23. EU Directive 2002/98/EC of the European Parliament and of the Council of 27

January 2003 setting standards of quality and safety for the collection, testing,
processing, storage and distribution of human blood and blood components and amending
Directive 2001/83/EC. Official Journal of the European Union, L33/30.
24. Annex 14, Manufacture of medicinal products derived from human blood
or human plasma. In: EU Guidelines to good manufacturing practice, medicinal
products for human and veterinary use, Part II – Basic requirements for active
substances used as starting materials, vol. 4. Brussels, European Commission, 2005.
25. Homeopathic preparations. In: European Pharmacopoeia. Council of

Europe. European pharmacopoeia, 6th ed. Strasbourg, Directorate for the Quality of
Medicines of the Council of Europe, 2007.
26. Harmonized tripartite guideline, derivation and characterization of substrates

used for production of biotechnological products (Q5D). International Conference on
Harmonisation, 1997.
27. Harmonized tripartite guideline, viral safety evaluation of biotechnology

products derived from cell lines of human or animal origin (Q5AR1). International
Conference on Harmonisation, 1999.
20
References
278
28. Directive 2001/18/EC of the European Parliament and of the Council on

the deliberate release into the environment of genetically modified organisms
and repealing Council Directive 90/220/EEC. Official Journal L 106 of 17.4. 2001.
29. Directive 90/219/EEC on the contained use of genetically modified

micro-organisms. Official Journal L 117 of 8.5, 1990:1.
30. European Medicines Agency. Excipients in the label and package leaflet of
medicinal products for human use. London, European Medicines Agency, 2003
(ENTR/F2/BL D (2003)).
31. European Commission Directive 2001/83/EC of the European Parliament

and the Council on the Community code relating to medicinal products for
human use (2001), amended by Directive 2004/27/EC of the European Parliament and
the Council, Chapter 2, Specific provisions applicable to homeopathic medicinal products.
Official Journal L 136, 30/4/2004:34–57.
32. 21 Code of Federal Regulations Parts 210 and 211: Current good manufacturing
practice in manufacturing, processing, packing or holding of drugs; general and current
good manufacturing practice for finished pharmaceuticals. Rockville, MD, US Food
and Drug Administration, 2006 (available at
http://www.fda.gov/cder/dmpq/cgmpregs.htm).
33. Australian regulatory guidelines for complementary medicines, Part III,

Evaluation of complementary medicine substances. Australian Government,
Department of Health and Ageing, Therapeutic Goods Administration,
Symonston, ACT, 2005 (available at:
http://www.tga.health.gov.au/docs/html/argcm.htm).
34. Good manufacturing practices guidance document. Ottawa, Health Canada,

Natural Health Products Directorate (NHPD), 2003.
35. Directive 2003/94/EC of the European Parliament and of the Council,

Principles and guidelines of good manufacturing practice in respect of medicinal
products for human use and investigational products for human use. Official
Journal L, 262, 14/10/2003:22–26.
36. Directive 2004/27/EC of the European Parliament and of the Council of

31 March 2004 amending Directive 2001/83/EC on the Community code relating
to medicinal products for human use (2004).
37. Harmonized tripartite guideline, validation of analytical procedures: text and

methodology. (Q2(R1)). International Conference on Harmonisation, 2005
(available at http://www.ich.org/cache/compo/276-254-1.html).
38. GSR 678 (E), Ministry of Health and Family Welfare notification - Good
manufacturing practices and requirements of premises, plant and equipments for
homoeopathy. New Delhi, Ministry of Health and Family Welfare, 31 October 2006.
39. Guidelines for development of consumer information for proper use of traditional
medicine and complementary/alternative medicine. Geneva, World Health
Organization, 2004.
21
40. WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance

systems. Geneva, World Health Organization 2004.
22
Annex280
1
Annex 1: List of participants in the WHO

consultation on quality of homeopathic
medicines, Milan, Italy, 25-27 June 2007
Dr Andy P. Bormeth, Executive Director, Homeopathic Pharmacopeia

Convention of the United States, Santa Rosa, CA , United States of America
Dr Rafael Peréz Cristina, Director, Centro Para el Control Estatal de la Calidad

de los Medicamentos, Ministerio de Salud Pública de Cuba, Havana, Cuba
Dr Eshwar Das, Deputy Adviser (Homeopathy), Department of Ayurveda, Yoga,

and Naturopathy, Unani, Shiddha and Homoeopathy, Ministry of Health and
Family Welfare, New Delhi, India (Co-Chairperson)
Dr Alessandro Discalzi, Directorate-General, Family and Social Solidarity,

Lombardy Region, Milano, Italy
Dr Benjamin Gilbert, Oswaldo Cruz Foundation (FIOCRUZ) , Farmanguinhos,

Rio de Janeiro, Brazil
Dr Ling Goh, Assessment Officer, Homeopathic Unit, Natural Health Products

Directorate, Health Canada, Ottawa, Ontario, Canada
Dr Sue Harris, Unit Manager, Medicines and Healthcare Products Regulatory

Agency, Department of Health, London, United Kingdom
Dr Shahzad Hussain, Officer in charge for Chemical Research and Traditional

Medicines, Drugs Control and Traditional Medicines Division, National Institute
of Health, Islamabad, Pakistan (Co-Rapporteur)
Dr Maurizio Italiano, Homeopathic Expert, WHO Collaborating Centre for

Traditional Medicine, State University of Milan, Milan, Italy
Dr Steven Kayne, Fellow, Faculty of Homeopathy, Hahnemann House, Luton,

United Kingdom
Dr Konstantin Keller, Chairperson, Herbal Medicines Committee, European

Medicines Evaluation Agency, London, United Kingdom (Co-Chairperson)
Dr Mohammad Shabbir Khan, Chief, Pashupati Homeopathic Hospital, Ministry

of Health and Population, Kathmandu, Nepal
Dr Christiane Kirchner, Licensing/Registration Division for Homeopathic

Medicinal Products, Federal Institute for Drugs and Medical Devices, Bonn,
Germany
23
Dr Burt H. Kroes, Agency of the Medicines Evaluation Board, The Hague, The
Netherlands
Ms Michelle McLaughlin, Sector Scientist, Office of Complementary Medicines,

Therapeutic Goods Administration, Department of Health and Ageing,
Symonston, ACT, Australia (Co-Rapporteur)
Dr Emilio Minelli, Deputy Director, WHO Collaborating Centre for Traditional

Medicine, Centre of Research in Medical Bioclimatology, Biotechnologies and
Natural Medicine, State University of Milan, Milan, Italy
Dr Tamás Paál, Director-General, National Institute of Pharmacy, Budapest,

Hungary (WHO Temporary Adviser)
Mrs Seetha Ramasamy, Head, Natural Products Unit, Centre for Product
Registration, National Pharmaceutical Control Bureau, Ministry of Health,
Selangor, Malaysia
Dr Mario Raul Santamaria Rangel, Manager, Homeopathic Herbals and

Alternative Drugs, Federal Commission for the Protection from Sanitary Risks,
Ministry of Health, Mexico City, Mexico
Ms Lucia Scrabbi, Planning Unit, Directorate-General of Health, Lombardy

Region, Milan, Italy
Dr Umberto Solimene, Director of the WHO Collaborating Centre for Traditional

Medicine, Centre of Research in Medical Bioclimatology, Biotechnologies and
Natural Medicine, State University of Milan, Milan, Italy
WHO Secretariat
Miss Tina Lu, Traditional Medicine, Department of Technical Cooperation for

Essential Drugs and Traditional Medicine, World Health Organization, Geneva,
Switzerland
Ms Yukiko Maruyama, Scientist, Traditional Medicine, Department of Technical

Cooperation for Essential Drugs and Traditional Medicine, World Health
Organization, Geneva, Switzerland
Dr Xiaorui Zhang, Coordinator, Traditional Medicine, Department of Technical

Cooperation for Essential Drugs and Traditional Medicine, World Health
Organization, Geneva, Switzerland
24
Annex282
2
Annex 2: Glossary
The terminology used in this document is commonly used within the

homeopathic community, albeit in a sometime inconsistent way. For the
purposes of this document an effort was made by the participants of the WHO
consultation on quality of homeopathic medicines, held in Milan, Italy in 2007, to
agree, by consensus, on the definitions used throughout this document. The
definitions in this glossary are not intended to be absolute, but to provide the
necessary consistency for a uniform and explicit regulation of homeopathic
medicines.
Active substance: Active substances are considered to be source materials

processed by one or a sequence of homeopathic manufacturing procedures listed
in pharmacopoeias in official use and other officially recognized documents (e.g.
mother tinctures, dilutions or triturations).
Contamination (1): The undesired introduction of impurities of a chemical or

microbiological nature, or of foreign matter, or of another homeopathic medicine
into or on to starting material, intermediate product or finished homeopathic
medicines during production, sampling, packaging or repackaging, storage or
transport.
Cross-contamination (1): The contamination of starting material, intermediate

product or finished product with another starting material or product during
production.
Diluent: Substance used for the preparation of a stock/starting material or the

potentization process and which may also represent the substance of the dosage
form. Liquid diluents usually consist of purified water, aqueous solution,
glycerol or ethanol of a suitable concentration or for which there is an
appropriate monograph. The commonest solid diluent is usually lactose
monohydrate.
Dilution: Dilution has two meanings in homeopathy:

• For a product, a dilution is a liquid homeopathic preparation which is
potentized as described below (see the definition of potentization).
Individual dilutions are also called potencies;
• As a procedure, dilution means the de-concentration process of a liquid or
a solid preparation. One part of each stage in the preparation of a
homeopathic medicine from its stock or previous dilution (potency) by
adding one part of a previous solid or liquid phase to a predetermined
weight or volume of the diluent (see Potentization below). Dilution occurs
at all stages of production of the homeopathic medicines whether by
addition of solid excipient in trituration or the addition of diluent in the
liquid phase and succussion.
Dinamization: see potentization
25
Dosage form: a dosage form in homeopathy complies with any relevant

specifications for that dosage form for which an appropriate characterization
exists in a pharmacopoeia in official use, or in other officially recognized
documents. The most commonly encountered homeopathic dosage form, the
globule (pillule or pellet), is a solid spherule which consists of lactose, sucrose or
any other suitable vehicle. Usually, preformed globules are impregnated with a
dilution or directly by a mother tincture. The homeopathic dosage form tablet is a
solid preparation which complies with any relevant characterization in the
pharmacopoeia in official use (or in other officially recognized documents) for
tablets. Homeopathic medicines in tablet form are either prepared by
impregnation of preformed tablets or by compression of triturations with the
vehicle. The most commonly used liquid homeopathic medicines are either alcoholic
solutions or oral liquids.
Excipient: Substance needed for manufacturing a dosage form (used after

potentization) such as wheat starch and magnesium stearate for tablets. It may
also represent the substance of the dosage form.
Foreign matter (2): This is material consisting of any or all of the following: parts
of the source material or materials other than those named with the limits
specified for the homeopathic medicine concerned; any organism, part or
product of an organism, other than that named in the specification and
description of the homeopathic medicine concerned.
Homeopath: A qualified provider (practitioner) of homeopathic treatment.
Homeopathic medicines: Any medicine prepared in accordance with a

homeopathic manufacturing procedure described by a pharmacopoeia in official
use or other officially recognized documents. A homeopathic medicine may
contain a number of homeopathic preparations.1
1
Note that some countries use terms such as "homeopathic drugs" or "homeopathic
preparations". Compare with definitions in:
United States of America: a homeopathic drug is any drug labelled as being
homeopathic and listed in the Homeopathic Pharmacopoeia of the United States (HPUS)
(3), an addendum to it, or its supplements. The potencies of homeopathic drugs are
specified in terms of dilution, i.e., 1x (1/10 dilution), 2x (1/100 dilution), etc.
Homeopathic drug products must contain diluents commonly used in homeopathic
pharmaceutics. Drug products containing homeopathic ingredients in combination with
non-homeopathic active ingredients are not homeopathic drug products. Food and Drug
Administration (4).
Canada: homeopathic medicines are products (i) manufactured from, or containing as
medicinal ingredients, only substances referenced in a homeopathic monograph in one of
the following homeopathic pharmacopoeias, as they are amended from time to time:
Homeopathic pharmacopeia of the United States (HPUS) (3); Homöopathisches Arzneibuch
(HAB) or German Homeopathic Pharmacopoeia (GHP) (5); Pharmacopée française or French
pharmacopoeia (PhF) (6); European pharmacopoeia (Ph.Eur.) (7); Encyclopedia of homeopathic
pharmacopoeia (EHP) (8); and (ii) prepared in accordance with the methods outlined in one
of the homeopathic pharmacopoeias listed above, as they are amended from time to time.
Natural Health Products Directorate (NHPD) (9): Evidence for Homeopathic Medicines
Guidance Document (2007)
India: homoeopathic medicines include any drug which is recorded in homoeopathic
provings or therapeutic efficacy of which has been established through long clinical
experience as recorded in authoritative Homoeopathic literature of India and abroad and
which is prepared according to the techniques of Homoeopathic pharmacy and covers
26
Annex284
2
Homeopathy: Classical homeopathy is a system of medicine using preparations

of substances whose effects, when administered to healthy subjects, correspond
to the manifestations of the disorder in the individual patients (see also section
3.1.1).1
Homeotherapy: A reference name for all therapeutic approaches that have

developed from homeopathic therapy as established by Hahnemann.
Homeotherapy comprises, among others: classical homeopathy; clinical
homeopathy; homeopathic combination products; anti-homotoxic therapy and
combination of ingredients of such Homoeopathic medicines but does not include a

medicine which is administered by parenteral route. Drugs and Cosmetics Act 1940, as
amended 2005 (10).
European Union: homeopathic medicinal products are any medicinal product prepared
from substances called homeopathic stocks in accordance with a homeopathic
manufacturing procedure described by the European Pharmacopoeia or, in the absence
thereof, by the pharmacopoeias currently used officially in the Member States. A
homeopathic medicinal product may contain a number of principles. Directive
2004/27/EC amending Directive 2001/83/EC (11).
Switzerland: homeopathic medicinal products are medicinal products containing
homeopathic active substances that are manufactured exclusively in accordance with the
fundamental principles of the homeopathic manufacturing procedures described in the
Pharmacopoeia, in the German Homeopathic Pharmacopoeia (“Homöopathischen
Arzneibuch” (HAB) (5)), in the French Pharmacopoeia (“Pharmacopée Fraçaise (Ph.F.)
(6); under “préparations homéopathiques”) or in the British Homeopathic
Pharmacopoeia (B.Hom.P.) (12) and that are used in accordance with the principles of
homeopathic therapy. Swiss Agency for Therapeutic Products (13).
In Australia Homeopathic preparations are preparations: (a) formulated for use on the
principle that it is capable of producing in a healthy person symptoms similar to those
which it is administered to alleviate; and (b) prepared according to the practices of
homeopathic pharmacy using the methods of: (i) serial dilution and succussion of a
mother tincture in water, ethanol, aqueous ethanol or glycerol; or (ii) serial trituration in
lactose. Therapeutic Goods Administration (14).
In the European Union homoeopathic preparations: are prepared from substances,
products or preparations called stocks, in accordance with a homoeopathic
manufacturing procedure. A homoeopathic preparation is usually designated by the
Latin name of the stock, followed by an indication of the degree of dilution. European
pharmacopoeia) (7)
In Switzerland homeopathic single drugs are homeopathic medicinal products with a
single homeopathic active substance: mother tinctures, solutions, powders, or liquid or
solid homeopathic dilutions. Swiss Agency for Therapeutic Products (13). Homaccords
are mixtures of single homeopathic drugs from the same starting material, with varying
potencies. Swiss Agency for Therapeutic Products (13). Homeopathic combinations:
Switzerland: :mixtures that contain exclusively homeopathic single drugs or homaccords.
Swiss Agency for Therapeutic Products (13).
1
Compare with definitions in:
India: a system of medicine which believes in a specialised method of treatment system
of curing natural diseases by administration of potentised drugs which have been
experimentally proved to possess the power of producing similar artificial symptoms on
healthy human beings. Department of Ayurveda, Yoga & Naturopathy, Unani, Sidda and
Homoeopathy (15)
United States of America: the practice of treating the syndromes and conditions which
constitute disease with remedies that have produced similar syndromes and conditions
in healthy subjects. Food and Drug Administration (4).
27
homotoxicology; isopathy; anthroposophic medicine; biochemic medicine

according to Dr Schüssler; spagyric therapy; gemmotherapy; lithotherapy; and
resonance homeopathy.
Imponderabilia: Homeopathic medicines prepared from energy, emanating from

natural and physical reactions. It means “not weighable”, i.e. which have no
perceptible weights. They are energy forms such as sunlight (Sol), magnetic fields
(Magnetis Polus Australis), radiation (X-ray).
Mother solution (also called solution): the most concentrated solution prepared
from a substance of mineral or chemical origin by dissolving it in alcohol or
purified water. It may also be prepared by exposing alcohol or purified water to
an energy source (see Imponderabilia).
Mother substance: see source material
Mother tincture (also called tincture): The initial homeopathic preparation made
from source material that can be further potentized (also called “liquid stock”),
sometimes used as homeopathic medicines, is regarded as the most concentrated
form of a finished homeopathic medicine. Mother tinctures are obtained
classically by maceration or percolation (sometimes also by digestion, infusion,
decoction or fermentation) techniques from source materials according to a
procedure prescribed by a recognized homeopathic pharmacopoeia. Sometimes a
mother tincture corresponds to the first decimal dilution, “1D” or “1X” (10-1),
mostly when dry plant material is used as starting material.
Nosodes: Homeopathic medicines prepared from disease products from humans

or animals; from pathogenic organisms or their metabolic products; or from
decomposition products of animal organs.
Potency: The denominated degree of serial trituration or dilution and succussion

that is reached for each homeopathic medicine. The degrees of dilution or
potencies are normally indicated by the letters D, DH or X for successive 1 to 10
(decimal) dilutions, the letters C, CH or K or CK for successive 1 to 100
(centesimal) dilutions while Q or LM denote successive 1 to 50 000
(Hahnemannian quinquagintamillesimal) dilutions. Dilution by 1 to 10 denotes 1
part processed with 9 parts of diluent (Hahnemannian decimal), dilution by 1 to
100, 1 part processed with 99 parts (Hahnemannian or Korsakovian centesimal),
and so on. The number preceding the letters (e.g. D, C or LM) normally indicate
the number of dilution steps employed (Table 1).
As a consequence of different views in various approaches in homeotherapy and

because the notion of these terms may depend on the nature of the starting
materials, the terms “high potency” and “low potency” cannot be defined
unambiguously.
Potentization (also called dinamization): The combined process of serial dilution

and succussion or trituration at each step in the manufacture of homeopathic
medicines from stocks. (According to the tenet of homeopathy, potentization
represents the process by which the activity of a homeopathic medicine is
developed.)
28
Annex286
2
Table 1. Potency table

Dilution ratio Common designation(s) Examples
a
1:10 X 1X, 2X, 3X, etc.
a
1:10 D D1, D2, D3, etc.
a
1:10 DH DH1, DH2, DH3, etc.
b
1:100 C 1C, 2C, 3C, etc.
C1, C2, C3, etc.
1:100b CH 1CH, 2CH, 3CH, etc.
CH1, CH2, CH3, etc.
1:100b CK 1CK, 2CK, 3CK, etc.
CK1, CK2, CK3, etc.
1:100b K 1K, 2K, 3K, etc.
K1, K2, K3, etc.
1:50 000a LM 1LM, 2LM, 3LM, etc.
1:50 000a Q Q1, Q2, Q3, etc.
a
For 1:10 and 1:50 000 dilution ratios only the Hahnemannian method of manufacture
(multi-flask method) is used.
b
For 1:100 dilution ratios a C potency is assumed to use the Hahnemannian method of
manufacture (multi-flask method) and can also be denoted as CH. When the Korsakovian
method of manufacture (single-flask method) is used, the potency is designated as CK or
K.
Raw Material: see source material
Sarcodes: Homeopathic medicines made from healthy animal tissues or

secretions. In Greek, sarcode means fleshly.
Source material (raw material, starting material, mother substance): Source

material is the original raw material used for the production of homeopathic
medicines. This material is obtained from natural sources, e.g. of botanical,
zoological, microbiological, mineral, chemical, animal and human origin, or
synthetic procedures. Source materials may undergo preliminary treatment in
order to be further processed.
Starting material: see source material
Stock: Substances or preparations made from the source materials (e.g. by

maceration, succussion or trituration) used as starting points for the production
of homeopathic medicines. 1
Succussion: A procedure of vigorous shaking with impact or elastic collision

carried out at each stage of dilution in the preparation of a homeopathic potency.
1
It should be noted that this term is not used in all homeopathic regulatory systems (it is
used in the French pharmacopoeia (6), European pharmacopoeia (7), and European Union
Directive 2001/83/EC (11), but not by others). Moreover, in certain homeopathic systems,
the stock is the mother tincture or the mother solution whereas, according to others, the
stock may also represent the source material itself. In the European Union stocks are
defined as substances, products or preparations used as starting materials for the
production of homoeopathic preparations. A stock is usually one of the following: a
mother tincture or a glycerol macerate, for raw materials of botanical, zoological or
human origin, or the substance itself, for raw materials of chemical or mineral origin.
European pharmacopoeia) (7)
29
In some pharmacopoeias, specific methods for transmitting the impact may be

described in other areas of homeotherapy.
Trituration: Trituration has two meanings in homeopathy. For a product, a

trituration means a solid homeopathic preparation that has been potentized. As a
homeopathic procedure, trituration means the de-concentration process of a solid
material with another solid material. It is a stage in the preparation of a solid
homeopathic medicine from its stock or previous trituration by adding one part
to a prescribed number of parts of diluent (lactose or other diluent as defined in
an appropriate pharmacopoeia in official use, or other officially recognized
documents.
Vehicle: See Diluent.
References
1. WHO guidelines on good manufacturing practices (GMP) for herbal medicines.

World Health Organization, 2007.
2. Quality control methods for medicinal plant materials. Geneva, World Health
Organization, 1998.

4. U.S. Food and Drug Administration. Compliance Policy Guide (CPG

7132.15) Conditions Under Which Homeopathic Drugs May be Marketed. Revised
March 1995.
5. German Homeopathic Pharmacopoeia (GHP) Vols 1 and 2. Stuttgart,

6. Pharmacopée Francaise [French Pharmacopoeia]. Vol. 3, 10th ed. Refondue +

7. Council of Europe. European pharmacopoeia, 6th ed. Strasbourg, Directorate

for the Quality of Medicines of the Council of Europe, 2006.)
8. Varma, PN, Vaid I. Encyclopedia of homeopathic pharmacopeoeia, 4 vols. New

Delhi, Jain, 2007.
9. Natural Health Products Directorate (NHPD). Evidence for homeopathic

medicines guidance document (2007):
10. (India) Drug and Cosmetics Act 1940, as amended 2005.
11. European Commission Directive 2001/83/EC of the European Parliament and

the Council on the Community code relating to medicinal products for human use (2001),
amended by Directive 2004/27/EC of the European Parliament and the Council,
Chapter 2, Specific provisions applicable to homeopathic medicinal products.
Official Journal L 136, 30/4/2004:34–57.
30
Annex288
2
12. British homeopathic pharmacopoeia. London, British Homoeopathic Society,

1876.
13. Swiss Agency for Therapeutic Products. Ordinance of the Swiss Agency for
Therapeutic Products on the simplified authorisation of complementary and herbal
medicinal products (KPAV, 2006).
14. Therapeutic Goods Administration, TGA, Therapeutic Goods Regulations

1990, Statutory Rules 1990 No. 394 as amended.
15. Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and

Homeopathy, Annual Report 2000–2001. Chapter 2. Ministry of Health & Family
Welfare, Government of India.
31
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3
Annex 3: Points to consider on safety of

homeopathic medicines from biological
origin
Extracted from the document of Heads of Medicines Agencies1 -

Homeopathic Medicinal Products Working Group
HOMEOPATHIC MEDICINAL PRODUCT WORKING GROUP

(HMPWG)
POINTS TO CONSIDER ON SAFETY OF HOMEOPATHIC

MEDICINAL PRODUCTS FROM BIOLOGICAL ORIGIN
DISCUSSION IN THE HMPWG January 2001-April 2005

RELEASE FOR CONSULTATION March 2005
DISCUSSION IN THE HMPWG December 2005
ADOPTION FOR TRANSMISSION TO HMA March 2007
1
The Heads of Medicines Agency is a network of the heads of the national competent
authorities whose organizations are responsible for the regulation of medicinal products
for human and veterinary use in the European economic area
33
PLAN
1. Introduction
2. Scope
3. Preparations involved in the manufacturing process
4. Biological starting material used for the production of homeopathic medicinal

products
4.1. Sourcing of biological materials
4.1.1. Animal origin
4.1.1.1 Viral contamination
4.1.1.2 Transmission of TSE
4.1.2. Medicinal products
4.1.3. Human origin
4.1.4. Products derived from human, animal and microbial cell
lines
4.1.5. Products derived from virus preparations
4.1.6. Genetically modified organisms
5. Manufacturing process and safety of homeopathic medicinal products and of

the first safe preparation
5.1. First safe preparations
5.2. Manufacturing of homeopathic medicinal products and of first safe
preparations
5.3. Human origin
5.4. Transmission of TSE
5.5. Products derived from biotechnology
6. Risk assessment of homeopathic medicinal products from biological origin
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3
1. Introduction
Homeopathic medicinal products of biological origin are diverse in nature. The

preparations include materials from a wide range of species, from humans to
bacterial and viral agents and from healthy as well as from pathological sources.
The large spectrum of substances implies that the quality and safety of
homeopathic medicinal products should be considered on a case-by-case basis
taking into account the individual character of each product and its intended use.
This document outlines the requirements to be fulfilled by homeopathic medicinal

products, from biological origin, in the registration procedure. In general,
homeopathic medicinal products of biological origin should warrant sufficient
quality and safety within the same principles of the other medicinal products.
Special precaution should be taken with nosodes due to their intrinsic pathological
nature and origin.
Biological materials, due to their complex nature, require additional precautions

related to the quality and safety of the preparation. According to the tissue/species
from where they originate, special attention should be paid to the microbiological
and viral safety, transmissibility of Spongiform Encephalopathies (TSE), or
adverse effects caused by additives/excipients. Therefore, homeopathic medicinal
products should demonstrate, amongst other, quality specifications for starting
materials and first safe preparations, as well as in-process quality controls.
Depending on the nature of the biological starting material, safety studies in

relation to the risk of transmitting infection agents have to be performed with
either the first safe preparation or, if possible, at the level of the stock. Regarding
viral safety, viral validation studies related to the species of origin should be
addressed.
A risk assessment with respect to viral safety must be carried out for homeopathic
medicinal products containing materials of biological origin. Risk assessment has
to consider all the factors that may influence the potential level of infectious
particles in the homeopathic medicinal product and the potential risk to the patient
derived from its intended use.
This document gives guidance on the minimum requirements to ensure the quality
and safety of the biological materials used in homeopathic medicinal products
taking into consideration their biological origin and the manufacturing steps
involved up to the first safe preparation.
2. Scope
This guideline applies only to homeopathic medicinal products for oral and
external use as stated in article 14 of the Directive 2001/83/EC, amended by
Commission Directive 2003/63/EC, or in article 17 of the Directive 2001/82/EC.
For parenteral forms, quality and safety should be demonstrated according to
35
article 16 or 19 of the same Directives, respectively. Nevertheless, safety measures

must have equivalent strength as for parenteral forms considering that their
intended use may involve application in skin lesions and mucosa.
Starting materials of biological origin may be obtained from:
• humans, e.g. human cell lines, healthy tissues or fluids, or nosodes such as
human lesions/infected materials;
• animals e.g. whole animals, organs, tissues, animal secretions, toxins, healthy
or diseased tissues and extracts (nosodes), blood products, parasites, animal
cell lines;
• micro-organisms (e.g. bacteria, viruses, microscopic fungi, plant parasites);
• plants e.g., parts of plants, plant secretions, extracts, mother tinctures, pollen,
plant cell lines, macroscopic fungi.
Plant materials are outside of the scope of this guidance. The quality required for
those products is defined elsewhere. Concerning fungi, only macroscopic fungi
are considered of plant origin and therefore fall outside this document –
microscopic fungi are to be considered together as microscopic organisms and
shall comply with this document.
3. Preparations involved in the manufacturing process
In the context of the present guidance the terms used were drawn from Directive
2004/27/CE and the European Pharmacopoeia. For clarification the
manufacturing processes within their own variability, are considering to include:
1. Human and animal species and microorganisms as source materials.
2. Starting materials corresponding to homogeneous preparations of
tissues/cells or extracts with no further processing.
3. Homeopathic stock obtained through manufacturing steps that may
involve macerations, enzymatic treatments, dilutions, extractions or any
other means to attain the bulk from where homeopathic dilutions will be
prepared.
4. First safe preparation, as the fraction obtained at any level of the
manufacturing process up to the last removal/inactivation step. First safe
preparation should comply with the principles of minimization the risk of
transmission of pathogenic agent.
5. Nosodes, consisting in homeopathic preparations made from products of
human or animal disease processes, from pathogens or their metabolic
products, from the decomposition products of animal organs, or from
cultured microorganisms.
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3
4. Biological starting materials used for the production of homeopathic

medicinal products
4.1. Sourcing of biological starting materials
4.1.1 Animal origin

When animal materials are sourced for production, safety precautions should be
taken to avoid transmission of pathogenic agents to humans and/or animals.
Starting materials of animal origin should comply with the principles of
minimization the risk of transmission of pathogenic agents, taking into account
the species specificities regarding harbouring infectious agents other than those
related with the expected homeopathic therapeutic agent. Possible species
infectivity will be taken in consideration in the viral validation studies for the
choice of relevant or, if needed, model viruses and will be part of the risk
assessment.
Under this principle, sourcing of the animal species should comply with guidance
from OIE to guarantee the sanitary safety of world trade in animals and animal
products. Whenever applicable, relevant texts of the European Pharmacopoeia and
clearly defined qualification procedures should be considered.
The general principles laid down below in this guidance should be followed.
When alternative procedures are applied justification is required.
The manufacturer of the stock or homeopathic medicinal product should ensure

that animal materials come from documented and recorded sources and should
perform regular audits of the suppliers. The supplier of animals should be subject
to routine legal supervision by a competent veterinary authority. Any exception to
these should be justified.
Healthy animals should be used for the production of homeopathic medicinal

products unless properly justified. Whenever possible, donor animals should be
held in closed breeding and production herds. Wild animal should be avoided as
far as possible.
The animals should be kept in groups and isolated from contact with other
animals at all times during transfer or use. The strain, origin and, if possible,
number of the animals should be specified. When diseased animals are used, such
as in nosodes, the characteristics of the pathologic condition and transmissibility
should be clearly defined. If an illness is induced in the animal, the nature, source
and strain (if relevant) of the substance/agent used should be documented.
When animal species of higher order are sourced, a regular health monitoring
system should be in place ensuring that the animals are subject to continuous and
systematic veterinary and laboratory monitoring to ensure freedom from
infectious agents. This should include constant monitoring of the animal herd by
the veterinarian, routine pathological examination of randomly selected animals,
serological analysis for a range of virus, bacteria and parasites and examination of
the health status. The results of the health monitoring of the animal should be well
documented.
37
The manufacturer of the homeopathic medicinal product should ensure that newly
emerging serious veterinary diseases in the animal species supplied, are
immediately reported to the competent authorities.
4.1.1.1 Viral and microbiological contamination
Special consideration should be given to possible viral and microbiological

contamination and tests for relevant viruses should be performed. The
microbiological quality should meet the requirements of the European
pharmacopoeia.
In general, viral status of the species involved should be properly characterised

taking into consideration the intended use. For those species remote to human
and/or animal with unknown risk of carrying human and/or animal pathogens,
other factors should be taken in consideration, namely the possibility of direct or
indirect disease transmission.
4.1.1.2 Transmission of TSE
When considering specifically the risk of transmission of TSE, raw and starting
materials, excipients as well as reagents participating in the manufacturing
process, namely from bovine, ovine and caprine origin, and any other TSE
susceptible species, should comply with Commission Directives 2001/83/EC as
amended by Commission Directive 2003/63/EC or 2001/82/EC, fulfilling the
requirements laid down in the Note for Guidance on “Minimising the risk of
transmitting animal spongiform encephalopathies via human and veterinarian
medicinal products” and its revisions and exemptions as defined for medicinal
products.
Whenever parts of animals suitable for human consumption are used, a veterinary
certificate should be sufficient to demonstrate compliance of starting material
used for homeopathic medicinal products considering its restricted oral and
external use.
4.1.2 Medicinal products
Starting materials currently used as medicinal products such as serums, vaccines,

toxins etc. should have the same quality as that for the approved medicinal
products and should comply with CPMP/BWP/3354/99 “Note for Guidance on
Production and Quality Control of Animal Immunoglobulins and Immunosera for
Human Use”.
4.1.3 Human origin
When using starting materials of human origin for production of homeopathic

medicinal products for human use the problem of transmission of adventitious
agents (viral and non-viral) should be addressed starting at the level of donor
selection and in relation to the tissue involved. Proper criteria for donor eligibility
have to be clearly defined. The requirements on tissue donors must follow the
Directive 2004/23/EC of the European Parliament and the Council of 31 March
2004 and Commission directives implementing Directive 2004/23/EC.
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3
Human material may contain blood or may have been exposed to it during the
extraction process, so the transmission of viruses is of particular concern,
therefore the selection of the donors must follow the Commission directive
2004/33/EC of 22 March 2004 “implementing Directive 2002/98/EC of the
European Parliament and of the Council as regards certain technical requirements
for blood and blood components” and other Commission directives implementing
Directive 2002/98/EC.
Cross species infectivity should be addressed if the product is used in a different

species.
4.1.4 Products derived from human, animal and microbial cell lines
Human, animal and microbial cell lines used for production or as starting
materials, should follow the recommendations covered in the guideline
CPMP/ICH/294/95 “Derivation and Characterisation of Cell Substrates used for
the Production of Biotechnological/Biological Products” or Guidelines for
production and control of immunological veterinary medicinal products Volume
7B Eudralex, CPMP/BWP/1793/02 “Note for Guidance on the Use of Bovine
Serum in the Manufacture of Human Biological Medicinal Products” and
CVMP/743/00 “Note for guidance on Requirements and Controls applied to
Bovine Serum (Foetal or Calf) used in the production of immunological
Veterinary Products”.
Furthermore, human and animal cell lines as starting materials should be prepared
according to the recommendations set for allogeneic and xenogeneic cell therapy
products, respectively in CPMP/BWP/41450/98 “Points to Consider on the
manufacture and quality control of human somatic cell therapy medicinal
products” and CPMP/BWP/3326/99 “Concept Paper on the Development of a
CPMP Points to Consider on Xenogeneic Cell Therapy”.
4.1.5 Products derived from virus preparations
Where a homeopathic medicinal product is derived from a virus preparation, there

should be strong assurance that the virus has been effectively inactivated during
the manufacturing process and the appropriate validation of the inactivation
process should be performed.
4.1.6 Genetically modified organisms

The use of genetically modified organisms as starting materials should be in
accordance with the Directives 2001/18/EC and 90/219/EEC (as amended).
5. Manufacturing process and safety of the Homeopathic Medicinal Product

and of the first safe preparation
5.1 First safe preparation
The first safe preparation should be defined on a case-by-case basis. First safe
preparation can be defined at any level of the manufacturing process up to the last
removal/inactivation step introduced in the process.
39
Only first safe preparations may be used to produce the homeopathic medicinal
products, which should comply with the principles of minimization the risk of
transmission of pathogenic agent, taking into account the species infection
potential other than the homeopathic therapeutic agent.
For manufacturing of human and/or animal derived homeopathic medicinal

products, both pathogenic and healthy, an adequate determination of what shall
be considered as the first safe preparation, for each stock is essential. This
determination ensures the correct definition of viral studies to be applied in
order to evaluate putative infectivity. Safety studies, taking both viral and non-
viral adventitious agents into consideration, should be performed at this lowest
level prior to manufacturing further dilutions and/or other homeopathic
preparations.
5.2 Manufacture of the homeopathic medicinal product and first safe

preparations
Dilutions alone and per se do not ensure biological safety of the first safe
preparation. Manufacturing steps at the level of homeopathic dilutions such as
solvent/detergent, filtration or pasteurisation may contribute to the safety of the
first safe preparation. First safe preparations should be properly characterised in
terms of microbiological, viral and TSE safety. Viral validation studies should be
performed on the production of this first safe preparation. The effectiveness of
the manufacturing process to inactivate or remove adventitious agents is
important for the biological safety of the first safe preparation of the homeopathic
medicinal product. Adequate measures are to be taken to minimise the risk of
agents of infection in the homeopathic preparations - it must comply with the
requirements of the European Pharmacopoeia monograph on Homeopathic
Preparations.
Validation of the process of viral inactivation/removal should be addressed in

specially designed viral validation studies with model viruses performed
according to the Guideline CPMP/BWP/268/95 “The Design, Contribution and
Interpretation of Studies Validating the Inactivation and Removal of Viruses”.
5.3. Human origin
Starting materials from human origin should be considered potentially infectious.

When human tissues or excretions are used, manufacturing should include
validated steps to reduce/eliminate contamination of the starting material and to
maximise the elimination of putative pathogenic agents that might be present.
Manufacture of the homeopathic medicinal product from human origin should
comply with the manufacturing section of the guideline CPMP/BWP/269/95 Rev.
3 “Note for guidance on Plasma Derived Medicinal Products” with due
adaptations properly justified according to the material involved and the intended
use.
5.4 Transmission of TSE
Starting materials and other substances participating in the manufacturing process

such as reagents obtained from tissues of bovine, caprine and ovine species as
well as other species sensitive to TSE’s should comply with the principles of
minimising the risk of transmission of TSE defined in the Commission directives
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2001/83/EC, as amended by Commission Directive 2003/63/EC or 2001/82 /EC,

fulfilling the requirements laid down in the “Note for Guidance on minimising the
risk of transmitting animal spongiform encephalopathies via human and
veterinarian medicinal products”. Compliance with the principles of minimising
the risk of transmitting animal spongiform encephalopathy should be
demonstrated by providing a certificate of suitability delivered by the EDQM, or
by providing complete scientific data for the product as stipulated in the Appendix
II of the Resolution AP-CSP (99) 4 (adopted by the public health committee).
5.5 Products derived from biotechnology
Homeopathic medicinal products derived from biotechnology should comply with

all relevant guidelines related to biotechnology, taking into consideration the risk
of contamination with adventitious agents, through the recombinant cell line used
for production (CPMP/ICH/139/95 Guideline “Analysis of the Expression
Construct in Cell Lines used for Production of r-DNA derived Protein Products”).
Also, when a cell line is used, this cell line should be fully characterised according
to the relevant requirements, e.g. CPMP/ICH/294/95 Guideline “Derivation and
Characterisation of Cell Substrates used for the Production of Biotechnological /
Biological Products”; CPMP/ICH/295/95 Guideline “Viral Safety Evaluation of
Biotechnology Products derived from Cell lines of Human or Animal Origin” and
/or guidelines for production and control of immunological veterinary medicinal
products Volume 7 B Eudralex . If relevant, the CVMP/743/00 “Note for
guidance on Requirements and Controls applied to Bovine Serum (Foetal or Calf)
used in the production of immunological Veterinary Products” should also be
taken into account.
6. Risk assessment of homeopathic medicinal products from biological origin

A risk assessment, considering all the factors that may influence the potential
transmission of infection agents to the recipients should be carried out under the
principals outlined in the European Pharmacopoeia (5.1.7). Risk assessment will
take into account the species origin, the tissues and cells, the manufacturing steps
involved and the intended use.
Viral contamination of a homeopathic medicinal product may arise from the

source material or from adventitious agents introduced by the production process.
Where the risk of contamination exists, three principal complementary

approaches can be adopted to control potential viral contamination of the
medicinal product:
- Selection of source materials and testing for viral contaminants, whenever

human pathogens are considered to be present.
- Testing the capacity of the production process to remove and/or

inactivate viruses up to the first safe preparation.
41
- Testing for viral contamination considered relevant at appropriate stages

of production.
The risk assessment should be performed considering:
- the species of origin,
- the organ, tissue, fluid of origin,
- the potential contaminants in view of the origin of the starting material

and the possibility to harbour human pathogens preferably including
field data,
- potential contaminants from the manufacturing process from risk

materials used during manufacture for example, enzymes, culture media,
etc
- the infectivity and pathogenicity of the potential contaminants for the

intended recipients of the homeopathic product, taking account of the
administration protocol,
- controls carried out on the starting material and at the first safe
preparation.
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4
Annex 4: Examples of national labelling

requirements for homeopathic medicines
in selected countries
Australia requires the following information on the label (1, 2):

• product name and name(s) of all active ingredients in the goods (i.e. name
of active ingredient or the substance from which the dilution was
prepared)
• homeopathic potency
• name of dosage form
• quantity of goods
• warning statements – if applicable
• batch number
• expiry date and storage conditions
• directions for use
• name and address of the sponsor or supplier
• statement of the purpose for which it is intended to be used (except where
goods are supplied solely to a complementary healthcare practitioner,
“For Practitioner Dispensing Only”)
• statement: “homeopathic product” or “homeopathic preparation”.
Canada requires the following labelling information (3, 4) on the inner/outer

label, as per the Labelling guidance document and the Evidence for homeopathic
medicines guidance document:
• The brand name must appear on the principal display panel.
• The prefix “DIN-HM” followed by an 8-digit number must appear on the
principal display panel.
• The dosage form must appear on the principal display panel.
• The word “Sterile” (for sterile products only) must appear on the
• The words “homeopathic medicine”, “homeopathic preparation”,
“homeopathic remedy” or “homeopathic drug” must appear on the
• A list of all medicinal ingredients including proper name and common
name, if different.
• The net amount in the immediate container (e.g. 5 ampoules) in terms of
weight, measure or number on the principal display panel.
• Product licence holder’s name and address including the company name
and postal code (or zip code).
• Importer’s name and address including the company name and postal
code.
• The homeopathic potency (e.g. 5CH) of each medicinal ingredient.
• The metric amount (e.g. 5 g) of each dilution.
• Recommended use or purpose (specific claims must be supported by
evidence).
43
• Recommended conditions of use including recommended dose, route of

administration, duration of use, dosage form, directions for use,
frequency, subpopulation and risk information (cautions and warnings,
contraindications and adverse reactions).
• The term “source:” or “source information:” preceding the website
address which provides a link to the NHPD website. A database listing
proper and common names of homeopathic medicines as well as
complete source information, as found in the accepted homeopathic
pharmacopeias, will be published on the NHPD website in the near
future.
• A description of source material for each medicinal ingredient as written
on the Product Licence Application form. Alternatively, source
information can be made available to consumers through a website as an
extension of the label. If this alternative is chosen, the label is required to
include the term “source:” or “source information:”, followed by either
the NHPD website (www.hc-sc.gc.ca/dhp-mps/prodnatur/index_e.html) or a
company or association website which provides a link to the NHPD
website. A database listing proper and common names of homeopathic
medicines as well as complete source information, as found in the
accepted homeopathic pharmacopeias, will be published on the NHPD
website in the near future.
• Recommended storage conditions, as per the Homoeopathic Pharmacopoeia
of the United States (HPUS) (5) requirements for ophthalmic/nasal
solutions: statements to the effect of “Protect from light”, “Do not touch
dropper end” and “Do not use beyond 4 weeks after opening” must be on
the label.
• The lot number, preceded by one of the following designations: “Lot
number”, “Lot No.”, “Lot”, or “(L)”, and the expiry date.
• A reference to the security feature of the product package should appear
on the label unless it is self-evident in the product packaging. Examples of
security packaging are seals, transparent wrappers and lids that are
sealed until opened.
• A list by common name of all non-medicinal ingredients, preceded by the
heading ‘Non-medicinal ingredients’ (to appear on the outer label only).
• The quantity of mercury contained in the product (to appear outer label
only) (only required if the product contains mercury or its salts or
derivatives as a non-medicinal ingredient).
The European Union requires the following labelling information (6):

• the name “homeopathic product”
• registration number
• scientific name of the stocks
• degree of dilution (making use of symbols of the pharmacopoeia)
• name and address of the registration holder and, where appropriate, the
manufacturer
• method of administration
• expiry date
• pharmaceutical form
• contents of the sales presentation
• special storage precautions, if any
• special warning, if applicable
• manufacturer’s batch number
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4
• statement: “homeopathic product without approved therapeutic

indications”
• warning advising the user to consult a doctor if the symptoms persist
during the use of the medicinal product.
India requires the following labelling information (7):

• label of innermost container shows the words “Homeopathic medicine”
• name of medicine
• potency of the homeopathic medicine
• name of each ingredient together with the potency and proportion
expressed in metric units, in the case of two or more ingredients
• name and address of manufacturer
• alcohol content, expressed as percentage by volume, in terms of ethyl
alcohol, except when the total quantity of the homeopathic medicine in
container is 30 ml or less
• in the case of a mother tincture additional information is required:
o a distinctive batch number preceded by the words “Batch No.” or
“Batch” or “Lot Number” or “Lot No. or “Lot” or any
distinguishing prefix;
o a manufacturing licence number preceded by the words
“Manufacturing Licence Number” or Mfg. Lic. No.” or “M.L.”
• no proprietary name shall be shown, if the homeopathic medicine
contains a single ingredient.
Switzerland requires the following labelling information (8).

• name of the product (for homeopathic single drugs: common or scientific
name of the active substance and potency, for homeopathic combinations:
common name of at least one active substances with an addition, e.g.
“comp.”)
• addendum “homeopathic medicinal product”
• dosage form
• contents of the retail pack
• qualitative and quantitative declaration of all active substances,
declaration of the excipients
• name and address of the registration holder
• manufacturer’s batch number
• facultative statement: “For individual therapy, use and dosage according
to the recommendation of the homeopathic expert”
• special risk information (cautions, warnings, contraindications – if
applicable)
• expiry date
• storage conditions
• authorization number.
United States of America

The US Food and Drug Administration (9) requires the following information
• name and place of business (manufacturer, packer, or distributor)
• statement of identity
• at least one major OTC indication for use
• statement of ingredients (quality and potency the product, e.g. 3x)
45
•documentation must be provided to support that those products or

ingredients which are not recognized officially in the HPUS are generally
recognized as homeopathic products or ingredients
• established name (English names are obligatory, Latin names can also be
provided)
• container size and net quantity
• warning statement.
The Homeopathic Pharmacopeia of the United States (HPUS) (6) requires:
• statement of identity
• potency of the homeopathic medicine
• net contents
• name and place of business of the manufacturer, packer or distributor
• National Drug Code (NDC) number or FDA establishment number
• “Homeopathic” designation (and possibly “HPUS” if made according to
an existing HPUS monograph and methods)
• adequate directions for use.
References
1. Therapeutic Goods Administration. Australian Regulatory Guidelines for

Complementary Medicines, Part I, Registration of Complementary Medicines (2005).
2. Therapeutic Goods Administration. General requirements for labels for

medicines, Therapeutic Goods Act 1989 No. 69 (2001)
3. Health Canada. Evidence for Homeopathic Medicines Guidance Document

(2007).
4. Health Canada. Labelling Standard Homeopathic Preparations (1997); Natural

Health Products Regulations, SOR/2003-196.

6. EU Commission Directive 2001/83/EC of the European Parliament and

the Council on the Community code relating to medicinal products for human
use (2001), amended by Directive 2004/27/EC of the European Parliament and
the Council, Chapter 2, Specific provisions applicable to homeopathic medicinal
products. Official Journal of the European Communities L 311 (28.11.2001).
7. (India) Drugs and Cosmetics Act, 1940, as amended 2005 (Part IX-A).
8. Ordinance of the Swiss Agency for Therapeutic Products of 9 November 2001 on

the requirements relating to the authorization of the placing on the market of medicines
(AMZV), Annex 1a (homeopathic or anthroposophic products without therapeutic
indication).
9. US Food and Drug Administration, FDA: Act 201 section 502, 503 CFR;
FDA/ORA CPG 7132.15
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Annex 5: Examples of national regulatory

requirements for homeopathic medicines
in selected countries
Australia (1)
The Australian Commonwealth, and the Government of New Zealand seek to
harmonize their regulatory system, creating a new joint Authority will replace
Australia’s Therapeutic Goods Administration (TGA) and the New Zealand
Medicines and Medical Devices Safety Authority (Medsafe).Legislation relating
to homeopathic medicines is still being developed.
Currently homeopathic medicines are recognized as low risk medicines, and may
only contain ingredients from a published list of permitted ingredients; they may
not contain scheduled medicines; do not have to be sterile; and are not intended
to be used in the prevention or treatment of a serious disease.
Class I medicines are not required to be evaluated for safety and quality, but
comply with certain legislative requirements; contain only substances previously
approved and are produced by a licensed manufacturer.
Homeopathic medicines are, with certain exceptions, not required to be listed
and are exempt from selected GMP requirements if all ingredients are diluted to
greater than a 1000-fold serial dilution of the mother tincture; the preparation is
not required to be sterile; and it does not contain ingredients of human origin, or
from listed parts of animals.
Canada (2–5)
Homeopathic medicines are regulated as natural health products for over-the-
counter use. Regulation covers manufacture, packaging, labelling, storage,
importation, distribution, sales and clinical trials. Ingredients must be listed in at
least one of the homeopathic pharmacopoeias accepted by the NHPD:
o Homeopathic Pharmacopeia of the United States (6)
o Homöopathisches Arzneibuch or German Homeopathic
Pharmacopoeia (7)
o Pharmacopée française or French Pharmacopoeia (8)
o European Pharmacopoeia (9)
o Encyclopedia of Homeopathic Pharmacopoeia (10).
There are criteria for drugs that are not accepted as homeopathic: drugs
administered by puncturing the dermis; drugs derived from substance in
Schedules I to IV of the Controlled Drugs and Substances Act (narcotic
ingredients); and drugs derived from substances in Schedule C of the Food and
Drugs Act (radiopharmaceuticals).
Homeopathic medicines have to comply with GMP specifications. For all
homeopathic medicines, licensing has to be proved by an eight-digit
identification number preceded by the letters DIN-HM. Applicants for product
licences must provide information on all ingredients of the product, on safety of
the product and on the text of the proposed label and the recommended
conditions of use.
47
European Union (11).

Homeopathic medicinal products are regulated according to Directive
2001/83/EC, which applies to industrially produced medicinal products for
human use – special provisions are applicable to homeopathic medicinal
products with regard to a simplified registration procedure and proof of
therapeutic efficacy. Homeopathic medicinal products are divided into two
categories:
• homeopathic medicinal products registered under the “simplified
procedure” are for oral or external use, bear no therapeutic indication on
the label and the preparations present a dilution of at least 1:10 000 of the
mother tincture; such products come under Article 14 of Directive
2001/83/EC (simplified registration procedure); No proof of therapeutic
efficacy is needed for these products.
• all other homeopathic medicinal products that do not comply with the
criteria listed for eligibility for the simplified procedure; are less diluted
than 1:10 000; are not intended for oral or external use; or are marketed
for a particular indication as self-care products; are covered by Article 16
of Directive 2001/83/EC (marketing authorization procedure).
Quality and safety of source material, mother tincture and authorized
homeopathic medicinal products must comply with European legislation for
medicinal products and with the standards of the European Pharmacopoeia.
Quality and safety standards of homeopathic medicinal products are warrant by
legislation and guidelines on good manufacturing practice (Directive
2003/94/EC), inspection and supervision, labelling and leaflet design, and
wholesale.
India (12–15)
Homeopathy is accepted as one of the National Systems of Medicine in India.
The Homoeopathic pharmacopoeia of India (16) covers: principles and standards for
manufacture; tests for identity, quality and purity; a homeopathic pharmaceutical
codex; and monographs of homeopathic medicines.
The Homoeopathic Pharmacopoeia Laboratory sets standards and performs
testing, as a national laboratory, on identity, purity and quality of homeopathic
medicines.
Objectives of good manufacturing practice cover special aspects of premises,
staff, plant and equipment for the manufacture of homeopathic medicines.
Homeopathic medicines shall only be purchased from a dealer or manufacturer
licensed under the Drugs and Cosmetics Rules 1945. Homeopathic medicines
containing more than 12% alcohol v/v (ethyl alcohol) shall not be packed and
sold in packages or bottles of more than 30 ml, but it may be sold to hospitals or
dispensaries in packages or bottles of not more than 100 ml.
Switzerland (17)
The homeopathic medicinal products are regulated according to their specific
characteristics and risks.
• The simplified authorisation for products with therapeutic indications
requires a complete dossier including proof of quality, safety and efficacy.
• The simplified authorization for products without therapeutic indications
is subdivided into three categories:
1. Simplified authorization for products with fantasy/brand names
and/or with dosage: complete dossier including proof of quality,
48
Annex306
5
safety and clinical tolerance, but without documentation of

efficacy.
2. Simplified authorization with a reduced dossier: in addition to the
general documentation (including basic information) a reduced
documentation specific for the preparation must be submitted.
3. Formal application procedure (applicable in most cases):
submission of a basic company dossier containing the
summarized information and confirmations relating to the
manufacturers and to the medicinal products;
electronic submission of an individual notification for each
substance and dosage form with basic information, i.e.
mention of manufacturing method and starting material;
additional documentation is only required in the case of
certain substances of animal or human origin, or for
medicinal products administered parenterally or applied
on or in the eye: single joint submission of master dossiers
for all medicinal products concerned.
There is an extensive positive list for starting materials and active substances
(Liste homöopathischer und anthroposophischer Stoffe (list HAS)) that defines which
of the procedures is applicable to the particular medicinal product without
indication. The list contains those substances for which the Agency has proof that
their use can be seen as traditional within homeopathy (or anthroposophic
medicine). It also contains those potencies for the substances for which safety has
been proven to the extent that all or at least certain items of documentation on
quality and security do not need to be submitted. The list is regularly revised and
can be expanded.
The basis for the quality is the guidelines on good manufacturing practice
(Directive 2003/94/EC (18)), inspection and supervision. Accepted standards are
the European Pharmacopoeia (Ph Eur) (9), the Swiss Pharmacopoeia (19), the German
Homeopathic Pharmacopoeia (GHP) (7), the homeopathic chapter of the French
Pharmacopoeia (Phf) (8), some specific manufacturing methods of the British
Homeopathic Pharmacopoeia (BHP) (20) and, in some cases, substance monographs
of the Homoeopathic Pharmacopoeia of the United States (HPUS) (6).
United States of America (21, 22).

Official homeopathic products are classified as drugs and must have a
monograph in the Homoeopathic Pharmacopoeia of the United States (HPUS) (6) as
opposed to non-official homeopathic drugs, which may be marketed if
ingredients are generally recognized as homeopathic. The FDA distinguishes
between official (HPUS-listed ingredients) and non-official homeopathic drugs
both of which are legal. Eligibility for inclusion in the HPUS requires that the
homeopathic product is proven to be safe, effective and prepared according to
HPUS provisions.
Homeopathic products must meet the standards for quality and purity set out in
the HPUS. The presence of the initials HPUS on the label of a product assures
that legal standards of strength, quality, purity and packing are respected.
Homeopathic products intended solely for self-limiting disease conditions
amenable to self-diagnosis and treatment may be marketed as over-the-counter
(OTC) drugs. Homeopathic products for conditions not amenable to OTC use
must be marketed as prescription products.
Homeopathic products must be manufactured in conformity with GMP, but are
exempt from provisions for expiration dating, tablet imprinting, and laboratory
determination of identity and strength. Requirements for stability must be met by
49
a written assessment on compatibility of ingredients and excipients and on

possible disintegration during expected period of use.
References
1. Therapeutic Goods Administration. Australian regulatory guidelines for

complementary medicines, part I–V. Symonston, ACT, Australian Government,
Department of Health and Ageing, Therapeutic Goods Administration, 2005.
2. Health Canada, Natural Health Products Directorate. Food and Drugs Act,
Natural Health Products Regulations, SOR/2003-196 (2003).
3. Health Canada, Natural Health Products Directorate. Overview of the

Natural Health Products Regulations Guidance Document (2003).
4. Health Canada, Natural Health Products Directorate. Good Manufacturing

Practice Guidance Document (2003);
5. Health Canada, Natural Health Products Directorate. Evidence for

Homeopathic Medicines Guidance Document (2007).

7. German Homeopathic Pharmacopoeia (GHP). Vols 1 and 2. Stuttgart,

8. Pharmacopée Francaise [French Pharmacopoeia]. Vol. 3, 10th ed. Refondue +

9. Council of Europe. European pharmacopoeia, 6th ed. Strasbourg,

Directorate for the Quality of Medicines of the Council of Europe, 2006.
10. Varma, PN, Vaid I. Encyclopedia of homeopathic pharmacopeoeia, 4 vols. New

Delhi, Jain, 2007.
11. EU Commission Directive 2001/83/EC of the European Parliament and

the Council on the Community code relating to medicinal products for human
use (2001), amended by Directive 2004/27/EC of the European Parliament and
the Council, Chapter 2, Specific provisions applicable to homeopathic medicinal
products. Official Journal of the European Communities L 311 (28.11.2001).
12. The Homoeopathy Central Council Act 1973 (No. 59 of 1973) Department of
Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy, Ministry of Health
& Family Welfare, Government of India.
13. The Homoeopathy Central Council Act (amended) 2002 (No. 51 of 2002).
14. Drugs and Cosmetics Act, 1940, as amended 2005: Schedule M (Good
Manufacturing Practice) of Drugs and Cosmetics Act.
50
Annex308
5
15. Ministry of Health & Family Welfare, Government of India. Schedule M

(Good manufacturing practice) of Drugs and Cosmetics Rules, 1945, as amended 2006
16. Homoeopathic pharmacopoeia of India. Vols. 1–8. Delhi, Controller of

Publications, 1970–2001
17. Verordnung vom 22. Juni 2006 des Schweizerischen Heilmittelinstituts

über die vereinfachte Zulassung von Komplementär- und Phytoarzneimitteln
(Komplementär- und Phytoarzneimittelverordnung, KPAV).
18. Directive 2003/94/EC of the European Parliament and of the Council,

Principles and guidelines of good manufacturing practice in respect of medicinal
products for human use and investigational products for human use. Official
Journal L, 262, 14/10/2003:22–26.).
19. Schweizerischen Pharmakopöe [Swiss pharmacopoeia] (Ph Helv). 10th ed.

Berne, Department of the Interior, 2006.
20. British homeopathic pharmacopoeia. London, British Homoeopathic Society,

1876.
21. U.S. Food and Drug Administration, FDA: Compliance Policy Guide,
CPG, 7132.15, Sec. 400.400; 21 CFR Parts 210 & 211, as amended.
22. 21 Code of Federal Regulations Parts 210 and 211: Current good
manufacturing practice in manufacturing, processing, packing or holding of
drugs; general and current good manufacturing practice for finished
pharmaceuticals. Rockville, MD, US Food and Drug Administration, 2006
(http://www.fda.gov/cder/dmpq/cgmpregs.htm).
51
309
310
ANNEXURE P-6
Cite as: 562 U. S. ____ (2011) 1
Opinion of the Court
NOTICE: This opinion is subject to formal revision before publication in the

preliminary print of the United States Reports. Readers are requested to
notify the Reporter of Decisions, Supreme Court of the United States, Wash
ington, D. C. 20543, of any typographical or other formal errors, in order
that corrections may be made before the preliminary print goes to press.
SUPREME COURT OF THE UNITED STATES

_________________
No. 09–152
_________________
RUSSELL BRUESEWITZ, ET AL., PETITIONERS v.

WYETH LLC, FKA WYETH, INC., FKA WYETH
LABORATORIES, ET AL.
ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF
APPEALS FOR THE THIRD CIRCUIT
[February 22, 2011]
JUSTICE SCALIA delivered the opinion of the Court.

We consider whether a preemption provision enacted in
the National Childhood Vaccine Injury Act of 1986
(NCVIA)1 bars state-law design-defect claims against
vaccine manufacturers.
I
A
For the last 66 years, vaccines have been subject to the
same federal premarket approval process as prescription
drugs, and compensation for vaccine-related injuries has
been left largely to the States.2 Under that regime, the
elimination of communicable diseases through vaccination
became “one of the greatest achievements” of public health
in the 20th century.3 But in the 1970’s and 1980’s vac
——————
1 42U. S. C. §300aa–22(b)(1).
2 See P. Hutt, R. Merrill, & L. Grossman, Food and Drug Law 912–
913, 1458 (3d ed. 2007).
3 Centers for Disease Control, Achievements in Public Health, 1900–
1999: Impact of Vaccines Universally Recommended for Children, 48

Morbidity and Mortality Weekly Report 243, 247 (Apr. 2, 1999).
311
2 BRUESEWITZ v. WYETH LLC
cines became, one might say, victims of their own success.

They had been so effective in preventing infectious dis
eases that the public became much less alarmed at the
threat of those diseases,4 and much more concerned with
the risk of injury from the vaccines themselves.5
Much of the concern centered around vaccines against
diphtheria, tetanus, and pertussis (DTP), which were
blamed for children’s disabilities and developmental de
lays. This led to a massive increase in vaccine-related tort
litigation. Whereas between 1978 and 1981 only nine
product-liability suits were filed against DTP manufactur
ers, by the mid-1980’s the suits numbered more than 200
each year.6 This destabilized the DTP vaccine market,
causing two of the three domestic manufacturers to with
draw; and the remaining manufacturer, Lederle Laborato
ries, estimated that its potential tort liability exceeded its
annual sales by a factor of 200.7 Vaccine shortages arose
when Lederle had production problems in 1984.8
Despite the large number of suits, there were many
complaints that obtaining compensation for legitimate
vaccine-inflicted injuries was too costly and difficult.9 A
——————
4 See Mortimer, Immunization Against Infectious Disease, 200 Sci
ence 902, 906 (1978).

5 See National Vaccine Advisory Committee, A Comprehensive Re
view of Federal Vaccine Safety Programs and Public Health Activities

2–3 (Dec. 2008) (hereinafter NVAC), http://www.hhs.gov/nvpo/nvac/
documents/vaccine-safety-review.pdf (as visited Feb. 18, 2011, and
available in Clerk of Court’s case file).
6 See Sing & Willian, Supplying Vaccines: An Overview of the Market
and Regulatory Context, in Supplying Vaccines: An Economic Analysis

of Critical Issues 45, 51–52 (M. Pauly, C. Robinson, S. Sepe, M. Sing, &
M. William eds. 1996).
7 See id., at 52.
8 See Centers for Disease Control, Diptheria-Tetanus-Pertussis Vac
cine Shortage, 33 Morbidity and Mortality Weekly Report 695–696

(Dec. 14, 1984).
9 See Apolinsky & Van Detta, Rethinking Liability for Vaccine Injury,
19 Cornell J. L. & Pub. Pol’y 537, 550–551 (2010); T. Burke, Lawyers,

312
Cite as: 562 U. S. ____ (2011) 3
significant number of parents were already declining

vaccination for their children,10 and concerns about com
pensation threatened to depress vaccination rates even
further.11 This was a source of concern to public health
officials, since vaccines are effective in preventing out
breaks of disease only if a large percentage of the popula
tion is vaccinated.12
To stabilize the vaccine market and facilitate compensa
tion, Congress enacted the NCVIA in 1986. The Act estab
lishes a no-fault compensation program “designed to work
faster and with greater ease than the civil tort system.”
Shalala v. Whitecotton, 514 U. S. 268, 269 (1995). A per
son injured by a vaccine, or his legal guardian, may file a
petition for compensation in the United States Court of
Federal Claims, naming the Secretary of Health and
Human Services as the respondent.13 A special master
then makes an informal adjudication of the petition within
(except for two limited exceptions) 240 days.14 The Court
of Federal Claims must review objections to the special
master’s decision and enter final judgment under a simi
larly tight statutory deadline.15 At that point, a claimant
has two options: to accept the court’s judgment and forgo a
traditional tort suit for damages, or to reject the judgment
and seek tort relief from the vaccine manufacturer.16
Fast, informal adjudication is made possible by the Act’s
Vaccine Injury Table, which lists the vaccines covered
under the Act; describes each vaccine’s compensable,
——————
Lawsuits, and Legal Rights: The Battle over Litigation in American
Society 146 (2002).
10 Mortimer, supra, at 906.
11 See Hagan, 45 Food Drug Cosm. L. J. 477, 479 (1990).
12 See R. Merrill, Introduction to Epidemiology 65–68 (2010).
13 See 42 U. S. C. §300aa–11(a)(1).
14 See §300aa–12(d)(3).
15 See §300aa–12(e), (g).
16 See §300aa–21(a).
313
adverse side effects; and indicates how soon after vaccina

tion those side effects should first manifest themselves.17
Claimants who show that a listed injury first manifested
itself at the appropriate time are prima facie entitled to
compensation.18 No showing of causation is necessary; the
Secretary bears the burden of disproving causation.19 A
claimant may also recover for unlisted side effects, and for
listed side effects that occur at times other than those
specified in the Table, but for those the claimant must
prove causation.20 Unlike in tort suits, claimants under
the Act are not required to show that the administered
vaccine was defectively manufactured, labeled, or de
signed.
Successful claimants receive compensation for medical,
rehabilitation, counseling, special education, and voca
tional training expenses; diminished earning capacity;
pain and suffering; and $250,000 for vaccine-related
deaths.21 Attorney’s fees are provided, not only for suc
cessful cases, but even for unsuccessful claims that are not
frivolous.22 These awards are paid out of a fund created by
an excise tax on each vaccine dose.23
The quid pro quo for this, designed to stabilize the
vaccine market, was the provision of significant tort
liability protections for vaccine manufacturers. The Act
requires claimants to seek relief through the compensation
program before filing suit for more than $1,000.24 Manu
facturers are generally immunized from liability for fail
——————
17 See §300aa–14(a); 42 CFR §100.3 (2009) (current Vaccine Injury
Table).
18 See 42 U. S. C. §§300aa–11(c)(1), 300aa–13(a)(1)(A).
19 See §300aa–13(a)(1)(B).
20 See §300aa–11(c)(1)(C)(ii).
21 See §300aa–15(a).
22 See §300aa–15(e).
23 See §300aa–15(i)(2); 26 U. S. C. §§4131, 9510.
24 See 42 U. S. C. §300aa–11(a)(2).
314
Cite as: 562 U. S. ____ (2011) 5
ure to warn if they have complied with all regulatory

requirements (including but not limited to warning re
quirements) and have given the warning either to the
claimant or the claimant’s physician.25 They are immu
nized from liability for punitive damages absent failure to
comply with regulatory requirements, “fraud,” “intentional
and wrongful withholding of information,” or other “crimi
nal or illegal activity.”26 And most relevant to the present
case, the Act expressly eliminates liability for a vaccine’s
unavoidable, adverse side effects:
“No vaccine manufacturer shall be liable in a civil ac
tion for damages arising from a vaccine-related injury
or death associated with the administration of a vac
cine after October 1, 1988, if the injury or death re
sulted from side effects that were unavoidable even
though the vaccine was properly prepared and was ac
companied by proper directions and warnings.”27
B
The vaccine at issue here is a DTP vaccine manufac
tured by Lederle Laboratories. It first received federal
approval in 1948 and received supplemental approvals in
1953 and 1970. Respondent Wyeth purchased Lederle in
1994 and stopped manufacturing the vaccine in 1998.
Hannah Bruesewitz was born on October 20, 1991. Her
pediatrician administered doses of the DTP vaccine ac
cording to the Center for Disease Control’s recommended
childhood immunization schedule. Within 24 hours of her
April 1992 vaccination, Hannah started to experience
——————
25 See §300aa–22(b)(2), (c). The immunity does not apply if the plain
tiff establishes by clear and convincing evidence that the manufacturer

was negligent, or was guilty of fraud, intentional and wrongful with
holding of information, or other unlawful activity. See §§300aa–
22(b)(2), 300aa–23(d)(2).
26 §300aa–23(d)(2).
27 §300aa–22(b)(1).
315
seizures.28 She suffered over 100 seizures during the next

month, and her doctors eventually diagnosed her with
“residual seizure disorder” and “developmental delay.”29
Hannah, now a teenager, is still diagnosed with both
conditions.
In April 1995, Hannah’s parents, Russell and Robalee
Bruesewitz, filed a vaccine injury petition in the United
States Court of Federal Claims, alleging that Hannah
suffered from on-Table residual seizure disorder and
encephalopathy injuries.30 A Special Master denied their
claims on various grounds, though they were awarded
$126,800 in attorney’s fees and costs. The Bruesewitzes
elected to reject the unfavorable judgment, and in October
2005 filed this lawsuit in Pennsylvania state court. Their
complaint alleged (as relevant here) that defective design
of Lederle’s DTP vaccine caused Hannah’s disabilities, and
that Lederle was subject to strict liability, and liability for
negligent design, under Pennsylvania common law.31
Wyeth removed the suit to the United States District
Court for the Eastern District of Pennsylvania, which
granted Wyeth summary judgment on the strict-liability
and negligence design-defect claims, holding that the
Pennsylvania law providing those causes of action was
preempted by 42 U. S. C. §300aa–22(b)(1).32 The United
States Court of Appeals for the Third Circuit affirmed.33
We granted certiorari. 559 U. S. ___ (2010).
——————
28 See Bruesewitz v. Secretary of Health and Human Servs., No. 95–
0266V, 2002 WL 31965744, *3 (Ct. Cl., Dec. 20, 2002).

29 561 F. 3d 233, 236 (CA3 2009).
30 See id., at *1.
31 See 561 F. 3d at 237. The complaint also made claims based upon
failure to warn and defective manufacture. These are no longer at

issue.
32 See id., at 237–238.
33 Id., at 235.
316
Cite as: 562 U. S. ____ (2011) 7
II
We set forth again the statutory text at issue:

though the vaccine was properly prepared and was ac
companied by proper directions and warnings.”34
The “even though” clause clarifies the word that precedes
it. It delineates the preventative measures that a vaccine
manufacturer must have taken for a side-effect to be con
sidered “unavoidable” under the statute. Provided that
there was proper manufacture and warning, any remain
ing side effects, including those resulting from design
defects, are deemed to have been unavoidable. State-law
design-defect claims are therefore preempted.
If a manufacturer could be held liable for failure to use a
different design, the word “unavoidable” would do no
work. A side effect of a vaccine could always have been
avoidable by use of a differently designed vaccine not
containing the harmful element. The language of the
provision thus suggests that the design of the vaccine is a
given, not subject to question in the tort action. What the
statute establishes as a complete defense must be un
avoidability (given safe manufacture and warning) with
respect to the particular design. Which plainly implies
that the design itself is not open to question.35
——————
34 42U. S. C. §300aa–22(b)(1).
35 The dissent advocates for another possibility: “[A] side effect is
‘unavoidable’ . . . where there is no feasible alternative design that
would eliminate the side effect of the vaccine without compromising its
cost and utility.” Post, at 15 (opinion of SOTOMAYOR, J.). The dissent
makes no effort to ground that position in the text of §300aa–22(b)(1).
317
A further textual indication leads to the same conclu

sion. Products-liability law establishes a classic and well
known triumvirate of grounds for liability: defective
manufacture, inadequate directions or warnings, and
defective design.36 If all three were intended to be pre
served, it would be strange to mention specifically only
two, and leave the third to implication. It would have
been much easier (and much more natural) to provide that
manufacturers would be liable for “defective manufacture,
defective directions or warning, and defective design.” It
seems that the statute fails to mention design-defect
liability “by deliberate choice, not inadvertence.” Barn
hart v. Peabody Coal Co., 537 U. S. 149, 168 (2003). Ex
pressio unius, exclusio alterius.
B
The dissent’s principal textual argument is mistaken.
We agree with its premise that “ ‘side effects that were
unavoidable’ must refer to side effects caused by a vac
cine’s design.”37 We do not comprehend, however, the
second step of its reasoning, which is that the use of
the conditional term “if” in the introductory phrase “if the
injury or death resulted from side effects that were un
avoidable” “plainly implies that some side effects stem
ming from a vaccine’s design are ‘unavoidable,’ while
——————
We doubt that Congress would introduce such an amorphous test by
implication when it otherwise micromanages vaccine manufacturers.
See infra, at 13–14. We have no idea how much more expensive an
alternative design can be before it “compromis[es]” a vaccine’s cost or
how much efficacy an alternative design can sacrifice to improve safety.
Neither does the dissent. And neither will the judges who must rule on
motions to dismiss, motions for summary judgment, and motions for
judgment as a matter of law. Which means that the test would proba
bly have no real-world effect.
36 W. Keeton, D. Dobbs, R. Keeton, & D. Owen, Prosser and Keeton on
Law of Torts 695 (5th ed. 1984); Restatement (Third) of Torts §2 (1999).
37 Post, at 3.
318
Cite as: 562 U. S. ____ (2011) 9
others are avoidable.”38 That is not so. The “if ” clause

makes total sense whether the design to which “unavoid
able” refers is (as the dissent believes) any feasible design
(making the side effects of the design used for the vaccine
at issue avoidable), or (as we believe) the particular design
used for the vaccine at issue (making its side effects un
avoidable). Under the latter view, the condition estab
lished by the “if” clause is that the vaccine have been
properly labeled and manufactured; and under the former,
that it have been properly designed, labeled, and manufac
tured. Neither view renders the “if ” clause a nullity.
Which of the two variants must be preferred is addressed
by our textual analysis, and is in no way determined by
the “if ” clause.
Petitioners’ and the dissent’s textual argument also
rests upon the proposition that the word “unavoidable” in
§300aa–22(b)(1) is a term of art that incorporates com
ment k to Restatement (Second) of Torts §402A (1963–
1964).39 The Restatement generally holds a manufacturer
strictly liable for harm to person or property caused by
“any product in a defective condition unreasonably dan
gerous to the user.”40 Comment k exempts from this
strict-liability rule “unavoidably unsafe products.” An
unavoidably unsafe product is defined by a hodge-podge of
criteria and a few examples, such as the Pasteur rabies
vaccine and experimental pharmaceuticals. Despite this
lack of clarity, petitioners seize upon one phrase in the
comment k analysis, and assert that by 1986 a majority of
courts had made this a sine qua non requirement for an
“unavoidably unsafe product”: a case-specific showing that
the product was “quite incapable of being made safer for
——————
38 Ibid.
39 See Brief for Petitioners 29.
40 Restatement §402A, p. 347.
319
[its] intended . . . use.”41

We have no need to consider the finer points of comment
k. Whatever consistent judicial gloss that comment may
have been given in 1986, there is no reason to believe that
§300aa–22(b)(1) was invoking it. The comment creates a
special category of “unavoidably unsafe products,” while
the statute refers to “side effects that were unavoidable.”
That the latter uses the adjective “unavoidable” and the
former the adverb “unavoidably” does not establish that
Congress had comment k in mind. “Unavoidable” is
hardly a rarely used word. Even the cases petitioners cite
as putting a definitive gloss on comment k use the precise
phrase “unavoidably unsafe product”;42 none attaches
special significance to the term “unavoidable” standing
alone.
The textual problems with petitioners’ interpretation do
——————
41 Id., Comment k, p. 353; Petitioners cite, inter alia, Kearl v. Lederle
Labs., 172 Cal. App. 3d 812, 828–830, 218 Cal. Rptr. 453, 463–464
(1985); Belle Bonfils Memorial Blood Bank v. Hansen, 665 P. 2d 118,
122 (Colo. 1983).
Though it is not pertinent to our analysis, we point out that a large
number of courts disagreed with that reading of comment k, and took it
to say that manufacturers did not face strict liability for side effects of
properly manufactured prescription drugs that were accompanied by
adequate warnings. See, e.g., Brown v. Superior Court, 227 Cal. Rptr.
768, 772–775 (Cal. App. 1986), (officially depublished), aff’d 44 Cal. 3d
1049, 751 P. 2d 470 (1988); McKee v. Moore, 648 P. 2d 21, 23 (Okla.
1982); Stone v. Smith, Kline & French Labs., 447 So. 2d 1301, 1303–
1304 (Ala. 1984); Lindsay v. Ortho Pharm. Corp., 637 F. 2d 87, 90–91
(CA2 1980) (applying N. Y. law); Wolfgruber v. Upjohn Co., 72 App. Div.
2d 59, 61, 423 N. Y. S. 2d 95, 96 (1979); Chambers v. G. D. Searle & Co.,
441 F. Supp. 377, 380–381 (D Md. 1975); Basko v. Sterling Drug, Inc.,
416 F. 2d 417, 425 (CA2 1969) (applying Conn. law).
42 See, e.g., Johnson v. American Cyanamid Co., 239 Kan. 279, 285,
718 P. 2d 1318, 1323 (1986); Feldman v. Lederle Labs., 97 N. J. 429,

440, 446–447, 479 A. 2d 374, 380, 383–384 (1984); Belle Bonfils Memo
rial Blood Bank supra, at 121–123; Cassisi v. Maytag Co., 396 So. 2d
1140, 1144, n. 4, 1146 (Fla. App. 1981); Racer v. Utterman, 629 S. W. 2d
387, 393 (Mo. App. 1981).
320
Cite as: 562 U. S. ____ (2011) 11
not end there. The phrase “even though” in the clause

“even though the vaccine was properly prepared and
[labeled]” is meant to signal the unexpected: unavoidable
side effects persist despite best manufacturing and label
ing practices.43 But petitioners’ reading eliminates any
opposition between the “even though” clause—called a
concessive subordinate clause by grammarians—and the
word “unavoidable.”44 Their reading makes preemption
turn equally on unavoidability, proper preparation, and
proper labeling. Thus, the dissent twice refers to the
requirements of proper preparation and proper labeling as
“two additional prerequisites” for preemption independent
of unavoidability.45 The primary textual justification for
the dissent’s position depends on that independence.46
But linking independent ideas is the job of a coordinating
junction like “and,” not a subordinating junction like “even
though.”47
——————
43 The dissent’s assertion that we treat “even though” as a synonym
for “because” misses the subtle distinction between “because” and

“despite.” See post, at 17, n. 14. “Even though” is a close cousin of the
latter. See Webster’s New International Dictionary 709, 2631 (2d ed.
1957). The statement “the car accident was unavoidable despite his
quick reflexes” indicates that quick reflexes could not avoid the acci
dent, and leaves open two unstated possibilities: (1) that other, un
stated means of avoiding the accident besides quick reflexes existed,
but came up short as well; or (2) that quick reflexes were the only
possible way to avoid the accident. Our interpretation of §300aa–
22(b)(1) explains why we think Congress meant the latter in this
context. (Incidentally, the statement “the car accident was unavoidable
because of his quick reflexes” makes no sense.)
44 See W. Follett, Modern American Usage: A Guide 61 (1966).
45 Post, at 9, 17.
46 Post, at 3–5.
47 The dissent responds that these “additional prerequisites” act “in a
concessive, subordinating fashion,” post, at 17, n. 14 (internal quotation

marks and brackets omitted). But that is no more true of the dissent’s
conjunctive interpretation of the present text than it is of all provisions
that set forth additional requirements—meaning that we could elimi
nate “even though” from our English lexicon, its function being entirely
321
Petitioners and the dissent contend that the interpreta

tion we propose would render part of §300aa–22(b)(1)
superfluous: Congress could have more tersely and more
clearly preempted design-defect claims by barring liability
“if . . . the vaccine was properly prepared and was accom
panied by proper directions and warnings.” The interven
ing passage (“the injury or death resulted from side effects
that were unavoidable even though”) is unnecessary. True
enough. But the rule against giving a portion of text an
interpretation which renders it superfluous does not pre
scribe that a passage which could have been more terse
does not mean what it says. The rule applies only if ver
bosity and prolixity can be eliminated by giving the offend
ing passage, or the remainder of the text, a competing
interpretation. That is not the case here.48 To be sure,
petitioners’ and the dissent’s interpretation gives inde
pendent meaning to the intervening passage (the supposed
meaning of comment k); but it does so only at the expense
of rendering the remainder of the provision superfluous.
Since a vaccine is not “quite incapable of being made safer
for [its] intended use” if manufacturing defects could have
been eliminated or better warnings provided, the entire
“even though” clause is a useless appendage.49 It would
suffice to say “if the injury or death resulted from side
effects that were unavoidable”—full stop.
——————
performed by “and.” No, we think “even though” has a distinctive
concessive, subordinating role to play.
48 Because the dissent has a superfluity problem of its own, its reli
ance on Bates v. Dow Agrosciences LLC, 544 U. S. 431 (2005), is mis

placed. See id., at 449 (adopting an interpretation that was “the only
one that makes sense of each phrase” in the relevant statute).
49 That is true regardless of whether §300aa–22(b)(1) incorporates
comment k. See Restatement §402A, Comment k, pp. 353, 354 (noting

that “unavoidably unsafe products” are exempt from strict liability
“with the qualification that they are properly prepared and marketed,
and proper warning is given”).
322
Cite as: 562 U. S. ____ (2011) 13
III
The structure of the NCVIA and of vaccine regulation in
general reinforces what the text of §300aa–22(b)(1) sug
gests. A vaccine’s license spells out the manufacturing
method that must be followed and the directions and
warnings that must accompany the product.50 Manufac
turers ordinarily must obtain the Food and Drug Admini
stration’s (FDA) approval before modifying either.51 De
viations from the license thus provide objective evidence of
manufacturing defects or inadequate warnings. Further
objective evidence comes from the FDA’s regulations—
more than 90 of them52—that pervasively regulate the
manufacturing process, down to the requirements for
plumbing and ventilation systems at each manufacturing
facility.53 Material noncompliance with any one of them,
or with any other FDA regulation, could cost the manufac
turer its regulatory-compliance defense.54
Design defects, in contrast, do not merit a single men
tion in the NCVIA or the FDA’s regulations. Indeed, the
FDA has never even spelled out in regulations the criteria
it uses to decide whether a vaccine is safe and effective for
its intended use.55 And the decision is surely not an easy
one. Drug manufacturers often could trade a little less
efficacy for a little more safety, but the safest design is not
always the best one. Striking the right balance between
safety and efficacy is especially difficult with respect to
vaccines, which affect public as well as individual health.
Yet the Act, which in every other respect micromanages
manufacturers, is silent on how to evaluate competing
designs. Are manufacturers liable only for failing to em
——————
50 See 42 U. S. C. §262(a), ( j); 21 CFR §§601.2(a), 314.105(b) (2010).
51 See §601.12.
52 See §§211.1 et seq., 600.10–600.15, 600.21–600.22, 820.1 et seq.
53 See §§211.46, 211.48.
54 See 42 U. S. C. §300aa–22(b)(2).
55 Hutt, Merrill, & Grossman, Food and Drug Law, at 685, 891.
323
ploy an alternative design that the FDA has approved for

distribution (an approval it takes years to obtain56)? Or
does it suffice that a vaccine design has been approved in
other countries? Or could there be liability for failure to
use a design that exists only in a lab? Neither the Act nor
the FDA regulations provide an answer, leaving the uni
verse of alternative designs to be limited only by an ex
pert’s imagination.
Jurors, of course, often decide similar questions with
little guidance, and we do not suggest that the absence
of guidance alone suggests preemption. But the lack of
guidance for design defects combined with the exten-
sive guidance for the two grounds of liability specifically
mentioned in the Act strongly suggests that design defects
were not mentioned because they are not a basis for
liability.
The mandates contained in the Act lead to the same
conclusion. Design-defect torts, broadly speaking, have
two beneficial effects: (1) prompting the development of
improved designs, and (2) providing compensation for
inflicted injuries. The NCVIA provides other means for
achieving both effects. We have already discussed the
Act’s generous compensation scheme. And the Act pro
vides many means of improving vaccine design. It directs
the Secretary of Health and Human Services to promote
“the development of childhood vaccines that result in
fewer and less serious adverse reactions.”57 It establishes
a National Vaccine Program, whose Director is “to achieve
optimal prevention of human infectious diseases . . . and to
achieve optimal prevention against adverse reactions.”58
The Program is to set priorities for federal vaccine re
search, and to coordinate federal vaccine safety and effi
——————
56 See Sing & William, Supplying Vaccines, at 66–67.
57 42 U. S. C. §300aa–27(a)(1).
58 §300aa–1.
324
Cite as: 562 U. S. ____ (2011) 15
cacy testing.59 The Act requires vaccine manufacturers

and health-care providers to report adverse side effects,60
and provides for monitoring of vaccine safety through a
collaboration with eight managed-care organizations.61
And of course whenever the FDA concludes that a vaccine
is unsafe, it may revoke the license.62
These provisions for federal agency improvement of
vaccine design, and for federally prescribed compensation,
once again suggest that §300aa–22(b)(1)’s silence regard
ing design-defect liability was not inadvertent. It instead
reflects a sensible choice to leave complex epidemiological
judgments about vaccine design to the FDA and the Na
tional Vaccine Program rather than juries.63
And finally, the Act’s structural quid pro quo leads to
the same conclusion: The vaccine manufacturers fund
from their sales an informal, efficient compensation pro
gram for vaccine injuries;64 in exchange they avoid costly
tort litigation and the occasional disproportionate jury
verdict.65 But design-defect allegations are the most
speculative and difficult type of products liability claim to
——————
59 See §§300aa–2(a)(1)–(3), 300aa–3.
60 See §300aa–25(b).
61 See NVAC 18–19.
62 See 21 CFR §601.5(b)(1)(vi) (2010).
63 The dissent quotes just part of this sentence, to make it appear that
we believe complex epidemiological judgments ought to be assigned in

that fashion. See post, at 26. We do not state our preference, but
merely note that it is Congress’s expressed preference—and in order to
preclude the argument that it is absurd to think Congress enacted such
a thing, we assert that the choice is reasonable and express some of the
reasons why. Leaving it to the jury may (or may not) be reasonable as
well; we express no view.
64 See 42 U. S. C. §300aa–15(i)(2); Pub. L. 99–660, §323(a), 100 Stat.
3784. The dissent’s unsupported speculation that demand in the

vaccine market is inelastic, see post, at 24, n. 22, sheds no light on
whether Congress regarded the tax as a quid pro quo, most Members of
Congress being neither professional economists nor law-and-economics
scholars.
65 See 42 U. S. C. §§300aa–11(a)(2), 300aa–22.
325
litigate. Taxing vaccine manufacturers’ product to fund

the compensation program, while leaving their liability for
design defect virtually unaltered, would hardly coax
manufacturers back into the market.
The dissent believes the Act’s mandates are irrelevant
because they do not spur innovation in precisely the same
way as state-law tort systems.66 That is a novel sugges
tion. Although we previously have expressed doubt that
Congress would quietly preempt product-liability claims
without providing a federal substitute, see Medtronic, Inc.
v. Lohr, 518 U. S. 470, 486–488 (1996) (plurality opinion),
we have never suggested we would be skeptical of preemp
tion unless the congressional substitute operated like the
tort system. We decline to adopt that stance today. The
dissent’s belief that the FDA and the National Vaccine
Program cannot alone spur adequate vaccine innovation is
probably questionable, but surely beside the point.
IV
Since our interpretation of §300aa–22(b)(1) is the only
interpretation supported by the text and structure of the
NCVIA, even those of us who believe legislative history is
a legitimate tool of statutory interpretation have no need
to resort to it. In any case, the dissent’s contention that it
would contradict our conclusion is mistaken.
The dissent’s legislative history relies on the following
syllogism: A 1986 House Committee Report states that
§300aa–22(b)(1) “sets forth the principle contained in
Comment k of Section 402A of the Restatement of Torts
(Second);”67 in 1986 comment k was “commonly under
stood” to require a case-specific showing that “no feasible
alternative design” existed; Congress therefore must have
intended §300aa–22(b)(1) to require that showing.68 The
——————
66 See post, at 21–24.
67 H.R. Rep. No. 99–908, pt. 1, p. 25 (1986) (hereinafter 1986 Report).
68 Post, at 7–8.
326
Cite as: 562 U. S. ____ (2011) 17
syllogism ignores unhelpful statements in the Report and

relies upon a term of art that did not exist in 1986.
Immediately after the language quoted by the dissent,
the 1986 Report notes the difficulty a jury would have in
faithfully assessing whether a feasible alternative design
exists when an innocent “young child, often badly injured
or killed” is the plaintiff.69 Eliminating that concern is
why the Report’s authors “strongly believ[e] that Com
ment k is appropriate and necessary as the policy for civil
actions seeking damages in tort.”70 The dissent’s interpre
tation of §300aa–22(b)(1) and its version of “the principle
in Comment K” adopted by the 1986 Report leave that
concern unaddressed.
The dissent buries another unfavorable piece of legisla
tive history. Because the Report believes that §300aa–
22(b)(1) should incorporate “the principle in Comment K”
and because the Act provides a generous no-fault compen
sation scheme, the Report counsels injured parties who
cannot prove a manufacturing or labeling defect to “pursue
recompense in the compensation system, not the tort
system.”71 That counsel echoes our interpretation of
§300aa–22(b)(1).
Not to worry, the dissent retorts, a Committee Report by
a later Congress “authoritative[ly]” vindicates its interpre
tation.72 Post-enactment legislative history (a contradic
tion in terms) is not a legitimate tool of statutory interpre
tation. See Jones v. United States, 526 U. S. 227, 238
——————
69 1986 Report, at 26; see ibid. (“[E]ven if the defendant manufacturer
may have made as safe a vaccine as anyone reasonably could expect, a
court or jury undoubtedly will find it difficult to rule in favor of the
‘innocent’ manufacturer if the equally ‘innocent’ child has to bear the
risk of loss with no other possibility of recompense”).
70 Ibid.
71 Ibid.
72 Post, at 12. This is a courageous adverb since we have previously
held that the only authoritative source of statutory meaning is the text
that has passed through the Article I process. See Exxon Mobil Corp. v.
Allapattah Services, Inc., 545 U. S. 546, 568 (2005).
327
(1999); United States v. Mine Workers, 330 U. S. 258, 281–

282 (1947). Real (pre-enactment) legislative history is
persuasive to some because it is thought to shed light on
what legislators understood an ambiguous statutory text
to mean when they voted to enact it into law. See Exxon
Mobil Corp. v. Allapattah Services, Inc., 545 U. S. 546, 568
(2005). But post-enactment legislative history by defini
tion “could have had no effect on the congressional vote,”
District of Columbia v. Heller, 554 U. S. 570, 605 (2008).
It does not matter that §300aa–22(b)(1) did not take
effect until the later Congress passed the excise tax that
funds the compensation scheme,73 and that the supposedly
dispositive Committee Report is attached to that funding
legislation.74 Those who voted on the relevant statutory
language were not necessarily the same persons who
crafted the statements in the later Committee Report; or if
they were did not necessarily have the same views at that
earlier time; and no one voting at that earlier time could
possibly have been informed by those later statements.
Permitting the legislative history of subsequent funding
legislation to alter the meaning of a statute would set a
dangerous precedent. Many provisions of federal law
depend on appropriations or include sunset provisions;75
they cannot be made the device for unenacted statutory
revision.
That brings us to the second flaw in the dissent’s syllo
gism: Comment k did not have a “commonly understood
meaning”76 in the mid-1980’s. Some courts thought it
required a case-specific showing that a product was “un
avoidably unsafe”; many others thought it categorically
exempted certain types of products from strict liability.77
——————
73 Pub. L. 99–960, §323(a), 100 Stat. 3784.
74 H. R. Rep. No. 100–391, pt. 1, p. 701 (1987).
75 See, e.g., Pub. L. 104–208, §§401, 403(a), 110 Stat. 3009–655 to
3009–656, 3009–659 to 3009–662, as amended, note following 8 U. S. C.

§1324a (2006 ed., Supp. III) (E-Verify program expires Sept. 30, 2012).
76 Post, at 8.
77 See n. 39, supra; post, at 7–8, n. 5.
328
Cite as: 562 U. S. ____ (2011) 19
When “all (or nearly all) of the” relevant judicial decisions

have given a term or concept a consistent judicial gloss, we
presume Congress intended the term or concept to have
that meaning when it incorporated it into a later-enacted
statute. Merck & Co. v. Reynolds, 559 U. S. ___, ___ (2010)
(SCALIA, J., concurring in part and concurring in judg
ment) (slip op., at 5). The consistent gloss represents
the public understanding of the term. We cannot make the
same assumption when widespread disagreement exists
among the lower courts. We must make do with giving the
term its most plausible meaning using the traditional
tools of statutory interpretation. That is what we have
done today.
* * *
For the foregoing reasons, we hold that the National
Childhood Vaccine Injury Act preempts all design-defect
claims against vaccine manufacturers brought by plain
tiffs who seek compensation for injury or death caused by
vaccine side effects. The judgment of the Court of Appeals
is affirmed.
It is so ordered.
JUSTICE KAGAN took no part in the consideration or

decision of this case.
329
Cite as: 562 U. S. ____ (2011) 1
BREYER, J., concurring

_________________
No. 09–152
_________________
[February 22, 2011]
JUSTICE BREYER, concurring.

I join the Court’s judgment and opinion. In my view,
the Court has the better of the purely textual argument.
But the textual question considered alone is a close
one. Hence, like the dissent, I would look to other
sources, including legislative history, statutory purpose,
and the views of the federal administrative agency, here
supported by expert medical opinion. Unlike the dissent,
however, I believe these other sources reinforce the
Court’s conclusion.
I
House Committee Report 99–908 contains an “authori
tative” account of Congress’ intent in drafting the pre
emption clause of the National Childhood Vaccine Injury
Act of 1986 (NCVIA or Act). See Garcia v. United States,
469 U. S. 70, 76 (1984) (“[T]he authoritative source for
finding the Legislature’s intent lies in the Committee
Reports on the bill”). That Report says that, “if” vaccine
injured persons
“cannot demonstrate under applicable law either that
a vaccine was improperly prepared or that it was ac
companied by improper directions or inadequate
warnings [they] should pursue recompense in the
330
compensation system, not the tort system.” H. R. Rep.

No. 99–908, pt. 1, p. 24 (1986) (hereinafter H. R.
Rep.).
The Report lists two specific kinds of tort suits that the
clause does not pre-empt (suits based on improper manu
facturing and improper labeling), while going on to state
that compensation for other tort claims, e.g., design-defect
claims, lies in “the [NCVIA’s no-fault] compensation sys
tem, not the tort system.” Ibid.
The strongest contrary argument rests upon the Re
port’s earlier description of the statute as “set[ting] forth
the principle contained in Comment k” (of the Restate
ment Second of Torts’ strict liability section, 402A) that “a
vaccine manufacturer should not be liable for injuries or
deaths resulting from unavoidable side effects.” Id., at 23
(emphasis added). But the appearance of the word “un
avoidable” in this last-mentioned sentence cannot provide
petitioners with much help. That is because nothing in
the Report suggests that the statute means the word
“unavoidable” to summon up an otherwise unmentioned
third exception encompassing suits based on design de
fects. Nor can the Report’s reference to comment k fill the
gap. The Report itself refers, not to comment k’s details,
but only to its “principle,” namely, that vaccine manufac
turers should not be held liable for unavoidable injuries.
It says nothing at all about who—judge, jury, or federal
safety agency—should decide whether a safer vaccine
could have been designed. Indeed, at the time Congress
wrote this Report, different state courts had come to very
different conclusions about that matter. See Cupp, Re
thinking Conscious Design Liability for Prescription
Drugs: The Restatement (Third) Standard Versus a Negli
gence Approach, 63 Geo. Wash. L. Rev. 76, 79 (1994–1995)
(“[C]ourts [had] adopted a broad range of conflicting inter
pretations” of comment k). Neither the word “unavoid
331
Cite as: 562 U. S. ____ (2011) 3
able” nor the phrase “the principle of Comment k” tells us

which courts’ view Congress intended to adopt. Silence
cannot tell us to follow those States where juries decided
the design-defect question.
II
The legislative history describes the statute more gen
erally as trying to protect the lives of children, in part
by ending “the instability and unpredictability of the
childhood vaccine market.” H. R. Rep., at 7; see ante, at
2–3. As the Committee Report makes clear, routine vacci
nation is “one of the most spectacularly effective public
health initiatives this country has ever undertaken.”
H. R. Rep., at 4. Before the development of routine whoop
ing cough vaccination, for example, “nearly all children”
in the United States caught the disease and more than
4,000 people died annually, most of them infants. U. S.
Dept. of Health and Human Services, Centers for Disease
Control and Prevention, What Would Happen if We
Stopped Vaccinations? http://www.cdc.gov/vaccines/vac-gen/
whatifstop.htm (all Internet materials as visited Feb. 17,
2011, and available in Clerk of Court’s case file); Prevent
ing Tetanus, Diphtheria, and Pertussis Among Adoles
cents: Use of Tetanus Toxoid, Reduced Diptheria Toxoid
and Acellular Pertussis Vaccines, 55 Morbidity and Mor
tality Weekly Report, No. RR–3, p. 2 (Mar. 24, 2006) (here
inafter Preventing Tetanus) (statistics for 1934–1943),
http://www.cdc.gov/mmwr/PDF/rr/rr5503.pdf; U. S. Dept.
of Health and Human Services, Centers for Disease Con
trol and Prevention, Epidemiology and Prevention of
Vaccine-Preventable Diseases 200 (11th ed. rev. May
2009). After vaccination became common, the number of
annual cases of whooping cough declined from over
200,000 to about 2,300, and the number of deaths from
about 4,000 to about 12. Preventing Tetanus 2; Childhood
Immunizations, House Committee on Energy and Com
332
merce, 99th Cong., 2d Sess., 10 (Comm. Print 1986) (here

inafter Childhood Immunizations).
But these gains are fragile; “[t]he causative agents for
these preventable childhood illnesses are ever present in
the environment, waiting for the opportunity to attack
the unprotected individual.” Hearing on S. 827 before the
Senate Committee on Labor and Human Resources, 99th
Cong., 2d Sess., pt. 2, pp. 20–21 (1985) (hereinafter Hear
ings) (testimony of the American Academy of Pediatrics);
see California Dept. of Public Health, Pertussis Re-
port (Jan. 7, 2011), www.cdph.ca.gov/programs/immunize/
Documents/PertussisReport2011–01–07.pdf (In 2010,
8,383 people in California caught whooping cough, and 10
infants died). Even a brief period when vaccination pro
grams are disrupted can lead to children’s deaths. Hear
ings 20–21; see Gangarosa et al., Impact of Anti-Vaccine
Movements on Pertussis Control: The Untold Story, 351
Lancet 356–361 (Jan. 31, 1998) (when vaccination pro
grams are disrupted, the number of cases of whooping
cough skyrockets, increasing by orders of magnitude).
In considering the NCVIA, Congress found that a sharp
increase in tort suits brought against whooping cough and
other vaccine manufacturers between 1980 and 1985 had
“prompted manufacturers to question their continued
participation in the vaccine market.” H. R. Rep., at 4;
Childhood Immunizations 85–86. Indeed, two whooping
cough vaccine manufacturers withdrew from the market,
and other vaccine manufacturers, “fac[ing] great difficulty
in obtaining [product liability] insurance,” told Congress
that they were considering “a similar course of action.”
H. R. Rep., at 4; Childhood Immunizations 68–70. The
Committee Report explains that, since there were only one
or two manufacturers of many childhood vaccines, “[t]he
loss of any of the existing manufacturers of childhood
vaccines . . . could create a genuine public health hazard”;
it “would present the very real possibility of vaccine short
333
Cite as: 562 U. S. ____ (2011) 5
ages, and, in turn, increasing numbers of unimmunized

children, and, perhaps, a resurgence of preventable dis
eases.” H. R. Rep., at 5. At the same time, Congress
sought to provide generous compensation to those whom
vaccines injured—as determined by an expert compensa
tion program. Id., at 5, 24.
Given these broad general purposes, to read the pre
emption clause as preserving design-defect suits seems
anomalous. The Department of Health and Human
Services (HHS) decides when a vaccine is safe enough to
be licensed and which licensed vaccines, with which
associated injuries, should be placed on the Vaccine In-
jury Table. 42 U. S. C. §300aa–14; ante, at 3–4; A
Comprehensive Review of Federal Vaccine Safety Pro
grams and Public Health Activities 13–15, 32–34
(Dec. 2008), http://www.hhs.gov/nvpo/nvac/documents/
vaccine-safety-review.pdf. A special master in the Act’s
compensation program determines whether someone has
suffered an injury listed on the Injury Table and, if not,
whether the vaccine nonetheless caused the injury. Ante,
at 3–4; §300aa–13. To allow a jury in effect to second
guess those determinations is to substitute less expert for
more expert judgment, thereby threatening manufacturers
with liability (indeed, strict liability) in instances where
any conflict between experts and nonexperts is likely to be
particularly severe—instances where Congress intended
the contrary. That is because potential tort plaintiffs are
unlikely to bring suit unless the specialized compensation
program has determined that they are not entitled to
compensation (say, because it concludes that the vaccine
did not cause the injury). Brief for United States as
Amicus Curiae 28 (“99.8% of successful Compensation
Program claimants have accepted their awards, foregoing
any tort remedies against vaccine manufacturers”). It is
difficult to reconcile these potential conflicts and the re
sulting tort liabilities with a statute that seeks to diminish
334
manufacturers’ product liability while simultaneously

augmenting the role of experts in making compensation
decisions.
III
The United States, reflecting the views of HHS, urges
the Court to read the Act as I and the majority would do.
It notes that the compensation program’s listed vaccines
have survived rigorous administrative safety review. It
says that to read the Act as permitting design-defect
lawsuits could lead to a recurrence of “exactly the crisis
that precipitated the Act,” namely withdrawals of vaccines
or vaccine manufacturers from the market, “disserv[ing]
the Act’s central purposes,” and hampering the ability of
the agency’s “expert regulators, in conjunction with the
medical community, [to] control the availability and with
drawal of a given vaccine.” Brief for United States as
Amicus Curiae 30, 31.
The United States is supported in this claim by leading
public health organizations, including the American Acad
emy of Pediatrics, the American Academy of Family Phy
sicians, the American College of Preventive Medicine, the
American Public Health Association, the American Medi
cal Association, the March of Dimes Foundation, the Pedi
atric Infectious Diseases Society, and 15 other similar
organizations. Brief for American Academy of Pediatrics
et al. as Amici Curiae (hereinafter AAP Brief). The Ameri
can Academy of Pediatrics has also supported the reten
tion of vaccine manufacturer tort liability (provided that
federal law structured state-law liability conditions in
ways that would take proper account of federal agency
views about safety). Hearings 14–15. But it nonetheless
tells us here, in respect to the specific question before us,
that the petitioners’ interpretation of the Act would un
dermine its basic purposes by threatening to “halt the
future production and development of childhood vaccines
335
Cite as: 562 U. S. ____ (2011) 7
in this country,” i.e., by “threaten[ing] a resurgence of the

very problems which . . . caused Congress to intervene” by
enacting this statute. AAP Brief 24 (internal quotation
marks omitted).
I would give significant weight to the views of HHS.
The law charges HHS with responsibility for overseeing
vaccine production and safety. It is “likely to have a thor
ough understanding” of the complicated and technical
subject matter of immunization policy, and it is compara
tively more “qualified to comprehend the likely impact of
state requirements.” Geier v. American Honda Motor Co.,
Inc., 529 U. S. 861, 883 (2000) (internal quotation marks
omitted); see Medtronic, Inc. v. Lohr, 518 U. S. 470, 506
(1996) (BREYER, J., concurring in part and concurring in
judgment) (the agency is in the best position to determine
“whether (or the extent to which) state requirements may
interfere with federal objectives”). HHS’s position is par
ticularly persuasive here because expert public health
organizations support its views and the matter concerns a
medical and scientific question of great importance: how
best to save the lives of children. See Skidmore v. Swift &
Co., 323 U. S. 134 (1944).
In sum, congressional reports and history, the statute’s
basic purpose as revealed by that history, and the views of
the expert agency along with those of relevant medical and
scientific associations, all support the Court’s conclusions.
I consequently agree with the Court.
336
Cite as: 562 U. S. ____ (2011) 1
SOTOMAYOR, J., dissenting

_________________
No. 09–152
_________________
[February 22, 2011]
JUSTICE SOTOMAYOR, with whom JUSTICE GINSBURG

joins, dissenting.
Vaccine manufacturers have long been subject to a legal
duty, rooted in basic principles of products liability law, to
improve the designs of their vaccines in light of advances
in science and technology. Until today, that duty was
enforceable through a traditional state-law tort action for
defective design. In holding that §22(b)(1) of the National
Childhood Vaccine Injury Act of 1986 (Vaccine Act or Act),
42 U. S. C. §300aa–22(b)(1), pre-empts all design defect
claims for injuries stemming from vaccines covered under
the Act, the Court imposes its own bare policy preference
over the considered judgment of Congress. In doing so,
the Court excises 13 words from the statutory text, mis
construes the Act’s legislative history, and disturbs the
careful balance Congress struck between compensating
vaccine-injured children and stabilizing the childhood
vaccine market. Its decision leaves a regulatory vacuum
in which no one ensures that vaccine manufacturers ade
quately take account of scientific and technological ad
vancements when designing or distributing their products.
Because nothing in the text, structure, or legislative his
tory of the Vaccine Act remotely suggests that Congress
intended such a result, I respectfully dissent.
337
Section 22 of the Vaccine Act provides “[s]tandards of

responsibility” to govern civil actions against vaccine
manufacturers. 42 U. S. C. §300aa–22. Section 22(a) sets
forth the “[g]eneral rule” that “State law shall apply to a
civil action brought for damages for a vaccine-related
injury or death.” §300aa–22(a). This baseline rule that
state law applies is subject to three narrow exceptions, one
of which, §22(b)(1), is at issue in this case. Section 22(b)(1)
provides:
though the vaccine was properly prepared and was
accompanied by proper directions and warnings.”
§300aa–22(b)(1).
The provision contains two key clauses: “if the injury or
death resulted from side effects that were unavoidable”
(the “if ” clause), and “even though the vaccine was prop
erly prepared and was accompanied by proper directions
and warnings” (the “even though” clause).
Blackletter products liability law generally recognizes
three different types of product defects: design defects,
manufacturing defects, and labeling defects (e.g., failure to
warn).1 The reference in the “even though” clause to a
“properly prepared” vaccine “accompanied by proper direc
tions and warnings” is an obvious reference to two such
defects—manufacturing and labeling defects. The plain
terms of the “even though” clause thus indicate that
——————
1 W. Keeton, D. Dobbs, R. Keeton, & D. Owen, Prosser and Keeton on
Law of Torts 695 (5th ed. 1984).

338
Cite as: 562 U. S. ____ (2011) 3
§22(b)(1) applies only where neither kind of defect is pre

sent. Because §22(b)(1) is invoked by vaccine manufactur
ers as a defense to tort liability, it follows that the “even
though” clause requires a vaccine manufacturer in each
civil action to demonstrate that its vaccine is free from
manufacturing and labeling defects to fall within the
liability exemption of §22(b)(1).2
Given that the “even though” clause requires the ab
sence of manufacturing and labeling defects, the “if ”
clause’s reference to “side effects that were unavoidable”
must refer to side effects caused by something other than
manufacturing and labeling defects. The only remaining
kind of product defect recognized under traditional prod
ucts liability law is a design defect. Thus, “side effects
that were unavoidable” must refer to side effects caused by
a vaccine’s design that were “unavoidable.” Because
§22(b)(1) uses the conditional term “if,” moreover, the text
plainly implies that some side effects stemming from a
vaccine’s design are “unavoidable,” while others are avoid
able. See Webster’s Third New International Dictionary
1124 (2002) (“if ” means “in the event that,” “so long as,” or
“on condition that”). Accordingly, because the “if ” clause
(like the “even though” clause) sets forth a condition to
invoke §22(b)(1)’s defense to tort liability, Congress must
also have intended a vaccine manufacturer to demonstrate
in each civil action that the particular side effects of a
vaccine’s design were “unavoidable.”
Congress’ use of conditional “if” clauses in two other
provisions of the Vaccine Act supports the conclusion that
§22(b)(1) requires an inquiry in each case in which a
manufacturer seeks to invoke the provision’s exception to
——————
2 See Silkwood v. Kerr-McGee Corp., 464 U. S. 238, 255 (1984); Brown
v. Earthboard Sports USA, Inc., 481 F. 3d 901, 912 (CA6 2007)

(“ ‘[F]ederal preemption is an affirmative defense upon which the
defendants bear the burden of proof ’ ” (quoting Fifth Third Bank v.
CSX Corp., 415 F. 3d 741, 745 (CA7 2005))).
339
state tort liability. In §22(b)(2), Congress created a pre

sumption that, for purposes of §22(b)(1), “a vaccine shall
be presumed to be accompanied by proper directions and
warnings if the vaccine manufacturer shows that it com
plied in all material respects with” federal labeling re
quirements. 42 U. S. C. §300aa–22(b)(2). Similarly, in
§23(d)(2), Congress created an exemption from punitive
damages “[i]f . . . the manufacturer shows that it complied,
in all material respects,” with applicable federal laws,
unless it engages in “fraud,” “intentional and wrongful
withholding of information” from federal regulators, or
“other criminal or illegal activity.” §300aa–23(d)(2). It
would be highly anomalous for Congress to use a condi
tional “if ” clause in §§22(b)(2) and 23(d)(2) to require a
specific inquiry in each case while using the same condi
tional “if ” clause in §22(b)(1) to denote a categorical ex
emption from liability. Cf. Erlenbaugh v. United States,
409 U. S. 239, 243 (1972) (“[A] legislative body generally
uses a particular word with a consistent meaning in a
given context”).
Indeed, when Congress intends to pre-empt design
defect claims categorically, it does so using categorical
(e.g., “all”) and/or declarative language (e.g., “shall”),
rather than a conditional term (“if ”). For example, in
a related context, Congress has authorized the Secretary
of Health and Human Services to designate a vaccine
designed to prevent a pandemic or epidemic as a “covered
countermeasure.” 42 U. S. C. §§247d–6d(b), (i)(1),
(i)(7)(A)(i). With respect to such “covered countermea
sure[s],” Congress provided that subject to certain excep
tions, “a covered person shall be immune from suit and
liability under Federal and State law with respect to all
claims for loss caused by, arising out of, relating to, or
resulting from the administration to or the use by an
individual of a covered countermeasure,” §247d–6d(a)(1)
(emphasis added), including specifically claims relating to
340
Cite as: 562 U. S. ____ (2011) 5
“the design” of the countermeasure, §247d–6d(a)(2)(B).

The plain text and structure of the Vaccine Act thus
compel the conclusion that §22(b)(1) pre-empts some—but
not all—design defect claims. Contrary to the majority’s
and respondent’s categorical reading, petitioners correctly
contend that, where a plaintiff has proved that she has
suffered an injury resulting from a side effect caused by
a vaccine’s design, a vaccine manufacturer may invoke
§22(b)(1)’s liability exemption only if it demonstrates that
the side effect stemming from the particular vaccine’s
design is “unavoidable,” and that the vaccine is otherwise
free from manufacturing and labeling defects.3
B
The legislative history confirms petitioners’ interpreta
tion of §22(b)(1) and sheds further light on its pre-emptive
scope. The House Energy and Commerce Committee
Report accompanying the Vaccine Act, H. R. Rep. No. 99–
908, pt. 1 (1986) (hereinafter 1986 Report), explains in
relevant part:
“Subsection (b)—Unavoidable Adverse Side Effects;
Direct Warnings.—This provision sets forth the prin
ciple contained in Comment K of Section 402A of the
Restatement of Torts (Second) that a vaccine manu
facturer should not be liable for injuries or deaths re
sulting from unavoidable side effects even though the
vaccine was properly prepared and accompanied by
proper directions and warnings.
“The Committee has set forth Comment K in this
bill because it intends that the principle in Comment
K regarding ‘unavoidably unsafe’ products, i.e., those
products which in the present state of human skill
and knowledge cannot be made safe, apply to the vac
——————
3 This leaves the question of what precisely §22(b)(1) means by “un
avoidable” side effects, which I address in the next section.

341
cines covered in the bill and that such products not be

the subject of liability in the tort system.” Id., at 25–
26.
The Report expressly adopts comment k of §402A of the
Restatement of Torts (Second) (1963–1964) (hereinafter
Restatement), which provides that “unavoidably unsafe”
products—i.e., those that “in the present state of human
knowledge, are quite incapable of being made safe for
their intended and ordinary use”—are not defective.4 As
“[a]n outstanding example” of an “[u]navoidably unsafe”
product, comment k cites “the vaccine for the Pasteur
treatment of rabies, which not uncommonly leads to very
serious and damaging consequences when it is injected”;
——————
4 Comment k provides as follows:
“Unavoidably unsafe products. There are some products which, in

the present state of human knowledge, are quite incapable of being
made safe for their intended and ordinary use. These are especially
common in the field of drugs. An outstanding example is the vaccine
for the Pasteur treatment of rabies, which not uncommonly leads to
very serious and damaging consequences when it is injected. Since the
disease itself invariably leads to a dreadful death, both the marketing
and the use of the vaccine are fully justified, notwithstanding the
unavoidable high degree of risk which they involve. Such a product,
properly prepared, and accompanied by proper directions and warning,
is not defective, nor is it unreasonably dangerous. The same is true of
many other drugs, vaccines, and the like, many of which for this very
reason cannot legally be sold except to physicians, or under the pre
scription of a physician. It is also true in particular of many new or
experimental drugs as to which, because of lack of time and opportunity
for sufficient medical experience, there can be no assurance of safety, or
perhaps even of purity of ingredients, but such experience as there is
justifies the marketing and use of the drug notwithstanding a medically
recognizable risk. The seller of such products, again with the qualifica
tion that they are properly prepared and marketed, and proper warning
is given, where the situation calls for it, is not to be held to strict
liability for unfortunate consequences attending their use, merely
because he has undertaken to supply the public with an apparently
useful and desirable product, attended with a known but apparently
reasonable risk.” Restatement 353–354.
342
Cite as: 562 U. S. ____ (2011) 7
“[s]ince the disease itself invariably leads to a dreadful

death, both the marketing and the use of the vaccine are
fully justified, notwithstanding the unavoidable high
degree of risk which they involve.” Id., at 353. Comment
k thus provides that “seller[s]” of “[u]navoidably unsafe”
products are “not to be held to strict liability” provided
that such products “are properly prepared and marketed,
and proper warning is given.” Ibid.
As the 1986 Report explains, Congress intended that the
“principle in Comment K regarding ‘unavoidably unsafe’
products” apply to the vaccines covered in the bill. 1986
Report 26. That intent, in turn, is manifested in the plain
text of §22(b)(1)—in particular, Congress’ use of the word
“unavoidable,” as well as the phrases “properly prepared”
and “accompanied by proper directions and warnings,”
which were taken nearly verbatim from comment k. 42
U. S. C. §300aa–22(b)(1); see Restatement 353–354 (“Such
a[n unavoidably unsafe] product, properly prepared, and
accompanied by proper directions and warning, is not
defective”). By the time of the Vaccine Act’s enactment in
1986, numerous state and federal courts had interpreted
comment k to mean that a product is “unavoidably unsafe”
when, given proper manufacture and labeling, no feasible
alternative design would reduce the safety risks without
compromising the product’s cost and utility.5 Given Con
——————
5 See, e.g., Smith ex rel. Smith v. Wyeth Labs., Inc., No. Civ. A 84–
2002, 1986 WL 720792, *5 (SD W. Va., Aug. 21, 1986) (“[A] prescription
drug is not ‘unavoidably unsafe’ when its dangers can be eliminated
through design changes that do not unduly affect its cost or utility”);
Kearl v. Lederle Labs., 172 Cal. App. 3d 812, 830, 218 Cal. Rptr. 453,
464 (1985) (“unavoidability” turns on “(i) whether the product was
designed to minimize—to the extent scientifically knowable at the time
it was distributed—the risk inherent in the product, and (ii) the avail
ability . . . of any alternative product that would have as effectively
accomplished the full intended purpose of the subject product”), disap
proved in part by Brown v. Superior Ct., 44 Cal. 3d 1049, 751 P. 2d 470
(1988); Belle Bonfils Memorial Blood Bank v. Hansen, 665 P. 2d 118,
343
gress’ expressed intent to codify the “principle in Comment

K,” 1986 Report 26, the term “unavoidable” in §22(b)(1) is
best understood as a term of art, which incorporates the
commonly understood meaning of “unavoidably unsafe”
products under comment k at the time of the Act’s enact
ment in 1986. See McDermott Int’l, Inc. v. Wilander, 498
U. S. 337, 342 (1991) (“[W]e assume that when a statute
uses . . . a term [of art], Congress intended it to have its
established meaning”); Morissette v. United States, 342
U. S. 246, 263 (1952) (same).6 Similarly, courts applying
——————
122 (Colo. 1983) (“[A]pplicability of comment k . . . depends upon the co
existence of several factors,” including that “the product’s benefits must
not be achievable in another manner; and the risk must be unavoidable
under the present state of knowledge”); see also 1 L. Frumer & M.
Friedman, Products Liability §§8.07[1]–[2], pp. 8–277 to 8–278 (2010)
(comment k applies “only to defects in design,” and there “must be no
feasible alternative design which on balance accomplishes the subject
product’s purpose with a lesser risk” (internal quotation marks omit
ted)). To be sure, a number of courts at the time of the Vaccine Act’s
enactment had interpreted comment k to preclude design defect claims
categorically for certain kinds of products, see Hill v. Searle Labs., 884
F. 2d 1064, 1068 (CA8 1989) (collecting cases), but as indicated by the
sources cited above, the courts that had construed comment k to apply
on a case-specific basis generally agreed on the basic elements of what
constituted an “unavoidably unsafe” product. See also n. 8, infra. The
majority’s suggestion that “judges who must rule on motions to dismiss,
motions for summary judgment, and motions for judgment as a matter
of law” are incapable of adjudicating claims alleging “unavoidable” side
effects, ante, at 7–8, n. 35, is thus belied by the experience of the many
courts that had adjudicated such claims for years by the time of the
Vaccine Act’s enactment.
6 The majority refuses to recognize that “unavoidable” is a term of art
derived from comment k, suggesting that “ ‘[u]navoidable’ is hardly a

rarely used word.” Ante, at 10. In fact, however, “unavoidable” is an
extremely rare word in the relevant context. It appears exactly once
(i.e., in §300aa–22(b)(1)) in the entirety of Title 42 of the U. S. Code
(“Public Health and Welfare”), which governs, inter alia, Social Secu
rity, see 42 U. S. C. §301 et seq., Medicare, see §1395 et seq., and several
other of the Federal Government’s largest entitlement programs. The
singular rarity in which Congress used the term supports the conclu
344
Cite as: 562 U. S. ____ (2011) 9
comment k had long required manufacturers invoking

the defense to demonstrate that their products were not
only “unavoidably unsafe” but also properly manufactured
and labeled.7 By requiring “prope[r] prepar[ation]” and
“proper directions and warnings” in §22(b)(1), Congress
plainly intended to incorporate these additional comment
k requirements.
The 1986 Report thus confirms petitioners’ interpreta
tion of §22(b)(1). The Report makes clear that “side effects
that were unavoidable” in §22(b)(1) refers to side effects
stemming from a vaccine’s design that were “unavoidable.”
By explaining what Congress meant by the term “un
avoidable,” moreover, the Report also confirms that
whether a side effect is “unavoidable” for purposes of
§22(b)(1) involves a specific inquiry in each case as to
whether the vaccine “in the present state of human skill
and knowledge cannot be made safe,” 1986 Report 26—i.e.,
whether a feasible alternative design existed that would
have eliminated the adverse side effects of the vaccine
without compromising its cost and utility. See Brief for
Kenneth W. Starr et al. as Amici Curiae 14–15 (“If a par
ticular plaintiff could show that her injury at issue was
avoidable . . . through the use of a feasible alternative
design for a specific vaccine, then she would satisfy the
plain language of the statute, because she would have
demonstrated that the side effects were not unavoidable”).
Finally, the Report confirms that the “even though” clause
is properly read to establish two additional prerequisites—
proper manufacturing and proper labeling—to qualify for
——————
sion that “unavoidable” is a term of art.
7 See, e.g., Brochu v. Ortho Pharmaceutical Corp., 642 F. 2d 652, 657
(CA1 1981); Needham v. White Labs., Inc., 639 F. 2d 394, 402 (CA7
1981); Reyes v. Wyeth Labs., 498 F. 2d 1264, 1274–1275 (CA5 1974);
Davis v. Wyeth Labs., 399 F. 2d 121, 127–129 (CA9 1968); Feldman v.
Lederle Labs., 97 N. J. 429, 448, 479 A. 2d 374, 384 (1984); see also
Toner v. Lederle Labs., 112 Idaho 328, 336, 732 P. 2d 297, 305 (1987).
345
§22(b)(1)’s liability exemption.8

In addition to the 1986 Report, one other piece of the
Act’s legislative history provides further confirmation of
the petitioners’ textual reading of §22(b)(1). When Con
gress enacted the Vaccine Act in 1986, it did not initially
include a source of payment for the no-fault compensation
program the Act established. The Act thus “made the
compensation program and accompanying tort reforms
contingent on the enactment of a tax to provide funding
——————
8 Respondent suggests an alternative reading of the 1986 Report.
According to respondent, “the principle in Comment K” is simply that of

nonliability for “unavoidably unsafe” products, and thus Congress’
stated intent in the 1986 Report to apply the “principle in Comment K”
to “the vaccines covered in the bill” means that Congress viewed the
covered vaccines as a class to be “ ‘unavoidably unsafe.’ ” 1986 Report
25–26; Brief for Respondent 42. The concurrence makes a similar
argument. Ante, at 1–2 (opinion of BREYER, J.). This interpretation
finds some support in the 1986 Report, which states that “if [injured
individuals] cannot demonstrate under applicable law either that a
vaccine was improperly prepared or that it was accompanied by im
proper directions or inadequate warnings [they] should pursue recom
pense in the compensation system, not the tort system.” 1986 Report
26. It also finds some support in the pre-Vaccine Act case law, which
reflected considerable disagreement in the courts over “whether com
ment k applies to pharmaceutical products across the board or only on
a case-by-case basis.” Ausness, Unavoidably Unsafe Products and
Strict Products Liability: What Liability Rule Should be Applied to the
Sellers of Pharmaceutical Products? 78 Ky. L. J. 705, 708, and n. 11
(1989–1990) (collecting cases). This interpretation, however, is under
mined by the fact that Congress has never directed the Food and Drug
Administration (FDA) or any other federal agency to review vaccines
for optimal vaccine design, see infra, at 20–22, and n. 19, and thus it
seems highly unlikely that Congress intended to eliminate the tradi
tional mechanism for such review (i.e., design defect liability), particu
larly given its express retention of state tort law in the Vaccine Act, see
42 U. S. C. §300aa–22(a). In any event, to the extent there is ambiguity
as to how precisely Congress intended the “principle in Comment K” to
apply to the covered vaccines, that ambiguity is explicitly resolved in
petitioners’ favor by the 1987 House Energy and Commerce Committee
Report, H. R. Rep. No. 100–391, pt. 1, pp. 690–691 (hereinafter 1987
Report). See infra this page and 11–12.
346
Cite as: 562 U. S. ____ (2011) 11
for the compensation.” 1987 Report 690. In 1987, Con

gress passed legislation to fund the compensation pro
gram. The House Energy and Commerce Committee
Report9 accompanying that legislation specifically stated
that “the codification of Comment (k) of The Restatement
(Second) of Torts was not intended to decide as a matter of
law the circumstances in which a vaccine should be
deemed unavoidably unsafe.” Id., at 691. The Committee
noted that “[a]n amendment to establish . . . that a manu
facturer’s failure to develop [a] safer vaccine was not
grounds for liability was rejected by the Committee during
its original consideration of the Act.” Ibid. In light of that
rejection, the Committee emphasized that “there should be
no misunderstanding that the Act undertook to decide as a
matter of law whether vaccines were unavoidably unsafe
or not,” and that “[t]his question is left to the courts to
determine in accordance with applicable law.” Ibid.
To be sure, postenactment legislative history created by
a subsequent Congress is ordinarily a hazardous basis
from which to infer the intent of the enacting Congress.
See Sullivan v. Finkelstein, 496 U. S. 617, 631–632 (1990)
(SCALIA, J., concurring in part). But unlike ordinary
postenactment legislative history, which is justifiably
given little or no weight, the 1987 Report reflects the
intent of the Congress that enacted the funding legislation
necessary to give operative effect to the principal provi
sions of the Vaccine Act, including §22(b)(1).10 Congress in
——————
9 The Third Circuit’s opinion below expressed uncertainty as to
whether the 1987 Report was authored by the House Budget Commit
tee or the House Energy and Commerce Committee. See 561 F. 3d 233,
250 (2009). As petitioners explain, although the Budget Committee
compiled and issued the Report, the Energy and Commerce Committee
wrote and approved the relevant language. Title IV of the Report,
entitled “Committee on Energy and Commerce,” comprises “two Com
mittee Prints approved by the Committee on Energy and Commerce for
inclusion in the forthcoming reconciliation bill.” 1987 Report 377, 380.
10 The majority suggests that the 1987 legislation creating the fund
347
1987 had a number of options before it, including adopting

an entirely different compensation scheme, as the Reagan
administration was proposing;11 establishing different
limitations on tort liability, including eliminating design
defect liability, as pharmaceutical industry leaders were
advocating;12 or not funding the compensation program at
all, which would have effectively nullified the relevant
portions of the Act. Because the tort reforms in the 1986
Act, including §22(b)(1), had no operative legal effect
unless and until Congress provided funding for the com
pensation program, the views of the Congress that enacted
that funding legislation are a proper and, indeed, authori
tative guide to the meaning of §22(b)(1). Those views, as
reflected in the 1987 Report, provide unequivocal confir
——————
ing mechanism is akin to appropriations legislation and that giving
weight to the legislative history of such legislation “would set a danger
ous precedent.” Ante, at 18. The difference, of course, is that appro
priations legislation ordinarily funds congressional enactments that
already have operative legal effect; in contrast, operation of the tort
reforms in the 1986 Act, including §22(b)(1), was expressly conditioned
on the enactment of a separate tax to fund the compensation program.
See §323(a), 100 Stat. 3784. Accordingly, this Court’s general reluc
tance to view appropriations legislation as modifying substantive
legislation, see, e.g., TVA v. Hill, 437 U. S. 153, 190 (1978), has no
bearing here.
11 See 1987 Report 700 (describing the administration’s alternative
proposal).
12 See, e.g., Hearings on Funding of the Childhood Vaccine Program
before the Subcommittee on Select Revenue Measures of the House

Committee on Ways and Means, 100th Cong., 1st Sess., 85 (1987)
(“[T]he liability provisions of the 1986 Act should be amended to assure
that manufacturers will not be found liable in the tort system if they
have fully complied with applicable government regulations. In par
ticular, manufacturers should not face liability under a ‘design defect’
theory in cases where plaintiffs challenge the decisions of public health
authorities and federal regulators that the licensed vaccines are the
best available way to protect children from deadly diseases” (statement
of Robert B. Johnson, President, Lederle Laboratories Division, Ameri
can Cyanamid Co.)).
348
Cite as: 562 U. S. ____ (2011) 13
mation of petitioners’ reading of §22(b)(1).

In sum, the text, structure, and legislative history of the
Vaccine Act are fully consistent with petitioners’ reading
of §22(b)(1). Accordingly, I believe §22(b)(1) exempts
vaccine manufacturers from tort liability only upon a
showing by the manufacturer in each case that the vaccine
was properly manufactured and labeled, and that the side
effects stemming from the vaccine’s design could not have
been prevented by a feasible alternative design that would
have eliminated the adverse side effects without compro
mising the vaccine’s cost and utility.
II
In contrast to the interpretation of §22(b)(1) set forth
above, the majority’s interpretation does considerable vio
lence to the statutory text, misconstrues the legislative
history, and draws the wrong conclusions from the struc
ture of the Vaccine Act and the broader federal scheme
regulating vaccines.
A
As a textual matter, the majority’s interpretation of
§22(b)(1) is fundamentally flawed in three central re
spects. First, the majority’s categorical reading rests on a
faulty and untenable premise. Second, its reading func
tionally excises 13 words from the statutory text, including
the key term “unavoidable.” And third, the majority en
tirely ignores the Vaccine Act’s default rule preserving
state tort law.
To begin, the majority states that “[a] side effect of a
vaccine could always have been avoidable by use of a
differently designed vaccine not containing the harmful
element.” Ante, at 7. From that premise, the majority
concludes that the statute must mean that “the design of
the vaccine is a given, not subject to question in the tort
action,” because construing the statute otherwise would
349
render §22(b)(1) a nullity. Ibid. A tort claimant, accord

ing to the majority, will always be able to point to a differ
ently designed vaccine not containing the “harmful ele
ment,” and if that were sufficient to show that a vaccine’s
side effects were not “unavoidable,” the statute would pre
empt nothing.
The starting premise of the majority’s interpretation,
however, is fatally flawed. Although in the most literal
sense, as the majority notes, a side effect can always be
avoided “by use of a differently designed vaccine not con
taining the harmful element,” ibid., this interpretation of
“unavoidable” would effectively read the term out of the
statute, and Congress could not have intended that result.
Indeed, §22(b)(1) specifically uses the conditional phrase
“if the injury or death resulted from side effects that were
unavoidable,” which plainly indicates that Congress con
templated that there would be some instances in which a
vaccine’s side effects are “unavoidable” and other in
stances in which they are not. See supra, at 3. The major
ity’s premise that a vaccine’s side effects can always be
“avoid[ed] by use of a differently designed vaccine not
containing the harmful element,” ante, at 7, entirely ig
nores the fact that removing the “harmful element” will
often result in a less effective (or entirely ineffective)
vaccine. A vaccine, by its nature, ordinarily employs a
killed or weakened form of a bacteria or virus to stimulate
antibody production;13 removing that bacteria or virus
might remove the “harmful element,” but it would also
necessarily render the vaccine inert. As explained above,
the legislative history of the Vaccine Act and the cases
interpreting comment k make clear that a side effect is
——————
13 SeeAmerican Academy of Pediatrics, Questions and Answers about
Vaccine Ingredients (Oct. 2008), http://www.aap.org/immunization/
families/faq/Vaccineingredients.pdf (all Internet materials as visited
Feb. 18, 2011, and available in Clerk of Court’s case file).
350
Cite as: 562 U. S. ____ (2011) 15
“unavoidable” for purposes of §22(b)(1) only where there is

no feasible alternative design that would eliminate the
side effect of the vaccine without compromising its cost
and utility. See supra, at 7. The majority’s premise—that
side effects stemming from a vaccine’s design are always
avoidable—is thus belied by the statutory text and legisla
tive history of §22(b)(1). And because its starting premise
is invalid, its conclusion—that the design of a vaccine is
not subject to challenge in a tort action—is also necessar
ily invalid.
The majority’s reading suffers from an even more fun
damental defect. If Congress intended to exempt vaccine
manufacturers categorically from all design defect liabil
ity, it more logically would have provided: “No vaccine
manufacturer shall be liable in a civil action for damages
arising from a vaccine-related injury or death associated
with the administration of a vaccine after October 1, 1988,
if the vaccine was properly prepared and was accompanied
by proper directions and warnings.” There would have
been no need for Congress to include the additional 13
words “the injury or death resulted from side effects that
were unavoidable even though.” See TRW Inc. v. An
drews, 534 U. S. 19, 31 (2001) (noting “cardinal principle
of statutory construction that a statute ought, upon the
whole, to be so construed that, if it can be prevented, no
clause, sentence, or word shall be superfluous, void, or
insignificant” (internal quotation marks omitted)).
In Bates v. Dow Agrosciences LLC, 544 U. S. 431 (2005),
this Court considered an analogous situation where an
express pre-emption provision stated that certain States
“ ‘shall not impose or continue in effect any requirements
for labeling or packaging in addition to or different from
those required under this subchapter.’ ” Id., at 436 (quot
ing 7 U. S. C. §136v(b) (2000 ed.)). The Bates Court
stated:
351
“Conspicuously absent from the submissions by [re

spondent] and the United States is any plausible al
ternative interpretation of ‘in addition to or different
from’ that would give that phrase meaning. Instead,
they appear to favor reading those words out of the
statute, which would leave the following: ‘Such State
shall not impose or continue in effect any require
ments for labeling or packaging.’ This amputated
version of [the statute] would no doubt have clearly
and succinctly commanded the pre-emption of all
state requirements concerning labeling. That Con
gress added the remainder of the provision is evidence
of its intent to draw a distinction between state label
ing requirements that are pre-empted and those that
are not.” 544 U. S., at 448–449.
As with the statutory interpretation rejected by this Court
in Bates, the majority’s interpretation of §22(b)(1) func
tionally excises 13 words out of the statute, including the
key term “unavoidable.” See Duncan v. Walker, 533 U. S.
167, 174 (2001) (“We are especially unwilling” to treat a
statutory term as surplusage “when the term occupies so
pivotal a place in the statutory scheme”). Although the
resulting “amputated version” of the statutory provision
“would no doubt have clearly and succinctly commanded
the pre-emption of all state” design defect claims, the fact
“[t]hat Congress added the remainder of the provision” is
strong evidence of its intent not to pre-empt design defect
claims categorically. Bates, 544 U. S., at 449; see also
American Home Prods. Corp. v. Ferrari, 284 Ga. 384, 393,
668 S. E. 2d 236, 242 (2008) (“ ‘If Congress had intended to
deprive injured parties of a long available form of compen
sation, it surely would have expressed that intent more
clearly’ ” (quoting Bates, 544 U. S., at 449)), cert. pending,
No. 08–1120.
Strikingly, the majority concedes that its interpretation
352
Cite as: 562 U. S. ____ (2011) 17
renders 13 words of the statute entirely superfluous. See

ante, at 12 (“The intervening passage (‘the injury or death
resulted from side effects that were unavoidable even
though’) is unnecessary. True enough”). Nevertheless, the
majority contends that “the rule against giving a portion of
text an interpretation which renders it superfluous . . .
applies only if verbosity and prolixity can be eliminated by
giving the offending passage, or the remainder of the text,
a competing interpretation.” Ibid. According to the major
ity, petitioners’ reading of §22(b)(1) renders the “even
though” clause superfluous because, to reach petitioners’
desired outcome, “[i]t would suffice to say ‘if the injury or
death resulted from side effects that were unavoidable’—
full stop.” Ibid. As explained above, however, the “even
though” clause establishes two additional prerequisites—
proper manufacturing and proper labeling—to qualify for
§22(b)(1)’s exemption from liability. Contrary to the ma
jority’s contention, then, the “even though” clause serves
an important function by limiting the scope of the pre
emption afforded by the preceding “if ” clause.14
The majority’s only other textual argument is based on
——————
14 In this manner, the “even though” clause functions in a “concessive
subordinat[ing]” fashion, ante, at 11, in accord with normal grammati

cal usage. According to the majority, however, the “even though” clause
“clarifies the word that precedes it” by “delineat[ing]” the conditions
that make a side effect “unavoidable” under the statute. Ante, at 7.
The majority’s interpretation hardly treats the clause as “concessive,”
and indeed strains the meaning of “even though.” In the majority’s
view, proper manufacturing and labeling are the sole prerequisites that
render a vaccine’s side effects unavoidable. Thus, an injurious side
effect is unavoidable because the vaccine was properly prepared and
labeled, not “even though” it was. The two conjunctions are not equiva
lent: The sentence “I am happy even though it is raining” can hardly be
read to mean that “I am happy because it is raining.” In any event, the
more fundamental point is that petitioners’ interpretation actually
gives meaning to the words “even though,” whereas the majority
concedes that its interpretation effectively reads those words entirely
out of the statute. See supra this page.
353
the expressio unius, exclusio alterius canon. According to

the majority, because blackletter products liability law
generally recognizes three different types of product de
fects, “[i]f all three were intended to be preserved, it would
be strange [for Congress] to mention specifically only
two”—namely, manufacturing and labeling defects in the
“even though” clause—“and leave the third to implication.”
Ante, at 8. The majority’s argument, however, ignores
that the default rule under the Vaccine Act is that state
law is preserved. As explained above, §22(a) expressly
provides that the “[g]eneral rule” is that “State law shall
apply to a civil action brought for damages for a vaccine
related injury or death.” 42 U. S. C. §300aa–22(a). Be
cause §22(a) already preserves state-law design defect
claims (to the extent the exemption in §22(b)(1) does not
apply), there was no need for Congress separately and
expressly to preserve design defect claims in §22(b)(1).
Indeed, Congress’ principal aim in enacting §22(b)(1) was
not to preserve manufacturing and labeling claims (those,
too, were already preserved by §22(a)), but rather, to
federalize comment k-type protection for “unavoidably
unsafe” vaccines. The “even though” clause simply func
tions to limit the applicability of that defense. The lack of
express language in §22(b)(1) specifically preserving de
sign defect claims thus cannot fairly be understood as
impliedly (and categorically) pre-empting such traditional
state tort claims, which had already been preserved by
§22(a).15
——————
15 This Court, moreover, has long operated on “the assumption that
the historic police powers of the States are not to be superseded by the
Federal Act unless that was the clear and manifest purpose of Con
gress.” Altria Group, Inc. v. Good, 555 U. S. ___, ___ (2008) (slip op., at
5) (internal quotation marks and alteration omitted). Given the long
history of state regulation of vaccines, see Brief for Petitioners 3–6, the
presumption provides an additional reason not to read §22(b)(1) as pre
empting all design defect claims, especially given Congress’ inclusion of
354
Cite as: 562 U. S. ____ (2011) 19
The majority also suggests that if Congress wished to

preserve design defect claims, it could have simply pro
vided that manufacturers would be liable for “defective
manufacture, defective directions or warning, and defec
tive design.” Ante, at 8 (internal quotation marks omit
ted). Putting aside the fact that §22(a) already preserves
design defect claims (to the extent §22(b)(1) does not ap
ply), the majority’s proposed solution would not have fully
effectuated Congress’ intent. As the legislative history
makes clear, Congress used the term “unavoidable” to
effectuate its intent that the “principle in Comment K
regarding ‘unavoidably unsafe’ products . . . apply to the
vaccines covered in the bill.” 1986 Report 26; see also
1987 Report 691. At the time of the Vaccine Act’s enact
ment in 1986, at least one State had expressly rejected
comment k,16 while many others had not addressed the
applicability of comment k specifically to vaccines or ap
plied comment k to civil actions proceeding on a theory
other than strict liability (e.g., negligence17). A statute
——————
an express saving clause in the same statutory section, see 42 U. S. C.
§300aa–22(a), and its use of the conditional “if” clause in defining the
pre-emptive scope of the provision. See Bates v. Dow Agrosciences LLC,
544 U. S. 431, 449 (2005) (“In areas of traditional state regulation, we
assume that a federal statute has not supplanted state law unless
Congress has made such an intention clear and manifest” (internal
quotation marks omitted)).
16 See Collins v. Eli Lilly Co., 116 Wis. 2d 166, 197, 342 N. W. 2d 37,
52 (1984) (“We conclude that the rule embodied in comment k is too

restrictive and, therefore, not commensurate with strict products
liability law in Wisconsin”). Collins did, however, “recognize that in
some exigent circumstances it may be necessary to place a drug on the
market before adequate testing can be done.” Ibid. It thus adopted a
narrower defense (based on “exigent circumstances”) than that recog
nized in other jurisdictions that had expressly adopted comment k.
17 See, e.g., Kearl, 172 Cal. App. 3d, at 831, n. 15, 218 Cal. Rptr., at
465, n. 15 (“[T]he unavoidably dangerous product doctrine merely

exempts the product from a strict liability design defect analysis; a
plaintiff remains free to pursue his design defect theory on the basis of
355
that simply stated that vaccine manufacturers would be

liable for “defective design” would be silent as to the avail
ability of a comment k-type defense for “unavoidably
unsafe” vaccines, and thus would not have fully achieved
Congress’ aim of extending greater liability protection
to vaccine manufacturers by providing comment k-type
protection in all civil actions as a matter of federal law.
B
The majority’s structural arguments fare no better than
its textual ones. The principal thrust of the majority’s
position is that, since nothing in the Vaccine Act or the
FDA’s regulations governing vaccines expressly mentions
design defects, Congress must have intended to remove
issues concerning the design of FDA-licensed vaccines
from the tort system. Ante, at 13. The flaw in that rea
soning, of course, is that the FDA’s silence on design de
fects existed long before the Vaccine Act was enacted.
Indeed, the majority itself concedes that the “FDA has
never even spelled out in regulations the criteria it uses to
decide whether a vaccine is safe and effective for its in
tended use.”18 Ibid. And yet it is undisputed that prior to
the Act, vaccine manufacturers had long been subject to
liability under state tort law for defective vaccine design.
That the Vaccine Act did not itself set forth a comprehen
sive regulatory scheme with respect to design defects is
thus best understood to mean not that Congress suddenly
decided to change course sub silentio and pre-empt a
——————
negligence”); Toner, 112 Idaho, at 340, 732 P. 2d, at 309–310 (“The
authorities universally agree that where a product is deemed unavoid
ably unsafe, the plaintiff is deprived of the advantage of a strict liabil
ity cause of action, but may proceed under a negligence cause of ac
tion”).
18 See 42 U. S. C. §262(a)(2)(C)(i)(I) (“The Secretary shall approve a
biologics license application . . . on the basis of a demonstration that . . .

the biological product that is the subject of the application is safe, pure,
and potent”).
356
Cite as: 562 U. S. ____ (2011) 21
longstanding, traditional category of state tort law, but

rather, that Congress intended to leave the status quo
alone (except, of course, with respect to those aspects of
state tort law that the Act expressly altered). See 1987
Report 691 (“It is not the Committee’s intention to pre
clude court actions under applicable law. The Commit
tee’s intent at the time of considering the Act . . . was . . .
to leave otherwise applicable law unaffected, except as
expressly altered by the Act”).
The majority also suggests that Congress necessarily
intended to pre-empt design defect claims since the aim of
such tort suits is to promote the development of improved
designs and provide compensation for injured individuals,
and the Vaccine Act “provides other means for achieving
both effects”—most notably through the no-fault compen
sation program and the National Vaccine Program. Ante,
at 14, and nn. 57–60 (citing 42 U. S. C. §§300aa–1, 300aa–
2(a)(1)–(3), 300aa–3, 300aa–25(b), 300aa–27(a)(1)). But
the majority’s position elides a significant difference be
tween state tort law and the federal regulatory scheme.
Although the Vaccine Act charges the Secretary of Health
and Human Services with the obligation to “promote the
development of childhood vaccines” and “make or assure
improvements in . . . vaccines, and research on vaccines,”
§300aa–27(a), neither the Act nor any other provision of
federal law places a legal duty on vaccine manufacturers
to improve the design of their vaccines to account for
scientific and technological advances. Indeed, the FDA
does not condition approval of a vaccine on it being the
most optimally designed among reasonably available
alternatives, nor does it (or any other federal entity) en
sure that licensed vaccines keep pace with technological
and scientific advances.19 Rather, the function of ensuring
——————
19 See, e.g., Hurley v. Lederle Labs., 863 F. 2d 1173, 1177 (CA5 1988)
(“[T]he FDA is a passive agency: it considers whether to approve

357
that vaccines are optimally designed in light of existing

science and technology has traditionally been left to the
States through the imposition of damages for design de
fects. Cf. Bates, 544 U. S., at 451 (“ ‘[T]he specter of dam
age actions may provide manufacturers with added dy
namic incentives to continue to keep abreast of all possible
injuries stemming from use of their product[s] so as to
forestall such actions through product improvement’ ”);
Wyeth v. Levine, 555 U. S. ___, ___ (2009) (slip op., at 22–
——————
vaccine designs only if and when manufacturers come forward with a
proposal”); Jones v. Lederle Labs., 695 F. Supp. 700, 711 (EDNY 1988)
(“[T]he agency takes the drugs and manufacturers as it finds them.
While its goal is to oversee inoculation with the best possible vaccine, it
is limited to reviewing only those drugs submitted by various manufac
turers, regardless of their flaws”). Although the FDA has authority
under existing regulations to revoke a manufacturer’s biologics licenses,
that authority can be exercised only where (as relevant here) “[t]he
licensed product is not safe and effective for all of its intended uses.” 21
CFR §601.5(b)(1)(vi) (2010); see §600.3(p) (defining “safety” as “relative
freedom from harmful effect to persons affected, directly or indirectly,
by a product when prudently administered, taking into consideration
the character of the product in relation to the condition of the recipient
at the time”). The regulation does not authorize the FDA to revoke a
biologics license for a manufacturer’s failure to adopt an optimal
vaccine design in light of existing science and technology. See Conk, Is
There a Design Defect in the Restatement (Third) of Torts: Products
Liability? 109 Yale L. J. 1087, 1128–1129 (1999–2000) (“The FDA does
not claim to review products for optimal design . . . . FDA review thus
asks less of drug . . . manufacturers than the common law of products
liability asks of other kinds of manufacturers”). At oral argument,
counsel for amicus United States stated that the Centers for Disease
Control and Prevention (CDC) routinely performs comparative analyses
of vaccines that are already on the market. See Tr. of Oral Arg. 44–45;
id., at 52–53 (describing CDC’s comparison of Sabin and Salk polio
vaccines). Neither the United States nor any of the parties, however,
has represented that CDC examines whether a safer alternative
vaccine could have been designed given practical and scientific limits,
the central inquiry in a state tort law action for design defect. CDC
does not issue biologics licenses, moreover, and thus has no authority to
require a manufacturer to adopt a different vaccine design.
358
Cite as: 562 U. S. ____ (2011) 23
23) (noting that the FDA has “traditionally regarded state

law as a complementary form of drug regulation” as
“[s]tate tort suits uncover unknown drug hazards and
provide incentives for drug manufacturers to disclose
safety risks promptly”).20 The importance of the States’
traditional regulatory role is only underscored by the
unique features of the vaccine market, in which there are
“only one or two manufacturers for a majority of the vac
cines listed on the routine childhood immunization sched
ule.” Brief for Respondent 55. The normal competitive
forces that spur innovation and improvements to existing
product lines in other markets thus operate with less force
in the vaccine market, particularly for vaccines that have
already been released and marketed to the public. Absent
a clear statutory mandate to the contrary, there is no
reason to think that Congress intended in the vaccine
context to eliminate the traditional incentive and deter
rence functions served by state tort liability in favor of a
federal regulatory scheme providing only carrots and no
sticks.21 See Levine, 555 U. S., at ___ (slip op., at 18) (“The
——————
20 Indeed, we observed in Levine that the FDA is perpetually under
staffed and underfunded, see 555 U. S., at ___, n. 11 (slip op., at 22,
n. 11), and the agency has been criticized in the past for its slow re
sponse in failing to withdraw or warn about potentially dangerous
products, see, e.g., L. Leveton, H. Sox, & M. Soto, Institute of Medicine,
HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
(1995) (criticizing FDA response to transmission of AIDS through blood
supply). These practical shortcomings reinforce the conclusion that
“state law offers an additional, and important, layer of consumer
protection that complements FDA regulation.” Levine, 555 U. S., at ___
(slip op., at 23).
21 The majority mischaracterizes my position as expressing a general
“skeptic[ism] of preemption unless the congressional substitute oper

ate[s] like the tort system.” Ante, at 16. Congress could, of course,
adopt a regulatory regime that operates differently from state tort
systems, and such a difference is not necessarily a reason to question
Congress’ pre-emptive intent. In the specific context of the Vaccine Act,
however, the relevant point is that this Court should not lightly assume
359
case for federal pre-emption is particularly weak where

Congress has indicated its awareness of the operation of
state law in a field of federal interest, and has nonetheless
decided to stand by both concepts and to tolerate whatever
tension there is between them.” (internal quotation marks
and alteration omitted)).
III
In enacting the Vaccine Act, Congress established a
carefully wrought federal scheme that balances the com
peting interests of vaccine-injured persons and vaccine
manufacturers. As the legislative history indicates, the
Act addressed “two overriding concerns”: “(a) the inade
quacy—from both the perspective of vaccine-injured per
sons as well as vaccine manufacturers—of the current
approach to compensating those who have been damaged
by a vaccine; and (b) the instability and unpredictability of
the childhood vaccine market.” 1986 Report 7. When
viewed in the context of the Vaccine Act as a whole,
§22(b)(1) is just one part of a broader statutory scheme
that balances the need for compensating vaccine-injured
children with added liability protections for vaccine manu
facturers to ensure a stable childhood vaccine market.
The principal innovation of the Act was the creation of
the no-fault compensation program—a scheme funded
entirely through an excise tax on vaccines.22 Through that
——————
that Congress intended sub silentio to displace a longstanding species
of state tort liability where, as here, Congress specifically included an
express saving clause preserving state law, there is a long history of
state-law regulation of vaccine design, and pre-emption of state law
would leave an important regulatory function—i.e., ensuring optimal
vaccine design—entirely unaddressed by the congressional substitute.
22 The majority’s suggestion that “vaccine manufacturers fund from
their sales” the compensation program is misleading. Ante, at 15.

Although the manufacturers nominally pay the tax, the amount of the
tax is specifically included in the vaccine price charged to purchasers.
See CDC Vaccine Price List (Feb. 15, 2011), http://www.cdc.gov/
360
Cite as: 562 U. S. ____ (2011) 25
program, Congress relieved vaccine manufacturers of the

burden of compensating victims of vaccine-related injuries
in the vast majority of cases23—an extremely significant
economic benefit that “functionally creat[es] a valuable
insurance policy for vaccine-related injuries.” Reply Brief
for Petitioners 10. The structure and legislative history,
moreover, point clearly to Congress’ intention to divert
would-be tort claimants into the compensation program,
rather than eliminate a longstanding category of tradi
tional tort claims. See 1986 Report 13 (“The Committee
anticipates that the speed of the compensation program,
the low transaction costs of the system, the no-fault na
ture of the required findings, and the relative certainty
and generosity of the system’s awards will divert a signifi
cant number of potential plaintiffs from litigation”). In
deed, although complete pre-emption of tort claims would
have eliminated the principal source of the “unpredictabil
ity” in the vaccine market, Congress specifically chose not
to pre-empt state tort claims categorically. See 42 U. S. C.
§300aa–22(a) (providing as a “[g]eneral rule” that “State
law shall apply to a civil action brought for damages for a
vaccine-related injury or death”). That decision reflects
Congress’ recognition that court actions are essential
——————
vaccines/programs/vfc/cdc-vac-price-list.htm. Accordingly, the only way
the vaccine manufacturers can be said to actually “fund” the compensa
tion program is if the cost of the excise tax has an impact on the num
ber of vaccines sold by the vaccine manufacturer. The majority points
to no evidence that the excise tax—which ordinarily amounts to 75
cents per dose, 26 U. S. C. §4131(b)—has any impact whatsoever on the
demand for vaccines.
23 See Brief for United States as Amicus Curiae 28 (“Department of
Justice records indicate that 99.8% of successful Compensation Pro

gram claimants have accepted their awards, foregoing any tort reme
dies against vaccine manufacturers”); S. Plotkin, W. Orenstein, & P.
Offit, Vaccines 1673 (5th ed. 2008) (noting that “[v]irtually all . . .
petitioners, even those who were not awarded compensation” under the
compensation program, choose to accept the program’s determination).
361
because they provide injured persons with significant

procedural tools—including, most importantly, civil dis
covery—that are not available in administrative proceed
ings under the compensation program. See §§300aa–
12(d)(2)(E), (d)(3). Congress thus clearly believed there
was still an important function to be played by state tort
law.
Instead of eliminating design defect liability entirely,
Congress enacted numerous measures to reduce manufac
turers’ liability exposure, including a limited regulatory
compliance presumption of adequate warnings, see
§300aa–22(b)(2), elimination of claims based on failure
to provide direct warnings to patients, §300aa–22(c), a
heightened standard for punitive damages, §300aa–
23(d)(2), and, of course, immunity from damages for “un
avoidable” side effects, §300aa–22(b)(1). Considered in
light of the Vaccine Act as a whole, §22(b)(1)’s exemption
from liability for unavoidably unsafe vaccines is just one
part of a broader statutory scheme that reflects Congress’
careful balance between providing adequate compensation
for vaccine-injured children and conferring substantial
benefits on vaccine manufacturers to ensure a stable and
predictable childhood vaccine supply.
The majority’s decision today disturbs that careful
balance based on a bare policy preference that it is better
“to leave complex epidemiological judgments about vaccine
design to the FDA and the National Vaccine Program
rather than juries.” Ante, at 15.24 To be sure, reasonable
minds can disagree about the wisdom of having juries
weigh the relative costs and benefits of a particular vac
cine design. But whatever the merits of the majority’s
——————
24 JUSTICE BREYER’s separate concurrence is even more explicitly
policy driven, reflecting his own preference for the “more expert judg
ment” of federal agencies over the “less expert” judgment of juries.
Ante, at 5.
362
Cite as: 562 U. S. ____ (2011) 27
policy preference, the decision to bar all design defect

claims against vaccine manufacturers is one that Congress
must make, not this Court.25 By construing §22(b)(1) to
——————
25 Respondent notes that there are some 5,000 petitions alleging a
causal link between certain vaccines and autism spectrum disorders

that are currently pending in an omnibus proceeding in the Court of
Federal Claims (Vaccine Court). Brief for Respondent 56–57. Accord
ing to respondent, a ruling that §22(b)(1) does not pre-empt design
defect claims could unleash a “crushing wave” of tort litigation that
would bankrupt vaccine manufacturers and deplete vaccine supply.
Id., at 28. This concern underlies many of the policy arguments in
respondent’s brief and appears to underlie the majority and concurring
opinions in this case. In the absence of any empirical data, however,
the prospect of an onslaught of autism-related tort litigation by claim
ants denied relief by the Vaccine Court seems wholly speculative. As
an initial matter, the special masters in the autism cases have thus far
uniformly rejected the alleged causal link between vaccines and autism.
See Brief for American Academy of Pediatrics et al. as Amici Curiae
20–21, n. 4 (collecting cases). To be sure, those rulings do not necessar
ily mean that no such causal link exists, cf. Brief for United States as
Amicus Curiae 29 (noting that injuries have been added to the Vaccine
Injury Table for existing vaccines), or that claimants will not ultimately
be able to prove such a link in a state tort action, particularly with the
added tool of civil discovery. But these rulings do highlight the sub
stantial hurdles to recovery a claimant faces. See Schafer v. American
Cyanamid Co., 20 F. 3d 1, 5 (CA1 1994) (“[A] petitioner to whom the
Vaccine Court gives nothing may see no point in trying to overcome tort
law’s yet more serious obstacles to recovery”). Trial courts, moreover,
have considerable experience in efficiently handling and disposing of
meritless products liability claims, and decades of tort litigation (in
cluding for design defect) in the prescription-drug context have not led
to shortages in prescription drugs. Despite the doomsday predictions of
respondent and the various amici cited by the concurrence, ante, at 6–7,
the possibility of a torrent of meritless lawsuits bankrupting manufac
turers and causing vaccine shortages seems remote at best. More
fundamentally, whatever the merits of these policy arguments, the
issue in this case is what Congress has decided, and as to that question,
the text, structure, and legislative history compel the conclusion that
Congress intended to leave the courthouse doors open for children who
have suffered severe injuries from defectively designed vaccines. The
majority’s policy-driven decision to the contrary usurps Congress’ role
and deprives such vaccine-injured children of a key remedy that Con
gress intended them to have.
363
pre-empt all design defect claims against vaccine manu

facturers for covered vaccines, the majority’s decision
leaves a regulatory vacuum in which no one—neither the
FDA nor any other federal agency, nor state and federal
juries—ensures that vaccine manufacturers adequately
take account of scientific and technological advancements.
This concern is especially acute with respect to vaccines
that have already been released and marketed to the
public. Manufacturers, given the lack of robust competi
tion in the vaccine market, will often have little or no
incentive to improve the designs of vaccines that are al
ready generating significant profit margins. Nothing in
the text, structure, or legislative history remotely suggests
that Congress intended that result.
I respectfully dissent.
364
(Slip Opinion) OCTOBER TERM, 2010 1
Syllabus
NOTE: Where it is feasible, a syllabus (headnote) will be released, as is

being done in connection with this case, at the time the opinion is issued.
The syllabus constitutes no part of the opinion of the Court but has been
prepared by the Reporter of Decisions for the convenience of the reader.
See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337.
Syllabus
BRUESEWITZ ET AL. v. WYETH LLC, FKA WYETH, INC.,

ET AL.
CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR

THE THIRD CIRCUIT
No. 09–152. Argued October 12, 2010—Decided February 22, 2011

The National Childhood Vaccine Injury Act of 1986 (NCVIA or Act) cre
ated a no-fault compensation program to stabilize a vaccine market
adversely affected by an increase in vaccine-related tort litigation
and to facilitate compensation to claimants who found pursuing le
gitimate vaccine-inflicted injuries too costly and difficult. The Act
provides that a party alleging a vaccine-related injury may file a peti
tion for compensation in the Court of Federal Claims, naming the
Health and Human Services Secretary as the respondent; that the
court must resolve the case by a specified deadline; and that the
claimant can then decide whether to accept the court’s judgment or
reject it and seek tort relief from the vaccine manufacturer. Awards
are paid out of a fund created by an excise tax on each vaccine dose.
As a quid pro quo, manufacturers enjoy significant tort-liability pro
tections. Most importantly, the Act eliminates manufacturer liability
for a vaccine’s unavoidable, adverse side effects.
Hannah Bruesewitz’s parents filed a vaccine-injury petition in the
Court of Federal Claims, claiming that Hannah became disabled af
ter receiving a diphtheria, tetanus, and pertussis (DTP) vaccine
manufactured by Lederle Laboratories (now owned by respondent
Wyeth). After that court denied their claim, they elected to reject the
unfavorable judgment and filed suit in Pennsylvania state court, al
leging, inter alia, that the defective design of Lederle’s DTP vaccine
caused Hannah’s disabilities, and that Lederle was subject to strict
liability and liability for negligent design under Pennsylvania com
mon law. Wyeth removed the suit to the Federal District Court. It
granted Wyeth summary judgment, holding that the relevant Penn
sylvania law was preempted by 42 U. S. C. §300aa–22(b)(1), which
365
Syllabus
provides that “[n]o vaccine manufacturer shall be liable in a civil ac

tion for damages arising from a vaccine-related injury or death asso
ciated with the administration of a vaccine after October 1, 1988, if
the injury or death resulted from side-effects that were unavoidable
even though the vaccine was properly prepared and was accompanied
by proper directions and warnings.” The Third Circuit affirmed.
Held: The NCVIA preempts all design-defect claims against vaccine
manufacturers brought by plaintiffs seeking compensation for injury
or death caused by a vaccine’s side effects. Pp. 7–19.
(a) Section 300aa–22(b)(1)’s text suggests that a vaccine’s design is
not open to question in a tort action. If a manufacturer could be held
liable for failure to use a different design, the “even though” clause
would do no work. A vaccine side effect could always have been
avoidable by use of a different vaccine not containing the harmful
element. The language of the provision thus suggests the design is
not subject to question in a tort action. What the statute establishes
as a complete defense must be unavoidability (given safe manufac
ture and warning) with respect to the particular design. This conclu
sion is supported by the fact that, although products-liability law es
tablishes three grounds for liability—defective manufacture,
inadequate directions or warnings, and defective design—the Act
mentions only manufacture and warnings. It thus seems that the
Act’s failure to mention design-defect liability is “by deliberate choice,
not inadvertence.” Barnhart v. Peabody Coal Co., 537 U. S. 149, 168.
Pp. 7–8.
(b) Contrary to petitioners’ argument, there is no reason to believe
that §300aa–22(b)(1)’s term “unavoidable” is a term of art incorporat
ing Restatement (Second) of Torts §402A, Comment k, which exempts
from strict liability rules “unavoidably unsafe products.” “Unavoid
able” is hardly a rarely used word, and cases interpreting comment k
attach special significance only to the term “unavoidably unsafe
products,” not the word “unavoidable” standing alone. Moreover,
reading the phrase “side effects that were unavoidable” to exempt in
juries caused by flawed design would require treating “even though”
as a coordinating conjunction linking independent ideas when it is a
concessive, subordinating conjunction conveying that one clause
weakens or qualifies the other. The canon against superfluity does
not undermine this Court’s interpretation because petitioners’ com
peting interpretation has superfluity problems of its own. Pp. 8–12.
(c) The structure of the NCVIA and of vaccine regulation in general
reinforces what §300aa–22(b)(1)’s text suggests. Design defects do
not merit a single mention in the Act or in Food and Drug Admini
stration regulations that pervasively regulate the drug manufactur
ing process. This lack of guidance for design defects, combined with
366
Cite as: 562 U. S. ____ (2011) 3
Syllabus
the extensive guidance for the two liability grounds specifically men
tioned in the Act, strongly suggests that design defects were not men
tioned because they are not a basis for liability. The Act’s mandates
lead to the same conclusion. It provides for federal agency improve
ment of vaccine design and for federally prescribed compensation,
which are other means for achieving the two beneficial effects of de
sign-defect torts—prompting the development of improved designs,
and providing compensation for inflicted injuries. The Act’s struc
tural quid pro quo also leads to the same conclusion. The vaccine
manufacturers fund an informal, efficient compensation program for
vaccine injuries in exchange for avoiding costly tort litigation and the
occasional disproportionate jury verdict. Taxing their product to fund
the compensation program, while leaving their liability for design de
fect virtually unaltered, would hardly coax them back into the mar
ket. Pp. 13–16.
561 F. 3d 233, affirmed.
SCALIA, J., delivered the opinion of the Court, in which ROBERTS,

C. J., and KENNEDY, THOMAS, BREYER, and ALITO, JJ., joined. BREYER,
J., filed a concurring opinion. SOTOMAYOR, J., filed a dissenting opinion,
in which GINSBURG, J., joined. KAGAN, J., took no part in the considera
tion or decision of the case.
367
CASE NOTE
ABDULLAHI V. PFIZER: SECOND CIRCUIT FINDS A NONCONSENSUAL
MEDICAL EXPERIMENTATION CLAIM ACTIONABLE UNDER ALIEN TORT
STATUTE
Anna Alman*
ABSTRACT
United States courts struggle to determine what international

human rights violations and against what violators could be raised
under the Alien Tort Statute by non-U.S. citizens. In 2009, the Second
Circuit's majority in Abdullahi v. Pfizer, Inc. found that nonconsensual
medical experimentation on humans violated a universally accepted
norm of customary international law. The court found that the
jurisdictional grounds under the Alien Tort Statute ("ATS") existed so
that non-U.S. citizens could bring these claims to U.S. district courts.
By integrating the principles outlined in Sosa, the court formulated
clear criteria for determination of whether an alleged transgression of
international law constitutes a norm of the law of nations and thus
represents a triable issue under the ATS. The Abdullahi case also
demonstrates a clear potential for international medical research to be
exploitive in nature. If global medical research is to be safely
accomplished, the international community will be forced to address the
issue through application of international and comparative law. This
case note provides in-depth analysis of the Abdullahi case and explores
its implications on future ATS litigation.
INTRODUCTION
It is universally accepted that administering medical experiments

on human subjects without their knowledge or consent is unethical and
immoral. For most people, the subject of nonconsensual
experimentation on humans brings up memory of the atrocious Nazi
medical experiments conducted on concentration camp prisoners,' or of
* University of Denver, Sturm College of Law, J.D. '12. The author thanks Professor
Brittany Glidden for her insightful comments, Julie Nichols for her editing suggestions,
and my husband John Lear for his amazing support.
1. United States v. Brandt, 2 Trials of War Criminals Before the Nuremberg
Military Tribunals Under Control Council Law No. 10, 181-82 (1949) [hereinafter
Brandt].
533
368
534 DENV. J. INT'L L. & POL'Y VOL. 40:4
the Tuskegee experiments on poor African-American men. 2 Despite

agreement that such experimentation is unacceptable and is prohibited
within the United States, 3 the role of domestic courts in adjudicating
these and other violations of international law remains uncertain and
highly controversial. 4 Specifically, United States courts have struggled
to determine what international human rights violations could be
raised by non-U.S. citizens or aliens and what violators could be sued
under the Alien Tort Statute ("ATS").6
In January 2009, in Abdullahi v. Pfizer, Inc., the Second Circuit's
majority found that nonconsensual medical experimentation on humans
violated a universally accepted norm of customary international law.6
The Abdullahi suit was brought by Nigerian children and their
guardians alleging that Pfizer conducted medical experimentations of a
new drug on the children without their informed consent during a
bacterial meningitis outbreak in Nigeria in 1996.7 Plaintiffs asserted
that, as a result of the new drug trials on two hundred children, eleven
children died, and many others were left with permanent blindness,
brain damage, loss of hearing, or paralysis. 8 The Second Circuit found
that jurisdiction existed under the ATS, allowing the foreign plaintiffs'
claims of nonconsensual medical testing to proceed.9 Significantly, the
Abdullahi court allowed private causes of action to be brought under
the ATS as long as "the violations occurred as the result of concerted
action" by the private individuals or organizations working together
with the state government. 10
This case comment provides in-depth analysis of the Abdullahi case
and explores the implications of the Abdullahi decision for future cases
brought to U.S. federal courts under the ATS. First, Part I surveys
formation and significant developments of the ATS. Second, Part II
provides the factual background and the procedural history of the case.
Third, Part III examines the majority's holding and reasoning as well as
discusses the dissenting opinion. Finally, Part IV addresses
implications of the Abdullahi decision on the ATS jurisprudence and
post-Abdullahi developments.
2. U.S. Public Health Service Syphilis Study at Tuskegee, CENTERS FOR DISEASE
CONTROL AND PREVENTION, available at http://www.cdc.gov/tuskegee/index.html.
3. General Requirements for Informed Consent, 45 C.F.R. § 46.116 (2012); see also
21 C.F.R. § 50.20 (2012).
4. See Paul R. Dubinsky, InternationalLaw in the Legal System of the United States,
58 AM. J. COMP. L. 455, 472-73 (2010).
5. Id. at 473; Alien Tort Statute, 28 U.S.C. § 1350 (2006).
6. Abdullahi v. Pfizer, Inc., 562 F.3d 163, 187 (2d Cir. 2009) [hereinafter Abdullahi].
7. Id. at 169-70.
8. Id. at 169.
9. Id. at 187.
10. Id. at 188-89.
369
2012 CASE NOTE 535
The Alien Tort Statute

The First Congress originally passed the ATS in 1789 allowing non-
U.S. citizens to sue "for a tort only, committed in violation of the law of
nations or treaty of the United States."" The statute grants federal
jurisdiction for suits alleging (1) torts committed anywhere in the world
(2) against a non-U.S. citizen who brings the action (3) in violation of
the law of nations. 12 Some courts and legal scholars consider the ATS
as having a "strictly jurisdictional nature" in the sense that the
statutory provision grants jurisdiction to federal courts without a
substantive power to create new causes of action.13 At the time of
enactment the ATS had a practical application for a limited set of
actions that asserted violations of the law of nations. 14 Specifically, the
ATS has been traditionally limited to claims for crimes against
ambassadors, violations of the right to safe passage, and crimes of
piracy.15 Because of the scarce legislative history and conflicting
historical interpretations of the ATS, non-American citizens randomly
invoked the statute to seek redress for violations of international law in
U.S. federal courts until 1980.16
While the ATS is a simple statute on its face, courts have struggled
to identify the requirements that a non-U.S. citizen must satisfy in
order to bring an ATS claim in a U.S. federal court. 17 Starting in 1980
with Filartigav. Pena-Irala,a number of cases attempted to clarify and
expand its statutory application to allow for new causes of action.18 In
Filartiga, after comprehensive examinations of numerous sources of
customary international law condemning the acts of torture, the Second
Circuit concluded that the right to be free from torture was proscribed
by the law of nations. 19 Because torture committed by state officials or
under the color of official authority violated universally accepted norms
of international law, the torture claim by non-U.S. citizens could be
brought under the ATS.20 Implicit in this finding is the notion that "a
state's treatment of its own citizens is a matter of international
11. 28 U.S.C. § 1350 (2006); Sosa v. Alvarez-Machain, 542 U.S. 692, 712-13 n.10
(2004) (explaining that the statute has been modified slightly since its initial enactment
in 1789) [hereinafter Sosa].
12. Kadic v. Karadzic, 70 F.3d 232, 238 (2d Cir. 1995) [hereinafter Kadic].
13. Sosa, supra note 11, at 713.
14. Id. at 720.
15. Abdullahi, supra note 6, at 173.
16. Sosa, supra note 11, at 712-13; see Filartiga v. Pena-Irala,630 F.2d 876, 887-
88 (2d Cir. 1980) [hereinafter Filartiga].
17. See Sosa, supra note 11, at 720-21.
18. Id. at 724-25; Kadic, supra note 12, at 241-44; see Filartiga,supranote 16, at 880.
19. Filartiga,supra note 16, at 884-85. In Filartiga,the relatives of a victim brought
the ATS action against a Paraguayan Police General who kidnapped and tortured to
death the 17-year old victim in retaliation for the family's political activities.
20. Id. at 880.
370
concern." 2' The Filartigacourt found that there was an international

consensus against the use of torture supported by numerous
international treaties and accords. 22 The issue of whether torture is a
norm of customary international law actionable under the ATS was
resolved. The ATS question after Filartigabecame: What does it take
for a well recognized norm of international law to qualify as the "law of
nations" in order for a U.S. federal court to exercise federal
jurisdiction? 23
Fifteen years after the Filartiga decision, the Second Circuit
addressed another ATS issue of who could be held liable under the
ATS. 24 The court in Kadic v. Karadzic held that "certain forms of
conduct violate the law of nations whether undertaken by those acting
under the auspices of a state or only as private individuals."25 In Kadic,
a group of victims of Bosnian war brought claims of crimes of genocide,
war crimes, crimes against humanity, rape, forced prostitution, and
forced pregnancy against the self proclaimed Bosnian-Serb leader. 26
The Kadic court emphasized that private persons might be found liable
under the ATS for violations of international humanitarian law,
genocide, and war crimes. 27 In addition, the court found the plaintiffs
satisfied the state action requirement for other crimes by showing that
the Bosnian-Serb leader acted under color of law because he acted in
concert with the state officials of the former Yugoslavia. 28 Later, some
courts also held that because the ATS contains no express exception for
corporations, the statute grants jurisdiction over torture claims against
corporate defendants. 29
Finally, in 2004, the U.S. Supreme Court weighed in on the scope of
the ATS. In the seminal opinion, Sosa v. Alvarez-Machain, Justice
Souter outlined the framework for determining whether a claim
properly asserts a violation of a norm of customary international law,
21. Id. at 881.

22. Id. at 882-84.
23. Id. at 880-81; see also In re Estate of FerdinandMarcos, 25 F.3d 1467, 1475 (9th
Cir. 1994) (concluding that the ATS creates a cause of action for violations of specific,
universal and obligatory international human rights standards).
24. Kadic, supra note 12, at 239.
25. Id.; see also Sinaltrainalv. Coca-Cola Co., 578 F.3d 1252, 1263 (11th Cir. 2009)
(finding that private parties, both individuals and corporations, may be liable for a
violation of the law of nations under the ATS).
27. Id. at 239-40.
28. Id. at 245.
29. The language of the statute limits who may sue and for what violations, but it
does not limit who may be sued. See, e.g., Romero v. Drummond Co., Inc., 552 F.3d 1303,
1315 (11th Cir. 2008); Khulumani v. Barclay National Bank, Ltd., 504 F.3d 254, 260 (2d
Cir. 2007) (per curiam).
371
2012 CASE NOTE 537
thus supporting a cause of action under the ATS.so In order for a

violation of the law of nations to be actionable under the ATS, the norm
prohibiting such violation must be "defined with a specificity
comparable to the features of the 18th-century paradigms" such as
transgression of the rights of ambassadors, piracy crimes, and
violations of safe conducts or passports. 31 The Supreme Court explained
that torts in violation of the customary international law could be
defined by common law because nothing has precluded federal courts
from "recognizing a claim under the law of nations as an element of
common law." 32 Nevertheless, because the understanding of federal
common law drastically changed in 1938 when the watershed opinion in
Erie R. Co. v. Tompkins rejected the concept of federal "general"
common law, the Supreme Court warned courts to exercise caution
when finding actionable norms under the ATS. 33 Thus, the Sosa court
called for judicial restraint in creating new private causes of actions
under the ATS emphasizing potential encroachment on the
34
decisionmaking region of Legislative and Executive branches.
In a nutshell, the federal courts can allow new private causes of
actions for international law violations to be brought under the ATS but
only when these norms have been accepted by civilized nations and are
shown to be analogous to the historic crimes against ambassadors,
piracy, and violation of safe conducts. 35 The Court explained that the
ATS affords jurisdiction to a very limited set of actions asserting
violations of international legal norms that are (1) specific, (2)
universal, and (3) well-recognized by most civilized nations that
consider these norms obligatory.36 While the Supreme Court admitted
that federal courts do have a capacity to adjudicate enforceable
international legal norms, it also called for "great caution" in applying
the law of nations and creating new private causes of actions under the
ATS. 37
CASE SUMMARY
In 1996, Pfizer, Inc., one of the world's largest pharmaceutical

companies, took advantage of a large outbreak of bacterial meningitis in
Nigeria, using it as an opportunity to test an unapproved and
30. Sosa, supra note 11, at 720, 724-26.

31. Id. at 724-25.
32. Id.
33. Id. at 726; see also Erie R. Co. v. Tompkins, 304 U.S. 64, 68 (1938).
34. See Sosa, supra note 11, at 727.
35. Id. at 725.
36. Id. at 732.
37. Id. at 728-29.
372
potentially harmful medication. 38 In order to get the U.S. Food and

Drug Administration's ("FDA") approval for the use of Trovafloxacin
Mesylate ("Trovan") on children in the U.S., Pfizer conducted a medical
research study for the new antibiotic on two hundred Nigerian children
sick with meningitis.3 9 Pfizer sent American doctors to conduct
experiments together with Nigerian doctors at the Infectious Disease
Hospital, a public hospital located in Kano, which is in the north of
Nigeria. 40 The company's goal was to obtain the FDA's approval of
Trovan through its comparison with another antibiotic Ceftriaxone.41
Financial analysts predicted at that time that Trovan would bring the
company a billion U.S. dollars in revenue if approved by the FDA.42
While Ceftriaxone is a well-established and FDA-approved antibiotic for
safe and effective treatment of bacterial meningitis in both adults and
children, preliminary animal trials of Trovan revealed severe side
effects, including degenerative joint disease, liver damage, and
abnormal bone conditions.43 Undeterred by these initial alarming
findings, Pfizer proceeded with the experiments. The researchers
divided the sick children in two groups: one group received the new
drug Trovan, while the other group received Ceftriaxone.44
This experiment was conducted without the patients' consent or
knowledge that they were experiment subjects. Plaintiffs claimed that
both American and Nigerian doctors working for Pfizer intentionally
failed to inform the children and their parents that the medical
experiments were being conducted. The doctors also failed to advise
Plaintiffs about the serious health risks involved in the drug studies.
Possibly the most appalling allegation of all was that the doctors failed
to inform Plaintiffs that a safe and effective alternative treatment for
meningitis was available at the same hospital through the non-
governmental organization "Doctors Without Borders."45 In their
lawsuit, Plaintiffs also alleged that Pfizer deliberately administered
lower doses of Ceftriaxone to the second group in order to boost the
effectiveness of Trovan in comparison to Ceftriaxone.46 Moreover, the
Pfizer doctors neglected to provide any follow-up medical care to the
38. See Petition for Writ of Certiorari at 3, Pfizer, Inc. v. Abdullahi, 130 S. Ct. 3541
(2010) (No. 09-34).
39. Id.
41. Id.
42. Joe Stephens, Where Profit and Lives Hang in Balance, WASHINGTON POST (Dec.
17, 2000), available at http://www.washingtonpost.com/wp-dyn/content/article/2007/
07/02/AR2007070201255.html.
44. Id.
45. Id. at 170.
46. Id.
373
2012 CASE NOTE 539
treated children after the conclusion of the medical experiments.47

Plaintiffs alleged that, as a result of the Trovan medical trials, eleven
children died and many others were left to suffer paralysis, brain
damage, or permanent sight or hearing loss. 4 8 Following the medical
experiments on the Nigerian children, the FDA never approved Trovan
for use on children and eventually severely restricted use of Trovan
even for adults. 49 Trovan was completely banned by the European
Union in 1999.50
Following these events, the injured children and their families
sought legal relief. In 2001, the injured Nigerian children and their
guardians brought a tort action against Pfizer under the ATS asserting
violations of customary international law (the Abdullahi action).51
Meanwhile, another group of plaintiffs brought a suit against Pfizer in
a federal court in Nigeria under the Nigerian law (the Adamu action).52
However, the Nigerian lawsuit was voluntarily dismissed by the
plaintiffs due to alleged corruption in the Nigerian legal system and the
plaintiffs' inability to obtain legal redress in Nigeria.5 3 The Adamu
plaintiffs then brought a lawsuit in the U.S, which was then
consolidated with the Abdullahi action. 54 The district court granted
Pfizer's motions to dismiss for failure to state a claim under the ATS.
The district court dismissed the claim on the grounds of forum non
conveniens on the condition that Pfizer agreed to litigate the lawsuit in
Nigeria.5 5 Plaintiffs appealed the dismissals to the Second Circuit,
which reversed and remanded on appeal for the reasons explained
below. 56
Majority's and Dissent's Opinions
In Abdullahi, the Second Circuit majority undertook a
comprehensive analysis of subject matter jurisdiction under the ATS
within the parameters outlined by the Supreme Court's opinion in Sosa.
By integrating the principles identified by the Second Circuit in
Filartiga,Kadic, and Flores5 7 with those provided by Sosa, the court
47. Id. at 169-70.

48. Id. at 170.
49. Company News; Suspension of Trovan Drug in Europe Is Urged,N.Y. TIMES (June
12, 1999), available at http://www.nytimes.com/1999/06/12/business/company-news-
suspension-of-trovan-drug-in-europe-is-urged.html.
51. Id.
52. Id. at 170-71.
53. Id.
54. Id. at 171.
55. Id.
56. Id. at 168-69.
57. Flores v. S. Peru Copper Corp., 414 F.3d 233, 247-48 (2d Cir. 2003) [hereinafter
Flores].
374
formulated clear criteria for determination of whether an alleged

transgression of international law constitutes a norm of the law of
nations and thus represents a triable issue under the ATS.
The Second Circuit clarified that a norm of international law
actionable under the ATS must be a norm that is (1) universally
adhered to by States out of sense of legal obligation, (2) specific and
definable, and (3) of "mutual" concern to States as opposed to "several"
concern to individual States.68
Sources of International Law
The court started its analysis with the examination of various
sources of international law.5 9 In determining whether nonconsensual
medical experimentation rises to the norm of international customary
law, the Second Circuit referred to the four sources listed in Article 38
of the Statute of the International Court of Justice: (1) "international
conventions" or treaties expressly accepted by States; (2) "international
custom, as evidence of a general practice accepted as law"; (3) "the
general principles of law recognized by civilized nations"; and (4)
"judicial decisions and the teachings of the most highly qualified
publicists of the various nations" as a secondary source of legal rules.60
As evidence of customary international law prohibiting nonconsensual
medical experimentations on human subjects, Plaintiffs cited the
Nuremberg Code,6 1 the World Medical Association's Declaration of
Helsinki, 62 the Ethical Guidelines by the Council for International
Organizations of Medical Services, 63 and article 7 of the International
Covenant on Civil and Political Rights ("ICCPR"). 64
The court admitted that none of the international legal authorities,
except the ICCPR, had been ratified by the U.S., and thus these
authorities, taken individually, would not have binding legal power in
U.S. federal courts. Nevertheless, the court also said that these non-
obligatory international legal norms "may, with time and in conjunction
with state practice, provide evidence that a norm has developed the
specificity, universality, and obligatory nature required for ATS

59. Id. at 174-75.
60. Id. at 175 (citing Statute of International Court of Justice art. 38(1), June 26,
1945, 59 Stat. 1055, 1 U.N.T.S 993).
61. Id. (citing Brandt,supra note 1, at 181-82).
62. Id. (citing World Med. Ass'n, Declaration of Helsinki: Ethical Principles for
Medical Research Involving Human Subjects, arts. 20, 22 (June 1964) (amended through
October 2008), available at http://www.wma.net/en/30publications/l0policies/b3/17c.pdf).
63. Id. (citing Council for Int'l Orgs. of Med. Serv., InternationalEthical Guidelines
for Biomedical Research Involving Human Subjects, guideline 4 (3d ed. 2002), [hereinafter
Council for Int'l Orgs. of Med. Serv.], available at http://www.cioms.ch/publications
/guidelines/guidelinesnov_2002).
64. Id. (citing International Covenant on Civil and Political Rights art. 7, opened for
signatureDec. 19, 1966, 999 U.N.T.S. 171 [hereinafter ICCPR]).
375
2012 CASE NOTE 541
jurisdiction." 65 The court further clarified that the scope of inquiry must
be not whether each source of international legal authority is binding by
itself but rather whether "a greater range of evidence" has been
considered and whether the probative value of all the sources taken as
a whole amounts to sufficient evidence of the current state of customary
international law. 6 6 Thus, even international agreements that are not
self-executing or that have not been ratified by the United States can
constitute evidence of the norm of customary international law broadly
accepted by the international community. 67
Principles of Universality
In order to properly bring a claim under the ATS, plaintiffs must
assert a violation of a norm of customary international law that is
universally accepted around the world as a binding legal obligation. 68
The court concluded that the prohibition of nonconsensual medical
experimentations, originally identified at the Nuremberg war crimes
trials, clearly represented such norm.6 9 The court's strongest reasoning
for finding the international agreement to prohibit nonconsensual
experimentation came from the fact that at least eighty-four countries
now require the informed consent from participants for purposes of
medical experimentations. 70 Through the advancements of
international conventions as well as development of domestic
regulations, the informed consent norm "has become firmly embedded
and has secured universal acceptance in the community of nations."71
Principles of Specificity
The court also stated that a norm of customary international law
must be "sufficiently specific." To be "sufficiently specific," the norm
must be analogous to the 18th-century paradigms of crimes against
ambassadors, piracy, or infringement on the right of safe conduct. 72
According to the victims' allegations, Pfizer failed to inform any of the
children or their guardians of the nature and risks of the medical
experiments despite the fact that the company was well aware of the
informed consent requirements. In other words, Pfizer doctors acted
knowingly and purposefully when they nonetheless proceeded with
65. Abdullahi, supra note 6, 176 (citing Filartiga,supra note 16, at 883).
66. Id.
67. Id.
68. Id. at 177.
69. Id.; see also ICCPR, supra note 65, art. 7; Brandt, supra note 1, at 181-82; Council
for Int'l Orgs. of Med. Serv., supra note 64, at guideline 4.
71. Id. at 183-84.
72. Id. at 184.
376
medical research. 73 The court found that the Nigerian victims alleged
ample facts that Pfizer knowingly and purposefully conducted the
medical experiments in a harmful manner.7 4 Thus, the allegations
against the Pfizer doctors, if proven true, would preclude any
assumptions of simple negligence in failure to inform the participants of
the nature and risks of the medical experiments.75 The court concluded
that prohibition of nonconsensual medical testing is "sufficiently
specific" the same way the customary international law prohibits
piracy. 76
Principles of Mutual Concern

The court also required examination of a norm of customary
international law from the perspective of the "mutual concern" to
States. When nations act in concert with each other out of a sense of
mutual concern, the nations make it their intention to prohibit certain
conduct that they collectively find reprehensible. Unlike matters of
"several concern" that involve issues in which individual States are only
"separately and independently interested," matters of "mutual concern"
encompass the objective of maintaining international peace and
stability. 77 In other words, matters of "mutual concern" compel nations
to cooperate with each other on eliminating mutually unwanted conduct
through the means of international conventions and agreements in
order to preserve international security and public health. 78
By conducting involuntary medical experimentations, the court
found that Pfizer threatened international efforts to prevent the spread
of contagious diseases across the international borders by fostering
mistrust and opposition not only to future drug trials but also to vital
public health programs organized by pharmaceutical companies. 79 For
example, after the reports about the Trovan medical trials resulting in
alleged deaths of the children came out in Nigeria, the local population
boycotted polio vaccination efforts in 2004, in part because of the
Trovan drug experiments.80 The resistance to polio vaccinations in
Nigeria resulted in the spread of the disease across Africa and the
73. Id.; but see Viet. Ass'n for Victims of Agent Orange v. Dow Chem. Co., 517 F.3d
104, 121-23 (2d Cir. 2008) (finding that because the plaintiffs did not allege that the
chemical was sprayed with the purpose to injure human population, "they fail[ed] to make
out a cognizable basis for their ATS claim.").
74. Abdullahi, supra note 6, at 184-85.
75. Id.
76. Id. at 184.
77. Id. at 185 (quoting Flores, supra note 58, at 249).
78. Id.
79. Id. at 186.
80. See Poliomyelitis in Nigeria and West/Central Africa, WORLD HEALTH ORG. (June
18, 2008), available at http://www.who.int/csr/doni/2008_06_18/en/index.html.
377
2012 CASE NOTE 543
Middle East.8 ' In addition, the court found that nonconsensual medical
trials conducted by American drug companies could contribute to
growing anti-U.S. sentiments around the world, further threatening the
already-volatile international security.82
The State Action Requirement

The court looked to the "color of law" jurisprudence of 42 U.S.C. §
1983 to determine whether a state action requirement was satisfied.8 3
When a private individual acts together with state officials or with
substantial state aid, the individual acts under "color of law." 84 The
Second Circuit concluded that a private cause of action under the ATS
could proceed as long as the private individual or organization "acted in
concert with" the state actor under the color of law.8 5 In Abdullahi, the
court found sufficiently close relationship between Pfizer and the
Nigerian governmental representatives who allegedly were involved in
every stage of the drug trials.86 Because the alleged illegal conduct took
place with substantial help of Nigerian doctors in a public hospital
provided to Pfizer by the local government specifically to conduct the
medical trials, the court concluded that the illegal conduct was the
"concerted action" between the American drug company and the
Nigerian government.8 7
The Dissenting Opinion

Although Judge Wesley agreed with the framework the majority
used to analyze claims under the ATS, he rejected the notion of private
cause of actions brought under the ATS.8 8 Judge Wesley maintained
that the correct application of Sosa framework to Abdullahi facts would
not result in the jurisdictional grant for nonconsensual medical
experimentations claims against private actors.8 9 He insisted that
nonconsensual medial experimentation "more closely resembles the acts
for which only state actors may be held responsible."9 0 Judge Wesley
reasoned that international law would only allow federal court
jurisdiction over private actors under the ATS when the conduct in
question is beyond the reach of any state, such as in crimes of piracy.
81. Id.
82. Abdullahi, supra note 6, at 187; see also Timothy S. Jost, The Globalization of
Health Law: The Case of Permissibility of Placebo-Based Research, 26 AM. J.L. & MED.
175, 175 (2000).
85. Id.
87. Id. at 188-89.
88. Id. at 192-93 (Wesley, J., dissenting).
89. Id. at 209.
90. Id. at 206.
378
544 DENV. J. INT'L L. & POLY VOL. 40:4
Because violations of medical experimentation fall under the

jurisdiction of domestic courts, these crimes cannot be incorporated by
analogy to crimes against ambassadors, piracy, and violation of safe
conducts as to reach private, non-state actors under the ATS. 91 With
respect to the sources of customary international laws accepted as
evidence by the majority, Judge Wesley concluded that the evidence
presented by plaintiffs was merely aspirational and insufficient to
uphold ATS jurisdiction for the private right of action. 92
Implications of Abdullahi Decision

It is undisputed that administering involuntarily medical
experimentation on humans without their consent is unethical, morally
reprehensible, and illegal. The controversy centers on whether such
conduct is a recognized norm of international law actionable under the
ATS. In reaching its conclusion that a nonconsensual medical
experimentation constitutes a norm of customary international law
actionable under the ATS, the Abdullahi majority carefully followed the
Sosa framework to the extent Sosa provided guidance. The Supreme
Court in Sosa affirmed that the ATS is purely jurisdictional. At the
same time, it did not preclude federal courts from recognizing new
norms of international law, even absent express statutory authority.
Moreover, although the Supreme Court in Sosa provided some
guideposts for determination of customary international law norms, the
Court evaded laying out a clear and functional framework clarifying
what causes of actions could be actionable under the ATS. The matter is
further complicated by the fact that Congress has not clarified the scope
and implications of the ATS.93
Although the Abdullahi opinion has been broadly criticized, 94 there
are two reasons to believe that the Second Circuit decided the case in
accordance with the framework outlined in Sosa. First, the Supreme
Court has denied the Pfizer's petition for a writ of certiorari, thus
rejecting an opportunity to overrule or correct the ATS framework set
forth by the Second Circuit in Abdullahi.95 The Supreme Court's denial
could also mean that either the factual basis of the case was not
adequate to warrant the Court's review of the ATS or that the issue was
not sufficiently important to the Court. In any case, the denial of the
91. Id.
92. Id. at 194-95, 198.
93. Flores,supra note 58, at 246.
94. In re S. African Apartheid Litig., 633 F. Supp. 2d 117, 123 (S.D.N.Y. 2009);
Dennis M. Coyne, InternationalPharmaceuticalMistrials: Existing Law for the Protection
of Foreign Human Subjects and Proposalfor Reform, 29 B.U. INT'L L.J. 427, 428 (2011).
95. Warren Richey, Supreme Court Allows Drug Test Case Against Pfizer to Proceed,
CHRISTIAN SCIENCE MONITOR (June 29, 2010), http://www.csmonitor.comlUSA/Justice
/2010/0629/Supreme-Court-allows-drug-test-case-against-Pfizer-to-proceed.
379
2012 CASE NOTE 545
writ of certiorari means that the Abdullahi decision stays as the

mandatory authority for the ATS claims within the Second Circuit's
jurisdiction.
Second, the fact that Congress has not acted in response to the
Abdullahi decision by expressly prohibiting suits by victims of
nonconsensual medical experimentations under the ATS might be a
good sign. Following the court's decision in Filartiga,Congress passed
the Torture Victim Protection Act in 1991 ("TVPA"), which specifically
allowed individuals to bring civil actions suits against "any individual
who, under actual or apparent authority, or color of law, of any foreign
nation . . . subjects an individual to torture."9 6 Moreover, the House
Report on the TVPA expressly referred to the Filartiga case with a
comment approving the Filartigacourt's reasoning.9 7 In other words, by
passing the TVPA, Congress authorized the cause of action for torture
that has been recognized in Filartigaunder the ATS. 98 It is reasonable
to draw parallels with the Filartigacase and anticipate that Congress
would be influenced by the Abdullahi decision holding that the
involuntarily medical experimentation contravenes the universally
accepted norms of customary international law.
It is important to note what issues the Abdullahi decision did not
address. While the Second Circuit in Abdullahi focused on whether
nonconsensual medical experimentation constituted a norm of
customary international law, the court did not address another
important matter: who could be sued as a violator under the ATS. Most
recently, the U.S. Supreme Court granted the petition for certiorari in
another Second Circuit's ATS case also brought by Nigerians. In Kiobel
v. Royal Dutch Petroleum Co., Nigerian plaintiffs brought claims
against the multinational oil company alleging extrajudicial killing,
torture, and crimes against humanity. 99 The plaintiffs claimed that the
company collaborated with the Nigerian government to commit these
violations of customary international law in response to the plaintiffs'
legitimate protests against oil exploration and production destroying
the local environment. The Second Circuit majority held that
corporations, unlike States and individuals, could not be held liable for
human rights violations. The court explained that although
corporations are considered "persons" under U.S. domestic law, such
liability under domestic law does not create a norm of customary
international law actionable against corporations under the ATS. Faced
with a high probability that the Supreme Court would affirm the
96. Flores,supra note 58, at 246-47 & n.21.

97. H.R. REP. NO. 102-367(I), at 3 (1991), reprinted in 1992 U.S.C.C.A.N. 84, 85.
99. Kiobel v. Royal Dutch Petroleum Co., 621 F.3d 111, 123 (2d Cir. 2010), cert.
granted, 132 S. Ct. 472 (Oct 17, 2011) (No. 10-1491).
380
Second Circuit's decision in favor of the corporate defendants resulting

in future inability of non-U.S. citizen victims to bring ATS claims
against corporations, the Abdullahi plaintiffs agreed to settle with
Pfizer. 100
CONCLUSION
The rapid globalization of medical research of new drugs and
heated debates around ethics of international medical research have
exposed the vulnerability of human research subjects in developing
countries suffering from widespread poverty, lack of education, and
corrupt authorities. The Abdullahi case demonstrates a clear potential
for international medical research to be exploitive in nature. If global
medical research is to be safely and ethically accomplished, the
international community will be forced to address the issue through
application of international and comparative law. 101 The Abdullahi
decision sends a plain message of intolerance of nonconsensual medical
testing to not only large multinational pharmaceutical companies but
also the international community at large. While Congress has yet to
pass any legislation codifying the Abdullahi approach and creating a
statutory cause of action for nonconsensual medical testing under the
ATS, the Abdullahi opinion could serve as a catalyst for congressional
action. The growing ATS litigation will help further assimilation of
international human rights law into the U.S. legal system and will
likely lead to further developments of new norms of customary
international law actionable under the ATS.
It is important to remember that the ATS is not just a monetary
redress, but also an avenue to tell the story of injustice for victims and
publicly name the perpetrators of abuse. Even though the ATS is a civil
statute, its goal is nevertheless to bring those guilty for serious human
right violations to answer for their actions. The ATS litigation also
facilitates better understanding of the role of international legal norms
within the U.S. legal system. The cases brought under the ATS also
help create a record of human rights violations precipitating changes in
the countries where violations took place. Most importantly, ATS
litigation helps bring worldwide awareness to human rights causes or
create political pressure necessary for changes to prevent future abuses.
100. See Sue Reisinger, Pfizer Settles Lawsuits Over Drug Trials on Children in
Nigeria, CORPORATE COUNSEL (Feb. 23, 2011), http://www.law.com/jsp/cc/PubArticle
CC.jsp?id=1202482854504 (discussing that while the settlement is confidential, Pfizer
established the trust fund that would pay a maximum of $175,000 per child to those able
to prove death or permanent disability due to the Trovan drug trial).
101. See Jost, supra note 83, at 175-76; James V. Lavery, Putting International
Research Ethics Guidelines to Work for the Benefit of Developing Countries, 4 YALE J.
HEALTH POL'Y L. & ETHICS 319, 320-22 (2004).
381
2012 CASE NOTE 547
The Filartigacourt emphasized that "for purposes of civil liability,

the torturer has become like the pirate and slave trader before him
hostis humani generis, an enemy of all mankind."1 02 Whether through
the Abdullahi court's application of the ATS, a Supreme Court's
opinion, or a Congressional act, the American society has the
responsibility to ensure that the medical researchers, both individuals
and corporations, conducting nonconsensual harmful medical
experiments on human beings abroad become the "enemies of all
mankind."
102. Filartiga,supranote 16, at 890.

382
ANNEXURE P-8
Quality Policy
We are committed to provide quality services in surveillance

programme of Adverse Event Following Immunization in
India and also to monitor the quality and safety of vaccines and
the vaccination processes by working with other stakeholders.
We shall endeavor to constantly and actively collaborate with all

immunization stakeholders to build confidence of community in
vaccines and immunization programme.
AEFI Surveillance Programme is committed to early detection,

management, reporting, investigation and feedback on AEFIs to
various stakeholders of immunization programme.
Dr. M. K. Aggarwal
Deputy Commissioner (UIP),

MoHFW, Government of India
383
Goals and Objective of AEFI Surveillance
1. Promptly detect, report and respond to AEFI.

2. Identify unusually high rates of AEFI related to a specific
vaccine lot/brand.
3. Promptly address programmatic errors through
implementation of corrective measures.
4. Estimate serious AEFI rates in the population and compare
these with local and global data.
5. Identify signals of unexpected adverse events and generate
new hypotheses about these events that must be confirmed by
planned studies and laboratory investigations.
Dr. M. K. Aggarwal
Deputy Commissioner (UIP),

MoHFW, Government of India
384
Annual Report 2012 - 2013
ANNEXURE P-9
ANNUAL REPORT
2012-13
Government of India
Ministry of Health & Family Welfare
Department of Ayurveda, Yoga &
Naturopathy, Unani, Siddha and
Homoeopathy (AYUSH)
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385
Chapter-1
Background of the Department

1.1 The Department of Indian Systems of GROWTH OF THE MEDICINAL PLANTS
Medicine and Homoeopathy (ISM&H) was SECTOR
established in the Ministry of Health & Family
Welfare in March, 1995. It was re-named as • To ensure sustained availability of quality
Department of Ayurveda, Yoga & Naturopathy, raw material from medicinal plants.
Unani, Siddha and Homoeopathy with acronym as
AYUSH in November, 2003. The Department is • To ensure conservation of medicinal plants.
responsible for policy formulation, development
• Capacity building in medicinal plants
and implementation of programmes for the
sector.
growth, development and propagation of
Ayurveda, Yoga and Naturopathy, Unani, Siddha
QUALITY RESEARCH IN AYUSH
and Homoeopathy (AYUSH) systems of Health
Care*. Sowa Rigpa is the recent addition to the • To promote quality research in AYUSH
existing family of AYUSH systems. with the objective of validating the systems
scientifically and safety and efficacy
1.2 VISION AND MISSION OF THE
evaluation of AYUSH remedies.
DEPARTMENT
• To encourage research for validation
1.2.1 The Vision of the Department is to position of fundamental principles of AYUSH
AYUSH systems as the preferred systems of Systems.
living and practice for attaining a healthy India.
The Department has identified its Mission^ in • To encourage development of new drugs
terms of seven broad thematic areas of AYUSH for high priority diseases of national
activities. The thematic areas are as follows: importance.
PROVISION OF QUALITY AYUSH SERVICES • To preserve through documentation local

health traditions and folklore for their
• Delivery of Quality AYUSH health care utilization for new drug development.
services to entire population.
• To promote inter-disciplinary research.
• AYUSH to be an integral part of the
health delivery system by mainstreaming • To protect Intellectual Property Rights
of AYUSH. (IPR) in AYUSH systems.
• To ensure healthy population through • To encourage research in preventive and

AYUSH interventions. promotive health through AYUSH.
• To ensure creation of enabling uniform EFFECTIVE HUMAN RESOURCE

legal framework for the practice of DEVELOPMENT
AYUSH practices and therapies.
• To ensure availability of quality education
• Utilization of trained AYUSH doctors at and training to AYUSH Doctors/
all levels of Health Care services. Scientists/Teachers.
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386
• To ensure availability of quality paramedical, • Protection of Traditional Knowledge.

pharmacy and nursing education and
training in AYUSH. DRUG ADMINISTRATION
• To empower AYUSH professionals with • To accelerate the Pharmacopoeial/

improved skills and attitudes. standardization work on AYUSH drugs.
• To promote capacity building of • To ensure availability of high quality

Institutions, Centres of Excellence AYUSH drugs.
(COEs), National Institutes, etc.
• To ensure enabling legal framework for
INFORMATION, EDUCATION AND production and distribution of safe and
COMMUNICATION quality AYUSH drugs.
• To propagate and promote AYUSH within • To strengthen regulatory infrastructure in

the country. Central and State Governments.
• To strive for global acceptance of AYUSH • To encourage AYUSH drug industry to

formulations. produce high quality AYUSH medicines
for national and international needs.
• To disseminate AYUSH practices and
therapies for better health. 1.3 National Health Policy, 1983** observed that the
country has a large stock of health manpower
• To encourage behavioural change through comprising of private practitioners in various
communication for better health. systems. This resource has not so far been
adequately utilized. The practitioners of AYUSH
INTERNATIONAL EXCHANGE systems enjoy high local acceptance and respect
PROGRAMMES/SEMINARS/WORKSHOPS and consequently exert considerable influence
ON AYUSH on health beliefs and practices. It is, therefore,
necessary to initiate organised measures to
• To propagate and promote AYUSH enable each of these systems of medicine and
systems outside the country and to ensure health care to develop in accordance with their
their global acceptance as systems of strengths. Simultaneously, planned efforts
medicine. should be made to dovetail the functioning of
the practitioners and integrate their service, at
• To collaborate with international bodies, the appropriate levels, within specified areas
e.g. World Health Organisation for of responsibility and functioning, in the over-
cross disciplinary standardization, global all health care delivery system, especially with
recognition and propagation of AYUSH regard to the preventive, promotive and public
systems. health objectives. Well-considered steps would
also be required to be taken to move towards a
• Global legal recognition of qualifications meaningful phased integration of the indigenous
and practice of AYUSH. and the modern systems. The significance of
the Alternative Systems of Medicine was further
• To promote collaborative research and emphasized in the National Health Policy,
education in AYUSH with other countries.
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387
2002***, which stated that Ayurveda, Siddha, (vi) Re-orient and prioritize research in ISM&H
Unani and Homoeopathy have a substantial to gradually validate drugs and therapies to
role because of the inherent advantages, such as address in particular the chronic and new
diversity, modest cost, low level of technological emerging life style related diseases;
input and the growing popularity of natural plant
based products, especially in the under-served, (vii) Create awareness about the strengths of
remote and tribal areas. The Policy also envisaged these systems in India and abroad and
the consolidation of documentary knowledge sensitize other stakeholders and providers
contained in these systems to protect it against of health; and
attack from foreign commercial entities by way
of malafide action under the Patent laws in other (viii) To provide full opportunity for the growth
countries. and development of these systems and
utilization of the potentiality, strength and
1.4 The National Policy on Indian Systems of revival of their glory.
Medicine & Homoeopathy, 2002 enunciated
following as its objectives: 1.5 The Policy outlines the following strategies to
achieve the objectives:
(i) To promote good health and expand the
outreach of health care to our people, (a) Legislative measures to check mushroom
particularly those not provided with health growth of substandard colleges;
cover, through preventive, promotive,
mitigating and curative intervention (b) Course curricula to be reinforced to raise
through ISM&H; the standards of medical training and to
equip trainees for utilization in national
(ii) To improve the quality of teachers health programmes;
and clinicians by revising curricula to
(c) Priority to research covering clinical trials,
contemporary relevance and researches by
pharmacology, toxicology, standardization
creating model institutions and Centres of
and study of pharmaco-kinetics in respect
Excellence and extending assistance for
of identified areas of strength;
creating infrastructural facilities;
(d) The National Medicinal Plants Board
(iii) To ensure affordable ISM&H services and to address all issues connected with
drugs, which are safe and efficacious; conservation and sustainable use of
medicinal plants leading to remunerative
(iv) To facilitate availability of raw drugs, farming, regulation of medicinal farms and
which are authentic and contain conservation of bio-diversity;
essential components as required under
pharmacopoeial standards to help improve (e) National Medicinal Plants Board to
quality of drugs, for domestic consumption acquire statutory status to be able to
and export; regulate registration of farmers and
cooperative societies, transportation,
(v) Integrate ISM&H in health care delivery marketing of medicinal plants and proper
system and National Programmes and procurement and supply of raw materials
ensure optimal use of the vast infrastructure to pharmaceutical industry;
of hospitals, dispensaries and physicians;
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388
(f) Protection of India’s traditional medicinal (o) States to be advised and supported to
knowledge to be undertaken through a augment facilities for drug manufacture
progressive creation of a Digital Library and testing;
for each system and eventually the codified
knowledge leading to innovation and good (p) Operational use of ISM in Reproductive
health outcomes; & Child Health (RCH) to be encouraged
in eleven identified areas, where the Indian
(g) Effort to integrate and mainstream Systems of Medicine would be useful
ISM&H in health care delivery system and for antenatal, intra-natal, post-natal and
in National Programmes; neonatal care;
(h) A range of options for utilization of (q) North Eastern States, rich in flora
ISM&H manpower in the health care and fauna, to be supported to develop
delivery system to be developed by infrastructure and awareness of ISM;
assigning specific goal oriented role and
responsibility to the ISM&H work force; (r) Keeping in view the global interest in
understanding ISM concepts and practices,
(i) Allopathic hospitals to be encouraged to modules to be formulated for introducing
set up AYUSH health facilities; Ayurveda and Yoga to medical schools and
institutions abroad and to expose medical
(j) Government to assist allopathic hospitals graduates;
to establish Panchkarma and Ksharsutra
facilities for the treatment of neurological (s) Awareness programmes on the utility and
disorders, musculo-skeletal problems as effectiveness of ISM&H to be launched
well as ambulatory treatment of fistula-in- through electronic and print media.
ano, bronchial asthma and dermatological
problems; 1.6 The Department envisages to achieve its vision,
mission and policy goals/objectives through a
(k) States to be encouraged to consolidate the series of Centrally Sponsored and Central Sector
ISM&H infrastructure and health services; Schemes as listed below:
(l) Pharmacopoeial work related to Ayurveda, 1.6.1 CENTRAL SECTOR SCHEMES

Unani, Siddha and Homoeopathy Drugs to
be expedited; (i) Central Sector Scheme for supporting
Re-orientation Training Programme and
(m) Industry to be encouraged to make use Continuing Medical Education (ROTP/
of quality certification and acquisition of CME) for AYUSH personnel.
GMP and ISO 9000 certification;
(ii) Scheme for Acquisition, Cataloguing,
(n) Quality Control Centers would be set up Digitization and Publication of Text Books
on regional basis to standardize the in- and Manuscripts.
process quality control of ISM products
and to modernize traditional processes (iii) Scheme for Upgradation of Institutions
without changing the concepts of ISM; to Centres of Excellence by providing
financial assistance to accredited AYUSH
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389
centres in Non-Governmental/Private 1.6.2 CENTRALLY SPONSORED SCHEMES

sector engaged in AYUSH education,
drug development and research, Clinical (i) Promotion of AYUSH:
Research /Folk medicine etc.
1.1 Development of AYUSH
(iv) Scheme for promoting AYUSH Institutions.
interventions in Public Health Initiatives. 1.2 Development of AYUSH Hospitals,
Dispensaries and Mainstreaming of
(v) Scheme for Revitalization of Local Health AYUSH.
Traditions, Midwifery Practices etc.
1.3 Drugs Quality Control.
(vi) Scheme for Extra Mural Research projects.
(ii) Setting up of specialized AYUSH facilities
(vii) Scheme for Information Education and in Government tertiary care AYUSH
Communication (IEC). Hospitals in Public Private Partnership
mode.
(viii) Scheme for supporting International
Exchange Programme, Seminars, (iii) National Mission on Medicinal Plants.
Workshops on AYUSH.
(ix) Development of common facilities for

AYUSH industry clusters. Footnotes:
1.* Allocation of Business Rules, 1961
(x) Support for development of Traditional
Knowledge Digital Library and protection 2. ^ Strategic Plan of Department of AYUSH
of AYUSH Intellectual Property Rights. 3. **National Health Policy, 1983
4. *** National Health Policy, 2002
(xi) Surveys on usage and acceptability of
AYUSH systems.
**********
(xii) National Medicinal Plants Board.
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Chapter-2
AYUSH Systems
2.1 INTRODUCTION life, disease and health. Ayurvedic knowledge
was comprehensively documented in around
2.1.1 AYUSH systems of medicines are a group of 5000 years back in the form of Agnivesha Tantra,
Indian systems of medicine and Homeopathy. Vashishtha Samhita, etc. However, these ancient
AYUSH is an acronym for Ayurveda, Yoga & treaties are not available. The Charak Samhita and
Naturopathy, Unani, Siddha & Sowa Rigpa, and Sushruta Samhita developed around 2500 BC are
Homoeopathy. Ayurveda is the oldest system the main treaties of Ayurveda fully available today.
practiced since more than 5000 years; whereas, According to Ayurveda, health is considered as a
Homeopathy is being practiced since last around pre-requisite for achieving the goals of life, i.e.
100 years. These systems are being practised in Dharma, Artha, Kama and Moksha. Ayurveda
the country with diverse preferences of people takes an integrated view of the physical, mental,
and infrastructural facilities. Ayurveda is more spiritual and social aspects of human beings
prevalent in the States of Kerala, Maharashtra, and about the inter relationships between these
Himachal Pradesh, Gujarat, Karnataka, Madhya aspects.
Pradesh, Rajasthan, Uttar Pradesh, Delhi,
Haryana, Punjab, Uttarakhand, Goa and Orissa. 2.2.2 The philosophy of Ayurveda is based on the theory
The practice of Unani System could be seen of Panchmahabhutas (five primordialelements),
in some parts of Andhra Pradesh, Karnataka, which postulates that all objects and living
Jammu & Kashmir, Bihar, Maharashtra, Madhya bodies are composed of these five elements.
Pradesh, Uttar Pradesh, Delhi and Rajasthan. The combinations of these five elements are
Homoeopathy is widely practiced in Uttar Pradesh, represented in the form of Tridoshas, viz. Vata
Kerala, West Bengal, Orissa, Andhra Pradesh, (Ether/Air), Pitta (Fire) and Kapha(Water/
Maharashtra, Punjab, Tamil Nadu, Bihar, Gujarat Earth). These three `Doshas’ are physiological
and the North Eastern States and the Siddha entities in living beings; whereas, Satva, Rajas and
system is practiced in the areas in Tamil Nadu, Tamas are the mental attributes. Ayurveda aims
Pondicherry and Kerala. Recently recognized to keep these structural and functional entities in
Sowa Rigpa system of medicine is prevalent a state of equilibrium, which signifies good health
in trans Himalayan regions including Jammu (Swasthya). Any imbalance due to internal or
& Kashmir, Himachal Pradesh, Uttarkhand, external factors causes disease and the treatment
Arunachal Pradesh and Sikkim. Besides, there are consists of restoring the equilibrium through
few educational institutes of Sowa Rigpa in UP various techniques, procedures, regimens, diet
and Karnataka. AYUSH services, as a whole, in and medicines.
the country, are provided by public, private and
voluntary sector organizations and the range of 2.2.3 Ayurveda considers the human being as a
their distribution varies from State to State. microcosm (Yatha pinde tatha brahmande),
which is a replica of the macrocosm (universe).
2.2 AYURVEDA SYSTEM The treatment in Ayurveda is holistic and
individualized. The preventive aspect of Ayurveda
2.2.1 The literal meaning of “Ayurveda” (Ayu (life)+ is called Svastha-Vritta and includes personal
Veda (Science)) is “Science of Life”. Ayurveda hygiene, regular daily routine, appropriate
developed out of the various Vedic hymns social behavior and use of Rasayana, i.e, use of
describing the fundamental philosophies about rejuvenative materials/food and rasayana drugs.
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391
The curative aspect consists of three major (v) Dravya GunaVigyan (Materia Medica and
categories - (i) Aushadhi (drugs); (ii) Various Pharmacology);
procedures including Panchakarma and Surgery;
and (iii) Satvavajaya (Methods for mind control). (vi) Rasa-Shashtra and Bhaishajya Kalpana
(Pharmaceuticals using minerals and
2.2.4 Practice of Ayurveda as a system of medicine metals);
has been recognized under IMCC Act, 1970. The
education of Ayurveda is regulated by a statutory (vii) Kaumar Bhritya – Bala Roga (Paediatrics);
body, viz. Central Council of Indian Medicine
(CCIM), Drugs & Cosmetics Act, 1940 regulates (viii) Prasuti-Tantra avum Stri Roga (Obstetrics
manufacturing and sales of Ayurvedic drugs. And Gynaecology);
During the Samhita period (1000 BC), Ayurveda
(ix) Swasth-Vritta (Social and Preventive
developed eight branches or specialties, which
Medicine);
were reason for it being called as Ashtanga
Ayurveda. Following are these specialties: -
(x) Kayachikitsa (Internal Medicine);
(i) Kayachikitsa (Internal Medicine) (xi) Rog Nidana evum Vikriti Vigyan
(Diagnostics and Pathology);
(ii) Kaumar Bhritya (Paediatrics)
(xii) ShalyaTantra (Samanya) (General Surgery);
(iii) Graha Chikitsa (Psychiatry)
(xiii) Shalya Tantra – Ksar Karma avum
(iv) Shalakya (Eye, ENT and Dentistry) Anushastra Karma (Kshara Karma and
Para - surgical procedure);
(v) Shalya Tantra (Surgery)
(xiv) Shalya Tantra (Asthi, Sandhi);
(vi) Agada-Tantra (Toxicology)
(xv) Shalakya Tantra – Netra Roga;
(vii) Rasayana (Immuno-modulation and
Gerentology) (xvi) Shalakya Tantra – Shiro-Nasa- Karna
Avum Kantha Roga (ENT);
(viii) Vajikarna (Science of fertility and healthy
progeny) (xvii) Shalakya Tantra – Danta Avum Mukha
Roga (Dentistry);
2.2.5 The above eight branches have over the years
and specifically during the last 50 years expanded (xviii) Manovigyana avum Manas Roga
into 22 specialties, which are as follows: (Psychiatry);
(i) Ayurveda Siddhanta (Fundamental (xix) Panchakarma;

Principles of Ayurveda);
(xx) Agad Tantra avum Vidhi Vaidyaka
(ii) Ayurveda Samhita; (Toxicology and Jurisprudence);
(iii) Rachna Sharira (Anatomy); (xxi) Sangyaharana (Anaesthesiology);
(iv) Kriya Sharira (Physiology); (xxii) Chhaya avumVikiranVigyan (Radiology).

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2.2.6 Bachelor, Master and Doctorate degrees in (i) Maruthuvam (General Medicine);
Ayurveda are imparted through the various
universities of India. (ii) Sirappu Maruthuvam (Special Medicine);
2.2.7 Two volumes of Ayurvedic Formulary of India (iii) Kuzhanthai Maruthuvam (Paediatrics);
(AFI) containing 636 compound formulations
and eight volumes of Ayurvedic Pharmacopoeia (iv) Gunapadam (Pharmacology);
of India (API) Part-1 containing 600 monographs
on single drugs and three volumes of Ayurvedic (v) Noi Nadal (Pathology);
Pharmacopoeia of India (API) Part-II containing
152 monographs on compound formulations (vi) Nanju Nool and Maruthuva Neethinool
have been published. (Toxicology).
2.3 SIDDHA SYSTEM 2.3.5 Siddha Pharmacopoeia of India, Vol-I is covering

73 monographs on single drugs and Vol-II
2.3.1 The Siddha System is one of the oldest systems is covering 66 monographs on single drugs.
of medicine in India and is practised mainly in Siddha Pharmacopoeia of India, Part-I, Vol-
Tamil Nadu and some other parts of South III compilation completed. Siddha Formulary
India. The term “Siddha” means ‘achievements’ of India, Part-I 22 divisions, 248 classical
and Siddhars were saintly persons who achieved formulations have been published in English
‘results’ in medicine. Eighteen Siddhars were said and Tamil. Siddha Formulary of India, Part-II
to have contributed towards the development of (Tamil) -23 divisions, 151 classical formulations
this medical system. Siddha literature is in Tamil has been published.
and it is largely therapeutic in nature.
2.4 UNANI SYSTEM
2.3.2 The diagnosis of diseases in Siddha involves
identifying its causes through the examination of 2.4.1 The Unani System of Medicine originated
pulse, urine, eyes, study of voice, colour of body, in Greece and passed through many countries
tongue and the status of the digestive system. before establishing itself in India during the
medieval period. It is based on well-established
2.3.3 The Siddha system of medicine emphasizes knowledge and practices relating to the
that medical treatment is oriented not merely promotion of positive health and prevention
towards the disease but has to take into account of disease. The Unani System has grown out of
the patients and their environment, age, sex, the fusion of traditional knowledge of ancient
race, habits, mental frame, habitat, diet, appetite, civilizations like Egypt, Arabia, Iran, China, Syria
physical condition, physiological constitution, etc. and India. It emphasizes the use of naturally
This means the treatment has to be individualistic. occurring, mostly herbal, medicines and also uses
Diagnosis and treatment in Siddha ensures lower some medicines of animal, marine and mineral
probability of mistakes in diagnosis or treatment. origin. This system of medicine was documented
in Al-Qanoon, a medical classics, by Sheikh Bu-
2.3.4 During the last four decades, there has been
Ali Sina (Avicena) (980-1037 AD), in Al-Havi
continuous development in Siddha medical
by Razi (850-923 AD) and in many other books
education and this has led to the establishment
written by the Unani physicians.
of the following six specialties in post-graduate
teaching and training:
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2.4.2 The Unani system is based on the humoral 2.4.7 Six volumes of National Formulary of Unani
theory, i.e. the presence of blood, phlegm, Medicine (NFUM) containing 1228 compound
yellow bile and black bile in every person. The formulations and six volumes of Unani
temperament of a person can accordingly be Pharmacopeia of India (UPI) containing 298
sanguine, phlegmatic, choleric and melancholic monographs on single drugs have been published.
depending on the presence and combination Two volumes of Pharmacopeia on compound
of humors. According to Unani theory, the formulations containing 100 compound drugs
humors and the drugs themselves are assigned have been published.
temperaments. Any change in quantity and
quality of the humors brings about a change in 2.5 HOMOEOPATHY
the status of the health of the human body. A
proper balance of humors is required for the 2.5.1 The Physicians from the time of Hippocrates
maintenance of health. (around 400 B.C.) have observed that certain
substances could produce symptoms of a disease
2.4.3 The treatment consists of three components, in healthy people similar to those of people
namely, preventive, promotive and curative. suffering from the disease. Dr. Christian Friedrich
Unani system of medicine has been found to Samuel Hahnemann, a German physician,
be efficacious in many conditions, particularly scientifically examined this phenomenon
Rheumatoid Arthritis, Jaundice, Filariasis, and codified the fundamental principles of
Eczema, Sinusitis and Bronchial Asthma. Homoeopathy. Homoeopathy was brought into
India around 1810 A.D. by European missionaries
2.4.4 For the prevention of disease and promotion and received official recognition by a Resolution
of health, the Unani System emphasizes on passed by the Constituent Assembly in 1948 and
six essential pre-requisites of life (Asbab-e- then by the Parliament.
SittaZarooria) - (a) pure air (b) food and water
(c) physical movement and rest (d) psychic 2.5.2 The first principle of Homoeopathy ‘Similia
movement and rest (e) sleep and wakefulness and Similibus Curentur’, says that a medicine which
(f) retention of useful materials and evacuation could induce a set of symptoms in healthy
of waste materials from the body. human beings would be capable of curing
a similar set of symptoms in human beings
2.4.5 There are four forms of treatment in Unani actually suffering from the disease. The second
Medicine - Pharmacotherapy, Dietotherapy, principle of ‘Single Medicine’ says that one
Regimental Therapy and Surgery. Regimental medicine should be administered at a time to a
therapy (Ilaj bit-Tadbir) is a speciality under particular patient during the treatment. The third
which various methods of treatment are used for principle of ‘Minimum Dose’ states that the bare
treating specific and complicated diseases. minimum dose of a drug which would induce a
curative action without any adverse effect should
2.4.6 During the last 50 years, seven Post Graduate be administered. Homoeopathy is based on the
specialities have been developed in (i) Kulliyat assumption that the causation of a disease mainly
(Fundamentals of Unani System of Medicine) depends upon the susceptibility or proneness of
(ii) Ilmul Adviya (Pharmacology) (iii) Amraz- an individual to the incidence of the particular
e-Niswan (Gynaecology) (iv) Amraz-e-Atfal disease in addition to the action of external
(Paediatrics) (v) Tahafuzzi-wa-SamajiTib (Social agents like bacteria, viruses, etc.
and Preventive Medicine) (vi) Moalejat (Medicine)
and (vii) Jarahiyat (Surgery).
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2.5.3 Homoeopathy is a method of treating diseases absolute knowledge. These two are the most
by administering drugs, which have been important meanings of the word Yoga according
experimentally proved to possess the power to ‘Panini’, the most well-known Sanskrit
to produce similar symptoms on healthy grammarian.
human beings. Treatment in Homoeopathy,
which is holistic in nature, focuses on an 2.6.2 Yoga is being practiced as part of healthy
individual’s response to a specific environment. lifestyle and has become part of our spiritual
Homoeopathic medicines are prepared mainly heritage. In the present era, Yoga is popular world-
from natural substances, such as plant products, wide because of its spiritual values, therapeutic
minerals and from animal sources. Homoeopathic credentials, its role in the prevention of diseases,
medicines do not have any toxic, poisonous promotion of health and management of lifestyle
or side effects. Homoeopathic treatment is related disorders. Several clinical studies have
economical as well and has a very broad public lucidly demonstrated the therapeutic potentials
acceptance. of Yoga in the treatment of many lifestyle related
or psychosomatic disorders. The specialty of this
2.5.4 Homoeopathy has its own areas of strength system is that it can get along with any other
in therapeutics and it is particularly useful in systems of health care.
treatment for allergies, autoimmune disorders
and viral infections. Many surgical, gynaecological 2.6.3 The aim of Yoga is complete cessation of all
and obstetrical and paediatric conditions and kinds of suffering (sorrow) and its root cause
ailments affecting the eyes, nose, ear, teeth, skin, ignorance and is known as Moksha or liberation.
sexual organs, etc., are amenable to homoeopathic The main objectives of Yoga are health,
treatment. Behavioral disorders, neurological happiness, harmony, spiritual quest, personality
problems and metabolic diseases can also be development, etc.
successfully treated by Homoeopathy. Apart from
the curative aspects, Homoeopathic medicines 2.6.4 Yoga is as old as civilization. The first
are also used in preventive and promotive health archaeological evidence of existence of Yoga
care. In recent times, there is an emergence of is found in Stone Seals excavated from Indus
interest in the use of Homoeopathic medicines Valley. Yoga was special feature of Indus Valley
in veterinary care, agriculture, dentistry, etc. Civilization (3000 BC). Yogic literature has been
Homoeopathic medical education has developed found in Vedas, Upanishadas, Darshanas, Epics,
in seven specialties in post-graduate teaching, Puranas, Aagmas, Tantras, etc. Rich sources
which are Materia Medica, Organon of Medicine, of Yoga have also been available in medieval,
Repertory, Practice of Medicine, Paediatrics, modern and contemporary literature.
Pharmacy and Psychiatry.
2.6.5 The Yoga referred in the Vedic and Upanishadic
2.6 YOGA literature has been depicted in three important
texts called Prasthanatrayi:
2.6.1 Yoga is essentially spiritual and it is an art
and science of healthy living, which focuses on (i) Principle Upanishads (Upadesha
bringing harmony between body and mind. The Prasthana);
word ‘Yoga’ has two meanings; the first comes
(ii) Vedanta Sutra of Badarayana (Nyaya
from the root ‘Yujir’ or ‘Union’, the second is
Prasthana);
derived from a different root ‘yuja’, which means
‘Samadhi’ – the highest state of mind and the (iii) Bhagavadgeeta (Sadhana Prasthana).
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These texts further lead to different schools of Yoga, (i) Doctrine of “Panchakoshas” (five sheaths/
like Jnana Yoga, Karma Yoga, Bhakti Yoga, Dhyana bodies) as found in Upanishads.
Yoga, etc.
(ii) Doctrine of “Chitta-vrittinirodha”,
2.6.6 The most important texts referred in Yoga are “kriyayoga”and “astangas” as found in
as follows: Patanjala Yoga Sutras;
(i) Patanjala Yoga Sutra (ii) Bhagavad Gita (iii) Doctrine of various kinds of “shuddhis”
found in Patanjala Yoga Suntra and
(iii) Vasistha Samhita (iv) Hatha Pradipika Hathayoga;
(v) Gheranda Samhitaq vi) Hatha-tattva
(iv) Doctrine of opening blocked channels of
Kaumudi
vayus and prana (nadishuddhi), opening
(vii) Siddha Sidhanta of lotuses and chakras, kumbhaka
Paddhati (viii) Goraksha Satkam pranayamas, mudras and dristies as found
in Hatha Yoga and Kundalini Yoga;
(ix) ShivaSamhita (x) Hatharatnavali
(v) Working with the mind on the lines of
(xi) Amanaska Yoga (xii) Yoga Bija
Patanjala Yoga Sutra, Mantra Yoga and
(xiii) Yoga Taravali (xiv) Goraksa Paddhati Hatha Yoga;
(xv) Siva Svarodaya, etc. (vi) Working on the lines of “Karma-Jnana

Bhakti” from Bhagawadgita;
2.6.7 However, the classical Yoga, which is one
of the Shad Darshanas, has been advocated (vii) Certain aspects of Tantra Yoga also get
by the great sage Patanjali, who lived around integrated in various Yoga practices.
approximately 200 BC. Patanjali wrote a book
known as Yoga Sutras, which contains 195 sutras. 2.6.9 The following Yogic practices are being
Patanjali advocates Ashtanga Yoga, which is practiced for prevention and management of
widely practiced from the ancient times till today. diseases:
They are:
(i) Shatkarma: These are six cleansing
Yama (Self-restraints); techniques in Yoga used to clean the
internal organs and systems of the
Niyama (Observance);
body. These are called as the process
Asana (Psycho-physical postures); of detoxification. Shatkarmas are Neti,
Dhouti, Basti, Kapalabhati, Nauli, Trataka;
Pranayama (Control of vital energy – breath;
Pratyahara (Withdrawal of senses); (ii) Yogasana: These are special patterns of
body that stabilise the mind through static
Dharana (Concentration); stretching. Yogasanas are psycho-physical
Dhyana (Meditation); in nature. They play a significant role in
toning up the neuro-musculo and glandular
Samadhi (Absorption or State of liberation). systems of the body. There are more than
84 asanas mentioned in the classical texts;
2.6.8 The following are the doctrines and concepts
adopted in Yoga Therapy:
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(iii) Pranayama: Pranayama is a practice which 2.7.3 The science of Naturopathy teaches us that
helps to regulate vital energies through the disease is Nature’s effort to eliminate the
regulation of breathing; morbid matter from the body to restore the
health. Hence, we must not suppress the outward
(iv) Mudra: These are special gestures/ symptoms of disease like fever, cough, loose
techniques formed with the combination motions, etc., but cooperate with Nature in the
of Asana and Pranayama and are used in process of eliminating morbid matter from the
channelization of Prana, the vital force; body.
(v) Dhyana: Sustain concentration on the 2.7.4 Some of the basic concepts of Naturopathy are
object is Dhyana. Dhyana is an integral outlined as under:
part of Yoga practice and is beneficial for
psychological and spiritual growth and also (i) Naturopathy believes in the concept
helps in health promotion. of unity of disease and unity of cure.
According to it, root cause of all diseases
2.6.10 Several leading Yoga Institutions have been is one, i.e. accumulation of morbid matter
engaged in the promotion and propagation of in the body and the remedy also is one, i.e.
Yoga according to their Guru-Shishya Parampara. elimination of those toxins from the body;
Many Institutions, Universities are conducting
Certificate, Diploma, Bachelors, Masters and (ii) Naturopathy considers bacteria and virus
Doctorate degrees courses in various aspects of to be secondary cause of disease. The
Yoga. primary cause of disease is accumulation
of morbid matter in the body. The
2.7 NATUROPATHY microbes survive in the body only when a
favourable atmosphere for their growth is
2.7.1 Naturopathy is a science of health and healing
established by the accumulation of morbid
and a drugless therapy based on well-founded
matter. Hence, the basic cause of disease is
philosophy. It has its own concept of health
morbid matter and microbes are only the
and disease and also principles of treatment.
secondary cause;
Naturopathy is a system of medicine that
advocates harmonious living with constructive (iii) Acute diseases are self-healing efforts of
principles of Nature on physical, mental, moral the body. Hence, they are taken as our
and spiritual planes. It has great health promotive friends, not enemies. Chronic diseases
and restorative, and disease preventive as well as are outcome of wrong treatment and
curative potential. suppression of the acute diseases;
2.7.2 According to Naturopathy, the primary cause (iv) Human body has remarkable recuperative
of disease, barring accidental or surgical injury, powers when left alone. Nature is the
is violation of Nature’s laws and the effects of greatest healer. The human body is a
violation of Nature’s laws are- self healing machine. It is endowed with
inherent healing power to prevent itself
(i) Lowered vitality;
from disease and regain health when fallen
ill;
(ii) Abnormal composition of blood and lymph;
(iii) Accumulation of morbid matter in the body. (v) In Naturopathy, the patient is at the centre
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of intervention and treatment, cure of 2.8 SOWA-RIGPA

disease is effected automatically with the
increase in vitality and detoxification of 2.8.1 Sowa-Rigpa is among the oldest surviving
body; health traditions of the world with a living history
of more than 2500 years. It has been in vogue
(vi) Naturopathy believes in holistic treatment. and practised in Himalayan regions through out
It not only treats the body as a whole, particularly in Leh and Laddakh (J&K), Himachal
instead of specific organs but also take into Pradesh, Arunachal Pradesh, Sikkim, Darjeeling,
account intervention at mental, moral and etc. Sowa-Rigpa is effective in managing chronic
spiritual planes; diseases like Asthma, Bronchitis, Arthritis, etc.
The basic theory of Sowa-Rigpa is explained in
(vii) Naturopathy does not use medicines. terms of (i) The body and the mind as the locus
According to it, “Food is Medicine”; of treatment; (ii) Antidote, i.e. the treatment;
(iii) The method of treatment through antidote;
(viii) Naturopathy accepts prayers also as a (iv) Medicines that cure the disease; and lastly
modality of treatment. According to (v) Pharmacology. Sowa- Rigpa emphasizes the
Gandhiji, “Rama Nama is the best Natural importance of the five cosmological physical
Treatment” meaning there by that prayer elements in the formation of the human body, the
according to one’s own faith is an important nature of disorders and the remedial measures.
part of treatment.
2.7.5 Some of the important therapies/therapeutic **********

modalities of Naturopathy, which are employed
not only for curative purposes but also for
prevention of diseases and promotion of health
are as under:
(i) Upvas Chikitsa (Fasting Therapy);
(ii) Aahar Chikitsa (Diet Therapy);
(iii) Mitti Chikitsa (Mud Therapy);
(iv) Jala Chikitsa (Hydrotherapy);
(v) Malish Chikitsa (Massage Therapy);
(vi) Surya Kiran Chikitsa (Heliotherapy);
(vii) Vayu Chikitsa (Air Therapy);
(viii) Yoga Chikitsa (Yoga Therapy).
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ANNEXURE P-10
Communication Guidelines for Building Vaccine

Confidence around AEFI
Government of India
Ministry of Health and Family Welfare New Delhi, 2013
399
Communication Guidelines for Building Vaccine

Confidence around AEFI
Government of India
New Delhi, 2013
400
401
402
403
404
PREFACE
What is the purpose of these guidelines?

The purpose of the guidelines on handling communication around Adverse Events Following
Immunization (AEFI) is to provide a communication resource for government officials handling the
Routine Immunization (RI) program.
Who will use these guidelines?
This document is a ready reckoner for State Immunization Officers (SEPIO) and District Immunization
Officers (DIO) on how communication should be leveraged to achieve the desired response to AEFI.
This document is intended to provide a brief orientation on how media, public and health workers etc.
think or react to AEFIs and how these adverse situations can be handled through communication.
Why were these guidelines developed?
The guidelines outline fundamentals of effective communication. These guidelines were developed
to constructively engage with stakeholders such as health workers, community, and media in case of
an AEFI.
What does this guide contain?
The guidelines talk about both proactive and reactive communication strategies during an AEFI. The
document also advocates the need for a strategic capacity building plan during normal situations in
this direction. This document carries take-home messages not only for those involved in program
implementation but for all who are closely or remotely linked to RI in any capacity.
We hope you find this document useful.
I
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406
ACKNOWLEDGEMENT
This document has been prepared by the Strategic Communications team at Immunization Technical
Support Unit (ITSU), Ministry of Health and Family Welfare (MOHFW), Government of India. The
contributions of the following in the development and completion of this work are highly
appreciated and gratefully acknowledged:
Bill and Melinda Gates Foundation (BMGF) and MOHFW for the financial support to develop and
publish the document.
Ms. Anuradha Gupta (AS & MD-NRHM), Dr. Rakesh Kumar (Joint Secretary, RCH), Dr. Ajay Khera (Deputy
Commissioner, Child Health & Immunization), Dr. Pradeep Haldar (Deputy Commissioner, UIP) and
Dr. M.K. Agarwal (Deputy Commissioner, UIP) for strategic guidance in developing the guidelines.
Prof. Ramanan Laxminarayan (Vice President, Public Health Foundation of India - ITSU/PHFI), Dr. Vijay
Kumar Moses (Director, ITSU), Dr. N.K. Arora (Chairman, National AEFI Committee), Ms. Nidhi Dubey
(Vice President, Global Health Strategies), Ms. Shelly Thakral (Senior Communication Officer, Bill and
Melinda Gates Foundation), Dr Patrick Zuber (Group Leader, Vaccine Safety Team, WHO, Geneva) for
reviewing the document to ensure technical soundness and consistency.
Dr. Jyoti Joshi Jain and Dr. Amrita Sekhar (AEFI Team - ITSU) for reviewing the document for factual
accuracy, uniformity and providing inputs from time to time.
Additionally Dr. Rajeev Gera (Senior Advisor - ITSU/PHFI), Dr. Balwinder Singh (Senior Associate
Advisor - ITSU/PHFI), Dr. Prem Singh and Mr. Amit Sharma (Monitoring & Evaluation Team, ITSU) for
the valuable inputs shared in the process.
Ms. Monica Chaturvedi (Senior Advisor, Strategic Communication - ITSU/PHFI) for editorial content
development, constant guidance and supervision in the creation of this document, Ms. Chaitali
Mukherjee (Manager, Strategic Communication) for proof reading the document, Ms. Nidhi Bisht and
Ms. Alka Chadha (Strategic Communication Team – ITSU/PHFI) for collation and content
development, designing and formatting the document.
We would like to thank and appreciate the work of MOHFW and organizations like WHO, UNICEF
whose works have been used as reference material in preparing this guide on handling risk
communication around AEFI.
II
INDEX 407
PREFACE i
ACKNOWLEDGMENT ii
ABBREVIATIONS 1
Chapter 1: BASIC CONCEPTS Of AEFI 3
1.1 Importance of communication 3
1.2 What is an AEFI? 3
1.3 Channels of reporting 3
1.3.1 Monthly routine reporting 3
1.3.2 Serious AEFI 4
Chapter 2: STRATEGIC COMMUNICATION FOR AEFI 5
2.1 Communication plan 5
2.1.1 Strategic communication plan is built on multiple communication strategies 5
2.2 How regular communication during RI prevents crisis? 7
2.2.1 Encourage community for immunization 7
2.2.2 Build vaccine confidence to decrease fear of AEFIs 7
Case Study 1 8
2.2.3 Steps for developing a communication plan 9
Chapter 3: MANAGING AEFI DURING CRISIS 12
3.1 AEFI crisis- a challenge and an opportunity 12
3.1.1 Communication fundamentals for handling an AEFI crisis 12
3.1.2 Role of custodians during an AEFI crisis 13
3.1.3 Prerequisites of handling an AEFI crisis 13
Diagram 1.1 Illustrative representation of communication flow during AEFI 14
Chapter 4: HOW AND WHEN TO RESPOND TO AEFIs – COMMUNICATION WITH KEY 15
STAKEHOLDERS
4.1 What is an AEFI surveillance? 15
4.1.1 Importance of an AEFI surveillance 15
4.1.2 AEFI surveillance involves a network of key players 15
4.2 Interaction with health workers 16
4.2.1 Stop the blame game, support health workers 16
4.2.2 Capacity building of health functionaries 16
4.3 Interaction with families and communities 16
4.3.1 Respond in a prompt manner 16
4.3.2 Disseminate key messages and combat rumours 16
4.3.3 Assess impact of AEFI on community 16
Chapter 5: INTERACTION WITH MEDIA 17
5.1 Understanding media perspective-5 Ws of media 17
5.2 Media is an ally and not a foe 17
Communication Guidelines for Building Vaccine Confidence around AEFI
408
5.3 Media management in routine situation 18

5.3.1 A database of journalists some frequently asked questions by the media 18
5.3.2 Information package 18
5.3.3 Information for different levels of media 18
5.3.4 A spokesperson system 18
5.3.5 Orientation workshops and field visits for media 19
- What is the media looking for?
Case Study 2 19
5.4 Media management when an AEFI has occurred 20
5.4.1 Monitor media 20
5.4.2 The AEFI committee could take the following immediate actions 20
5.5 Getting emergency information to the media 20
5.5.1 Press Statement 21
5.5.2 Press Release 21
(a) Press Statement vs Press Release 21
(b) Press Statement is not the same as Press Release 21
(c) Steps for writing a Press Release 21
(d) Sample Press Statement 24
(e) Sample Press Release 25
5.5.3 Press Conference 27
(a) Steps to be followed when preparing for a press conference 27
(b) Checklist for setting up a press conference 27
5.5.4 Press Interview 28
(a) Simple rules to be followed during a press interview 28
5.5.5 Key Messages 29
(a) Some more examples of messaging specific to the situation 29
5.6 Post AEFI actions 29
5.6.1 Keeping promises to the media 29
5.6.2 Providing answers to questions 29
5.6.3 Keeping media informed about subsequent developments - some sensitive 29
questions that the spokesperson needs to be prepared with answers
(a) Sample of positive media reporting 31
(b) Sample of negative media reporting 32
Chapter 6: THE WAY FORWARD 33
6.1 Key initiatives by the Government 33
6.2 Handling communication around AEFI 33
6.2.1 Communication action points for each level 35
Chapter 7: CONCLUSION 41
REFERENCES 43
409
ABBREVIATIONS
AC Assistant Commissioner
AEFI Adverse Events Following Immunization
ANM Auxiliary Nurse Midwife
AS Additional Secretary
ASHA Accredited Social Health Activist
AWW Anganwadi Worker
BCC Behavior Change Communication
CDL Central Drug Laboratory
CMO Chief Medical Officer
CSF Cerebro-Spinal Fluid
DC Deputy Commissioner
DIO District Immunization Officer
DIR Detailed Information Report
EPI Expanded Program on Immunization
FIR First Information Report
FW Family Welfare
GAVI Global Alliance on Vaccines and Immunization
HMIS Health Management Information System
HIV Human Immunodeficiency Virus
HW Health Worker
IEC Information Education Communication
IPC Interpersonal Communication
KAP Knowledge Attitude and Practice
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410
MO Medical Officer
MGDs Millennium Development Goals
MD Managing Director
NSS National Service Scheme
NCT National Capital Territory
NRHM National Rural Health Mission
NTAGI National Technical Advisory Group on Immunization
OPV Oral Polio Vaccine
PATH Program for Appropriate Technology in Health
PIR Preliminary Investigation Report
RCH Reproductive and Child Health
RI Routine Immunization
RIMS Routine Immunization Monitoring System
SEPIO State Expanded Programme on Immunization (EPI) Officer
UIP Universal Immunization Programme
UNICEF United Nations Children’s Fund
USAID United States Agency for International Development
VPD Vaccine Preventable Disease
WHO World Health Organization
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1
Chapter
Basic Concepts of AEFI
I ndia continues to face a

significant burden of
deaths and illnesses
many of which are
attributable to vaccine
1.1 Importance of communication
India’s current health system does not suffer from any technological
and funding constraints. The country has easy access to new vaccines
and receives ample support from several international donors.
preventable diseases However, the health system needs to be strengthened to improve
(VPD). All EPI programmes delivery of immunization services, while making people utilize and
aim to achieve high demand these services. Bridging this demand-supply gap is not an easy
immunization coverage in task and that is where strategic communication (IEC and BCC) along
order to bring down with the media plays a critical role.
morbidity and mortality
Strategic communication could contribute substantially to achieving
from vaccine preventable
and maintaining high immunization coverage. However, merely
diseases. A significant
making the services available does not ensure that they will be utilized.
number of these deaths
Similarly, incentivizing the utilization has also been found to have little
occur in children and can
impact in the long-term. To achieve a sustained response, it is pertinent
be prevented by providing
to address at the level of what people think, believe and what guides
safe vaccinations in a
their decision-making, on whether or not immunization services should
timely manner. The
be utilized.
government understands
the gravity of the situation
and immunization is 1.2 What is an AEFI?
placed high on agenda at Although vaccines produced and regulated in keeping with WHO
policy level. The standards are very safe, no vaccine is without risk of a potential adverse
Government of India reaction. And rarely, adverse events following immunization (AEFI)
declared 2012–13 as the
occur.1 WHOs revised standard definition for AEFI is, “Any untoward
“Year of Intensification of medical occurrence which follows immunization and which does not
Routine Immunization necessarily have a causal relationship with the usage of vaccine”. The
(RI)”. adverse event may be any unfavourable or unintended sign, abnormal
laboratory finding, symptom or disease.
1.3 Channels of reporting

Any question from the public or any other stakeholder about the safety
of vaccination is a cause for concern. Perhaps these questions must be
swiftly and effectively investigated and appropriate action taken. This
is done through channels of AEFI reporting outlined below:
1.3.1 Monthly routine reporting

The routine reporting of AEFIs is done monthly for all non-serious
1
http://www.unicef.org/rosa/Immunization_report_17May_05(final_editing_text).pdf
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412
AEFIs. Reporting under this category is coordinated nearest government PHC, CHC, District Hospital or
by the districts – from the health worker (ANM) up District Immunization Officer (DIO) / by the quickest
to the national level – through monthly progress means of communication available such as tele-
reports using existing reporting formats of NRHM, phone or messenger. Notification should be
HMIS, RIMS etc. It is necessary for the ANM to followed up by investigation report and conse-
submit a “Nil” report incase no AEFI is reported from quently lead to detailed data analysis and causality
her area during the month. assessment.
1.3.2 Serious AEFI 2

Step 1 :
A serious AEFI is defined as, “any untoward medical AEFI
occurrence that results in death, hospitalization or Notification
prolongation of hospitalization, persistent or signifi-
cant disability/incapacity or is life threatening”. All
serious AEFIs require systematic causality assessment.
However, AEFIs that need systematic causality
assessment are: Step 2:
AEFI
>AEFIs that may be caused by programme error, Investigation
e.g. a cluster of bacterial abscesses, high grade
fever (higher than 102 degree F), persistent
inconsolable screaming (for more than 3 hours),
seizure, hypotonic hypo responsive episode
Step 3: AEFI
(HHE) etc.
Data Analysis
>Serious unexplained AEFI occurring within 30 and Causality
days after vaccination and not listed in product Assessment
label.
>Events causing significant parental and commu-
nity concern.
The key to the problem is effective communication.
Following a serious AEFI, the atmosphere is typically What we need is proper and tailored communica-
characterized by a sense of anguish, fear and a tion on vaccine safety – in terms of risks and
feeling of mistrust amongst the community towards potential benefits, capacity building of immuniza-
the earnest efforts of the government. The situation tion managers to handle difficult communication
is compounded by hostility and negative coverage situations and a proper strategy to constructively
from the media and anti-vaccine lobbyists, who use engage all the key stakeholders such as policy
it as a platform to blame the project and prepared- makers, communities and media in the process.
ness of the program to handle the situation. All
This document on communication around AEFI is a
these hamper program progress and cause the
sincere effort in this direction and will serve as a
program to come to a standstill.
useful guide in better responding to an AEFI
When a serious AEFI occurs, the first person who situation with the level of sensitivity and responsi-
identifies the event sends notification immediately. bility it demands. It is also envisaged to pave the
This ‘first’ person should notify the case to the way to build capacity for handling AEFIs in future.
2
http://www.cdsco.nic.in/AEFI%20Guidelines%20Print%20ready%202010.pdf
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1
2
Chapter
Strategic Communication
for AEFI
A strategic
communication
plan should
address both short-term
crisis situations (for
Effective communication on vaccination, including managing public
reactions, requires much investment of resources and efforts into
strategic communication for immunization. Strategic communication is
an evidence-based, result-oriented process, undertaken in consultation
with the participant groups. It stimulates positive and measurable
example, if an AEFI
behaviour and social change as it is intrinsically linked to other
occurs) and long-term
programme elements and cognisant of the local context and favours a
support that the
multiplicity of communication approaches.
immunization
programme requires, Keeping in context the stimulatory effect of communication on health
both at the national and programs, its importance can be effectively utilized for developing
local level. strategies around RI. To have a sustained impact on behaviours of
individuals and groups, communication efforts need to be strategic,
participatory, based on evidence from research, result-oriented and
well-funded. 3
A communication
plan allows us to
be proactive as
well as reactive when an
AEFI occurs. Every
2.1 Communication plan
A communication plan supporting immunization programmes or
campaigns is the basic tool for minimizing the possible negative
immunization team repercussions of an AEFI (and other causes for public concern around
needs to be prepared vaccine-related issues). Not all issues dealing with public trust are
with a strategic related to AEFIs. Some rumours and disbeliefs are attributed to other
communication plan. factors. For instance, economically, culturally or socially marginalized
groups often have less trust in government-provided commodities and
services. This low level of trust can fuel rumours and opposition to
vaccination (for example, "OPV sterilizes or causes HIV"). Public trust is
also prejudiced by people's individual and collective memories of
negative experiences (for example, forced sterilization campaigns or
not receiving proper health services, attitudes of the health care staff ).
2.1.1 Strategic communication plan is built on multiple

communication strategies
The communication strategy mix varies according to the situation and
context. All communication strategies aim to establish trust and
credibilityamong parents and the communities they serve. A
comprehensive communication strategy encompasses the following
pillars:
3
5
414
>Advocacy: aims to shape public opinion and (c) Inter-personal communication (IPC)
influence decision-makers at various levels to activities with the target groups complement
develop and implement good immunization and provide further explanation to the mass
policies, including allocating sufficient media messages. The BCC strategy
resources. effectively uses the reach and depth of
various communication channels to reach
>Behaviour change communication (BCC), also its audiences.
referred to as programme communication
management, enhances immunization >Social and community mobilization creates
knowledge and positively influences attitudes partnerships that support immunization efforts
and practices of individuals and groups towards and stimulate engagement and commitment for
immunization. This can be aimed at parents, immunization.
health workers and other influential groups.
BCC uses a mix of different channels –
mass media (for example, TV, radio, and
print), reminder media (for example,
REACH
brochures, flip charts, street plays and
D CHANNEL MIX
puppet shows) and inter-personal
E
communication (IPC) channels
P MASS MEDIA
(traditional media, opinion leaders and
T
health workers).
H
MID-MEDIA
(a) Mass media creates general
awareness and builds opinions
within the community by IPC
reaching large sections of the
community.
(b) Mid-media reinforce messages since they Considering the important role front line workers
are more effective in encouraging actual (FLW) play in motivating the community to access
behaviour change by clarifying myths and public health services, the communication strategy
misconceptions associated with various shall strive to enhance the effectiveness of IPC
social customs and norms. dialogues on child health between the service
Policy makers and media

working in the area
Tertiary target of child health and Risk
Advocacy
audience Routine Immunization Communication
Secondary Doctor, nurses, frontline

target audience health workers, Planning and
BCC community influencers
Management
and religious leaders
Primary
target audience Current and future
Social parents, family and Service
Mobilization grandparents, Delivery
community
6
415
provider and the target audience at specific points of communication with individuals or groups, or
contact. community and social mobilization efforts, and
these should all contribute to reducing the number
2.2 How regular communication of vaccine-preventable diseases among children in
India. This concerted approach will encourage the
during RI prevents crisis community for immunization.
Regular communication with the community, local 2.2.2 Build confidence in vaccine to decrease
and national media and routine reporting of AEFIs fear of AEFIs
help to make the system alert and responsive to
address issues at every level and find suitable Unsupported fears, anguish, concerns and anxiety
solutions to an emerging situation before it about vaccine safety are a growing threat to the
snowballs into a crisis. This helps in the following future of global immunization in the techno-savvy
ways to: age of the internet and social media, which allows
mass diffusion of misinformation and opinions
>Improve relations between health providers and irrespective of their accuracy or authenticity. The
communities. emerging crisis of public faith in vaccines is no
>Promote use of participatory learning and longer an occurrence in the developed countries
d e c i s i o n - m a k i n g m e t h o d s t o i m p ro ve only as anti-vaccination groups become more
community involvement. sophisticated and extend their global reach. The
>Sensitize and hone the inter-personal growing number of vaccines in use and the
communication skills of health workers, doctors complexity of vaccination schedules heighten the
and other health care providers to effectively prospective for public concerns and questioning.
disseminate information on RI. One should also have specific plans to tackle
rumour management especially in regions not
>Hold discussions with and provide counseling
cove re d by m e d i a a n d d i f f i c u l t- to - re a c h
services for caretakers.
populations.
>Provide supportive supervision skills at all levels.
To face the embryonic challenges, countries and
2.2.1 Encourage community for Routine global immunization partners must make it a
Immunization: priority to build public trust and confidence in
vaccines through execution of approaches such as
Building trust and credibility in vaccines cannot be
the following:
addressed in a one-time response. It is an on-going
process that is embedded in a communication plan, >Vaccine risk communication methodology with
based on evidence and uses a variety of special focus on risk communication strategy
communication strategies to engage with target >Timely and accurate communication of
audiences. information (expected severe and mild after-
Advance preparedness, training of staff, coordination effects) and implementation of surveillance
between partners and having a communication plan systems for monitoring AEFIs
are the basic ingredients to overcome and avoid a >On going public engagement to perceive,
crisis caused by an AEFI. To have a sustained impact listen and better understand public concerns
on behaviours of individuals and groups, strategic >Communication research to gain insights into
communication plans have to be closely coordinated the factors that affect public trust in vaccines.
with immunization services and based on a well-
developed surveillance system.
Ultimately, the communication plan and its
strategies should have an integrated approach,
whether it is media advocacy, behaviour change
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416
Case Study 1
Adverse events during a Vitamin A campaign,

Assam, India
Background:
The state government in Assam launched a state-wide 'Pulse Vitamin A' Campaign in
November 2001. During the week after the campaign, children developed adverse
reactions and a few children died. Instantly, the media picked up the news. Many
journalists reported the events incorrectly and numbers of affected children were
inflated. Some reported erroneously that the vitamin A given
to children was outdated. Other reports confused the
T
his case study vitamin A campaign with the Pulse Polio campaign, which
illustrates that had an impact on the polio programme as well. It was
negative media reported that health workers were not properly trained. The
reports about a reports caused wide-spread panic in the state. Scores of
campaign can easily parents started rushing children, who had no signs of any
affect another campaign adverse events, to hospitals. Moreover, the local reports were
and how a proactive quickly picked up by the international media. At the end, two
strategy should be in laboratories in India and Australia confirmed that the vitamin
place to counter such A used in the campaign met all recommended standards,
situations. and post-mortems confirmed that vitamin A was not the
cause of death.
Response included:
>The state government ordered an inquiry headed by a senior government official.
>There was a joint WHO and UNICEF investigation team lead by the Deputy Director of
the National Institute of Nutrition.
>Samples were sent to the national testing laboratory as well as to Australia. Several
post-mortems were conducted.
>The national government established a high-level committee to review the situation
and made recommendations for future vitamin A programmes.
Lessons learned:
>The pervasive negative and incorrect media reporting led to a drastic drop in the
vitamin A coverage in the whole state. It required substantial efforts and resources to
redress the situation. To prevent similar situations, a long term communication plan
and proactive strategy should be in place. A media workshop was held in the state
capital to train journalists.
>The case also illustrates that negative media reports about a campaign can easily
affect another campaign. In this case, the 'Pulse Polio campaign' was affected because
of the association with the 'Pulse Vitamin A Campaign'.
Source: UNICEF - Building trust and responding to AEFI in South Asia - Using Strategic Communication
8
417
Hence, if effective communication is exercised at all levels, it can avert the possibilities of a crisis. If at all a
crisis occurs, it can be managed by the following steps :
2.2.3 Steps for developing a communication response:

The following are the steps to build a strong communication response:
1 2 3 4 5 6
Crisis Identification of Developing a crisis Identify key Identify key Identify key channels
Identification target audience communication plan messages stakeholders of communication
Step 1: Crisis identification >Respect gender differences. For example, talking

Before you begin work on your crisis communication to a female audience may differ from
plan, make sure that you have clear information and communicating to a male audience depending on
understanding of the crisis or rumour. the cultural contexts.
>Available information on source of spread >Take religious and cultural contexts into
account. For example, reassurance to people from
>Existing and potential routes of information different religious and cultural settings (Hindus,
spread Muslims, Sikhs, Christians, and Tribals) differs from
>Target audience one another as people have different beliefs,
customs and perceptions.
>Audience reactions on the situation at hand
>Respect decision-making roles in the socio-
>Assessment of reporting (negative and positive
cultural context. For example, talking to mothers-
reports) on the issue
in-law or fathers in some culture may be critical to
Step 2: Identification of target audience4 ensure adequate coverage.
>Gather as much information as possible about Step 3: Developing the crisis communication
your target audience to ensure you design plan
messages they will hear. For example, providing
>The communication plan would need to define
reassurance to concerned parents differs from
the objectives, target audiences, key messages
communicating newly available evidence to
and the channels of communication. It should
experts at a conference.
clearly spell out which channel has larger
>Consider the age range of your audience. For penetration than the other and what kind of
example, informing teenagers about RI or vaccines media mix will help to reach out to the
at school differs from talking to community elders unreached population.
for encouraging participation in mass campaigns.
Preparing a crisis plan involves: 5
>Take into account differing educational levels.
For example, talking to school children differs >Build strategic links with journalists and
f ro m t a l k i n g to q ua l i f i e d nu r s e s a t a n different media (TV, radio, newspaper). Identify
immunization clinic. o p i n i o n a n d l o c a l l e a d e r s, i n f l u e nt i a l
spokespersons to communicate vaccine safety
>Mind language problems. For example, speaking messages to the target audience.
to someone in the same local language differs
from speaking to someone who has difficulties >Study the level of knowledge, attitudes and
understanding your language. practices of community members towards
immunization.
4
http://www.vaccine-safety-training.org/communicating-in-public.html
5
WHO Vaccine basic safety e-learning course at www.who.int/vaccine/documents
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418
>Train staff (health workers and vaccinators) to political leaders and assure them that proper
address vaccine-related issues in case an AEFI medical care will be provided and that the vaccine
occurs or when any questions arise around the is safe to continue vaccination in the area.
safety of vaccines.
Champions for immunization safety
>Ensure everybody involved knows what the
action plan is and what their individual roles are. Identify robust spokespersons from among the
following:
Step 4: Identify key messages
>Acclaimed media personalities (elderly, new
>Key messages give the most important comers, associated with social work etc.)
information that you want the media and the >Sportspersons (upcoming young sports
public to know. One or two sentences can get to personalities, national heroes, yesteryears great
the heart of the matter. players etc.)
>Key messages need to be catchy, contextually >Respectable political figures and social activists
relevant to the audience and should be easy to
retain. >Business tycoons and entrepreneurs (associated
with CSR initiatives)
Some key messages for the media and public These spokespersons can serve as role models or
champions who would speak in the public about
The dangers of vaccine-preventable diseases
>
the issue and testimonials from positive deviants,
are many times greater than the risks of a
which would reflect changing social norms and
serious adverse reaction to the vaccine.
increasing social acceptability of vaccination for
Vaccines are continuously monitored and
> children. These messages are important since
tested around the world and in India before caregivers or parents do not perceive partial or no
they are approved for use. immunization of children as inherently risky.
Vaccines are safe and benefit children's
>
Step 6: Identify key channels of
health all through their lives.
communication
Side effects of most vaccines are minor and
>
self-limited, last only a few days and do not Select an appropriate mix of channels such as
disrupt daily life. television, radio, newspaper, internet, mobile
phones, posters/banners, and folk media,
depending upon their relevance to the target
Step 5: Identify key stakeholders population.
Depending on the crisis and its key concerns, Mass media helps to promote the “hook” behaviour
identify key stakeholders to address concerns and and mid-media and IPC (in health facilities and at
prevent panic. For any AEFI, the local health care the community level) help promote other
(immunization) providers, district and state EPI behaviours vigorously. Mid-media activities led by
managers and paediatricians will be critical links, civil society and community groups help to create a
who have to address issues of concern such as norm as these activities are inspired by situations
death and cluster of reported AEFI cases. from day-to-day life and reflect barriers that impede
For instance, if there is panic as a result of an their progress. As a result, it triggers the thought
adverse event such as vomiting, fever, abscess process of the community by pushing them to
formation following vaccination campaign, identify reach a “tipping point” from where the behaviours
key stakeholders such as parents of concerned start changing.
children, community leaders, religious leaders, and
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419
Mobile phone
Printed material Video or DVD messages
Radio and Local health

Television MAIN SOURCES FOR workers
INFORMATION
ABOUT VACCINE
SAFETY
Parents, guardians Health education

and vaccinees campaigns
Online resources &

Religious and/or communication
community leaders networks Visiting experts
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3
Chapter
Managing AEFI During

A n AEFI crisis is
a situation
where in
information about an
Crisis
AEFI (real or supposed)
can lead to a loss of 3.1 AEFI crisis – a challenge and an
confidence in the
vaccine or in the opportunity
immunization service.
An AEFI crisis is both a challenge and an opportunity 6 to improve
communication on immunization issues. This is an opportunity to
CRISIS - A CHALLENGE dispel negative rumours, to take action, to upgrade policies and
? Unexpected series procedures, if required, and to correct any errors or lapses in
of events immunization practices.
? Events are out of
3.1.1 Communication fundamentals for handling an AEFI
control
? The outcome is crisis 7
uncertain Fear and anger are barriers to effective communication. An
? Threat to existing essential element of any good communication response is the
situation ability to communicate the benefits of vaccination vis-à-vis the
significantly lower risks of adverse reactions.
CRISIS – AN
Keep the following communication essentials in mind while
OPPORTUNITY
? Improve dealing with the public during a crisis:
communication >Listen to what the public is saying
? Dispel negative >Keep people informed
rumours >Understand risk perception of the community
? Take required action >Identify needs of media as it is the gateway to public opinion
to upgrade policies >Develop a quick and appropriate official response
and procedures
>Disseminate timely and accurate messages
? Correct errors or
>Same message should be communicated by all partners
lapses in best
>Identify and engage a trusted spokesperson
practise
>Use same platforms for positive messages as used for negative
messaging/publicity
6
WHO website http://www.vaccine-safety-training.org/impact-of-rumours-and-
crises.html
7
UNICEF (2004) Building Trust in Immunization - Partnering with the Media. New
York; and: Agency for Toxic Substances and Disease Registry (2001) A Primer on
Health Risk Communication Principles and Practices, USA
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421
3.1.2 Role of custodians during an AEFI crisis >Assess the origins of rumours and be prepared
with a number of potential strategies to counter
Custodians are keepers of good and positive
them.
relationships with the community, for example,
government officials, consultants, and NGOs who >Foster long-term partnerships with the media
are in regular touch with the community. They need to promote responsible public health reporting.
to make rigorous efforts to share findings of an AEFI >Build partnerships with professional organizations
investigation with the affected family, community and credible national spokespersons inside and
members and the media to prevent the community outside the Ministry of Health.
from losing confidence and having negative public
opinion about immunization. Many events that >Collaborate with the National Immunization
occur just after vaccination may well have occurred Committee dealing with vaccine safety issues.
whether or not the child had been vaccinated. >Wor k through different channels and
These events are coincidental, which is often very spokespersons to promote accurate information
difficult to explain to parents who see their child and cooperation to ultimately enhance public
vaccinated one day and becoming ill the next. trust in immunization.
3.1.3 Prerequisites of handling an AEFI crisis >Monitor the community's knowledge, attitudes
and practices toward immunization, particularly
>Respond swiftly with accurate information
after an adverse event has occurred.
based on evidence.
>Record lessons learned in handling
>Know how to deal with concerns on broad
communication responses to AEFI.
vaccine safety issues often coming from the
media versus individual AEFI cases. The above prerequisites are represented in diagram
1.1 on page no. 14
13
1.1 ILLUSTRATIVE REPRESENTATION OF COMMUNICATION FLOW DURING AEFI
ROLES
COMMUNICATION FLOW WHAT IS TO BE DONE, IN NEXT48 HOURS
ANM with support from
Health Worker (ANM) community mobilizer
ASHA/ AWW
(ASHA/AWW) reports
Site ?
Confirm AEFI suspected AEFI to Medical
Immediate ?
Complete First Investigation Report (FIR) officer
Medical Officer (MO) Verifies nature of AEFI and

reports serious AEFI
24 Hours immediately by FIR
Pvt. Practitioner
?
Initiate investigation following receipt of FIR Completes PIR within 7
?
Complete PIR based on verbal autopsy method days of event and sends to
District Immunization S
District ?
Collaborate with other stakeholders such as, state and national level
Officer (DIO) O
District AEFI committee, drug inspector, team
U
14
conducting autopsy Completes DIR within 90 R
?
Collect other lab samples/reports such as, vaccine days of event and sends to C
24 Hours samples, CSF, serum, hospital reports state and national level E
:
State M
O
H
State Immunization ?
Receive DIR from DIO On recieving of DIR, SIO
F
Officer (SIO) - Inform, if necessary, State Drug Controller should involve State AEFI W
- Review causality of case with State AEFI committee committee to classify the
AEFI and take corrective
action, as required
National
Deputy Commissioner (DC) Review case and take

Immunization Division, corrective action, as
MOHFW, Govt. of India required, with guidance
from National AEFI
422
committee
423
4
Chapter
How and when to Respond
to AEFIs– Communication
with Key Stakeholders
4.1 What is an AEFI surveillance?
It is the practice of detecting, assessing, understanding, responding,
ensuring and preventing adverse vaccine reactions, monitoring safety of all
aspects of immunization, including vaccine quality, storage, handling,
administration, disposal of sharps and management of waste as well as
signal detection.
4.1.1 Importance of an AEFI surveillance8

AEFI surveillance is important as it helps in detecting and identifying the
problems with vaccines’ lots/brands, promptly addressing programmatic
errors by taking corrective measures and maintaining the confidence of
community and health workers by creating awareness about vaccine risks. It
also helps in estimating the rates of occurrence of AEFIs in the local
population, besides generating new hypothesis (signal detection) about
vaccine reaction that are specific to the population of the country or region.
4.1.2 AEFI surveillance system involves a network of key players:
Sub-centre level - ANM/AWW/ASHA/Health Supervisor
PHC/CHC/Corporation/Ward/Urban level - Medical Officer
District level - CMO/DIO/District AEFI Committee
State level - Director FW/State EPI officer/State AEFI Committee
National level - Deputy Commissioner (UIP), MOHFW /

National AEFI Committee and Secretariat
Also includes key professional health

(medical, nursing) bodies and private sector
8
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424
4.2 Interaction with health 4.3 Interacting with families

workers and communities
4.2.1 Stop the blame game, support the 4.3.1 Respond in a prompt manner
health workers >An immediate response to the bereaved family,
Health workers are a vital source of information in the moment an AEFI occurs, is a good response.
AEFI investigation. Many health workers do not >A prompt response to the bereaved family or
report an AEFI due to fear of blame or sanctions. In community, with regular information on the
addition, whenever a serious AEFI occurs, local status of investigation, will have a lasting effect
health workers and vaccinators have to be and aid in dispelling potential fears and myths
safeguarded, as they might become targets of around immunization in general.
resentment and be confronted by affected
>Demonstrate commitment by listening patiently
community members.
to the concerns and fears of the affected families
4.2.2 Capacity building of health and community.
functionaries >Take immediate steps to verify the facts and
Orient and empower health functionaries at every determine what has really happened.
level, be it doctors, frontline workers (ANM, ASHA, 4.3.2 Disseminate key messages and combat
and AWW) and vaccinators, to handle queries from
rumours
the community, especially from parents. Moreover,
equip them with technical information on possible >Use the same channels to disseminate messages
adverse events and provide them support of key as those that were used to spread the rumours.
spokespersons at local and national levels. >Timely dissemination of a consistent set of easy-
Health workers and vaccinators should be skilled in to-understand key messages to concerned
inter-personal communication (IPC) skills with families and communities will help to appease
families and communities. This means that health their anxiety and reaffirm their faith in the
workers are able to share accurate immunization health system.
facts, respond to questions, clarify possible doubts, >Widely circulate and disseminate key messages.
and encourage families to adopt healthy
>Everyone from the Minister of Health at the
behavioural practices, including understanding the
national level to the dispensary attendant and
impor tance of immunization and availing
health workers at the Primary Health Centre
immunization services.
should know and use the key messages.
IPC involves refining good listening skills and the
ability to empathise and be supportive with the 4.3.3 Assess impact of AEFI on community
family and the community. While identifying health >Most importantly, a sound communication
workers for IPC training, you should give primary response to AEFI is incomplete without
importance to good communication and listening monitoring immunization coverage and the
skills, besides looking at their passion to serve the attitudes and practices of the affected
community. community (or communities) after the AEFI.
District Immunization Officers (DIOs) could also >For a robust system, regular interaction with key
benefit from training in communication and media stakeholders and building their capacities and
management. IPC skills of health workers cannot be skills to handle crisis with sensitivity and
achieved through a one-time training. Refresher efficiency are needed.
trainings should be a regular feature of the >Media is an important partner and a regular
immunization programme, as this would provide interaction with them will help to develop
them a platform to share challenges faced at proactive responses in a timely manner. We
various levels of programme implementation and discuss interaction with the media in the next
find possible solutions. Good IPC skills of health chapter.
workers also rely on support from supervisors and
regular monitoring of the quality and accuracy of
the information shared.
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5
Chapter
Interaction with Media

T he media
(newspaper,
radio, television,
and social media) is the
fourth pillar of
5.1 Understanding media perspective
The media is interested in stories that will attract attention and boost their
sales. One technique is to sensationalize, dramatize and personalize events,
democracy and plays an
including events that are either unrelated to immunization (coincidental)
important role in
or based on a localised programme error with wider implications.
forming public
perception. The role of In addition, the media tends to report on the number of events, ignoring
media is critical as the the larger context of the fewer rate of occurrence of such events. If given
messages disseminated inappropriate material, the media can depict health services or officials
by the media could responsible for immunization as being uncaring, impersonal, incompetent,
boost or blemish a or even dangerous.
program. The media is Media coverage is likely to raise public concern about immunization. Public
likely to publicize the trust in vaccines is often eroded, when during an adverse event, negative
following events: publicity of the event by the media acquires centre stage. Media serves as
> when AEFI results in an important gateway to inform the public and shape their views and
death or disability attitudes towards vaccines and immunization.
Health professionals become the object of blame during a crisis situation as
> when it unearths
they are often accused of not having done their job properly or being
"threatening facts"
untruthful.
> when it obtains
information before 5.2 Media is an ally and not a foe
the health
Media can also be a helpful ally in communicating public health messages
professionals do.
such as reminding the public of the importance of immunization and the
risks of diseases. In addition, media also plays an important role in
advocating continued and increased
investments in immunization. Building a
5 Ws and 1H of media
personal relationship with key health
reporters will help media personnel WHO - is affected/is
understand the public health responsible?
perspective of the immunization WHAT - has happened?
programme. What is being done?
WHERE - has it
To keep the public regularly informed happened?
about immunization, the benefits WHEN - did it happen?
accruing from vaccination and to WHY - did it happen?
encourage families and communities to HOW did it happen?
access immunization services building a
long-term partnership with the media is
important.
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426
report AEFI incidents in a sensational manner. An

5.3 Media management in information package may contain the following
routine situation documents, both in hard and soft copy:
An effective communication plan should be in place > Frequently Asked Questions (FAQs) on
before an immunization campaign starts and as immunization in general and AEFI
part of on-going communication support to the RI > Fact sheet or technical brief on a specific
programme. Effective communication with the vaccine-preventable disease
media includes the following: > Recent updates - progress made in India and
> efficient coordination with the field staff outside - and a few case studies
> a plan > Graphs and illustrations
> trained personnel > Immunization photographs
> a budget
> Contact addresses of spokespersons (experts)
> practiced responses to potential issues around
that the media can talk to.
AEFI.
Check and permanently remove all old and
outdated material from this information package.
What is media looking for?
5.3.3 Information for different levels of
Disaster, malpractice and negligence media
Drama with personal aspects
Local media: Read and believed by people at the
Controversy or conflict community level.
Number of people affected
National media: Seen and read by governments
Unexpected outcomes
and national opinion leaders; has a wide reach and
Polarity of views influences national agendas.
Location (close to own country or hospital)
I n t e r n at i o n a l m e d i a : S e e n a n d re a d i n
Celebrity link- heroes and heroines
headquarters of international organizations, has
resources to produce investigative reporting, can
influence national agendas.
A good media plan consists of the following:
5.3.1 A database of journalists

Some frequently asked questions by media:
Have a list of print and electronic media journalists
covering health (local, national, international) with Why did this crisis happen? Was the
their contact information. Update every quarter any government sleeping?
changes in the media list. Mention updating date Could the situation have been averted had
somewhere on the page or file for easy recall. it been timely and adequately responded
to?
5.3.2 Information package
What do you have to say on the occurrence
Keep the media informed through email or letters
of this incidence?
by sending regular updates on any plans,
programmes, decisions, etc. Who is at fault for this loss and crisis?
Sensitize media about health aspects like benefits How does the government plan to handle
of immunization and its impact - globally and the situation?
nationally. Prepare monthly or quarterly updates. What is the relief being provided to the
Pay special attention to stringers of major dailies, TV affected families and communities?
channels, stationed in remote areas as they may What are the actions taken so far?
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427
Case Study 2
This case illustrates how a Proactive Media Approach facilitated

balanced coverage when an adverse event occurred.
Event:
In 2003, Pakistan, eight of 13 children vaccinated that day developed adverse reactions
after two hours, including high-grade fever, vomiting and diarrhoea; six children recovered
and two died.
Cause for AEFI:

Programmatic error (vaccine related)
Government response:
An investigation team visited the affected village, the parents and paediatric ward of the
district hospital. Blood samples of hospitalized children were sent for culture and sensitivity
test. Autopsy of one of the deceased children was done.
Communication efforts:
Engaging with the media at different levels (national, district and local).
Holding exclusive media briefings.
Sharing regular technical briefs with journalists.
Monitoring media reporting (news items, articles or statements), reviewed by an inter-
departmental forum, which determines course of action to be taken in case of incorrect
media coverage, for example, rebuttal, informal clarification with the reporter or editor,
organizing a press conference or sending out a general response by electronic media.
Sharing relevant information with parents.
Regular mandatory orientation for all team members, including that of safety and
efficacy of vaccines.
Lessons learnt:
A proactive media approach can facilitate balanced coverage when an AEFI occurs. This
includes giving technical briefings to the media, issuing press releases, and senior
government officials serving as spokespersons on a regular basis.
Regular training of field staff (vaccinators/Medical Officers) on AEFIs and close
supervision are critical to prevent programme errors and maintain public confidence.
Communication efforts to avoid incorrect media reporting While district teams need to
be trained in advance to establish AEFI surveillance, mandatory orientation for all team
members, especially on issues of safety and efficacy of vaccines, will help strengthen
their capacity in communication planning and media management.
Source: UNICEF - Building trust and responding to AEFI in South Asia - Using Strategic Communication
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428
5.3.4 A spokesperson system 5.4.2 Immediate actions taken by the AEFI

Identify in advance an appropriate spokesperson (or committee
several spokespersons in different agencies). Share > Analyse the rumour, its level, and potential to
contact details of spokespersons before an cause damage.
immunization campaign starts with all concerned
> Anticipate how situations might evolve
focal points at the district, state and national levels.
following response; prepare before responding.
This limits the possibility of conflicting messages
coming from different sources. Ensure > Use a simple solution to deal with a simple
spokespersons have experience or some training in mistake. If it is an isolated error, make a polite
dealing with media. call to the reporter and offer to help the
reporter with correct data and facts, then and in
5.3.5 Orientation workshops and field visits
the future.
for media
> If the rumour is confined to a small audience,
Journalists will have a better understanding of the correct it within that group only. If the error is
advantages of immunization and the complexities widely reported, you may call a media
of an immunization programme if orientation conference to present correct facts before it
workshops and field visits are conducted for them. leads to further damage or proves detrimental
The workshops and deliberations will also help to the programme goals.
identify in advance the kind of questions or
> Plan in advance ways to prevent rumours.
concerns that journalists have. Always take note of
all proceedings and discussions with journalists.
This will help you in being prepared with 5.5 Getting emergency
appropriate answers when required.
information to the media
5.4 Media management when Historically speaking, the press and print media
have played a major role in influencing and shaping
an AEFI occurs9 public opinion. To avoid negative reports around
AEFIs, an early and prompt response is required.
While every single AEFI must be investigated in
However, this is made complicated by the fact that
detail, all AEFI cases may not lead to a crisis.
it takes time to investigate AEFIs and acquire and
Spokespersons must regularly undertake risk
corroborate relevant information.
communication, informing stakeholders (care givers
and media) about possible mild-to-severe AEFI and Therefore, the onus is on the concerned public
the likelihood of their occurrence (frequency). health official or agency to ensure that correct
messages reach out to the public and wrong
5.4.1 Monitor media
messages, if sent out by another agency or press,
When an AEF Ioccurs, substantive in accuracies can are clarified in a timely manner. A Crisis Response
get reported, for example, regarding the number of Team (CRT) consisting of government officials,
AEFI cases, gravity of the case, allegations of technical experts, representatives from partner
negligence, or simple rumours about vaccine organizations etc. should be in place to respond to
procurement, storage and delivery. The SEPIO or media queries in a timely manner.
DIO, assisted by the AEFI Committee, should move
Some common ways of communicating with the
quickly to correct them because the longer
public through media are the following:
misinformation remains in the information
environment, the more difficult it becomes to > Press statement
correct. > Press release
> Press conference
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> Press interview these ready. At the end of your communication with
> Key messages media, mention: For more information, contact
AEFI Committee Chairman (with the relevant
5.5.1 Press statement person's name), so that the media can refer to the
A press statement includes the following: relevant person in case of any queries.
> A complete account of the event action (a) Press statement versus press release
planned for handling the event, framed in its
A press statement is an official position or
context (example, was it an isolated event or a
perspective of the organization. It is essential
cluster of AEFI or coincidental event?)
particularly if a severe AEFI is reported.
> An outline of actions taken or planned (such as
AEFI investigation) A press release is also released by the organization
but includes a descriptive narrative of the incidence,
> A description of the cause of the event (but only
covering the who, what, when, where, why, and
when this is known with reasonable certainty)
howaspects of the event.
> An assurance that corrective action has been
taken or will be taken (b) Press statement is not the same as
> Information on the 5Ws and 1H of journalism press release
(When, Where, Who, What, Why and How)
What is a press What is a press
> More than one opinion on the issue at hand.
statement? release?
May include references to relevant publications,
Is not a news Is a news
video materials or website.
Is an official position Describes in
> Names and contact details of persons to be or perspective of detail as to what
reached for additional information or materials. the organization happened
In addition, monitoring media coverage and Usually a press Not every press
reporting trends, especially the local media, and release is issued release needs to
meeting with opponents and supporters from the simultaneously with be accompanied
a statement by a statement
media, are part of good communication practices.
You may have to issue corrections (rejoinders) if
incorrect reporting continues.
(c) Steps for writing a press release
10
5.5.2 Press release Step 1: Write the headline
The press release must specifically answer the 5Ws

and 1 H for journalists: Step 2: Write the press release body
> Who is affected? Who is responsible?

Step 3: Answer the 5 Ws and the H
> What has happened? What is being done?
> When did it happen? Step 4: Include the organisation information
> Where has it happened? and profile
> Why did it happen?
Step 5: Wrap it all up
> How did it happen?
Mention names and contact details of AEFI
Step 6: Note to the editors
Committee members (at the top), and name and
contact details of the spokesperson (AEFI
Committee may also recommend the name of a Step 7: Include contact information
medical expert) for further details, should
journalists have more questions (at the end). Keep Step 8: Signal the end
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Step 1: Write the headline would not read the rest of the body, if the first
paragraph is poorly written and is not
> Headlines should be concise, clear and direct-to-
interesting.
the-point. It is the ultimate source of impact of
the whole press release and is a powerful > Include facts in the body of the press release.
statement that can make or break your press
Step 3: Answer the 5 Ws and 1H
release.
> A press releases should answer the who, what,
> When writing the news release, headlines
when, why, where and howquestions.
should employ enticing words that can grab the
attention of the readers in the same way as > Write the press release in this manner:
when it is in the newspaper.
! Headline
> The words should be in bold and larger than the ! A brief summary in the first paragraph
plain body text and in the present tense.
! The event or, if there are achievements
> Capitalize the first word and all proper nouns in ! Products involved
the headline.
! People behind it
> Find the most significant keywords in the body
! Concluding summary
of your press release for you to have a quick start
in writing the headline. ! The profile of the company
> The length of a press release should not exceed
> Use powerful words and include those keywords
three pages.
you have extracted to form a logical, powerful
and attention-grabbing headline. Step 4: Include the organisation information
> It may be about a recent award the organization and profile
received, an event worth telling about, or a new > Journalists and media people can get the
product release or service. organisation s profile in this section of the press
release, especially if your press release is picked
Step 2: Write the press release body
up and written about.
> Write the body of the press release the way you
> Write the title, which is about the organisation.
would write a news story.
> Describe the organisation in 5 6 sentences.
> The press release body should start with the
date and city where it originated. You can omit > Include the link of your organisation s website at
the city if it will only confuse the reader. the end of this particular section of the press
release.
> The first sentence is vital. If it grabs the attention
of the reader firmly, the reader would want to Step 5: Wrap it all up
read the entire press release.
> If there are available supporting links, include
> If the first sentence does not have a firm hold on them in the press release.
your reader s attention, chances are he or she
will skip the whole body and move on. The body Step 6: Note to the editors
of the press release should briefly summarize > The note should contain the brief about the
what is currently happening. Furthermore, the topic with facts and figures for quick reference
following sentences should support the for the editor. The note helps the editor to
previous sentence. understand the topic in greater detail and guide
> The first paragraph could summarize the press the team for factually accurate reporting.
release; the rest of the body provides the details
of the story. Journalists and media personnel
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431
Step 7: Include contact information ! Office address

! Telephone and fax numbers with proper
> Provide contact information of the people
extensions
behind the press release or provide contact
! Mobile number
information of your department to the
journalist, if they would want to interview the ! Availability of time
principal people behind the press release. ! Email address
! Website address
> Include the following in your contact
information: Step 8: Signal the end
1. Organization s name
> End your press release properly by putting signs.
2. Contact details of the nodal person
Put (#) symbol at the centre right after the last
line.
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(d) Sample press statement
Press Information Bureau

Government of India
Ministry of Health and Family Welfare
15-March-2013 13:10 IST
Expanded Programme of Immunization
Under the Expanded Programme of Immunization (EPI) 8 vaccines are provided. These vaccines
prevent Diphtheria, Pertussis, Tetanus (DPT), Polio, Measles, severe form of Childhood Tuberculosis
(Bacillus Calmette-Guérin i.e. BCG), Hepatitis B, Japanese Encephalitis and disease caused by
Haempohilus influenza type b like meningitis, pneumonia etc.
Hib containing Pentavalent vaccine has been introduced in the states of Kerala, Tamil Nadu, Goa,
Gujarat, Haryana, Jammu and Kashmir, Karnataka and Puducherry.
Certain states like Andhra Pradesh, Assam, Bihar, Chhattisgarh, Delhi, Jharkhand, Madhya Pradesh,
Punjab, Rajasthan, Uttarakhand and West Bengal have requested the Government of India to
introduce Pentavalent vaccine under the EPI in their State. Decision will depend on availability of
resources.
The Pentavalent Vaccineused under EPI is licensed by Drug Controller General of India after
examining the safety and efficacy of the vaccine. Further, each batch of vaccine is tested before
release to the states. First in-house testing by manufacturer and thereafter tested and cleared by
Central Drug Laboratory (CDL) Kasauli, Himachal Pradesh. Adverse Events Following Immunization
(AEFI) is also monitored and investigated by Districts/State/National AEFI committees to track all
kinds of adverse events that may occur following vaccination, whether related or unrelated, to
ensure safety of Pentavalent vaccine.
The above information was given by the Union Minister for Health & Family Welfare, Shri Ghulam
Nabi Azad, in a written reply to a question in the Lok Sabha today.
####
Source: Press Information Bureau website http://pib.nic.in/newsite/erelease.aspx?relid=93717
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(e) Sample press release
HEADLINE
18 Million Indian Children to Receive Life Saving Five-in-One Vaccine
PRESS RELEASE BODY/ 5Ws and 1H
GENEVA, 12 August 2009 - More than 18 million children in India will be immunised with a pentavalent five-
in-one vaccine thanks to funding worth US$ 165 million from the GAVI Alliance, a public-private partnership
which brings together all key players in immunisation including the Indian government, the World Health
Organization, UNICEF, donors, industry and the Hib Initiative.
WHO?
A decision bye combination vaccine in India, where some 27 million children are born each year. This is the
first phase of a national roll-out which will start in 10 states.
WHAT?
India s important and far-sighted decision to introduce the pentavalent vaccine will bring the country and
the world significantly closer to achieving Millennium Development Goal 4 which aims to reduce child
mortality by two-thirds by 2015,said Dr. Julian Lob-Levyt. With such a significant number of pneumonia
deaths occurring in India, we are pleased to see India recognizing the importance of adding protection
against Hib while continuing to work on strengthening routine immunization.
WHEN?
The decision to approve the funding was communicated to Indian Health Minister Gulam Nabi Azad by GAVI
Alliance Deputy CEO Helen Evans on Tuesday, 11th August.
The introduction of the pentavalent vaccine in India is a critical step in our government s efforts to protect
all Indian children from deadly diseases," said India's Health Minister Gulam Nabi Azad. "We are glad to be
working with the GAVI Alliance to turn this long-held vision into a reality for millions of families. I am
extremely thankful to GAVI for assistance given for pentavalent vaccine."
WHERE?
In one of its largest-ever single grants, GAVI will fund the first two years of pentavalent vaccine introduction
in India. In the first year the pentavalent vaccine will reach more than 10 million children in 10 states -- about
40 percent of India s total number of babies born each year.
WHY? District
Level
By funding the introduction of the pentavalent vaccine, GAVI will equip IndiaImmunization
to expand its use in the rest of
the country. Officer (DIO)
HOW?
Introduction of Hib vaccine in India will save thousands of children s lives,said Panna Choudhury, President
of the Indian Academy of Pediatrics. Routine use of Hib vaccine is an essential piece of a comprehensive
pneumonia control strategy to reduce the disease's terrible burden on children.
No child should die or suffer from this preventable disease,said Dr. Mathuram Santosham, executive
committee member of the Hib Initiative at Johns Hopkins Bloomberg School of Public Health. Hib vaccine is
a safe, effective intervention that has been used for more than nearly 20 years in developed countries. Where
used routinely in countries such as Kenya, Uganda and the Gambia, it has been proven to virtually eliminate
Hib disease.
Pentavalent vaccine is now available from Indian suppliers and is expected to be used both in children in
India and around the world. With increasing demand, this indigenous supply will play an important role in
saving children s lives.
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BACKGROUNDER
The pentavalent vaccine protects against five potential killers -- diphtheria, tetanus, pertussis (whooping
cough), hepatitis B, and Haemophilus influenzae type b (often known as Hib) which causes some severe
forms of pneumonia and meningitis. Children need to be vaccinated three times before they can be
considered fully immunised.
While children in all countries are routinely immunised against diphtheria, tetanus, pertussis and
increasingly hepatitis B, the introduction of this pentavalent vaccine in India will mean that now more
than 90% of the world s poorest children will be vaccinated against Hib.
Globally Hib kills more than 370,000 children under-five every year; nearly 20% of these children die in
India. Survivors are often permanently paralyzed, deafened or brain damaged. Routine introduction of
Hib vaccine has been proven to prevent the majority of severe bacterial meningitis and up to one third of
life-threatening cases of bacterial pneumonia, the leading infectious cause of death in children
worldwide.
ORGANISATION NAME AND PROFILE
The GAVI Alliance is a Geneva-based public-private partnership aimed at improving health in the world's
poorest countries. The Alliance brings together developing country and donor governments, the World
Health Organization, UNICEF, the World Bank, the vaccine industry in both industrialized and developing
countries, research and technical agencies, NGOs, the Bill & Melinda Gates Foundation and other private
philanthropists.
GAVI support consists of providing life-saving vaccines and strengthening health systems. Since 2000,
213 million children have been vaccinated and 3.4 million premature deaths averted thanks to GAVI-
funded programmes.
For more information, please visit: www.gavialliance.org and see the new section on GAVI and
pentavalent vaccine.
The Hib Initiative unites experts from Johns Hopkins Bloomberg School of Public Health, the London
School of Hygiene and Tropical Medicine, the World Health Organization, and the Centers for Disease
Control and Prevention (CDC) and provides technical, coordination and communication support to
countries making decisions regarding the use of Hib vaccine. The Hib Initiative is supported by a 4-year
grant from the GAVI Alliance. The Hib vaccine is being used or will soon be used in at least 62 developing
countries eligible for support from the GAVI Alliance. For more information, please visit:
www.hibaction.org
NOTE TO THE EDITOR
Haemophilus influenzae type B (Hib) is a bacterium which causes severe pneumonia, meningitis and other
life-threatening conditions in children less than five years of age. An estimated 24 to 30 lakh serious cases
and 72,000 child deaths due to Hib diseases (pneumonia and meningitis) are reported every year in India.
Pneumonia is the leading cause of death in 1 59 month old children (16%) in India. Giving pentavalent
vaccine means reducing the number of pricks to a child from six to three, with additional protection from
Hib diseases. The Hib Vaccination can prevent over a third of pneumonia cases and 90% of Hib meningitis
cases. Furthermore, 15 35% of meningitis survivors suffer permanent neurologic damage.
FOR MORE INFORMATION, CONTACT:
GAVI Alliance: Dan Thomas, Tel: +41.22.909.6524 and +41 79 251 8581, dthomas@gavialliance.org
Ariane Leroy, Tel: +41.22.909.6521 and +41.79.340.1878,aleroy@gavialliance.org
Hib Initiative: Rose Reis, Communications Associate, Tel: +1- 410-502-4283, rreis@jhsph.edu
India's Ministry of Health & Family Welfare: Dr. Sunil D. Khaparde + 91-9958097015
SIGNAL THE END

#######
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11
5.5.3 Press conference
Press conferences need to be used judiciously, because the results can fall flat if there is lack of preparation
and the journalists are assertive. With different stakeholders being present, everything must be planned well.
Press conferences may need to be conducted if an AEFI is reported extensively and widely and there is a
need to provide accurate facts and de-sensationalize the story. A press conference enables all journalists to
have the same information, thus there is less likelihood of the event being 'sensationalized'.
(a) Steps to be followed when preparing (b) Check list for setting up a press
for a press conference: conference:
Step 1: Plan ahead, at least two weeks before the News conferences are both fun and serious. Don't
event. Talk about what you want to do and how spoil the fun: be ready to enjoy the high energy of
you want to do it. getting an important story on TV, radio, and in the
paper. Prepare yourself as well as you can. Some
Step 2: Tell your group about your ideas; get your points to double -check before your news
members ideas and decide on the message you conference:
want to give out.
> Clearly state a good reason for holding a press
conference: the news you are going to reveal
Step 3: Prepare props, posters, banners has not been covered in the press yet, or there is
and a press kit. an emergency, or an important new issue.
> Decide what message you want to deliver
through the media. Outline your demands to a
Step 4: Organize a list of reporters you plan to
decision-maker (someone who has the power
contact about your news conference.
to give you what you want). Include information
about what people can do to help, and the date,
time and place of your next action.
Step 5: Write and deliver news advisory.
> Work out the location of the press conference.
Find an appropriate place that is convenient
and has the facilities you need. The location
Step 6: Write the statement you plan to make at depends on your needs and the specific
the conference. Keep it short. circumstances of your situation.
> Dramatize your position by choosing a good
backdrop. If you decide to hold the press
Step 7: Finalize all details. Write a news release. conference indoors, provide technical
assistance for reporters such as phones,
microphones, and sufficient light.
Step 8: Call reporters to remind them about > Set the date and time of the press conference,
tomorrow's conference. taking into account reporters deadlines. Usually
the best days of the week to get news coverage
are Tuesday through Thursday. Check to see
Step 9: On the day of the conference, arrive early that there are no competing news events
to make/supervise arrangements, organize
already scheduled at the time of your
materials, etc.
conference.
Step 10: After the conference is over, hand deliver > Invite the media: Send a press conference
copies of your news release and statements to advisory to appropriate local media outlets at
reporters who did not show up. least a week before the press conference. Follow
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up with a phone call two days before the press guests may wish to have a copy of written
conference to make sure everyone received the statements or a press release. You can prepare
advisory. Call them a day before to remind them a packet of fact sheets, charts or graphs.
about the event.
> Invite guests: Make phone calls and send CAUTION
written invitations to prospective guests you Press conferences need to be used judiciously,
want to have at the press conference such as as the speakers might have to face the hostility
other members of your group, allies, and of reporters. It requires careful preparation and
friendly politicians. management, especially if different
stakeholders are present.
Press kit
A press kit is your background material: fact 12
sheets, news release, text of the statement, and 5.5.4 Press interview
visual materials such as photographs. It can > Preparing for an interview is comparable to
help reporters create and produce their stories. preparing a press release. Find out who is
conducting the interview and the organization
> Prepare speakers to deliver your message she or he works for. The individual or their
! Generally, it is good to have just one or two organization may have a particular point of view
speakers in a press conference, so that (for example, a bias in favour of or against
people do not talk on top of each other, or vaccination), or they may have a reputation for
mix the message. fairness in news reporting.
! Rehearse with the speakers to make > Another consideration might be whether the
statements brief and clear and, usually, no interviewer has any prior medical or scientific
longer than 10 minutes. training that may influence the kind of
! Speakers should be experienced on the questions you could be asked.
subject and able to respond to questions > Most importantly, consider the emphasis you
after the statement. need to place on key messages you want to get
! Often reporters want to interview the across.
speaker/spokesperson. Let the press know
(a) Rules to be followed during a press
that the speaker is available after the press
conference.
interview:
! Maintain eye contact with the interviewer.
! Prepare your speakers with 30-second
answers for radio or TV, and quotable, ! Dress in a professional manner.
simple messages for reporters. Help your ! Think before you speak and take time to
speaker practice with a video camera or frame your answers.
tape recorder.
! Speak clearly and audibly in simple
> Choose a moderator for the press conversational language.
conference. You need a person to control t h e
! Stick to the facts and avoid speculation or
process and keep reporters on the subject. If
personal opinions
someone goes off the subject, the moderator
can return the focus by saying: That is an ! Make sure you get your key message into
interesting point, but we are here t o d a y t o the dialogue more than once if possible.
discuss... ! Be enthusiastic and engaged in the
> Prepare background materials. Reporters and conversation try not to look nervous, even
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if you feel uncomfortable about being 5.6 Post-AEFI actions14

interviewed.
! Never say No comment! 5.6.1 Keeping promises to the media
Remember, there is no such thing as an "off the record" If the media has been promised to be kept
statement that you can be certain the interviewer will updated about investigation findings, make
keep confidential. sure they are updated by the promised date. If
13 the findings have been delayed, ensure the
5.5.5 Key messages
media is informed, since they would be
The best messages get to the heart of the problem expecting answers.
without lengthy explanations. Listeners and viewers
always tend to remember that one key message 5.6.2 Providing answers to unanswered
even if they remember nothing else. Try to repeat questions
the message at least once during a media interview.
During a media conference, if a question could not
For example, some effective messages on
be answered for any reason - for example, due to
immunization could be:
absence of data, or if you were unprepared to
> Immunization is the most cost-effective health answer the question - get back to the media with
intervention. answers as soon as possible.
> Immunization is the right of every child. 5.6.3 Keeping media informed of
subsequent developments
If a decision or action is taken at the highest levels
Some more examples of situation- following AEFI investigations or during the
specific messages investigations and the public must know about it,
Benefits of immunization in preventing keep the media informed though a press release or
diseases are well proven. hard copy document.
Un-immunised children are at greater risk
of diseases and complications.
Vaccine-preventable diseases cause
millions of deaths and disability.
Continued use of vaccines is the only
solution to avert this situation.
Vaccines do cause some reactions, but
these are rarely serious and hardly ever
cause long-term problems (have data
ready and available to substantiate this
fact).
A surveillance system detects and is
primed to investigate even the most
minor suspected problems regarding
immunization. The AEFI is currently
being investigated, but it is likely to be
coincidental or due to a local problem
(depending on type of event); the
immunization programme must continue
to keep the population safe from disease.
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Some typical journalistic questions are

given below. Please remember that no
matter how provocative the tone of the
question is, acknowledge the concern
of the journalist and stick to your facts
and respond in a cool manner.
What are the benefits of introducing the ---
- vaccine as a part of the Universal
Immunization Programme?
What is the approval process for licensing
a new vaccine in India?
How is the safety of a new vaccine
evaluated?
What tests have been conducted to
ascertain safety in Indian context?
How is this programme funded? What is
the cost of the vaccine?
What is the role of partner organisations
such as WHO, UNICEF, and GAVI?
Why don t health authorities train
vaccinators so that these accidents are
avoided?
Why are injections for vaccines and other
medical procedures still dangerous in our
state or country?
Why are vaccines that damage our
children with serious side effects still
given?
Why parents are not told the truth about
vaccines? Is there something that is being
hidden?
Questions on specific vaccines
How safe is the pentavalent vaccine that is
used in India?
Why was the vaccine launched only in
Tamil Nadu and Kerala?
What was the impact of the vaccine in the
two states? How do we know?
How many children have been immunized
using pentavalent vaccine and what is the
success rate? How many children will
benefit from this vaccine?
Source: ITSU-UNICEF Media guide
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(a) Sample of positive media reporting
India takes pentavalent vaccine to 5 million children
Five million Indian children were vaccinated with the five-in-one pentavalent shots in just over a year.
Jammu and Kashmir became the sixth State to introduce the vaccine as part of the Universal
Immunization Programme. The vaccine, with one shot, offers protection against diphtheria, tetanus,
whooping cough, hepatitis B and Haemophilus influenza B (Hib). This will bring down child mortality
and morbidity drastically,says Ajay Khera, Deputy Commissioner, Child Health and Immunization,
Ministry of Health & Family Welfare.
There are about 27 million children under one year in the country at any given point of time, and the
intention is to take the benefits of the pentavalent to all of them, he adds. The pentavalent vaccine
was introduced in Tamil Nadu and Kerala in December of 2011, the two States with high vaccine
coverage and solid public health systems.
After an evaluation of the two States in August 2012, the decision to expand was taken. The
pentavalent vaccine was then introduced in phases in Haryana, Puducherry, Goa, and Gujarat, with
Jammu and Kashmir being the latest to join the list.
At present, the vaccines are being procured by UNICEF, with funding from GAVI. The operational costs
are borne by the government, Dr. Khera points out. We need to preserve the vaccine in a good cold
chain system, use single use auto disable syringes and provide manpower support to the
administration of the vaccine,he explains. The vaccines are provided free of cost under the public
health scheme, while in the public sector, between Rs. 400 and Rs. 700 is charged per dose. Infants are
given three doses of the pentavalent vaccine at six, 10 and 14 weeks of age.
Replying to an RTI application by Kerala-based doctor K.V. Babu, the Ministry indicated that Kerala
had a total of 11 deaths in 2012, and Tamil Nadu four, listed under 'Adverse Effects Following
Immunization' (AEFI) using the pentavalent vaccine. In 2011, the year of introduction, there was one
death in Kerala. We need to ask whether the vaccine is safe after all, with periodic assessments. The
life of every child is precious, and we cannot afford to lose children from vaccination,Dr. Babu says.
Responding to this, Dr. Khera explains, The vaccine safety surveillance system enables us to
understand whether programmatic errors are happening. That does not mean that whatever AEFIs
are reported do not have a direct association with the vaccine administration. Since we are keen on
tracking the pentavalent, we allow even deaths occurring a week after the vaccination to be
reported.He points out that on an average 3,600 children under the age of five years die every day in
the country, due to various factors. The point is that there can be many factors causing the death of
children, the vaccine might be incidental. However, we investigate every reported case of death or
even other adverse effects.
In fact, the vaccine has been available in the private sector in India for over a decade now, he said. The
vaccine has been demonstrated to be efficacious and effective in numerous studies and is widely
supported by global and Indian health communities.
Source: The Hindu, 2013
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(b) Sample of negative media reporting
Infant dies after measles vaccine in BBMP hospital
BANGALORE: Mystery shrouds the death of a nine-month-old baby, who died within hours of
being administered a measles vaccine at the Magadi Road maternity hospital run by Bruhat
Bengaluru Mahanagara Palike (BBMP) on Thursday evening.
The child, Nisarga, daughter of Ramu and Prema of Ranganathapura in Kamakshipalya, was
taken to the maternity hospital for her measles shot. "There were 49 children who were
administered the inoculation on the same day. But none of them had any problem," said BBMP
chief health officer Dr K E Manjula.
A complaint lodged before the Kamakshipalya police by Prema stated that around 10.30 am,
duty doctor Dr T Shobha had administered the inoculation and they returned home. The child
was given milk and put to sleep. Around 4.30 pm, before Ramu came home from work in a
private firm, she found froth coming out of the child's mouth.
A panicky Prema took Nisarga to a nearby private hospital, where the doctors declared the child
dead.
A distraught Prema waited for her husband to come home and around 11.30 pm, they went to
the police station and lodged the complaint against the doctor for medical negligence. Police
then sent the body for postmortem.
"We cannot jump to conclusions about medical negligence. We are awaiting the viscera and
pathology test reports from the forensic science laboratory. Only after that will we consider
taking any action," an investigating officer said.
Meanwhile, Dr Manjula told TOI that the death cannot be due to medical negligence. "We have
collected the report on the child's death. As there is no confirmation of medical negligence, we
are waiting for the forensic report. There were 49 children of the same age group who
underwent inoculation on that day. We are surprised how such a thing happened," she said.
The chief medical officer added that BBMP will contemplate action against the doctor in charge
of the maternity hospital only after the forensic report arrives.
Source: Times of India website, 2011
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441
6
Chapter
The Way Forward

Communication for immunization is more complex than it appears. Even
tougher is communicating about vaccine safety or risks and AEFI. The
challenges are many:
> The audience is diverse, their levels of understanding are different,
and their attention spans are different.
> The influence of negative communication is much more than that
of positive communication.
> The goals and motives of the media are different than that of ours.
> Science is too technical to be communicated easily.
Therefore, handling communication around AEFIs cannot be left to
happen on a hit-and-trial basis. Communication around AEFI demands
serious efforts in skills and knowledge building to manage risk
communication.
Though crisis situations demand an immediate response, there is a need
for continuous and consistent capacity building in this direction, even at
times when there is no crisis.
6.1 Key initiatives by the Government

> Establishing the Immunization Technical Support Unit (ITSU) with
AEFI and Strategic Communication as two important pillars:
An AEFI team has been set up to provide technical and strategic
guidance to capacity building for handling AEFI.
A Strategic Communications team has been set up to provide
technical assistance to MOHFW in strengthening communication
capacities of the states.
> Establishing an AEFI Secretariat at ITSU to assist the National AEFI
committee and coordinate the work of the program.
> Establishing an AEFI Collaborating Centre at the Department of
Paediatrics, Lady Hardinge Medical College, New Delhi, for providing
technical oversight.
> Establishing a Media-sub Committee under the National AEFI
Committee.
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442
! tailored to needs and understanding of

6.2 Handling communication audience and situation, backed with strong
around AEFI:15 scientific evidence.
> Invest in communication research: > More often than not, service providers are
Communication initiatives should be strongly unaware of details around vaccine safety issues.
rooted in research. The present perception is Therefore, apart from communicating with the
that most AEFIs are believed to be caused by end beneficiaries and media, it is essential to
and not directly attributable to vaccines. communicate with health care providers as
well.
> Studies on causality assessment and the nature
of manifestation of adverse effects (individual > Special mechanisms and opportunities should
versus cohort representation) etc. can provide be built-in to forge partnerships with
strong supporting evidence to communication development partners to build a concerted
aimed at dispelling myths and fears around communication response for handling AEFIs.
AEFI. It will also be useful to carry out For example, MOHFW, UNICEF, WHO, Global
population behavioral studies on communities Health Strategies, Johns Hopkins, Indian
recently affected by an adverse event following Academy of Pediatrics, NTAGI, and senior
immunization. journalists can be partners.
> Communication research on KAP, media > Establish mechanisms for cross-learning and
behaviors and what appeals to people can sharing of experiences among immunization
guide policy and programmatic initiatives in managers and health communicators for
improving communication around AEFI. The handling AEFIs.
research can play a critical role in working with > The aim should be to 'make people believe
pockets of resistance due to cultural and you and give them reasons to believe you'.
religious beliefs etc. The belief and faith built through open, regular
> Communication material on AEFI should not be and transparent communication, both about
developed on an ad-hoc basis but should be benefits and risks of vaccination, can ensure
strategically developed keeping the long-term that the occurrence of a few incidences of AEFI
perspective in mind. Communication should be do not reverse or dismantle the years of effort
and investment that have gone into improving
! consistent, coherent, and timely,
routine immunization.
! carry a positive appeal,
15
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443
6.2.1 Communication action points for each level for different types of serious AEFIs
(1) Death
Level of intervention Communication action points

Community Health > Immediately meet the parents and care givers and empathise with
Level Worker them.
> Hear them patiently.
> Ask some village elders or religious leaders to accompany you when
you go to meet the family.
> Followup with the family after one or two days and ensure their well-
being.
> Respect their space.
> Explain them the extent to which the benefits of vaccination outweigh
risks.
> Send the information to the Medical Officer or District Immunization
Officer immediately.
> Listen to what the parents and the public are saying.
Block Medical > Take the most trusted health worker along when you go to meet the
Level Officer family.
> Take control of the situation and reassure the community without
appearing judgemental.
> Keep people and media informed by providing them facts and
accurate information.
> If facts are not yet ready, inform them that the matter is being looked
into and the facts will be out in 'x' days (specify it).
> Understand risk perception of the family and the community.
> Disseminate timely and accurate messages.
> Get to the source of information and check factual accuracy of the
information.
> Conduct a meeting of supportive opinion leaders and journalists to
District District
discuss the situation and find possible solutions and way forward.
Level Immunization
> Understand the community's perception towards immunization and
Officer (DIO)
vaccination history of other children in the family.
> Identify support groups from within the community who could be
positive role models in your approach.
> Convince the community that vaccination at large is beneficial for
children.
> Respond to negative media questions with positive answers (few
sample questions are given in 5.6.3).
(Question: "Ever since xxx vaccine has been administered, many children
have died from vaccination. What do you have to say on this?"
Answer: "Immunisation saves lives. Since the immunisation programme
began, XX children have been vaccinated. Without vaccination, children
are more 'at risk' of getting potentially life-threatening diseases than
from vaccination.")
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444
State Level State > Do not overdo visiting the affected family and respect their space.
EPI Officer > Share feedback with community representatives.
> Review media coverage reports- look into the style and accuracy
of reporting.
> Prepare a database of journalists, both supportive and
unsupportive (identify journalists from the database as detailed in
section 5.3.1).
> Prepare a list of print and electronic media journalists covering
health at state level with their contact details (identify journalists
from the database as detailed in section 5.3.1).
> Identify spokespersons and orient them on how to respond to the
issue (identify spokespersons as detailed in section 5.3.4).
> Disseminate at appropriate times a consistent set of easy-to-
understand key messages to concerned families and communities
to appease their anxiety and reaffirm their faith in the health
system.
> Organize orientation workshops and deliberations for journalists.
This will help identify, in advance, the questions or concerns that
journalists specifically have.
> Organize regular orientation workshops and field visits for
journalists to help them better understand the advantages of
immunization and complexities of an immunization programme.
> Involve school teachers; this will send correct information and
message to parents and care givers of children and educate them.
> Review media coverage reports; look into the style and accuracy of
National Govt. official/
reporting.
Level National AEFI
Committee > Prepare a database of journalists, both supportive and
unsupportive (identify journalists from the database as detailed in
section 5.3.1).
> Prepare a list of print and electronic media journalists
coveringhealth at state level with their contact details (identify
journalists from the database as detailed in section 5.3.1).
> Identify spokespersons and orient them on how to handle media
queries (identify spokespersons as detailed in section 5.3.4).
> Organize visits for journalists to enable them to get a better
understanding of the immunization program and government
efforts.
> Participate in 'talk shows' on the issue to clarify the negative
picture and scotch further rumours from rising.
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445
(2) Hospitalization / Prolonged illness
Community Health > Assist the parents or care givers to get access to proper medical care
Level Worker at the hospital.
> Follow up with the family again after one or two days and ensure
their well- being.
> Appreciate efforts of the parents or care givers in getting their child
vaccinated.
> Explain to them the benefits of vaccination outweigh its risks.
> Send the information to the Block Immunization Officer immediately.
Block Medical > Listen to what the parents and public are saying and assure them of
Level Officer full support and best of medical care.
> Take the health worker along when you go to meet the family.
> Take control of the situation and do not blame the health worker for
AEFI.
> If facts are not yet ready, inform them that the matter is being looked
into and facts will be out in 'x'days (specify it).
> Understand risk perception of the family and the community.
> Disseminate timely and accurate messages to the media.
District District > Get to the source of information and check factual accuracy of the
Level Immunization information.
Officer (DIO) > Conduct a meeting of supportive opinion leaders and journalists to
discuss the situation and find possible solutions and way forward.
> Understand the community's perception towards immunization and
the vaccination history of other children in the family.
> Identify deviant support groups from within the community who
could be positive role models and help you in reaching out to the
community with the message that vaccination at large is beneficial
for children.
(Question: "Ever since xxx vaccine has been administered, many
children have died from vaccination. What do you have to say on this?"
Answer: "Immunisation saves lives. Since the immunisation
programme began, XX children have been vaccinated. Without
vaccination, children are more 'at risk' of getting potentially life-
threatening diseases than from vaccination.")
State State > Review media coverage reports; look into the style and accuracy of
Level EPI Officer reporting.
> Prepare a database of journalists, both supportive and unsupportive.
> Prepare a list of print and electronic media journalists covering
health at the state level with their contact details.
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446
> Identify spokespersons (including some from the community) and

orient them on how to respond to the issue.
understand key messages to concerned families and communities to
appease their anxiety and reaffirm their faith in the health system.
> Organize orientation workshops and deliberations for journalists.
This will help identify in advance the kind of questions or concerns
that journalists specifically have.
> Organize regular orientation workshops and field visits for journalists
to help them achieve a better understanding of immunization
advantages as well as complexities of an immunization programme.
> Involve school teachers; this will send correct information and
message to parents and care givers of children and educate them.
reporting.
National Govt. official/ > Prepare a database of journalists, both supportive and unsupportive
Level National AEFI (identify journalists from the database as detailed in section 5.3.1).
Committee > Prepare a list of print and electronic media journalists covering
health at state level with their contact details (identify journalists from
the database as detailed in section 5.3.1).
> Organize visits for journalists to enable them to get a better
understanding of the immunization program and government
efforts.
> Participate in 'talk shows' on the issue to clarify the negative picture
and appease further rumors from rising.
(3) Disability
Community Health > Immediately meet the parents or the care givers and empathize with
Level Worker them.
> Hear them patiently.
> Ask some village elders or religious leaders to accompany when you
go to meet the family.
> Follow up with the family again after one or two days and ensure the
well-being of the child.
> Send the information to the Block Immunization Officer immediately.
Block Medical > Listen to what the parents and the public are saying.
Level Officer > Take the health worker along when you go to meet the family.
38
447
> Take control of the situation and do not blame the health worker for
AEFI.
> If the facts are not yet ready, inform them that the matter is being
looked into and the facts will be out in some time.
District District > Conduct a meeting of supportive opinion leaders and journalists to
Level Immunization discuss the situation and find possible solutions and way forward.
Officer (DIO) > Understand the community's perception towards immunization and
vaccination history of other children in the family.
(Question: "Ever since xxx vaccine has been administered, many chil-
dren have died from vaccination. What do you have to say on this?"
Answer: "Immunisation saves lives. Since the immunisation programme
began, XX children have been vaccinated. Without vaccination, children
are more 'at risk' of getting potentially life-threatening diseases than
from vaccination.")
> Identify spokespersons and orient them on how to respond to the
State State
issue (identify spokespersons as detailed in section 5.3.4).
Level EPI Officer
understand key messages to concerned families and communities to
appease their anxiety and reaffirm their faith in the health system.
> Organize orientation workshops and deliberations for journalists. This
will help you to identify the kind of questions or concerns that journal-
ists have.
> Involve school teachers; this will send correct information and mes-
sage to parents and caregivers of children and educate them.
National Govt. official/
reporting.
Level National AEFI
> Prepare a database of journalists, both supportive and unsupportive
Committee
(identify journalists from the database as detailed in section 5.3.1).
> Prepare a list of print and electronic media journalists covering health
at state level with their contact details (identify journalists from the
database as detailed in section 5.3.1).
> Organize visits for journalists to enable them to get a better under-
standing of the immunization program and government efforts.
> Participate in 'talk shows' on the issue to clarify the negative picture
and appease further rumors from rising.
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448
40
449
7
Chapter
Conclusion
India is striving hard to achieve the Millennium Development Goals
(MDGs). The efforts towards improving child health are gradually
showing results. From the 'under satisfactory' performance in the past,
we have successfully brought up the performance to 'on- track'.
Intensification of Routine Immunization is one of the core strategies
contributing to the gains in this direction. With millions of children still
unimmunized, the goal of achieving universal immunization is distant,
but not unattainable.
The government has introduced many initiatives to reach the
unreached and marginalized population. These include strengthening
health systems and making new expensive vaccines available for free or
at minimal cost at health facilities. Despite earnest efforts of the
government, AEFI act as a barrier or rather a threat to achieving the
intended goal for Routine Immunization.
Given the dynamic nature of the Routine Immunization programme, its
coverage in the media has a direct implication on how the programme
is perceived. In many cases, the 'news report' also serves as a
communication tool to influence positive behaviour change in
communities, or even otherwise. Achievements of the programme
generate positive coverage, but a single case of AEFI leads to a spurt in
negative reporting, with the media questioning the programme
strategy. Technically incorrect information may lead to distorted
reporting such as reporting AEFI cases as negative fallout of the
concerned vaccine. At the same time, public health officials with limited
capacities of handling media and unrest amongst communities tend to
adopt an evasive strategy. These have negative implications not only on
the overall routine immunization program but also on the health of our
children. Such a situation calls for building capacities of government
officials on handling communication around AEFI.
We need to create an enabling environment where service providers are
aware of AEFIs and are equipped with necessary skill sets to deal with
them and strive to decrease reactions due to avertable causes. The
current and projected demand for immunization calls for a multi-
pronged strategic approach and investment in risk communication
41
450
with short-term and long-term action plans and important way to do this is to make regular
goals for generating an effective communication public announcements recognizing those
response to routine and crisis situations around districts that have achieved high coverage.
AEFI. The 'Communication Guidelines on AEFI' is a Raising public awareness about the impact of
step in this direction. vaccination programs on reducing disease
incidence and saving lives is also the need of
Some action points for improving the
the hour.
immunization program
6. Although personal anecdotes and experiences
1. There is no 'one-size-fits-all' communication
have persuaded government officials to
strategy. Strategies with tailored messages that
support specific vaccine programs, advocacy
use appropriate channels are required to reach
programs need to use evidence and data to
specific segments of the population, whether
highlight the benefits and cost effectiveness of
decision-makers or remote hard to reach
vaccinations over other health interventions.
populations.
Without well-planned advocacy, new vaccines
2. Proactive communication actions are needed to are not likely to be funded by governments and
curtail and prevent negative publicity and demand from caregivers and health service
resistance to immunization and to build providers is unlikely to rise.
continuous trust in vaccination programs by
7. The impact of print materials, or other single
working with opinion leaders who influence
information mediums, depends in part on
perceptions and behaviours of caregivers.
whether they are used with other
3. Positive attitudes and good inter-personal communication channels.
communication skills of front line health
8. Communication interventions should be
workers are decisive to promote long-term
tailored, based on information distinguishing
compliance well-designed, easy-to-use tools
knowledge and attitudes among users and
can often bridge the gap if inter-personal
non-users of immunization services.
communication skill-building programs cannot
be assured. 9. Grassroots communication strategies are more
likely to succeed if they are integrated with the
4. Strengthening and supervising communication
provision of other community health and social
skills of health service providers should be
needs.
integral to immunization planning and training.
10. Effective communication interventions can
5. In-country advocacy coalitions are key to
increase demand but if the quality or
building and maintaining awareness about the
availability of services is poor, many caregivers
value of immunization programs. One
are not likely to return to complete vaccination
schedules.
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451
REFERENCES
1. Building Trust and responding to AEFI in South Asia: Using Strategic Communication
2. Communication on Immunization- Building Trust European Centre for Disease
Prevention and Control http://www.ecdc.europa.eu/en/publicatios/publications/ter
immunization-and-trust.pdf
3. WHO Vaccine basic safety e-learning course at www.who.int/vaccine/documents
4. http://pib.nic.in/newsite/erelease.aspx?relid=91539
5. http://www.unicef.org/india/media_8106.htm
6. http://www.vaccine-safety-training.org /responding to-rumours-and-crises.html
7. http://www.cdsco.nic.in/AEFI%20Guidelines%20Print%20ready%202010.pdf
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About Immunization Technical Support Unit (ITSU)

The Immunization Technical Support Unit (ITSU) was established by the Public Health
Foundation of India (PHFI) in March 2012, under the auspices of the Ministry of Health and
Family Welfare (MoHFW) to support the Universal Immunization Programme (UIP).
The overall vision of the ITSU is to catalyze national improvements in routine immunization
by providing technical and management expertise required to design, create, implement,
and institutionalize a stronger immunization program fully led by the Government of India,
and supported from the Bill and Melinda Gates Foundation.
The ITSU works with the MoHFW to strengthen Government of India's efforts to improve
routine immunization coverage through six different pillars:
Six Pillars of ITSU
AEFI
Vaccine Strategic
Management
Monitoring & Logistics and Planning and Evidence Strategic
and Vaccine
Evaluation Cold Chain System to Policy Communication
Quality and
Management Design
Safety
The ITSU serves to harmonize various initiatives being piloted or implemented in different
states by all immunization partners and provide a single platform for discussions,
development of strategies and coordination with partners for scaling up the successful
models.
453
concept, design and print by GENESIS 98100 33682 genesisadvt@hotmail.com

ANNEXURE P-11 454
THE SECOND SCHEDULE
(Rule 3)
DISTRIBUTION OF SUBJECTS AMONG THE DEPARTMENTS {YIBHAG)
MINISTRY OF AGRICULTURE AND FARMERS WELFARE 1

(KRISHI EVAM KISAN KALYAN MANTRALAYA)
A. DEPARTMENT OF AGRICULTURE, COOPERATION AND FARMERS

WELFARE
(KRISHI, SAHKARITA EVAM KISAN KALYAN VIBHAG)
PART I
The following subjects which fall within List I of the Seventh Schedule to the
Constitution of India :
1. Liaison with international Agri-Organisations like Food and Agriculture organisation
of the United Nations, handling of CARE goods concerning agriculture, etc.
2. Participation in international conferences, associations and other bodies concerning
agriculture and implementation of decisions made thereat.
3. Convention on Locust Control.
4. Plant Quarantine.
5. Industries, the control of which by the Union is declared by Parliament by law to be
expedient in Public interest; as far as these relate to:-
(a) Development of agricultural industries including machinery, fertilizer and
seeds but excluding cotton, ginning and pressing with the limitation that in
regard to the development of agricultural industries, including machinery
and fertilizer, the functions of the Department of Agriculture, Cooperation
and Farmers Welfare do not go further than the formulation of demands and
the fixation of targets;
(b) Shellac Industry.
6. Agricultural Census.
7. Omitted. 2
8. Omitted. 3
9. Omitted. 4
10. Indian People's Natural Calamity Trust.
11. Technology Mission on Oilseeds and Pulses.
PART II
The following subjects which fall within List III of the Seventh Schedule to the
Constitution of India (as regards legislation only):
1 Modified vide Amendment series no.317 dated 27.08.2015

2 Omitted vide Amendment series no.319 dated 12.09.2015
3 Omitted vide Amendment series no.319 dated 12.09.2015 ( Earlier modified vide Amendment series no.288
dated 14.10.2006)
13
455
12. Adulteration of agricultural products other than foodstuffs.
13. Economic Planning (Agricultural Economics and Statistics).
14. Professions (excluding Veterinary Practice).
15. Prevention of the extention from one State to another of infectious or contagious
diseases or pests affecting plants including locusts.
16. Price control of agricultural commodities except foodgrains, sugar, vanaspati, oil
seeds, vegetable oils, cakes and fats, jute, cotton and tea.
17. Administration of the Dangerous Machine (Regulation) Act, 1983 (35 of 1983).
Part III
For the Union Territories the subjects mentioned in Parts I and II above, so far as they
exist in regard to these territories and, in addition, to the following subjects which fall within
List II of the Seventh Schedule to the Constitution of India:
18. Agriculture (Other than agricultural education and research) protection against pests
and prevention of plant diseases.
19. Co-operation in agricultural sector. 1
20. General Policy relating to the marketing of agricultural produce including pricing,
exports etc.
21. Omitted.2
22. The Agricultural Produce (Grading and Marking) Act, 1937 (1 of 1937).
23. Omitted. 3
24. General Policy in the field of Co-operation and Co-ordination of co-operation

activities in all sectors.
Note:- The Ministries concerned are responsible for Co-operatives in the respective fields.
25. Matters relating to National Co-operative Organisation.
26. National Co-operative Development Cooperation.
27. Incorporation, regulation and winding up of Co-operative societies with objects not
confined to one State including administration of 'the Multi-State Co-operative Societies Act,
2002 (39 of 2002)':
Provided that the administrative Ministry or Department shall be 'the Central
Government' for the purpose of exercising powers under the Multi-State Co-operative
Societies Act, 2002 (39 of 2002), for Co-operative units functioning under its control.
28. Training of personnel of co-operative departments and co-operative institutions

(including education of members, office bearers and non-officials).
PART IV
General and Consequential:

14
456
29. All Matters relating to international cooperation and assistance in agriculture and
allied subjects other than the items of work allocated to Department of Agricultural Research
and Education.
30. Agriculture and horticulture.
31. Bio-aesthetic Planning.
32. Agricultural Production-Grow more food .
33. Land Reclamation.
34. Infrastructure for post harvest management of agriculture and horticulture.
35. National Land Use and Conservation Board.
36. Development of Cotton, Jute and Sugarcane.
37. Soil Survey in connection with development programmes.
38. Financial assistance to State Soil Conservation Schemes.
39. Projection of demand of fertilizers and manures at all-India, zone or region level;
fixation of targets, nutrient-wise, for zones or regions.
40. Administration of the Fertilizer (Control) Order, 1957.
41. Monitoring of Pesticides Residues at National Level.
42. Administration of the Insecticides Act, 1968 (46 of 1968).
43. Agricultural Implements and Machinery.
44. Organisation and Development of extension education and training in the country.
45. Omitted. 1
46. Production of oil seeds.
46A. Production of plant material, development of nurseries and plantations for bio-fuels
including coordination with other Ministries or Departments in this regard. 2
47. Omitted. 3
48. Machanised Farms.
49. Organic Farming (all matters including development and promotion but excluding
matters relating to certification of organic foods/products for export purpose).
50. On Farm Water Management.
51. Omitted. 4
52. All attached and Subordinate Offices or other organisations concerned with any of the
subjects specified in this list except the Directorate of Agricultural Aviation.

2 Inserted vide Amendment series no.287 dated 12.07.2006
15
457
53. Quality control of fertilizers.
54. National Rainfed Area Authority (NRAA). 1
PARTV2
55. Matters relating to damage to crops and co-ordination of relief measures necessitated
by drought, hailstorm and pest-attacks, cold wave and frost.
56. Matters relating to loss of human life due to drought.
57. Agricultural credit and indebtedness.
58. Crop Insurance.
59. Crop campaigns, crop competitions and farmers organisations including Farmer
Producer Organisations.
60. Agricultural Schemes received from States and Union Territories for landless
agricultural labour.
61. Setting up of agricultural markets in rural areas.
62. Warehousing in rural areas including rural godowns.
63. Schemes for welfare of farmers.
1 Inserted vide Amendment series no.312 dated 21.3.2015 (earlier inserted in erstwhile Planning Commission
vide amendment series no.298 dated 17.08.2010)

16
458
B. DEPARTMENT OF AGRICULTURAL RESEARCH AND EDUCATION
(KRISHI ANUSANDHAN AUR SHIKSHA VIBHAG)
PART I
Constitution of India:
1. International cooperation and assistance in the field of agricultural research and
education including relations with foreign and international agricultural research and
education institutions and organisations.
2. Fundamental, applied and operational research and higher education including
coordination of such research and higher education in agriculture, agroforestry,
animal husbandry, dairying, fisheries, agricultural engineering and horticulture
including agricultural statistics, economics and marketing.
3. Coordination and determination of standards in institutions for higher education or
research and scientific and technical institutions in so far as they relate to food and
agriculture including animal husbandry, dairying and fisheries. Development of
Human Resources in Agricultural Research/Extensions and Education.
4. Cess for financing to the Indian Council of Agricultural Research and the Commodity
Research Programmes other than those relating to tea, coffee and rubber.
5. Sugarcane research.
PART II
For Union Territories the subjects mentioned in Part I above, so far as they exist in
regard to these Territories and in addition the following subject which falls within List II of
the Seventh Schedule to the Constitution of India:
6. Agricultural Education and Research.
PARTIII
General and Consequential:
7. Plant, animal and fish introduction and exploration.
8. All India Soil and Land Use Survey relating to research training, co-relation,
classification, soil mapping and interpretation.
9. Financial assistance to State Governments and Agricultural Universities in respect of
agricultural research and educational schemes and programmes.
10. National Demonstrations.
11. Indian Council of Agricultural Research and its constituent Institutes, National
Research Centres, Project Directorates, Bureaux and All India Coordinated Projects.
12. Research and Development on production and improvement ofbio-fuels plants. 1

17
459
C. DEPARTMENT OF ANIMAL HUSBANDRY, DAIRYING AND FISHERIES
1(PASHUPALAN, DAIRY AUR MATSYAPALAN VIBHAG)
PART I
Constitution of India:
1. Industries, the control of which by the Union is declared by Parliament by law to be
expedient in Public interest as far as these relate to Development of Livestock, fish and
birds feed and dairy, poultry and fish products with the limitation that in regard to the
development of industries, the functions of the Department of Animal Husbandry and
Dairying do not go further than the formulation of the demand and fixation of targets.
2. Liaison and cooperation with international organizations in matters relating to
livestock, poultry and fisheries development.
3. Livestock Census.
4. Livestock Statistics.
5. Matters relating to loss of livestock due to natural calamities.
6. Regulation of Livestock importation, Animal Quarantine and Certification.
7. Fishing and fisheries (inland, marine and beyond territorial waters).
8. Fishery Survey of India, Mumbai.
PART II
The following subjects which fall within List III of the Seventh Schedule to the
Constitution of India (as regards legislation only):
9. Profession of Veterinary Practice.
10. Prevention of the extension from one State to another or infectious or contagious
diseases or pests affecting animals, fish and birds.
11. Conversion of indigenous breeds; introduction and maintenance of Central Herd
Books for indigenous breeds of livestock.
12. Pattern of financial assistance to various State Undertakings, Dairy Development
Schemes through State agencies/Co-operative Unions.
PARTIII
For the Union Territories the subjects mentioned in parts I and II above, so far as they
exist in regard to these territories and, in addition, to the following subjects which fall within
List II of the Seventh Schedule to the Constitution of India:
13. Preservation, protection and improvement of stocks and prevention of diseases of
animals, fish and birds, Veterinary training and practice.
14. Courts of Wards.
15. Insurance oflivestock, fish and birds.
PART IV
16. Matters relating to cattle utilisation and slaughter.
17. Fodder development.
1 Modified vide Amendment series no.280 dated 09.03.2005.

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460
MINISTRY OF AYURVEDA, YOGA AND NATUROPATHY, UNANI,
SIDDHA AND HOMOEOPATHY (AYUSH) (AYURVEDA, YOGA AUR
PRAKRATIK CHIKITSA, UNANI, SIDDHA AUR HOMOEOPATHY
(AYUSH) MANTRALAYA)1
I. UNION BUSINESS
1. Formulation of policy and policy issues for development and propagation of
Ayurveda, Siddha, Unani, Homoeopathy, Yoga and Naturopathy systems.
2. Development and implementation of programmes including Central schemes and

Centrally sponsored schemes for development and propagation of Ayurveda, Siddha, Unani,
Homoeopathy, Yoga and Naturopathy systems.
3. Co-ordination and promotion of research and development including assistance

therefor in Ayurveda, Siddha, Unani, Homoeopathy, Yoga and Naturopathy systems.
4. Setting up and maintenance of Central institutions for research and development,

education and standards relating to Ayurveda, Siddha, Unani, Homoeopathy, Yoga and
Naturopathy systems.
5. All issues and matters requiring action at the level of Government in regard to-
(a) Pharmacopoeia! Laboratory for Indian Medicine, Ghaziabad;
(b) Homoeopathic Pharmacopoeia Laboratory, Ghaziabad;
(c) Central Council of Indian Medicines;
(d) Central Council of Homoeopathy;
(e) Ayurvedic Pharmacopoeia Committee;

(f) Homoeopathic Pharmacopoeia Committee;
(g) Unani Pharmacopoeia Committee;
(h) Siddha Pharmacopoeia Committee;
(i) Ayurvedic, Siddha and Unani Drugs Technical Advisory Board;
G) Central Council for Research in Ayurveda and Siddha;
(k) Central Council for Research in Homoeopathy;
(1) Central Council for Research in Unani Medicine;
(m) Central Council for Research in Yoga and Naturopathy;
(n) National Institute of Ayurveda;
(o) National Institute of Homoeopathy;
(p) National Institute ofNaturopathy;
(q) National Institute of Yoga;
1 Inserted vide Amendment series no.310 dated 08.12.2014 (Earlier modified vide amendment series no.279
dated 01.03.2005 as D/o AYUSH)

19
461
(r) National Institute of Unani Medicine;
(s) National Institute of Siddha;
(t) Institute of Post-Graduate Teaching and Research, Gujarat Ayurveda
University;
(u) Indian Medicines and Pharmaceuticals Corporation Limited;
(v) Rashtriya Ayurveda Vidyapeeth.
6. Education, Training and Research in all aspects of Indian Systems of Medicine
including higher training abroad.
7. Matters of cadre formation and control including formation and amendment of
recruitment rules, recruitment, promotion and all other service matters relating to Indian
Systems of Medicine and Homoeopathy doctors of Central Government Health Scheme
including doctors in Indian Systems of Medicine and Homoeopathy central hospitals
requiring action at Government level.
Note.- Day-to-day administration and management will continue to be with the Director,
Central Government Health Scheme.
8. Liaison with foreign countries and international bodies as regards matters relating to
Indian Systems of Medicine and Homoeopathy.
9. Matters relating to scientific societies/associations and charitable and religious
endowments relating to Indian Systems of Medicine and Homoeopathy.
10. Matters relating to quality and standards for drugs in Indian Systems of Medicine and
Homoeopathy to the extent such matters require action at the level of Government.
11. Consultation and coordination with State Governments, Non-Government
Organisations and institutions for review of work and programmes in Indian Systems of
Medicine and Homoeopathy.
12. Statistics relating to various aspects of Indian Systems of Medicine and
Homoeopathy.
13. Proposals and matters concerning Union Territories requmng sanction and
concurrence of Government of India in regard to Indian Systems of Medicine and
Homoeopathy.
14. Legislative proposals pertaining to Indian Systems of Medicine and Homoeopathy of
individual states requiring sanction and concurrence of Government of India.
15. Medicinal Plant Board.
20
462
MINISTRY OF HEAL TH AND FAMILY WELFARE
(SWASTHYA AUR PARIVAR KALYAN MANTRALAYA)
A. DEPARTMENT OF HEALTH AND FAMILY WELFARE 1
(SWASTHYA AUR PARIVAR KALYAN VIBHAG)
I. UNION BUSINESS
1. Union agencies and institutes for research or for the promotion of special studies in
medicine and nutrition including all matters relating to -
(a) Central Research Institute;
(b) All India Institute of Hygiene and Public Health;
(c) National Institute of Communicable Diseases;
(d) Central Drugs Laboratory;
(e) Rajkumari Amrit Kaur College of Nursing;
(f) Lady Reading Health School;
(g) Central Institute of Psychiatry;
(h) Dr.Ram Manohar Lohia Hospital and Nursing Home;
(i) Safdarjang Hospital;
(j) Medical Stores Organisation;
(k) B.C.G. Vaccine Laboratory;
(1) Jawaharlal Institute of Post-Graduate Medical Education and Research;
(m) Smt. Sucheta Kirpalani Medical College and Hospital and Kalawati Saran
Children's Hospital;
(n) Central Government Health Scheme (CGHS);
(o) Central Health Service;
(p) Serologist and Chemical Examiner to the Government of India.
(q) National AIDS Control Organisation (NACO). 2
2. All matters relating to the following Institutions-
(a) Central Food Laboratory.
(b) Central Food and Standardisation Laboratory.
(c) Central Indian Pharmacopoeia Laboratory.
(d) All India Institute of Physical Medicine and Rehabilitation.
(e) National Tuberculosis Institute.
(f) Central Leprosy Teaching and Research Institute.
1Modified vide Amendment series no.279 dated 01.03.2005

2Inserted vide Amendment series no.282 dated 12.01.2006; Omitted vide Amendment series no.294 dated
20.12.2008 and re-inserted vide Amendment series no.307 dated 06.08.2014
71
463
(g) Regional Leprosy Training and Research Centre, Raipur (Uttar Pradesh), Aska
(Orissa), Gauripur(West Bengal), Teetulmari (Bihar).
(h) Port Quarantine (sea and air) seamen's and marine hospitals and hospitals
connected with port quarantine.
(i) Port and Air Port Health Organisations.
(j) Medical Examination of seamen.
(k) International Health Regulations.
(1) World Health Organisation (WHO).
3 (a) The Food Safety and Standards Act, 2006 (34 of 2006) 1
(b) The Prevention of Food Adulteration Act, 1954 (37 of 1954) and the Central
Food Laboratory. 2
4. Higher training abroad in medical and allied subjects.

5. Coordination of work in respect of International Conferences in India and abroad in
medical and related fields.
6. Health Programmes relating to-
(a) International aid for Health Programmes.
(b) National Programme for Control of Blindness.
(c) National Leprosy Eradication Programme.

(d) National Tuberculosis Control Programme.
(e) National Malaria Eradication Programme.
(f) All National Programmes relating to control and eradication of communicable
diseases.
(g) Bilateral Cultural Exchange Programmes relating to control and eradication of
communicable diseases.
7. Fellowships-for training in India and abroad in various medical and health subjects.
8. Matters relating to epidemics - Problems connected with supply of medicines, effects
of malnutrition and shortage of drinking water leading to various diseases as a result
of natural calamities.
II. LIST OF BUSINESS FOR LEGISLATIVE AND EXECUTIVE
PURPOSES IN RESPECT OF UNION TERRITORIES.
9. Public Health hospitals and dispensaries.
10. Scientific societies and associations pertaining to subjects dealt with in the
Department.
11. Charitable and religious endowments pertaining to subjects dealt with in the
Department.

72
464
III. LIST OF BUSINESS WITH WHICH THE CENTRAL GOVERNMENT
DEAL IN A LEGISLATIVE CAPACITY ONLY FOR THE UNION
AND IN BOTH LEGISLATIVE AND EXECUTIVE CAPACITIES FOR
ALL UNION TERRITORIES.
12. All Matters relating to-
(a) The Medical profession and medical education.

(b) The nursing profession and nursing education.
(c) Pharmacists and Pharmacy education.

(d) The dental profession and dental education.
(e) Mental Health.
(f) Drugs Standards.
(g) Advertisements relating to drugs and medicines.

(h) Prevention of the extension from one State to another of infectious or
contagious diseases affecting human beings.
(i) Prevention of adulteration of foodstuffs and drugs.
(j). Regulatory aspects namely quality, safety, labelling and performance of
medical devices 1.
IV. MISCELLANEOUS BUSINESS

(a) The Medical Council oflndia.

(b) The Central Councils of Health and Family Welfare.
(c) Dental Council of India.
(d) Indian Nursing Council.
(e) Pharmacy Council of India
(f) Indian Pharmacopoeia Committee.
14. Concession of medical attendance and treatment for Central Government servants
other than (i) those in Railway Service (ii) those paid from Defence Service Estimates
(iii) officers governed by the All India Services (Medical Attendance) Rules, 1954
and (iv) officers governed by the Medical Attendance Rules, 1956.
15. Medical Examination and Medical Boards for Central Civil Services [other than those
controlled by the Department of Railways and those paid from Defence Services
Estimates excepting Civilian Services.].
15 A. Rashtriya Swasthya Bima Yojana. 2
1 Inserted vide amendment series no.315 dated 5.8.2015.

2 Inserted vide amendment series no.313 dated 24.03.2015
73
465
(a) Grants to Vallabhbhai Patel Chest Institute (under Delhi university).
(b) Grants to Indian Red Cross Society.
(c) Spas and Health resorts.
(d) National Board of Examination.
(e) Chittaranjan National Cancer Research Centre.
(f) All India Institute of Medical Sciences.
(g) All India Institute of Speech and Hearing.
(h) Pasteur Institute of India.
(i) Physiotherapy Training Centre, King Edward Memorial Hospital.
(j) National Institute of Mental Health and Neuro Sciences.
(k) Hospital Services Consultancy Corporation Limited.
V. FAMILY WELFARE MATTERS
17. Policy and organisation for Family Welfare.
18. All matters relating to:-
(a) National Health Mission 1.
(b) National Commission on Population.
(c) Reproductive and Child Health.
19. Inter-sectoral coordination in accordance with the National Population Policy.
20. Matters related to Janasankhya Sthiarta Kosh and Empowered Action Group.
21. Organisation and direction of education, training and research in all aspects of family
welfare including higher training abroad.
22. Production and supply of aids to Family Planning.
23. Liaision with foreign countries and international bodies as regards matters relating to
family welfare.
24. Family Welfare Schemes and projects with external assistance.
25. International Institute of Population Sciences, Mumbai.
26. Development and production of audiovisual aids, extensional education and
information in relation to population and family welfare.
27. Promoting Public Private Partnership for the Family Welfare Programme.
28. All Matters relating to following Institutions:-
(a) Hindustan Latex Limited, Thiruvananthapuram.
(b) National Institute of Health and Family Welfare, New Delhi.
29. Implementation of Pre-conception and Pre-natal Diagnostic Techniques (Prohibition
of Sex Selection) Act, 1994 (57 of 1994) - Medical Termination of Pregnancy Act,
1971 (34 of 1971).
1 Amended vide series no.326 dated 21.5.2016

74
466
B. Omitted1

75
467
C. DEPARTMENT OF HEALTH RESEARCH (SWASTHYA ANUSANDHAN
VIBHAG) 1
1. Promotion and co-ordination of basic, applied and clinical research including clinical
trials and operational research in areas related to medical, health, biomedical and
medical profession and education through development of infrastructure, manpower
and skills in cutting edge areas and management of related information thereto.
2. Promote and provide guidance on research governance issues, including ethical issues
in medical and health research.
3. Inter-sectoral coordination and promotion of public - private - partnership in medical,
bio-medical and health research related areas.
4. Advanced training in research areas concerning medicine and health, including grant
of fellowships for such training in India and abroad.
5. International co-operation in medical and health research, including work related to
international conferences in related areas in India and abroad.
6. Technical support for dealing with epidemics and natural calamities.
7. Investigation of outbreaks due to new and exotic agents and development of tools for
prevention.
8. Matters relating to Scientific societies and associations, Charitable and religious
endowments in medicine and health research areas.
9. Coordination between organizations and institutes under the Central and State
Governments in areas related to the subjects entrusted to the Department and for the
promotion of special studies in medicine and health.
10. Indian Council of Medical Research.

76
468
D. Omitted1
1 Omitted vide Amendment series no.307 dated 06.08.2014 (earlier inserted vide amendment series no.294 dated
20.12.2008)
77
ANNEXURE P-12
469
Government of India (Allocation of Business) Rules, 1961

भारत सरकार (कार्य आबंटन) ननर्म, 1961
(As Amended up to 31st January, 2017)

(31 जनवरी, 2017 तक र्था संशोधित)
CABINET SECRETARIAT
मंत्रिमंडल सधिवालर्
470
Index
Subject Pg.No.
I. Order dated 14.01.1961 6
II. First Schedule 8
III. Second Schedule 13
Ministry/ Department
Ministry of Agriculture and Farmers Welfare (Krishi Evam Kisan

Kalyan Mantralaya)
1. (i) Department of Agriculture, Cooperation and Farmers Welfare 13
(Krishi, Sahkarita Evam Kisan Kalyan Vibhag)
2. (ii) Department of Agricultural Research and Education (Krishi 17
Anusandhan aur Shiksha Vibhag)
3. (iii) Department of Animal Husbandry, Dairying and Fisheries 18
(Pashupalan, Dairy aur Matsyapalan Vibhag)
4. Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and 19

Homoeopathy (AYUSH) (Ayurveda, Yoga aur Prakratik Chikitsa,
Unani, Siddha aur Homoeopathy (AYUSH) Mantralaya)
Ministry of Chemicals and Fertilizers (Rasayan aur Urvarak

Mantralaya)
5. (i) Department of Chemicals and Petro-Chemicals (Rasayan aur 21
Petro-Rasayan Vibhag)
6. (ii) Department of Fertilizers (Urvarak Vibhag) 22
7. (iii) Department of Pharmaceuticals (Aushadh Vibhag) 23
8. Ministry of Civil Aviation (Nagar Vimanan Mantralaya) 24
9. Ministry of Coal (Koyala Mantralaya) 25
Ministry of Commerce and Industry (Vanijya aur Udyog

Mantralaya)
10. (i) Department of Commerce (Vanijya Vibhag) 26
11. (ii) Department of Industrial Policy and Promotion (Audyogik Niti 29
aur Samvardhan Vibhag)
Ministry of Communications (Sanchar Mantralaya)

12. (i) Department of Telecommunications (Doorsanchar Vibhag) 31
13. (ii) Department of Posts (Dak Vibhag) 33
Ministry of Consumer Affairs, Food and Public Distribution

(Upbhokta Mamle, Khadya aur Sarvajanik Vitaran Mantralaya)
14. (i) Department of Consumer Affairs (Upbhokta Mamle Vibhag) 35
1
471
15. (ii) Department of Food and Public Distribution (Khadya aur 36
Sarvajanik Vitaran Vibhag)
16. Ministry of Corporate Affairs (Corporate Karya Mantralaya) 37
17. Ministry of Culture (Sanskriti Mantralaya) 38
Ministry of Defence (Raksha Mantralaya)

18. (i) Department of Defence (Raksha Vibhag) 41
19. (ii) Department of Defence Production (Raksha Utpadan Vibhag) 43
20. (iii) Department of Defence Research and Development (Raksha 44
Anusandhan aur Vikas Vibhag)
21. (iv) Department of Ex-Servicemen Welfare (Poorva Senani Kalyan 46
Vibhag)
22. Ministry of Development of North Eastern Region (Uttar Poorvi Kshetra 47

Vikas Mantralaya)
23. Ministry of Drinking Water and Sanitation (Peya Jal aur Swachchhata 48
Mantralaya)
24. Ministry of Earth Sciences (Prithvi Vigyan Mantralaya) 49
25. Ministry of Electronics and Information Technology (Electroniki aur 50

Soochana Praudyogiki Mantralaya)
26. Ministry of Environment, Forest and Climate Change (Paryavaran, Van 51

aur Jalvaayu Parivartan Mantralaya)
27. Ministry of External Affairs (Videsh Mantralaya) 53
Ministry of Finance (Vitta Mantralaya)

28. (i) Department of Economic Affairs (Arthik Karya Vibhag) 57
29. (ii) Department of Expenditure (Vyaya Vibhag) 62
30. (iii) Department of Revenue (Rajaswa Vibhag) 64
31. (iv) Department of Investment and Public Asset Management 66
(DIPAM) (Nivesh aur Lok Parisampatti Prabandhan
Vibhag(DIPAM))
32. (v) Department of Financial Services (Vittiya Sewayen Vibhag) 67
33. Ministry of Food Processing Industries (Khadya Prasanskaran Udyog 69

Mantralaya)
Ministry of Health and Family Welfare (Swasthya aur Parivar

Kalyan Mantralaya)
34. (i) Department of Health and Family Welfare (Swasthya aur Parivar 70
Kalyan Vibhag)
35. (iii) Department of Health Research (Swasthya Anusandhan Vibhag) 75
Ministry of Heavy Industries and Public Enterprises (Bhari Udyog

aur Lok Udyam Mantralaya)
36. (i) Department of Heavy Industry (Bhari Udyog Vibhag) 77
2
472
RASHTRAPATI BHAVAN
NEW DELHI
January 14,1961/Pausa 24, 1882(S)
ORDER
THE GOVERNMENT OF INDIA (ALLOCATION OF BUSINESS) RULES
In exercise of the powers conferred by clause (3) of article 77 of the Constitution and
in supercession of all previous rules and orders on the subject the President hereby makes the
following rules for the allocation of the business of the Government of India.
1. Short Title - These rules may be called the Government of India (Allocation of
Business) Rules, 1961.
2. Allocation of Business - The business of the Government of India shall be transacted
in the Ministries, Departments, Secretariats and Offices specified in the First Schedule to
these rules (all of which are hereinafter referred to as "departments").
3. Distribution of Subjects1 –
(1) The distribution of subjects among the departments shall be as specified in the
Second Schedule to these Rules and shall include all attached and subordinate
offices or other organisations including Public Sector Undertakings concerned
with their subjects and Sub-rules (2), (3) and (4) of this Rule.
(2) The compiling of the accounts of each Department shall stand allocated to that
Department with effect from the date from which the President relieves, by
order made under the first proviso to sub-section (1) of Section 10 of the
Comptroller and Auditor General's (Duties, Powers and Conditions of Service)
Act, 1971; the Comptroller and Auditor General from the responsibility for
compiling the accounts of that Department.
(3) Where sanction for the prosecution of any person for any offence is required
to be accorded-
a) If he is a Government servant, by the Department which is the Cadre
Controlling authority for the service of which he is a member, and in
any other case, by the Department in which he was working at the time
of commission of the alleged offence;
b) If he is a public servant other than a Government servant, appointed by
the Central Government, by the Department administratively
concerned with the organisation in which he was working at the time
of commission of the alleged offence; and
c) In any other case, by the Department which administers the Act under
which the alleged offence is comitted;
Provided that where, for offences alleged to have been comitted,

sanction is required under more than one Act, it shall be competent for the
Department which administers any of such Acts to accord sanction under all
such Acts.
1
Substituted vide 116th Amendment dated 29.03.1976, thereafter, sub-para 3(1) substituted
and sub-paras 3(3) and 3(4) inserted vide 187th Amendment dated 30.09.1986. Further
modified vide Amendment series no.271 dated 06.01.2004.
6
473
(4) Notwithstanding anything contained in sub-rule (3), the President may, by
general or special order, direct that in any case or class of cases, the sanction
shall be by the Department of Personnel and Training.
4. Allocation of Departments among Ministers1 –
(1) The business of the Government of India allocated to Cabinet Secretariat is

and, shall always be deemed to have been, allotted to the Prime Minister. ($)
(2) Subject to the provisions of sub-rule (1), the President may, on the advise of
the Prime Minister, allocate the business of the Government of India among
Ministers by assigning one or more departments to the charge of a Minister.
(3) Notwithstanding anything contained in sub-rule(1) or sub-rule(2), the

President may, on the advice of the Prime Minister -
(a) associate in relation to the business allotted to a Minister under either

of the said sub-rules, another Minister or Deputy Minister to perform
such functions as may be assigned to him; or
(b) entrust the responsibility for specified items of business affecting any
one or more than one Department to a Minister who is in charge of any
other Department or to a Minister without Portfolio who is not in
charge of any Department.
RAJENDRA PRASAD
PRESIDENT
1
Substituted by Amendment series no.87 dated 26.10.1970.
7
474
THE FIRST SCHEDULE
(Rule 2)
MINISTRIES, DEPARTMENTS, SECRETARIATS AND OFFICES
(MANTRALAYA, VIBHAG, SACHIVALAYA TATHA KARYALAYA)
1. Ministry of Agriculture and Farmers Welfare (Krishi Evam Kisan Kalyan

Mantralaya)1
(i) Department of Agriculture, Cooperation and Farmers Welfare (Krishi,
Sahkarita Evam Kisan Kalyan Vibhag)2
(ii) Department of Agricultural Research and Education (Krishi Anusandhan aur
Shiksha Vibhag)
(iii) Department of Animal Husbandry, Dairying and Fisheries (Pashupalan, Dairy
aur Matsyapalan Vibhag)3
2. Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy
(AYUSH) (Ayurveda, Yoga aur Prakratik Chikitsa, Unani, Siddha aur Homoeopathy
(AYUSH) Mantralaya)4
3. Ministry of Chemicals and Fertilizers (Rasayan aur Urvarak Mantralaya)
(i) Department of Chemicals and Petro-Chemicals (Rasayan aur Petro-Rasayan
Vibhag)
(ii) Department of Fertilizers (Urvarak Vibhag)
(iii) Department of Pharmaceuticals (Aushadh Vibhag) 5
4. Ministry of Civil Aviation (Nagar Vimanan Mantralaya)
5. Ministry of Coal (Koyala Mantralaya)6
6. Ministry of Commerce and Industry (Vanijya aur Udyog Mantralaya)
(i) Department of Commerce (Vanijya Vibhag)
(ii) Department of Industrial Policy and Promotion (Audyogik Niti aur
Samvardhan Vibhag)
7. Ministry of Communications (Sanchar Mantralaya)7
(i) Department of Telecommunications (Doorsanchar Vibhag)
(ii) Department of Posts (Dak Vibhag)
(iii) Omitted8
7A. -----9
8. Ministry of Consumer Affairs, Food and Public Distribution (Upbhokta Mamle,
Khadya aur Sarvajanik Vitaran Mantralaya)
(i) Department of Consumer Affairs (Upbhokta Mamle Vibhag)
(ii) Department of Food and Public Distribution (Khadya aur Sarvajanik Vitaran
Vibhag)
1
Modified vide Amendment series no.317 dated 27.08.2015
2
3
4
Inserted vide Amendment series no.310 dated 08.12.2014.
5
Inserted vide Amendment series no.293 dated 01.07.2008 and modified vide Amendment 298 dated 17.8.2010
6
7
8
Omitted vide Amendment series no.327 dated 16.07.2016
9
8
475
MINISTRY OF AYURVEDA, YOGA AND NATUROPATHY, UNANI,
SIDDHA AND HOMOEOPATHY (AYUSH) (AYURVEDA, YOGA AUR
PRAKRATIK CHIKITSA, UNANI, SIDDHA AUR HOMOEOPATHY
(AYUSH) MANTRALAYA)1
I. UNION BUSINESS
1. Formulation of policy and policy issues for development and propagation of
2. Development and implementation of programmes including Central schemes and
Centrally sponsored schemes for development and propagation of Ayurveda, Siddha, Unani,
3. Co-ordination and promotion of research and development including assistance
therefor in Ayurveda, Siddha, Unani, Homoeopathy, Yoga and Naturopathy systems.
4. Setting up and maintenance of Central institutions for research and development,
education and standards relating to Ayurveda, Siddha, Unani, Homoeopathy, Yoga and
Naturopathy systems.
(a) Pharmacopoeial Laboratory for Indian Medicine, Ghaziabad;
(j) Central Council for Research in Ayurveda and Siddha;
(k) Central Council for Research in Homoeopathy;
(l) Central Council for Research in Unani Medicine;
(m) Central Council for Research in Yoga and Naturopathy;
(n) National Institute of Ayurveda;
(o) National Institute of Homoeopathy;
(p) National Institute of Naturopathy;
(q) National Institute of Yoga;
1
Inserted vide Amendment series no.310 dated 08.12.2014 (Earlier modified vide amendment series no.279
19
476
(r) National Institute of Unani Medicine;
(s) National Institute of Siddha;
(t) Institute of Post-Graduate Teaching and Research, Gujarat Ayurveda
University;
(u) Indian Medicines and Pharmaceuticals Corporation Limited;
(v) Rashtriya Ayurveda Vidyapeeth.
6. Education, Training and Research in all aspects of Indian Systems of Medicine
7. Matters of cadre formation and control including formation and amendment of
recruitment rules, recruitment, promotion and all other service matters relating to Indian
Systems of Medicine and Homoeopathy doctors of Central Government Health Scheme
including doctors in Indian Systems of Medicine and Homoeopathy central hospitals
requiring action at Government level.
Note.- Day-to-day administration and management will continue to be with the Director,
8. Liaison with foreign countries and international bodies as regards matters relating to
Indian Systems of Medicine and Homoeopathy.
9. Matters relating to scientific societies/associations and charitable and religious
endowments relating to Indian Systems of Medicine and Homoeopathy.
11. Consultation and coordination with State Governments, Non-Government
Organisations and institutions for review of work and programmes in Indian Systems of
Medicine and Homoeopathy.
12. Statistics relating to various aspects of Indian Systems of Medicine and
Homoeopathy.
13. Proposals and matters concerning Union Territories requiring sanction and
concurrence of Government of India in regard to Indian Systems of Medicine and
Homoeopathy.
15. Medicinal Plant Board.
20
477
MINISTRY OF HEALTH AND FAMILY WELFARE
A. DEPARTMENT OF HEALTH AND FAMILY WELFARE1
I. UNION BUSINESS
1. Union agencies and institutes for research or for the promotion of special studies in
medicine and nutrition including all matters relating to -
(l) Jawaharlal Institute of Post-Graduate Medical Education and Research;
(m) Smt. Sucheta Kirpalani Medical College and Hospital and Kalawati Saran
Children's Hospital;
(q) National AIDS Control Organisation (NACO).2
1
2
Inserted vide Amendment series no.282 dated 12.01.2006; Omitted vide Amendment series no.294 dated
20.12.2008 and re-inserted vide Amendment series no.307 dated 06.08.2014
70
478
(g) Regional Leprosy Training and Research Centre, Raipur (Uttar Pradesh), Aska
(Orissa), Gauripur(West Bengal), Teetulmari (Bihar).
(h) Port Quarantine (sea and air) seamen's and marine hospitals and hospitals
connected with port quarantine.
(l) World Health Organisation (WHO).
1
3 (a) The Food Safety and Standards Act, 2006 (34 of 2006)
(b) The Prevention of Food Adulteration Act, 1954 (37 of 1954) and the Central
Food Laboratory. 2
5. Coordination of work in respect of International Conferences in India and abroad in
medical and related fields.
(f) All National Programmes relating to control and eradication of communicable
diseases.
8. Matters relating to epidemics - Problems connected with supply of medicines, effects
of malnutrition and shortage of drinking water leading to various diseases as a result
of natural calamities.
II. LIST OF BUSINESS FOR LEGISLATIVE AND EXECUTIVE
PURPOSES IN RESPECT OF UNION TERRITORIES.
10. Scientific societies and associations pertaining to subjects dealt with in the
Department.
11. Charitable and religious endowments pertaining to subjects dealt with in the
Department.
1
Inserted vide Amendment series no.291 dated 17.09.2007
2
71
479
III. LIST OF BUSINESS WITH WHICH THE CENTRAL GOVERNMENT
DEAL IN A LEGISLATIVE CAPACITY ONLY FOR THE UNION
AND IN BOTH LEGISLATIVE AND EXECUTIVE CAPACITIES FOR
ALL UNION TERRITORIES.
(e) Mental Health.
(h) Prevention of the extension from one State to another of infectious or
contagious diseases affecting human beings.
(j). Regulatory aspects namely quality, safety, labelling and performance of
medical devices1.
(a) The Medical Council of India.
14. Concession of medical attendance and treatment for Central Government servants
other than (i) those in Railway Service (ii) those paid from Defence Service Estimates
(iii) officers governed by the All India Services (Medical Attendance) Rules, 1954
and (iv) officers governed by the Medical Attendance Rules, 1956.
controlled by the Department of Railways and those paid from Defence Services
Estimates excepting Civilian Services.].
15 A. Rashtriya Swasthya Bima Yojana.2
1
Inserted vide amendment series no.315 dated 5.8.2015.
2
Inserted vide amendment series no.313 dated 24.03.2015
72
480
(a) National Health Mission1.
21. Organisation and direction of education, training and research in all aspects of family
welfare including higher training abroad.
23. Liaision with foreign countries and international bodies as regards matters relating to
family welfare.
26. Development and production of audiovisual aids, extensional education and
information in relation to population and family welfare.
29. Implementation of Pre-conception and Pre-natal Diagnostic Techniques (Prohibition
of Sex Selection) Act, 1994 (57 of 1994) – Medical Termination of Pregnancy Act,
1971 (34 of 1971).
____________
1
Amended vide series no.326 dated 21.5.2016
73
481
B. Omitted1
1
74
482
C. DEPARTMENT OF HEALTH RESEARCH (SWASTHYA ANUSANDHAN
VIBHAG) 1
1. Promotion and co-ordination of basic, applied and clinical research including clinical
trials and operational research in areas related to medical, health, biomedical and
medical profession and education through development of infrastructure, manpower
and skills in cutting edge areas and management of related information thereto.
2. Promote and provide guidance on research governance issues, including ethical issues
in medical and health research.
3. Inter-sectoral coordination and promotion of public - private - partnership in medical,
bio-medical and health research related areas.
4. Advanced training in research areas concerning medicine and health, including grant
of fellowships for such training in India and abroad.
prevention.
8. Matters relating to Scientific societies and associations, Charitable and religious
endowments in medicine and health research areas.
9. Coordination between organizations and institutes under the Central and State
Governments in areas related to the subjects entrusted to the Department and for the
promotion of special studies in medicine and health.
1
75
483
D. Omitted1
1
Omitted vide Amendment series no.307 dated 06.08.2014 (earlier inserted vide amendment series no.294 dated
20.12.2008)
76
Page 1 Thursday, January 13, 2022
484
~<crc_® SCC Online Web Edition: http://www.scconline.com
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ANNEXURE P-13
KALPANA MEHTA v. UNION OF INDIA 295

(Record of Proceedings)
a
(BEFORE DIPAK MISRA AND PRAFULLA C. PANT, JJ.)§
Writ Petitions (C) No. 558 of2012 with
No. 921 of 2013, decided on January 13, 2015
KALPANA MEHTA AND OTHERS Petitioners;
Ve rsus
b
UNION OF INDIA AND OTHERS Respondents.
With
(BEFORE DIPAK MISRA, R.K. AGRAWAL AND PRAFULLA C. PANT, JJ.)§
Writ Petitions (C) No. 558 of2012 with
No. 921 of 2013, decided on April 21, 2015
C
Versus
With
d (BEFORE DIPAK MISRA AND SHIVA KIRT! SINGH, JJ.)§
Writ Petitions (C) No. 558 of 2012 with No. 921
of 2013, decided on November 17, 2015
Versus
e UNION OF INDIA AND OTHERS Respondents.
With
(BEFORE DIPAK MISRA AND SHIVA KIRT! SINGH, JJ.)§
f
KALPANA MEHTA AND OTHERS Petitioners ;
Versus
§ Ed.: Given the nature of these orders, they have been published in SCC, together, in chronological
order, by the date of the order, as one combined report with the citation: (2017) 7 SCC 295. This is
to facilitate a holistic view of the matters decided in such orders. Furthermore, to make it possible
to search for a particular order by date as well, in SCC Online, each order has been reported
h separately with an independent citation with reference to the page on which it falls in SCC , in the
combined report of all the orders i.e. (2017) 7 SCC 302; (2017) 7 SCC 304; (2017) 7 SCC 305;
(2017) 7 SCC 306 and (2017) 7 SCC 307.
485
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296 SUPRE1\1E COURT CASES (2017) 7 sec

With
(BEFORE DIPAK MISRA AND ROHINTON FALi NARIMAN, JJ.)§
a
Writ Petitions (C) No. 558 of 2012t with
Versus
b
Writ Petitions (C) No. 558 of 2012 with
No. 921 of 2013, decided on January 13, 2015
With
With C

With
d
With
A. Constitution of India - Arts. 32, 136 and 226 and Arts. 105, 194, 121
and 122 - Reliance upon report of Parliamentary Standing Committee by
Court for purpose of fact-finding, and issuance of directions or writs, based e
thereon - Permissibility of - Report of Parliamentary Standing Committee
- Evidential value of- Matter referred to Constitution Bench
- Reference to reports of Parliamentary Standing Committee for
understanding the Constitution or the legislation, not the same as placing
reliance upon it as a piece of evidence to establish a fact, based on which
directions or writs may be issued by Court f
- Held, while exercising the power of judicial review or placing reliance
on the report of Parliamentary Standing Committee, the doctrine of restraint
has to be applied - As the invitation to contest a Parliamentary Standing
Committee report, which would be inevitable if it were to be relied on to
issue directions or writs by Court, is likely to disturb the delicate balance
that the Constitution provides between the constitutional institutions and a g
contest/adjudication on the report, could run counter to the spirit of privilege
of Parliament which the Constitution protects
- Moreover, for issuance of a writ of mandamus, it is primary to establish
that one has a right and, in the case at hand, an effort has been made to rely
on the Parliamentary Standing Committee's report to create a right, which is
legally not permissible h
t Under Article 32 of the Constitution of India
486
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- In the present case, whilst taking the prima facie view that a
Parliamentary Standing Committee report may not be tendered as a document
a to augment the stance on the factual score that a particular activity is
unacceptable or erroneous, the issue, being a substantial question of law
relating to interpretation of the Constitution, referred to a Constitution Bench
- Parliament and State Legislatures - Lok Sabha Rules of Procedure and
Conduct of Business - Rr. 270, 271, 274 and 277 - Drugs, Cosmetics,
Medical Practice & Practitioners and Public Health - Drugs, Cosmetics and
b Pharmacy - Drugs, Medicines and Medicaments - Introduction of new drug
- Approval of, by authorities concerned - Proper procedure and safeguards
for
B. Parliament and State Legislatures - Lok Sabha Rules of Procedure
and Conduct of Business - Rr. 2(1), 270 and 274 - Standing Committee -
What is - Nature and role of - Nature of procedure of Standing Committee
C
- Value and weight to be accorded to reports of
- Standing Committees are periodically elected by the House or
nominated by the Speaker, Lok Sabha, or the Chairman, Raj ya Sabha, singly or
jointly and are permanent in nature - Procedure of the Committee is neither
inquisitorial nor adjudicative and sui generis - Reports of the Committees are
for the assistance of Parliament and the procedure for drawing up such reports,
d is entirely a matter for the Committee and it has authority to receive evidence
from witnesses-But it is for their own assistance - Further, no person has
a right to be heard by the Committee and principles of natural justice are not
applicable - Lok Sabha Rules of Procedure and Conduct of Business, Rr. 2(1)
and Ch. 26
C. Courts, Tribunals and Judiciary-Judicial Review/Judicial Activism/
e Judicial Legislation - Judicial Review - Generally - Held, the basic
principle of judicial review is to ascertain the propriety of the decision-making
process on the parameters of reasonableness and propriety of executive
decisions
Writ petitions were preferred in the years 2012 and 2013 and the debate had
centred around on many an aspect relating to action taken by the Drugs Controller
General of India and the Indian Council of Medical Research (ICMR) pertaining
f to approval of a vaccine, namely, Human Papilloma Virus (HPV) manufactured
by Respondent 7, M/s GlaxoSmithKline Asia Pvt. Ltd. and Respondent 8,
MSD Pharmaceuticals Pvt. Ltd., respectively for preventing cervical cancer
in women and the experimentation of the vaccine done as an immunisation
by the Governments of Gujarat and Andhra Pradesh (before bifurcation, the
State of Andhra Pradesh, eventually the State of Andhra Pradesh and the
g State of Telangana) with the charity provided by Respondent 6, namely, PATH
International. The issue also arose with regard to the untimely death of certain
persons and grant of compensation.
The petitioners, in Writ Petition (C) No. 558 of 2012 and Writ Petition (C)
No. 921 of2013 drew the attention of the Courtto the 8lstReportdated 22-12-2014
of the Parliamentary Standing Committee.
h
The Attorney General for India filed a written note of submission contending,
inter alia, that the reports of the Parliamentary Standing Committee were at best
487
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external aids of construction in order to determine the surrounding circumstances or
the historical facts for the purpose of discerning the mischief sought to be remedied,
but not for any other purpose.
a
Relying on Rule 277 of the Lok Sabha Rules of Procedure and Conduct of
Business (for short "the Rules"), the petitioners, inter alia, contended that the report
of the Standing Committee had a persuasive value and hence, could be taken note
of for the purpose of fact finding by the Court. It was also contended that the report
of the Committee was in the public domain and could be relied upon.
The issue involved in the matter was: Whether the Court while exercising the
power of judicial review or its expansive jurisdiction under Article 32 dealing with b
the public interest litigation, can advert to the report of the Parliamentary Standing
Committee and on that basis issue directions.
Framing questions for reference of the matter to a Constitution Bench, the
Supreme Court
Held:
C
Standing Committees are those which are periodically elected by the House
or nominated by the Speaker, Lok Sabha, or the Chairman, Rajya Sabha,
singly or jointly and are permanent in nature. In terms of their functions,
Standing Committees may be classified into two categories. One category of
Committees like the Departmentally Related Standing Committees (DRSCs),
Financial Committees, etc., scrutinise the functioning of the Government as
per their respective mandate. The other category of Committees like the Rules d
Committee, House Committee, Joint Committee on Salaries and Allowances, etc.
deal with matters relating to the Houses and members. (Para 41)
"The Committee System in India : Effectiveness in Enforcing Executive Accountability",
Hanoi Session, March 2015, referred to
The procedure of the Committee is neither inquisitorial nor adjudicative. It
has its own character. The procedure is sui generis. In the Westminster system, e
Parliament also deals with the matter of accountability of the Executive and
S landing Committees of Parliament, on many an occasion, examine the propriety
and wisdom of the conduct of the executive. The reports of the Committees are
for the assistance of Parliament. The procedure for drawing up such reports, is
entirely a matter for the Committee and it has authority to receive evidence from
witnesses-but it is for their own assistance. No person has a right to be heard by
the Committee even if the Committee is examining a matter which may result in an f
adverse comment on the conduct of such person. The principles of natural justice
are not applicable. (Para 43)
The reference to Constituent Assembly Debates, reports of the Parliamentary
S landing Committee and the speeches made in Parliament or for that matter,
debates held in Parliament are only meant for understanding the Constitution or
the legislation, as the case may be. It is quite different than to place reliance upon g
Parliamentary Standing Committee report as a piece of evidence to establish a
fact. (Paras 44 to 60)
Raja Ram Pal v. Lok Sabha, (2007) 3 SCC 184; Krishan Lal Cera v. State of Haryana, (2011)
10 SCC 529; A.K. Roy v. Union of India, (1982) 1 SCC 271 : 1982 SCC (Cri) 152; M.S.M.
Sharma v. Shree Krishna Sinha, AIR 1960 SC 1186; Sarojini Ramaswami v. Union ofIndia,
(1992) 4 sec 506; Arun Kumar Agrawal V. Union of India, (2013) 7 sec 1; R. V. Murphy,
(1986) 5 NSWLR 18 : (1986) 64 ALR 498; Office of Govt. Commerce v. Information h
Commr., 2008 EWHC 737 (Admin); Indra Sawhney v. Union of India, 1992 Supp (3) SCC
488
-----------------------------------------------------------------------------------------------------------------------------------------------------------

217 : 1992 SCC (L&S) Supp 1; Madhu Limaye, In re, (1969) 1 SCC 292; Union of India
v. Harbhajan Singh Dhillon, (1971) 2 SCC 779; Kesavananda Bharati v. State of Ke rala,
(1973) 4 SCC 225; Mano} Nantla v. Union of India, (2014) 9 SCC 1; Jyoti Harshad Mehta
a V. Custodian, (2009) 10 sec 564 : (2010) 2 sec (Cri) 1494; State of W.B. V. Union of
India, AIR 1963 SC 1241; K.P. Varghese v. !TO, (1981) 4 SCC 173 : 1981 SCC (Tax) 293;
Ramesh Yeshwant Prabhoo v. Prabhakar Kashinath Kunte, (1996) 1 SCC 130; Novartis AG
v. Union of India, (2013) 6 SCC 1 : (2013) 3 SCC (Civ) 227; State of M.P. v. Dadabhoy 's
N ew Chirimiri Ponri Hill Collie ry Co. (P) Ltd., (1972) 1 SCC 298; Union of India v. Steel
Stock Holders' Syndicate, (1976) 3 SCC 108; Surana Steels (P) Ltd. v. CIT, (1999) 4 SCC
306; R. v. Secy. of StateforTrade exp Anderson Strathclyde Plc., (1983) 2 All ER 233 (DC);
b SBlv. National Housing Bank, (2013) 16 SCC 538: (2014) 5 SCC (Civ) 523, referred to
Lok Shikshana Trust v. CIT, (1976) 1 SCC 254 : 1976 SCC (Tax) 14; Indian Chamber of
Commerce v. CIT, (1976) 1 SCC 324 : 1976 SCC (Tax) 41; CIT v. Surat Art Silk Cloth
Manufacturers' Assn., (1980) 2 SCC 31 : 1980 SCC (Tax) 170; Ram Krishna Dalmia v.
S.R. Tendolkar, AIR 1958 SC 538; TT Antony v. State of Kerala, (2001) 6 SCC 181 : 2001
SCC (Cri) 1048, cited
Committee set up by RBI on 30-4-1992 which submitted six reports and the Final Report
C submitted on 7-5-1993, referred to
See the Janakiraman Committee's first interim report, May 1992, p. 1, cited
What is necessary to understand from Article 105(2) is that no member of
Parliament can be made liable for any proceeding in any court because of what he
has stated in a committee. The Parliamentary Standing Committee is a committee
constituted under the Rules and what a member speaks over there is absolutely
d within the domain of that committee. Freedom of speech of a member of a
committee is only guided subject to provisions of the Constitution and the rules and
standing orders regulating the procedure of Parliament. It is also seemly to note
that Article 105(4) categorically lays the postulate that clauses (1), (2) and (3) shall
apply to any committee of Parliament. Article 121 makes it vivid that Parliament
shall not discuss as regards the conduct of any Judge of the Supreme Court or of
a High Court in the discharge of his duties, except upon a motion been presented
e before the President of India praying for removal of the Judge as provided in the
Constitution. Thus, the discussion of Parliament is restricted by a constitutional
provision. Article 122 stipulates a restraint on courts to inquire into proceedings of
Parliament. (Paras 64, 67 and 68)
The purpose of referring to the aforesaid Articles is that while exercising the
power of judicial review or to place reliance on the report of the Parliamentary
f Standing Committee, the doctrine of restraint has to be applied by the Supreme
Court as required under the Constitution. The submission "looking at the report",
is nothing but placing reliance thereupon. The view of a member of Parliament or a
member of the Parliamentary Standing Committee who enjoys freedom of speech
and expression within the constitutional parameters and the rules or regulations
framed by Parliament inside Parliament or the Committee is not to be adverted to
by the court in a lis. (Para 69)
g
Hamilton v. Al Fayed, (2001) 1 AC 395 : (2000) 2 WLR 609 (HL), referred to
Hamilton v. Al Fayed, (1999) 1 WLR 1569 (CA); Hunter v. Chief Constable of the West
Midlands Police, 1982 AC 529 : (1981) 3 WLR 906 (HL), cited
For issuance of a writ of mandamus, it is primary to establish that one
has a right and, in the case at hand, an effort has been made to rely on the
Parliamentary Standing Committees report to create a right which is legally not
h permissible. (Para 71)
489
-----------------------------------------------------------------------------------------------------------------------------------------------------------

The controversy has to be seen from the perspective of judicial review. The
basic principle of judicial review is to ascertain the propriety of the decision-
making process on the parameters of reasonableness and propriety of the executive a
decisions. We are not discussing about the parameters pertaining to the challenge
of amendments to the Constitution or the constitutionality of a statute. When a
writ of mandamus is sought on the foundation of a factual score, the Court is
required to address the facts asserted and the averments made and what has been
stated in oppugnation. Once the Court is asked to look at the report, the same
can be challenged by the other side, for it cannot be accepted without affording
an opportunity of being heard to the respondents. The invitation to contest a b
Parliamentary Standing Committee report is likely to disturb the delicate balance
that the Constitution provides between the constitutional institutions. If the Court
allows contest and adjudicates on the report, it may run counter to the spirit of
privilege of Parliament which the Constitution protects. (Para 72)
Thus, prima facie, the Parliamentary Standing Committee report may not
C
be tendered as a document to augment the stance on the factual score that a
particular activity is unacceptable or erroneous. However, regard being had to the
substantial question of law relating to interpretation of the Constitution involved,
the issue be referred to the Constitution Bench under Article 145(3) of the
Constitution. (Para 73)
The following questions are framed for the purpose of reference to the
Constitution Bench: d
(i) Whether in a litigation filed before the Supreme Court either under
Article 32 or Article 136 of the Constitution of India, the Court can refer to
and place reliance upon the report of the Parliamentary Standing Committee?
(ii) Whether such a report can be looked at for the purpose of reference
and, if so, can there be restrictions for the purpose of reference regard being e
had to the concept of parliamentary privilege and the delicate balance between
the constitutional institutions that Articles 105, 121 and 122 of the Constitution
conceive? (Paras 73.1 and 73.2)
Kalpana Mehta v. Union of India, WP (C) No. 558 of 2012, order dated 12-8-2014 (SC),
referred to
VN-D/58536/C f
Advocates who appeared in this case :
P.S. Patwalia, Tushar Mehta, Additional Solicitors General, Colin Gonsalves, Anand
Grover, R.S. Suri, C.A. Sundaram, Shyam Divan, Gourab Banerji, Harish N. Salve
and A.K. Panda, Senior Advocates [Ms Abhiti Gupta, Ms Jyoti Mendiratta (Advocate-
on-Record), Mihir Samson, Ms Lorraine Misquith, Purushottam Sharma Tripathi
(Advocate-on-Record), Mukesh Kr. Singh, Gaurav Goyal, Ms N. Annapoorani
(Advocate-on-Record), Charul Sarin, A. Deb Kumar, Ms Sushma Suri, D.S. Mabra g
(Advocate-on-Record), Ms Krishna Sarma, Ms Manisha Singh, Navnit Kumar,
Ms Vartika W alia (for Mis Corporate L aw Group), Ms Jaya Krishnan, Riku Sarma ,
Ms Barnali Das (for M/s Corporate Law Group), Ms Nandini Gore, Ms Aditi Bhatt,
Karlik Bhatnagar, Ms Tahira Karanjawala, Abhishek Roy, Ms Manik Karanjawala
(for M/s Karanjawala & Co.), Ms Hemantika Wahi (Advocate-on-Record), Ms Swati
Vaibhav, Ms Preeti Bhardwaj, Ms Sanjana Ramachandran (for M/s Parekh &
Co.), Guntur Prabhakar (Advocate-on-Record), Ms Prerna Singh, S. Udaya Kr. h
Sagar (Advocate-on-Record), Krishna Kr. Singh, A. Gupta, Ms Jyoti Mendiratta,
490
-----------------------------------------------------------------------------------------------------------------------------------------------------------

Purushottam Sharma Tripathi, Guntur Prabhakar, Ms Prerna S., S. Udaya Kr. Sagar,
Ms Vartika W. , Jayakrishnan Kumar, Ms B. Das (for Mis Corporate Law Group),
Ms Hemantika Wahi, Ms Jesal Wahi, Ms Puja Singh, R.N. Karanjawala, Abhishek Ray,
a Ms Trishala Kulkarni, D.S. Mahra, Deepak Yadav, Ms N. Annapoorani (Mis Parekh &
Co.), Ms Divya Jyoti Jaipuriar, Ms Nivedita Saxena, Ravi Chandra Praka sh, Shantanu
J., Ranvir Singh Chhibbar, B.V. Niren, Barnali Das (for Mis Corporate Law Group)
(Advocate-on-Record), C.A. Sundaram, Ms Vertika Walia (for Mis Corporate Law
Group) (Advoca te-on-Record), Ms Vinakshi K adan, Deepa nk Yadav, J.D. Gill, Aj ay
Sharma, N avnit Kumar (for Mis Corporate Law Group) (Advocate-on-Record) , Saket
Sikri, Ms C.K. Sucharita, Kabir Ali Zia Choudhary, Kumesh Kumar Singh , Lorraine
b M., Ms Vartika Walia, Jaya Krishnan Kumar, Ms Barndi Das (for Mis Corporate Law
Group), Abhishek Naik (for Mis Parekh & Co.), Jasbir Bidhuri, Ms Natasha Sehrawat,
Ms M anik Karanj aw ala, Ms Vaidehi Misra, Sahil Tagotra, Mis K aranj awala & Co.,
Ms M amta Singh , S. Udaya Kumar Sagar, Ms Rekh a Pandey, Ms Sunita Sharma, G.S.
Makker and Mrityunjai Singh, Advocates] for the appearing parties.
Chronological list of cases cited on page(s)
1. (2014) 9 SCC 1, Mano} Narula v. Union of India 316a
C 2. WP (C) No. 558 of 2012, order dated 12-8-2014 (SC), Kalpana
M ehta v. Union of India 302b, 305a-b, 307e , 308a-b
3. (2013) 16 SCC 538: (20 14) 5 SCC (Civ) 523, SBiv. N ational
Housing Bank 318b-c
4. (2013) 7 SCC 1, Arun Kumar Agrawal v. Union of India 315d
5. (2013) 6 SCC 1 : (2013) 3 SCC (Civ) 227, Novartis AG v. Union of India 317c-d
6. (2011) 10 SCC 529, K rishan Lal Gera v. State of Haryana 313g-h
d 7. (2009) 10 SCC 564: (20 10) 2 SCC (Cri) 1494, Jyoti Harshad M ehta
v. Custodian 3 l 6b-c
8. 2008 EWHC 737 (Admin) , Office of Govt. Commerce v. Infonnation Commr. 3l5f
9. (2007) 3 SCC 184, Raja Ram Pal v. Lok Sabha 313f-g, 314g-h
10. (2001) 6 SCC 181: 2001 SCC (Cri) 1048, T.T. Antony v. State of Kerala 318e
11. (2001) 1 AC 395: (2000) 2 WLR 609 (HL), Hamilton v. A l Fayed 32 la -b
12. (1999) 4 SCC 306, Surana Steels (P) Ltd. v. CIT 3 l 7c-d
e 13. (1999) 1 WLR 1569 (CA) , Hamilton v. Al Fayed 32lb
14. (1996) 1 SCC 130, Ramesh Yeshwant Prabhoo v. Prabhakar
Kashinath Kunte 317c
15. (1992) 4 SCC 506, Sarojini Ramaswami v. Union of India 3 15b
16. 1992 Supp (3) SCC 217: 1992 SCC (L&S) Supp 1, Indra Sawhney
v. Union of India 315g
17. (1986) 5 NSWLR 18: (1986) 64 ALR 498, R. v. Murphy 315e-f
f 18. (19 83) 2 All ER 233 (DC), R. v. Secy. of State f o r Trade ex p
Anderson Strathclyde Plc. 317f
19. (1982) 1 sec 271 : 1982 sec (Cri) 152, A.K. Roy V. Union of India 3 l4a-b
20. 1982 AC 529 : (1981) 3 WLR 906 (HL), Hunter v. Chief Constable
of the West Midlands Police 321b
21. (19 81) 4 SCC 173 : 1981 SCC (Tax) 293, K.P. Varghese v. ITO 316/, 317c-d
22. (1980) 2 SCC 31 : 1980 SCC (Tax) 170, CIT v. Surat A rt Silk Cloth
Manufacturers' Assn. 317b
g 23. (1976) 3 SCC 108, Union of India v. Steel Stock Holders' Syndicate 317c-d
24. (1976) 1 SCC 324: 1976 SCC (Tax) 41, Indian Chambe r of
Commerce v. CIT 3 17b
25. (1976) 1 SCC 254: 1976 SCC (Tax) 14, Lok Shikshana Trust v. CIT 3l 7a-b
26. (1973) 4 SCC 225, Kesavananda Bharati v. State of Kerala 316a
27. (1972) 1 SCC 298, State of M.P. v. Dadabhoy 's New Chirimiri Ponri
Hill Collie ry Co. ( P) Ltd. 317c-d
h 28. (1971) 2 SCC 779, Union of India v. Harbhajan Singh Dhillon 3 16a
29. (1969) 1 SCC 292, Madhu Limaye, In re 316a
491
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30. AIR 1963 SC 1241, State of W.B. v. Union of India 316c-d
31. AIR 1960 SC 1186, M.S.M. Sharma v. Shree Krishna Sinha 314g
32. AIR 1958 SC 538, Ram Krishna Dalmia v. S.R. Tendolkar 318d-e
a
(2017) 7 sec 302
ORDER dated 13-1-2015
(BEFORE DIPAK MISRA AND PRAFULLA C. PANT, JJ.)
WP (C) No. 558 of2012 with WP (C) No. 921 of2013
1. On 12-8-2014 1 , while dealing with the controversy at length, this Court b
had posed the following questions:
1.1. "(i) Whether before the drug was accepted to be used as a vaccine
in India, the Drugs Controller General of India and ICMR had followed the
procedure for said introduction?
1.2. (ii) What is the action taken after the Parliamentary Committee had
submitted the 72nd Report on 30-8-2013? c
1.3. (iii) What are the reasons for choosing certain places in Gujarat and
Andhra Pradesh?
1.4. (iv) What has actually caused the deaths and other ailments who had
been administered the said vaccine?
1.5. (v) Assuming this vaccine has been administered, regard being had to d
the nature of the vaccine, being not an ordinary one, what steps have been taken
for monitoring the same by the competent authorities of the Union of India,
who are concerned with health of the nation as well as the State Governments
who have an equal role in this regard?
1.6. (vi) The girls who were administered the vaccine, whether proper
consent has been taken from their parents/guardians, as we have been apprised e
at the Bar that the young girls had not reached the age of majority?
1.7. (vii) What protocol is required to be observed/followed, assuming this
kind of vaccination is required to be carried out?"
2. After posing the questions, the Court had proceeded to express thus:
"Regard being had to the aforesaid concerns, which are posed in the
f
aforesaid questions, we think it apposite that the State of Gujarat, State of
Andhra Pradesh and State of Telangana be impleaded as parties. Hence,
liberty is granted to the petitioners to take steps to serve Standing Counsel
for the States of Gujarat, Andhra Pradesh and Telangana in both the
petitions. Dasti, in addition, is permitted. Be it stated, their appearance shall
be in respect of both the petitions.
g
At this juncture, a submission was made to the effect that
manufacturing companies, M/s GlaxoSmithKline Asia Pvt. Ltd. and MSD
Pharmaceuticals Pvt. Ltd. [Respondents 7 and 8 respectively in WP (C)
No. 558 of 2012] should be served. Mr Jyoti Mendiratta, Advocate,
undertakes to take appropriate steps to effect service on the said companies.
Dasti, in addition, is permitted. The learned counsel for the petitioners are h
Kalpana Mehta v. Union of India, WP (C) No. 558 of 2012, order dated 12-8-2014 (SC)
492
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also granted liberty to effect service on the Ethics Committee concerned
of all the three States. This Court hopes and trust that on the next date of
a hearing, the Standing Counsel of all the States shall remain present and
argue the matter.
At this juncture, we are obligated to state that the Union oflndia, who is
required to assist this Court in proper perspective, shall direct its competent
authority to produce the file by which the Drugs Controller General of India
had approved the vaccine for introduction in India. Mr Suri, learned Senior
b Counsel for the Union of India will produce the said file. Additionally, the
relevant documents shall also be provided to the counsel concerned for the
petitioners.
The learned counsel for the Union of India shall apprise this Court
what steps have been taken by the Union of India on the basis of the
Parliamentary Committee Report. The counsel for the State, who have
C appeared, shall file their counter-affidavits within a period of four weeks.
The Union oflndia shall also file their counter-affidavit in WP (C) No. 921
of 2013 within four weeks. Rejoinder-affidavit, if any, be filed within two
weeks therefrom. By the same time, rejoinder-affidavit to the counter-
affidavit filed by PATH International be filed. Mr Dipank Yadav, Advocate,
who appears for ICMR shall also produce the file ofICMR dealing with this
d vaccine by the next date. Let the writ petitions be listed on 28-10-2014."
3. Mr Colin Gonsalves, learned Senior Counsel appearing for the petitioner
in WP (C) No. 558 of 2012 and Mr Anand Grover, learned Senior Counsel
for the petitioner in WP (C) No. 921 of 2013, have drawn our attention to the
81st Report dated 22-12-2014 of the Parliamentary Standing Committee. On
e a perusal of the said Report, we find some defects being noticed and certain
suggestions have been given. Mr R.S. Suri, learned Senior Counsel appearing
for the Union oflndia, shall obtain instructions from the competent authorities
of the Union of India as to what steps are being thought of on the basis of the
aforesaid Report.
4. The next issue that we intend to address today relates to the "concept
f of consent" and the resultant deaths. It is submitted by Mr Gonsalves that
though innovative explanations have been given by stating that some girls in
the States of Gujarat and Telangana have expired due to snake bite and fever,
yet in actuality, it is due to administration of vaccination. It is also urged by
Mr Gonsalves and Mr Grover that though the number of vaccinations that have
been carried out for the purpose of experimentation, there is no data with regard
g to the adverse effects that have been faced by the young girls.
5. Mr R.S. Suri, learned Senior Counsel appearing for the Union of India,
Ms Hemantika Wahi, learned counsel appearing for the State of Gujarat and
Mr Udaya Sagar, learned counsel appearing for the State of Telangana, shall
state by way of affidavit, what is the procedure/protocol to be followed while
obtaining consent. The stand taken by the Union of India and the States shall
h
493
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be clear and in consonance with law, for the affidavit is not expected to be filed
in contravention of what has been envisaged in law.
6. At present, we are obliged to state that the present public interest a
litigation has to be perceived from the point of view of rectification, if any, and
caution for the future. When we use the word "rectification", we mean apart
from the questions which have been posed earlier, the factum of consent and
the procedure followed in consent and the sequitur of such consent are to be
kept in view. The "caution" would convey what steps have to be taken in future
so that these kind of grievances do not arise. b
7. The learned counsel appearing for the Union of India and the States of
Gujarat and Telangana shall file their respective affidavits keeping in view the
directions given hereinabove. To elucidate, the affidavit filed by the Union of
India shall contain explicitly:
(i) what steps they intend to take on the basis of the report given by the c
Parliamentary Standing Committee,
(ii) what is the procedure to be followed for the purposes of consent
and what steps are required to be taken to find out the sufferings, if any, by
the persons who were vaccinated, and
(iii) the liability of compensation, if any, to be paid and whose liability
it would be. d
8. Let the requisite affidavits be filed within four weeks hence. Rejoinder,
if any, be filed within two weeks therefrom. List the matter on 21-4-2015.
(2011) 1 sec 304

e
(BEFORE DIPAK MISRA, R.K. AGRAWAL AND PRAFULLA C. PANT, JJ.)
9. The learned counsel appearing for Respondents 1 and 2 has handed over
the copy of the affidavit filed in compliance with the order dated 13-1-2015 2 .
10. Mr Anand Grover, learned Senior Counsel for the petitioner in Writ
f
Petition (Civil) No. 921 of 2013, states that the said affidavit may meet with the
requirement of Writ Petition (Civil) No. 558 of 2012, Kalpana Mehta v. Union
of India but it would not cover the controversy raised in Writ Petition (Civil)
No. 921 of2013 filed by Sama-Resource Group for Women.
11. In view of the above, the learned counsel for the respondents shall file
a separate affidavit meeting the requirements of the matter regard being had to g
the earlier order passed on 13-1-2015 2 .
12. Let the matters be listed on 4-8-2015. All the States are directed to
comply with the earlier order and serve the copy of the affidavits filed by them
on the other side.
h
2 Set out in paras 1 to 8, above.
494
-----------------------------------------------------------------------------------------------------------------------------------------------------------

c2011) 1 sec 305
a (BEFORE DIPAK MISRA AND SHIVA KIRT! SINGH, JJ.)
13. On 12-8-2014 1 , after hearing the learned counsel for the parties at
length, this Court had stated that the questions that really cause concern are:
"13.1. (i) Whether before the drug was accepted to be used as a vaccine
b in India, the Drugs Controller General of India and ICMR had followed the
submitted the 72nd Report on 30-8-2013?
Andhra Pradesh?
C
been administered the said vaccine?
13.5. (v) Assuming this vaccine has been administered, regard being had to
for monitoring the same by the competent authorities of the Union oflndia, who
d are concerned with the health of the nation as well as the State Governments
consent has been taken from their parents/guardians, as we have been apprised
at the Bar that the young girls had not reached the age of majority?
e 13.7. (vii) What protocol is required to be observed/followed, assuming this
14. After so stating, the Court has proceeded to direct as follows:
"Regard being had to the aforesaid concerns, which are posed in the
aforesaid questions, we think it apposite that the State of Gujarat, State of
f Andhra Pradesh and State of Telangana be impleaded as parties. Hence,
liberty is granted to the petitioners to take steps to serve Standing Counsel
for the States of Gujarat, Andhra Pradesh and Telangana in both the
petitions. Dasti, in addition, is permitted. Be it stated, their appearance shall
be in respect of both the petitions.
At this juncture, a submission was made to the effect that
g manufacturing companies, M/s GlaxoSmithKline Asia Pvt. Ltd. and MSD
Pharmaceuticals Pvt. Ltd. [Respondents 7 and 8 respectively in WP (C)
No. 558 of 2012] should be served. Mr Jyoti Mendiratta, Advocate,
undertakes to take appropriate steps to effect service on the said companies.
Dasti, in addition, is permitted. The learned counsel for the petitioners are
also granted liberty to effect service on the Ethics Committee concerned
h
Kalpana Mehta v. Union of India, WP (C) No. 558 of 2012, order dated 12-8-2014 (SC)
495
-----------------------------------------------------------------------------------------------------------------------------------------------------------

of all the three States. This Court hopes and trust that on the next date of
hearing, the Standing Counsel of all the States shall remain present and
argue the matter. a
At this juncture, we are obligated to state that the Union of India, who is
required to assist this Court in proper perspective, shall direct its competent
authority to produce the file by which the Drugs Controller General of India
had approved the vaccine for introduction in India. Mr Suri, learned Senior
Counsel for the Union of India will produce the said file. Additionally, the
relevant documents shall also be provided to the counsel concerned for the b
petitioners."
After the said order came to be passed, an additional affidavit has been filed
by the Union of India and the reply thereto has also been filed. It is submitted
by Mr Tushar Mehta, learned Additional Solicitor General that the two files,
as directed by this Court, shall be filed before this Court by tomorrow i.e. C
18-11-2015.
15. It is also submitted by Mr Mehta, that the rules in question have been
amended and the detailed safeguards have been provided prior to taking consent
of the person who has expressed her consent for accepting vaccination. Be it
noted, the learned Additional Solicitor General has further clarified that the
rules do not specifically pertain to vaccination but to all kinds of trial of any d
drug. Needless to say, the learned counsel shall apprise us about the steps taken
on the basis of the Parliamentary Committee Report submitted on 30-8-2013.
16. The other aspects shall also be dealt with in accordance with the rules
that have been amended after the affidavit has been filed.
17. Let the matter be listed for hearing on 18-11-2015. It shall be taken e
at 11.00 a.m. Mr Gonsalves, learned Senior Counsel, has taken the burden of
arguing first.
(2011) 1 sec 306

(BEFORE DIPAK MISRA AND SHIVA KIRTI SINGH, JJ.) f
18. Let the matter be listed on 20-1-2016 on which date Mr Tushar Mehta,
learned Additional Solicitor General shall produce the file dealing with the
vaccine in question.
19. Be it noted, a substantial issue in law has arisen in course of hearing of g
this case which pertains to exercise of power of judicial review when a report
of the Parliamentary Standing Committee is filed before the Court.
20. Mr Harish Salve and Mr C.A. Sundaram, learned Senior Counsel
and Mr Tushar Mehta, learned Additional Solicitor General appearing for the
respondents pray for some time to argue the matter.
h
496
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KALPANA MEHTA v. UNION OF INDIA ( Dipak Misra, J.) 307

21. Mr Colin Gonsalves, learned Senior Counsel, shall also address the
issue with regard to the power of judicial review of this Court, regard being had
a to the question posed.
22. The learned counsel for the parties are at liberty to file written notes or
submissions on or before 11-1-2016.
c2011) 1 sec 307

JUDGMENT dated 5-4-2017
b (BEFORE DIPAK MISRA AND ROHINTON FALi NARIMAN, JJ.)
Writ Petition (C) No. 558 of 2012 with WP (C) No. 921 of 2013

DIPAK MISRA, J.- Though the present writ petitions were preferred
in the years 2012 and 2013 and the debate had centred around on many
C an aspect relating to action taken by the Drugs Controller General of
India and the Indian Council of Medical Research (ICMR) pertaining to
approval of a vaccine, namely, Human Papilloma Virus (HPV) manufactured
by Respondent 7, M/s GlaxoSmithKline Asia Pvt. Ltd. and Respondent 8,
MSD Pharmaceuticals Pvt. Ltd., respectively for preventing cervical cancer in
women and the experimentation of the vaccine was done as an immunisation
d by the Governments of Gujarat and Andhra Pradesh (before bifurcation, the
State of Andhra Pradesh, eventually the State of Andhra Pradesh and the
State ofTelangana) with the charity provided by Respondent 6, namely, PATH
International. The issue also arose with regard to the untimely death of certain
persons and grant of compensation. Certain orders were passed by this Court
from time to time.
e 24. A stage came in the lifespan of this litigation, which is still in
continuation, when the Court vide order dated 12-8-2014 1 , had posed the
following questions:
24.1. "(i) Whether before the drug was accepted to be used as a vaccine
in India, the Drngs Controller General of India and ICMR had followed the
f
submitted the 72nd Report on 30-8-2013?
Andhra Pradesh?
g been administered the said vaccine?
24.5. (v) Assuming this vaccine has been administered, regard being had to
for monitoring the same by the competent authorities of the Union of India,
who are concerned with health of the nation as well as the State Governments
h
l Kalpana Mehta v. Union of India, WP (C) No. 558 of 2012, order dated 12-8-2014 (SC)
497
-----------------------------------------------------------------------------------------------------------------------------------------------------------

consent has been taken from their parents/guardians, as we have been apprised
at the Bar that the young girls had not reached the age of majority? a
24.7. (vii) What protocol is required to be observed/followed, assuming this
25. In the said order dated 12-8-2014 1, the Court had also directed as
follows:
"At this juncture, we are obligated to state that the Union of India, b
who is required to assist this Court in proper perspective, shall direct its
competent authority to produce the file by which the Drugs Controller
General of India had approved the vaccine for introduction in India.
Mr Suri, learned Senior Counsel for the Union of India will produce the
said file. Additionally, the relevant documents shall also be provided to the
counsel concerned for the petitioners." C
26. In the course of proceedings, affidavits were filed by the Union oflndia
and the State of Gujarat. The learned counsel for the petitioners, Mr Colin
Gonsalves in Writ Petition (C) No. 558 of 2012 and Mr Anand Grover in
Writ Petition (C) No. 921 of2013 had drawn the attention of this Court to the
81st Report dated 22-12-2014 of the Parliamentary Standing Committee. Be it
noted, when the report of the Parliamentary Standing Committee was produced, d
the question arose with regard to the "concept of consent" for administration of
vaccine and the resultant illness suffered by the victims and such other issues
and the Court had issued certain directions for filing of affidavits pertaining to
steps that have been taken by the Governments concerned keeping in view the
various instructions given from time to time including what has been stated in
the report of the Parliamentary Standing Committee. e
27. It is worthy to note here that certain affidavits were filed about the safety
measures being undertaken with regard to the consent and the method of trial
and the improvements made thereon. In essence, the stand of the Union oflndia
and the States was that the vaccine was necessary and steps have been taken
to avoid any kind of hazards. That apart, the factual allegations made by the
petitioners were also controverted. f
28. On 18-11-2015 3 , an issue was raised by the learned Senior Counsel
appearing for Respondent 8, MSD Pharmaceuticals Pvt. Ltd. and by the learned
Additional Solicitor General whether this Court while exercising the power of
judicial review or its expansive jurisdiction under Article 32 dealing with the
public interest litigation, can advert to the report of the Parliamentary Standing
g
Committee and on that basis issue directions. After the said issue was posed, the
learned counsel for the parties sought time to file written notes of submissions
and argue the matter. Regard being had to importance of the matter, assistance
of the learned Attorney General for India was sought.
h
l Kalpana Mehta v. Union of India, WP (C) No. 558 of 2012, order dated 12-8-2014 (SC)
3 Set out in paras 18 to 22, above.
498
-----------------------------------------------------------------------------------------------------------------------------------------------------------

29. Mr Mukul Rohatgi, learned Attorney General for India has filed
a written note of submission contending, inter alia, that the reports of the
a Parliamentary Standing Committee are at best external aids of construction in
order to determine the surrounding circumstances or the historical facts for the
purpose of discerning the mischief sought to be remedied, but not for any other
purpose. He has referred to certain authorities which we shall refer to in the
course of our deliberation. We may clarify that though Mr Rohatgi has filed the
written note of submissions, today we have been assisted by Mr Ranjit Kumar,
b learned Solicitor General, Mr A.K. Panda and Mr Ajit Kumar Sinha, learned
Senior Counsel and Mrs Rekha Pandey, learned counsel on behalf of the Union
of India.
30. Mr Grover and Mr Gonsalves, learned Senior Counsel appearing for
the petitioners, who intend to reply on the report of the Parliamentary Standing
Committee submitted that looking at the report of the Parliamentary Standing
C Committee by this Court in a writ petition preferred under Article 32 of the
Constitution is only to be apprised about facts to arrive at a conclusion for the
purpose of issue of necessitous directions and there cannot be absolute rule
that it cannot be looked at. According to them, there is no impediment to rely
on the said report as the reports of the Parliamentary Standing Committee are
put on the website and in such a situation, the Court can always take aid of
d the report not only for the purpose of understanding the legislative intendment
of a legislation, but also for taking the facts into consideration to issue any
prerogative writ. The learned Senior Counsel would contend that as long as the
reference to report does not violate the freedom of speech of the members of
the Committee or there is no attempt to impugn the report or criticise the same,
reliance on the same should not be prohibited. It is urged by Mr Gonsalves that
e the role of Parliament in the modern democracy has gone beyond the traditional
concept and the perception is to have a transparent society and when there is
access to the report, there is no warrant not to utilise the same in a proceeding
before the Court.
31. The learned Senior Counsel appearing for the Union of India would
in reply submit that the arguments advanced by the learned counsel for the
f petitioners are to be tested on the constitutional parameters and various Articles
of the Constitution are to be read in proper perspective. It is asserted by
him that the constitutional scheme does not favour the interpretation which is
sought to be placed by the learned counsel for the petitioners. According to the
learned counsel for the Union of India, the report of the Parliamentary S landing
Committees are meant to guide the functioning of the departments and work as
g a precursor to the debate in Parliament but not meant to be used in court as it
does not countenance any contest in a court of law.
32. To appreciate the controversy, we may usefully refer to the Rules
of Procedure and Conduct of Business of Lok Sabha Rules (for short "the
Rules"). Rule 2 of the Rules defines "Parliamentary Committee". For the sake
of completeness, we reproduce the same:
h
499
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"2. (1) ... "Parliamentary Committee" means a Committee which is
appointed or elected by the House or nominated by the Speaker and which
works under the direction of the Speaker and presents its report to the House a
or to the Speaker and the Secretariat for which is provided by the Lok Sabha
Secretariat."
33. Chapter 26 of the Rules deals with Parliamentary Committees and the
matters regarding appointment, quorum, decisions of the committee, etc. There
are two kinds of Parliamentary Committees: (i) Standing Committees, and (ii)
Ad hoc Committees. The Standing Committees are categorised by their nature b
of functions. The Standing Committees of the Lok Sabha are as follows:
(a) Financial Committees;
(b) Subject Committees or departmentally related Standing
Committees of the two houses;
(c) Houses Committee i.e. the committees relating to the day to day C
business of the House;
(d) Enquiry Committee;
(e) Scrutiny Committees;
(j) Service Committees;
34. A list of Standing Committees of Lok Sabha along with its membership d
is reproduced as under:
Name of Committee : Number of Members i

:Business Advisory Committee : 15 :
1Committee of Privileges 1 15 i
)Committee on Absence of Members from the Sittings of 15 i i
(the House Committee on Empowerment of Women j ! e
:Committee on Estimates : 30 :
(Committee on Government Assurances 1 15 :
j~~::~~~:: ~~ ·~:ii~;~n~aid. on. the Table ······························--j-·················· ~ ;··················!

)Committee on Private Members Bills and Resolutions 1 15 l
1Committee on Public Accounts 1 22 i f
!~~::~~~:: ~~ ·~~~~;d~:~=r~~~~r:tion ·································!···················i~··················!

)Committee on the Welfare of Scheduled Castes and i 30 i
l Scheduled Tribes l l
ittouse Committee i 12 i
(Joint Committee on Offices of Profit 1 15 : g
( Joint Committee on Salaries and Allowances of Members i 15 l
l of Parliament l l
j~~::r~~=~t~~ee................................................................... j................... {5··················l
.................................................................................................................................................,.......................................... •
•
Apart from the above, there are various departmentally related Standing
Committees under various Ministries. h
500
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35. From the aforesaid, it is quite clear that there are various departmentally
related Standing Committees under various Ministries. It is apt to note here
a that in the case at hand, Rule 270 of the Rules, which deals with the functions
of the Parliamentary Committee meant for Committees of the Rajya Sabha, is
relevant. It reads as follows:
"270. Functions.-Each of the Standing Committees shall have the
following functions, namely-
b (a) to consider the Demands for Grants of the related Ministries/
Departments and report thereon. The report shall not suggest anything of
the nature of cut motions;
(b) to examine Bills, pertaining to the related Ministries/Departments,
referred to the Committee by the Chairman or the Speaker, as the case may
be, and report thereon;
C (c) to consider the annual reports of the Ministries/Departments and
report thereon; and
(d) to consider national basic long-term policy documents presented to
the Houses, if referred to the Committee by the Chairman or the Speaker,
as the case may be, and report thereon:
Provided that the Standing Committees shall not consider matters of
d
day-to-day administration of the related Ministries/Departments."
36. Rule 271 provides for applicability of provisions relating to functions.
Rule 274 deals with the report of the Committee. The said Rule reads as follows:
"274. Report of the Committee.-(!) The report of the Standing
Committee shall be based on broad consensus.
e
(2) Any member of the Committee may record a minute of dissent on the
report of the Committee.
(3) The report of the Committee, together with the minutes of dissent, if
any, shall be presented to the Houses."
37. Rule 274(3) is extremely significant, for it provides that the report of
f the Committee together with the minutes of the dissent, if any, is to be presented
to the House. Rule 277 stipulates that the report is to have persuasive value.
The said Rule is as follows:
"277. Reports to have persuasive value.-The report of a Standing
Committee shall have persuasive value and shall be treated as considered
advice given by the Committee."
g
38. Relying on the said Rule 277, it is argued by the learned counsel for the
petitioners that the report of the S landing Committee has a persuasive value and
hence, it can be taken note of for the purpose of fact finding by this Court. The
learned counsel for the Union of India, on the contrary, would contend that as
per the scheme of the Rules, it is meant to have persuasive value and considered
h as an advice given by the S landing Committee to Parliament.
501
-----------------------------------------------------------------------------------------------------------------------------------------------------------

39. It is submitted on behalf of the Union of India that Rules 277-279
deal with submission of the Report of the Committee and provide that if no
time-frame is given, the same would be submitted within a month from the a
appointment of the Committee and the reports shall be presented to the House
by the Chairperson. It is further urged that the reports submitted by the different
Committees are examined/debated by the House and only thereafter they are
adopted. Our attention has been drawn to Rule 277 and Rule 278 made for
Lok Sabha which provide for scope of advice regarding reports submitted by
Select/Joint Committees. In essence, the purpose of reliance is, it is a matter of b
concern to the debates in Parliament.
40. At this juncture, we may look at the origin and working of the
Parliamentary Committee. The committee system in India, as has been stated
in "The Committee System in India : Effectiveness in Enforcing Executive
Accountability", Hanoi Session, March 2015, is as follows: C
"The origin of the committee system in India can be traced back to
the Constitutional Reforms of 1919. The Standing Orders of the Central
Legislative Assembly provided for a Committee on Petitions relating to
Bills, Select Committee on Amendments of Standing Orders, and Select
Committee on Bills. There was also a provision for a Public Accounts
Committee and a Joint Committee on a Bill. Apart from Committees of the d
Legislative Assembly, Members of both Houses of the Central Legislature
also served on the Standing Advisory Committees attached to various
Departments of the Government oflndia. All these committees were purely
advisory in character and functioned under the control of the Government
with the Minister in charge of the Department acting as the Chairman of
the Committee. e
After the Constitution came into force, the position of the Central
Legislative Assembly changed altogether and the committee system
underwent transformation. Not only did the number of committees
increase, but their functions and powers were also enlarged.
By their nature, Parliamentary Committees are of two kinds: Standing
Committees and Ad hoc Committees. Standing Committees are permanent f
and regular committees which are constituted from time to time in
pursuance of the provisions of an Act of Parliament or Rules of Procedure
and Conduct of Business in Lok Sabha. The work of these Committees is
of continuous nature. The Financial Committees, Departmentally Related
Standing Committees (DRSCs) and some other Committees come under
the category of Standing Committees. Ad hoc Committees are appointed g
for a specific purpose and they cease to exist when they finish the task
assigned to them and submit a report. The principal Ad hoc Committees are
the Select and Joint Committees on Bills. Railway Convention Committee,
Joint Committee on Food Management in Parliament House Complex, etc.
also come under the category of Ad hoc Committees."
h
502
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41. In the said document in respect of the Standing Committees of
Parliament, it has been observed:
a "Standing Committees are those which are periodically elected by
the House or nominated by the Speaker, Lok Sabha, or the Chairman,
Rajya Sabha, singly or jointly and are permanent in nature. In terms
of their functions, Standing Committees may be classified into two
categories. One category of Committees like the Departmentally Related
Standing Committees (DRSCs), Financial Committees, etc., scrutinise the
b functioning of the Government as per their respective mandate. The other
category of Committees like the Rules Committee, House Committee, Joint
Committee on Salaries and Allowances, etc. deal with matters relating to
the Houses and members."
42. We have referred to the same as a holistic reading of the said document
conveys that the Parliamentary Standing Committee makes the executive
C accountable to it on certain issues. As is indicated hereinbefore, Mr Grover and
Mr Gonsalves, learned Senior Counsel appearing for the writ petitioners, would
contend that the executive being accountable to the Parliamentary Standing
Committee, the report of the Committee which is in the public domain and
hence, that can be relied upon by them to buttress a fact situation and in any
way, establish it. The learned counsel for the Union oflndia and the contesting
d respondents, per contra, would urge that the Parliamentary Standing Committee
report cannot be tendered as a piece of evidence to prove a fact and once it is
referred to, it invites a contest and criticism.
43. We may fruitfully state that the procedure of the Committee is neither
inquisitorial nor adjudicative. It has its own character. The procedure is sui
generis. In the Westminster system, Parliament also deals with the matter
e of accountability of the Executive and Standing Committees of Parliament,
on many an occasion, examine the propriety and wisdom of the conduct
of the executive. The reports of the Committees are for the assistance of
Parliament. The procedure for drawing up such reports, is entirely a matter for
the Committee and it has authority to receive evidence from witnesses-but it
is for their own assistance. No person has a right to be heard by the Committee
even if the Committee is examining a matter which may result in an adverse
f
comment on the conduct of such person. The principles of natural justice are
not applicable.
44. It is apt to note here that Mr Grover and Mr Gonsalves have placed
reliance on the authority of Raja Ram Palv. Lok Sabha 4 , whereininpara43l(a),
it has been said: (SCC p. 371)
g "431 . ... (a) Parliament is a coordinate organ and its views do deserve
defence even while its acts are amenable to judicial scrutiny."
45. The learned counsel for the petitioners have also placed reliance on a
two-Judge Bench decision in Krishan Lal Gera v. State of Haryana 5 . In the
said case, the report submitted by the Parliamentary Standing Committee on
h
4 c2007) 3 sec 184
s c2011) 10 sec 529
503
-----------------------------------------------------------------------------------------------------------------------------------------------------------

Human Resources Development has been referred to. They have also cited
certain English authorities which relate to reliance upon the report in trials
without impugning the same. a
46. At this stage, we may gainfully refer to the authorities cited by the
learned counsel for the Union of India and the contesting respondents. In A.K.
Roy v. Union of lndia 6 , it has been held thus: (SCC pp. 310-11, para 51)
"51 . ... But we find ourselves unable to intervene in a matter of this
nature by issuing a mandamus to the Central Government obligating it b
to bring the provisions of Section 3 into force. Parliament having left
to the unfettered judgment of the Central Government the question as
regards the time for bringing the provisions of the 44th Amendment
into force, it is not for the court to compel the Government to do that
which, according to the mandate of Parliament, lies in its discretion to do
C
when it considers it opportune to do it. The executive is responsible to
Parliament and if Parliament considers that the executive has betrayed its
trust by not bringing any provision of the Amendment into force, it can
censure the executive. It would be quite anomalous that the inaction of
the executive should have the approval of Parliament and yet we should
show our disapproval of it by issuing a mandamus. The court's power d
of judicial review in such cases has to be capable of being exercised
both positively and negatively, if needed it has that power: positively, by
issuing a mandamus calling upon the Government to act and negatively
by inhibiting it from acting. If it were permissible to the court to compel
the Government by a mandamus to bring a constitutional amendment into
force on the ground that the Government has failed to do what it ought e
to have done, it would be equally permissible to the court to prevent the
Government from acting, on some such ground as that, the time was not yet
ripe for issuing the notification for bringing the Amendment into force."
47. The aforesaid passage shows that the Court does not have the power
to direct Parliament to bring an Act into force. Drawing an analogy, it is f
canvassed that as the Court cannot issue a writ to implement the report of the
Parliamentary Standing Committee or rely on it for the purpose of issuance of
a writ.
48. Ms Manisha Singh, learned counsel appearing for Respondent 6,
PATH International, contended that the report of the Parliamentary Standing
g
Committee cannot be assailed as has been held in M.S.M. Sharma v. Shree
Krishna Sinha 7 . In this regard, she has drawn our attention to para 431(0) of
Raja Ram Pal4 which states thus: (SCC p. 372)
6 (1982) 1 sec 271: 1982 sec (Cri) 1s2 h

7 AIR 1960 SC 1186
4 Raja Ram Pal v. Lok Sabha, (2007) 3 SCC 184
504
-----------------------------------------------------------------------------------------------------------------------------------------------------------

"431. . . . (o) The truth or correctness of the material will not be
questioned by the court nor will it go into the adequacy of the material or
a substitute its opinion for that of the legislature."
Reliance has been placed on the aforesaid conclusion to lay thrust on the point
that there cannot be a combat or dispute over the report of the Parliamentary
Standing Committee in a court of law and, therefore, the respondents are
debarred from contesting the same and that is the singular ground not to place
reliance upon the same.
b
49. In Sarojini Ramaswami v. Union of lndia 8 , the Court observed that
a finding of guilt recorded by the Parliamentary Standing Committee on the
charges is not conclusive and final and Parliament can still hold that charges
levelled against the person concerned do not amount to misbehaviour and may
decide not to adopt the motion. Though the decision was rendered in a different
C context, it has been taken aid of to bolster the proposition that the report of
the Parliamentary Standing Committee does not attain finality, inasmuch as
it is subject to debate in Parliament and subject to further action taken by
Parliament.
50. Inspiration has also been drawn from the authority in Arun Kumar
Agrawal v. Union of lndia 9 , wherein it has been stated in the context of the
d
report of the Comptroller and Auditor General of India (CAG) that the report
of CAG is always subject to parliamentary debates and it is possible that the
Parliamentary Accounts Committee can accept the Ministry's objection to the
CAG report or reject the report of CAG. What has been stated is that CAG
though indisputably is an independent constitutional functionary, yet it is for
e Parliament to decide whether after receiving the report i.e. the Parliamentary
Accounts Committee to make its comments on the CAG' s report. The emphasis
is on the areas of demarcation of power of Parliament and its supremacy within
its sphere.
51. On behalf of the Union of India, two decisions, namely, R. v. M urphy 10
and Office of Govt. Commerce v. Information Commr. 11 have been referred
f to highlight that there has been exclusion of discussion of the parliamentary
report.
52. At this juncture, we may note with profit, how this Court has taken
aid of the debates of the Constituent Assembly, parliamentary notes, speeches
given in Parliament and the report of the Parliamentary Standing Committee. In
g Indra Sawhney v. Union of India 12, Jeevan Reddy, J., speaking for the majority,
held that debates in the Constituent Assembly can be relied upon as an aid to
interpretation of a constitutional provision and for the said purpose, the learned
s (1992) 4 sec so6

9 c2013) 7 sec 1
h 10 (1986) 5 NSWLR 18: (1986) 64 ALR 498
11 2008 EWHC 737 (Admin)
12 1992 Supp (3) SCC 217: 1992 SCC (L&S) Supp 1
505
-----------------------------------------------------------------------------------------------------------------------------------------------------------

Judge relied upon the decisions in Madhu Limaye, In re 13 , Union of India v.
Harbhajan Singh Dhillon 14 and several opinions in Kesavananda Bharati v.
State of Kerala 15 . a
53. In Mano} Narula v. Union of India 16 , the majority of the Constitution
Bench relied on the Constituent Assembly Debates while dealing with the
concept of constitutional trust.
54. As the Constituent Assembly Debates are referred to for interpretation
of a constitutional provision and especially to understand the context, similarly
b
judicial notice of parliamentary proceedings can be taken note of for the
purpose of appreciating the intention of the legislature.
55. In Jyoti Harshad Mehta v. Custodian 17 , it has been held that reports
of the Joint Parliamentary Committee are admissible only for the purpose of
tracing the legal history of the legislation.
56. In this regard, we may also usefully state that the speeches of Ministers C
in Parliament are referred to on certain occasions for limited purposes. A
Constitution Bench in State of W.B. v. Union of lndia 18 has held: (AIR p. 1247,
para 13)
"I 3 . ... It is however well settled that the Statement of Objects and
Reasons accompanying a Bill, when introduced in Parliament, cannot be
d
used to determine the true meaning and effect of the substantive provisions
of the statute. They cannot be used except for the limited purpose of
understanding the background and the antecedent state of affairs leading
up to the legislation. But we cannot use this statement as an aid to the
construction of the enactment or to show that the legislature did not intend
to acquire the proprietary rights vested in the State or in any way to affect
e
the State Governments' rights as owners of minerals. A statute, as passed by
Parliament, is the expression of the collective intention of the legislature as
a whole, and any statement made by an individual, albeit a Minister, of the
intention and objects of the Act cannot be used to cut down the generality
of the words used in the statute."
57. In K.P. Varghese v. lTO 19 the Court while referring to the budget speech f
of the Minister ruled: (SCC p. 184, para 8)
"8 . ... Now it is true that the speeches made by the members of
the legislature on the floor of the House when a Bill for enacting a
statutory provision is being debated are inadmissible for the purpose of
interpreting the statutory provision but the speech made by the Mover of
the Bill explaining the reason for the introduction of the Bill can certainly g
13 (1969) 1 sec 292

14 (1971) 2 sec 779
15 (1973) 4 sec 225
16 (2014) 9 sec 1
11 (2009) 10 sec 564: c2010) 2 sec (Cri) 1494 h
18 AIR 1963 SC 1241
19 (1981) 4 SCC 173: 1981 SCC (Tax) 293
506
-----------------------------------------------------------------------------------------------------------------------------------------------------------

be referred to for the purpose of ascertaining the mischief sought to be
remedied by the legislation and the object and purpose for which the
a legislation is enacted. This is in accord with the recent trend in juristic
thought not only in western countries but also in India that interpretation
of a statute being an exercise in the ascertainment of meaning, everything
which is logically relevant should be admissible. In fact there are at least
three decisions of this Court, one in Lok Shikshana Trust v. CIT2°, the other
in Indian Chamber of Commerce v. CIT2 1 and the third in CIT v. Surat Art
b Silk Cloth Manufacturers' Assn. 22 where the speech made by the Finance
Minister while introducing the exclusionary clause in Section 2 clause (15)
of the Act was relied upon by the Court for the purpose of ascertaining
what was the reason for introducing that clause."
58. Similar references have also been made in Ramesh Yeshwant Prabhoo
v. Prabhakar Kashinath Kunte 23 . That apart, parliamentary debates have also
C
been referred to appreciate the context relating to the construction of a statute
in Novartis AG v. Union of India 24 , State of M.P. v. Dadabhoy's New Chirimiri
Ponri Hill Colliery Co. (P) Ltd. 25 , Union of India v. Steel Stock Holders'
Syndicate 26 , K.P. Varghese 19 and Surana Steels (P) Ltd. v. CIT27 .
59*. We have referred to these authorities to highlight that the said speeches
d have been referred to or not referred to for the purposes indicated therein and
when the meaning of a statute is not clear or ambiguous, the circumstances that
led to passing of the legislation can be looked into to ascertain the intention
of the legislature.
60. Thus observed, the reference to Constituent Assembly Debates, reports
of the Parliamentary Standing Committee and the speeches made in Parliament
or for that matter, debates held in Parliament are only meant for understanding
e
the Constitution or the legislation, as the case may be. It is quite different than
to place reliance upon Parliamentary Standing Committee report as a piece of
evidence to establish a fact. We have been commended to the authority by the
learned counsel appearing for the Union of India in R. v. Secy. of State for Trade
exp Anderson Strathclyde Plc. 28 : (All ER p. 239b-d)
f "In my judgment there is no distinction between using a report in
Hansard for the purpose of supporting a cause of action arising out of
something which occurred outside the House, and using a report for the
purpose of supporting a ground for relief in proceedings for judicial review
20 (1976) 1 SCC 254: 1976 SCC (Tax) 14: AIR 1976 SC 10

g 21 (1976) 1 sec 324: 1976 sec (Tax) 41
22 (1980) 2 SCC 31: 1980 SCC (Tax) 170: AIR 1980 SC 387
23 (1996) 1 sec 130
24 (2013) 6 sec 1 : (2013) 3 sec (Civ) 227
25 (1972) 1 sec 298
26 (1976) 3 sec 108
19 K.P. Varghese v. ITO, (1981) 4 SCC 173: 1981 SCC (Tax) 293
h 27 (1999) 4 sec 306
* Ed.: Para 59 corrected vide Official Corrigendum No. F.3/Ed.B.J./56/2017 dated 7-9-2017.
28 (1983) 2 All ER 233 (DC)
507
-----------------------------------------------------------------------------------------------------------------------------------------------------------

in respect of something which occurred outside the House. In both cases
the court would have to do more than take note of the fact that a certain
statement was made in the House on a certain date. It would have to a
consider the statement or statements with a view to determining what was
the true meaning of them, and what were the proper inferences to be drawn
from them. This, in my judgment, would be contrary to Article 9 of the
Bill of Rights. It would be doing what Blackstone said was not to be done,
namely, to examine, discuss and adjudge on a matter which was being
considered in Parliament. Moreover, it would be an invasion by the court of b
the right of every member of Parliament to free speech in the House with
the possible adverse effects referred to by Browne, J."
61. In this regard, a reference to a three-Judge Bench decision in SB!
v. National Housing Bank29 would be apposite. The Court was dealing with
an appeal preferred under Section 10 of the Special Court (Trial of Offences
Relating to Transactions in Securities) Act 27 of 1992. In the said case, this C
Court noticed that the learned Judge of the Special Court had extensively relied
upon the Second Interim of the Janakiraman Committee 30 on the ground that
the same was filed by the first defendant. The Court in that context held: (SCC
p. 558, paras 50-51)
"50. It is well settled by a long line of judicial authority that the d
findings of even a statutory commission appointed under the Commissions
of Inquiry Act, 1952 are not enforceable proprio vigore as held in Ram
Krishna Dalmia v. S.R. Tendolkar 31 and the statements made before
such Commission are expressly made inadmissible in any subsequent
proceedings civil or criminal. The leading judicial pronouncements on that
question were succinctly analysed by this Court in T.T. Antony v. State of e
Kerala 32 , SCC paras 29-34. Para 34 of the judgment inter alia reads: (SCC
p. 204)
'34 . ... In our view, the courts, civil or criminal, are not bound
by the report or findings of the Commission of Inquiry as they have
to arrive at their own decision on the evidence placed before them in
accordance with law.' f
51. Therefore, courts are not bound by the conclusions and findings
rendered by such commissions. The statements made before such
commission cannot be used as evidence before any civil or criminal court. It
should logically follow that even the conclusions based on such statements
can also not be used as evidence in any court. The Janakiraman Committee g
is not even a statutory body authorised to collect evidence in the legal sense.
29 (2013) 16 sec 538: (2014) 5 sec (Civ) 523

30 Committee set up by RBI on 30-4-1992 which submitted six reports and the Final Report was
on 7-5-1993 h
31 AIR 1958 SC 538
32 c2001) 6 sec 181: 2001 sec (Cri) 1048
508
-----------------------------------------------------------------------------------------------------------------------------------------------------------

It is a body set up by the Governor of Reserve Bank of India obviously in
exercise of its administrative functions,
a ' ... the Governor, RBI set up a committee on 30-4-1992 to
investigate into the possible irregularities in funds management by
commercial banks and financial institutions, and in particular, in
relation to their dealings in government securities, public sector bonds
and similar instruments. The Committee was required to investigate
various aspects of the transactions of SBI and other commercial banks
b as well as financial institutions in this regard.' 33 "
And again: (SCC p. 559, para 53)
"53. The report of such a committee in our view can at best be the
opinion of the Committee based on its own examination of the records of
the various banks (including the plaintiff and the first defendant) and the
C statements recorded (by the Committee) of the various persons examined
by the Committee. In our considered view the report of the Janakiraman
Committee is not evidence within the meaning of Evidence Act which the
Special Court is bound to follow."
62. We have referred to the said authority as this Court has thought it
appropriate to state following the precedents that the report of a statutory
d
committee cannot be received as evidence of facts stated in the report.
63. Having dwelled upon this aspect, we may refer to certain relevant
Articles of the Constitution. Article 105 deals with powers, privileges, etc. of
the Houses of Parliament and of the members and committees thereof. To have
a complete picture, the said Article is reproduced in entirety:
e "105. Powers, privileges, etc., of the Houses of Parliament and of the
members and committees thereof.-(!) Subject to the provisions of this
Constitution and to the rules and standing orders regulating the procedure of
Parliament, there shall be freedom of speech in Parliament.
(2) No member of Parliament shall be liable to any proceedings in any
court in respect of anything said or any vote given by him in Parliament or any
f committee thereof, and no person shall be so liable in respect of the publication
by or under the authority of either House of Parliament of any report, paper,
votes or proceedings.
(3) In other respects, the powers, privileges and immunities of each House
of Parliament, and of the members and the committees of each House, shall
be such as may from time to time be defined by Parliament by law, and, until
g so defined, shall be those of that House and of its members and committees
immediately before the coming into force of Section 15 of the Constitution
(Forty-fourth Amendment) Act, 1978.
(4) The provisions of clauses (1), (2) and (3) shall apply in relation to
persons who by virtue of this Constitution have the right to speak in, and
otherwise to take part in the proceedings of, a House of Parliament or any
h committee thereof as they apply in relation to members of Parliament."
33 See the Janakiraman Committee' s first interim report, May 1992, p. 1.
509
-----------------------------------------------------------------------------------------------------------------------------------------------------------

64. What is necessary to understand from Article 105(2) is that no member
of Parliame nt can be made liable for any proceeding in any court be cause of
what h e has state d in a committee . The Parliam entary Standing Committee is a
a committee constituted under the Rules and wha t a m e mber speaks over there
is absolutely within the domain of that committee. Freedom of speech of a
member of a committee is only guided subject to provisions of the Constitution
and the Rules and Standing Orders regulating the procedure of Parliament. It
is also seemly to note that Article 105(4) categorically lays the postulate that
clauses (1), (2) and (3) shall apply to any committee of Parliame nt. b
65. Article 118 deals with rules of procedure. Clause (1) of the said Article
stipulates that each House of Parliament may make rules for regulating, subject
to the provisions of the Constitution, its procedure and the conduct o f its
business. Thus, the said Article empowers Parliament to regulate its procedure
apart from what has been stated directly in the Constitution.
66. Article 121 provides restriction on discussion in Parliament. The same C
is extracted below:
"121. Restriction on discussion in Parliament.-(!) No discussion shall
take place in Parliament with respect to the conduct of any Judge of the
Supreme Court or of a High Court in the discharge of his duties except upon
a motion for presenting an address to the President praying for the removal of
the Judge as hereinafter provided." d
67. The aforesaid Article 121 makes it vivid that Parliament shall not
discuss as regards the conduct of any Judge of the Supreme Court or of a High
Court in the discharge of his duties, except upon a motion been presented before
the President of India praying for removal of the Judge as provided in the
Constitution. Thus, the discussion of Parliament is restricted by a constitutional e
provision.
68. Article 122 stipulates a restraint on courts to inquire into proceedings of
Parliament. The said Article being absolutely significant is reproduced below:
"122. Courts not to inquire into proceedings of Parliament.-(!) The
validity of any proceedings in Parliament shall not be called in question on the
ground of any alleged irregularity of procedure. f
(2) No officer or member of Parliament in whom powers are vested by or
under this Constitution for regulating procedure or the conduct of business, or
for maintaining order, in Parliament shall be subject to the jurisdiction of any
court in respect of the exercise by him of those powers."
69. The purpose of referring to the aforesaid Article s is that while g
exercising the power of judicial review or to place reliance on the report of the
Parliamentary Standing Committee, the doctrine of restraint has to be applied
by this Court as required under the Constitution. What is argued by the learned
counsel for the petitioners is that there is no question of any kind of judicial
review from this Court or attributing anything on the conduct of any of the
members of the Committee, but to look at the report for understanding the h
controversy before us. The submission "looking at the report," as we perceive,
510
-----------------------------------------------------------------------------------------------------------------------------------------------------------

is nothing but placing reliance thereupon. The view of a member of Parliament
or a member of the Parliamentary Standing Committee who enjoys freedom
a of speech and expression within the constitutional parameters and the rules or
regulations framed by Parliament inside Parliament or the Committee is not to
be adverted to by the court in a lis.
70. In this regard, it is appropriate to refer to the observations made by the
House of Lords in Hamilton v. Al Fayed 34 : (AC pp. 406 & 407-08)
"The Court of Appeal held 35 , first, that apart from any question of
b
parliamentary privilege the principle in Hunter case 36 had no application: a
parliamentary decision was not analogous to a decision of the court. Next,
the Court of Appeal held that the proceedings before the PCS, his report
and its acceptance by the CSP were all "parliamentary proceedings" and
therefore any attempt to investigate or challenge any of the procedures
C
adopted constituted a breach of parliamentary privilege: they constituted
a "questioning" of parliamentary procedures. They therefore held that the
Judge had been in error and had himself breached parliamentary procedure
by criticising the procedures adopted by the PCS. The conclusion of the
Court of Appeal on these two points met the concerns of the Solicitor
General. The Court of Appeal were clearly correct on these points and they
d were not further challenged on appeal to your Lordships' House.
* * *
Presumably because of the way the case was presented to them, the
Court of Appeal never considered the relevant question (viz. whether there
should be a fair trial stay) raised by Question 2 of the summons. The
only way in which Mr Al Fayed could justify his defamatory statements
e was by detailed challenge to Mr Hamilton's conduct in Parliament, which
challenge would be precluded by parliamentary privilege. That being so,
it would in my judgment have been impossible for Mr Al Fayed to have
had a fair trial in this action if he had been precluded from challenging
the evidence produced to the parliamentary committees on behalf of
Mr Hamilton. Had it not been for Section 13, the court should, in my
f judgment, have stayed the libel action brought by Mr Hamilton by making
an order under para 2 of the summons. However, Section 13 does apply to
this case and provides a complete answer to it." (emphasis in original)
71. We will be failing in our duty if we do not note another submission
of the learned Solicitor General that for issuance of a writ of mandamus, it is
primary to establish that one has a right and, in the case at hand, an effort has
g been made to rely on the Parliamentary Standing Committee's report to create
a right which is legally not permissible.
72. The controversy has to be seen from the perspective of judicial review.
The basic principle of judicial review is to ascertain the propriety of the
h 34 (2001) 1 AC 395: (2000) 2 WLR 609 (HL)

35 Hamilton v. Al Fayed, (1999) 1 WLR 1569 (CA)
36 Hunter v. Chief Constable of the West Midlands Police, 1982 AC 529: (1981) 3 WLR 906 (HL)
511
-----------------------------------------------------------------------------------------------------------------------------------------------------------

decision-making process on the parameters of reasonableness and propriety of
the executive decisions. We are not discussing about the parameters pertaining
to the challenge of amendments to the Constitution or the constitutionality of a
a statute. When a writ of mandamus is sought on the foundation of a factual
score, the Court is required to address the facts asserted and the averments
made and what has been stated in oppugnation. Once the Court is asked to look
at the report, the same can be challenged by the other side, for it cannot be
accepted without affording an opportunity of being heard to the respondents.
The invitation to contest a Parliamentary Standing Committee report is likely b
to disturb the delicate balance that the Constitution provides between the
constitutional institutions. If the Court allows contest and adjudicates on the
report, it may run counter to the spirit of privilege of Parliament which the
Constitution protects.
73. As advised at present, we are prima facie of the view that the
Parliamentary Standing Committee report may not be tendered as a document C
to augment the stance on the factual score that a particular activity is
unacceptable or erroneous. However, regard being had to the substantial
question of law relating to interpretation of the Constitution involved, we
think it appropriate that the issue be referred to the Constitution Bench under
Article 145(3) of the Constitution. We frame the following questions for the
purpose of reference to the Constitution Bench: d
73.1. (i) Whether in a litigation filed before this Court either under
Article 32 or Article 136 of the Constitution of India, the Court can refer to and
place reliance upon the report of the Parliamentary Standing Committee?
73.2. (ii) Whether such a report can be looked at for the purpose ofreference
and, if so, can there be restrictions for the purpose of reference regard being
had to the concept of parliamentary privilege and the delicate balance between e
the constitutional institutions that Articles 105, 121 and 122 of the Constitution
conceive?
74. Let the papers be placed before the Hon'ble the Chief Justice of India
for constitution of appropriate Bench.
f
h
sec Online Web Edition, Copyright© 2017
Page 1 Friday, September 8, 2017
ANNEXURE P-14 512
sec Online Web Edition: http://www.scconline.com
TruePrint™ source: Supreme Court Cases

(BEFORE MADAN B. LOKUR AND DEEPAK GUPTA, JJ.)
a
Writ Petition (C) No. 444 of 2013
GAURAV KUMAR BANSAL Petitioner;
Versus
UNION OF INDIA AND OTHERS .. Respondents.
With
Writ Petition (C) No. 823 of 2013 b
FOUNDATION FOR RESTORATION OF NATIONAL
VALUES Petitioner;
Versus
UNION OF INDIA AND OTHERS .. Respondents.
Writ Petitions (C) No. 444 of 2013t with c
No. 823 of 2013, decided on May 8, 2017
Human and Civil Rights - Disaster Management Act, 2005 -
Implementation of - Urgency of, light of unprecedented flood and landslide
disaster occurring in Uttarakhand in 2013 leading to widespread damage to
life, limb and property - Many other States also not fully prepared to deal
with disasters - Situation reviewed on progress made since Supreme Court d
had intervened - Further directions issued
SB-D/58655/C
Advocates who appeared in this case :
Petitioner-in-Person;
Vibhu Tiwari and Ravi Prakash Mehrotra, Advocates, for the Petitioner;
Anil Grover, D.K. Thakur, Sanchar Anand, S.S. Shamshery, Additional Advocates e
General, Rana Mukherjee, Ms V. Mohana and AK. Sanghi, Senior Advocates [Vimal
Roy Jad, Shadman Ali, Ms Sadhana Sandhu, Ms Kiran Bhardwaj, Ms Sunita Sharma,
R.R. Rajesh, Raj Bahadur, Ms Sushma Suri, G.S. Makker, D.S. Mahra, Harvinder
Chowdhury, R.R. Raheja, B. Krishna Prasad, Chirag M. Shroff, Ms Neha Sangwan,
Guntur Prabhakar, Ms Prerna Singh, Anil Shrivastav, Rituraj Biswas, Shuvodeep Roy,
Sayooj Mohandas, Gopal Singh, Manish Kumar, Aniruddha P. Mayee, A Selvin
Raja, Ms Hemantika Wahi, Ms Jesal Wahi, Ms Puja Singh, Arjun Vinod Bobde, f
Ms Praneeta Sharma, Ms Richa Relhan, Ms Noopur Singhal, Sanjay Kr. Visen, Manik
Garg, Dr Monika Gusain, Shariq Ahmed, Varinder Kr. Sharma, Ms Pragati Neekhra, M.
Shoeb Alam, Ms Fauzi Shakil, Ujjwal Singh, Tapesh Kr. Singh, Mohd. Waquas, Sukant
Vikram, Aditya Pratap Singh, Anil Kr. Jha, R.K. Ojha, Joseph Aristotle S., Ms Priya
Aristotle, Ms K. Priyadarshini, Ashish Yadav, Ms Romsha Raj, G. Prakash, Jishnu
M.L., Ms Priyanka Prakash, Ms Beena Prakash, Manu Srinath, Mishra Saurabh, Ankit
Kr. Lal, Ms Vanshaja Shukla, Mahaling Pandarge, Nishant R. Katneshwarkar, Sapam g
Biswajit Meitei, Naresh Kr. Gaur, Ashok Kr. Singh, Ms Linthoingambi Thongam,
Ranjan Mukherjee, Subhro Sanyal, Ms K. Enatoli Serna, Edward Belho, Amit Kr.
Singh, K. Luikang Michael, Ms Elix Gangmei, Z.H. Isaac Haiding, Pawan Upadhyay,
Sarvjit Pratap Singh, Ms Sharmila Upadhyay, Apoorv Singhal, Rishi Chawla, Anant
K. Vatsya, Kuldip Singh, Amit Sharma, Ankit Raj, Ms Ruchi Kohli, Ms Aruna Mathur,
Avneesh Arputham, Ms Anuradha Arputham, Amit Arora (for M/s Arputham Aruna
& Co.), B. Balaji, S. Kumar, S. Udaya Kr. Sagar, Mrityunjai Singh, Ms Varsha Poddar, h
t Under Article 32 of the Constitution of India

sec Online Web Edition: http://www.scconline.com 513
GAURAV KUMAR BANSAL v. UNION OF INDIA (Lokur, ].) 731

Vinay Garg, Sameer Singh, Tanmay Agrawal, Deepam Garg, Ms Rachana Srivastava,
Aviral Saxena, Ms Monika Sukrit R. Kapoor, Ms Nitya Madhusoodanan, Raja
Chatterjee, Chanchal Kr. Ganguli, Runa Bhuyan, Bhupesh Narula, KV. Jagdishvaran,
a Ms G. Indira, Ms Harvinder Chowdhury, V.G. Pragasasm, S. Prabu Ramasubramanian,
D. Mahesh Babu, Nikhil Goel, Ms Naveen Goel, Ashutosh Ghade, Ms Anitha Shenoy,
T.N. Rama Rao, Hitesh Kr. Sharma, T. Veera Reddy and G.N. Reddy, Advocates] for
the Respondents.

MADAN B. LOKUR, J.- These two writ petitions were filed under
b
Article 32 of the Constitution consequent upon the unprecedented flood and
landslide disaster that occurred in Uttarakhand in 2013. Undoubtedly the
disaster led to widespread damage to life, limb and property and according to
the petitioners, the adverse impact of the disaster could have been mitigated
had there been effective implementation of the Disaster Management Act, 2005
C
(for short "the Act") and adequate preparedness by the State Government of
Uttarakhand. It was alleged in the writ petitions that many of the other States
were also not fully prepared to deal with a disaster and therefore necessary
directions ought to be given by this Court for proper implementation of the Act.
2. This Court took up the petitions in public interest and required responses
to be filed by the State Governments. However, as per the normal practice,
d the State Governments were lax and extremely slow in filing affidavits.
The Union Government was also a little slow in ensuring that the Act is
implemented in letter and spirit. Resultantly and apparently on the prodding of
this Court, the Union Government took some positive action and on 25-2-2016
a communication was sent to the Chief Secretaries of all the States by the Joint
Secretary (Policy and Plan) of the National Disaster Management Authority
e (for short "the NOMA"). Through this letter, NOMA required the Chief
Secretaries of all the States to frame minimum standards of relief for victims
of disaster. This Court also required the Chief Secretaries to formulate (among
other things) guidelines on minimum standards of relief for food, water,
sanitation, medical cover to be provided to persons affected by a disaster and
also special provisions to be made for widows and orphans. Unsurprisingly,
f there was again some laxity in complying with the directions of this Court.
3. On 5-4-2016, it was brought to the notice of this Court that Section 11
of the Act requires the drawing up of a National Plan for disaster management
in consultation with State Governments and expert bodies or organisations in
the field of disaster management. It was brought out that while there is a policy
document but the National Plan has not yet been finalised.
g 4. It was also brought out that under Section 23 of the Act, each State
is required to formulate a State Plan for disaster management and under
Section 31 of the Act each district is required to formulate a plan for disaster
management. It is unfortunate that more than 10 years after the passage of
the Act by Parliament, many of the States had not taken adequate steps to
ensure that the requirements under the Act were complied with and disaster
h management plan formulated.

S. To make matters worse, we were informed on 14-9-2016 that some States
particularly Himachal Pradesh, Kerala, Maharashtra, Meghalaya, Uttar Pradesh
and West Bengal had not yet responded to communications sent by NOMA. a
Eventually, however, it appears that all the State Governments have woken up
to their statutory duties and have formulated appropriate plans.
6. In the hearing held on 28-4-2017, it was brought to our notice by the
learned counsel appearing for NOMA that a National Advisory Committee
has since been constituted under Section 7 of the Act by a Notification
dated 18-11-2016 and the Committee has a tenure of two years. Similarly, under b
Section 8 of the Act, a National Executive Committee has also been constituted
by a Notification issued on 27-9-2006 and that it is a continuing Committee in
terms of the provisions of the Act.
7. It was further pointed out that a National Plan has been approved and
placed on the website of NOMA in terms of Section 11 of the Act and the
guidelines for minimum standards of relief under Section 12 of the Act have C
also been placed on the website of NOMA.
8. In further compliance with the provisions of the Act, a State Disaster
Management Authority has been constituted in all the States and Union
Territories under Section 14 of the Act and a State Executive Committee
mandated under Section 20 of the Act has been constituted except in the Union
Territory of Chandigarh. d
9. It was pointed out by the petitioner appearing in person that an Advisory
Committee had not been constituted by the State Disaster Management
Authority under Section 17 of the Act and that necessary directions should be
given in this regard. Section 17 of the Act reads as follows:
"17. Constitution of Advisory Committee by the State Authority.- e
(1) A State Authority may, as and when it considers necessary, constitute
an Advisory Committee, consisting of experts in the field of disaster
management and having practical experience of disaster management to make
recommendations on different aspects of disaster management.
(2) The members of the Advisory Committee shall be paid such
allowances as may be prescribed by the State Government." f
10. On a plain reading of the above provision, we find that there is no
mandate making obligatory the establishment of an Advisory Committee. It
is really for the State Disaster Management Authority to constitute one or
more Advisory Committees as and when it becomes necessary to do so on
different aspects of disaster management. Consequently, on the plain language
of Section 17 of the Act, it is not possible for us to give any direction as prayed g
for by the petitioner.
11. As far as the preparation of the State Plan under Section 23 of the Act
is concerned, we have been informed by the learned counsel for NOMA that
all States except Andhra Pradesh and Telangana have prepared a State Disaster
Management Plan which is very much in place.
h
GAURAV KUMAR BANSAL v. UNION OF INDIA ( Lokur, ].) 733

12. As far as the districts are concerned, it is stated that the District
Disaster Management Authority has been constituted in every district under
a Section 25 of the Act and out of 684 districts in the country, a District Disaster
Management Plan is in place in 615 districts while it is under process in the
remaining districts.
13. On a review of the steps that have been taken by NOMA, we are of
the opinion that there has been sufficient compliance with the provisions of
the Act and it is not necessary for us to issue any particular directions. All
b we need say is that it is absolutely necessary for NOMA constituted at the
national level and the State Disaster Management Authority at the State level to
be ever vigilant and ensure that if any unfortunate disaster strikes there should
be total preparedness and that minimum standards of relief are provided to all
concerned. However, it would be advisable for NOMA to regularly publish
its Annual Report (the last one on our record is of 2013-2014), to review and
C update all plans on the basis of experiences and to make its website ndma.gov.in
multilingual so that all concerned may benefit.
14. With these observations, we dispose of the writ petitions while
acknowledging the efforts put in by the petitioners in bringing into focus the
necessity of implementing the statute that might affect any one at any time.
15. The writ petitions are disposed of.
d
h
1/11/22, 10:49 AM homeopathy: Prez endorses Modi's homeopathy line I Kolkata News - Times of India
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I
THIS STORY IS FROM MAY19, 2017
Prez endorses Modi's homeopathy line

~janta ChakraborJ:y_(htt12s://timesofindia.indiatimes.com/toire12orter/author-Ajanta-ChakraborJ:Y.-ll740.cms). /TN N / May 19, 2017, 18:36 1ST
□ □ □ □ □ rarticl1s1~tt/58752326cms)
ARTICLES
.(b!:!;i:2s: imesofindia.indiatimes.com
endorses-modis-homeoQ:athY.:
line/articleshow/58752326.cmsj
_(httr2s://timesofindia.indiatimes.com/.
kolkata-restaurants-accused-of-servi1
food/articleshow/58752242.cms).
.{httos://timesofindia.indiatimes.ffilr0!5€l~Wit\fl(~!mii'&!ish,/blockchainlthe-
indian-cry12to-bill-2027-what-lies-ahead-for-cr,Y.QtQ:--=====--
investors/articleshow/88570455.cms).
KOLKATA: If the Modi government is

{https://timesofindia.indiati,,µ{Gi~@tiiVU.tl:i i ngs Indian, and
benqal-qovernmnet-needs-to-redraw-tobacco-
ded ICatI ng a ministry exclusively to o LIVENOW
r:2oli91/articleshow/58750614.cms).
AYUSH, president Pranab Mukherjee Omicron variant live updates:
wasn't lacking in enthusiasm when he India"s Omicron tally mounts to
4,461; most cases in...
batted for homeopathy here on Friday,
saying it was playing a key role in
healthcare.
Speaking at a ceremony at the Science

City auditorium where leading
homeopaths and students of the
variant-live-ugdates-covid-19-.@..0.Y.s_ry.,:
discipline were awarded, the president ll~iveblog/88820021.cms}
10:40 (1ST) Jan 11
said, "As an alternate system of medicine,
systems like BY.urveda, Unani, Covid peak in Delhi, Mumbai
by mid-January, UP by
Homeopathy and Siddha are playing a key
month-end, says IIT-Kanpur
role in the health care service of our
expert
country. Homeopathy has great 44 MORE UPDATES >
advantage of cost compared to allopathy,
which is very costly. Apart from low-cost of
https://timesofindia.indiatimes.com/city/kolkata/prez-endorses-modis-homeopathy-line/articleshow/58752326.cms#_ga=2.16873117 4.628843527.. . . 1/6

1/11/22, 10:49 AM homeopathy: Prez endorses Modi's homeopathy line I Kolkata News - Times of India
517
treatment, it doesn't have any side-effect,
unlike allopathy where treating one
ailment prepares ground for other
ailments."
But he pointed out that considering the

~n rs s Mod i's demand of this form of medicine, there
was a huge shortage in qualified
practitioners.
The president reminded the audience of TRENDING TOPICS

homeopathy's strong Kolkata connection,
Omicron Variant in India
and how the city "which had a ready field
_(https://timesofindia.indiatimes.com/india/orr
of acceptance of homeopathy as the
variant-live-updates-covid-19-january.:
alternative medicine." He spoke of ll/livebloq/88820021.cms).
Calcutta Homeopathic College, set up in
Covid Cases in India
7878. "The country's first homeopathy _(https://timesofindia.indiatimes.com/india/cO\
college was established in 7878, that too 19-7-day-average-deaths-up-66-cases-dip-aft,
located in Kolkata" the president said, 13-day-rise/articleshow/88820318.cms)
smiling as he referred toJogn Martin ,&,jnath Sing.!J.
Honigberger, who lived in Calcutta in the .(https://timesofindia.indiatimes.com/india/de1

minister-rajnath-singh-tests-covid-
19th century and was called the "cholera
positive/articleshow/88810418.cms).
doctor" because he managed to cure
Novak Djokovic
himself of the disease by taking "ipecac"
_(https://timesofindia.indiatimes.com/sports/te
every half an hour.
stories/novak-djokovic-australian-visa-battle-
damagi!Jg-on-all-fronts-
Turning the pages of history to Calcuttans
j!to/articleshow/88823690.cms).
who had popularized homeopathy, the
Covid Booster Dose
like of Mahendra Lal Sircar, Rajendralal
_(https://timesofindia.indiatimes.com/india/ad,
Dutta or Babu Ra hen Dutta, who had of-precaution-dose-of-covid-vaccine-to-higb:J
cured lswar Chandra VidY.asagar of PQpulation-begins-today/articleshow/8879712
asthma, and to Satish Chandra Sa manta,

the MP from Bengal who piloted a move
RELATED STORIES
in the constituent assembly to establish
the Central Council of Homeopathy, Now,_get health ti~
Mukherjee said, "There was a growing over P-hone for free
consciousness in the minds of these
.(.tl:llg;s://timesofindia.indiatimes.com/cit
people as to how to make homeopathy !Q:_get-ayurveda-and-naturor2athy-cent
soon/articleshow/58087400.cms}.
much more effective; it was necessary to
have an organised system of alternative
/https://timesofindia.indiatimes.com/in(
medicine ... Today the system has laws-likely-on-ayurveda-
homoeogathy/articleshow/57765957.crr
developed."
The president said a homeopathy centre

has been opened at Rashtrapati Bhavan:
"In Rashtrapati Bhavan, we have
established homeopathy clinics, people
tell me that they are fully satisfied with the
service." The president presented the
Malati Allen Noble Award to 78 toppers
from 796 homeopathic medical colleges
across the country and two from colleges
in Bangladesh.
https://timesofindia.indiatimes.com/city/kolkata/prez-endorses-modis-homeopathy-line/articleshow/58752326.cms#_ga=2.16873117 4.628843527.... 2/6

518
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519
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Eighth Edition 2007
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. '-'
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520
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521
10630 Art. 226 Part VI-The States-Chapter V-The High Courts in the States
High court may interfere wher~_action is being taken under an invalid law, arbi-
10
trary or without sanction of law.2"' Interfe,r,,~nce is also justified in cases where the
1
authority locked jurisdiction to issue notice.~"',.
The rule that alternative remedy be exhausted before invoking jurisdiction under
Art. 226 has been characterised as a rule of policies, convenience and discretion, a
self imposed restraint involved by courts themselves, rather than a rule of law. The
availability of alternative remedy does ,,!;lot operate as a bar to the exercise of writ
2 12
courts jurisdiction of judicial review. -' It was held that existence of alternative
2373
remedy is relevant to the exercise of discretion and is not a rule of law .
Exceptions to the Rule of Exhaustion in India
1. Our Supreme Court has, accordingly, acknowledged a number of exceptional
circumstances under which relief under Art. 226 may be granted notwithstanding the
fact that the petitioner has not exhausted his statutory remedies. These exceptions
make our writ jurisdiction far more effective and wider than in England and make it
comparable to that in the U.SA. where liberal exceptions to the exhaustion of statuto-
2374
ry remedies postponing judicial review are admitted (though the decisions are not,
in all respects, uniform.
. 1 crrcumstances
2 . What th ese except1ona . . 1y enumerated231s
are, cannot b e exh aust1ve
because the matter is pre-eminently one for the discretion of the Court issuing the
2376
writ, which is to be exercised according to the facts of each case. It is the law, that a
claimant will not be required to avail some other procedure if that other procedure is
'"less satisfactory" or "'otherwise in appropriate" In each case the question is whether
the court should exercise its discretion, it would be both foolish and impossible to seek
2377
to anticipate" all the factors that may properly influence the court's discretion. Nev-
ertheless, the fallowing may be mentioned amongst in here the Cou av
grant relief even thoug t e statutory reme 1es have not been exhausted-
(i) Where ~here 'f,~s a complete lac~ of jurisdictio~,.}1/ith the officer or authori-
ty or tnbunal., 8 to take the action 1mpugned,--'- 9 e.g., where the proceed-
2370. Bunnah Construction Co. v. State of On"ssa, AIR 1962 SC 1320 : 1962 (Supp-I) SCR 242; Collector
of Customs and Excise, Cochin v. A.S. Bava, AIR 1968 SC 13: (1968) 1 SCR 82: Johanna! Murli-
dhar and Co. v. Agricultural Income-tcvc Officer, Assam, AIR 1970 SC 1980 : ( 1970) 3 SCC 331.
2371. Union of India v. Hindalco Industries. (2003) 5 SCC 194: A.IR 2003 SC 4086: Union of India v.
VICCO Laboratories, (2007) 13 SCC 270.
2372. M.P. State Agro Industries Development Cropn. Ltd. \'. Jahan Khan, AIR 2007 SC 3153 : (2007)
10 sec 88; State of H.P. V. Gujarat Ambuja Cements Lui., (2005) 6 sec 499; Sanjana M. Wig V.
Hindustan Petro C01poration Ltd., AIR 2005 SC 3454 : (2005) 8 SCC 242; Harbanslal Sahnia v.
Indian Oil C01pn. Ltd., AIR 2003 SC 2120: (2003) 2 SCC 107: Whirlpool Corporation v. Regis-
trar of Trade Marks, AIR 1999 SC 22: (1998) 8 SCC 1.
2373. BCPP Mazdoor Sangh v. NTPC, AIR 2008 SC 336: (2007) 14 SCC 234; Rajasthan SEB \'. Union
of India, (2008) 5 SCC 632.
2374. Leedom v. !ntemational Union, (1956) 352 US 145 (excess of jurisdiction); Public Utilities
Commn. v. U.S., (1958) 355 US 534 (constitutionality of statute challenged); City Bank v. Sclmad-
er, (1934) 291 US 24: Smith v. Illinois Bell Co., (1926) 270 US 587 (591) [statutory remedy
would be futile or dilatory). _ ______ _ _ _____ _
2375. Abraham v. I.T.O., AIR 1961 SC 609: (1961) 2 SCR 765.
2376. State of U.P. v. Mohd. Nooh, (1958) SCR 595 (605-07) : AIR 1958 SC 86.
2377. R. v. Hereford Magistrate Court exp. Rmvlands, (1998) QB 110.
2378. S.T.O. v. Shiv Ratan, AIR l 966 SC 142 : (1965) 3 SCR 71; Calcutta Discount Co. v. l.T.0., AIR
1961 SC 372 (380): (1961) 2 SCR 241.
237~. S.T.O. v. Shiv Ratan, AIR 1966 SC 142: (1965) 3 SCR 71~ Calcutta Discount Co. v. l.T.O., AIR
1961 SC 372 (380) : (1961) 2 SCR 241; Bhopal Sugar Industries v. Dube, AIR 1964 SC 1037 :
(1964) 1 SCR 481 : (1963) 14 STC 406 (SC).
522
Power of High Courts to Issue Certain Writs Art. 226 10631
. h 1s
imrs have been taken under a 1aw w h1c . u ltra vu-es
. 23so
or upon an err0 -
. neous interpre\~\ion of the statut~ gr where the il:1-p~sition is _wit~out au-
thority of law--'" 1 or ultra vires;- 38- The same pnnc1ple aI?phe.s m ca~es
where action is taken on the b~siJ of a rule (delegated de leg1slat1ve) which
is ultra vires the parent Act."'""' 8-' or without any materials to support t_he
conclusion that the statutorv conditions precedent for the assumption of Ju-
risdiction did exist: 2384 but ~ot where the determination of the ·urisdictional
fact itself involves a lo . ea orate in mry on ta? ng evidence an ·
cannot be made on affidavit:~ :,
(ii) Where the imp!;!oned order has been made in violation of the principles _of
natural justice/!sG The reason behind this rule is that when an authonty
2380. Cf. Carl Still\·. State of Bihar, AIR 1961 SC 1615 (1621): (1962) 2 SCR 81: Balmram v. Zila
Parishad, AIR 1969 SC 556 (559): ( 1969) 1 SCR 518; Collector of Customs v, Bava, 1968 SC 13
(15).
2381. Beharilal v. S.T.O .. ( 1965) 17 STC 508 (509) (SC): E.B. Ke,ubradih Colliery v. Union of India,
AIR 1983 Del 70.
2382. Beharilal v. S.T.O., (1965) 17 STC 508 (509) (SC): E.B. Kendwadih Colliery r. Union of India,
AIR 1983 Del 70. See also State of Bombay v. United Motors (India> Ltd., AIR 1953 SC 252 :
1953 SCR 1069: M.P. State Agro Industries Development C017m. v. Johan Khan, AIR 2007 SC
3153: (2007) 10 SCC 88; Whirlpool Corporation v. Registrar of Trade lvlarks, AIR 1999 SC 22:
( 1998) 8 SCC 1: Harbanslal Salmia v. Indian Oil Co1pn. Ltd.• AIR 2003 SC 2120 : (2003) 2 SCC
107: Himmarlal Harilcil Mehta v. State of M.P., AIR l 954 SC 403 : 1954 SCR 1122: State of Ra-
jasthan r. Karamchand Tlwppar and Bros.. AIR 1965 SC 913: Tata Engineering and Locomotive
Co. Led. r Asst. Commissioner of Cornmercial Taxes, AIR 1967 SC 1401 : (1967) 2 SCR 751:
Bhopal Sugar Industries Ltd., M.P. v. Sales Tax Officer. AIR 1967 SC 549 : (1964) 1 SCR 488;
Asst. Collector of Central Excise. v. Dunlop India Ltd., AIR 1985 SC 330 : ( 1985) 1 SCC 260:
Srme of U.P. v. Rc~fiquddin. AIR 1988 SC 162 : 1987 (Supp) SCC 401: Paradip Port Trust v.
Sales Tax Q{f7cer. AIR 1999 SC 552 : ( 1998) 4 SCC 90: T.N. State Transport Corpn. v. Neethivi-
langan Kumbakonam. AIR 2001 SC 2309: (2001) 9 SCC 99.
2383. See also Mohammad Yasin v. Town A.rea Committee, AIR 1952 SC 115 : 1952 SCR 572.
2384. Calcutta Discoum Co. v. l.T.O .. AIR 1961 SC 372 (380): (1961) 2 SCR 241. See also Whirlpool
Corporarion v. Regisrrar ,f Trade A1arks. AIR 1999 SC 22 : (1998) 8 SCC 1: Veeri Chettiar v.
STO, AIR 1971 Mad 155; Kzmtesh Gupto, Dr. r. /l,1anagement of Hindu Kanya Mahavidyalaya,
AIR 1987 SC 2186: (1987) 4 SCC 525: Sales Tax Officer, Jodhpur v. Shiv Ratan G. Mohatta,
AIR 1966 SC 142 : (1965) 3 SCR 71: P lvfohanuned v. RTA, AIR 1993 Ker 74; State of' Kamat aka
State Road Transport C01p11. v. Pauli Govis. AIR 1996 Kant 245: Harbanslal Salmia ;,_ Indian Oil
Co17m. Ltd.. AIR 2003 SC 2120 : (2003) 2 SCC 107: Sanjay Sales Coqm. v. National Mindral
,-- , · Dei·elopment Co,pn., AIR 1993 AP 62: East India Commercial Co. Ltd. v. Collector of Customs,
SC
. OJltb'- ,ry..~~-u)A.IR 1962 1s~n :tfi963)_ 3 .SCR 338~ (' ltd. v. (1_1iion7{tffidiii; .t\TRJ:98<J1=.<!l :.mi._._ /_1:)r ~.
/lr·) •2385; 'S.T.O. v. Shfr Ratan. A.IR 1966 SC 142 965) 3 SCR 71· CI. iscoz o. v.1.T.V:,'A.IR
-
NJ ., ." : . "41 xnress NewS?a?ers i·. Workers, AIR 1963 SC 569 (574)
~1"-,,, , ~: o 963) 3 s.cR 540 : 0 9_62! 2 LLJ 22. . _ . . .
,"Jti/ ~ 2.,86. Cf. Carl Std/\'. State of B1/zar, AIR 1961 SC 161) (1621) : (1962) 2 SCR 81: Baburam v. Z1la
Parishad. AIR 1969 SC 556 (559) : (1969) 1 SCR 518. See also 1\-l.P. State Agro Industries De-
velopmem Corp11. i·. Jahan Khan. AIR 2007 SC 3153: (2007) 10 SCC 88; Popcorn Entertainment
.-. City Industrial Dei·elopmem Corpn., (2007) 9 SCC 593: l/e11kereswara11 ,·. Ramchand Sobhraj
Wadhwani. AIR 1961 SC 1506 : (1962) 1 SCC 753. See also Harbanslal Salmia v. Indian Oil
Corpn Ltd.. AIR 2003 SC 2120 : (2003) 2 SCC 107: l'd.P. State Agro Industries Development
Coqm. r. Jahan Khan. AlR 2007 SC 3153 : (2007) 10 SCC 88: Popcom Emertainmenr ,·. City In-
dustrial Derelopmenr C01pn., (2007) 9 SCC 593: Whirlpool C01poration v. Registrar of Trade
Marks. AIR 1999 SC 22 : ( 1998) 8 SCC 1: State of H.P. ,,. Gujarat A.mbuja Cement Ltd... (2005) 6
SCC 499 : AIR 2005 SC 3936: Sanjana A1. Wig v. Hindu.wan Petroleum Lid.. (2005) 8 SCC 242 :
AIR 2005 SC 3454: K. Kumar v. Secretary Srate Transport Authority. AIR 2002 Mad 78: Voltas
Vo!kart Employees Union,·. Voltas Limited. (2000) l .i\'lLJ 692: (2000) 2 LW 123 : (2000) 1 CTC
184 ('Mad): P.R. Ramachandrcm r. Tamil Nadu Water Supply and Drainage Board. (1996) 1 MLJ
415: (1996) ILW 90 (1\fad): Jfahanagar Citizen Council i·. District Consumer Redressed Forum.
AIR 1997AP 111: Smt. Sushi la Chand v. State Tram,po11 Amhoriry. AIR 1999 Ori 1: P. Subbara-
yappa r. RTA.. AIR 1989 Kant 297.
523
10632 Art. 226 Part VI-The States-Chapter V-The High Courts in the States
makes an order prejudicial to the writ petitioner, in violation of the princi-

ples of natural justice, the order is treated as non est. Therefore it can be
challen~ed tru;quth a writ petition, even though there is an alternative rem-
edy available.- 8
(iii) Where the right to obtain .,the statutory remedy has been lost or barred for
no fault of the petitioner;2 -' 88 In a case where the High Court dismissed the
writ petition, on the ground of alternative remedy the Supreme Court set
aside the same on the ground that the writ petition was pending before High
Court for more than five years and since the question to be decided is a
pure question of law. it was not proper O,f!Jhe part of High Court to relegate
the petitioner to the alternative remedy."'""'~ 9 But this principle cannot apply
to cases where the petitioner has lost the remedy through his own de-
fault. 2390 ""
(iv) Where it is evident from the acts of the statutory appellate or revisional
auth01Jl¥i that it would be futile to approach him for revising the impugned
order;--
2392
(v) Where it is beyond the competence of the statutory authority to grant
relief on the ground urged in the petition under Art. 226, e.g.-
Where the objection of the petitioner is not against a particular entry in
the Electoral Roll prepared under a municipalJJiw, but that the entire Roll
has been prepared in contravention of the law .2., 9-' The same principle applies
where the grievance of the petitioner is otherwise bfVfmd the scope of an
election petition. But there is no such invariable rule ..:.!9-.
2387. See also T.R. Ramaih v. Dy. Commission, AIR 1975 Kant 77: Yeshwant v. Hindustan Petroleum
Corpn.. AIR 1988 Born 408: State of U.P. v. lvlohd. 1Vooh, AIR 1958 SC 86: (1958) SCR 595: Ta-
ta Electric & Locomotii.·e Co. v. Co,mnr of Commercial Taxes. AIR 1967 SC 1401: Babu Ram v.
Zilla Parishad, AIR 1969 SC 566 : (1969) I SCR 518: State of U.P. i·. Indian Hume Pipe Co.,
AIR 1977 SC 1132 : (1977) 2 SCC 724; Vellasamy v. Inspector General of Poiice, Tamil Nadu,
AIR 1982 SC 82 : ( 198 i) 4 SCC 247: Titaghur Paper 1'1/ills v. State of Orissa. AIR 1983 SC 603 :
(1983) 2 SCC 433; Ranjan Ramnath Patil v. State of Maharashtra, AIR 2001 Born 361: Smt.
Sushi/a Chand v. State Transport Authority, AIR 1999 Ori I.
2388. Collector v. Sanv,:armal, (1968) SC dated 16-2-1968.
2389. See Bal Krishna Aganrnl v. State of U.P., (1995) I SCC 614: Durga Enterprises (PJ Ltd. i·.
Principal Secretary, Govemmem of U.P., (2004) 13 SCC 665: K.M.A. Abdul Waheeb v. Tahsil-
dar, ( 1994) 2 MLJ 58 (Mad): Javi Enterprises v. Commissioner of Customs, (2006) 3 iv1LJ 740
(Mad). See also Raj Soni v. Air Officer-in-charge of Administration, AIR 1990 SC 1305 :
(1990) 3 SCC 261; L. Hirday Narain v. Income-Tax Officer, Bareiily, AIR 1971 SC 33: (1970)
2 SCC 355; M.S. Judicial Service Assocn. v. High Courr of Judicature at Bombay, AIR 2002
SC 1181 : (2002) 3 SCC 244: K.K. Shrirnstava v. Bhupendra Kumar Jain, AIR 1977 SC 1703 :
( I 977) 2 sec 494.
2390. A. V. Venkete.nvaran, Collector of Cusioms v. Ramchand Sobhraj 1,,Vadlzwani, AIR 1961 SC 1506:
(1962) 1 SCR 753.
2391. A. V. Venkateswaran, Collector o_f Customs -i·. Ramchand Sobhraj Wadlnrani, AIR 1961 SC 1506
(1509-10): (1962) 1 SCR 753: cf. Collector of Monghyr v. Keslwv, AIR 1962 SC 1694 (1703) :
(1963) 1 SCR 98; Bhopal Sugar Industries v. Dube, AIR 1964 SC 1037: (1964) 1 SCR 481: M.G.
Abrol, Additional Collector of Customs v. Shanti/al Chhotelal and Co., AIR 1966 SC 197 (202) :
(1966) 1 SCR 284. See also Ram and Slryam Co. v. State of Haryana, AIR 1985 SC 1147: (1985)
3 SCC 267; Vati Pers v. Femandeo Lopez, AIR 1989 SC 2206: (1989) 4 SCC 671.
2392. Collector o_f Customs v. Bava. 1968 SC 13 (15): K.S. Venkataraman and Co. (P) Ltd. v. State of
Madras, AIR 1966 SC 1089 : (1966) 2 SCR 229 : (1966) 17 STC 418.
2393. Chief Commr. v. Radhey Shaym. AIR 1957 SC 304: 1957 SCR 68 (para. 12).
2394. Slzrivastava v. State of Pw~;ab, ( 1977) UJSC 344 (para. 4).
524
Power of High Courts to Issue Certain ·writs Art. 226 10633

2395
(vi) Where fundamental rights have been infringed by the impugneq order,
2 96
e.g., by the demand of a tax which offends against Art. 14 or 19. "'
(vii) Where there is an error apparent on the face of the record or wh_,ere
2 97
there is
failure of justice due to a misreading of the provision of an Act. -'
(viii) Where although an alternative remedy was available, High Court enter-
tained the petition on the merits. it could not dismiss the ~etition on the
98
ground that such alternative remedy has not been availed of.-
(ix) Where the petition raises important question as the interpretation of statuto-
2399
ry provisions or rules which it is in public interest to decide speedily.
In fact the court has held it should not refuse to exercise jurisdiction merely
on the ground that the petitioner has not exhausted an alternative reme-
dy .2400
(x) Where the alternative remedy is an empty formality, a writ petition could
be entertained. In a case where the Government has taken a policy decision,
challenging an order which was issued as the basis of policy decision
2401
would be a futile attempt.
(xi) When facts are not in dispute and the case involves the question of transfer
of large number of employees, and the decision could be taken on interpre-
tation of appointment order and th~ ~eement, directing the parties to re-
sort to other remedies is not proper:Ao
The object underlying the rule that an alternative remedy should be availed, is that
the High Court should not be made a substitute for all other remedies available to an
aggrieved party for redressal of his grievances. The restraint is evolved by the court
themselves and cannot be treated as a constitutional embargo on the power of the
High Court under Art. 226. Existence of alternative remedy does not per se constitute
a bar to the court issuing a writ, the court is not obligated as a rigid norm to always
relegate the writ petitioner to the alternative remedy. It is not a rigid rule but has
s01ne flexibility inherent therein. It is well established that an alternative remedy is
2403
not an absolute bar to the maintainability of a writ petition. The rule is not ri~id
but somewhat flexible and it is primarily a matter of discretion of the writ court. 40
4
2395. A.. V. l/enkateswaran, Collector of Customs v. Ramchand Sobhraj Wadhwani, AIR 1961 SC 1506
(1509-10): (1962) 1 SCR 753; cf. Collector of Monghyr v. Keshav, AIR 1962 SC 1694 (1703):
(1963) 1 SCR 98; Bhopal Sugar Industries v. Dube, AIR 1964 SC 1037: (1964) 1 SCR 481.
2396. Coffee Board v. Jt. C.T.0., AIR 1971 SC 870: (1970) 3 SCR 147: (1969) 3 SCC 349.
2397. Hoshiar Singh v. Dy. Commissioner, AIR 1972 Del 260; State of U.P. v. Mohd. Nooh, AIR 1958
SC 86 : (1958) SCR 595.
2398. L. Hirday 1Varain v. Income-Tax Officer, Bareilly, AIR 1971 SC 33: (1970) 2 SCC 355. See also
Durlabh Kumar v. Dt. Judge, AIR 1973 MP 175; A.. V. Venkateswaran, Collector of Customs v.
Ramclumd Sobhraj Wadhwani, AIR 1961 SC 1506: (1962) 1 SCR 753; Dy. Commr. of Commer-
cial Taxes v. H.P. Sri Ramulu, AIR 1977 SC 870. But see State of U.P. v. U.P. Rajya Khanij Vikas
Nigam Sangarsh Samitee, (2008) 12 SCC 675.
2399. Buddhu v. Municipal Board, AIR 1952 All 753 (FB); Lala Raj kishore v. Dt. Board, AIR 1954 All
675; J.K. Manufactures v. STO, AIR 1970 All 362 (FB).
2400. Girdhari Lal Jalan v. State of Bihar, ( 1989) SC Cr R 536.
2401. Dhampur Sugar lvfills Ltd. i-. State of U.P., AIR 2008 SC 48 : (2007) 8 SCC 338. See also Go-
vindraj ,·. District Collector, (1996) 1 :t-.ill 5 (Mad).
2402. BCPP lv!a::.door Sangh r. 1'lTPC, AIR 2008 SC 336: (2007) 14 SCC 234.
2403. Kuntesh Gupta v. management, H.K. Mahavidyalaya, AIR 1987 SC 2186 : (1987) 4 SCC 525.
2404. A. V. Venkateswaran, Collector of Customs v. Ramchand Sobhraj Wadhwani, AIR 1961 SC 1506 :
(1962) 1 SCR 753: Harbanslal Sahnia v. Indian Oil C01pn. Ltd., AIR 2003 SC 2120 : (2003) 2
sec 101.
525
ANNEXURE P-17
Commentary on the
Const1tut1on. . ..
of India
9th Edition
EditorialAdvisors
Justice T S =Doabia
FormerJudge. Punjab & Haryana, Madhya Pradesh
andJammu & Kashmir High Courts _
Justice M L S_inghal .
Former Judge, Allahabad and Gauhati High Courts
in collaboration with Specialist Editors
. Forewo~d by .
Justice M N Venkatachaliah
Former Chief Justice ofIndia
13
Articles 294 to 311 (Contd.) ··
. .
• · LexisNexis®
526
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First Edition (November) 1950

Second Edition (January) ·1952
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Fourth Edition in 5 Volumes 1961
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Sixth Edition in 18 Volumes 1973
Seventh Edition A-R Volumes 1991
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Ninth Edition 2014
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528
1676
[CHAPTER IV
RIGHT TO PRO_PERTY
Persons not to be Art. 300-A. ·No person_ shall be deprived· of his
deprived of property save· property save by authority of law.]
by authority of law.
SYNOPSIS
1. Amendment: Scope of Article 300-A 8. Who can complain of violation of
2. History of the Right to Property Article 300-A................................... 13819
under the Indian Constitution ..... ...... 13806 9. Regressive effects of the 44th
3. Applicability of case-law under Amendment, 1978............................ 13821
Article 31(1) ..................................... 13807 10. Does the constitutional obligation to .
4. ~ffects of f\rticle 300-A on statutory pay compensation still survive?....... 13823
interpretation...... .,,............................. 13807 - 'Eminent Domain '-Position
- _'Deprived' ......................... ;...... 13807 in U.S.A................................... 13831
S. Nature of Right under Article 300-A 13810 - 'Eminent · Domain'-Position
6.· 'Property' .......... ~................................ 13813. in India ..................... ~............... 13831
7. 'Save by authority of law' .. :............. 13818 - 'Eminent Domain'-Position
in U.K. ..................................... 13831
11.· ·Jucli~ial view since 1978 .................. 13835
Amendment: Scope of Article 300-A

. This Article has- been inserted by the Constitution (44th Amendment) Act, 1978.
Prior to this amendment, the right to property was guarant~ed by Art.· 31. While cl.
( 1) of that Article has been shifted from Part III, to Art. 300-A, cl. (2) of that Article,
which dealt with compulsory acquisition of property, has been repealed. Sub-cl. ·(f)
of cl. (1) of Art. 19, which guaranteed the fundamental right to acquire and hold
property, has also been omitted by· the same 44th Amendment Act, 1978, with effect
from 20-6-79.
The result of thes~ changes, in short, is. that-
(a) The right to hold prooerty has ceased to be a fundamental right under the
Constitution of India. t677 · .
(b) It has been left to· the Legislature to deprive a person by the authority of
law; if such law takes away a man's property without payment of any
compensation, the validity of sueh law cannot be challenged before the
superior Courts as unconstitutional on the ground that no compensation has
been paid or made payable by such law [see further, below].
Of course, if one's· property is taken away· by the Executive without the authority
of law, he would still be entitled_ to legal relief on the ground that such executive·
action is in coritraveritiori of Art. 300-A, but since the provision in the present article
has been brought outside the purview of Part III, the aggrieved individual would not
be competent to move the Supreme Court under Art. 32, 1678 for any violation of Art.
300-A. His remedy would he under Art. 226 or by a civil suit.
1676. lnsc11cd by the Constitution (44th Amendment) Act, 1978, s:34 (w.e.f. 20-6-1979).
1677. Stat,~ oj'M,1harashtra v. Chandrabhan, AIR 1983 SC 803 (para. 2).
1678. Bi,'ihmnher v. State of U.P.• AIR 1982 SC 33 (para. 40).
13804
529
f Per.wms not to be deprived of property save by authority<~/' law Art. 300.. A 13805
Article 300-A ensures that a person cannot be deprived of his property by an

executive fiat. The right in property can be curtailed, abridged, or modified by t!te
State only by exercising Legislative power. It can be done only in accordance with
law. No law, no deprivation of property is the principle underlying Art. 300-A. An
executive order depriving a person of his property, without backed by law, is not
constitutionally valid. 1679_ · ·
The constitutional right to property under Art. 300-A "is not a basic structure of
Constitution. 1680 The Right to Property till 1978 (The Forty Fourth Amendment Act,
1978) was recognized as the fundamental right of a citizen and though no longer a
fundamental right is otherwise a zealous possession of which one cannot be divested
1681
save by the authority of law as is enjoined by Art. 300-A of the Constitution.
Government Servants' right to pension is property and it cannot be reduced by
Government merely by an execution order without hearing the affected person. 1682
Goods seized by the police without authority of law were directed to be restored in
Wazir Chand v. State of H.P. 1683 The State has no right to take law into their own
hands and evict a person by an executive order. It was observed that such an action is
"destructive of the basic principle of the rule of law". It was held: ·
"The action of the Government in taldng law into their hands an(! dispossessing the
petitioners by the display of force, exhibits a callous disregard of the normal
requirement of the rule of law apart from what might legitimately and reasonably be
expected from a Government functioning in a society governed by a Constitution which
guarantees to its citizens against arbitrary invasion by the Executive of peaceful
possession of property. We have here the highly discriminatory ap.d autocratic act which
deprives a oerson of the possession of the property without reference. to any law or legal
authority ."1684
A person cannot be deprived or dispossessed from property by use of force or with
help of police. The State can resume the land only in accordance with law and legal
steps under the West Bengal Eastern Hotel (Acquisition of Undertaking) Act, 1980
would mean action under any relevant law, not use of police power. 1685 ·
Under this Article, right to property is a human right as well as constitutional

right. Hence, it cannot be taken away except in accordance with law.1 686 Even
though the right to hold property has ceased to be a fundamental right, it is a
human right. Restriction which can be imposed in carrying a busine.ss in relation to
a property which includes all types of properties capable of being owned including
1679. State of Mysore v. K.C. Adiga, AIR 1976 SC 853: (1976) 2 sec 495; Elizabeth Samuel Aaron v.
State of Kerala, AIR 1991 Ker 162; See also Bishamber Dayal Chandra Mohan v. State of U.P.,
AIR 1982 SC 33: (1982) I sec 39.
1680. Jilubhai Nambhai Khacker v. State of Gujarat, AIR 1995 SC 142: 1995 (Supp-1) SCC 596; S.B.
Narayanacharya Public Trust v. State of Gujarat, AIR 2001 Guj 208; Tukaram Kana Joshi v.
M.l.D.C., AIR 2013 SC 565.
1681. Lalaram v. Jaipur Development Authority, 2015 AIR SCW 6849: AIR 2016 SC (Civil) 387.
1682. Deokinandan Prasad v. State of Bihar, AIR 1971 SC 1409: (1971) 2 SCC 330; State of Punjab v.
Iqbal Singh, AIR 1976 SC 667 : (1976) 2 SCC 1; State of Punjab v. K.R. Engineering, AIR 1973
sc 834 : (1973) 1 sec 120. ·
1683. Wazir Chand v. State of H.P., AIR 1954 SC 415 : (1955) 1 SCR 408.
1684. See also S.R. Ejaz v..T.N. Handloom Weavers' Co-op. Society Ltd., AIR 2002 SC 1152: (2002) 3
SCC 137; State of U.P. v. Maharaja Dharmander Pratap Singh, (1989) 2 SCC 505; State <f U.I'.
v. Manohar, (2005) 2 SCC 126. See also Meghmala v. G. Narasimha Reddy, (2010) 8 SCC 383.
1685. State of West Bengal v. -Vishnunarayan & Associates (P.) Ltd., (2002) 4 SCC 134. Sec nlsn /Jisltav
Das v. State of Punjab, AIR 1961 SC 1570: (1962) 2 SCR 69.
1686. N. Padmamma v. S. Ramkrishna Reddy, AIR 2008 SC 2834 : (2008) 15 SCC 517; A.-;/am
Mohammed Merchant v. Competent Authority, (2008) 14 sec 186.
530
13806 Art. 300.. A Part XII-Finance, Property, etc.-Chap. IV-Right, etc.

'.!
intellectual proferty must be reasonable within the meaning of Art.· 19(6) of the i:
168
Constitution. . · · · · · · ·
. . . . .
An adµrinistrative authority can interfere with :an indiv~d~ars _property rights on!y
if there is law giving it necessary power. Further, the adnnmstration .can do so only 1n
accordance with law. 1688 ·
· Ownership. of l~nd jurispru~entially inyolyes a bundle of rights. One su~h righ! is
the right to transfer. Such a nght being 1nc1dental to the nght of ownership, having
regard to Art. 300-A of the Constitution cannot be taken _away save by authority of
law. 1689 A State ainendinent to Registration Act which provides that R_egistrar shall :\
refuse registration in regard to .documents executed by power. of attorney of the Ji
owner was held to· be violative of Art. 300-A. It was observed that a person may not .;{
have any' near relative or otherwise unable to attend office of the Sub Regi~trar or :'.i-~
Registrar within whose jurisdiction the property is situated. He may be even out of i {~
the country. .Jn the absence of any substantive provision contained in-a Parliamentary 11,
or Legislative act, he cannot be restrained from .dealing with his property .in· any }~
manner he likes. Such statutory interdict would be16oiposed to one's right to property. '}J
as envisaged under Art. 300-A of the· Constitution. · . .. · ·•.$.
:'1
-The Supreme Court held that the right to property has been recognized as a right :1
guaranteed under the Constitution in favour of a citizen/person and hence, no person can '.~
be deprived of this valuable right which Constitution has given to him_ save by authority -~
of law. 1691 Under Art. 300-A, no person can be deprived of his property save by authority
of law. Acquisition of land is an act falling in the purview of eminent domain of the State
and_ it essentially relates to the concept of compulsory acquisition as opposed to yoluntacy . 1
sale. The provisions of Law Acquisition Act provide a complete machination for 1
deprivation of property in accordance with law, under the Act. Justifiability _and fairness :~
of such comjensation is subject to judicial review within the confines of the four comers ~~
1 2
of the Act. The Court also held that right to property is a very important right since Ii
without ·right to some property, the· other rights. becomes illusory. 1693 Invoking urgency ~
. clause to acquire property which enables government to acquire property without hearing ~-l
the affected person when 1694 in fact there is no urgency, amounts to deprivation of property -~
without authority of law. St;tte's action conducting auction behind the land owners ·i.
back and without their knowledge would amount to deprivation of their land without .. ~
following the procedure prescribed in law and would be violative of their Constitutional .i
right guaranteed under Art. 300-A of the Constitution. 1~95 . ·;

·'
:
History of the Right to Property under the Indian Constitution
Since the commencement of the Constitution on January 26, 1950, there have been
various ups and_ downs in the ~onstitution as regards the 'safeguards relating to the
right to property, through as many as eight Amendments up to 1985-
(a) The First Amendment Act, 1951.
1687. Union of India v. Martin Lottery Agencies Ltd., (2009) 12 SCC 209.
1688. State of Mysore v. K.C. Adiga, AIR 1976 SC 853 : (1976) 2 SCC 495-.
1689. DLF Qutab Enclave Complex Educational Charitable Trust v. State of Haryana, (2003) 5 SCC 662.
'i
1690. State of Rajasthan v. Basant Nahata, AIR 2005 SC 3401. .
1691. ·Prabin Ram Phukan v. State of Assam, 2015 AIR SCW 213 : AIR 2015 SC 1252 : AIR 2015 SC
(Civil) 1046. .
1692. Trisha/a Jain v. State of Uttaranchal. (2011) 6 sec 47.
1693. Dev Sharn v. State of U.P.• (2011) 4 SCC 769.
1694. State of West Bengal v. Prafulla Chum Law, (2011) 4 SCC 537. · ·
1695. Prabin Ram Phukan v. State of Assam, 2015 AIR sew 213: AIR 2015 SC·1252: AIR 2015 SC
(Civil) 1046. .
531
Persons not to be deprived ofproperty save by authority of law Art. 300-A 13807
(b) The Fourth Amendment Act, 1955.

(c) The Seventeenth Amendment Act, 1964.
(d) The Twenty Fifth Amendment Act, 1971.
(e) The Thirty Ninth Amendment Act, 1975.,
(f) The Fortieth Amendment Act, 1976.
(g) The Forty Second Amendment Act, 1976.
(h) The Forty Fourth Amendment Act, 1978.
The effects of these Amendment Acts up to 1976 have been fully explained, with the
judicial gloss thereon, at pp. 3631 and 3632 of this Commentary in Vol. ID (Eighth Edn.).
In this Volume, we are to examine the effects of the Forty Fourth Amendment Act,
1978.
Article 300-A of the Constitution recognizes the right to property as constitutional
right of a person, which was till 1978 (The Forty Fourth Amendment Act, 1978)
recognized as the fundament~l right of a citizen. Indeed whether fundamental or
constitutional, the fact remains that it has always been recognized as a right
guaranteed under the Constitution in favour of a citizen/person and hence, ·no person
can be deprived of this valuable right which Constitution has given to him save by
authority of law. 1696 . ·
Applicability of case-law under Article 31(1)

Since Art. 3_00-A bodily reproduces cl. (1) of Art. 31, the judicial interpretation and
the mass of cases under that Clause, stated at, will be applicable to Art. 300-A, unless
stated otherwise below. ·
Effects of Article 300-A on statutory interpretation
While Art. 300-A, not being a fundamental right, does not enable a party to
challenge the validity of a law under Art. 32'> on the ground of contravention of Art.
300-A, nevertheless, the Court should so interpret a statute, if possible, that it may
not have the effect of depriving a person of his property without authority of Iaw. 1697
Thus, even though a statute does not provide for restitution of property to a person
who has been deprived of his property by an order,-purported to have been made
under a statute, which is a nullity, the Court may order restitution, in the exercise of a
power ancillary to its power to declare the impugned order as ultra vires the statute
and a nuility.
'Deprived'
Deprivation of property m:ay take place in various ·ways, such as destruction1698 or
confiscation, 1699 or revocation of a proprietary right granted by a private proprietor, 1700
seizure of goods1701 or immovable property from the possession of an individual or
assumption of control of a business, in exercise of the 'police power' of a State. Thus,
1696. Prabin Ram Phukan v. State of Assam, 2015 AIR SCW 213: AIR 2015 SC 1252: AIR 2015 SC
(Civil) 1046.
1697. Misra & Co. v. Hindustan Aeronautics, AIR 1986 Ori 20 (para. 7) (DB).
1698. Chiranjit Lal v. Union of India, (1950) SCR 869 (925).
1699. Anand.av. State of Orissa, (1955) 2 SCR 919 (922). .
1700. Virendra v. scare ofU.E'., (19.J.J) I SCR 41.5; Promodv.·sraie ofOrissa, AIR 1962 SC 1266.
1701. Bishamber v. State of U.P., AIR 1982 SC 33 (para. 40); Wazir v. State of H.P., (1955) 1 SCR 408.
532
13808 Art. 300-A Part XII-Finance, Property,. etc.-Chap. IV-Right, etc.
there is a 'deprivation' where a municipal authority, under statutor,rcpower, pulls down

10
dangerous premises, 1702 or an insolvent is divested of his property. .
'Deprivation' is to be distinguished from 'restriction' of the rights following from

1704
ownership, which falls short. of dispossession of the owner from those rights.
There would be a 'deprivation' within the· meaning of Art. 31(1) if a substantial
bulk 1705 of the rights constituting property is taken away, e.g., where the right to
occupy, transfer, assign or sub-let is taken away from a leasehold interest or a trustee ·
is removed from the manaiement of a public trust, 1706 or a person's property is
declared 'evacuee property'. 07
But there is no deprivation-
. (a) Where the State simply refuses to recognise a contract to which it is not a
party_ 1708 .
(b) Where an educational institution is temporarily deprived of its right to

manage its property to secure compliance with the provisions of a statute
enacted to control the system of education. 1709
(c) Where the right in question is not an absolute right but a defeasible one; 1710
e.g., where the right to hold an office is terminated by the abolition of the
post; 1111 or by making.rules of retirement, or where a grant of property is
subject to a condition and for the violation of that condition the grant is
revoked. 1712 · · .
An order on an employer to contribute one anna in the rupee of his employee's

wages towards Provident Fund for which the emploY.ee has also to make an equal
contribution did not amount to deprivation of property1713 The imposition of a special
contribution under s. 73A of Employees State Insurance Act did not result in
acquisition of property and hence, there is no deprivation. 1714 _ .
Even if a person has obtained the property unlawfully, he cannot be deprived of _the
said property without authority of law and any such deprivation would be void. 1715 If
goods are seized from a person on the ground that they are smuggled goods, it is an
exercise of police power and- would amount to deprivation of property when the.same
is seized without authority of law. 1716 A demand for tax under an invalid law would
amount to deprivation of property. 171.7
1702. Nathubhai v~ Municipal Corpn., AIR 1959 Born 332 (338).

1703. Vajrapl!,ri v. New Theatres, (1959) 2 MU 469 (473).
1704. State of Bombay v. Bhanji, (1955) 1 SCR 777 (780).
1705. Chiranjit Lal v. Union of India, (1950) SCR 869 (925).
1706. Bishan Das v. State of Punjab, AIR 1961 SC 1570.
1707. Zafar Ali v. Asstt. Custodian, (1962) 1 SCR 749.
1708. Ananda v. State of Orissa, (1955) 2 SCR 919; Shantabai v. State of Bombay, AIR 1958 SC 532
(533): 1959 SCR 265.
1709. Katra Education Society v. State of U.P., AIR 1967 SC 1307 (1312).
1710. Vadia v. State of Saurashtra, AIR 1967 SC 346 (348).
1711. Ramanathan v. State of Kerala, AIR 1973 SC 2641; Nagapaj v. State of A.P., AIR 1986 SC 556
(para 35).
1712. Manchegowda v. State of Karnataka, AIR 1984 SC 1151 (para. 19).
1713. Nadir Ali Khan v. Union of India, AIR 1958 Punj 177.
1714. K.C. Sa,:ma v. Regional Director, ES/ Corpn., AIR 1962 Ass 120.
1715. Rabindra Kumar v. Forest Officer, AIR 1955 Manipur 49; Wazir Chand v. State of H.P.. AIR
1954 SC 415: (1955) 1 SCR 408; See also Bishan Das v. State of Punjab, AIR 1961 SC 1570:
(1962) 2 SCR 69.
1716. Balchand Patni v. Customs Officer, AIR 1956 Tripura 35.
1717. Coffee Board, Bangalore v. Jt. Commercial Tax Officer, AIR 1971 SC 870: (1970) 3 SCR 147.
533
Persons not to be deprived ofproperty save by authority of law Art. 300-A 13809
The provision of Kerala Forest Act, 1961 which provides that tusks of dead
elephants "shall be deemed to be the _property of Government" .was held_ bad. The
deeming provision shows· that the _property~ did ::not belong to Gove~ent: _It was helc:l
that per~ons · who carried on business :i11 timber and ~s part of their business; had to
catch and tame elephants for training them to d;rag timber were totally depnved of
their right and since the Act did not provide for c;ompensation, it amqunts tc;,
deprivation of property. 1718 · · ' · ·
Taldng· away property by ~overnment without payment of compensation· amounts -

to deprivation of property .17 Copyright· is a right to property ;and the same can be
. d on
acquire - Iy on payment of compensation.
. ino_ : . . . . . _:
·Since the right to receive pension· under the Service Rules for service rendered
before retirement is 'property' , 1721 subsequent· reduction of pension would be·
'deprivation' within the purview of Art. 300-A. 1722 .· ·
The phrase "deprivation -of property of a person" must be considered in the factual
situation of a case. Deprivation connotes different concepts-'Deprivation of property
by acquisition or requisition or taking p9sses~ion for a public purpose. Article 300-A
gets attracted to an acquisition or taking possession pf private property by necessary
implication for the public purpose in accordance with law. De~rivation by any other
mode is. not acquisition or taking possession under Art. -300".A. 1 23 . -
Refusal of sanction to erect a building does not amount to d·eprivation within the
meaning of this Article. 1724 Non-payment of rerit by a public authority will amount to
deprivation.1 725 · ·
A citizen has no fundame~tal right ·to trade_ or business in liquor as a beverage.

State has every ;right to exercise monopoly since trade or· business in liquor_ as a
bev~rage is res extra commercium. Any restriction or lhni~ation -placed by the. State
in lieu of its monopoly does not amount to deprivation. 1726__
When a person accepts membership-of a co-operative society by submitting to the
bye-laws and places on himself a qualified restriction in his right to. transfer the
property by stipulating that the same would be transferred back to the society or with
prior consent of the society to a person qualified to be a member of society, it is not
an absolute restraint ·on alienation violative .of s. 10 of the Transfer of Property Act.
Such a clause does not violate Art. 300-A since there is no deprivation of
property. 1727 . · :· · · · ·.. · · · .
Where deprivation is an exercise of police power, there is no deprivation in law. 1728
1718. K. Madhavan v. State of Kerala, AIR 1964 Ker 287., .

1719. M. Naga Vekata Lakshmi v. Vishiikapatanam Municipal Corpn., (2007) 8 SCC 748. See also
Jilubhai Nambhai Khochar v. State of Gujarat, AIR 1995 SC 142 : -1995 (Supp-1) SCC 596. : .-
1720. ·Entertainment Network (India) Ltd. v. Super Cassette IndustriesLtd., {2008): 13 SCC 30.- - · . ·
1721. Vajrapuri v. New Theatres, (1959) 2 MU 469 (473). .
1722. State of Kerala v. Padmanabhan, AIR 1985 SC 356 (para.I). Cf. Salabuddin v. State of U.P., AIR
1984 SC 1905 (paras. 5-6). See also Bharat Petroleum Sta.ff Pensioners v. Bharat Petroleum
Corpn. Ltd., AIR 1988 SC 1407: (1988) 3 SCC 32. . : . . ·
1723. Jilubai Nanbhdi Khachar v. State of Gujarat, AIR 1995 SC 142: 1995 (Supp-I) sec 596.
1724. Giridharlal Soni v. Municipal Corpn., Calcutta, AIR 2001 Cal 12.
1725. Manmatha Nath Kayal v. Dt. Manager, FCI, AIR 1996 Cal 316.
1726. Khoday Distilleries v. State of Karnataka; (995) 1 SCC 574. . . ·· ·· · ·
1727. Zoroastrian Co-op. Housing Society Ltd. v. Dt. Registrar, Co-op. Societies, AIR 2005 SC
2306. - .
1728. Jilubai Nanbhai Khachar v. State of Gujarat, AIR 1995 SC 142 : 1995 (Supp-I) SCC 596.
534
13810 Art. 300-A Part XII-Finance, Property, etc.-Chap. IV-Right, etc.
Nature of Right under Article 300-A

The right to property though is not a basic feature of ~he .Constitution or a
fundamental right, it is now considered to be, not only a const1tut1onal or a st8:tutory
right, but also. a human right. 1729 Human rights are considered to be in !ealm of
individual rights and now said rights are gaining an even greater multi faceted
dimension. The right to property is considered, very much to be a part of such new
dimension 1730 Right to property while ceasing to be a fundamental right would, however,
be given express recognition as a legal right, _provision being made that no person shall be
. d ofh"1s property save 1n
depnve . accordance w1'thl-aw. 1131
Section 5A (right to make objection) of the Land Acquisition Act, 1894 confers a
valuable right in_ favour of the person whose lands are sought to be acquired and
having regard to the provision contained in Art. 300-A, it is held to be akin to a
fundamental right. 1732 - .
.i
I
According to Prof. Tripathi P.J(., in his-article "Right to Property and Forty-fourth
Amendment - Better protected than before", 1733
"after the 44th amendment, the right to property has become more fundamental than
before because with the repeal of many exceptions to the right to property, contained in
repealed Art. 31, all laws relating to acquisition and requisition of property will have to
satisfy the common law requirement of Eminent Domain of public purpose and
adequate compensation." 1734
Calcutta High Court held that a financier or hypothecator cannot use physical force to
seize the hypothecated vehicle. If there is default in payment since no one could be
deprived possession of any propem without due process of law and the debtor is
entitled to protection_ of ¾t. 300-A. 1 5 Normally, since the owners of property have th:e
right to use and enjoy the property which includes the right of management, the same
could be regulated by statutory provision and authorities are required to act strictly
according to statutory provision, i.e., within the parameters of their powers under the
statute. Any violation of statutory provision will be violative of Art. 300-A. 1736
Authority of law under this article would mean "valid law". 1737
1729. Tukaram Kana Joshi v. M.I.D.C., AIR 2013 SC 565. (Vide: Lachhman Dass v. Jagat Ram (2007)
10 SCC 448; Amarjit Singh v. State of Punjab, (2010) 10 SCC 43; Nannada Bachao Andolan v.
State of Madhya Pradesh, AIR 2011 SC 1989; State of Haryana v. Mukesh Kumar, AIR 2012 SC
559 and Delhi Airtech Services Pvt. Ltd. v. State of U.P., AIR 2012 SC 573). See also Vimlaben
Ajithbai Patel v. Vatslaben Ashokbhai Patel, AIR 2008 SC 2675 : (2008) 4 SCC 649; Karnataka
State Financial Corpn. v. N. Narasimhaih, AIR 2008 SC 1797 : (2008) 5 SCC 176; Entertainment
Network (India) Ltd. v.-Super Cassette Industries Ltd., (2008) 13 SCC 30; N. Padmanabhan v. S.
Ramakrishna Reddy, AIR 2008 SC 2834: (2008) 15 SCC 517; State of Kerala v. People's Union
for Civil Liberties, (2009) 8 SCC 4.6; Aslam Mohammed Merchant v. Competent Authority, (2008)
14 SCC 186; Union of India v. Martin Lottery Agency Ltd., (2009) 12 SCC 209; Chandigarh
Housing Board v. Major Gen. Devinder Singh, AIR 2007 SC 1723 : (2007) 9 SCC 67.
1730. Tukaram Kana Joshi v. M.LD.C., AIR 2013 SC 565. .· _
1731. Chairman, Indore Vikas Pradhik.aran v. Pure Industrial Coke & Chemicals Ltd., AIR 2007 SC
2458: (2007) s sec 10s.
1732. Hindustan Petroleum Corpn. Ltd. v. Darius Shapur Chand, AIR 2005 SC 3520 : (2005) 7 sec
627..
1733. AIR 1980 (Journal) 49. .
1734. See also H.M. SEERVAI ON CONSTITUTIONAL LAW OF INDIA, 3rd Edn. 1984, Vol. II, pp. 1088-
1089.
1735. Ashok Kumar Singh v. State of Bengal, AIR 2004 Cal 46.
1736. See Bhavnagar University v. Palitana Sugar Mills (P.) Ltd., (2003) 2 sec 111; Ganga Co-op.
Housing Society Ltd. v. Municipal Corpn. of Greater Bombay, A~ 2004 Born 64. See also
Kunniyil Hassan v. Seery., Corporation of Calicut, AIR 1997 Ker 185.
1737. Amel Kumar Bose v. State ofW.B., AIR 2004 Cal 148. .
535
Persons not to be deprived of property save by authority of law Art. 300-A 1381 I
A ban on imposition on the trade of impoI1ed ivory is not violative of Art. 300-A
since the same is not a law for the purpose of acquisition·and-requisition of property
by the State. Tlie primary object of the law is the preservation of el~phants and not
for utilisation ·of property ;~or_ p~blic P°IBise and hence, _this ~de will not _get
attracted and no compensation 1s payable. · ·
Article 300-A imposes a duty and obligation that no person. can be::deprived of his
property save by _authority of law. Article 300-A creates a right in favour of· a person
that he should not be deprived of his property save by authority of law. Even a right
to mon~y is property and hence, non-payment_ of rent by .a statutory body to the. land
owner is violative of Art. 300-A. 1739 · · · · · · , _·
A lease executed between the State Government as a lessor and a company as

lessee is• not a mere contract, but it creates a transfer of interest ·in property 'and
creates a right in rem and the right of lessee is an interest in_ property which·-is
protected, under this Article. 1740 Demolition of property.- and eviction of a less~e
otherwise than in accordance· with law is violative of Art. 300-A. In such <;ases, the
. lessee is_ entitleq to be put b~ck in possession and· also for damages!
1741
It ·held ·was
that ·provision of Rajasthan ·Municipalities Act could not ·be interpreted in such a
manner as to deprive the owners of immovable properties situated in· municipal area
of their right available under the Transfer of Property Act. 1742 - . . ..
.A person who has no "interest in land" i.e., a licensee is not entitled to protection
of this · Article: The "Kumkf' right holders are, therefore, not entitled to · any
compensation since holders are only licensees. 1743 _· . . · . ·
When the property of a person is acquired and vests in Government without

payment of compensation,. it would be illegal and denying the .-citizen of-his right to
property under , this. Article. 1744 It is held that the_· right to. acquire·. a person's
property under Land Acquisition Act is coupled with a duty to pay compensation
and it is also an implied duty that the compensation be paid as. "expeditiouslf' as
possible. Any delay in payment will also amount to violation of Art. 300-A. 174 The
proceedings for acquisition must also be coillpleted without unreasonable delay. 1746
Taking possession of land without any acquisition will amount to violation· of this
article and such action on the part of Government will amount to a "high;_handed
act~vity"_. 174?
Wµen·. a citiz_en has been deprived of his· belongings otherwise than in accordance ·
with procedure prescribed under law, it_ could not be said that the said _deprivation
was brought about ·by officers of State· '-while acting and discharging sovereign
function of State as Art. 300-A prohibits depriving any person of his property
1738. Ivory Traders.&Mfg. Assn.·v. Union of India, AIR 1997 Del 267; See alsolndian Handicrafts•
Emporium v. Union of India, (2003) 7 sec 589. · ·
1739. Yogendra Pal v. Municipality, Bhattinda, AIR 1994 SC 2250 : (1994) 5 SCC 709; Also. See
Alpaai Nagrik Grih Nirman Sahakari Sanstha v. State ofM.P., AIR.1996 MP 133; Mantnath Nath
Kayal v. Dt. Magistrate, AIR 1996 Cal 316.· · .· · ·-
1740. Municipal Co'rpri. of Greater Bombay v. Lala Pancham, Al.R 1965 SC 1008: (1965) 1 SCR'542~. ·
1741. -Hindustan Petroleum Corpn. v. State of Bihar, AIR 1996 Pat 163. . - . · . ·
1742. Municipal Corpn., Jodhpur v. Raj Kumar, AIR 2002 Raj 348. · : · ·
1743. Deva Kumara Shetty v. State of Kamataka, 1998 AIHC 2918 (Karn).
1744. Rakesh Prasad Tiwari v. Union oflndia, AIR 1995 AP 75.
1745. Billa Linga Reddy v.-RDO, AIR 1996 AP 3.·. .
1746. See Parag Construction v. State of Maharashtra, (2008) 16 SCC 198. ·.
1747. See Sri Nath Educational Society, Sisra v. State of U.P.,-AIR 1996 All 187; See also K. Sai Rt~clcfy
v. Dy. Executive Engineer, AIR 1995 AP 208; State of U.P. v. Mari.ohar, (2005) 2 SCC 126.
536
ANNEXURE P-18
-----------------------------------------------------------------------------------------------------------------------------------------------------------
IONLINE;p'
True Print'"
b
THE
SUPREME COURT CASES
c201s) 7 sec
C
(BEFORE DIPAK MISRA, C.J. AND DR A.K. SIKRI,
A.M. KHANWILKAR, DR D.Y. CHANDRACHUD, ASH0K BHUSHAN, JJ.)
d Ve rsus
Writ Petitions (C) No. 558 of 2012t with
No. 921 of 2013, decided on May 9, 2018
A. Parliament and State Legislatures - Parliamentary privilege - Facts
e and Observations contained in Parliamentary Committee Reports - Extent
to which may be relied on in court, and probative value - Adjudication
of factual and legal issues - Appropriate authority for, is court of law
- Approach to be followed in respect of contentious facts in said reports
as distinguished from report itself - Government sponsored immunisation
programme - Death of young girls - Adverse observations and comments
f against said programme in two reports of Parliamentary Committee -
Reliance upon by petitioners in present PIL - Extent to which permissible
and actionable
- Said reports, held, per curiam, admissible in evidence under S. 74,
Evidence Act of which judicial notice shall be taken under S. 57(4), Evidence
g Act - Moreover, for their production in court, permission of Speaker not
necessary as they are already in public domain - It is court and not
Parliament which has to adjudicate all factual and legal issues - People also
have a right to know - No exception can be taken to the petitioners obtaining
72nd and 81st Reports of Parliamentary Standing Committee, for using them
as evidence in court - But Parliamentary Committee Report not substantive
h evidence in case of findings of misdemeanour or breach of duty by public
t Under Article 32 of the Constitution of India.

537
-----------------------------------------------------------------------------------------------------------------------------------------------------------
2 SUPREME COURT CASES c201s) 7 sec

officials or private individuals or an evasion of law or any other lis or dispute
- Court has to consider other evidence and adudicate independently upon
any lis/dispute(s) arising, in accordance with law - Court proceedings are a
independent of Parliament and based on multiple inputs and evidence - It is
certainly possible for court to determine facts and form an opinion in law at
variance with Parliamentary Committee report
- Disputable facts stated in Parliamentary Committee Reports are not
conclusive evidence for deciding rights of parties and thus not binding - There
is no presumption that contents of Parliamentary Committee Reports are true b
and correct - To be binding they have to be adjudicated upon by court, and
adjudicating body is not Parliament but court - Right to adduce independent
evidence by all parties is covered by procedural safeguard of right to be heard
- Court has a duty to independently adjudicate same as per law - Such
adjudication and said rights of parties and duty of court is as per constitutional
scheme of judicial review, separation of powers and rule of law C
- There is functional complementarity between purpose of investigation

by Parliamentary Committee and adjudication by court - Said purpose being
to secure accountability, transparency and responsiveness - To deprive court
of valuable insight of a Parliamentary Committee would amount to excluding
an important source of information from purview of court - PIL is a flexible d
tool to provide innovative remedies to marginalised sections who have suffered
discrimination and prejudice - Court has intervened to ensure structural
probity of system of good governance
- However, in view of Parliamentary privileg e and immunity, neither any
party nor court can que stion or impeach validity of Parliamentary Committee
Reports, only Parliament itself can approve or disapprove reports of its e
Committees for publication - Further, no Member of Parliament can be held
liable for anything said in Parliament nor in any Committee [Art. 105(2)]
- Committees of House of Parliament are established by/under authority of
Parliament and they represent and are comprised within Parliament and are as
much a part of Parliament - Hence reports of Parliamentary Committees also
covered by said protection of Art. 105(2) - Reference to present Constitution f
Bench, answered accordingly - Constitution of India - Arts. 105, 194,
118, 121, 122, 19(1)(a), 32, 136 and 226 - Evidence Act, 1872 - Ss. 74
and 57(4) - Constitutional Law - Silences of the Constitution/Implied
Limitation - Parliamentary Proceedings (Protection of Publication) Act, 1977,
S. 3 (Paras 111 to 166, 233 to 241, 257 to 278 and 334 to 403 and 428 to 450)
g
B. Parliament and State Legislatures - Parliamentary privilege -
Breach of parliamentary privilege and contempt of Parliament - Actions
not amounting to said breach and contempt, discussed (non-exhaustively),per
curiam
- (a) Judicial notice (including, as aids to construction of statutes) of
course of proceedings of Parliament/Parliamentary Committee reports/Other h
publications by or under authority of Parliament and/or their admissibility and
538
-----------------------------------------------------------------------------------------------------------------------------------------------------------

(non-conclusive) reliance in evidence in courts of law, (b) Judicial review of
legislation/legislative action within the well-established parameters of judicial
a review, (c) Judicial review of proceedings in Parliament which may be tainted
on account of substantive or gross illegality or unconstitutionality, (d) Usability
of published Parliamentary reports by general public who have a right to know
about said reports as step towards governance of country, and (e) Fair criticism
of Parliamentary Committee Reports by general public showing pubic concern,
without any personal attack on MPs or without tarnishing image of MPs or
b House by vulgar and abusive language, held (per curiam), permissible and not
a breach of parliamentary privilege nor contempt of Parliament
- However, neither any party nor court can question or impeach
validity of Parliamentary Committee Reports, only Parliament itself can
approve or disapprove reports of its Committees for publication -
Further no Member of Parliament can be held liable for anything said in
C Parliament or in any Committee [Art. 105(2)] - Reports of Parliament
also covered by said protection of Art. 105(2) - Constitution of India
- Arts. 105, 194, 118, 121, 122, 19(1)(a), 32, 136 and 226 -
Evidence Act, 1872 - Ss. 74 and 57(4) - Constitutional Interpretation
- Aids to construction - External aids - Parliamentary Committee
Reports (Paras 111 to 166, 257 to 278, 334 to 403 and 428 to 450)
d
C. Constitutional Law - Grant and Separation of powers - Primacy
of Constitution - Constitutional supremacy in India - Nature of, explained
(per curiam) - Constitution is supreme - Three organs of Government,
that is, executive, legislature and judiciary are created, empowered and
their powers limited by Constitution - If a law transgresses constitutional
e limitation, it can be declared ultra vires by constitutional courts - Rule of
law, separation of powers and judicial review are the basic features of the
Constitution -As per Constitution, Supreme Court is its final interpreter and
protector of rights - Functional complementarity of legislature, executive
and judiciary, explained, per Chandrachud, J., concurring
- Indian Constitution does not adopt a rigid separation of powers
f - Constitution does not strictly prohibit overlapping of functions of the
three organs, nor desirable also - Delicate balance must be maintained -
Constitutional limitation, a facet of separation of powers - Each organ have
their own broad spheres and essential functions, should not encroach into
others' domain and their essential functions resulting in wresting away of
regime of constitutional accountability - Judicial review being a basic feature
g of Constitution, there is no breach of Constitution, when court declares a law
as invalid - Power over sword and purse given to executive and legislature,
but their functioning within constitutional limits is ensured by power of judicial
review entrusted to courts - Horizons of judicial review expanding into
spheres of social and economic justice - Court has to perform oversight
function with more urgency to enforce positive socio-economic rights in case
h of governmental inaction - Separation of power doctrine cannot be reduced
539
-----------------------------------------------------------------------------------------------------------------------------------------------------------

to its descriptive content, bereft of its normative features - In Indian context,
no institution of governance lies above the Constitution and no entrustment of
power is absolute a
- Mutual supervision, interdependence and coordination between
legislature and judiciary are required to protect rights of citizens,
ensure good governance and serve public interest - When courts
enter upon issues of public interest they do not discharge function
which is adversarial - Constitution of India - Arts. 32, 136, 226,
105, 118(1), 121, 122 and 19(1)(a) - Bill of Rights, 1688, Art. b
IX (Paras 20 to 38,233 to 256,266 to 269,312 to 330,413 to 422 and449.8)
D. Constitutional Law - Judicial power - Power of judicial review in
India - Scope of, explained
- Power of judicial review not unfettered - Judges expected to exercise
judicial restraint, while interpreting Constitution and other laws - But judicial C
abdication and judicial passivism, not warranted when fundamental rights of

individuals are in jeopardy- For interpreting inalienable fundamental rights of
individuals, liberal and progressive attitude required - Words and Phrases -
" Judicial review", "judicial abdication", "judicial passivism" (Paras 40 to 4 7)
E. Constitutional Interpretation - Constitution an organic (living) d
document -Approach and duty of courts while interpreting same, explained,
per curiam - Constitutional interpretation not frozen by its original
understanding - Constitution, an organic document, must continuously
evolve to meet aspirations and challenges of present and future - Courts must
interpret it accordingly
e
- Provisions of Constitution of free India distinguished from colonial
provisions - Democratic transformation places individual at core of concern
of Government - Thus precepts drawn from colonial past including
Parliamentary privilege must be interpreted having regard to, empowerment,
rights of individuals and access to justice - Fundamental rights must be
interpreted collectively and not as isolated protections - Courts must adopt f
comprehensive test of arbitrariness for such interpretation so that said rights
are available to the fullest extent - Rational inference and deduction, is
permissible within constitutional limits - Present case not about protection
of parliamentary privilege, but about duty and limits of court when a case
requires reliance on reports of Parliamentary Standing Committees in context
of Arts. 105 and 122 g
- Constitutional Law - Silences of the Constitution/Implied Limitation
- Rational inference and deduction - Constitution of India, Arts. 32, 136,
226, 105, 118(1), 121, 122 and 19(1)(c) (Paras 48 to 63 and 271 to 274)
F. Parliament and State Legislatures - Parliamentary Committees -
Role, functions and importance, stated - Parliamentary Committees are focal h
point for legislation and oversight - They are usually small groups of MPs
540
-----------------------------------------------------------------------------------------------------------------------------------------------------------

who critically review assigned topics in-depth - They identify politically and
technically feasible alternatives - They consider a wide range of topics -
a They are vital institutions in eminent democracies such as USA, UK, Canada
and Australia, etc. - They occupy importance in field of governance -
Constitution of India, Arts. 105 and 194 (Paras 72 to 82)
G. Parliament and State Legislatures - Parliamentary Committees -
Different types, role, function and importance, discussed,per curiam
b - Some types of Committees scrutinise functioning of Government -
While some other types deal with matters relating to Houses and Members -
Some may be permanent and others ad hoc - Said Committees share burden
of complex and diverse legislative functions of Parliament - Parliamentary
Committees are appointed or elected by House or nominated by Speaker
- They works under direction of and present their reports to Speaker -
C Committee system in India is designed to enlighten MPs on whole range
of governmental actions, dynamics of democracy and India's strengths and
weaknesses through detailed studies - It is designed to enhance capabilities
of MPs to shoulder greater responsibilities and broaden their horizons - Lok
Sabha Rules of Procedure and Conduct of Business - Ch. 26 and Rr. 2,
77, 78, 270, 271, 274(3) and 277 - Constitution of India, Arts. 105 and
d 194 (Paras 83 and 90, 190 to 198 and 334 to 367)
H. Parliament and State Legislatures - Parliamentary privilege -
Rationale behind, explained,per curiam
- Parliamentary privilege protects MPs from undue interference and
unreasonable impediment - It enables Parliament and its Members to function
e effectively and efficiently - It is important for any parliamentary democracy
- MPs have full freedom for what they speak in House - Freedom of
speech under Art. 105(2) is quite distinct from that under Art. 19(1)(a) -
Parliament regulates its own procedure by framing rules under Art. 118 - Bill
of Rights, 1688- Art. IX- Parliamentary privilege in UK, whether absolute,
development of law and current position - Constitution of India, Arts. 105,
f 118, 121, 122 and 194 and Art. 19(1)(a) (Paras 99 to 110 and 180 to 189)
I. Parliament and State Legislatures - Parliamentary privilege -
Parliamentary privilege in India distinguished from that in UK
- Per curiam, law in India qualitatively different from UK- Fundamental
difference arises from supremacy of Constitution in India - Judicial review
g is basic feature of Indian Constitution - Judicial scrutiny of parliamentary
privileges is not excluded where a fundamental right is violated or a
gross illegality occurs or there is a violation of constitutional provision as
distinguished from mere irregularity of procedure, in view of Art. 122(1)
- Constitution of India, Arts. 105, 118, 121, 122, 194, 32, 136 and
226 (Paras 198 to 232, 365 to 375 and 403)
h
541
-----------------------------------------------------------------------------------------------------------------------------------------------------------

Facts
The writ petition as a public interest litigation has been filed by three
petitioners, Petitioners 1 and 2 claim to be working for women health whereas a
Petitioner 3 is a registered Society working with women organisations to help
them to improve their lives and livelihood and to seek justice for marginalised
communities. In July 2009, the petitioners became aware of a so-called
demonstration project work being carried out in the States of Andhra Pradesh
and Gujarat by PATH (Respondent 6), a US based NGO along with the Indian
Council of Medical Research (ICMR) and the Governments of Andhra Pradesh and
b
Gujarat. In the above project about 32,000 young adolescent girls in the age group
of 10-14 years were to be administered HPV (human papilloma virus) vaccines
purported to be effective in preventing cervical cancer. HPV vaccine, namely,
"Gardasil" is manufactured by Respondent 7-Glaxosmithkline Asia Pvt. Ltd. and
"Cervarix" by Respondent 8-MSD Pharmaceuticals (P) Ltd., licensed in India only
in July 2008 and September 2008 respectively by the Drug Controller General
of India. In July 2009 vaccine Gardasil in Khammam District in Andhra Pradesh C
was administered. Few girl children died. On 15-4-2010, the Government of India
appointed a committee to enquire into "alleged irregularities in the conduct of
studies using human papilloma virus (HPV) vaccine" by PATH in India. The final
report of the Committee was submitted on 15-2-2011. The Enquiry Committee
noted several discrepancies.
The Parliamentary Standing Committee of the Department of Health Research, d
Ministry of Health and Family Welfare while examining the demand for grants
(2010-11) of Department of Health Research took up the issue of trial of
HPV vaccine on children in the districts of Khammam, Andhra Pradesh and
Vadodara, Gujarat. The Parliamentary Standing Committee (PSC) deliberated on
the subject and held various meetings. The Committee heard the UoI, ICMR,
Department of Drugs Controller General of India and also took oral evidence. e
The Departmental Standing Committee submitted its report (72nd Report) to the
Rajya Sabha on 30-8-2013 which was also laid on the table of the Lok Sabha on
30-8-2013. The PSC found various shortcomings and lapses of the Government
Departments, ICMR as well as on part of Respondents 6 to 8. Various directions
and recommendations were issued by the Committee.
Again a detailed report, namely, 81st Report on "action taken by the f
Government on the recommendations/observations contained in the 72nd Report
on the alleged irregularities in the conduct of studies using human papilloma virus
(HPV) vaccine by PATH" in India was submitted to the Rajya Sabha on 23-12-2014
and also laid on the table of the Lok Sabha on 23-12-2014. Both the reports have
been brought on record.
At the hearing, the petitioners relied upon the 81st Report of the Parliamentary g
S landing Committee dated 22-12-2014. The petitioners sought to place reliance on
the Report so as to enable the Court to be apprised of the facts and to facilitate
its conclusions and directions. This was objected to. The issue which arose before
the Court was whether a report of a Parliamentary Standing Committee can be
relied upon in a public interest litigation under Article 32 or Article 226 of the
Constitution. If it could be adverted to, then an allied issue was the extent to which h
reliance could be placed upon it and its probative value.
542
-----------------------------------------------------------------------------------------------------------------------------------------------------------

Answering the reference in the terms below, the Supreme Court
Held:
a Per Dipak Misra, C.J. (for himself and Khanwilkar, J.; Sikri and
Chandrachud, JJ. and Bhushan, J., concurring)
Constitution, an organic document, must continuously evolve to meet

aspirations and challenges of present and future
b For maintaining democratic process and to avoid political friction, it is
necessary to direct the political parties within the purview of the constitutional
umbrella to strongly adhere to constitutional values. There is no denial of the fact
that the judiciary takes note of the obtaining empirical facts and the aspirations of
the generation that are telescoped into the future. If constitutional provisions have
to be perceived from the prism of growth and development in the context of time
so as to actualise the social and political will of the people that was put to in words,
C they have to be understood in their life and spirit with the further potentiality to
change. While interpreting serious issues, it would always be prudent, as a matter
of constitutional necessity, to widen the search for the true meaning, purport and
ambit of the provision under consideration. No provision, and indeed no word
or expression, of the Constitution exists in isolation-they are necessarily related
to, transforming and, in turn, being transformed by other provisions, words and
d phrases in the Constitution. While interpreting a constitutional provision, one has
to be guided by the letter, spirit and purpose of the language employed therein
and also the constitutional silences or abeyances that are discoverable. The scope
and discovery has a connection with the theory of constitutional implication.
Additionally, the interpretative process of a provision of a Constitution is also
required to accentuate the purpose and convey the message of the Constitution
which is intrinsic to the Constitution. (Paras 48 to 50 and 54)
e S.R. Bommaiv. Union of India, (1994) 3 SCC 1; GVK Industries Ltd. v. CIT, (2011) 4 SCC 36;
Supreme Court Advocates-on-Record Assn. v. Union of India, (1993) 4 SCC 441, relied on
Reflections on Free-Fann Method in Constitutional Inte rpretation, (1995) 108 Harv L Rev
1221, cited
The Constitution being an organic document, its ongoing interpretation is
permissible. While interpreting the Constitution, the courts are not only required to
f take into consideration their own experience over time, the international treaties and
covenants but also keep the doctrine of flexibility in mind. With the passage of time,
the interpretative process has become expansive. It has been built brick by brick to
broaden the sphere of rights and to assert the constitutional supremacy to meet the
legitimate expectations of the citizens. The words of the Constitution have been
injected life to express connotative meaning. The interpretation of the Constitution
cannot be frozen by its original understanding, for the Constitution has evolved and
g must continuously evolve to meet the aspirations and challenges of the present and
the future. The duty of the constitutional courts to interpret the Constitution opened
the path for succeeding generations to meet the challenges. (Paras 51 to 53)
Union of India v. Naveenlindal, (2004) 2 SCC 510; K.S. Puttaswamy v. Union ofIndia, (2017)
10 SCC 1; Kesavananda Bharati v. State of Kera/a, (1973) 4 SCC 225; State of Rajasthan
V. Union of India, (1977) 3 sec 592; /.R. Coelho V. State of T.N., (2007) 2 sec 1; State
h of WB. v. Anwar Ali Sarkar, 1952 SCR 284 : AIR 1952 SC 75 : 1952 Cri LJ 510; K.C.
Gajapati Narayan Deo v. State of Orissa, 1954 SCR 1 : AIR 1953 SC 375; Deep Chand
v. State of U.P., 1959 Supp (2) SCR 8: AIR 1959 SC 648; Attorney General for Ontario
543
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v. Attorney General for Canada, 1912 AC 571 (PC); Indira N ehru Gandhi v. Raj Narain,
1975 Supp sec 1; State ofT.N. V. State of Kera/a, (2014) 12 sec 696; Bhim Singh V. Union
of India, (2010) 5 SCC 538; Kesavananda Bharati v. State of Kera/a, (1973) 4 SCC 225;
I.R. Coelho v. State of T.N., (2007) 2 SCC 1; Ram Jawaya Kapur v. State of Punjab, ( 1955) a
2 SCR 225 : AlR 1955 SC 549; Union of India v. Raghubir Singh, (1989) 2 SCC 754;
Virendra Singh v. State of U.P., AlR 1954 SC 447; K.S. Srinivasan v. Union of India, AlR
1958 SC 419, relied on
Binoy Viswam v. Union of India, (2017) 7 SCC 59; State of H.P. v. Parent of a Student of
Medical College, (1985) 3 SCC 169; Mansukhlal Vithaldas Chauhan v. State of Gujarat,
(1997) 7 SCC 622: 1997 SCC (Cri) 1120: 1997 SCC (L&S) 1784; Federation of Railway
Officers Assn. v. Union of India, (2003) 4 SCC 289; State of Maharashtra v. Raghunath b
Gajanan Waingankar, (2004) 6 SCC 584; Aravali Golf Club v. Chander Hass, (2008) 1
SCC 683: (2008) 1 SCC (L&S) 289;AsifHameedv. State of l&K, 1989 Supp (2) SCC 364;
S.C. Chandra v. State of Jharkhand , (2007) 8 SCC 279 : (2007) 2 SCC (L&S) 897; Suresh
Seth v. Indore Municipal Corpn., (2005) 13 SCC 287; Supreme Court Employees' Welfare
Assn. v. Union of India, (1989) 4 SCC 187 : 1989 SCC (L&S) 569; Census Commr. v. R.
Krishnamurthy, (2015) 2 SCC 796: (2015) 1 SCC (L&S) 589; Premium Granites v. State
ofT.N., (1994) 2 SCC 691; M.P. Oil Extraction v. State of M.P., (1997) 7 SCC 592; State of c
M.P. v. Narmada Bachao Andolan, (2011) 7 SCC 639 : (2011) 3 SCC (Civ) 875; State of
Punjab v. Ram Lubhaya Bagga, (1998) 4 SCC 117: 1998 SCC (L&S) 1021, affirmed
Cooley, Constitutional Limitation (8th Edn., Vol. I), referred to
R. v. Burah, 1878 SCC OnLine PC 17: (1877-78) 5 IA 178; Powers, Privileges and Immunities
of State Legislatures, In re, Special Reference No. 1 of 1964, AIR 1965 SC 745 : (1965)
1 SCR 413, cited
Parliamentary privilege - Rationale behind d
Parliamentary privilege was introduced to prevent any undue interference
in the working of Parliament and thereby enable the Members of Parliament
to function effectively and efficiently without unreasonable impediment. Till
date, parliamentary privilege remains an important feature in any parliamentary
democracy. Conceptually parliamentary privilege protects tl1e MPs and sustains
legislative functionalism. And said protection is absolute. (Paras 99 and 110) e
Raja Ram Pal v. Lok Sabha, (2007) 3 SCC 184; Powe rs, Privileges and Immunities of State
Legislatures, In re, Special Reference No. 1 of 1964, AlR 1965 SC 745: (1965) 1 SCR 413,
relied on
Black's Law Dictionary, 6th Edn., 1990, p. 1197, referred to
Article 105(2) of the Constitution of India clearly lays the postulate that
no Member of Parliament shall be made liable to any proceedings in any court f
in respect of anything he has said in the committee. Freedom of speech that is
available to the Members on the floor of the legislature is quite distinct from
the freedom which is available to the citizens under Article 19(1)(a) of the
Constitution. Members of Parliament enjoy full freedom in respect of what they
speak inside the House. There is complete constitutional protection under Article
105(4). Article 118 enables the Parliament to regulate its procedure apart from g
what has been stated directly in the Constitution. The rules and standing orders
may regulate the procedure of the legislature apart from the limits prescribed by
the Constitution. (Paras 101 to 108)
Powers, Privileges and Immunities of State Legislatures, In re, Special Reference No. 1 of
1964, AlR 1965 SC 745 : (1965) 1 SCR 413, referred to
h
544
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There are limitations for both court and legislature
The normal impact of parliamentary privilege is to prevent the Court from
a entertaining any evidence, cross-examination or submissions which challenge
the veracity or propriety of anything done in the course of parliamentary
proceedings. (Para 111)
Hamilton v. Al Fayed, (2001) 1 AC 395 : (2000) 2 WLR 609 (HL), relied on
Wellesleyv.DukeofBeaufort, (1831) 2Russ &M639: 39 ER538: 1831 EngR 809, approved
UK Joint Committee Report, 1999, referred to
b Nowadays, people, in their efforts to obtain redress, press expansively in areas
where the limits of the courts' jurisdiction are not clear. If Parliament does not
act, the courts may find themselves compelled to do so. In order to prevent abuses
in the guise of privilege the courts must inquire into the legitimacy of a claim of
parliamentary privilege. (Paras 113 to 115)
New Brunswick Broadcasting Co. v. Nova Scotia (Sp eaker of the House of Assembly), 1993
SCC OnLine Can SC 8: (1993) 1 SCR 319; Harvey v. Attorney General for N ew Brunswick,
C 1996 SCC OnLine Can SC 80 : (1996) 2 SCR 876; Bradlaugh v. Gossett, (1884) LR 12
QED 271 : 53 LJQB 290 : 50 LT 620 (DC), referred to
Ashby v. White, (1703) 2 Ld Raym 938: 92 ER 126; Stockdale v. Hansard, (1839) 9 Ad & E 1:
112 ER 1112 (QB); Sheriff of Middlesex, (1840) 11 Ad & E 273: (1840) 113 ER 419, c ited
Sir William Holdsworth, A History of English Law, ref erred to
Articles 121 and 122 are extremely significant as they are really meant to state
d the restrictions imposed by the Constitution on both the institutions. Wise Judges
never forget that the best way to sustain the dignity and status of their office is
to deserve respect from the public at large by the quality of their judgments, the
fearlessness, fairness and objectivity of their approach, and by the restraint, dignity
and decorum which they observe in their judicial conduct. What is true of the
judicature is equally true of the legislatures. (Paras 117 to 120)
e Raja Ram Pal v. Lok Sabha, (2007) 3 SCC 184; Powers, Privileges and Immunities of State
Legislatures, In re, Special Reference No. I of 1964, AIR 1965 SC 745: (1965) 1 SCR 413,
relied on
The constitutional courts are not prevented from scrutinising the validity
of the action of the legislature trespassing on the fundamental rights conferred
on the citizens. There is no absolute immunity to the parliamentary proceeding
under Article 105(3) of the Constitution; that the enforcement of privilege by
f the legislature can result in judicial scrutiny though subject to the restrictions
contained in other constitutional provisions such as Articles 122 and 212.
Article 122(1) and Article 212(1) prohibit the validity of any proceedings in the
legislature from being called in question in a court merely on the ground of
irregularity of procedure, and the proceedings which may be tainted on account of
substantive or gross illegality or unconstitutionality are not protected from judicial
g scrutiny. (Paras 121 and 122)
Reliance on parliamentary proceedings as external aids for construction of a
statute, permissible
The basic purpose of all canons of the Constitution is to ascertain with
reasonable certainty the intention of Parliament and for the said purpose, external
aids such as reports of Special Committee preceding the enactment, the existing
h state of law, the environment necessitating enactment of a legislation and the object
sought to be achieved, etc. which Parliament held the luxury of availing should not
545
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be denied to the court whose primary function is to give effect to the real intention
of the legislature in enacting a statute. Such a denial would deprive the Court of
a substantial and illuminating aid to construction and, therefore, the reports of a
Committees which preceded the enactment of a law, reports of Joint Parliamentary
Committees and a report of a commission set up for collecting information can be
referred to as external aids of construction. (Para 123)
R.S. Nayak v. A.R. Antulay, (1984) 2 SCC 183 : 1984 SCC (Cri) 172, relied on
A statute, as passed by Parliament, is the expression of the collective intention
of the legislature as a whole, and any statement made by an individual, albeit a
b
Minister, of the intention and objects of the Act cannot be used to cut down the
generality of the words used in the statute. The speech made by the mover of the
Bill explaining the reasons for introducing the Bill can certainly be referred to for
ascertaining the mischief sought to be remedied and the object and the purpose of
the legislation in question. Where the meaning of the words in a statute is plain,
then the language prevails, but in case of obscurity or lack of harmony with other
provisions and in other special circumstances, it may be legitimate to take external C
assistance to determine the object of the provisions, the mischief sought to be
remedied, the social context, the words of the authors and other allied matters. The
Court can take aid of the report of the Parliamentary Committee for the purpose of
appreciating the historical background of the statutory provisions and it can also
refer to committee report or the speech of the Minister on the floor of the House
of Parliament if there is any kind of ambiguity or incongruity in a provision of an d
enactment. (Paras 124 to 134)
K.P. Varghese v. CIT, (1981) 4 SCC 173 : 1981 SCC (Tax) 293; Ramesh Yeshwant Prabhoo
v. Prabhakar Kashinath Kunte, (1996) 1 SCC 130; Novartis AG v. Union of India, (2013)
6 SCC 1 : (2013) 3 SCC (Civ) 227; State of M.P. v. Dadabhoy's New Chirimiri Ponri Hill
Colliery Co. (P) Ltd., (1972) 1 SCC 298; Union of India v. Steel Stock Holders' Syndicate,
(1976) 3 SCC 108; Surana Steels (P) Ltd. v. CIT, (1999) 4 SCC 306; ; Dharam Dutt v.
Union of India , (2004) 1 SCC 712; Khudiram Das v. State ofW.B., (1975) 2 SCC 81: 1975 e
SCC (Cri) 435, affirmed
State of W.B. v. Union of India, AIR 1963 SC 1241; Ashoka Kumar Thakur v. Union of India,
(2008) 6 SCC 1 : 3 SCEC 35; CIT v. Surat Art Silk Cloth Manufacturers' Assn., (1980) 2
SCC 31: 1980 SCC (Tax) 170; Pepper (Insp ector of Taxes ) v. Hart, 1993 AC 593: (1992) 3
WLR 1032: 1992 UKHL 3; R. v. Vasil, 1981 SCC OnLine Can SC 19: (1981) 1 SCR 469:
(1981) 121 DLR (3d) 41; Anti-Inflation Act, In re, 1976 SCC OnLine Can SC 69 : (1976) 2
SCR 373: (1976) 68 DLR (3d) 452; I.R. Coelho v. State of T.N., (2007) 2 SCC 1; Rustom f
Cavasjee Cooper v. Union of India, (1970) 1 SCC 248; Sakal Papers ( P) Ltd. v. Union of
India, (1962) 3 SCR 842: AIR 1962 SC 305; Sambhu Nath Sarkar v. State of W.B., (1973)
1 SCC 856 : 1973 SCC (Cri) 618 ; Haradhan Saha v. State of W.B. , (1975) 3 SCC 198 :
1974 SCC (Cri) 816; Maneka Gandhi v. Union of India, (1978) 1 SCC 248; M. Nagaraj
V. Union of India, (2006) 8 sec 212 : (2007) 1 sec (L&S) 1013; B.R. Kapur V. State of
T.N., (2001) 7 SCC 231; Minerva Mills Ltd. v. Union of India, (1980) 3 SCC 625; Manoj
Narula v. Union of India, (2014) 9 SCC 1; M elbourne Corpn. v. Commonwealth, (1947)
74 CLR 31 (Aust); Australian Capital Television Pty. Ltd. v. Commonwealth , (1992) 177 g
CLR 106 (Aust); Kuldip Nayar v. Union of India, (2006) 7 SCC 1; G. Narayanaswami v. G.
Pannerselvam, (1972) 3 SCC 717; Union of India v. Sankalchand Himatlal Sheth, (1977) 4
SCC 193: 1977 SCC (L&S) 435; Massa chusetts Bonding & Insurance Co v. United States ,
1956 SCC OnLine US SC 102: 1 L Ed 2d 189 : 352 US 128 (1956) , relied on
A.K. Gopalan v. State of Madras, AIR 1950 SC 27 : (1950) 51 Cri LJ 1383 : 1950 SCR 88,
held, overruled
h
546
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The petitioners do not intend to seek liberty from Parliament or the
Parliamentary Committee to be questioned or cross-examined. In fact, reliance of
a the report has nothing to do with what is protected by the Constitution under Article
105. The court proceedings are independent of Parliament and based on multiple
inputs, materials and evidence and in such a situation, the parties are at liberty to
persuade the court to come to a determination of facts and form an opinion in law at
variance with the Parliamentary Committee report. The further submissions of the
petitioners relying on the report would not come within the scope of parliamentary
privilege. (Para 137)
b
Parliamentary Committee Reports are public documents and admissible under
S. 74, Evidence Act-Judicial notice can be taken of said reports under S. 57(4)
of the Evidence Act - Fair comments by citizens showing public concern is
permissible - In all such circumstances, question of parliamentary privilege
would not arise
C
Section 57(4) of the Evidence Act casts an obligation on the courts to take
judicial notice of the course of proceedings of Parliament. (Para 140)
Lok Shikshana Trust v. CIT, (1976) 1 SCC 254: 1976 SCC (Tax) 14, affirmed
There can be no dispute that Parliamentary Standing Committee report being
in the public domain is a public document. Therefore, it is admissible under
Section 7 4 of the Evidence Act and judicial notice can be taken of such a document
as envisaged under Section 57(4) of the Evidence Act. There can be no scintilla
d
of doubt that the said document can be taken on record. It can be taken aid of
to understand and appreciate a statutory provision if it is unclear, ambiguous or
incongruous. It can also be taken aid of to appreciate what mischief the legislative
enactment intended to avoid. (Para 142)
Additionally, it can be stated with certitude that there can be a fair comment
on the report and a citizen in his own manner can advance a criticism in respect
e
of what the report has stated. Needless to emphasise that the right to fair comment
is guaranteed to the citizens. It is because freedom of speech, as permissible
within constitutional parameters, is essential for all democratic institutions. Fair
comments show public concern and, therefore, such comments cannot be taken
exception to. That is left to public opinion and perception on which the grand pillar
of democracy is further strengthened. And, in all such circumstances, the question
f of parliamentary privilege would not arise. (Para 142)
Entering the Committee System: State Committee Assignments, Ronald D. Hedlund, Political;
Research Quarterly, Vol. 42, Issue 4, pp. 597-625, relied on
Woodrow Wilson, "Congressional Government", 1885, quoted in the JCOC Final Report,
(Baltimore, the Johns Hopkins University Press, 1981) p. 69; National Democratic Institute
for International Affairs, Parliament's Organization: The Role of Committees and Party
Whips - NDI Workshop in M angochi, M alawi, June 1995 (Washington: National
g Democratic Institute for International Affairs, 1995); An Introduction to the Procedure of
House of Commons; Lord Beaconsfield in Hansard, 3rd Series, Vol. 235 (1877) p. 1478;
"Growth of Committee System in the Central Legislature of India 1920-1947"; "The
Committee System in India: Effectiveness in Enforcing Executive Accountability", Hanoi
Session, M arch 2015, India, referred to
h
547
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Parliamentary Committee and reports distinguished from contestable matter
contained in them
In the case at hand, the controversy does not end there inasmuch as the a
petitioners have placed reliance upon the contents of the Parliamentary Standing
Committee report and the respondents submit that they are forced to controvert the
same. In such a situation, the Court would be duty-bound to afford the respondents
an opportunity of being heard in consonance with the principles of natural justice.
This, in turn, would give rise to a very peculiar situation as the respondents
would invariably be left with the option either to: (i) accept, without contest, the
b
opinion expressed in the Parliamentary Stan ding Committee report and the facts
stated therein; or (ii) contest the correctness of the opinion of the Parliamentary
Standing Committee report and the facts stated therein. In the former scenario, the
respondents at the very least would be put in an inequitable and disadvantageous
position. It is in the latter scenario that the Court would be called upon to adjudicate
the contentious facts stated in the report. Ergo, whenever a contest to a factual
finding in a PSC report is likely and probable, the Court should refrain from doing C
so. It is one thing to say that the report being a public document is admissible in
evidence, but it is quite different to allow a challenge. (Para 143)
It is worthy to note here that there is an intrinsic difference between
parliamentary proceedings which are in the nature of statement of a Minister or of
a Mover of a Bill made in Parliament for highlighting the purpose of an enactment
or, for that matter, a Parliamentary Committee report that had come into existence d
prior to the enactment of a law and a contestable/conflicting matter of "fact" stated
in the Parliamentary Committee report. It is the parliamentary proceedings falling
within the former category of which courts are enjoined under Section 57(4) to take
judicial notice of, whereas, for the latter category of parliamentary proceedings,
the truthfulness of the contestable matter of fact stated during such proceedings has
to be proved in the manner known to law. (Para 144) e
This again is to the hazardous zone wherein taking judicial notice of
Parliamentary Standing Committee reports for a factual finding will obviously be
required to be proved for ascertaining the truth of a contestable matter of fact stated
in the said report. (Para 145)
Taking judicial notice of the Parliamentary Standing Committee report can
only be to the extent that such a report exists. The said report can be taken aid of f
for understanding the statutory provision wherever it is felt so necessary or to take
cognizance of a historical fact that is different from a contest. The word "contest",
according to Black 's Law Dictionary, means to make defence to an adverse claim
in a court of law; to oppose, resist or dispute; to strive to win or hold; to controvert,
litigate, call in question, challenge to defend. This being the meaning of the word
"contest", the submission to adjudge the lis on the factual score of the report is to g
be negatived. (Para 146)
In many cases, the Supreme Court has referred to and taken note of various
Parliamentary Committee reports. But in said cases, the question of contest/
challenge never emerged. That being the position, the said judgments do not render
any assistance to the controversy in question. (Paras 147 to 153)
Catering Cleaners of Southern Railway v. Union of India , (1987) 1 sec 700 : 1987 sec h
(L&S) 77; State of Maharashtra v. Mi/ind, (2001) 1 SCC 4: 2001 SCC (L&S) 117; Aruna
Roy v. Union of India, (2002) 7 SCC 368 : 5 SCEC 310; M.C. Mehta v. Union of India,
548
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(2017) 7 SCC 243; Lal Babu Priyadarshi v. Amritpal Singh, (2015) 16 SCC 795: (2016) 3
SCC (Civ) 649; Gujarat Electricity Board v. Hind Mazdoor Sabha, (1995) 5 SCC 27: 1995
SCC (L&S) 1166; Modem Dental College & Research Centre v. State ofM.P., (2016) 7 SCC
a 353 : 7 SCEC 1; Krishan Lal Cera v. State of Haryana, (2011) 10 SCC 529, distinguished
Adjudication, duty of court - Court also has duty to strike balance between
judiciary and legislature - Admissibility of Parliamentary Committee Reports
and judicial notice of same - Fair comments on same by public showing public
concern is permissible
A party can always establish its case on the materials on record and the
b court can independently adjudicate the controversy without allowing a challenge
to Parliamentary Standing Committee report. The court has a constitutional duty to
strike a delicate balance between the legislature and the judiciary. It is more so when
the issue does not involve a fundamental right that is affected by parliamentary
action. A constitutional court cannot abdicate its duty to allow injustice to get any
space or not allow real space to a principle that has certain range of acceptability.
C The court ought not to shy away from its primary responsibility of interpreting
the Constitution and other statutes in a manner that is not only legally tenable but
also facilitates the progress and development of the avowed purpose of the rights-
oriented Constitution. Therefore, the constitutional courts should always adopt a
progressive approach and display a dynamic and spirited discharge of duties regard
being had to the concepts of judicial statesmanship and judicial engagement, for
d they subserve the larger public interest. (Paras 154 to 157)
Lakshmi Kant Pandey v. Union of India , (1984) 2 SCC 244; Vishaka v. State of Rajasthan,
(1997) 6 SCC 241 : 1997 SCC (Cri) 932; Prakash Singh v. Union of India, (2006) 8 SCC
1 : (2006) 3 SCC (Cri) 417; Shakti Vahini v. Union of India, (2018) 7 SCC 192, affinned
Common Cause v. Union of India, (2018) 5 SCC 1, relied on
Jajbhay v. Cassim, 1939 AD 537; Miranda v. Arizona, 1966 SCC OnLine US SC 112: 16 L
Ed 2d 694 : 384 US 436 (1966), refe rred to
e In the case at hand, having regard to the constitutional obligation the
Parliamentary Standing Committee report or any Parliamentary Committee report
can be taken judicial notice of and regarded as admissible in evidence, but
it can neither be impinged nor challenged nor its validity can be called in
question. (Para 158)
Conclusions
f
In view of tl1e aforesaid analysis, the referred questions are answered in tl1e
following manner: (Para 159)
(i) Parliamentary Standing Committee report can be taken aid of for the
purpose of interpretation of a statutory provision wherever it is so necessary and
also it can be taken note of as existence of a historical fact. (Para 159.1)
g (ii) Judicial notice can be taken of the Parliamentary Standing Committee
report under Section 57(4) of the Evidence Act and it is admissible under Section 74
of the said Act. (Para 159.2)
(iii) In a litigation filed either under Article 32 or Article 136 of the
Constitution of India, the Supreme Court can take on record the report of the
Parliamentary Standing Committee. However, the report cannot be impinged or
h challenged in a court of law. (Para 159.3)
549
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(iv) Where the fact is contentious, the petitioner can always collect the facts
from many a source and produce such facts by way of affidavits, and the court can
render its verdict by way of independent adjudication. (Para 159.4)
a
(v) The Parliamentary Standing Committee report being in the public domain
can invite fair comments and criticism from the citizens as in such a situation, the
citizens do not really comment upon any Member of Parliament to invite the hazard
of violation of parliamentary privilege . (Para 159.5)
The reference is answered accordingly. (Para 160)
Let the writ petitions be listed before the appropriate Bench for
b
hearing. (Para 161)
KalpanaMehta v. Union of India, (2017) 7 SCC 295; KalpanaMehta v. Union ofIndia , (2017)
7 SCC 295 : (2017) 7 SCC 307; Kalpana Mehta v. Union of India, (2017) 7 SCC 295 :
(2017) 7 SCC 302; Kalpana Mehta v. Union of India, (2017) 7 SCC 295 : (2017) 7 SCC
305; Kalpana M ehta v. Union of India, (2017) 7 SCC 295 : (2017) 7 SCC 306, referred to
Per Sikri and Chandrachud, JJ. (concurring)
C
The Constitution
Articles 105, 118, 119 and 121 are comprised in Part V of the Constitution
which deals with the Union and form a part of Chapter II, which deals with
Parliament. (Para 180)
Free speech within Parliament is crucial for democratic governance. It is
through the fearless expression of their views that Parliamentarians pursue their
commitment to those who elect them. The power of speech exacts democratic d
accountability from elected governments. The free flow of dialogue ensures that
in framing legislation and overseeing government policies, Parliament reflects the
diverse views of the electorate which an elected institution represents. (Para 181)
The Constitution recognises free speech as a fundamental right in Article 19(1)
(a). A separate articulation of that right in Article 105(1) shows how important
the debates and expression of view in Parliament have been viewed by the e
draftspersons. Article 105(1) is not a simple reiteration or for that matter, a
surplusage. Article 105(4) widens the scope of the protection. Committees of the
Houses of Parliament are established by and under the authority of Parliament.
They represent Parliament. They are comprised within Parliament and are as much,
Parliament. The provisions contained in Chapter II of Part V are mirrored, in
the case of the State Legislatures, in Chapter III of Part VI. The corresponding
f
provisions in regard to State Legislatures are contained in Articles 194, 208, 209
and 212. The same protection which extends to parliamentary proceedings is
extended to proceedings in or before the Committees constituted by each House.
Parliament has been vested with a complete and exclusive authority to regulate its
own procedure and the conduct of its business. (Paras 182 to 188)
The Constitution has carefully engrafted provisions to ensure institutional
comity between Parliament and the judiciary. Under Article 121, the conduct of a g
Judge of the Supreme Court or of a High Court in the discharge of duties cannot
be discussed in Parliament (except upon a motion for removal). Article 211 makes
a similar provision in regard to the State Legislatures. (Para 189)
Parliamentary privilege in India
The law in India has witnessed a marked degree of evolution. Indian
jurisprudence on the subject has recognised the importance of the freedom of h
speech in Parliament, the principle of separation of powers and the concomitant
550
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protection afforded to Members from being held liable for what is spoken in
Parliament. Principles grounded in the common law in UK have not remained just
in the realm of common law. Our precedent on the subject notices the qualitative
a
difference between parliamentary democracy in UK and in India. The fundamental
difference arises from the supremacy of the Indian Constitution which subjects all
constitutional authorities to the mandate of a written Constitution. (Para 218)
1964, AIR 1965 SC 745: (1965) 1 SCR 413; P.V. Narasimha Rao v. State, (1998) 4 SCC
626: 1998 SCC (Cri) 1108; Richard WilliamPrebble v. Television New Zealand Ltd., (1995)
b 1 AC 321 : (1994) 3 WLR 970: (1994) 3 All ER 407 (PC); R. v. Currie, 1992 (unreported);
Raja Ram Pal v. Lok Sabha, (2007) 3 SCC 184, relied on
Bradlaugh v. Gossett, (1884) LR 12 QBD 271 : 53 LJQB 290: 50 LT 620 (DC), approved
Constitutional supremacy mandates that every institution of governance is
subject to the norms embodied in the constitutional text. The Constitution does
not allow for the existence of absolute power in the institutions which it creates.
Judicial review as a part of the basic features of the Constitution is intended to
C
ensure that every institution acts within its bounds and limits. The fundamental
rights guaranteed to citizens are an assurance of liberty and a recognition of the
autonomy which inheres in every person. Hence, judicial scrutiny of the exercise
of parliamentary privileges is not excluded where a fundamental right is violated
or a gross illegality occurs or where there is a violation of the constitutional
provision as distinguished from mere irregularity of procedure, in view of Article
d 122(1). (Paras 222 to 227)
Raja Ram Pal v. Lok Sabha, (2007) 3 SCC 184; Amarinder Singh v. Punjab Vidhan Sabha,
(2010) 6 SCC 113 : (2010) 2 SCC (Cri) 1343, relied on
Separation of powers: A nuanced modern doctrine
Many contemporary scholars have differed on the normative importance of
the doctrine of separation. Yet, even scholars who emphasise the importance of
e
the separation of powers in the UK acknowledge that the Constitution does not
strictly observe such a separation. Courts in the UK do not possess a direct power
of judicial review to invalidate legislation tl1ough, witl1 tl1e enactment of tl1e Human
Rights Act, the doctrine of incompatibility has become an entrenched feature of
the law. (Para 230)
Peter A. Gerangelos, The Separation of Powers and Legislative Inteiference in Judicial
f Process, Constitutional Principles and Limitations (Hart Publishing , 2009); See A.
Tomkins, Public Law (Oxford University Press, 2003) 37 (as cited by Gerangelos at p. 274);
E. Barendt, "Separating of Powers and Constitutional Government" [1995] Public Law
599 at 599-60, C. Munro, Studies in Constitutional Law, 2nd Edn. (London, Butterworths,
1999) at 304, T.R.S. Allan, Law Liberty and Justice, The Legal Foundations of British
Constitutionalism (Oxford, Clarendon Press, 1993) Chs. 3 and 8, and T.R.S. Allan,
Constitutional Justice, A Liberal Theory of the Rule of Law (Oxford, Oxford University
g Press, 2001); R. Stevens, "A Loss oflnnocence?: Judicial Independence and the Separation
of Powers" (1999) 19 Oxford Journal of Legal Studies 365, referred to
The importance of the principle of separation essentially lies in the
independence of the judiciary. Though the supremacy of Parliament is one of the
fundamental features in UK and the unwritten Constitution does not mandate a
strict separation of powers, it would be difficult to regard a State which has no
h control on legislative supremacy as a constitutional State founded on the rule of
law. Consequently, where the rule oflaw and constitutionalism govern society there
551
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may yet be fundamental principles inhering in the nature of the polity, which can
be enforced by the judiciary even against Parliament, in the absence of a written
Constitution. In other words, even in the context of an unwritten Constitution, the a
law has a certain internal morality as a part of which it embodies fundamental
notions of justice and fairness. (Para 232)
Allan, Law, Liberty and Justice; Gerangelos, at p. 277, referred to
Current view of doctrine of separation of powers
The interpretation of the doctrine of separation of powers has evolved from
being a "one branch - one function approach" with limited exceptions, to a concept b
which involves an integration of the "division of work" and "checks and balances".
The doctrine of separation of power has developed to fulfil the changing needs of
society and its growing necessities. The current view on the doctrine of separation
of powers also seeks to incorporate mutual supervision, interdependence and
coordination because the ultimate aim of the different branches of the Government,
through their distinct functions is to ensure good governance and to serve public C
interest, which is essential in the background of growing social and economic
interests in a welfare State. This stands in contrast with the former and original
interpretation of the doctrine, which sought to compartmentalise and isolate the
different branches of the Government from one another, with limited permissible
exceptions. (Paras 233 to 238)
Aileen Kavanagh, The Constitutional Separation of Powers, Chapter 11 in David Dyzenhaus d
and Malcolm Thorburn (eds.) Philosophical Foundations of Constitutional Law, (Oxford
University Press, 2016) 221; M.J.C. Vile, Constitutionalism and the Separation of
Powers (Oxford University Press, 1967); D. Kyritsis, "What is Good a bout Legal
Conventionalism?" (2008) 14 Legal Theory 135, 154 (as cited in Philosophical Foundations
of Constitutional Law, at p. 235); Philosophical Foundations of Constitutional Law, at
p. 236; K. Malleson, 'The Rehabilitation of Separation of Powers in UK' in L. de Groot-van
Leeuwen and W. Rombouts, Separation ofPowers in Theory and Practice: An International
Perspective (Nijmegen: Wolf Publishing, 2010) 99-122, 115 (as cited in Philosophical e
Foundations of Constitutional Law, at p. 237); J. Waldron, "Authority for Officials" in L.
Meyer, S. Paulson and T. Pogge (eds.), Rights, Culture, and the Law: Themes from the Legal
and Political Philosophy of Joseph Raz (Oxford University Press, 2003) 45-70; J. King,
"Institutional Approaches to Judicial Restraint" (2008) 28 Oxford Journal of Legal Studies
409, 428; Buckley v. Attorney General, 1950 Irish Reports 67, 80 (per O 'Bryne, J.) (as cited
in Philosophical Foundations of Constitutional Law, at p. 235), referred to
f
The traditional doctrine of separation should be reshaped to make it relevant to
the practical realities of modern Government. The shared growth of administrative
powers of the bureaucracy in the modern State defies the tripartite division.
Therefore, a realistic modern application of the theory is necessary. The modern
system of Government has grown in ways previously thought unfathomable, and
now encompasses a breadth and diversity previously unseen. The Government
today is characterised by the increase in powers of its agencies and the rapid g
growth of organisations which can neither be classified as exclusively public
or private bodies. These modern systems of Government and the existence and
rapid rise of supranational organisations defy the traditional three way division of
powers. Administrative bodies are not defined by a uniform design, and exercise
institutional fluidity in a manner which has come to characterise the administrative
State's organisational complexity: in a single instance, they exercise powers and h
perform functions that might have been formerly classified as executive, judicial
552
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or legislative in nature. In this view, the modern State is distinctly different
from Locke 's seventeenth century Model and Montesquieu's eighteenth century
a ideas. (Paras 239 and 240)
Eoin Carolan, The N ew Separation of Powers- A Theory for the Modern State (Oxford
University Press, 2009) 253; Eoin Carolan, "The Problems with the Theory of Separation
of Powers", SSRN, (2011) 26; Op cit fn 162 a t p. 256, ref erred to
Indian Constitution does not adopt a rigid separation
While the Indian Constitution has been held to have recognised the doctrine
b of separation of powers, it does not adopt a rigid separation. Whether legislative
authority has extended beyond its constitutional boundaries or the fundamental
rights have been contravened cannot be decided by the legislature, but is a matter
entrusted exclusively to judicial decision. (Paras 242 and 243)
Indira Nehru Gandhi v. Raj Narain, 1975 Supp SCC 1; Ramfawaya Kapurv.State of Punjab,
(1955) 2 SCR 225 : AIR 1955 SC 549; State of TN. v. State of Kerala, (2014) 12 SCC
696; Powers, Privileges and Immunities of State Legislatures, In re, Special Reference No. 1
C of 1964, AIR 1965 SC 745 : (1965) 1 SCR 413; Kesavananda Bharati v. State of Kerala,
(1973) 4 SCC 225, referred to
The doctrine of separation restrains the legislature from declaring a judgment
of a court to be void and of no effect. However, in the exercise of its law-making
authority, a legislature possessed oflegislative competence can enact validating law
which remedies a defect pointed out in a judgment of a court. While the legislature
d cannot ordain that a decision rendered by the court is invalid, it may by enacting
a law, take away the basis of the judgment such that the conditions on which it is
based are so fundamentally altered that the decision could not have been given in
the altered circumstances. (Para 248)
I.N. Saksena v. State of M.P., (1976) 4 SCC 750 : 1977 SCC (L&S) 36; Indian Aluminium
Co. v. State of Kerala, (1996) 7 SCC 637; S.S. Bola v. B.D. Sardana, (1997) 8 SCC 522;
Shri Prithvi Cotton Mills Ltd. v. Broach Borough Municipality, (1969) 2 SCC 283; Supreme
e Court Advocates-on-Record Assn. v. Union of India, (2016) 5 SCC 1, ref erred to
In the evolution of separation of powers doctrine, traditionally the checks
and balances dimension was only associated with governmental excesses
and violations. But in today's world of positive rights and justifiable social
and economic entitlements, hybrid administrative bodies, private functionaries
discharging public functions, the court has to perform the oversight function with
f more urgency and enlarge the field of checks and balances to include governmental
inaction. Otherwise the country would be transformed into a state of repose.
Social engineering as well as institutional engineering therefore forms part of this
obligation. (Para 249)
State of U.P. v. feet S. Bisht, (2007) 6 SCC 586, affinned
There is a link between separation and the need to ensure accountability of
g each branch of Government. While the Constitution does not prohibit overlapping
functions, what it prohibits is the exercise of functions by a branch in a way which
"results in wresting away of the regime of constitutional accountability". While
the essential functions of one organ of the State cannot be taken over by the other
and that a sense of institutional comity must guide the work of the legislature,
executive and judiciary, the practical problems which arise in tl1e unfolding of
h democracy can be resolved through robust constitutional cultures and mechanisms.
The separation doctrine cannot be reduced to its descriptive content, bereft of its
553
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normative features. Evidently, it has both normative and descriptive features. In
applying it to the Indian Constitution, the significant precept to be borne in mind
is that no institution of governance lies above the Constitution. No entrustment of a
power is absolute. (Paras 250 to 256)
Bhim Singh v. Union of India, (2010) 5 SCC 538, relied on
Supreme Court Advocates-on-Record Assn. v. Union of India, (2016) 5 SCC 1; State of WB.
v. Committee for Protection of Democratic Rights, (2010) 3 sec 571 : (2010) 2 sec (Cri)
401; Common Cause v. Union of India, (2017) 7 SCC 158, referred to
Kesavananda Bharati v. State of Kerala, (1973) 4 SCC 225; Tata Power Co. Ltd. v. Reliance
Energy Ltd., (2009) 16 SCC 659; Namit Sharma v. Union of India, (2013) 1 SCC 745 : b
(2013) 1 sec (Civ) 786: (2013) 1 sec (Cri) 737: (2013) 1 sec (L&S) 244, cited
Parliamentary Committee does not decide lis between contesting disputants
nor does it perform any adjudicating function
The Parliamentary Committees owe their existence to Parliament. They report
to Parliament. They comprise of the Members of Parliament. Their work consists
of tendering advice to the legislature. A Parliamentary Committee does not decide c
a lis between contesting disputants nor does it perform an adjudicatory function.
A committee appointed by the House can undoubtedly receive evidence, including
expert evidence, both oral aud documentary. A Select Committee may be appointed
by the House to scrutinise a Bill. When the committee performs its task, its report
is subject to further discussion and debate in the House in the course of which the
legislative body would decide as to whether the Bill should be enacted into law. The d
validity of the advice which is tendered by a Parliamentary Committee in framing
its recommendations for legislation cannot be subject to a challenge before a court
of law. The advice tendered is, after all, what it purports to be: it is advice to the
legislating body. The correctness of or the expediency or justification for the advice
is a matter to be considered by the legislature and by it alone. (Para 257)
The contents of the report of a Parliamentary Committee may have a bearing e
on diverse perspectives like matters of policy and purpose of law, statements made
by persons who have deposed before the Committee, findings of misdemeanour
implicating a breach of duty by public officials or private individuals or an evasion
of law. (Paras 258 and 259)
Justice G.P. Singh, Principles of Statutory Interpretation (14th Edn.) 253, referred to
Functional complementarity f
In matters involving public interest which come up before the court, a
grievance is often made of the violation of the fundamental rights of persons who
by reason of poverty, ignorance or marginalised status are unable to seek access
to justice. Public interest litigation has been perceived as social action litigation
because a relaxation of the rules of standing has enabled constitutional courts
to reach out to those who have suffered discrimination and prejudice. Whatever g
be the source of such discrimination - the feudal and patriarchal structures of
Indian society being among them - public interest litigation has enabled courts
to develop flexible tools of decision-making and pursue im1ovative remedies. The
writ of continuing mandamus is one of them. In the process, the violation of the
fundamental rights of those groups of citizens who may not be able to seek access to
justice is sought to be remedied. Public interest litigation has emerged as a powerful h
tool to provide justice to the marginalised. In matters involving issues of public
554
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interest, courts have been called upon to scrutinise the failure of the State or its
agencies to implement law and to provide social welfare benefits to those for whom
a they are envisaged under legislation. Courts have intervened to ensure the structural
probity of the system of democratic governance. Executive power has been made
accountable to the guarantee against arbitrariness (Article 14) and to fundamental
liberties (principally Articles 19 and 21). (Para 263)
Committees of Parliament attached to ministries/departments of the
Government perform the function of holding the Government accountable to
b implement its policies and its duties under legislation. The performance of
governmental agencies may form the subject-matter of such a report. In other
cases, the deficiencies of the legislative framework in remedying social wrongs
may be the subject of an evaluation by a Parliamentary Committee. The work
of a Parliamentary Committee may traverse the area of social welfare either in
terms of the extent to which existing legislation is being effectively implemented
or in highlighting the lacunae in its framework. There is no reason in principle
C
why the wide jurisdiction of the High Courts under Article 226 or of the Supreme
Court under Article 32 should be exercised in a manner oblivious to the enormous
work which is carried out by Parliamentary Committees in the field. The work of
the committee is to secure alacrity on the part of the Government in alleviating
deprivations of social justice and in securing efficient and accountable governance.
When courts enter upon issues of public interest and adjudicate upon them, they
d do not discharge a function which is adversarial. The constitutional function of
adjudication in matters of public interest is in step with the role of Parliamentary
Committees which is to secure accountability, transparency and responsiveness in
the Government. In such areas, the doctrine of separation does not militate against
the court relying upon the report of a Parliamentary Committee. The court does not
adjudge the validity of the report nor for that matter does it embark upon a scrutiny
e into its correctness. There is a functional complementarity between the purpose
of the investigation by the Parliamentary Committee and the adjudication by the
court. To deprive the court of the valuable insight of a Parliamentary Committee
would amount to excluding an important source of information from the purview
of the court. To do so on the supposed hypothesis that it would amount to a breach
of parliamentary privilege would be to miss the wood for the trees. Once the report
of the Parliamentary Committee has been published it lies in the public domain.
f
There is no reason or justification to exclude it from the purview of the material to
which the court seeks recourse to understand the problem with which it is required
to deal. The court must look at the report with a robust commonsense, conscious
of the fact that it is not called upon to determine the validity of the report which
constitutes advice tendered to Parliament. The extent to which the court would rely
upon a report must necessarily vary from case to case and no absolute rule can be
g laid down in that regard. (Para 264)
Findings of misdemeanour or breach of duty by public officials or private
individuals or an evasion of law - Parliamentary Committee Report not
substantive evidence - Court has to consider other evidence and deal with it
independently
h There may, however, be contentious matters in the report of a Parliamentary
Committee in regard to which the court will tread with circumspection. For
555
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instance, the report of the committee may contain a finding of misdemeanour
involving either officials of the Government or private individuals bearing on a
violation of law. If the issue before the court for adjudication is whether there a
has in fact been a breach of duty or a violation of law by a public official or
a private interest, the court would have to deal with it independently and arrive
at its own conclusions based on the material before it. Obviously in such a case
the finding by a Parliamentary Committee cannot constitute substantive evidence
before the court. The Parliamentary Committee is not called upon to decide a lis
or dispute involving contesting parties and when an occasion to do so arises before
the court, it has to make its determination based on the material which is admissible b
before it. An individual whose conduct has been commented upon in the report of
a Parliamentary Committee cannot be held guilty of a violation on the basis of that
finding. (Para 265)
Jyoti Harshad Mehta v. Custodian, (2009) 10 SCC 564: (2010) 2 SCC (Cri) 1494, referred to
Judicial notice
C
Section 57 of the Evidence Act, 1872 speaks of facts of which the court must
take judicial notice. However, the truth of a disputable question of fact would
have to be independently proved before the court. In view of Section 57(4) of the
Evidence Act, the court has to take judicial notice of the proceedings of both the
Houses of Parliament and is expected to treat the proceedings of the two Houses of
Parliament as proved on the production of the copies of the journals or the reports
d
containing proceedings of the two Houses of Parliament which are published by
them. (Paras 266 and 269)
Lok Shikshana Trust v. CIT, (1976) 1 SCC 254: 1976 SCC (Tax) 14; "The Englishman" Ltd.
v. Lajpat Rai, 1910 SCC OnLine Cal 224: ILR (1910) 37 Cal 760: 14 CWN 945 : 6 IC
81; Onkar Nath v. State (UT of Delhi), (1977) 2 SCC 611: 1977 SCC (Cri) 388; Baburao
V. Union of India, 1988 Supp sec 401, affinned
Gerald Lord Strickland v. Cannelo Mifsud Bonnici, 1934 SCC OnLine PC 51 : AIR 1935 PC e
34: 153 IC 1, relied on
Conclusion
The Constitution is about empowerment. The democratic transformation to
which it aspires places the individual at the core of the concerns of governance. For
a colonial regime, individuals were subordinate to the law. Since the Constitution is
about transformation and its vision is about empowerment, our reading of precepts f
drawn from a colonial past, including parliamentary privilege, must be subjected
to a nuance that facilitates the assertion of rights and access to justice. The Indian
society must move from the culture of authority and submission to the law, to one
of justification and rights under the law. (Paras 271 to 273)
Justice Albie Sachs, The Strange Alchemy of Life and Law (Oxford University Press 2009)
pp. 32-33, ref erred to
g
Once the fulfilment of individual rights and human freedoms is placed at the
forefront of constitutional discourse, the resolution of the present case presents
no difficulty. History and contemporary events across the world are a reminder
that blackouts of information are used as a willing ally to totalitarian excesses of
power. They have no place in a democracy. Placing reliance on the report of a
Parliamentary Committee does not infringe parliamentary privilege. No Member
h
of Parliament is sought to be made liable for what has been said or for a vote
556
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tendered in the course of a debate. The correctness or validity of the report of a
Parliamentary Committee is not a matter which can be agitated before the Court
a nor does the Court exercise such a function. Where an issue of fact referred to in
the report of the Parliamentary Committee becomes contentious, it undoubtedly
has to be proved before a court independently on the basis of the material on the
record. (Para 274)
Parliamentary Committees are an intrinsic part of the process by which
the elected legislature in a democracy exacts accountability on the part of the
Government. Department related Parliamentary Standing Committees undertake
b
the meticulous exercise of scrutinising the implementation of law, including
welfare legislation and the performance of the departments of the State. The
purpose of law is to promote order for the benefit of the citizen and to protect
rights and entitlements guaranteed by the Constitution and by statute. Access to
justice as a means of securing fundamental freedoms and realising socio-economic
entitlements is complementary to the work of other organs of the State. The modern
C doctrine of separation of powers has moved away from a "one organ - one function"
approach, to a more realistic perspective which recognises the complementarity
in the work which is performed by institutions of governance. Judicial review is
founded on the need to ensure accountable governance in the administration of
law as an instrument of realising the rights guaranteed by the Constitution. If tl1e
function of judicial review in facilitating the realisation of socio-economic rights
d is construed in the context of the modern notion of separation of powers, there is
no real conflict between the independence of the judicial process and its reliance
on published reports of Parliamentary Committees. Ultimately it is for the court in
each case to determine the relevance of a report to the case at hand and the extent
to which reliance can be placed upon it to facilitate access to justice. Reports of
Parliamentary Committees become part of the published record of the State. As
e
a matter of principle, there is no reason or justification to exclude them from the
purview of the judicial process, for purposes such as understanding the historical
background of a law, the nature of the problem, the causes of a social evil and
the remedies which may provide answers to intractable problems of governance.
The court will in tl1e facts of a case determine when a matter which is contentious
between the parties would have to be adjudicated upon independently on the basis
of the evidence adduced in accordance with law. (Para 275)
f Dingle v. Associated N ewspapers Ltd., (1960) 2 QB 405 : (1960) 2 WLR 430; Church of
Scientology of California v. Johnson Smith, (1972) 1 QB 522: (1971) 3 WLR 434; Richard
William Prebble v. Television New Zealand Ltd., (1995) 1 AC 321 : (1994) 3 WLR 970:
(1994) 3 All ER 407 (PC); Burdettv. Abbot, (1811) 14 East 1 : 104 ER 501; British Railways
Boardv.Pickin, 1974AC 765: (1974) 2 WLR 208 (HL);R. v.Murphy, (1986) 64 ALR498:
(1986) 5 NSWLR 18; Toussaint v. Attorney General of Saint Vincent and the Grenadines ,
(2007) 1 WLR 2825: 2007 UKPC 48 (PC); R. (Bradley) v. Secy. of State for Work and
g Pensions, 2009 QB 114: (2008) 3 WLR 1059: 2007 EWHC 242 (Admin); Office of Govt.
Commerce v. Information Commr., 2010 QB 98: (2009) 3 WLR 627; R. (Wheeler) v. Office
of the Prime Minister, 2014 EWHC 3815 (Admin); Buchanan v. Jennings, (2005) 1 AC
115 : (2004) 3 WLR 1163 : 2004 UKPC 36; Buchanan v. Jennings, (2002) 3 NZLR 145
(CA); Hamilton v. Al Fayed, (2001) 1 AC 395 : (2000) 2 WLR 609 (HL); Bradlaugh v.
Gossett, (1884) LR 12 QBD 271 : 53 LJQB 290 : 50 LT 620 (DC); Stockdale v. Hansard,
(1839) 9 Ad & E 1 : 112 ER 1112 (QB); Pepper(InspectorofTaxes) v. Hart, 1993 AC 593:
h (1992) 3 WLR 1032 : 1992 UKHL 3, referred to
557
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State of M.P. v. Dadabhoy's N ew Chirimiri Ponri Hill Colliery Co. (P) Ltd., (1972) 1 SCC
298; R. v. Secy. of State for the Home Department, exp Brind, (1991) 1 AC 696: (1991)
2 WLR 588: (1991) 1 All ER 720 (HL); Wilson v. First County Trust Ltd. (No. 2), (2004)
1 AC 816 : (2003) 3 WLR 568 : 2003 UKHL 40 (HL); R. v. F, 2007 QB 960 : (2007) 3 a
WLR 164 (CA), cited
In the circumstances, the reference is answered by holding that:
(i) As a matter of principle, there is no reason why reliance upon the report of a
Parliamentary Standing Committee cannot be placed in proceedings under Article
32 or Article 136 of the Constitution; (Para 276.1)
b
(ii) Once the report of a Parliamentary Committee has been published,
reference to it in the course of judicial proceedings will not constitute a breach of
parliamentary privilege; (Para 276.2)
(iii) The validity of the report of a Parliamentary Committee cannot be called
into question in the court. No Member of Parliament or person can be made
liable for what is stated in the course of the proceedings before a Parliamentary C
Committee or for a vote tendered or given; and (Para 276.3)
(iv) When a matter before the court assumes a contentious character, a finding
of fact by the court must be premised on the evidence adduced in the judicial
proceeding as explained in paras 265 and 274. (Para 276.4)
Per Bhushan, J. (concurring) d
Parliamentary privileges - Origin and meaning

The origin and evolution of parliamentary privilege is traceable from the
High Court of British Parliament. The term "parliamentary privilege" refers to
the immunity and powers possessed by each of the Houses of Parliament and by
the Members of Parliament, which allow them to carry out their parliamentary e
functions effectively. (Paras 312 to 314)
Erskine May, Parliamentary Practice, 24th Edn. Chapter XII, referred to
The privileges of the Indian Legislatures have also gradually developed along
with the progress in the constitutional development of the country. There is absolute
protection to a Member of Parliament against any proceeding in any court, in
respect of anything said or vote given by him in Parliament or any committee f
thereof. The words "in other respects" in Article 105(3) clearly refer to powers,
privileges and immunities which are not mentioned and referred to in Articles
105(1) and (2). Article 105(3) makes applicable the same powers, privileges and
immunities which are not mentioned and referred to in Articles 105(1) and (2).
Article 105(3) makes applicable the same powers, privileges and immunities for
Indian Parliament which were enjoyed by the House of Commons at the time of g
enforcement of the Constitution of India. (Paras 315 to 323)
P.V. Narasimha Rao v. State, (1998) 4 SCC 626: 1998 SCC (Cri) 1108, relied on
Halsbury 's Laws of England, 5th Edn. Vol. 78, referred to
Privileges of the House of Commons
The privileges of Indian Parliament are the privileges which were enjoyed by h
the British House of Commons. There is a complete immunity to the Members of
558
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Parliament from any proceeding for anything said in any committee of Parliament.
However, the issue in present case is whether, there is any breach of privileges of
a Parliament in accepting, referring and relying on a Parliamentary Committee report
by the Supreme Court. (Paras 324 to 330)
Homi D. Mistry v. Nafisul Hussan, 1956 SCC OnLine Born 175: ILR 1957 Born 218; M.S.M.
Sharma v. Sri Krishna Sinha, AIR 1959 SC 395; C. Subramaniam v. Speaker of the Madras
Legislative Assembly, 1968 SCC OnLine Mad 64: AIR 1969 Mad 10; HarendraNath Barua
v. Dev Kanta Barua, 1958 SCC OnLine Gau 16: AIR 1958 Assam 160, cited
b Halsbury 's Laws of England, 5th Edn., Vol. 78; Erskine May: Parliamentary Practice; M.N.
Kaul and S.L. Shakdher: Practice & Procedure of Parliament, 7th Edn., published by Lok
Sabha Secretariat, referred to
The Role of Parliamentary Committees Enormous duties and
responsibilities not limited to legislation alone Their functions relate to
welfare of people
C The business of Parliament is transacted in accordance with the rules of
procedure as framed under Article 118 of the Constitution of India. Over the
years, the functions of Parliament have no longer remained restricted merely
to legislating. Various Committees of both Rajya Sabha and Lok Sabha are
entrusted with enormous duties and responsibilities in reference to the functions
of Parliament. (Para 334)
d F.W. M aitland: Constitutional History of England; Dr Subhash C. Kashyap: Parliamentary
Procedure, 2nd Edn., referred to
Apart from the supervision, the Committees also make recommendations
and issue directions. They play an important role in functioning of the entire
Government which is directly related to the welfare of the people of the
country. (Para 340)
e
Publication of parliamentary reports - People have a right to know - No
exception can be taken in the petitioners obtaining 72nd and 81st Reports of
Parliamentary Standing Committee
Publication of proceedings of Parliament serves public purpose. By
Constitution (Forty-fourth Amendment) Act, 1978, Article 361-A was inserted
in the Constitution providing for "protection of publication of proceedings by
f
Parliament and State Legislatures". Apart from publication of the proceedings
of Parliament, including tl1e reports of the Committees, now, they are also
permitted to be broadcast on electronic media. Such publication is encouraged
by Parliament. The general public is keenly interested in knowing about the
parliamentary proceedings including parliamentary reports which are steps towards
the governance of the country. (Paras 341 to 346)
g
Wason v. Walter, (1868) LR 4 QB 73, referred to
The right to know about the reports only arises when they have been
published for use of the public in general and not when they are being prepared
and not yet submitted to the Speaker. Thus, no exception can be taken in
the petitioners obtaining 72nd and 81st Reports of Parliamentary Standing
h Committee. (Para 347)
559
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Rules and Procedures of Parliament are permitted to be given in evidence in
court- These are public documents and judicial notice can be taken of them
From time to time, the papers and proceedings of Parliament have been a
permitted to be given in evidence in courts of law by Parliament. Though after
the enforcement of the Right to Information Act, 2005, on the basis of a report
submitted by the Committee of Privileges, the procedure for making available
documents relating to the proceedings of the House has been modified. Documents
relating to the proceedings of the House or any Committee of the House which
are public documents should be taken judicial notice of and requests for certified b
copies thereof may not be ordinarily made unless there are sufficient reasons for
making such requests. (Paras 348 to 351)
M.N. Kaul and S.L. Shakdher: Practice & Procedure of Parliam ent, 7th Edn., published by
Lok Sa bha Secretariat, ref erred to
Section 57(4) of the Evidence Act makes it clear that the course of proceeding
of Parliament and the Legislature, established under any law are facts of which C
judicial notice shall be taken by the Court. The expression "course of proceeding
of Parliament" is an expression of wide import. Article 118(1) of the Constitution
makes it clear that the proceedings of Parliamentary Stan ding Committee including
its report are proceedings which are covered by the expression "course of
proceeding of Parliament". The effect of Section 57(4) is not diminished by
the amendments made in Section 57(4) by the Presidential Adaptation Order in
d
exercise of power under Article 372(2). (Paras 353 to 358)
According to Section 74 of the Evidence Act documents forming the acts,
or records of the acts of legislature of any part of India is a public document.
Parliament has already adopted the report of the privilege committee that for those
documents which are public documents within the meaning of the Evidence Act,
there is no requirement of any permission of Speaker of Lok Sabha for producing
e
such documents as evidence in court. However, mere fact that a document is
admissible in evidence whether a public or private document does not lead to draw
any presumption that the contents of the documents also are true and correct and
constitute evidence as defined under Section 3 of the Evidence Act. The question as
to what weight the Court should give to the findings of a Parliamentary Committee
Report will ultimately depend on the totality of circumstances brought b efore the
f
Court. (Paras 360 to 364)
Standard Chartered Bank v. A .B.F.S.L., 2001 SCC OnLine Born 588, approved
Gerald Lord Strickland v. Cannelo Mifsud Bonnici, 1934 SCC OnLine PC 51 : AIR 1935 PC
34: 153 IC 1, referred to
Nature and extent ofparliamentary privileges regarding reports of Committees
of British Parliament
g
In the Constituent Assembly Debates on draft Article 85 (now Article 105 of
the Constitution of India) and draft Article 169 (now Article 194 of the Constitution
of India), various amendments suggested were not adopted. Thus, the privileges
which our Parliament and State Legislatures enjoy are privileges enjoyed by the
House of Commons of the United Kingdom at the time of commencement of the
Constitution. (Paras 365 and 366)
h
Constituent Assembly Debates on 3-6-1949, (CAD Vol. 8, p. 583); Erskine May:
Parliamentary Practice, 24th Edn., referred to
560
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Participation of Members of Parliament is also by various other recognised
forms such as voting, giving notice of a motion, presenting a petition or submitting
a a report of a committee, the modern forms of expression by which the wish and
will of Parliamentarians is expressed. (Paras 369 to 375)
Bradlaugh v. Gossett, (1884) LR 12 QBD 271 : 53 LJQB 290 : 50 LT 620 (DC); Stockdale
v. Hansard, (1839) 9 Ad & E 1 : 112 ER 1112 (QB); Dingle v. Associated N ewspapers
Ltd., (1960) 2 QB 405: (1960) 2 WLR 430; Church of S cientology of California v. Johnson
Smith, (1972) 1 QB 522: (1971) 3 WLR 434; Richard William Prebble v. Television New
Zealand Ltd., (1995) 1 AC 321 : (1994) 3 WLR 970 : (1994) 3 All ER 407 (PC); Burdett
b v. Abbot, (1811) 14 East 1 : 104 ER 501, referred to
Court can independently decide lis on basis of evidence - Observation in
Parliamentary Committee Report can be relied on but cannot be held to binding
between parties
Use of parliamentary materials including Standing Committee report in courts,
does not violate the parliamentary privilege as enshrined in Article 9 of the
C (English) Bill of Rights (1688). All references to parliamentary proceedings
and materials do not amount to breach of privilege to invite contempt of
Parliament. However, no party can be allowed to "question" or "impeach" report
of Parliamentary Committee. The court has the right to decide the "lis" on the
basis of the material and evidence brought by the parties. Any observation in the
report or inference of the Committee cannot be held to be binding between the
d parties or prohibit either of the parties to lead evidence to prove their stand in
court of law. Unfair disadvantage stands removed in the above manner. The rules of
Parliament, procedure permit the production of parliamentary materials in a court
oflaw as evidence. The parliamentary materials which are public documents can be
submitted before the Court without taking any permission from Parliament. Thus,
no exception can be taken in producing reports of Parliament Committee before a
e court of law. The Evidence Act, 1872, which regulates the admission of evidence
in court of law, also refers to proceedings in Parliament as a public document
of which the Court shall take judicial notice. Therefore, there is no violation of
any parliamentary privilege in accepting reports of Parliamentary Committee in
court. (Paras 376 to 397)
Pepper (Inspector of Taxes) v. Hart, 1993 AC 593 : (1992) 3 WLR 1032 : 1992 UKHL 3;
Richard William Prebble v. Television N ew Zealand Ltd., (1995) 1 AC 321 : (1994) 3 WLR
f 970: (1994) 3 All ER 407 (PC); R. v. Murphy, (1986) 64 ALR 498: (1986) 5 NSWLR 18;
R. v. Secy. of State for the Home Department, exp Brind, (1991) 1 AC 696: (1991) 2 WLR
588 : (1991) 1 All ER 720 (HL); Wilson v. First County Trust Ltd. (No. 2), (2004) 1 AC
816: (2003) 3 WLR 568: 2003 UKHL 40 (HL); R. v. F., 2007 QB 960: (2007) 3 WLR 164
(CA); Office of Govt. Commerce v. Inf01mation Comm;:, 2010 QB 98: (2009) 3 WLR 627;
Catering Cleaners of Southe rn Railway v. Union of India, (1987) 1 sec 700 : 1987 sec
(L&S) 77; State of Maharashtra v. Milind, (2001) 1 SCC 4: 2001 SCC (L&S) 117; Aruna
g Roy v. Union of India, (2002) 7 SCC 368 : 5 SCEC 310; M.C. Mehta v. Union of India,
(2017) 7 SCC 243; Lal Babu Priyadarshi v. Amritpal Singh, (2015) 16 SCC 795: (2016) 3
SCC (Civ) 649; Gujarat Electricity Board v. Hind Mazdoor Sabha, (1995) 5 SCC 27: 1995
SCC (L&S) 1166; Modem Dental College & Research Centre v. State of M .P., (2016) 7
SCC 353: 7 SCEC 1; KrishanLal Gera v. State ofHaryana, (2011) 10 SCC 529; Federation
of Tour Operators v. HM Treasury, 2007 EWHC 2062 (Admin): 2008 STC 547; R. v. Secy.
of State for Trade, exp Anderson Strathclyde Plc., (1983) 2 All ER 233 (DC), referred to
h R. v. Secy. of State for Home Department, 2002 QB 129 : (2001) 3 WLR 323 : 2001 EWCA
Civ 789 , cited
561
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Exclusionary rules how far applicable in the Indian context
It is not disputed that parliamentary reports and materials can be used for
the purposes of taking into consideration legislative history for interpretation of a
statute as well as for considering the statement made by a Minister. When there
is no breach of privilege in considering the parliamentary materials and reports of
the Committee by the Court for the above two purposes, there is no reason why
courts should be debarred from accepting the parliamentary materials and reports
as evidence before it, provided the parties are not permitted to question or impeach
the reports. (Paras 399 to 412) b
Standard Chartered Bank v. A.B.F.S.L., 2001 SCC OnLine Born 588; SB! v. National Housing
Bank, (2013) 16 SCC 538 : (2014) 5 SCC (Civ) 523; Common Cause v. Union of India,
(2017) 7 SCC 158, distinguished
Jyoti Harshad Mehta v. Custodian, (2009) 10 SCC 564 : (2010) 2 SCC (Cri) 1494; State of
Mysore v. R. V. Bidap, (1974) 3 SCC 337 : 1973 SCC (L&S) 538, referred to
Black-Clawson International Ltd. v. Papienverke Waldhof-Aschaffenburg A.G., 1975 AC 591 :
(1975) 2 WLR 513 (HL); R. v. Olugboja, 1982 QB 320 : (1981) 3 WLR 585 (CA); R. c
v. Bloxham, (1983) 1 AC 109 : (1982) 2 WLR 392 (HL); Ram Krishna Dalmia v. S.R.
Tendolkar, AIR 1958 SC 538; Madhava Singh v. Secy. of State for India in Council, 1904
SCC OnLine PC 18: (1903-04) 31 IA 239;M. V. Rajwade v. S.M. Hassan, 1953 SCC OnLine
MP 90: AIR 1954 Nag 71 : 1954 Cri LJ 366; State of Karnataka v. Union of India, (1977)
4 SCC 608; Sham Kant v. State of Maharashtra, 1992 Supp (2) SCC 521 : 1992 SCC (Cri)
765; TT Antony v. State of Kerala, (2001) 6 SCC 181 : 2001 SCC (Cri) 1048, c ited
Separation of powers and maintaining a delicate balance between the d
Legislature, Executive and Judiciary
The essential characteristic of a Federation is distribution of limited
Executive, Legislative and Judicial authority and the supremacy of the
Ram Jawaya Kapur v. State of Punjab, (1955) 2 SCR 225 : AIR 1955 SC 549, relied on
The Constitution does not envisage supremacy of any of the three organs e
of the State. But, functioning of all the three organs is controlled by the
Constitution. Wherever, interaction and deliberations among the three organs have
been envisaged, a delicate balance and mutual respect are contemplated. All the
three organs have to strive to achieve the constitutional goal set out for "We the
People". Mutual harmony and respect have to be maintained by all the three organs
to serve the Constitution under which we all live. (Para 414) f
Kesavananda Bharati v. State ofKerala , ( 1973) 4 SCC 225; Powers, Privileges and Immunities
of State Legislatures, In re, Special Reference No. 1 of 1964, AIR 1965 SC 745 : (1965)
1 SCR 413, relied on
There is no parliamentary privilege that Parliamentary Committee reports
or other parliamentary materials cannot be given in evidence in any court of
law. By accepting Parliamentary Report as an evidence, there is no breach of g
any parliamentary privilege. There is a vital difference between parliamentary
sovereignty in England and constitutional supremacy in this country. Any law made
by Parliament, which violates the fundamental rights guaranteed under Part III of
the Constitution, can be set aside by the Supreme Court in exercise of jurisdiction of
judicial review which has been granted by the Constitution to the Supreme Court.
Parliamentary sovereignty, as enjoyed by the United Kingdom is not a parallel h
example in reference to functioning of different organs in this country, as controlled
562
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by the Constitution of India. The parliamentary privilege, as guaranteed under
Article 9 of the Bill of Rights, 1688 that no proceeding of Parliament can be
a questioned and impeached thus has to be applied, subject to express constitutional
provisions as contained in the Constitution of India. (Para 415)
Although, there is no rigid separation of powers under the Constitution of
India, but functions of all the three wings have been sufficiently differentiated
and each has freedom to carry out its functions unhindered by any other wing
of the State. However, in functioning of all the three organs, a delicate balance,
b mutual harmony and respect have to be maintained for true working of the
Article 121 and Article 122 of the Constitution of India
Although, heading of Article 122 reads "Courts not to enquire into proceedings
of Parliament" but substantive provision of the Constitution, as contained in
Article 122(1) debars the court from questioning the validity of any parliamentary
C proceeding on the ground of any alleged irregularity or procedure. The embargo
on the court to question the proceeding is thus limited on the aforesaid ground
alone. There is no total prohibition from examining the validity of the proceeding if
the proceedings are clearly in breach of fundamental rights or other constitutional
provisions. (Para 418)
d 1964, AIR 1965 SC 745 : (1965) 1 SCR 413, relied on
The power of judicial review enjoyed by the Supreme Court in reference to
legislation and some parliamentary proceedings are recognised exceptions, when
the Supreme Court can enter into parliamentary domain. In all other respects,
parliamentary supremacy with regard to its proceedings, the procedure followed
has to be accepted. (Para 421)
e On the strength of Article 122, it cannot be contended that Parliamentary
S landing Committee reports can neither be admitted in evidence in court nor the
said reports can be utilised for any purpose. (Para 422)
Fair comments on reports of Parliamentary Committee, permissible and not
breach of privilege
Deeper public interest is served in making public, the conduct of a public
f
servant or any inquiry public. Fair comments on report of the Parliamentary
Committee are fully protected under the rights guaranteed under Article 19(1)(a).
However, the comments when turn into personal attack on the individual Member
of Parliament or the House or made in vulgar or abusive language tarnishing the
image of Member or the House, the said comments amount to contempt of the
House and breach of privilege. No party is precluded in making fair comments on
g the Parliamentary Committee report which comments remain within the bounds of
a fair comments and does not transgress the limits prescribed for fair comments
without breach of privilege. The Parliamentary Committee reports when published,
the Press is entitled to make fair comments. (Paras 423 to 438)
Pepper(InspectorofTaxes) v. Hart, 1993 AC 593: (1992) 3 WLR 1032: 1992 UKHL 3 (HL);
Adam v. Ward, 1917 AC 309 (HL); Powers, Privileges and Immunities of State Legislatures,
h In re, Sp ecial Ref erence No. 1 of 1964, AIR 1965 SC 745: (1965) 1 SCR 413; R. v. Murphy,
(1986) 64 ALR 498: (1986) 5 NSWLR 18, relied on
563
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Wason v. Walter, (1868) LR 4 QB 73; Burdett v. Abbot, (1811) 14 East 1 : 104 ER 501,
approved
Ramesh Thappar v. State of Madras, 1950 SCR 594 : AIR 1950 SC 124 : (1950) 51 Cri LJ
1514; Bennett Coleman & Co. v. Union of India, (1972) 2 SCC 788, referred to a
Andre Paul Terence Ambard v. Attorney General of Trinidad and Tobago, 1936 SCC OnLine
PC 15 : AIR 1936 PC 141, cited
Justice Albie Sachs, The Strange Alchemy of Life and Law (Oxford University Press 2009)
pp. 32-33, relied on
Erskine M ay: Parliamentary Practice (24h Edn.), referred to
Issues have to be adjudicated by court independently - Facts stated in b
Parliamentary Committee report cannot be treated as binding and conclusive
"Adjudication" is the power of Court to decide and pronounce a judgment and
carry it into effect between the persons and parties who bring a cause before it for a
decision. Both for civil and criminal cases people look forward to courts for justice.
To decide the controversy between its subject had always been treated as a part
of sovereign functions. Constitutional law developments emphasised separation
C
of powers of governmental functions for protecting rights and liberties of people.
The apprehension of the respondents that their case shall be prejudiced if the
Court accepts the Parliamentary Committee report in evidence, is misplaced. By
acceptance of a Parliamentary Committee report in evidence does not mean that
facts stated in the Report stand proved. When issues, facts come before a court of
law for adjudication, the court is to decide the issues on the basis of evidence and
materials brought before it and in which adjudication Parliamentary Committee d
report may only be one of the materials, what weight has to be given to one or
other evidence is the adjudicatory function of the court which may differ from case
to case. The Parliamentary Committee reports cannot be treated as conclusive or
binding of what has been concluded in the Report. When adjudication of any claim
fastening any civil or criminal liability on an individual is up in a court of law, it
is open for a party to rely on all evidence and materials which is in its power and
court has to decide the issues on consideration of the entire material brought before e
it. When the Parliamentary Committee report is not adjudication of any civil or
criminal liability of the private respondents, their fear that acceptance of report shall
prejudice their case is unfounded. By accepting Parliamentary Committee report
on the record in this case and considering the Report by the Supreme Court, the
respondents' right to dispel conclusions and findings in the Report is not taken away
and they are free to prove their case in accordance with law. (Paras 440 to 448) f
State of Karnataka v. Union of India, (1977) 4 SCC 608, relied on
I.R. Coelho v. State of T.N., (2007) 2 SCC 1; Powers, Privileges and Immunities of State
Legislatures, In re, Spec ial Reference No. I of 1964, AIR 1965 SC 745: (1965) 1 SCR 413;
Dingle v. Associated N ewspapers Ltd., (1960) 2 QB 405 : (1960) 2 WLR 430, referred to
Montesquieu, L'Esprit des Lois, 1748; James Madison The Federalist 47, 48 and 51, referred
to
g
Conclusions
(i) According to Article 105(2) of the Constitution no Member of Parliament
can be held liable for anything said by him in Parliament or in any committee. The
reports submitted by Members of Parliament are also fully covered by protection
extended under Article 105(2) of the Constitution. (Para 449.1)
(ii) The publication of the reports not being only permitted, but also are h
being encouraged by Parliament. The general public is keenly interested in
564
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knowing about the parliamentary proceedings including parliamentary reports
which are steps towards the governance of the country. The right to know about
a the reports only arises when they have been published for use of the public in
general. (Para 449.2)
(iii) Section 57(4) of the Evidence Act, 1872 makes it clear that the course of
proceedings of Parliament and the Legislature, established under any law are facts
of which judicial notice shall be taken by the Court. (Para 449.3)
(iv) Parliament has already adopted a report of "privilege committee", that for
b those documents which are public documents within the meaning of the Evidence
Act, there is no requirement of any permission of the Speaker of Lok Sabha for
producing such documents as evidence in court. (Para 449.4)
(v) That mere fact that document is admissible in evidence whether a public or
private document does not lead to draw any presumption that the contents of the
documents are also true and correct. (Para 449.5)
C (vi) When a party relies on any fact stated in the Parliamentary Committee
report as the matter of noticing an event or history no exception can be taken on
such reliance of the report. However, no party can be allowed to "question" or
"impeach" report of Parliamentary Committee. The parliamentary privilege, that it
shall not be impeached or questioned outside Parliament shall equally apply both
to a party who files claim in the court and other who objects to it. Any observation
in the report or inference of the Committee cannot be held to be binding between
d
the parties. The parties are at liberty to lead evidence independently to prove their
stand in a court of law. (Para 449.6)
(vii) Both the parties have not disputed that parliamentary reports can be used
for the purposes of legislative history of a statute as well as for considering the
statement made by a minister. When there is no breach of privilege in considering
the parliamentary materials and reports of the Committee by the Court for the
e
above two purposes, there is no valid reason for not accepting the submission of the
petitioner that courts are not debarred from accepting the parliamentary materials
and reports, on record, before it, provided tl1e court does not proceed to permit the
parties to question and impeach the reports. (Para 449.7)
(viii) The Constitution does not envisage supremacy of any of the tluee
organs of the State. But, functioning of all the three organs is controlled by the
f Constitution. Wherever, interaction and deliberations among the three organs have
been envisaged, a delicate balance and mutual respect are contemplated. All the
three organs have to strive to achieve the constitutional goal set out for "We the
People". Mutual harmony and respect have to be maintained by all the three organs
to serve the Constitution under which we all live. (Para 449.8)
(ix) Fair comments on report of the Parliamentary Committee are fully
g protected under the rights guaranteed under Article 19(l)(a). However, the
comments when turn into personal attack on the individual Member of Parliament
or the House or made in vulgar or abusive language tarnishing the image of the
Member or the House, the said comments amount to contempt of the House and
breach of privilege. (Para 449.9)
(x) The function of adjudicating rights of the parties has been entrusted to
h the constituted courts as per constitutional scheme, which adjudication has to
be made after observing the procedural safeguards which include the right to be
565
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heard and the right to produce evidence. Parliament, however, is not vested with
any adjudicatory jurisdiction which belongs to judicature under the constitutional
scheme. (Para 449 .10) a
(xi) Admissibility of a Parliamentary Committee report in evidence does not
mean that facts stated in the Report stand proved. When issues of facts come before
a court of law for adjudication, the court is to decide the issues on the basis of
evidence and materials brought before it. (Para 449 .11)
The questions having been answered as above, the writ petitions to be listed
before the appropriate Bench for hearing. (Para 450) b
SS-D/60470/C
Chronological list of cases cited on page(s)
1. (2018) 7 SCC 192, Shakti Vahini v. Union of India 85e-f
2. (2018) 5 SCC 1, Common Cause v. Union of India 85e-f
3. (2017) 10 sec 1, K.S. Puttaswamy V. Union of India 51a-b
4. (2017) 7 SCC 295, Kalpana Mehta v. Union of India 37a, 87c, 87c-d, 137/-g
5. (2017) 7 SCC 295 : (2017) 7 SCC 307, Kalpana Mehta v. Union of C
India 37d-e, 38b, 63c, 63c-d,
63e, 88c, 88e-f, 88g,
89a, 135g-h, 138a
6. (2017) 7 SCC 295 : (2017) 7 SCC 306, Kalpana Mehta v. Union of
India 137/-g, 137g, 138a
7. (2017) 7 SCC 295 : (2017) 7 SCC 305, Kalpana Mehta v. Union of India 137/-g
8. (2017) 7 SCC 295 : (2017) 7 SCC 302, Kalpana Mehta v. Union of India 137/-g d
9. (2017) 7 sec 243, M.C. Mehta V. Union of India 83e-f, 173d-e
10. (2017) 7 SCC 158, Common Cause v. Union of India 124/-g, 178g, 179a
11. (2017) 7 sec 59, Binoy Viswam V. Union of India 43a
12. (2016) 7 SCC 353 : 7 SCEC 1, Modem Dental College & Research
Centre v. State of M.P. 84a-b, 173e
13. (2016) 5 SCC 1, Supreme Court Advocates-on-Record Assn. v. Union
of India 123b-c, 124c e
14. (2015) 16 SCC 795 : (2016) 3 SCC (Civ) 649, Lal Babu Priyadarshi
v. Amritpal Singh 83/-g, 173e
15. (2015) 2 sec 796: (2015) 1 sec (L&S) 589, Census Comm;: V. R.
Krishnamurthy 48b, 48b-c
16. (2014) 12 sec 696, State of T.N. V. State of Kerala 44f-g, 122e-f
17. (2014) 9 SCC 1, Mano} Narula v. Union of India 53b,53d
18. 2014 EWHC 3815 (Admin), R. (Wheeler) v. Office of the Prime Minister 106c-d f
19. (2013) 16 sec 538 : (2014) 5 sec (Civ) 523, SB! V. National
Housing Bank 177!, 178c
20. (2013) 6 sec 1 : (2013) 3 sec (Civ) 227, Novartis AG V. Union of India 78a
21. (2013) 1 sec 745 : (2013) 1 sec (Civ) 786: (2013) 1 sec (Cri)
737 : (2013) 1 SCC (L&S) 244, Namit Sharma v. Union of India 128c-d
22. (2011) 10 SCC 529, Krishan Lal Cera v. State of Haryana 84a-b, 173e
23. (2011) 7 sec 639 : (2011) 3 sec (Civ) 875, State of M .P. V.
Narmada Bachao Andolan 48b-c g
24. (2011) 4 SCC 36, GVK Industries Ltd. v. CIT 49f-g, 50b-c
25. (2010) 6 SCC 113 : (2010) 2 SCC (Cri) 1343, Amarinder Singh v.
Punjab Vidhan Sabha 114d
26. (2010) 5 SCC 538, Bhim Singh v. Union of India 45a, 123g
27. (2010) 3 sec 571 : (2010) 2 sec (Cri) 401, State of W.B. V.
Committee for Protection of Democratic Rights 124e-f
28. 2010 QB 98: (2009) 3 WLR 627, Office of Govt. Commerce v. h
Information Commr. 105a, 169a, 171!, 172c-d
566
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29. (2009) 16 SCC 659, Tata Power Co. Ltd. v. Reliance Energy Ltd. 128c-d
30. (2009) 10 SCC 564 : (2010) 2 SCC (Cri) 1494, Jyoti Harshad Mehta
v. Custodian 130c-d, 176f-g, 176g, 177a, 177c, 177d
a 31. 2009 QB 114: (2008) 3 WLR 1059: 2007 EWHC 242
(Admin), R. (Bradley) v. Secy. ofStatefor Work and
Pensions 104a, 104a-b, 170c
32. (2008) 6 SCC 1 : 3 SCEC 35, Ashoka Kumar Thakur v. Union of India 78a
33. (2008) 1 SCC 683 : (2008) 1 SCC (L&S) 289, Aravali Golf Club v.
Chander Hass 45c-d
34. (2007) 8 SCC 279 : (2007) 2 SCC (L&S) 897, S.C. Chandra v. State
b of Jharkhand 47f
35. (2007) 6 sec 586, State of U.P. V. feet S. Bisht 123b-c
36. (2007) 3 SCC 184, Raja Ram Pal v. Lok Sabha 70g, 73c-d,
73d, 74d, 112d-e,
113b-c, 113e, 114a-b, 114d
37. (2007) 2 sec 1, /.R. Coelho V. State of T.N. 41c-d, 41d, 46a, 46a-b,
5 lg, 52a-b, 52c-d,
C 53a, 122c-d, 187g
38. (2007) 1 WLR 2825 : 2007 UKPC 48 (PC), Toussaint v. Attorney
General of Saint Vincent and the Grenadines 102g, 103b,
103f, 167d-e, 168d, 170a, 170b
39. 2007 EWHC 2062 (Admin): 2008 STC 547, Federation of Tour
Operators v. HM Treasury 169/, 172d
40. 2007 QB 960 : (2007) 3 WLR 164 (CA), R. v. F. 104c-d
d 41. (2006) 8 SCC 212: (2007) 1 SCC (L&S) 1013,M. Nagarajv. Union
of India 52d-e
42. (2006) 8 SCC 1 : (2006) 3 SCC (Cri) 417, Prakash Singh v. Union of India 85e-f
43. (2006) 7 SCC 1, Kuldip Nayar v. Union of India 54a, 79f-g
44. (2005) 13 SCC 287, Suresh Seth v. Indore Municipal Corpn. 47f-g
45. (2005) 1 AC 115 : (2004) 3 WLR 1163 : 2004 UKPC 36, Buchanan
v. Jennings 107f-g, 108e
46. (2004) 6 SCC 584, State of Maharashtra v. Raghunath Gajanan Waingankar 45b-c
e 47. (2004) 2 SCC 510, Union of India v. Naveen Jindal 50f
48. (2004) 1 SCC 712, Dharam Dutt v. Union of India 79e
49. (2004) 1 AC 816: (2003) 3 WLR 568: 2003 UKHL 40 (HL) , Wilson
v. First County Trust Ltd. (No. 2) 104c, 104d,
106f-g, 167a, 167b
50. (2003) 4 SCC 289, Federation of Railway Officers Assn. v. Union of
India 45b-c, 83 c, 173c-d
f 51. (2002) 7 SCC 368: 5 SCEC 310, Aruna Roy v. Union of India 83d, 173d
52. (2002) 3 NZLR 145 (CA), Buchanan v. Jennings 107f-g
53. 2002 QB 129 : (2001) 3 WLR 323 : 2001 EWCA Civ 789, R. v. Secy.
of State for Home Depanment 169d
54. (2001) 7 sec 231, B.R. Kapur V. State of T.N. 52f-g
55. (2001) 6 sec 181 : 2001 sec (Cri) 1048, T.T. Antony V. State of Kerala 178a
56. (2001) 1 SCC 4 : 2001 SCC (L&S) 117, State of Maharashtra v.
g Milind 83b, 173c-d
57. 2001 SCC OnLine Born 588, Standard Chanered Bank v.
A.B.F.S.L. 158/, 159b, 159g
58. (2001) 1 AC 395 : (2000) 2 WLR 609 (HL) , Hamilton v. Al
Fayed 71b, lOlf-g,
102d, 102/, 172b-c
59. (1999) 4 SCC 306, Surana Steels (P) Ltd. v. CIT 78a
h 60. (1998) 4 sec 626: 1998 sec (Cri) 1108, P.V. Narasimha Rao V.
State llla, 111/, 145c
567
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61. (1998) 4 SCC 117 : 1998 SCC (L&S) 1021, State of Punjab v. Ram
Lubhaya Bagga 48b-c
62. (1997) 8 SCC 522, S.S. Bola v. B.D. Sa rdana l 23b-c
63 . (1997) 7 sec 622 : 1997 sec (Cri) 1120: 1997 sec (L&S) 17 84, a
Mansukhlal Vithaldas Chauhan v. State of Gujarat 45b-c
64. (1997) 7 SCC 592, M.P. Oil Extractio n v. State of M.P. 48b-c
65 . (1997) 6 SCC 241 : 1997 SCC (Cri) 93 2, Vishaka v. State of Rajasthan 85e-f
66. (1996) 7 SCC 637, Indian Aluminium Co. v. State of Kerala l23b-c
67. (1996) 1 SCC 130, Ramesh Yeshwant Prabhoo v. Prabhakar
Kashinath Kunte 77g
68. 1996 SCC OnLine Can SC 80 : (1996) 2 SCR 876, Harvey v. b
Attorney General for New Brunswick 72a
69. (1995) 5 SCC 27: 1995 SCC (L&S) 1166, Gujarat Electricity Board
v. Hind Mazdoor Sabha 84a, l73c-d
70. (1995) 1 AC 321 : (1994) 3 W LR 970: (199 4) 3 All ER 407
(PC), Richard William P rebble v. Television New Zealand
Ltd. lO0b-c , lOla , lOlb, lOld,
103a, 104a, l04a-b, 11 lb-c, C
166a, l67f-g, 168b
71. (1994) 3 SCC 1, S.R. Bommai v. Union of India 49d-e, 50f-g
72. (199 4) 2 sec 691, P remium G ranites V. State of T.N. 48b
73 . (1993) 4 SCC 441 , S upreme Court Advocates-on-Record Assn. v.
Union of India 51c
74. 1993 SCC OnLine Can SC 8 : (1993) 1 SCR 319, New Brunswick
Broadcasting Co. v. Nova Scotia (Speaker of the House of Assembly) 71g d
75. 1993 AC 593 : (1992) 3 WLR 1032 : 1992 UKHL 3 (HL), Pepper
(Inspector of Taxes) v. Hart 78f-g, 99e-f, 100a, lO0e-f,
103c, l04b-c, 164b, l64e-f,
165c, l65f-g, 167a, l67a-b,
167d, 168e, 171d, 183c-d
76. 1992 Supp (2) SCC 521 : 1992 SCC (Cri) 765, Sha m Kant v. State of Maharashtra 178a
77. (1992) 177 CLR 106 (Aust), A ustralian Capital Television Pty. Ltd. v.
Commonwealth 53e-f e
78. 1992 (unreported), R. v. Currie lllb-c
79. (1991) 1 AC 696: (1991) 2 W LR 588: (1991) 1 All ER 720
(HL), R. v. Secy. of State fo r the Ho me Department, exp
Brind 104b-c, l65d-e, 165e,
l67d-e, 17le-f
80. (1989) 4 SCC 187: 1989 SCC (L&S) 569, Supreme Court
Employees ' Welfare Assn. v. Union of India 48a f
81. (1989) 2 SCC 754, Union of India v. Raghubir Singh 46e-f
82. 1989 Supp (2) SCC 364, Asif Hameed v. State of J&K 45d-e
83. 1988 Supp SCC 401, Baburao v. Union of India 132a
84. (1987) 1 SCC 700: 1987 SCC (L&S) 77, Catering Cleaners of
Southern Railway v. Union of India 82h, 173c
85. (1986) 64 ALR 498: (1986) 5 N SW LR 18, R. v.
Murphy lOla , lOld-e, 166e, 185a g
86. (1985) 3 SCC 169, State of H.P. v. Parent of a Student of Medical College 44d-e
87. (1984) 2 SCC 244, Lakshmi Kant Pandey v. Union of India 85 e-f
88 . (1984) 2 SCC 183 : 1984 SCC (Cri) 172, R.S. Nayak v. A .R.
A ntulay 76f-g, 175a, 175d
89 . (1983) 2 All ER 233 (DC), R. v. Secy. of State for Trade, exp
Anderson Strathclyde P fc. l 70f-g, l 7ld-e, l 7le-f
90. (1983) 1 AC 109 : (1982) 2 WLR 392 (HL), R. v. Bloxham l 76a-b h
91. 1982 QB 320 : (1981) 3 WLR 585 (CA), R. v. Olugboja 176a-b
568
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92. (1981) 4 SCC 173 : 1981 SCC (Tax) 293, K.P. Varghese v. CIT 77d-e, 78a
93. 1981 SCC OnLine Can SC 19 : (1981) 1 SCR 469 : (1981) 121 DLR
(3d) 41, R. v. Vasil 79a-b
a 94. (1980) 3 SCC 625, Minerva Mills Ltd. v. Union of India 53a-b
95. (1980) 2 SCC 31 : 1980 SCC (Tax) 170, CIT v. Surat An Silk Cloth
Manufacturers' Assn. 78c-d
96. (1978) 1 SCC 248, Maneka Gandhi v. Union of India 52a, 52b-c, 52c-d
97. (1977) 4 SCC 608, State of Karnataka v. Union of India 178a, 189a
98. (1977) 4 sec 193 : 1977 sec (L&S) 435, Union of India V.
Sankalchand Himatlal Sheth 54c
b 99. (1977) 3 SCC 592, State of Rajasthan v. Union of India 41a
100. (1977) 2 SCC 611 : 1977 SCC (Cri) 388, Onkar Nath v. State (UT of Delhi) l3lc-d
101. (1976) 4 SCC 750 : 1977 SCC (L&S) 36, IN. Saksena v. State of M.P. l23b-c
102. (1976) 3 SCC 108, Union of India v. Steel Stock Holders' Syndicate 78a
103. (1976) 1 SCC 254: 1976 SCC (Tax) 14, Lok Shikshana Trust v.
CIT 81c-d, 130g
104. 1976 SCC OnLine Can SC 69 : (1976) 2 SCR 373 : (1976) 68 DLR
C (3d) 452, Anti-Inflation Act, In re 79e
105. (1975) 3 SCC 198 : 1974 SCC (Cri) 816, Haradhan Saha v. State of W.B. 52a
106. (1975) 2 SCC 81 : 1975 SCC (Cri) 435, Khudiram Das v. State of W.B. 52a
107. 1975 Supp SCC 1, Indira Nehru Gandhi v. Raj Narain 43e, 46a, 122b
108. 1975 AC 591 : (1975) 2 WLR 513 (HL), Black-Clawson
International Ltd. v. Papierwerke Waldhof-Aschaffenburg A.G. l75d-e
109. (1974) 3 SCC 337: 1973 SCC (L&S) 538, State of Mysore v. R. V.
d Bidap l 74d-e, 175c-d
110. 1974 AC 765 : (1974) 2 WLR 208 (HL), British Railways Board v. Pickin lO0e
111. (1973) 4 sec 225, Kesavananda Bharati V. State of
Kerala 40f-g, 44d, 46a,
53a-b, l2ld, 128c-d, 179f
112. (1973) 1 SCC 856: 1973 SCC (Cri) 618, Sambhu Nath Sarkar v.
State of W.B. 52a
113. (1972) 3 SCC 717, G. Narayanaswami v. G. Pannerselvam 54a
e 114. (1972) 2 SCC 788, Bennett Coleman & Co. v. Union of India 182d
115. (1972) 1 SCC 298, State of M.P. v. Dadabhoy 's New Chirimiri Ponri
Hill Colliery Co. (P) Ltd. 78a
116. (1972) 1 QB 522: (1971) 3 WLR 434, Church of Scientology of
California v. Johnson Smith 99b, 99c, 99d, 163c, l63c-d
117. (1970) 1 SCC 248, Rustom Cavasjee Cooper v. Union of India 5lg
118. (1969) 2 SCC 283, Shri Prithvi Cotton Mills Ltd. v. Broach Borough Municipality
f l23b-c
119. 1968 SCC OnLine Mad 64: AIR 1969 Mad 10, C. Subramaniam v.
Speaker of the Madras Legislative Assembly 148d-e
120. 1966 SCC OnLine US SC 112 : 16 L Ed 2d 694 : 384 US 436 (1966),
Miranda v. Arizona 85b-c
121. AIR 1965 SC 745 : (1965) 1 SCR 413, Powe rs, Privileges and
Immunities of State Legislatures, In re, Special Reference
g No. 1 of 1964 46b-c, 68b, 68e-f, 69a, 69e,
70a, 70b-c, 70e, 70g, 73c-d,
73e, 73!, 74a-b, ll0a, 121c,
145!, l46f-g, 180a, 181b-c, 181g,
185f-g, 185g, 186b, 188f
122. AIR 1963 SC 1241, State of W.B. v. Union of India 77b-c
123. (1962) 3 SCR 842: AIR 1962 SC 305, Sakal Papers (P) Ltd. v.
h Union of India 52a
569
-----------------------------------------------------------------------------------------------------------------------------------------------------------

124. (1960) 2 QB 405 : (1960) 2 WLR 430, Dingle v. Associated
Newspapers Ltd. 99a, l62c-d, 162e,
163c-d, 163d, 189d
125. AIR 1959 SC 395 , M .S.M. Shanna v. Sri Krishna Sinha 148d-e, 148/, a
183e, 183e, 184a
126. 1959 Supp (2) SCR 8 : AIR 1959 SC 648, Deep Chand v. State of
U.P. 42c , 42f
127. 1958 SCC OnLine Gau 16: AIR 1958 Assam 160, Harendra Nath
Barua v. De v Kanta Barua 148e
128. AIR 1958 SC 538, Ram Krishna Dalmia v. S.R. Tendolkar 177g, 178a
129. AIR 1958 SC 4 19, K.S. S rinivasan v. Union of India 49b b
130. 1956 SCC O nLine Born 175 : IL R 1957 Born 218, Homi D. Mistry v.
Nafisul Hussan l48d-e
131. 1956 SCC OnLine US SC 102: 1 L Ed 2d 189 : 352 US 128 (1956),
Massachusetts Bonding & Insurance Co v. United States 54c-d
132. (1955) 2 SCR 225 : AIR 1955 SC 549, Ram Jawaya Kapur v. State
of Punjab 44a, l 2la- b, l 79d
133. AIR 1954 SC 447, Virendra Singh v. State of U.P. 48f C
134. 1954 SCR 1 : AIR 1953 SC 375, K.C. Gajapati Narayan Deo v. State
of Orissa 42b, 42f-g
135. 1953 SCC OnLine MP 90 : AIR 195 4 Nag 71 : 195 4 Cri LJ 366,
M . V. Rajwade v. S.M . Hassan 178a
136. 1952 SCR 284 : AIR 1952 SC 75: 1952 Cri LJ 510, State ofW.B. v.
Anwar Ali Sarkar 41g
137. 1950 SCR 594: AIR 1950 SC 124: (1950) 51 Cri LJ 1514, Ramesh d
Thappa r v. State of Madras 182c
138. AIR 1950 SC 27 : (1950) 5 1 Cri LJ 1383 : 1950 SCR 88, A .K.
Gopalan v. State of Madras (held , overruled) 5lf-g, 52a
139. (1947) 74 CLR 31 (Aust), M elbourne Corpn. v. Commonwealth 53e
140. 1939 AD 537, Jajbhay v. Cassim 85a
14 1. 1936 SCC OnLine PC 15 : AIR 1936 PC 141, And re Paul Terence
Ambard v. Attorney General of Trinidad and Tobago 186c
142. 1934 SCC OnLine PC 51 : AIR 1935 PC 34: 153 IC 1, Gerald Lord e
Strickland v. Carmelo Mifsud Bonnici 131c, l58d-e
143. 1917 AC 309 (HL) , Adam v. Ward 184e
144. 1912 AC 571 (PC), Attorney General fo r Onta rio v. Attorney General
for Canada 42f
145. 1910 SCC OnLine Cal 224: ILR (1910) 37 Cal 760: 14 CWN 945 :
6 IC 81, "The Englishman" Ltd. v. Lajpat Rai 131c
146. 1904 SCC OnLine PC 18 : (1903-04) 31 IA 239, Madhava Singh v. f
Secy. of State fo r India in Council 177g-h
147. (1884) LR 12 QBD 27 1 : 53 LJQB 290: 50 LT 620 (DC) , Bradlaugh
v. Gossett 72b, 72f-g, 98f-g, 99d,
lO0e, lllb-c, 113b-c, 162a,
162e, 162f-g
14 8. 1878 SCC OnLine PC 17 : (1877-78) 5 IA 178, R. v. Burah 42e
149 . (1868) LR 4 QB 7 3, Wason v. Walter 15lf-g, 151g, 152d, 182e-f, g
182e-:f
150. (1840) 11 Ad & E 273: (1840) 113 ER 419, Sheriff of Middlesex 72f-g
151. (1839) 9 Ad & E 1 : 112 ER 1112 (QB) , Stockdale v. Hansard 72!, lO0e,
161/, 162b-c
152. (1831) 2 Russ & M 639 : 39 ER 538 : 1831 Eng R 809, Wellesley v.
Duke of Beaufort 71c
153. (1811) 14 E as t 1 : 104 ER 501, Burdett v. Abbot lO0e, 162b, 185f-g h
154. (1703) 2 Ld Ra yrn 938 : 92 ER 126, Ashby v. White 72f
570
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KALPANA MEHTA v. UNION OF INDIA ( Dipak Misra, C.J.) 35

The Judgments* of the Court were delivered by
DIPAK MISRA, C.J. (for himself and Khanwilkar, J.; Sikri and
a Chandrachud, JI. and Bhushan, J., concurring)-
INDEX
iSl. No. : Heading Page No.

: A. :Introduction : 35 :
b !···· B. ·····! T~~ [ac~~~eb~~~:;~:ied ··························································l·········· ~~············1
!1. . ~•. . !1~:;;:fi~~:o;~~:E~~;~r:~'·········································J··········

F. Constitutional limitations upon the legislature 1
!~. . . .J1 41
C
!···· ~: ·····! ~::::n0ef ~~~~:i::~~:f.powers···········································i"·········· :~•···········1
i I. )Interpretation of the Constitution - The nature of duty 1 49 1
! !cast upon this Court ! !
: : I. l : Interpretation of fundamental rights : 51 :
; 1 I.2 hnterpretation of other constitutional provisions 1 52 1
l J. 1 A persp1ective on the role of Parliamentary Committees 1 55 1
d
l K. hnternational position of Parliamentary Committees 1 58 1
1 1 K.l :Parliamentary Committees in England 1 58 1
i ) K.2 !Parliamentary Committees in the United States of1 58 !
! ! \America ! !
: : K.3 : Parliamentary Committees in Canada : 59 :
; 1 K.4 !Parliamentary Committees in Australia 1 60 1
1 L. !Parliam~ntary Committees in India 1 60 1
e i i L.l !Rules of Procedure and Conduct of Business in 1 63 1
i i iLok Sabha i i
; M. i Parliam~ntary privilege i 66 i
i ) M.1 !Parliamentary privilege under the Indian 1 67 !
i i i Constitution i i
i i M.2 jJudicial review of parliamentary proceedings and i 71 j
f ! j lits privilege ! !
: N. :Reliance on parliamentary proceedings as external aids : 76 :
l O. 1Section 57(4) of the Evidence Act 1 80 1
i P. !The decisions in which Parliamentary Standing 1 82 1
! jCommittee report(s) have been referred to i i
t. .. Q......iconc1usions ............................................................................ L......... 86············i
g A. Introduction
1. In a parliamentary democracy where human rights are placed on a
high pedestal and a rights-oriented Constitution is sought to be interpreted, it
becomes the obligation on the part of the constitutional courts to strike a balance
between emphatic hermeneutics on progressive perception of the provisions
h
* Ed.: Dipak l\1isra, C.J. delivered the leading opinion of the Court for himself and Khanwilkar, J.
Sikri & Chandrachud, JJ. and Bhushan, J. delivered concurring opinions.
571
-----------------------------------------------------------------------------------------------------------------------------------------------------------

of the Constitution on the one hand and the self-imposed judicial restraint
founded on self-discipline on the other hand, regard being had to the nature and
character of the article that falls for interpretation and its constitutional vision a
and purpose.
2. The courts never allow a constitutional provision to be narrowly
construed keeping in view the principle that the Constitution is a living
document and organic which has the innate potentiality to take many a concept
within its fold. The courts, being alive to their constitutional sensibility,
do possess a progressive outlook having a telescopic view of the growing b
jurisprudence. Nonetheless, occasions do arise where the constitutional
consciousness is invoked to remind the Court that it should not be totally
oblivious of the idea, being the final arbiter of the Constitution, to strike
the requisite balance whenever there is a necessity, for the Founding Fathers
had wisely conceived the same in various articles of the grand fundamental
document.
C
3. In the present case, this delicate balance is the cardinal issue, as it seems
to us, and it needs to be resolved in the backdrop of both the principles. The
factual score that has given rise to the present reference to be dealt with by
us is centred on the issue as to whether a Parliamentary Standing Committee
(PSC) report can be placed reliance upon for adjudication of a fact in issue and
also for what other purposes it can be taken aid of. That apart, to arrive at the
ultimate conclusion, we will be required to navigate and steer through certain d
foundational fundamentals which take within its ambit the supremacy of the
Constitution, constitutional limitations, separation of powers, power of judicial
review and self-imposed restraint, interpretation of constitutional provisions in
many a sphere, the duty of Parliamentary Committee in various democracies
and also certain statutory provisions of the Evidence Act, 1872 (for brevity "the
Evidence Act"). e
B. The factual background
4. The initial debate and deliberation before the two-Judge Bench that
was hearing the instant writ petitions had focussed around the justifiability
of the action taken by the Drugs Controller General of India and the Indian
Council of Medical Research (ICMR) pertaining to the approval of a vaccine,
namely, Human Papilloma Virus (HPV) manufactured by Respondent 7, f
M/s GlaxoSmithKline Asia Pvt. Ltd., and Respondent 8, MSD Pharmaceuticals
(P) Ltd., for preventing cervical cancer in women and the experimentation of
the vaccine was done as an immunisation by the Governments of Gujarat and
Andhra Pradesh (before bifurcation, the State of Andhra Pradesh, eventually the
State of Andhra Pradesh and the State of Telangana) with the charity provided
by Respondent 6, namely, PATH International. g
5. Apart from the aforesaid issue, the grievance with regard to the untimely
death of certain persons and the grant of compensation on the foundation
that there had been experiment of the drugs on young girls who had not
reached the age of majority without the consent of their parents/guardians
was also highlighted. Be it stated, it was also projected that women, though
being fully informed, had become victims of the said vaccination. In essence, h
the submissions were advanced pertaining to the hazards of the vaccination
572
-----------------------------------------------------------------------------------------------------------------------------------------------------------

and obtaining of consent without making the persons aware of the possible
after-effects and the consequences of the administration of such vaccine. The
a two-Judge Bench had passed certain orders 1 from time to time with which we
are not presently concerned.
6. In the course of hearing before the two-Judge Bench, the learned counsel
for the writ petitioners had invited the attention of the Bench to a report of
the Parliamentary Standing Committee (PSC) and the Court had directed the
Governments to file affidavits regarding the steps taken keeping in view the
b various instructions given from time to time including what has been stated in
the report of the PSC. Certain affidavits were filed by the respondents stating
about the safety of the vaccination and the steps taken to avoid any kind of
hazard or jeopardy. That apart, the allegations made in the writ petitions were
also controverted.
B.1 The Reference
C
7. When the matter stood thus, the learned Senior Counsel for
Respondent 8, MSD Pharmaceuticals (P) Ltd., and the learned Additional
Solicitor General appearing for the Union of India submitted that this Court,
while exercising the power of judicial review or its expansive jurisdiction under
Article 32 of the Constitution of India dealing with public interest litigation,
cannot advert to the report of the PSC and on that basis, exercise the power of
d
issue of a writ in the nature of mandamus and issue directions. The assistance
of the learned Attorney General was also sought keeping in view the gravity
of the issue involved.
8. After hearing the matter, the two-Judge Bench in Kalpana Mehta v.
Union of India 2 thought it appropriate to refer it to a Constitution Bench
e under Article 145(3) of the Constitution and in that regard, the Division Bench
expressed thus: (SCC pp. 321-22, paras 72 & 73)
"72. The controversy has to be seen from the perspective of judicial
review. The basic principle of judicial review is to ascertain the propriety
of the decision-making process on the parameters of reasonableness and
propriety of the executive decisions. We are not discussing about the
f parameters pertaining to the challenge of amendments to the Constitution
or the constitutionality of a statute. When a writ of mandamus is sought on
the foundation of a factual score, the Court is required to address the facts
asserted and the averments made and what has been stated in oppugnation.
Once the Court is asked to look at the report, the same can be challenged by
the other side, for it cannot be accepted without affording an opportunity
g of being heard to the respondents. The invitation to contest a Parliamentary
Standing Committee report is likely to disturb the delicate balance that the
Constitution provides between the constitutional institutions. If the Court
allows contest and adjudicates on the report, it may run counter to the spirit
of privilege of Parliament which the Constitution protects.
h
l Kalpana Mehta v. Union of India , (2017) 7 SCC 295
2 c2017) 7 sec 295 : (2017) 7 sec 307
573
-----------------------------------------------------------------------------------------------------------------------------------------------------------

73. As advised at present, we are prima facie of the view that
the Parliamentary S landing Committee report may not be tendered as a
document to augment the stance on the factual score that a particular a
activity is unacceptable or erroneous. However, regard being had to the
substantial question of law relating to interpretation of the Constitution
involved, we think it appropriate that the issue be referred to the
Constitution Bench under Article 145(3) of the Constitution."
9. Thereafter, the two-Judge Bench framed the following questions for the
purpose of reference to the Constitution Bench: (Kalpana Mehta case 2 , SCC b
p. 322, para 73)
"73.J. (i) Whether in a litigation filed before this Court either under
Article 32 or Article 136 of the Constitution of India, the Court can
refer to and place reliance upon the report of the Parliamentary S landing
Committee? C
73.2. (ii) Whether such a report can be looked at for the purpose of
reference and, if so, can there be restrictions for the purpose of reference
regard being had to the concept of parliamentary privilege and the delicate
balance between the constitutional institutions that Articles 105, 121 and
122 of the Constitution conceive?"
Because of the aforesaid reference, the matter has been placed before us. d
C. Contentions of the petitioners

10. At the very outset, it is essential to state that the argument has been
advanced by the learned counsel appearing for the petitioners that the lis raised
neither relates to parliamentary privileges as set out in Article 105 of the
Constitution nor does it pertain to the concept of separation of powers nor e
does it require any adjudication relating to the issue of mandamus for the
enforcement of the recommendations of the PSC report. What is suggested
is that the Court should not decide the controversy as per the facts stated in
the report of the PSC treating it to be conclusive; rather the Court should take
judicial notice of the same as provided under Section 57(4) of the Evidence
Act. It is also urged that the Court has the jurisdiction under Article 32 of the f
Constitution to conduct an independent inquiry being assisted by the Court
Commissioners and also give direction for production of the documents from
the executive.
11. It is put forth in simplest terms that the petitioners are entitled to bring
the facts stated in the report to the notice of the Court and persuade the Court
to analyse the said facts and express an opinion at variance with the report, g
for the proceedings in the Court are independent of the PSC report which
only has persuasive value. Emphasising the concept of "judicial notice", it is
propounded that the scope of judicial review does not rest on a narrow spectrum
and the Court under the Constitution is within its rights to draw factual and legal
h
2 Kalpana Mehta v. Union of India, (2017) 7 SCC 295 : (2017) 7 SCC 307
574
-----------------------------------------------------------------------------------------------------------------------------------------------------------

conclusions on the basis of wide spectrum of inputs and materials including
what has been stated in the PSC report.
a 12. The aforesaid submission, as is noticeable, intends to convey that no
constitutional debate should be raised with regard to reliance on the report
of PSC and the Court should decide without reference to the concepts of
parliamentary privilege, separation of powers and comity of institutions. The
argument, in entirety, put forth by the petitioners is not founded on the said
bedrock inasmuch as Mr Colin Gonsalves and Mr Anand Grover, learned
b Senior Counsel appearing for the petitioners, have argued that the constitutional
court in exercise of the power of judicial review can take note of the report of
the PSC and also rely upon the said report within the constitutional parameters
and the proposition does not invite any constitutional discordance.
13. It is further contended by the counsel for the petitioners that the concept
of parliamentary privilege is enshrined under Article 105 of the Constitution
C which guarantees freedom of speech within the House during the course of the
proceedings of the House and the said freedom has been conferred to ensure that
the Members of Parliament express themselves freely in Parliament without
fear of any impediment of inviting any civil or criminal proceedings. The initial
part of clause (2) of Article 105 confers, inter alia, immunity to the Members of
Parliament from civil and criminal proceedings before any court in respect of
d "anything said" or "any vote given" by Members of Parliament in Parliament
or any committee thereof.
14. It is argued that this being the position, the factual score of the instant
case does not invite the wrath of violation of parliamentary privilege which
Article 105 seeks to protect. It is because the limited issue that emerges in
the present case is to see the Parliamentary Standing Committee reports. Thus,
e looking at the report for arriving at the truth by the Court in its expansive
jurisdiction under Article 32 of the Constitution remotely touches the concept
of privilege under Article 105 of the Constitution.
15. It is further canvassed that the facts that have been arrived at by the
Parliamentary Committee are of immense assistance for the adjudication of the
controversy in question and in such a situation, it is crystal clear that the purpose
f
of the petitioners is not to file a civil or criminal case against any Member of
Parliament or any member of the Standing Committee. Therefore, the violation
of parliamentary privilege does not arise.
16. The learned counsel for the petitioners would contend that this Court
is neither called upon to comment expressly or otherwise on the report nor a
g writ of mandamus has been sought for enforcement of the recommendations in
the report. It is brought on record so that the Court can look at the facts stated
therein and arrive at a just conclusion in support of other facts.
D. Contentions of the respondents
17. Both the facets of the arguments advanced by the learned counsel
appearing for the petitioners have been seriously opposed by Mr K.K.
h Venugopal, learned Attorney General for India, Mr Harish N. Salve, Mr Gourab
575
-----------------------------------------------------------------------------------------------------------------------------------------------------------

Banerji and Mr Shyam Divan, learned Senior Counsel appearing for the
contesting respondents. Their basic propositions are grounded, first on
constitutional provisions which prescribe the privilege of Parliament and how a
the report of a PSC is not amenable to contest and the limited reliance that has
been placed by this Court on the report of PSC or the speech of a Minister on the
floor of the legislature only to understand the provisions of a statute in certain
context and second, the limited interpretation that is required to be placed on
the words "judicial notice" as used in Section 57(4) of the Evidence Act regard
being had to the context. It is urged by them that allowing contest and criticism b
of the report would definitely create a stir in the constitutional balance.
18. It is also highlighted that in a public interest litigation, the Court has
relaxed the principle of locus standi, encouraged epistolary jurisdiction, treated
the petitioner as a relator, required the parties on certain occasions not to take
an adversarial position and also not allowed technicalities to create any kind
of impediment in the dispensation of justice but the said category of cases C
cannot be put on a high pedestal to create a concavity in the federal structure
of the Constitution or allow to place a different kind of interpretation on a
constitutional provision which will usher in a crack in the healthy spirit of the
Constitution.
19. We shall refer to the arguments and the authorities cited by both sides in
the course of our deliberation. Suffice it to mention, the fundamental analysis d
has to be done on the base of the constitutional provisions, the constitutional
values and the precedents. To address the issue singularly from the prism
of Section 57(4) of the Evidence Act, we are afraid, will tantamount to
oversimplification of the issue. Therefore, the said aspect shall be addressed to
at the appropriate stage.
e
E. Supremacy of the Constitution
20. The Constitution of India is the supreme fundamental law and all
laws have to be in consonance or in accord with the Constitution. The
constitutional provisions postulate the conditions for the functioning of the
legislature and the executive and prescribe that the Supreme Court is the final
interpreter of the Constitution. All statutory laws are required to conform to f
the fundamental law, that is, the Constitution. The functionaries of the three
wings, namely, the legislature, the executive and the judiciary, as has been
stated in Kesavananda Bharati v. State of Kerala 3 , derive their authority and
jurisdiction from the Constitution. Parliament has the exclusive authority to
make laws and that is how the supremacy of Parliament in the field of legislation
is understood. There is a distinction between parliamentary supremacy in g
the field of legislation and constitutional supremacy. The Constitution is
the fundamental document that provides for constitutionalism, constitutional
governance and also sets out morality, norms and values which are inhered
in various articles and sometimes are decipherable from the constitutional
silence. Its inherent dynamism makes it organic and, therefore, the concept of
"constitutional sovereignty" is sacrosanct. It is extremely sacred and, as stated h
3 (1973) 4 sec 225: AIR 1973 SC 1461
576
-----------------------------------------------------------------------------------------------------------------------------------------------------------

earlier, the authorities get their powers from the Constitution. It is "the source".
Sometimes, the constitutional sovereignty is described as the supremacy of the
a Constitution.
21. In State of Rajas than v. Union of India 4 , Bhagwati, J. (as his Lordship
then was), in his concurring opinion, stated that the Constitution is suprema
lex, the paramount law of the land and there is no department or branch
of Government above or beyond it. The learned Judge, proceeding further,
observed that every organ of the Government, be it the executive or the
b legislature or the judiciary, derives its authority from the Constitution and it has
to act within the limits of its authority. 0 bserving about the power of this Court,
he ruled that this Court is the ultimate interpreter of the Constitution and to this
Court is assigned the delicate task of determining what is the power conferred
on each branch of the Government, whether it is limited, and if so, what are
the limits and whether any action of that branch transgresses such limits. He
C further observed that it is for this Court to uphold the constitutional values and
to enforce the constitutional limitations, for it is the essence of the rule of law.
Elaborating the said concept, Sabharwal, C.J. in I.R. Coelho v. State of T.N. 5 ,
speaking for the nine-Judge Bench, held that the supremacy of the Constitution
embodies that constitutional bodies are required to comply with the provisions
of the Constitution. It also mandates a mechanism for testing the validity of
d legislative acts through an independent organ viz. the judiciary.
22. Be it noted, in the I.R. Coelho case 5 , a distinction was drawn between
parliamentary and constitutional sovereignty. Speaking on the same, the Bench
opined that our Constitution was framed by a Constituent Assembly which was
not Parliament. It is in the exercise of law-making power by the Constituent
Assembly that we have a controlled Constitution. Articles 14, 19 and 21
e represent the foundational values which form the bedrock of the rule of law.
These are the principles of constitutionality which form the basis of judicial
review apart from the rule of law and separation of powers.
23. Thus, the three wings of the State are bound by the doctrine of
constitutional sovereignty and all are governed by the framework of the
Constitution. The Constitution does not accept transgression of constitutional
f
supremacy and that is how the boundary is set.
F. Constitutional limitations upon the legislature
24. The law-making power of Parliament or the State Legislature is bound
by the concept of constitutional limitation. It is necessary to appreciate what
precisely is meant by constitutional limitation.
g
25. In State of W.B. v. Anwar Ali Sarkar6 , this Court, in the context
of freedom of speech and expression conferred by Article 19(1)(a) of the
Constitution, applied the principle of constitutional limitation and opined
that where a law purports to authorise the imposition of restrictions on
h 4 (1977) 3 sec 592

5 c2001) 2 sec 1
6 1952 SCR 284: AIR 1952 SC 75: 1952 Cri LJ 510
577
-----------------------------------------------------------------------------------------------------------------------------------------------------------

a fundamental right in a language wide enough to cover restrictions both
within and without the limits of constitutionally permissible legislative action
affecting such right, it is not possible to uphold it even so far as it may be applied a
within the constitutional limits, as it is not severable. So long as the possibility
of its being applied for purposes not sanctioned by the Constitution cannot be
ruled out, it must be held to be wholly unconstitutional and void. The emphasis
was laid on constitutional limitation.
26. In K.C. Gajapati Narayan Deo v. State of Orissa7 , the Court adverted
to the real purpose of legislation and colourable legislation and, in that context, b
expressed that when a scrutiny is made, it may appear that the real purpose
of a legislation is different from what appears on the face of it. It would be a
colourable legislation only if it is shown that the real object is different as a
consequence of which it lies within the exclusive field of another legislature.
27. Dwelling upon the legal effect of a constitutional limitation of
legislative power with respect to a law made in derogation of that limitation, C
the Court in Deep Chand v. State of U.P. 8 reproduced a passage from Cooley's
book on Constitutional Limitation (8th Edn., Vol. I) which is to the following
effect: (AIR p. 656, para 14)
"14 . ... 'From what examination has been given to this subject, it
appears that whether a statute is constitutional or not is always a question d
of power; that is, a question whether the legislature in the particular case,
in respect to the subject-matter of the Act, the manner in which its object
is to be accomplished, and the mode of enacting it, has kept within the
constitutional limits and observed the constitutional conditions.' "
Thereafter, the Constitution Bench referred to the observations of the Judicial
Committee in R. v. Burah 9 wherein it was observed that whenever a question as e
to whether the legislature has exceeded its prescribed limits arises, the courts of
justice determine the said question by looking into the terms of the instrument
which created the legislative powers affirmatively and which restricted the said
powers negatively.
28. The Constitution Bench in D eep Chand case 8 also referred to the
f
observations of the Judicial Committee in Attorney General for Ontario v.
Attorney Gene ral for Canada 10 which were later on lucidly explained by
Mukherjea, J., (as he then was) in K.C. Gajapati Narayan D eo 7 to the effect
that if the Constitution distributes the legislative powers amongst different
bodies which have to act within their respective spheres marked out by specific
legislative entries or if there are limitations on the legislature in the form of g
fundamental rights, the question will arise as to whether, in a particular case,
the legislature has transgressed the limits of its constitutional power in respect
of the subject-matter of the statute or in the method of making it.
7 1954 SCR 1 : AIR 1953 SC 375

8 1959 Supp (2) SCR 8: AIR 1959 SC 648 h
9 1878 SCC OnLine PC 17 : (1877-78) 5 IA 178
10 1912 AC 571 (PC)
578
-----------------------------------------------------------------------------------------------------------------------------------------------------------

29. Recently, in Binoy Viswam v. Union of India 11 this Court, while dealing
with the exercise of sovereign power of the Centre and the States in the
a context of levy of taxes, duties and fees, observed that the said exercise of
power is subject to constitutional limitation. It is imperative to remember
that our Constitution has, with the avowed purpose, laid down the powers
exercised by the three wings of the State and in exercise of the said power,
the authorities are constitutionally required to act within their spheres having
mutual institutional respect to realise the constitutional goal and to see that there
b is no constitutional transgression. The grammar of constitutional limitation has
to be perceived as the constitutional fulcrum where control operates among the
several power holders, that is, legislature, executive and judiciary. It is because
the Constitution has created the three organs of the State.
30. Under the Constitution, Parliament and the State Legislatures have
been entrusted with the power of law-making. Needless to say, if there is a
C transgression of the constitutional limitation, the law made by the legislature
has to be declared ultra vires by the constitutional courts. That power has been
conferred on the courts under the Constitution and that is why, we have used
the terminology "constitutional sovereignty". It is an accepted principle that
the rule of law constitutes the core of our Constitution and it is the essence
of the rule of law that the exercise of the power by the State, whether it b e
d the legislature or the executive or any other authority, should be within the
constitutional limitations.
G. Doctrine of separation of powers
31. Having stated about constitutional sovereignty and constitutional
limitation, we may presently address the issue as to how the Constitution of
e India has been understood in the context of division of functions of the State.
32. In Indira Nehru Gandhi v. Raj Narain 12 , Beg, J., in his concurring
opinion, quoted what M.C. Setalvad, a distinguished jurist of India, had said
in "The Common Law in India" (The Hamlyn Lectures), 12th Series, 1960.
We think it appropriate to reproduce the paragraph in entirety: (SCC p. 217,
para 572)
f
"572 . ... 'The Constitution divides the fun ctions of the Union into the
three categories of executive, legislative and judicial functions following
the pattern of the British North America Act and the Commonwealth of
Australia Act. Though this division of functions is not based on the doctrine
of separation of powers as in the United States yet there is a broad division
of functions between the appropriate authorities so that, for example, the
g legislature will not be entitled to arrogate to itself the judicial function of
adjudication.
'I2 . ... Th e Indian Constitution has not indeed recognised the
doctrine of separation of powers in its absolute rigidity but the
functions of the different parts or branches of the Government have
h
11 (2017) 7 sec 59
12 1975 Supp SCC 1
579
-----------------------------------------------------------------------------------------------------------------------------------------------------------

been sufficiently diffe rentiated and conse quently it can very well be
said that our Constitution do es not contemplate assumption, by one
o rgan or part of the State, of fun ctions that e sse ntially belong to a
anothe r.' [See Ram Jawaya Kapur v. State of Punjab 13 (AIR p. 556,
para 12)].
This will no doubt strike one accustomed to the established supremacy
of Parliament in England as unusual. In the course of its historical
development Parliament has performed and in a way still performs
judicial functions. Indeed the expression "Court of Parliament" is not b
unfamiliar to English lawyers. However, a differentiation of the functions
of different departments is an invariable feature of all written Constitutions.
The very purpose of a written Constitution is the demarcation of the
powers of different departments of Government so that the exercise
of their powers may be limited to their particular fields. In countries
C
governed by a written Constitution, as India is, the supreme authority is
not Parliament but the Constitution. Contrasting it with the supremacy
of Parliament, Dicey has characterised it as the supremacy of the
Constitution.' " (emphasis supplied)
33. The doctrine of separation of powers has become concrete in the Indian
context when the Court in Kesavananda Bharati case 3 treated the same as d
a basic feature of the Constitution of India. In State of H.P. v. Parent of a
Student of Medical College 14 , this Court ruled that it is entirely a matter for
the executive branch of the Government to decide whether or not to introduce
any particular legislation. Of course, any member of the legislature can also
introduce legislation but the Court certainly cannot mandate the executive or
any member of the legislature to initiate legislation, howsoever necessary or e
desirable the Court may consider it to be. That is not a matter which is within
the sphere of the functions and duties allocated to the judiciary under the
Constitution. The Court further observed that it cannot usurp the functions
assigned to the legislature under the Constitution and it cannot even indirectly
require the executive to introduce a particular legislation or the legislature to
pass it or assume to itself a supervisory role over the law-making activities of f
the executive and the legislature.
34. In State ofT.N. v. State of Kerala 15 , this Court, laying down the principle
of separation of powers, stated that even without express provision of the
separation of powers, the doctrine of separation of powers is an entrenched
principle in the Constitution of India. The doctrine of separation of powers
informs the Indian constitutional structure and it is an essential constituent of g
the rule of law.
13 (1955) 2 SCR 225 : AIR 1955 SC 549

3 Kesa vananda Bharati v. State ofKerala, (1973) 4 SCC 225: AIR 1973 SC 1461 h
14 (1985)3SCC169
15 (2014) 12 sec 696
580
-----------------------------------------------------------------------------------------------------------------------------------------------------------

35. In Bhim Singh v. Union of India 16 , the Court, for understanding the
concept of separation of powers, observed that two aspects must be borne in
a mind. One, that separation of powers is an essential feature of the Constitution
and secondly, that in modern governance, a strict separation is neither possible
nor desirable. Nevertheless, till this principle of accountability is preserved,
there is no violation of separation of powers and the same is founded on keen
scrutiny of the constitutional text. The Constitution does not strictly prohibit
overlap of functions and, in fact, provides for some overlap in a parliamentary
b democracy. What it prohibits is such exercise of function of the other branch
which results in wresting away of the regime of constitutional accountability.
36. In Mansukhlal Vithaldas Chauhan v. State of Gujarat 17 , Federation
of Railway Officers Assn. v. Union of India 18 and State of Maharashtra v.
Raghunath Gajanan Waingankar 19 , the Court applied the principle of restraint,
acknowledging and respecting the constitutional limitation upon the judiciary
C to recognise the doctrine of separation of powers and restrain itself from
entering into the domain of the legislature. Elaborating further, this Court in
Aravali Golf Club v. Chander Hass 20 observed that under our constitutional
scheme, the Legislature, the Executive and the Judiciary have their own broad
spheres of operation and each organ must have respect for the others and must
not encroach into each other's domain, otherwise the delicate balance in the
d Constitution will be upset, and there will be a reaction.
37. In Asif Hameed v. State of J&K2 1, the Court observed that the
Constitution-makers have meticulously defined the functions of various organs
of the State. The Legislature, the Executive and the Judiciary have to function
within their own spheres demarcated under the Constitution. It further ruled that
e
the Constitution trusts the judgment of these organs to function and exercise
their discretion by strictly following the procedure prescribed therein. The
functioning of democracy depends upon the strength and independence of each
of its organs. The Legislature and the Executive, the two facets of people's will,
have all the powers including that of finance. The judiciary has no power over
the sword or the purse. Nonetheless, it has power to ensure that the aforesaid
f
two main organs of the State function within the constitutional limits. It is
the sentinel of democracy. Judicial review is a powerful weapon to restrain
unconstitutional exercise of power by the legislature and the executive. The
expanding horizon of judicial review has taken in its fold the concept of social
and economic justice. The exercise of powers by the legislature and executive
is subject to judicial restraint and the only check on the exercise of power by
g the judiciary is the self-imposed discipline of judicial restraint.
16 (2010) 5 sec 538

17 (1997) 7 sec 622: 1997 sec (Cri) 1120: 1997 sec (L&S) 1784: AIR 1997 sc 3400
18 (2003) 4 sec 289 : AIR 2003 SC 1344
h 19 (2004) 6 sec 584 : AIR 2004 SC 4264
20 (2008) 1 sec 683 : (2008) 1 sec (L&S) 289
21 1989 Supp (2) SCC 364 : AIR 1989 SC 1899
581
-----------------------------------------------------------------------------------------------------------------------------------------------------------

38. In l.R. Co elho 5 , adverting to the issue of separation of powers, the nine-
Judge Bench referred to the basic structure doctrine laid down in Kesavananda
Bharati 3 by the majority and the reiteration thereof in Indira Nehru Gandhi 12 a
and reproduced a passage from Alexander Hamilton's book The Federalist and
eventually held: (I.R. Co elho case 5 , SCC p . 87, para 67)
"67. The Supreme Court has long held that the separation of powers
is part of the basic structure of the Constitution. Even before the basic
structure doctrine became part of constitutional law, the importance of the b
separation of powers on our system of governance was recognised by this
Court in Special Reference No. I of 1964 22 ."
39. From the above authorities, it is quite vivid that the concept of
constitutional limitation is a facet of the doctrine of separation of powers.
At this stage, we may clearly state that there can really be no straitjacket
C
approach in the sphere of separation of powers when issues involve democracy,
the essential morality that flows from the Constitution, interest of the citizens
in certain spheres like environment, sustenance of social interest, etc. and
empowering the populace with the right to information or right to know
in matters relating to candidates contesting election. There can be many an
example where this Court has issued directions to the executive and also d
formulated guidelines for facilitation and in furtherance of fundamental rights
and sometimes for the actualisation and fructification of statutory rights.
H. Power ofjudicial review
40. While focussing on the exercise of the power of judicial review, it has
to be borne in mind that the source of authority is the Constitution of India. e
The Court has the adjudicating authority to scrutinise the limits of the power
and transgression of such limits. The nature and scope of judicial review has
been succinctly stated in Union of India v. Raghubir Singh 23 by R.S. Pathak,
C.J. thus: (SCC p. 766, para 7)
"7.... The range of judicial review recognised in the superior judiciary
f
of India is perhaps the widest and the most extensive known to the world
of law .... With this impressive expanse of judicial power, it is only right
that the superior courts in India should be conscious of the enormous
responsibility which rest on them. This is specially true of the Supreme
Court, for as the highest Court in the entire judicial system the law declared
by it is, by Article 141 of the Constitution, binding on all courts within the g
territory of India."
5 l.R. Coelho v. State ofT.N., (2007) 2 SCC 1

3 Kesavananda Bharati v. State of Kera/a, (1973) 4 SCC 225: AIR 1973 SC 1461
12 Indira N ehru Gandhi v. Raj Narain, 1975 Supp SCC 1
22 Powers, Privileges and Immunities of State Legislatu res, In re, Special Reference No. I of h
1964, AIR 1965 SC 745 : (1965) 1 SCR 413
23 (1989) 2 sec 754
582
-----------------------------------------------------------------------------------------------------------------------------------------------------------

And again: (SCC p. 767, para 11)
"11. Legal compulsions cannot be limited by existing legal
a propositions, because there will always be, beyond the frontiers of the
existing law, new areas inviting judicial scrutiny and judicial choice-
making which could well affect the validity of existing legal dogma. The
search for solutions responsive to a changed social era involves a search
not only among competing propositions of law, or competing versions of a
legal proposition, or the modalities of an indeterminacy such as "fairness"
b or "reasonableness", but also among propositions from outside the ruling
law, corresponding to the empirical knowledge or accepted values of
present time and place, relevant to the dispensing of justice within the new
parameters."
The aforesaid two passages lay immense responsibility on the Court pertaining
to the exercise of the power keeping in view the accepted values of the present.
C An organic instrument requires the Court to draw strength from the spirit of
the Constitution. The propelling element of the Constitution commands the
realisation of the values. The aspiring dynamism of the interpretative process
also expects the same.
41. This Court has the constitutional power and the authority to interpret
the constitutional provisions as well as the statutory provisions. The conferment
d of the power of judicial review has a great sanctity as the constitutional
court has the power to declare any law as tmconstitutional if there is lack
of competence of the legislature keeping in view the field of legislation as
provided in the Constitution or if a provision contravenes or runs counter to
any of the fundamental rights or any constitutional provision or if a provision
is manifestly arbitrary.
e 42. When we speak about judicial review, it is also necessary to be alive
to the concept of judicial restraint. The duty of judicial review which the
Constitution has bestowed upon the judiciary is not unfettered; it comes within
the conception of judicial restraint. The principle of judicial restraint requires
that Judges ought to decide cases while being within their defined limits
of power. Judges are expected to interpret any law or any provision of the
Constitution as per the limits laid down by the Constitution.
f
43. In S. C. Chandra v. State of Jharkhand 24 , it has been ruled that the
judiciary should exercise restraint and ordinarily should not encroach into
the legislative domain. In this regard, a reference to a three-Judge Bench
decision in Suresh Se th v. Indore Municipal Corpn. 25 is quite instructive.
In the said case, a prayer was made before this Court to issue directions
for appropriate amendment in the M.P. Municipal Corporation Act, 1956.
g Repelling the submission, the Court held that it is purely a matter of policy
which is for the elected representatives of the people to decide and no directions
can be issued by the Court in this regard. The Court further observed that this
Court cannot issue directions to the legislature to make any particular kind of
enactment. In this context, the Court held that under our constitutional scheme,
h
24 (2007) 8 sec 279 : (2007) 2 sec (L&S) 897
25 (2005) 13 sec 287
583
-----------------------------------------------------------------------------------------------------------------------------------------------------------

Parliament and Legislative Assemblies exercise sovereign power to enact law
and no outside power or authority can issue a direction to enact a particular kind
of legislation. While so holding, the Court referred to the decision in Suprem e a
Court Employees' We lfare Assn. v. Union of lndia 26 wherein it was held that
no court can direct a legislature to enact a particular law and similarly when
an executive authority exercises a legislative power by way of a subordinate
legislation pursuant to the delegated authority of a legislature, such executive
authority cannot be asked to enact a law which it has been empowered to do
under the delegated authority.
b
44. Recently, in Cen sus Commr. v. R. Krishnamurthy 27 , the Court, after
referring to Premium Granites v. State of T.N. 28 , M.P. Oil Extraction v. State
of M.P. 29 , State of M.P. v. Narmada Bachao Andolan 30 and State of Punjab v.
Ram Lubhaya Bagga 31 , held: (R. Krishnamurthy case 27 , SCC p. 809, para 33)
"33. From the aforesaid pronouncement of law, it is clear as noonday
that it is not within the domain of the courts to embark upon an enquiry as to C
whether a particular public policy is wise and acceptable or whether a better
policy could be evolved. The court can only interfere if the policy framed
is absolutely capricious or not informed by reasons or totally arbitrary and
founded ipse dixit offending the basic requirement of Article 14 of the
Constitution. In certain matters, as often said, there can be opinions and
opinions but the court is not expected to sit as an appellate authority on d
an opinion."
45. At this juncture, we think it apt to clearly state that the judicial restraint
cannot and should not be such that it amounts to judicial abdication and
judicial passivism. The Judiciary cannot abdicate the solemn duty which the
Constitution has placed on its shoulders i.e. to protect the fundamental rights
e
of the citizens guaranteed under Part III of the Constitution. The constitutional
courts cannot sit in oblivion when fundamental rights of individuals are
at stake. Our Constitution has conceived the constitutional courts to act as
defenders against illegal intrusion of the fundamental rights of individuals.
The Constitution, under its aegis, has armed the constitutional courts with
wide powers which the courts should exercise, without an iota of hesitation
f
or apprehension, when the fundamental rights of individuals are in jeopardy.
Elucidating on the said aspect, this Court in Virendra Singh v. State of U.P. 32
has observed: (AIR p. 454, para 34)
"34 . ... We have upon us the whole armour of the Constitution and
walk from henceforth in its enlightened ways, wearing the breastplate of
its protecting provisions and flashing the flaming sword of its inspiration." g
26 (1989) 4 sec 187 : 1989 sec (L&S) 569

21 (2015) 2 sec 796: c2015) 1 sec (L&S) 589
28 (1994) 2 sec 691
29 (1997) 7 sec 592
30 (2011) 7 sec 639: (2011) 3 sec (Civ) 875 h
31 (1998) 4 sec 111 : 1998 sec (L&S) 1021
32 AIR 1954 SC 447
584
-----------------------------------------------------------------------------------------------------------------------------------------------------------

46. While interpreting fundamental rights, the constitutional courts should
remember that whenever an occasion arises, the courts have to adopt a
a liberal approach with the object to infuse lively spirit and vigour so that the
fundamental rights do not suffer. When we say so, it may not be understood
that while interpreting fundamental rights, the constitutional courts should
altogether depart from the doctrine of precedents but it is the obligation of the
constitutional courts to act as sentinel on th e qui vive to ardently guard the
fundamental rights of individuals bestowed upon by the Constitution. The duty
of this Court, in this context, has been aptly described in K.S. Srinivasan v.
b
Union of India 33 wherein it was stated: (AIR p. 433, para 50)
"50 . ... All I can see is a man who has been wronged and I can see a
plain way out. I would take it."
47. Such an approach applies with more zeal in case of Article 32 of the
Constitution which has been described by Dr B.R. Ambedkar as "the very
C soul of the Constitution - the very heart of it - the most important Article".
Article 32 enjoys special status and, therefore, it is incumbent upon this Court,
in matters under Article 32, to adopt a progressive attitude. This would be in
consonance with the duty of this Court under the Constitution, that is, to secure
the inalienable fundamental rights of individuals.
I. Interpretation of the Constitution - The nature of duty cast upon this
d Court
48. Having stated about the supremacy of the Constitution and the
principles of constitutional limitation, separation of powers and the spheres
of judicial review, it is necessary to dwell upon the concept of constitutional
interpretation. In S.R. Bommai v. Union of lndia 34 , it has been said that for
maintaining democratic process and to avoid political friction, it is necessary
e to direct the political parties within the purview of the constitutional umbrella
to strongly adhere to constitutional values. There is no denial of the fact that
the judiciary takes note of the obtaining empirical facts and the aspirations of
the generation that are telescoped into the future. If constitutional provisions
have to be perceived from the prism of growth and development in the context
of time so as to actualise the social and political will of the people that was put
f to in words, they have to be understood in their life and spirit with the further
potentiality to change.
49. A five-Judge Bench in GVK Industries Ltd. v. CIT35 has lucidly
expressed that our Constitution charges the various organs of the State with
affirmative responsibilities of protecting the welfare and the security of the
nation. Legislative powers are granted to enable the accomplishment of the
g goals of the nation. The powers of judicial review are granted in order to ensure
that the legislative and executive powers are used within the bounds specified
by the Constitution. The powers referred by the Constitution and implied and
borne by the constitutional text have to be perforce admitted. Nevertheless, the
very essence of constitutionalism is also that no organ of the State may arrogate
h 33 AIR 1958 SC 419

34 (1994) 3 sec 1
35 (2011) 4 sec 36
585
-----------------------------------------------------------------------------------------------------------------------------------------------------------

to itself powers beyond what is specified by the Constitution. Speaking on the
duty of the judiciary, the Court has opined that judicial restraint is necessary in
dealing with the powers of another coordinate branch of the Government; but a
restraint cannot imply abdication of the responsibility of walking on that edge.
SO. Stressing on the facet of interpreting any law, including the
Constitution, the Court observed that the text of the provision under
consideration would be the primary source for discerning the meanings that
inhere in the enactment. It has also been laid down that in the light of the serious
issues , it would always be prudent, as a matter of constitutional necessity, to
b
widen the search for the true meaning, purport and ambit of the provision
under consideration. No provision, and indeed no word or expression, of the
Constitution exists in isolation-they are necessarily related to, transforming
and, in turn, being transformed by other provisions, words and phrases in the
Constitution. Therefore, the Court went on to say: ( GVK Industries case 35 , SCC
p. 59, para 38)
C
"38. Our Constitution is both long and also an intricate matrix of
meanings, purposes and structures. It is only by locating a particular
constitutional provision under consideration within that constitutional
matrix could one hope to be able to discern its true meaning, purport and
ambit. As Prof. Laurence Tribe points out:
'[T]o understand the Constitution as a legal text, it is essential d
to recognize the ... sort of text it is: a constitutive text that purports,
in the name of the people . . . to bring into being a number of
distinct but inter-related institutions and practices, at once legal and
political, and to define the rules governing those institutions and
practices.' (See "Reflections on Free-Form Method in Constitutional
Interpretation " 36 , Harv L Rev p. 1235.)" (emphasis in original) e
51. The Constitution being an organic document, its ongoing interpretation
is permissible. The supremacy of the Constitution is essential to bring
social changes in the national polity evolved with the passage of time. The
interpretation of the Constitution is a difficult task. While doing so, the
constitutional courts are not only required to take into consideration their own
experience over time, the international treaties and covenants but also keep the f
doctrine of flexibility in mind. It has been so stated in Union of India v. Naveen
Jindal 37 •
52. In S.R. Bommai 34 the Court ruled that correct interpretation in proper
perspective would be in the defence of democracy and in order to maintain
the democratic process on an even keel even in the face of possible friction, it
is but the duty of the Court to interpret the Constitution to bring the political g
parties within the purview of the constitutional parameters for accountability
and to abide by the Constitution and the laws for their strict adherence. With
the passage of time, the interpretative process has become expansive. It has
35 GVK Industries Ltd. v. CIT, (2011) 4 SCC 36

36 Reflections on Free-Form Method in Constitutional Interpretation, (1995) 108 Harv L Rev 1221 h
37 (2004) 2 sec 510
34 S.R. Bommai v. Union of India, (1994) 3 SCC 1
586
-----------------------------------------------------------------------------------------------------------------------------------------------------------

been built brick by brick to broaden the sphere of rights and to assert the
constitutional supremacy to meet the legitimate expectations of the citizens.
a The words of the Constitution have been injected life to express connotative
meaning.
53. Recently, in K.S. Puttaswamy v. Union of lndia 38 , one of us (Dr D.Y.
Chandrachud, J.) has opined that constitutional developments have taken
place as the words of the Constitution have been interpreted to deal with
new exigencies requiring an expansive reading of liberties and freedoms to
b preserve human rights under the Rule of Law. It has been further observed
that the interpretation of the Constitution cannot be frozen by its original
understanding, for the Constitution has evolved and must continuously evolve
to meet the aspirations and challenges of the present and the future. The duty
of the constitutional courts to interpret the Constitution opened the path for
succeeding generations to meet the challenges. Be it stated, the Court was
dealing with privacy as a matter of fundamental right.
C
54. In Supreme Court Advocates-on-Record Assn. v. Union of lndia 39 ,
the Court exposited that the Constitution has not only to be read in the light
of contemporary circumstances and values but also in such a way that the
circumstances and values of the present generation are given expression in
its provisions. The Court has observed that constitutional interpretation is as
much a process of creation as one of discovery. Thus viewed, the process of
d
interpretation ought to meet the values and aspirations of the present generation
and it has two facets, namely, process of creation and discovery. It has to be
remembered that while interpreting a constitutional provision, one has to be
guided by the letter, spirit and purpose of the language employed therein and
also the constitutional silences or abeyances that are discoverable. The scope
and discovery has a connection with the theory of constitutional implication.
e Additionally, the interpretative process of a provision of a Constitution is also
required to accentuate the purpose and convey the message of the Constitution
which is intrinsic to the Constitution.
1.1 Interpretation of fundamental rights
55. While adverting to the concept of the duty of the Court, we shall focus
on the interpretative process adopted by this Court in respect of fundamental
f
rights. In the initial years, after the Constitution came into force, the Court
viewed each fundamental right as separate and distinct. That apart, the rule of
restrictive interpretation was applied. The contours were narrow and limited.
It is noticeable from the decision in A.K. Gopalan v. State of Madras 40 . The
perception changed when the Court focussed on the actual impairment caused
by the law rather than the literal validity of the law as has been observed in l.R.
g
Coelho 5 . l.R. Coelho 5 referred to Rustom Cavasjee Cooper v. Union of lndia 41
and understood that the view rendered therein disapproved the viewpoint in
38 (2017) 10 sec 1
39 (1993) 4 sec 441
h 40 AIR 1950 SC 27: (1950) 51 Cri LJ 1383: 1950 SCR 88
41 (1970) 1 sec 248
587
-----------------------------------------------------------------------------------------------------------------------------------------------------------

A.K. Gopalan 40
and reflected upon the concept of impact doctrine in Sakal
Papers (P) Ltd. v. Union of lndia 42 . The Court, after referring to Sambhu Nath
Sarkar v. State of W.B. 43 , Haradhan Saha v. State of W.B. 44 and Khudiram a
Das v. State of W.B. 45 , reproduced a passage from Man eka Gandhi v. Union of
India 46 which reads thus: (I.R. Coelho case 5 , SCC p. 83, para 57)
"57 . ... '6 . ... The law, must, therefore, now be taken to be well
settled that Article 2/ does not exclude Article 19 and that even if there
is a law prescribing a procedure for depriving a person of "personal
liberty" and there is consequently no infringement of the fundamental b
right conferred by Article 21, such law, insofar as it abridges or takes
away any fundamental right under Article 19 would have to meet
the challenge of that article.' (Maneka Gandhi case 46 , SCC p. 282,
para 6)" (emphasis in original)
56. The Court reproduced a passage from the opinion expressed by Krishna
C
Iyer, J. which stated that the proposition is indubitable that Article 21 does not,
in a given situation, exclude Article 19 if both the rights are breached.
57. In I.R. Coelho 5 , the Court clearly spelt out that post Maneka Gandhi 46 ,
it is clear that the development of fundamental rights had been such that it no
longer involves the interpretation of rights as isolated protections which directly
arise but they collectively form a comprehensive test against the arbitrary
d
exercise of powers in any area that occurs as an inevitable consequence. The
Court observed that the protection of fundamental rights has been considerably
widened. In that context, reference had been made to M. Nagaraj v. Union of
India 47 wherein it has been held that a fundamental right becomes fundamental
because it has foundational value. That apart, one has also to see the structure of
the article in which the fundamental value is incorporated. Fundamental right
is a limitation on the power of the State. A Constitution and, in particular, that e
of it which protects and which entrenches fundamental rights and freedoms to
which all persons in the State are to be entitled is to be given a generous and
purposive construction. The Court must interpret the Constitution in a manner
which would enable the citizens to enjoy the rights guaranteed by itin the fullest
measure.
f
1.2 Interpretation of other constitutional provisions
58. In this regard, we may note how the Constitution Benches have applied
the principles of interpretation in relation to other constitutional provisions
which are fundamental to constitutional governance and democracy. In B.R.
Kapur v. State of T.N. 48 , while deciding a writ of quo warranto, the majority
g
40 A.K. Gopalan v. State of Madras, AIR 1950 SC 27 : (1950) 51 Cri LJ 1383 : 1950 SCR 88
42 (1962) 3 SCR 842 : AIR 1962 SC 305
43 (1973) 1 sec 856: 1973 sec (Cri) 618: (1974) 1 scR 1
44 (1975) 3 sec 198 : 1974 sec (Cri) 816 : (1975) 1 scR 778
45 (1975) 2 sec 81 : 1975 sec (Cri) 435 : (1975) 2 scR 832
46 (1978) 1 sec 248
5 l.R. Coelho v. State of TN. , (2007) 2 SCC 1 h
47 (2006) 8 sec 212 : (2007) 1 sec (L&S) 1013
48 (2001) 7 sec 231
588
-----------------------------------------------------------------------------------------------------------------------------------------------------------

ruled that if a non-legislator could be sworn in as the Chief Minister under
Article 164 of the Constitution, then he must satisfy the qualification of
a membership of a legislator as postulated under Article 173. l.R. Co elho5, while
deciding the doctrine of implied limitation and referring to various opinions
stated in Kesavananda Bharati 3 and Minerva Mills Ltd. v. Union of India 49 ,
ruled that the principle of implied limitation is attracted to the sphere of
constitutional interpretation.
59. In Mano} Narula v. Union of India 50 , the Court, while interpreting
b Article 75(1) of the Constitution, opined that reading of implied limitation to
the said provision would tantamount to prohibition or adding a disqualification
which is neither expressly stated nor impliedly discernible from the provision.
Eventually, the majority expressed that when there is no disqualification for
a person against whom charges have been framed in respect of heinous or
serious offences or offences relating to corruption to contest the election, it
is difficult to read the prohibition into Article 7 5(1) by interpretative process
C
or, for that matter, into Article 164(1) to the powers of the Prime Minister or
the Chief Minister in such a manner. That would come within the criterion
of eligibility and would amount to prescribing an eligibility qualification and
adding a disqualification which has not been stipulated in the Constitution.
In the absence of any constitutional prohibition or statutory embargo, such
disqualification cannot be read into Article 7 5(1) or Article 164(1) of the
d Constitution.
60. Another aspect that was highlighted in Mano} Narula 50 pertained
to constitutional implication and it was observed that the said principle
of implication is fundamentally founded on rational inference of an idea
from the words used in the text. The concept of legitimate deduction is
always recognised. In M elbourne Corpn. v. Commonwealth 51 , Dixon, J.
e opined that constitutional implication should be based on considerations which
are compelling. Mason, C.J., in Australian Capital Television Pty. Ltd. v.
Commonwealth 52 (Political Advertising case), has ruled that there can be
structural implications which are "logically or practically necessary for the
preservation of the integrity of that structure". Any proposition that is arrived
at taking this route of interpretation must find some resting pillar or strength on
f the basis of certain words in the text or the scheme of the text. In the absence
of the same, it may not be permissible for a court to deduce any proposition as
that would defeat the legitimacy of reasoning. A proposition can be established
by reading a number of articles cohesively, for that will be in the domain of
substantive legitimacy. Elaborating further, the Court proceeded to state that the
said process has its own limitation for the Court cannot rewrite a constitutional
g provision. To justify the adoption of the said method of interpretation, there has
to be a constitutional foundation.

3 Kesavananda Bharati v. State of Kera/a, (1973) 4 SCC 225: AIR 1973 SC 1461
49 (1980) 3 sec 625
h 50 (2014) 9 sec 1
51 (194 7) 74 CLR 31 (Aust)
52 (1992) 177 CLR 106 (Aust)
589
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61. In Kuldip Nayar v. Union of India 53 ,
a Constitution Bench, while
interpreting Article 80 of the Constitution of India, relied upon a passage
from G. Narayanaswami v. G. Pannerselvam 54 . The said authority clearly a
lays down that courts should interpret in a broad and generous spirit the
document which contains the fundamental law of the land. The Court observed
that it may be desirable to give a broad and generous construction to the
constitutional provisions, but while doing so, the rule of "plain meaning" or
"literal" interpretation, which remains "the primary rule", has also to be kept
in mind. In the context of Article 80(4) of the Constitution in the context of b
"the representatives of each State", the Court repelled the argument that it is
inherent in the expression "representative" that he/she must first necessarily
be an elector in the State. It ruled that the "representative" of the State is the
person chosen by the electors who can be any person who, in the opinion of
the electors, is fit to represent them.
62. The Court, in Union of India v. Sankalchand Himatlal Sheth 55 , ruled C
that it is to be remembered that when the Court interprets a constitutional
provision, it breathes life into the inert words used in the founding document.
The problem before the constitutional court is not a mere verbal problem.
"Literalness", observed Frankfurter, J., "may strangle meaning" and he went
on to add in Massachusetts Bonding & Insurance Co v. United States 56 that
"there is no surer way to misread a document than to read it literally". The Court d
cannot interpret a provision of the Constitution by making "a fortress out of the
dictionary". The significance of a constitutional problem is vital, not formal:
it has to be gathered not simply by taking the words and a dictionary, but by
considering the purpose and intendment of the Framers as gathered from the
context and the setting in which the words occur. The difficulty of gathering the
true intent of the law-giver from the words used in the statute was expressed e
by Holmes, J. in a striking and epigrammatic fashion when he said: "Ideas
are not often hard but the words are the devil5 7 " and this difficulty is all the
greater when the words to be construed occur in a constitutional provision, for,
as pointed out by Cardozo, J., "the process of constitutional interpretation is in
the ultimate analysis one of reading values into its clauses".
63. In this backdrop, it is necessary to state that the Court has an enormous f
responsibility when it functions as the final arbiter of the interpretation of the
constitutional provision.
64. We have discussed the concepts of supremacy of the Constitution
and constitutional limitation, separation of powers, the ambit and scope of
judicial review, judicial restraint, the progressive method adopted by the Court
while interpreting fundamental rights and the expansive conception of such g
inherent rights. We have also deliberated upon the interpretation of other
constitutional provisions that really do not touch the area of fundamental rights
53 (2006) 1 sec 1
54 (1972) 3 sec 717
55 (1977) 4 sec 193: 1977 sec (L&S) 435 h
56 1956 SCC OnLine US SC 102: 1 L Ed 2d 189: 352 US 128 (1956)
57 R.E. Megarry, "A Second Miscellany-at-Law" (Stevens, London 1973) p. 152.
590
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but are fundamental for constitutional governance and the duty of the Court
is not to transgress the constitutional boundaries. We may immediately add
a that in the case at hand, we are not concerned with the interpretation of such
constitutional provisions which have impact on the fundamental rights of the
citizens. We are concerned with the interpretation of certain provisions that
relate to parliamentary privilege and what is protected by the Constitution in
certain articles. This situation has emerged in the context of the Court's role to
rely upon the reports of Parliamentary Standing Committees in the context of
b the constitutional provisions contained in Articles 105 and 122.
J. A perspective on the role of Parliamentary Committees
65. It is necessary to understand the role of the Parliamentary Standing
Committees or Ad hoc Committees. They are constituted with certain purposes.
The formation of committee has history. "Committees have been described
as a primary organisational device whereby legislatures can accommodate an
C
increase in the number of Bills being introduced, while continuing to scrutinise
legislation; handle the greater complexity and technical nature of Bills under
review without an exponential growth in size; develop "division of labours"
among members for considering legislation .... " 58 .
66. Woodrow Wilson, the 28th President of the United States, was quoted
d as saying in 1885 that "it is not far from the truth to say that Congress in session
is Congress on public exhibition, whilst Congress in its Committee rooms is
Congress at work" 59 . This is because most of the work of Congress was referred
to committees for detailed review to inform debate on the floor of the House.
67. Former US Representative James Shannon commented during a 1995
conference on the role of committees in Malawi's Legislature:
e
"Around the world there is a trend to move toward more reliance on
committees to conduct the work of Parliament, and the greatest reason for
this trend is a concern for efficiency. The demands on a modern Parliament
are numerous and it is not possible for the whole House to consider all the
details necessary for performing the proper function of a legislature." 60
f 68. Lord Campion in his book61 has explained the dual sense in which the
word "committee" was used in old parliamentary language:
"In early days it is not the body as a whole but each single member that
is meant by the term, 'the body is described as the committee' to whom
58 Source - Entering the Committee System: State Committee Assignments, Ronald

g
D. Hedlund, Political; Research Quarterly, Vol. 42, Issue 4, pp. 597-625.
59 Woodrow Wilson, "Congressional Government", 1885, quoted in the JCOC Final
Report, (Baltimore, the Johns Hopkins University Press, 1981) p. 69.
60 National Democratic Institute for International Affairs, Parliament's Organization:
The Role of Committees and Party Whips - NDI Workshop in Mangochi, Malawi,
June 1995 (Washington: National Democratic Institute for International Affairs,
h
1995).
61 An Introduction to the Procedure of House of Commons.
591
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the bill is committed. The formation of the terms is the same as that of any
other English word which denotes the recipient in a bilateral relation of
obligation, such as trustee, lessee, nominee, appointee. The body is usually a
referred to in the old authorities as 'committee'. But it was not long before
it became usual to describe the totality of those to whom a bill was referred
as a 'committee' in an abstract sense. In both the English word emphasis
the idea of delegation and not that of representation in which the German
word aussehuss expresses."
69. The utility of a committee has been succinctly expressed by Lord b
Beaconsfield62 :
"I do not think there is anyone who more values the labour of
Parliamentary Committees than myself. They obtain for the country
an extraordinary mass of valuable information, which probably would
not otherwise be had or available, and formed, as they necessarily are, C
of chosen men their reports are pregnant with prudent and sagacious
suggestion for the improvements of the administration of affairs."
70. The importance of committees in today's democracy has further been
detailed thus63:
"Committees may not be of much service in the more spectacular d
aspect of these democratic institutions, and they might not be of much
use in shaping fundamental policy, or laying down basic principles of
government. But they are absolutely indispensable for the detailed work
of supervision and control of the administration. Not infrequently, do
they carry out great pieces of constructive legislation of public economy.
Investigation of a complicated social problem, prior to legislation, maybe e
and is frequently carried out by such legislative committees, the value of
whose service cannot be exaggerated. They are useful for obtaining expert
advice when the problem is a technical one involving several branches
within an organisation, or when experts are required to advise upon a highly
technical problem definable within narrow limits. The provision of advice
based on an inquiry involving the examination of witnesses is also a task f
suitable for a committee. The employment of small committees, chosen
from the Members of the House, for dealing with some of the items of the
business of the House is not only convenient but is also in accordance with
the established convention of Parliament. This procedure is particularly
helpful in dealing with matters which, because of their special or technical
nature, are better considered in detail by a committee of the House. Besides g
expediting legislative business, committees serve other useful services.
Service on these committees keeps the Members adequately supplied with
information, deepens their insight into affairs and steady their judgment,
providing invaluable training to aspirants to office, and the general level of
knowledge and ability in the legislature rises. Committees properly attuned
h
62 Lord Beaconsfield in Hansard, 3rd Series, Vol. 235 (1877) p. 1478.
63 "Growth of Committee System in the Central Legislature of India 1920-194T'.
592
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to the spirit and forms parliamentary government can serve the country
well as the eyes and ears and to some extent the brain of the legislature,
a the more so since the functions and fields of interest of the Government
increase day by day."
71. Also, in the said book, the following observations have been made with
respect to the functions of committees:
"As the committee system developed in the course of time the various
b functions of these bodies were differentiated into a few fixed types and a
standard of size appropriate to each of these functions was also arrived at.
These committees are appointed for a variety of purposes. One of the major
purposes for which committees are appointed is the public investigation
of problems out of the report upon which legislation can be built up.
Secondly, committees are appointed to legislate. Bills referred to such
C
committees are thoroughly discussed and drafted before they become laws.
Example of such committees are the Select Committees in the Indian
Legislature . Thirdly, committees are appointed to scrutinise and control.
These committees are entrnsted with the task of seeing whether or how a
process is being performed, and by their conduct of this task they serve
to provide the means of some sort of control over the carrying out of the
d process."
72. Today Parliamentary Committee systems have emerged as a creative
way of parliaments to perform their basic functions. They serve as the focal
point for legislation and oversight. In a number of parliaments, bills, resolutions
and matters on specific issues are referred to specific committees for debate
and recommendations are made to the House for further debate. Parliamentary
e Committees have emerged as vibrant and central institutions of democratic
parliaments of today's world. Parliaments across the globe set up their own
rules on how committees are established, the composition, the mandate and
how chairpersons are to be selected but they do have certain characteristics in
common. They are usually a small group of MPs brought together to critically
review issues related to a particular subject-matter or to review a specific bill.
f They are often expected to present their observations and recommendations to
the Chamber for final debate.
73. Often committees have a multi-party composition. They examine
specific matters of policy or government administration or performance.
Effective committees have developed a degree of expertise in a given
policy area, often through continuing involvement and stable memberships.
g This expertise is both recognised and valued by their colleagues. They are
able to represent diversity as also reconcile enough differences to sustain
recommendations for action. Also, they are important enough so that people
inside and outside the legislature seek to influence outcomes by providing
information about what they want and what they will accept. Furthermore, they
provide a means for a legislative body to consider a wide range of topics in-
h depth and to identify politically and technically feasible alternatives.
593
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K. International position of Parliamentary Committees
74. Before we proceed to dwell upon the said aspect in the Indian context,
we think it apt to have a holistic view of the role of Parliamentary Standing a
Committees in a parliamentary democracy.
75. History divulges that Parliamentary Standing Committees have been
very vital institutions in most of the eminent democracies such as USA, United
Kingdom, Canada, Australia, etc. Over the years, the committee system has
come to occupy importance in the field of governance.
b
K.1 Parliamentary Committees in England
76. British parliamentary history validates that Parliamentary Committees
have existed in some form or the other since the 14th century. Perhaps the
committee system originated with the "triers and examiners of petitions" -
they were individual members selected for drawing up legislations to carry into
effect citizens' prayers that were expressed through petitions. By the middle c
of the 16th century, a stable committee system came into existence. These
Parliamentary Committees are sub-legislative organisations each consisting
of a small number of Members of Parliament from the House of Commons,
or peers from the House of Lords, or a mix of both appointed to deal with
particular areas or issues; most are made up of Members of the Commons. 64
The majority of Parliamentary Committees are Select Committees which are d
designed to:
1. Superintend the work of departments and agencies;
2. Examine topical issues affecting the country or individual regions;
and
3. Review and advise on the procedures, workings and rules of the e
House.
77. The other committees such as "Departmental Select Committees"
are designed to oversee and examine the work of individual government
departments, "Topical Select Committee" examines contemporary issues of
significance and "Internal Select Committees" have responsibility with respect
to the day-to-day running of Parliament. 65 It helps Parliament to have a very f
powerful network of committees to ensure executive accountability.
K.2 Parliamentary Committees in the United States of America
78. Parliamentary Committees are essential to the effective operation of
Parliament in the United States. Due to the high volume and complexity
of its work, the Senate divides its tasks among 20 permanent committees, g
4 joint committees and occasionally temporary committees. Although the
Senate committee system is similar to that of the House of Representatives,
it has its own guidelines within which each committee adopts its own rules.
This creates considerable variation among the panels. The chair of each
committee and a majority of its members represent the majority party. The
h
64 <http://www.parliament.uk/business/committees/>.
65 Ibid.
594
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chair primarily controls a committee's business. Each party assigns its own
members to committees, and each committee distributes its members among its
a sub-committees. 66 The Senate places limits on the number and types of panels
any one senator may serve on and chair. Committees receive varying levels of
operating funds and employ varying numbers of aides. Each hires its own staff.
The majority party controls most committee staff and resources, but a portion
is shared with the minority.
79. The role and responsibilities of Parliamentary Committees in the United
b States of America are as follows:
79.1. As "little legislatures", committees monitor ongoing governmental
operations, identify issues suitable for legislative review, gather and evaluate
information and recommend courses of action to their parent body.
79.2. The committee membership enables members to develop specialised
knowledge of the matters under their jurisdiction.
C
79.3. Standing Committees generally have legislative jurisdiction. Sub-
committees handle specific areas of the committee's work. Select and joint
committees generally handle oversight or housekeeping responsibilities. 67
79.4. Several thousand bills and resolutions are referred to committees
during each 2-year Congress. Committees select a small percentage for
d consideration, and those not addressed often receive no further action. The bills
that committees report help to set the Senate's agenda.
80. When a committee or sub-committee favours a measure, it usually takes
four actions: first it asks relevant executive agencies for written comments on
the measure; second, it holds hearings to gather information and views from
non-committee experts and at committee hearings, these witnesses summarise
e submitted statements and then respond to questions from the senators; third,
a committee meets to perfect the measure through amendments, and non-
committee members sometimes attempt to influence the language; and fourth,
when the language is agreed upon, the committee sends the measure back to
the full Senate, usually along with a written report describing its purposes and
provisions. A committee's influence extends to its enactment of bills into law. A
f committee that considers a measure will manage the full Senate's deliberation
on it. Also, its members will be appointed to any conference committee created
to reconcile its version of a bill with the version passed by the House of
Representatives.
K.3 Parliamentary Committees in Canada
g 81. Parliament in Canada also functions through various Standing
Committees established by Standing Orders of the House of Commons or
the Senate. It studies matters referred to it by special order or, within its
66 See <https://www.britannica.com/topic/Congress-of-the-United-States> for details.

67 Other types of committees deal with the confirmation or rejection of presidential
nominees. Committee hearings that focus on the implementation and investigation
h of programmes are known as oversight hearings, whereas committee investigations
examine allegations of wrongdoing.
595
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area of responsibility in the Standing Orders, may undertake studies on its
own initiative. There are presently 23 Standing Committees (including two
standing joint committees) in the House and 20 in the Canadian Senate. 68 a
They, in general, examine the administration, policy developments and
budgetary estimates of government departments and agencies. Certain Standing
Committees are also given mandates to examine matters that have implications
such as official languages policy and multiculturalism policy.
K.4 Parliamentary Committees in Australia
b
82. The primary object of Parliamentary Committees in Australia is to
perform functions which the Houses themselves are not well fitted to perform
i.e. finding out the facts of a case, examining witnesses, sifting evidence, and
drawing up reasoned conclusions. Because of their composition and method
of procedure, which is strnctured but generally informal compared with the
Houses, committees are well suited to the gathering of evidence from expert
C
groups or individuals. 69 In a sense, they "take Parliament to the people" and
allow organisations and individuals to participate in policy making and to have
their views placed on the public record and considered as part of the decision-
making process. Not only do committee inquiries enable Members to be better
informed about community views but in simply undertaking an inquiry, the
committee may promote public debate on the subject at issue. The all-party d
composition of most committees and their propensity to operate across party
lines are important features. 70 This bipartisan approach generally manifests
itself throughout the conduct of inquiries and the drawing up of conclusions.
Committees oversee and scrntinise the Executive and contribute towards a
better-informed administration and government policy-making process. 71 In
respect of their formal proceedings, committees are microcosms and extensions e
of the Houses themselves, limited in their power of inquiry by the extent of the
authority delegated to them and governed for the most part in their proceedings
by procedures and practices which reflect those which prevail in the House by
which they were appointed.
L. Parliamentary Committees in India
f
83. Having reflected upon the Parliamentary Committees and their role
in other democracies, we may now proceed to deal with the Parliamentary
Committees in India. The long freedom strnggle in India was not just a
movement to achieve freedom from British Rule. It was as much a movement
68 Special Committees (sometimes called Select Committees) e.g. the Special Joint g
Committee of the Sena te a nd of the House of Commons on the Constitution
of Canada , are sometimes established by the House to study specific issues or
to investigate public opinion on policy decisions. They are sometimes called
task forces but should not be confused with government taskforces . See <http://
www.thecanadianencyclopedia.ca/en/article/committeesl>.
69 See <https://www.aph.gov.au/Parliamentary _Business/Committees>. h
70 Ibid.
71 Ibid.
596
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to free ourselves from the various social evils and socio-economic inequities
and discriminations, to lift the deprived and the downtrodden from the sludge
a of poverty and to give them a stake in the overall transformation of the country.
It was with this larger national objective that a democratic polity based on
parliamentary system was conceived and formally declared in 1936 as "the
establishment of a democratic State", a sovereign State which would promote
and foster "full democracy" and usher in a new social and economic order.
84. The Founding Fathers of the Constitution perceived that such a system
b would respond effectively to the problems arising from our diversity as also
to the myriad socio-economic factors that the nation was faced with. With
that objective, in the political system that we established, prominence was
given to Parliament, the organ that directly represents the people and as such
accountable to them.
85. At this juncture, we may look at the origin and working of the
C Parliamentary Committee. The committee system in India, as has been stated
in "The Committee System in India: Effectiveness in Enforcing Executive
Accountability", Hanoi Session, March 2015, is as follows:
"The origin of the committee system in India can be traced back to
the Constitutional Reforms of 1919. The Standing Orders of the Central
Legislative Assembly provided for a Committee on Petitions relating to
d
Bills, Select Committee on Amendments of Standing Orders, and Select
Committee on Bills. There was also a provision for a Public Accounts
Committee and a Joint Committee on a Bill. Apart from Committees of the
Legislative Assembly, Members of both Houses of the Central Legislature
also served on the Standing Advisory Committees attached to various
departments of the Government oflndia. All these committees were purely
e
advisory in character and functioned under the control of the Government
with the Minister in charge of the Department acting as the Chairman of
the Committee.
After the Constitution came into force, the position of the Central
Legislative Assembly changed altogether and the committee system
f underwent transformation. Not only did the number of committees
increase, but their functions and powers were also enlarged.
By their nature, Parliamentary Committees are of two kinds: Standing
Committees and Ad hoc Committees. Standing Committees are permanent
and regular committees which are constituted from time to time in
pursuance of the provisions of an Act of Parliament or Rules of Procedure
g and Conduct of Business in Lok Sabha. The work of these Committees is
of continuous nature. The Financial Committees, Departmentally Related
Standing Committees (DRSCs) and some other committees come under
the category of Standing Committees. Ad hoc Committees are appointed
for a specific purpose and they cease to exist when they finish the task
assigned to them and submit a report. The principal Ad hoc Committees are
h the Select and Joint Committees on Bills. Railway Convention Committee,
597
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Joint Committee on Food Management in Parliament House Complex, etc.
also come under the category of Ad hoc Committees."
86. In the said document, it has been observed thus in respect of the a
Standing Committees of Parliament:
"Standing Committees are those which are periodically elected by
the House or nominated by the Speaker, Lok Sabha, or the Chairman,
Rajya Sabha, singly or jointly and are permanent in nature. In terms
of their functions, Standing Committees may be classified into two b
categories. One category of Committees like the Departmentally Related
Standing Committees (DRSCs), Financial Committees, etc., scrutinise the
functioning of the Government as per their respective mandate. The other
category of Committees like the Rules Committee, House Committee, Joint
Committee on Salaries and Allowances, etc. deal with matters relating to
the Houses and Members." C
87. The functions of Parliament in modern times are not only diverse and
complex in nature but also considerable in volume and the time at its disposal
is limited. It cannot, therefore, give close consideration to all the legislative
and other matters that come up before it. A good deal of its business is,
therefore, transacted in the Committees of the House known as Parliamentary
Committees. Parliamentary Committee means a Committee which is appointed d
or elected by the House or nominated by the Speaker and which works under the
direction of the Speaker and presents its report to the House or to the Speaker.
88. Founded on English traditions, the Indian Parliament's committee
system has a vital role in the parliamentary democracy. Generally speaking,
the Parliamentary Committees are of two kinds: S landing Committees and Ad
hoc Committees. Standing Committees are permanent and regular committees e
which are constituted from time to time in pursuance of the provisions of
an Act of Parliament or Rules of Procedure and Conduct of Business in
the Lok Sabha. The work of these committees is of continuous nature. The
Financial Committees, Department Related Standing Committees (DRSCs)
and some other committees too come under the category of Standing
Committees. The Ad hoc Committees are appointed for specific purposes as f
and when the need arises and they cease to exist as soon as they complete
the work assigned to them. 72 The Parliamentary Committees are invariably
larger in size and are recommendatory in nature. Be it stated, there are 24
Department Related S landing Committees covering under their jurisdiction
all the Ministries/Departments of the Government of India. Each of these
Committees consists of 31 Members - 21 from Lok Sabha and 10 from Raj ya g
Sabha to be nominated by the Speaker, Lok Sabha and the Chairman, Raj ya
Sabha, respectively. The term of office of these committees does not exceed
one year.
72 The principal Ad hoc Committees are the Select and Joint Committees on Bills. Railway h
Convention Committee, Joint Committee on Food Management in Parliament House Complex,
etc. also come under the category of Ad hoc Committees.
598
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L.1 Rules of Procedure and Conduct of Business in the Lok Sabha
89. A close look at the functioning of these committees discloses the fact
a that the committee system is designed to enlighten Members of Parliament
(MPs) on the whole range of governmental action including defence, external
affairs, industry and commerce, agriculture, health and finance. They offer
opportunities to the Members of Parliament to realise and comprehend the
dynamics of democracy. The Members of Parliament receive information
about parliamentary workings as well as perspective on India's strengths and
b weaknesses through the detailed studies undertaken by Standing Committees.
Indian Parliamentary Committees are a huge basin of information which are
made available to the Members of Parliament in order to educate themselves
and contribute ideas to strengthen the parliamentary system and improve
governance. The committee system is designed to enhance the capabilities of
Members of Parliament to shoulder greater responsibilities and broaden their
C horizons.
90. As has been stated in the referral judgment2 with regard to the
Parliamentary Committee, we may usefully refer to the Rules of Procedure and
Conduct of Business in Lok Sabha (for short "the Rules"). Rule 2 of the Rules
defines "Parliamentary Committee". It reads as follows: (Kalpana Mehta case 2 ,
sec p. 310, para 32)
d
"2. (1) ... "Parliamentary Committee" means a Committee which is
works under the direction of the Speaker and presents its report to the House
Secretariat;"
e 91. From the referral judgment2 , we may reproduce the following
paragraphs dealing with the relevant Rules: KalpanaMehta case 2 , SCC p. 310,
paras 33 & 34)
"33. Chapter 26 of the Rules deals with Parliamentary Committees and
the matters regarding appointment, quorum, decisions of the committee,
etc. There are two kinds of Parliamentary Committees: (i) Standing
f
Committees, and (ii) Ad hoc Committees. The Standing Committees are
categorised by their nature of functions. The Standing Committees of the
Lok Sabha are as follows:
(a) Financial Committees;
(b) Subject Committees or Departmentally Related Standing
g Committees of the two Houses;
(c) Houses Committee i.e. the committees relating to the
day-to-day business of the House;
(d) Enquiry Committee;
(e) Scrutiny Committees;
h (f) Service Committees;
599
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34. A list of Standing Committees of Lok Sabha along with its
membership is reproduced as under:
a
Name of Committee Number of
Members
:Business Advisory Committee : 15 :
lcommittee of Privileges 1 15 i
)Committee on Absence of Members from the Sittings of the i 15 i
i House of Committee on Empowerment of Women i i
: Committee on Estimates : 30 : b
(Committee on Government Assurances 1 15 1
!~~::~~~:: ~: .::~~;~n~aid.on. the Table ...................................... ( ............. !; . . . .... . i
(Committee on Private Members Bills and Resolutions 1 15 1
1Committee on Public Accounts 1 22 i
!i~~::~~~:: ~: ·~~~~;d~~~=~:~~:f:tion ········--······························j···············

Committee on the Welfare of Scheduled Castes and Scheduled i
~~ ·············· i
30 i
C
!Tribes i i
iHouse Committee i 12 i
(Joint Committee on Offices of Profit 1 15 :
)Joint Committee on Salaries and Allowances of Members of i 15 i d
i Parliament i i
j~~::r~~;~:::ee.......................................................................... j............... (5 ···············i
............................................................................................................•....................................
Apart from the above, there are various Departmentally Related Standing
Committees under various Ministries."
e
92. Rules 77 and 78 of the Rules read as under:
"77. Motions after presentation of Select/Joint Committee reports.-(1)
After the presentation of the final report of a Select Committee of the House
or a Joint Committee of the Houses, as the case may be, on a Bill, the Member
in charge may move-
(a) that the Bill as reported by the Select Committee of the House f
or the Joint Committee of the Houses, as the case may be, be taken into
consideration; or
(b) that the Bill as reported by the Select Committee of the House or
the Joint Committee of the Houses, as the case may be, be re-committed to
the same Select Committee or to a new Select Committee, or to the same
Joint Committee or to a new Joint Committee with the concurrence of the g
Council, either-
(i) without limitation, or
(ii) with respect to particular clauses or amendments only, or
(iii) with instructions to the Committee to make some particular
or additional provision in the Bill, or h
600
-----------------------------------------------------------------------------------------------------------------------------------------------------------

(c) that the Bill as reported by the Select Committee of the House
or the Joint Committee of the Houses, be circulated or recirculated, as
a the case may be, for the purpose of eliciting opinion or further opinion
thereon:
Provided that any Member may object to any such motion being made if
a copy of the report has not been made available for the use of Members for
two days before the day on which the motion is made and such objection shall
prevail, unless the Speaker allows the motion to be made.
b (2) If the Member in charge moves that the Bill as reported by the Select
Committee of the House or the Joint Committee of the Houses, as the case
may be, be taken into consideration, any Member may move as an amendment
that the Bill be re-committed or be circulated or recirculated for the purpose
of eliciting opinion or further opinion thereon.
78. Scope of debate on Select/Joint Committee reports .-The debate on
C a motion that the Bill as reported by the Select Committee of the House or the
Joint Committee of the Houses, as the case may be, be taken into consideration
shall be confined to consideration of the report of the Committee and the
matters referred to in that report or any alternative suggestions consistent with
the principle of the Bill."
93. Rule 270 of the Rules, which deals with the functions of the
d Parliamentary Committee meant for Committees of the Rajya Sabha, is
relevant. It reads as follows:
(a) to consider the Demands for Grants of the related Ministries/
e Departments and report thereon. The report shall not suggest anything of
(c) to consider the annual reports of the Ministries/Departments and
f report thereon; and
Provided that the Standing Committees shall not consider matters of day-
g to-day administration of the related Ministries/Departments."
94. Rule 271 provides for the applicability of provisions relating to
functions. Rule 27 4 deals with the report of the Committee. The said Rule reads
as follows:
"274. Report of the Committee.-(!) The report of the Standing
Committee shall be based on broad consensus.
h
601
-----------------------------------------------------------------------------------------------------------------------------------------------------------

(2) Any member of the Committee may record a minute of dissent on the
report of the Committee.
(3) The report of the Committee, together with the minutes of dissent, if a
any, shall be presented to the Houses."
95. Rule 274(3) is extremely significant, for it provides that the report of
the Committee together with the minutes of the dissent, if any, is to be presented
to the House. Rule 277 stipulates that the report is to have persuasive value. In
this context, Rule 277 is worth quoting:
b
"277. Reports to have persuasive value .-The report of a Standing
The aforesaid rule makes it quite vivid that the report of the Committee is
treated as an advice given by the Committee and it is meant for Parliament.
C
M. Parliamentary privilege
96. Black's Law Dictionary, 6th Edn., 1990, p. 1197, defines "privilege" as
"a particular and peculiar benefit or advantage enjoyed by a person,
company, or class, beyond the common advantages of other citizens.
An exceptional or extraordinary power or exemption. A peculiar right, d
advantage, exemption, power, franchise, or immunity held by a person or
class, not generally possessed by others".
97. "Parliamentary privilege" is defined by author Erskine May in Erskine
May's Treatise on the Law, Privileges, Proceedings and Usage of Parliam ent:
"Parliamentary privilege is the sum of the peculiar rights enjoyed by e
each House collectively ... and by Members of each House individually,
without which they could not discharge their functions, and which exceed
those possessed by other bodies or individuals. Thus privilege, though part
of the law of the land, is to a certain extent an exemption from the general
law." 73
f
98. The concept of parliamentary privilege has its origin in Westminster,
Britain in the 17th century with the passage of the Bill of Rights 1688. Article
IX of the Bill of Rights, which laid down the concept of parliamentary privilege,
reads as under:
"That the freedom of speech and debates or proceedings in Parliament
ought not to be impeached or questioned in any court or place out of g
Parliament."
99. Parliamentary privilege was introduced to prevent any undue
interference in the working of Parliament and thereby enable the Members
of Parliament to function effectively and efficiently without unreasonable
impediment. Till date, parliamentary privilege remains an important feature in
h
73 May, 22nd Edn., p. 65. For other definitions of "privilege", see Maingot, 2nd Edn., pp. 12-3.
602
-----------------------------------------------------------------------------------------------------------------------------------------------------------

any parliamentary democracy. The concept of parliamentary privilege requires
a balancing act of two opposite arguments as noted by Thomas Erskine May:
a "On the one hand, the privileges of Parliament are rights 'absolutely
necessary for the due execution of its powers'; and on the other, the
privilege of Parliament granted in regard of public service 'must not be
used for the danger of the commonwealth' ." 74
M.1 Parliamentary privilege under the Indian Constitution
b 100. Having dealt with the role of the Parliamentary Standing Committee
or Parliamentary Committees, it is necessary to understand the status of
Parliamentary Committee and the privileges it enjoys in the Indian context.
Article 105 of the Constitution of India, being relevant in this context, is
reproduced below:
"105. Powers, privileges, etc. of the Houses of Parliament and of the
C Members and committees thereof.-(1) Subject to the provisions of this
Constitution and the rules and standing orders regulating the procedure of
(2) No Member of Parliament shall be liable to any proceedings in any
committee thereof, and no person shall be so liable in respect of the publication
d by or under the authority of either House of Parliament of any report, paper,
of Parliament, and of the Members and the committees of each House, shall
so defined shall be those of that House and of its Members and committees
e immediately before the coming into force of Section 15 of the Constitution
committee thereof as they apply in relation to Members of Parliament."
f 101. Clause (2) of the aforesaid Article clearly lays the postulate that no
Member of Parliament shall be made liable to any proceedings in any court in
respect of anything he has said in the committee. Freedom of speech that is
available to the Members on the floor of the legislature is quite distinct from
the freedom which is available to the citizens under Article 19(1 )(a) of the
Constitution. Members of Parliament enjoy full freedom in respect of what
g they speak inside the House. Article 105( 4) categorically stipulates that the
provisions of clauses (1), (2) and (3) shall apply in relation to persons, who
by virtue of this Constitution, have the right to speak in, and otherwise to take
part in the proceedings of, a House of Parliament or any committee thereof as
they apply in relation to the Members of Parliament. Thus, there is complete
constitutional protection. It is worthy to note that Article 118 provides that each
h House of Parliament may make rules for regulating, subject to the provisions
74 Erskine May, 24th Edn., p. 209.
603
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of this Constitution, its procedure and the conduct of its business. Condignly
analysed, Parliament has been enabled by the Constitution to regulate its
procedure apart from what has been stated directly in the Constitution. a
102. Article 105 of the Constitution is read mutatis mutandis with Article
194 of the Constitution as the language in both the articles is identical, except
that Article 105 employs the word "Parliament" whereas Article 194 uses the
words "Legislature of a State". Therefore, the interpretation of one of these
articles would invariably apply to the other and vice versa.
103. In U.P. Assembly case (Special Reference No. 1 of 1964)22 , the b
controversy pertained to the privileges of the House in relation to the
fundamental rights of the citizens. The decision expressly stated that the Court
was not dealing with the internal proceedings of the House. We may profitably
reproduce two passages from the said judgment: (AIR pp. 781 & 790, paras 108
& 141)
"108. The obvious answer to this contention is that we are not dealing C
with any matter relating to the internal management of the House in the
present proceedings. We are dealing with the power of the House to punish
citizens for contempt alleged to have been committed by them outside, the
four walls of the House, and that essentially raises different considerations.
* * *
141. In conclusion, we ought to add that throughout our discussion we d
have consistently attempted to make it clear that the main point which we
are discussing is the right of the House to claim that a general warrant issued
by it in respect of its contempt alleged to have been committed by a citizen
who is not a Member of the House outside the four walls of the House, is
conclusive, for it is on that claim that the House has chosen to take the view
that the Judges, the Advocate, and the party have committed contempt by e
reference to their conduct in the habeas corpus petition pending before the
Lucknow Bench of the Allahabad High Court. ... "
104. The Court further observed: (U.P. Assembly case 22 , AIR p. 763,
para 43)
"43. In this connection it is necessary to remember that the status, f
dignity and importance of these two respective institutions, the legislatures
and the judicature, are derived primarily from the status, dignity and
importance of the respective causes that are assigned to their charge by the
Constitution. These two august bodies as well as the executive which is
another important constituent of a democratic State, must function not in
antinovel nor in a spirit of hostility, but rationally, harmoniously and in a g
spirit of understanding within their respective spheres, for such harmonious
working of the three constituents of the democratic State alone will help
the peaceful development, growth and stabilisation of the democratic way
of life in this country."
h
22 Powers, Privileges and Immunities of State Legislatures, In re, Special Reference No. 1 of
1964, AIR 1965 SC 745 : (1965) 1 SCR 413
604
-----------------------------------------------------------------------------------------------------------------------------------------------------------

105. In the said case, the Court was interpreting Article 194 of the
Constitution and, in that context, it held: (U.P. Assembly case 22 , AIR p. 760,
a para 31)
"31 . ... While interpreting this clause, it is necessary to emphasise
that the provisions of the Constitution subject to which freedom of speech
has been conferred on the legislators, are not the general provisions of
the Constitution but only such of them as relate to the regulation of the
procedure of the legislature. The rnles and standing orders may regulate the
b procedure of the legislature and some of the provisions of the Constitution
may also purport to regulate it; these are, for instance, Articles 208 and 211.
The adjectival clause "regulating the procedure of the legislature" governs
both the preceding clauses relating to "the provisions of the Constitution"
and "the rnles and standing orders". Therefore, clause (1) confers on
the legislators specifically the right of freedom of speech subject to the
C
limitation prescribed by its first part. It would thus appear that by making
this clause subject only to the specified provisions of the Constitution, the
Constitution-makers wanted to make it clear that they thought it necessary
to confer on the legislators freedom of speech separately and, in a sense,
independently of Article 19(1)(a). If all that the legislators were entitled to
claim was the freedom of speech and expression enshrined in Article 19(1)
d (a), it would have been unnecessary to confer the same right specifically
in the manner adopted by Article 194(1); and so, it would be legitimate
to conclude that Article 19(1)(a) is not one of the provisions of the
Constitution which controls the first part of clause (1) of Article 194."
106. Proceeding further, the Court in U.P. Assembly case 22 went on to
e say that clause (2) emphasises the fact that the said freedom is intended to
be absolute and unfettered. Similar freedom is guaranteed to the legislators
in respect of the votes they may give in the legislature or any committee
thereof. Interpreting clause (3), the Court rnled that the first part of this clause
empowers the Legislatures of the States to make laws prescribing their powers,
privileges and immunities; the latter part provides that until such laws are
f made, the legislatures in question shall enjoy the same powers, privileges
and immunities which the House of Commons enjoyed at the commencement
of the Constitution. The Constitution-makers, the Court observed, must have
thought that the legislatures would take some time to make laws in respect
of their powers, privileges and immunities. During the interval, it was clearly
necessary to confer on them the necessary powers, privileges and immunities.
g There can be little doubt that the powers, privileges and immunities which are
contemplated by clause (3) are incidental powers, privileges and immunities
which every legislature must possess in order that it may be able to function
effectively, and that explains the purpose of the latter part of clause (3).
107. The Court stated that all the four clauses of Article 194 are not in
terms made subject to the provisions contained in Part III. In fact, clause (2) is
h
1964, AIR 1965 SC 745 : (1965) 1 SCR 413
605
-----------------------------------------------------------------------------------------------------------------------------------------------------------

couched in such wide terms that in exercising the rights conferred on them by
clause (1), if the legislators by their speeches contravene any of the fundamental
rights guaranteed by Part III, they would not be liable for any action in any a
court. It further said: (U.P. Assembly case 22 , AIR p. 761, para 36)
"36. ... In dealing with the effect of the provisions contained in clause
(3) of Article 194, wherever it appears that there is a conflict between
the said provisions and the provisions pertaining to fundamental rights, an
attempt will have to be made to resolve the said conflict by the adoption of
the nlle of harmonious constrnction .... " b
108. Dealing with the plenary powers of the legislature, the Court ruled in
U.P. Assembly case 22 that these powers are controlled by the basic concepts of
the written Constitution itself and can be exercised within the legislative fields
allotted to their jurisdiction by the three Lists under the Seventh Schedule; but
beyond the Lists, the legislatures cannot travel. They can no doubt exercise their C
plenary legislative authority and discharge their legislative functions by virtue
of the powers conferred on them by the relevant provisions of the Constitution;
but the basis of the power is the Constitution itself. Besides, the legislative
supremacy of our legislatures including Parliament is normally controlled by
the provisions contained in Part III of the Constitution. If the legislatures step
beyond the legislative fields assigned to them, or while acting within their d
respective fields, they trespass on the fundamental rights of the citizens in a
manner not justified by the relevant articles dealing with the said fundamental
rights, their legislative actions are liable to be struck down by the courts in
India. Therefore, it is necessary to remember that though our legislatures have
plenary powers, yet they function within the limits prescribed by the material
and relevant provisions of the Constitution. e
109. Adverting to Article 212(1) of the Constitution, the Court in U.P.
Assembly case 22 held that the said Article seems to make it possible for a citizen
to call in question in the appropriate court of law the validity of any proceedings
inside the legislative chamber if his case is that the said proceedings suffer not
from mere irregularity of procedure, but from an illegality. If the impugned
procedure is illegal and unconstitutional, it would be open to be scrutinised in f
a court of law, though such scrutiny is prohibited if the complaint against the
procedure is no more than this that the procedure was irregular. That again is
another indication which may afford some assistance in construing the scope
and extent of the powers conferred on the House by Article 194(3).
110. In Raja Ram Pal v. Lok Sabha 75 , the Court, after referring to U.P.
Assembly case (Special Reference No. I of 1964)22 , observed that the privileges g
of Parliament are rights which are "absolutely necessary for the due execution
of its powers" which are enjoyed by individual Members as the House would
not be able to perform its functions without unimpeded use of the services of
22 Powers, Privileges and Immunities of State Legislatures, In re, Special Reference No. 1 of h
1964, AIR 1965 SC 745 : (1965) 1 SCR 413
75 (2007) 3 sec 184
606
-----------------------------------------------------------------------------------------------------------------------------------------------------------

its Members and also for the protection of its Members and the vindication
of its own authority and dignity. The Court, for the said purpose, referred to
a May's Parliamentary Practice . Parliamentary privilege conceptually protects
the Members of Parliament from undue pressure and allows them freedom to
function within their domain regard being had to the idea of sustenance of
legislative functionalism. The aforesaid protection is absolute.
M.2 Judicial review of parliamentary proceedings and its privilege
111. Commenting upon the effect of parliamentary privilege, the House
b
of Lords in Hamilton v. Al Fayed76 (Hamilton), AC p. 407 pointed out that
the normal impact of parliamentary privilege is to prevent the Court from
entertaining any evidence, cross-examination or submissions which challenge
the veracity or propriety of anything done in the course of parliamentary
proceedings.
C 112. With regard to the role of the Court in the context of parliamentary
privileges, Lord Brougham, in Wellesley v. Duke of B eaufort77 , has opined that
it is incumbent upon the courts of law to defend their high and sacred duty
of guarding themselves, the liberties and the properties of the subject, and
protecting the respectability and the very existence of the Houses of Parliament
themselves, against wild and extravagant and groundless and inconsistent
d notions of privilege.
113. The 1999 UK Joint Committee Report offers a useful analysis of the
respective roles to be played by Parliament and the courts in advancing the law
of parliamentary privilege:
"There may be good sense sometimes in leaving well alone when
problems have not arisen in practice. Seeking to clarify and define
e
boundaries may stir up disputes where currently none exists. But
Parliament is not always well advised to adopt a passive stance. There
is merit, in the particularly important areas of parliamentary privilege, in
making the boundaries reasonably clear before difficulties arise. Nowadays
people are increasingly vigorous in their efforts to obtain redress for
perceived wrongs. In their court cases they press expansively in areas where
f
the limits of the courts' jurisdiction are not clear. Faced with demarcation
problems in this jurisdictional no-man's land, the Judges perforce must
determine the position of the boundary. If Parliament does not act, the
courts may find themselves compelled to do so."
114. With respect to the position of parliamentary privileges and the role
g of the courts in Canada, the Supreme Court of Canada in N e w Brunswick
Broadcasting Co. v. Nova Scotia (Sp eaker of the House of Assembly )7 8 opined
that the Canadian legislative bodies possess such inherent privileges as may
be necessary to their proper functioning and that the said privileges are part
of the fundamental law of the land and are, hence, constitutional. Further, the
h 76 (2001) 1 AC 395 : (2000) 2 WLR 609 (HL)

77 (1831) 2 Russ & M 639 : 39 ER 538 : 1831 Eng R 809
78 1993 SCC OnLine Can SC 8: (1993) 1 SCR 319
607
-----------------------------------------------------------------------------------------------------------------------------------------------------------

Court observed that the courts have the power to determine if the privilege
claimed is necessary to the capacity of the legislature to function, but have no
power to review the correctness of a particular decision made pursuant to the a
privilege. In Harvey v. Attorney General for New Brunswick7 9 , the Court has
held that in order to prevent abuses in the guise of privilege from trumping
legitimate Charter interests, the courts must inquire into the legitimacy of a
claim of parliamentary privilege.
115. With respect to the review of parliamentary privilege, Lord Coleridge,
C.J., in Bradlaugh v. Gossett80 , observed that the question as to whether in all b
cases and under all circumstances the Houses are the sole judges of their own
privileges is not necessary to be determined in this case and that to allow any
review of parliamentary privilege by a court of law may lead and has led to
very grave complications. However, the Law Lord remarked that to hold the
resolutions of either House absolutely beyond any inquiry in any court of law
may land in conclusion not free from grave complications and it is enough to
C
say that in theory the question is extremely hard to solve.
116. Sir William Holdsworth in his book81 has also made the following
observations with regard to review of parliamentary privileges:
"There are two maxims or principles which govern this subject. The
first tells us that 'Privilege of Parliament is part of the law of the land';
the second that 'Each House is the judge of its own privileges'. Now at d
first sight it may seem that these maxims are contradictory. If privilege of
Parliament is part of the law of the land its meaning and extent must be
interpreted by the courts, just like any other part of the law; and therefore,
neither House can add to its privileges by its own resolution, any more than
it can add to any other part of the law by such a resolution.
On the other hand if it is true that each House is the sole judge of its own e
privileges, it might seem that each House was the sole judge as to whether
or not it had got a privilege, and so could add to its privileges by its own
resolution. This apparent contradiction is solved if the proper application
of these two maxims is attended to. The first maxim applies to cases like
Ashby v. White 82 and Stockdale v. Hansard 83 , in which the question at issue
was the existence of a privilege claimed by the House. f
This is a matter of law which the courts must decide, without paying
any attention to a resolution of the House on the subject. The second maxim
applies to cases like that of the Sheriff of Middlesex 84 and Bradlaugh v.
Gossett 80 , in which an attempt was made to question, not the existence but
the mode of user of an undoubted privilege. On this matter the courts will
g
not interfere because each House is the sole judge of the question whether,
when or how it will use one of its undoubted privileges."
79 1996 SCC OnLine Can SC 80: (1996) 2 SCR 876

80 (1884) LR 12 QBD 271 : 53 LJQB 290: 50 LT 620 (DC)
81 A Histo1y of English Law.
82 (1703) 2 Ld Rayrn 938 : 92 ER 126 h
83 (1839)9Ad&El :112ER1112(QB)
84 (1840) 11 Ad&E273: (1840) 113ER419
608
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117. At this juncture, it is fruitful to refer to Articles 121 and 122 of the
Constitution. They read as follows:
a "121. Restriction on discussion in Parliament.-No discussions shall
take place in Parliament with respect to the conduct of any Judge of the
Supreme Court or of a High Court in the discharge of his duties except upon
a motion for presenting an address to the President praying for the removal of
the Judge as hereinafter provided.
122. Courts not to inquire into proceedings of Parliament.-(!) The
b validity of any proceedings in Parliament shall not be called in question on the
ground of any alleged irregularity of procedure.
(2) No officer or Member of Parliament in whom powers are vested by or
under this Constitution for regulating procedure or the conduct of business, or
C
118. As we perceive, the aforesaid Articles are extremely significant as
they are really meant to state the restrictions imposed by the Constitution on
both the institutions.
119. In Raja Ram Pal7 5 , a Constitution Bench, after referring to U.P
Assembly case (Sp ecial Reference No. 1 of 1964)22 , opined: (Raja Ram Pal
d case 75 , sec p. 315, paras 267 & 268)
"267. Indeed, the thrust of the decision was on the examination of the
power to issue unspeaking warrants immune from the review of the courts,
and not on the power to deal with contempt itself. A close reading of the
case demonstrates that the Court treated the power to punish for contempt
as a privilege of the House. Speaking of the legislatures in India, it was
e
stated: ( U.P Assembly case 22 , AIR p. 786, para 125)
'125. There is no doubt that the House has the power to punish for
contempt committed outside its chamber, and from that point of view
it may claim one of the rights possessed by a court of record.'
268. Speaking of the Judges' power to punish for contempt, the Court
f observed: (U.P Assembly case 22 , AIR p. 791, para 142)
'42 . ... We ought never to forget that the power to punish for
contempt large as it is, must always be exercised cautiously, wisely
and with circumspection. Frequent or indiscriminate use of this power
in anger or irritation would not help to sustain the dignity or status of
g the court, but may sometimes affect it adversely. Wise Judges never
forget that the best way to sustain the dignity and status of their office
is to deserve respect from the public at large by the quality of their
judgments, the fearlessness, fairness and objectivity of their approach,
and by the restraint, dignity and decorum which they observe in their
h 75 Raja Ram Pal v. Lok Sabha , (2007) 3 SCC 184

1964, AIR 1965 SC 745 : (1965) 1 SCR 413
609
-----------------------------------------------------------------------------------------------------------------------------------------------------------

judicial conduct. We venture to think that what is true of th e judicature
is equally true of the legislatures.' " (emphasis in original)
And again: (SCC pp. 315-16, para 269) a
"269. It is evident, therefore, that in the opinion of the Court in U.P.
Assembly case (Special Reference No. 1 of 1964 )22 , legislatures in India do
enjoy the power to punish for contempt. It is equally clear that while the
fact that the House of Commons enjoyed the power to issue unspeaking
warrants in its capacity of a court of record was one concern, what actually b
worried the Court was not the source of the power per se, but the "judicial"
nature of power to issue unspeaking warrant insofar as it was directly
in conflict with the scheme of the Constitution whereby citizens were
guaranteed fundamental rights and the power to enforce the fundamental
rights is vested in the courts. It was not the power to punish for contempt
about which the Court had reservations. Rather, the abovequoted passage C
shows that such power had been accepted by the Court. The issue decided
concerned the non-reviewability of the warrant issued by the legislature, in
the light of various constitutional provisions."
120. After referring to various other decisions, the Court summarised the
principles relating to the parameters of judicial review in relation to exercise
of parliamentary provisions. Some of the conclusions being relevant for the d
present purpose are reproduced below: (Raja Ram Pal case 75 , SCC pp. 371-73,
para 431)
"(a) Parliament is a coordinate organ and its views do deserve
deference even while its acts are amenable to judicial scrutiny;
(b) The constitutional system of Government abhors absolutism and e
it being the cardinal principle of our Constitution that no one, howsoever
lofty, can claim to be the sole judge of the power given under the
Constitution, mere coordinate constitutional status, or even the status of
an exalted constitutional functionaries, does not dis entitle this Court from
exercising its jurisdiction of judicial review of actions which partake the
character of judicial or quasi-judicial decision; f
(c) The expediency and necessity of exercise of power or privilege by
the legislature are for the determination of the legislative authority and not
for determination by the courts;
(d) The judicial review of the manner of exercise of power of contempt
or privilege does not mean the said jurisdiction is being usurped by the
judicature; g
* * *
22 Powers, Privileges and Immunities of State Legislatures, In re, Special Ref erence No. 1 of h
1964, AIR 1965 SC 745 : (1965) 1 SCR 413
610
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(j) The fact that Parliament is an august body of coordinate
constitutional position does not mean that there can be no judicially
a manageable standards to review exercise of its power;
(g) While the area of powers, privileges and immunities of the
legislature being exceptional and extraordinary its acts, particularly relating
to exercise thereof, ought not to be tested on the traditional parameters of
judicial review in the same manner as an ordinary administrative action
would be tested, and the Court would confine itself to the acknowledged
b parameters of judicial review and within the judicially discoverable and
manageable standards, there is no foundation to the plea that a legislative
body cannot be attributed jurisdictional error;
(h) The judicature is not prevented from scrutinising the validity of the
action of the legislature trespassing on the fundamental rights conferred
on the citizens;
C
(i) The broad contention that the exercise of privileges by legislatures
cannot be decided against the touchstone of fundamental rights or the
constitutional provisions is not correct;
(j) If a citizen, whether a non-Member or a Member of the legislature,
complains that his fundamental rights under Article 20 or 21 had been
contravened, it is the duty of this Court to examine the merits of
d
the said contention, especially when the impugned action entails civil
consequences;
(k) There is no basis to the claim of bar of exclusive cognizance or
absolute immunity to the parliamentary proceedings in Article 105(3) of
the Constitution;
e (l) The manner of enforcement of privilege by the legislature can result
in judicial scrutiny, though subject to the restrictions contained in the other
constitutional provisions, for example Article 122 or 212;
(m) Article 122(1) and Article 212(1) displace the broad doctrine of
exclusive cognizance of the legislature in England of exclusive cognizance
of internal proceedings of the House rendering irrelevant the case law that
f emanated from courts in that jurisdiction; inasmuch as the same has no
application to the system of governance provided by the Constitution of
India;
(n) Article 122(1) and Article 212(1) prohibit the validity of any
proceedings in legislature from being called in question in a court merely
on the ground of irregularity of procedure;
g
* * *
(r) Mere availability of the Rules of Procedure and Conduct of
Business, as made by the legislature in exercise of enabling powers under
the Constitution, is never a guarantee that they have been duly followed;
(s) The proceedings which may be tainted on account of substantive
h or gross illegality or unconstitutionality are not protected from judicial
scrutiny;
611
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(t) Even if some of the material on which the action is taken is found
to be irrelevant, the court would still not interfere so long as there is some
relevant material sustaining the action; a
(u) An ouster clause attaching finality to a determination does
ordinarily oust the power of the court to review the decision but not
on grounds of lack of jurisdiction or it being a nullity for some
reason such as gross illegality, irrationality, violation of constitutional
mandate, mala fides, non-compliance with rules of natural justice and
perversity." (emphasis supplied) b
121. The aforesaid summarisation succinctly deals with the judicial review
in the sense that the constitutional courts are not prevented from scrntinising
the validity of the action of the legislature trespassing on the fundamental
rights conferred on the citizens; that there is no absolute immunity to the
parliamentary proceeding under Article 105(3) of the Constitution; that the
C
enforcement of privilege by the legislature can result in judicial scrutiny
though subject to the restrictions contained in other constitutional provisions
such as Articles 122 and 212; that Article 122(1) and Article 212(1) prohibit
the validity of any proceedings in the legislature from being called in
question in a court merely on the ground of irregularity of procedure, and the
proceedings which may be tainted on account of substantive or gross illegality
d
or unconstitutionality are not protected from judicial scrutiny.
122. We are presently concerned with the interpretation of two
constitutional provisions, namely, Articles 122 and 105. It has been submitted
by the learned counsel on behalf of the petitioners that the reports of
Parliamentary Committees have various facets, namely, statement of fact made
to the committee, statement of policy made to the committee, statements
e
of fact made by Members of Parliament in Parliament and inference drawn
from facts and findings of fact and law and, therefore, the Court is required
to pose the question as to which of the above aspects of the Parliamentary
Committee reports can be placed reliance upon. The contention is structured
on the foundation that committee reports are admissible in evidence and in
public interest litigation in exercise of power under Article 32 for interpreting
f
the legislation and directing the implementation of constitutional or statutory
obligation by the executive.
N. Reliance on parliamentary proceedings as external aids
123. A Constitution Bench in R.S. Nayak v. A.R. Antulay 85 , after referring
to various decisions of this Court and development in the law, opined that the
exclusionary rule is flickering in its dying embers in its native land of birth and g
has been given a decent burial by this Court. The Constitution Bench further
observed that the basic purpose of all canons of the Constitution is to ascertain
with reasonable certainty the intention of Parliament and for the said purpose,
external aids such as reports of Special Committee preceding the enactment, the
existing state of law, the environment necessitating enactment of a legislation
h
85 (1984) 2 sec 183 : 1984 sec (Cri) 1n
612
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and the object sought to be achieved, etc. which Parliament held the luxury of
availing should not be denied to the court whose primary function is to give
a effect to the real intention of the legislature in enacting a statute. The Court
was of the view that such a denial would deprive the Court of a substantial
and illuminating aid to construction and, therefore, the Court decided to depart
from the earlier decisions and held that reports of committees which preceded
the enactment of a law, reports of Joint Parliamentary Committees and a report
of a commission set up for collecting information can be referred to as external
b aids of construction.
124. In this regard, we may also usefully state that the speeches of Ministers
in Parliament are referred to on certain occasions for limited purposes. A
Constitution Bench in State of WE. v. Union of India 86 has opined that it is,
however, well settled that the Statement of Objects and Reasons accompanying
a Bill, when introduced in Parliament, cannot be used to determine the true
C meaning and effect of the substantive provisions of the statute. They cannot be
used except for the limited purpose of understanding the background and the
antecedent state of affairs leading up to the legislation. The same cannot be used
as an aid to the construction of the enactment or to show that the legislature did
not intend to acquire the proprietary rights vested in the State or, in any way, to
affect the State Governments' rights as owners of minerals. A statute, as passed
d by Parliament, is the expression of the collective intention of the legislature
as a whole, and any statement made by an individual, albeit a Minister, of the
intention and objects of the Act cannot be used to cut down the generality of
the words used in the statute.
125. In K.P. Varghese v. CIT87 , the Court, while referring to the Budget
Speech of the Minister, ruled that speeches made by Members of legislatures
e on the floor of the House where a Bill for enacting a statutory provision is being
debated are inadmissible for the purpose of interpreting the statutory provision.
But the Court made it clear that the speech made by the mover of the Bill
explaining the reasons for introducing the Bill can certainly be referred to for
ascertaining the mischief sought to be remedied and the object and the purpose
of the legislation in question. Such a view, as per the Court, was in consonance
f with the juristic thought not only in the western countries but also in India as in
the exercise of interpretation of a statute, everything which is logically relevant
should be admitted. Thereafter, the Court acknowledged a few decisions of this
Court where speeches made by the Finance Minister were relied upon by the
Court for the purpose of ascertaining the reason for introducing a particular
clause.
g
126. Similar references have also been made in Ramesh Yeshwant Prabhoo
v. Prabhakar Kashinath Kunte 88 . That apart, parliamentary debates have also
been referred to appreciate the context relating to the constrnction of a statute
h 86 AIR 1963 SC 1241

87 (1981) 4 sec 173: 1981 sec (Tax) 293
88 (1996) 1 sec 130
613
-----------------------------------------------------------------------------------------------------------------------------------------------------------

in Novartis AG v. Union of India 89 , State of M.P. v. Dadabhoy 's New Chirimiri
Ponri Hill Colliery Co. (P) Ltd. 90 , Union of India v. Steel Stock Holders'
Syndicate 91 , K.P. Varghese 87 and Surana Steels (P) Ltd. v. CII9 2 . a
127. InAshoka Kumar Thakur v. Union of India 93 , this Court, after referring
to Crawford on Statutory Construction, observed that the rule of exclusion
followed in the British courts has been criticised by jurists as artificial and there
is a strong case for whittling down the said rule. The Court was of the view that
the trend of academic opinion and practice in the European system suggests that
the interpretation of a statute being an exercise in the ascertainment of meaning, b
everything which is logically relevant should be admissible which implies that
although such extrinsic materials shall not be decisive, yet they should at least
be admissible. Further, the Court took note of the fact that there is authority
to suggest that resort should be had to these extrinsic materials only in case of
incongruities and ambiguities. Where the meaning of the words in a statute is
plain, then the language prevails, but in case of obscurity or lack of harmony C
with other provisions and in other special circumstances, it may be legitimate to
take external assistance to determine the object of the provisions, the mischief
sought to be remedied, the social context, the words of the authors and other
allied matters.
128. In CIT v. Surat Art Silk Cloth Manufacturers' Assn. 94 , this Court held:
(SCC p. 75, para 76) d
"76. It is legitimate to look at the state of law prevailing leading to the
legislation so as to see what was the mischief at which the Act was directed.
This Court has on many occasions taken judicial notice of such matters as
the reports of Parliamentary Committees, and of such other facts as must
be assumed to have been within the contemplation of the legislature when
the Acts in question were passed." e
129. We have referred to these authorities to highlight that the reports or
speeches have been referred to or not referred to for the purposes indicated
therein and when the meaning of a statute is not clear or ambiguous, the
circumstances that led to the passing of the legislation can be looked into
in order to ascertain the intention of the legislature. It is because the reports
assume significance and become relevant because they precede the formative f
process of a legislation.
130. In Pepper (Inspector of Taxes) v. Hart 95 , Lord Browne-Wilkinson,
delivering the main speech, set out the test as follows: (AC p. 640)
"I therefore reach the conclusion, subject to any question of
Parliamentary privilege, that the exclusionary rule should be relaxed so
g
89 (2013) 6 sec 1 : (2013) 3 sec (Civ) 227
90 (1972) 1 sec 298
91 (1976)3SCC108
87 K.P. Varghese v. CIT, (1981) 4 SCC 173: 1981 SCC (Tax) 293
92 (1999) 4 sec 306
93 (2008) 6 sec 1 : 3 SCEC 35 h
94 (1980) 2 SCC 31 : 1980 SCC (Tax) 170
95 1993 AC 593: (1992) 3 WLR 1032: 1992 UKHL 3 (HL)
614
-----------------------------------------------------------------------------------------------------------------------------------------------------------

as to permit reference to Parliamentary materials where (a) legislation is
ambiguous or obscure, or leads to an absurdity; (b) the material relied upon
a consists of one or more statements by a Minister or other promoter of
the Bill together if necessary with such other Parliamentary material as is
necessary to understand such statements and their effect; (c) the statements
relied upon are clear."
131. The Supreme Court of Canada in R. v. Vasil 96 relied on parliamentary
materials to interpret the phrase "unlawful object" in Section 212(c) of the
b Canadian Criminal Code. Speaking for the majority, Lamer, J. (as he then was)
said: (SCC OnLine Can SC)
"Reference to Hansard is not usually advisable. However, as Canada
has, at the time of codification, subject to few changes, adopted the English
Draft Code of 1878, it is relevant to know whether Canada did so in
C relation to the various sections for the reasons advanced by the English
Commissioners or for reasons of its own.
Indeed, a reading of Sir John Thompson's comments in Hansard of
12-4-1892, (House of Commons Debates, Dominion of Canada, Session
1892, Vol. I at pp. 1378-85) very clearly confirms that all that relates to
murder was taken directly from the English Draft Code of 1878. Sir John
d Thompson explained the proposed murder sections by frequently quoting
verbatim the reasons given by the Royal Commissioners in Great Britain,
and it is evident that Canada adopted not only the British Commissioners'
proposed sections but also their reasons."
The Canadian authorities, as is noticeable from Anti-Inflation Act, In re 97 , have
relaxed the exclusionary rule.
e
132. In Dharam Dutt v. Union of India 98 , the Court took note of the three
Parliamentary Standing Committees appointed at different points of time which
had recommended the taking over of Sapru House on the ground of declining
standard of the Institution. Further, this Court took note that it had already
pointed out in an earlier part of this judgment that in the present case, successive
f
Parliamentary Committees had found substance in the complaints received
that an institution of national importance was suffering from mismanagement
and maladministration and in pursuance of such PSC report, the Central
Government acted on such findings.
133. In Kuldip Nayar 53 , certain amendments in the Representation of the
People Act, 1951 were challenged which had the effect of adopting an open
g ballot system instead of a secret ballot system for elections to the Rajya Sabha.
Defending the amendment, the Union of India submitted a copy of a Report
of the Ethics Committee of Parliament which recommended the open ballot
system for the aforesaid purpose. The Committee had noted the emerging
96 1981 SCC OnLine Can SC 19 : (1981) 1 SCR 469 : (1981) 121 DLR (3d) 41
h 97 1976 SCC OnLine Can SC 69: (1976) 2 SCR 373: (1976) 68 DLR (3d) 452
98 (2004) 1 sec 112
53 Kuldip Nayar v. Union of India, (2006) 7 SCC 1
615
-----------------------------------------------------------------------------------------------------------------------------------------------------------

trends of cross voting in elections for Rajya Sabha and Legislative Councils
in the State. It also made a reference to rampant allegations that large sums of
money and other considerations encourage the electorate to vote in a particular a
manner sometimes leading to defeat of official candidates belonging to their
own political party. In this context, the Court took note of the recommendations
of the Committee report while testing the vires of the impugned amendment.
134. From the aforesaid, it clear as day that the Court can take aid of
the report of the Parliamentary Committee for the purpose of appreciating
the historical background of the statutory provisions and it can also refer to b
committee report or the speech of the Minister on the floor of the House of
Parliament if there is any kind of ambiguity or incongruity in a provision of
an enactment.
135. Further, it is quite vivid on what occasions and situations
the Parliamentary Standing Committee reports or the reports of other
Parliamentary Committees can be taken note of by the court and for what C
purpose. Relying on the same for the purpose of interpreting the meaning of
the statutory provision where it is ambiguous and unclear or, for that matter, to
appreciate the background of the enacted law is quite different from referring
to it for the purpose of arriving at a factual finding. That may invite a contest,
a challenge, a dispute and, if a contest arises, the Court, in such circumstances,
will be called upon to rule on the same. d
136. In the case at hand, what is urged by the learned counsel for the
petitioners is that though no interpretation is involved, yet they can refer to
the report of the Parliamentary S landing Committee to establish a fact which
they have pleaded and asserted in the writ petition. According to them, the
committees are constituted to make the executive accountable and when the
public interest litigation is preferred to safeguard the public interest, the report e
assumes great significance and it is extremely necessary to refer to the same to
arrive at the truth of the controversy. In such a situation, they would contend
that the question of aid does not relate to any kind of parliamentary privilege.
137. It is the stand of the petitioners that they do not intend to seek
liberty from Parliament or the Parliamentary Committee to be questioned or
f
cross-examined. In fact, reliance of the report has nothing to do with what is
protected by the Constitution under Article 105. The court proceedings are
independent of Parliament and based on multiple inputs, materials and evidence
and in such a situation, the parties are at liberty to persuade the court to come
to a determination of facts and form an opinion in law at variance with the
Parliamentary Committee report. The learned counsel for the petitioners would
g
further submit that advancing submissions relying on the report would not come
within the scope of parliamentary privilege.
0. Section 57(4) of the Evidence Act
138. The learned counsel for the petitioners propound that under
Section 57(4) of the Evidence Act, the Parliamentary Standing Committee
report can be judicially taken note of as such report comes within the ambit of h
the said provision.
616
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139. To appreciate the stand, it is necessary to scan the relevant clause (4)
of Section 57 of the Evidence Act. It reads as follows:
a "57. Facts of which Court must take judicial notice .-The Court shall
take judicial notice of the following facts-
* * *
(4) The course of proceeding of Parliament of the United Kingdom,
of the Constituent Assembly of India, of Parliament and of the legislatures
established under any law for the time being in force in a Province or in
b
the States;"
140. Section 57 is a part of Chapter III of the Evidence Act which deals
with "Facts which need not be proved". Section 57 rests on the assumption
that the facts scripted in the thirteen sub-sections are relevant under any one
or more sections of Chapter II which deals with "relevancy of facts". Thus,
C Section 57, by employing the word "shall", casts an obligation upon the courts
to take judicial notice of the said facts. Section 57, clause (4) of the Evidence
Act casts an obligation on the courts to take judicial notice of the course of
proceedings of Parliament.
141. This Court, in Lok Shikshana Trust v. CTI99 , has observed that
Section 57, clause (4) enjoins upon the courts to take judicial notice of the
d course of proceedings of Parliament on the assumption that it is relevant.
142. There can be no dispute that Parliamentary Standing Committee report
being in the public domain is a public document. Therefore, it is admissible
under Section 7 4 of the Evidence Act and judicial notice can be taken of such
a document as envisaged under Section 57(4) of the Evidence Act. There can
be no scintilla of doubt that the said document can be taken on record. As
e stated earlier, it can be taken aid of to understand and appreciate a statutory
provision if it is unclear, ambiguous or incongruous. It can also be taken aid
of to appreciate what mischief the legislative enactment intended to avoid.
Additionally, it can be stated with certitude that there can be a fair comment on
the report and a citizen in his own manner can advance a criticism in respect of
what the report has stated. Needless to emphasise that the right to fair comment
f is guaranteed to the citizens. It is because freedom of speech, as permissible
within constitutional parameters, is essential for all democratic institutions. Fair
comments show public concern and, therefore, such comments cannot be taken
exception to. That is left to public opinion and perception on which the grand
pillar of democracy is further strengthened. And, in all such circumstances, the
question of parliamentary privilege would not arise.
g
143. In the case at hand, the controversy does not end there inasmuch as
the petitioners have placed reliance upon the contents of the Parliamentary
S landing Committee report and the respondents submit that they are forced
to controvert the same. Be it clearly stated, the petitioners intend to rely on
the contents of the report and invite a contest. In such a situation, the Court
would be duty-bound to afford the respondents an opportunity of being heard
h
99 (1976) 1 SCC 254 : 1976 SCC (Tax) 14
617
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in consonance with the principles of natural justice. This, in turn, would give
rise to a very peculiar situation as the respondents would invariably be left with
the option either to: (i) accept, without contest, the opinion expressed in the a
Parliamentary Standing Committee report and the facts stated therein; or (ii)
contest the correctness of the opinion of the Parliamentary Standing Committee
report and the facts stated therein. In the former scenario, the respondents at
the very least would be put in an inequitable and disadvantageous position.
It is in the latter scenario that the Court would be called upon to adjudicate
the contentious facts stated in the report. Ergo, whenever a contest to a factual b
finding in a PSC report is likely and probable, the Court should refrain from
doing so. It is one thing to say that the report being a public document is
admissible in evidence, but it is quite different to allow a challenge.
144. It is worthy to note here that there is an intrinsic difference between
parliamentary proceedings which are in the nature of statement of a Minister
or of a Mover of a Bill made in Parliament for highlighting the purpose of an C
enactment or, for that matter, a Parliamentary Committee report that had come
into existence prior to the enactment of a law and a contestable/conflicting
matter of "fact" stated in the Parliamentary Committee report. It is the
parliamentary proceedings falling within the former category of which courts
are enjoined under Section 57, clause (4) to take judicial notice of, whereas,
for the latter category of parliamentary proceedings, the truthfulness of the d
contestable matter of fact stated during such proceedings has to be proved in
the manner known to law.
145. This again brings us to the hazardous zone wherein taking judicial
notice of Parliamentary Standing Committee reports for a factual finding will
obviously be required to be proved for ascertaining the truth of a contestable
matter of fact stated in the said report. e
146. Taking judicial notice of the Parliamentary S landing Committee report
can only be to the extent that such a report exists. As already stated, the said
report can be taken aid of for understanding the statutory provision wherever it
is felt so necessary or to take cognizance of a historical fact that is different from
a contest. The word "contest", according to Black's Law Dictionary, means to
make defence to an adverse claim in a court of law; to oppose, resist or dispute; f
to strive to win or hold; to controvert, litigate, call in question, challenge
to defend. This being the meaning of the word "contest", the submission to
adjudge the lis on the factual score of the report is to be negatived.
P. The decisions in which Parliamentary Standing Committee report(s) have
been referred to g
147. Before we proceed to record our conclusions, it is necessary to allude
to various authorities cited by the petitioners herein highlighting the occasions
where this Court has referred to and taken note of various Parliamentary
Committee reports. In Catering Cleaners of Southern Railway v. Union of
lndia 100 , the catering cleaners of the Southern Railway filed a writ petition
h
100 (1987) 1 sec 100: 1987 sec (L&S) 77
618
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praying for abolition of the contract labour system and their absorption as direct
employees of the principal employer viz. the Southern Railway. This Court
a referred to the Parliamentary Committee report under the Chairmanship ofK.P.
Tewari which had dealt with the question of abolishing the contract labour
system and regularising the services of the catering cleaners. The Committee
had, inter alia, recommended that the Government should consider direct
employment of catering cleaners by the Railway Administration to avoid their
exploitation.
b 148. In State of Maharashtra v. Milind 101 , the issue was whether the
tribe of "Halba-Koshtis" were treated as "Halbas" in the specified areas
of Vidarbha. This Court, in the said case, referred to the report of Joint
Parliamentary Committee which did not make any recommendation to include
"Halba-Koshti" in the Scheduled Tribes Order. Again, in Federation of Railway
Officers Assn. 18 , this Court alluded to the reports and recommendations of
C several committees such as the Railways Reforms Committee in 1984 which
recommended the formation of new four zones; the Standing Committee report
of Parliament on Railway which recommended for creation of new zones on
the basis of work load, efficiency and effective management and the Rakesh
Mohan Committee Report which had suggested that the formation of additional
zones would be of dubious merit and would add substantial cost and be of little
d value to the system.
149. In Aruna Roy v. Union of India 102 , the education policy framed by
NCERT was challenged by the petitioners. This Court while dealing with the
said issue, referred, in extenso, to the Parliamentary Committee report which
had made several recommendations in this regard. After so referring to the
report, the Court was of the view that if the recommendations made by the
e Parliamentary Committee are accepted by the NCERT and are sought to be
implemented, it cannot be stated that its action is arbitrary or unjustified.
150. In M.C. Mehta v. Union of India 103 , this Court referred to the report
of the Standing Committee of Parliament on Petroleum & Natural Gas which
expressed concern over the phenomenal rise of air pollution and made some
f recommendations. The Court, in this case, made it clear that it had mentioned
the report only for indicating that the Government was and is proactively
supporting the reduction of vehicular pollution by controlling the emission
norms and complying with the Bharat Stage standards.
151. In Lal Babu Priyadarshi v. Amritpal Singh 104 , while dealing with a
trade mark case under various sections of the Trade and Merchandise Marks
g Act, 1958 [repealed by the Trade Marks Act, 1999 (47 of 1999)], this Court
referred to the Eighth Report on the Trade Marks Bill, 1993 submitted by
the Parliamentary Standing Committee which was of the opinion that any
101 c2001) 1 sec 4: 2001 sec (L&S) 111
18 Federation of Railway Officers Assn. v. Union of India, (2003) 4 SCC 289 : AIR 2003 SC 1344
h 102 (2002) 7 sec 368: 5 SCEC 310
103 c2017) 7 sec 243
104 (2015) 16 sec 795 : (2016) 3 sec (Civ) 649
619
-----------------------------------------------------------------------------------------------------------------------------------------------------------

symbol relating to gods, goddesses or places of worship should not ordinarily
be registered as a trade mark.
152. The petitioners have also referred to other cases such as Gujarat a
Electricity Board v. Hind Mazdoor Sabha 105 ,
Modern Dental College &
R esearch Centre v. State of M.P. 106 andKrishan Lal Gera v. State ofHaryana 107
wherein also this Court has made a passing reference to reports of the
Parliament Standing Committees.
153. We have, for the sake of completeness, noted the decisions relied upon b
by the petitioners to advance their stand. But it is condign to mention here that
in the abovereferred cases, the question of contest/challenge never emerged.
In all the cases, the situation never arose that warranted any contest amongst
the competing parties for arriving at a particular factual finding. That being
the position, the said judgments, in our considered opinion, do not render any
assistance to the controversy in question. C
154. We have distinguished the said decisions, as we are disposed to
think that a party can always establish his case on the materials on record
and the Court can independently adjudicate the controversy without allowing
a challenge to Parliamentary Standing Committee report. We think so as
the Court has a constitutional duty to strike a delicate balance between the
d
legislature and the judiciary. It is more so when the issue does not involve a
fundamental right that is affected by parliamentary action. In such a situation,
we may deal with the concept of jurisprudential foundational principle having
due regard to constitutional conscience. The perception of self-evolved judicial
restraint and the idea of jurisprudential progression has to be juxtaposed
for a seemly balance. There is no straitjacket formula for determining what e
constitutes judicial restraint and judicial progressionism. Sometimes, there is
necessity for the courts to conceptualise a path that can be a wise middle
path. The middle course between these two views is the concept of judicial
engagement so that the concept of judicial restraint does not take the colour
of judicial abdication or judicial passivism. Judicial engagement requires that
the courts maintain their constitutional obligation to remain the sentinel on qui f
vive. It requires a vigilant progressive judiciary for the rights and liberties of
the citizens to be sustained. Thus, as long as a decision of a court is progressive
being in accord with the theory of judicial engagement, the approach would
be to ensure the proper discharge of duty by the constitutional courts so as to
secure the inalienable rights of the citizens recognised by the Constitution. A
constitutional court cannot abdicate its duty to allow injustice to get any space g
or not allow real space to a principle that has certain range of acceptability.
105 (1995) 5 sec 27: 1995 sec (L&S) 1166 h

106 (2016) 7 sec 353: 7 SCEC 1
107 c2011) 10 sec 529
620
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155. Stradford, C.J., speaking the tone and tenor in Jajbhay v. Cassim 108 ,
AD p. 542 has observed:
a "Now the Roman-Dutch law, which we must apply, is a living system
capable of growth and development to allow adaptation to the increasing
complexities and activities of modern civilised life. The instruments of that
development are our own courts of law. In saying that, of course, I do not
mean that it is permissible for a court of law to alter the law; its function is
to elucidate, expound and apply the law. But it would be idle to deny that
b in the process of the exercise of those functions rules of law are slowly and
beneficially evolved."
156. In Miranda v. Arizona 109 , the Supreme Court of the United States
observed: (SCC OnLine US SC para 169)
"169. That the Court's holding today is neither compelled nor even
strongly suggested by the language of the Fifth Amendment, is at odds
C
with American and English legal history, and involves a departure from a
long line of precedent does not prove either that the Court has exceeded its
powers or that the Court is wrong or unwise in its present reinterpretation
of the Fifth Amendment. It does, however, underscore the obvious-that
the Court has not discovered or found the law in making today's decision,
nor has it derived it from some irrefutable sources; what it has done is to
d make new law and new public policy in much the same way that it has in
the course of interpreting other great clauses of the Constitution. This is
what the Court historically has done. Indeed, it is what it must do and will
continue to do until and unless there is some fundamental change in the
constitutional distribution of governmental powers."
157. In the Indian context, this Court has recognised the comprehensive,
e
progressive and engaging role of constitutional courts in a catena of judgments
starting from Lakshmi Kant Pandey v. Union of lndia 110 , Vishaka v. State of
Rajasthan 111 , Prakash Singh v. Union of lndia 112 , Common Cause v. Union
of lndia 113 and Shakti Vahini v. Union of lndia 114 . In all these judgments, the
dynamic and spirited duty of the Supreme Court has been recognised and it
has been highlighted that this Court ought not to shy away from its primary
f
responsibility of interpreting the Constitution and other statutes in a manner that
is not only legally tenable but also facilitates the progress and development of
the avowed purpose of the rights-oriented Constitution. The Constitution itself
being a dynamic, lively and ever changing document adapts to the paradigm of
epochs. That being the situation, it is also for this Court to take a fresh look and
mould the existing precepts to suit the new emerging situations. Therefore, the
g constitutional courts should always adopt a progressive approach and display
108 1939 AD 537

109 1966 SCC OnLine US SC 112: 16 L Ed 2d 694: 384 US 436 (1966)
110 (1984) 2 sec 244
111 (1997) 6 sec 241: 1997 sec (Cri) 932
h 112 c2006) 8 sec 1 : c2006) 3 sec (Cri) 417
113 c2018) s sec 1
114 (2018)7SCC192
621
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a dynamic and spirited discharge of duties regard being had to the concepts
of judicial statesmanship and judicial engagement, for they subserve the larger
public interest. a
158. In the case at hand, the constitutional obligation persuades us to
take the view that the Parliamentary Standing Committee report or any
Parliamentary Committee report can be taken judicial notice of and regarded
as admissible in evidence, but it can neither be impinged nor challenged nor its
validity can be called in question.
Q. Conclusions b
159. In view of the aforesaid analysis, we answer the referred questions in
the following manner:
159.1. Parliamentary Standing Committee report can be taken aid of for the
purpose of interpretation of a statutory provision wherever it is so necessary
and also it can be taken note of as existence of a historical fact.
159.2. Judicial notice can be taken of the Parliamentary Standing C
Committee report under Section 57(4) of the Evidence Act and it is admissible
under Section 74 of the said Act.
159.3. In a litigation filed either under Article 32 or Article 136 of
the Constitution of India, this Court can take on record the report of the
Parliamentary Standing Committee. However, the report cannot be impinged
or challenged in a court of law. d
159.4. Where the fact is contentious, the petitioner can always collect the
facts from many a source and produce such facts by way of affidavits, and the
court can render its verdict by way of independent adjudication.
159.5. The Parliamentary Standing Committee report being in the public
domain can invite fair comments and criticism from the citizens as in such a
situation, the citizens do not really comment upon any Member of Parliament e
to invite the hazard of violation of parliamentary privilege.
160. The reference is answered accordingly.
161. Let the writ petitions be listed before the appropriate Bench for
hearing.
DR D.Y. CHANDRACHUD, J. (for Sikri, J. and himself, concurring)- This
judgment has been divided into sections to facilitate analysis. They are: f
INDEX
i Sl. No. : Heading Page No.

: A. : Reference to the Constitution Bench : 87 :
1 B. [Submissions 1 1 89
1 C. [The Constitution 1 1 92 g
1 D. [Parliamentary Standing Committees 1 1 95
1 E. [Parliamentary privilege 1 1 98
1 l E.1 :UK decisions 1 1 98
1 l E.2 hndia 1 1109
1 F. lSeparation of powers: A nuanced modern doctrine 1 1115
; ~: !~::i 1~t:~onna81 relationship·······················································+·········~~~ ···········i

.........................................................................................................................................................
h
622
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KALPANA MEHTA v. UNION OF INDIA (Dr Chandrachud, J.) 87

A. Reference to the Constitution Bench
163. Two public interest petitions instituted before this Court under Article
a 32 of the Constitution in 2012 and 2013 have placed into focus the process
adopted for licensing vaccines 115 to prevent cervical cancer. The petitioners
allege that the process of licensing was not preceded by adequate clinical trials
to ensure the safety and efficacy of the vaccines. Nearly twenty-four thousand
adolescent girls are alleged to have been vaccinated in Gujarat and before its
bifurcation, in Andhra Pradesh without following safeguards. The trials are
b alleged to have been conducted under the auspices of a project initiated by the
sixth respondent. The drugs are manufactured and marketed by the seventh and
eighth respondents. Each of them produces pharmaceuticals. The petition calls
into question the role of the Drugs Controller General of India and the Indian
Council of Medical Research. The administration of the vaccine is alleged to
have resulted in serious health disorders. Deaths were reported.
C
164. On 12-8-2014 116 , a Bench of two Judges formulated the questions
which would have to be addressed in the course of the proceedings. 117 They
are: (Kalpana Mehta case 116 , SCC p. 302, para 1)
"1.1. ( i) 'Whether before the drug was accepted to be used as a vaccine
in India, the Drugs Controller General oflndia and ICMR had followed the
d procedure for said introduction?
1.2. (ii) What is the action taken after the Parliamentary Committee
had submitted the 72nd Report on 30-8-2013?
1 .3. (iii) What are the reasons for choosing certain places in Gujarat
and Andhra Pradesh?
1.4. (iv) What has actually caused the deaths and other ailments who
e had been administered the said vaccine?
1. 5. ( v) Assuming this vaccine has been administered, regard being had
to the nature of the vaccine, being not an ordinary one, what steps have been
taken for monitoring the same by the competent authorities of the Union
of India, who are concerned with health of the nation as well as the State
Governments who have an equal role in this regard?
f
consent has been taken from their parents/guardians, as we have been
apprised at the Bar that the young girls had not reached the age of majority?
1.7. (vii) What protocol is required to be observed/followed, assuming
this kind of vaccination is required to be carried out?' "
g 165. At the hearing, the petitioners relied upon the 81st Report of the
Parliamentary Standing Committee dated 22-12-2014. The petitioners sought
to place reliance on the Report so as to enable the Court to be apprised of the
facts and to facilitate its conclusions and directions. This was objected to.
h 115 Human Papilloma Virus (HPV).

116 Kalpana Mehta v. Union of India , (2017) 7 SCC 295, paras 1 and 2.
117 WP (C) No. 558 of 2012.
623
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166. The issue which arose before the Court was whether a report of a
Parliamentary S landing Committee can be relied upon in a public interest
litigation under Article 32 or Article 226. If it could be adverted to, then a
an allied issue was the extent to which reliance could be placed upon it
and its probative value. The then Attorney General for India, in response
to a request for assistance, submitted that reports of Parliamentary Standing
Committees are at best an external aid to construction, to determine the
surrounding circumstances or historical facts for understanding the mischief
sought to be remedied by legislation. The Union Government urged that reports b
of Parliamentary Standing Committees are meant to guide the functioning of
its departments and are a precursor to debates in Parliament. However, those
reports (it was urged) cannot be utilised in court nor can they be subject to a
contest between litigating parties.
167. In an order dated 5-4-2017 2 , a two-Judge Bench of this Court adverted
to Articles 105 and 122 of the Constitution and observed thus: (Kalpana Mehta C
case 2 , sec pp. 320-21, para 69)
"69. The purpose of referring to the aforesaid Articles is that while
exercising the power of judicial review or to place reliance on the report
of the Parliamentary Standing Committee, the doctrine of restraint has
to be applied by this Court as required under the Constitution. What is
argued by the learned counsel for the petitioners is that there is no question d
of any kind of judicial review from this Court or attributing anything
on the conduct of any of the members of the Committee, but to look at
the report for understanding the controversy before us. The submission
"looking at the report", as we perceive, is nothing but placing reliance
thereupon. The view of a Member of Parliament or a Member of the
Parliamentary Standing Committee who enjoys freedom of speech and e
expression within the constitutional parameters and the rules or regulations
framed by Parliament inside Parliament or the Committee is not to be
adverted to by the court in a lis."
168. The referring order2 notes that when a mandamus is sought, the
Court has to address the facts which are the foundation of the case and the
opposition, in response. If a court were to be called upon to peruse the report f
of a Parliamentary Standing Committee, a contestant to the litigation may
well seek to challenge it. Such a challenge, according to the Court, in the
form of "an invitation to contest" the report of a Parliamentary Committee "is
likely to disturb the delicate balance that the Constitution provides between
the constitutional institutions". Such a contest and adjudication would (in
that view) be contrary to the privileges of Parliament which the Constitution g
protects. Hence according to the Court: (Kalpana Mehta case 2 , SCC p. 322,
para 73)
"73 . ... we are prima facie of the view that the Parliamentary Standing
Committee report may not be tendered as a document to augment the stance
on the factual score that a particular activity is unacceptable or erroneous."
h
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169. A substantial question involving the interpretation of the Constitution
having arisen, two questions have been referred to the Constitution Bench under
a Article 145(3): (Kalpana Mehta case 2 , SCC p. 322, para 73)
"73. I. (i) Whether in a litigation filed before this Court either under
Article 32 or Article 136 of the Constitution of India, the Court can
refer to and place reliance upon the report of the Parliamentary Standing
Committee?
73.2. (ii) Whether such a report can be looked at for the purpose of
b
B. Submissions
C 170. Leading the submissions on behalf of the petitioners, Mr Harish Salve,
learned Senior Counsel underscored the importance of three constitutional
principles:
(i) Privileges of Parliament;
(ii) Comity of institutions; and
d (iii) Separation of powers.
Based on them, the submission is that reference to what transpires in a
co-equal constitutional institution must be circumspect and consistent with
due deference to and comity between institutions. Freedom of speech and
expression is implicit in the working of every institution and it is that institution
alone which can regulate its own processes. In Parliament, what speakers state
e is controlled by the House or, as the case may be, by its Committee and a
falsehood in Parliament is punishable by that institution alone.
171. It has been urged that if what is stated in a report of a Parliamentary
Standing Committee were to be impeached in a court of law, that would
affect the control of the Committee and of Parliament itself. The functions
performed by Parliament and by the judiciary as two co-equal branches are, it
f
is urged, completely different. Parliamentary business is either for the purpose
of enforcing accountability of the Government or to enact legislation. The
function of judicial institutions is adjudicatory. The courts resolve a lis on
objective satisfaction and have a duty to act judicially. The courts would not, it
has been urged, receive as evidence of facts any material whose truth or integrity
cannot be assailed in court.
g
172. On the above conceptual foundation, Mr Salve urged that the report of
a Parliamentary Standing Committee can be relied upon in a judicial proceeding
in two exceptional situations:
(i) Where it becomes necessary for the court to examine the legislative
history of a statutory provision;
h
625
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(ii) As a source from which the policy of the Government, as reflected
in the statements made by a Minister before the House can be discerned;
and a
(iii) Reports of Parliamentary Standing Committees are meant for
consideration before Parliament and can only be regarded as "considered
advice" to the House.
Except in the two situations enumerated above, no petition seeking a mandamus
can be brought before the court on the basis of such a report for the reason that
(i) No right can be founded on the recommendation of a House Committee; b
and (ii) Relying on such a report may result in a challenge before the court,
impinging upon parliamentary privileges.
173. Mr K.K. Venugopal, the learned Attorney General for India has
supported the adoption of a rule of exclusion, based on the privileges of the
legislature, separation of powers and as a matter of textual interpretation of the
C
Constitution. In his submission:
173.1. Committees of Parliament being an essential adjunct to Parliament,
and their reports being for the purpose of advising and guiding Parliament in
framing laws and the executive for framing policies, it would be a breach of
privilege of Parliament to judicially scrutinise and/or review these reports for
any purpose whatsoever; d
173.2. The broad separation of powers, which is a part of the basic structure
of the Constitution of India, would prevent courts from subjecting the reports
of Parliamentary Standing Committees to scrutiny or judicial review; and
173.3. A conjoint reading of Articles 105 and 122 of the Constitution
would establish that, expressly or by necessary implication, there is a bar on
the courts from scrutinising or judicially reviewing the functioning or reports e
of the committees of Parliament.
174. Refuting the submissions which have been urged by the Attorney
General and on behalf of the pharmaceutical companies, Mr Colin Gonsalves,
learned Senior Counsel urges that there can be no objection to reliance being
placed on the report of a Parliamentary Standing Committee where (as in the
present case) there is no attempt: f
(i) to criticise Parliament;

(ii) to summon a witness; or
(iii) to breach a privilege of the legislating body.
The report of a Parliamentary Standing Committee is (it is urged) relied upon
only for the court to seek guidance from it. The court may derive such support g
in whichever manner it may best regard in the interest of justice, to advance a
cause which has been brought in a social action litigation.
175. According to Mr Gonsalves, the core of the submission (urged by
Mr Salve) is that because his clients object to the findings in the Report, it
becomes a contentious issue. Mr Gonsalves submits that this Court should
h
not allow what in substance is an argument for a blackout against the highest
626
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court taking notice of the report in its PIL jurisdiction. The submission is that
the Court need not treat any of the facts contained in the report as conclusive
a except those that are permitted by Section 57 of the Evidence Act, 1872. No
mandamus is sought that the recommendations of the Parliamentary Committee
be enforced. The Court, it has been urged, will not be invited to comment
upon the report even if it were not to agree with the contents of the report.
The learned counsel urged that the legislative function of Parliament is distinct
from the oversight which it exercises over government departments. An issue of
b parliamentary privileges arises when the court makes a Member of Parliament
or of a Parliamentary Committee liable in a civil or criminal action for what is
stated in Parliament. Such is not the position here.
176. Mr Gonsalves submitted that in significant respects, our Constitution
marks a historical break from the English Parliamentary tradition. India
has adopted the doctrine of constitutional supremacy and not Parliamentary
C sovereignty, as in the UK. Hence, cases decided under the English Common
Law cannot be transplanted, without regard to context, in Indian jurisprudence
on the subject. The unrestrained use of parliamentary privileges, it has
been urged, stands modified in the Indian context, which is governed by
constitutional supremacy. In matters involving public interest or issues of a
national character, both the institutions - Parliament and the courts - must
d act together. As a matter of fact, Parliament has placed the report of its S landing
Committee in the public domain. It is ironical, Mr Gonsalves urges, that in the
present case, it is the executive which seeks to protect itself from disclosure in
the guise of parliamentary privileges.
177. Finally, it has been urged that the public interest jurisdiction is
not adversarial and constitutes a distinctly Indian phenomenon. Where the
e fulfilment and pursuit of a constitutional goal, national purpose or public
interest is in issue, both Parliament and the judiciary will act in comity. No issue
arises here in relation to the separation of powers or breach of parliamentary
privilege. On the contrary, it has been submitted that the approach of the
respondents is not in accordance with the march of transparency in our law.
178. Mr Anand Grover, learned Senior Counsel submitted that if there is
f no dispute that a certain statement was made before Parliament or, as the case
may be, a Parliamentary Standing Committee, such a statement can be relied
upon as a fact of it being stated in Parliament. The truth of the statement is, in
the submission of the learned Senior Counsel, another and distinct issue. The
report is uncontentious not as regards the truth of its contents but of it having
been made. The Court in the exercise of its power of judicial review will not
g hold that an inference drawn by a Parliamentary Committee is wrong. But the
Court can certainly look at a statement where there is no dispute of it having
been made.
179. Mr Shy am Divan and Mr Gourab Banerji, learned Senior Counsel have
broadly pursued the same line of argument as the learned Attorney General for
India and Mr Harish Salve.
h
627
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C. The Constitution
180. Articles 105, 118, 119 and 121 are comprised in Part V of the
Constitution which deals with the Union and form a part of Chapter II, which a
deals with Parliament. Article 105 is extracted below:
"105. Powers, privileges, etc., of the Houses of Parliament and of the
Members and committees thereof.-(!) Subject to the provisions of this
(2) No Member of Parliament shall be liable to any proceedings in any b
C
so defined, shall be those of that House and of its Members and committees
persons who by virtue of this Constitution have the right to speak in, and d
committee thereof as they apply in relation to Members of Parliament."
181. The first major principle which emerges from Article 105 is that it
expects, recognises and protects the freedom of speech in Parliament. Stated in
a sentence, the principle enunciates a vital norm for the existence of democracy.
e
Parliament represents collectively, through the representative character of
its Members, the voice and aspirations of the people. Free speech within
Parliament is crucial for democratic governance. It is through the fearless
expression of their views that Parliamentarians pursue their commitment to
those who elect them. The power of speech exacts democratic accountability
from elected governments. The free flow of dialogue ensures that in framing
f
legislation and overseeing government policies, Parliament reflects the diverse
views of the electorate which an elected institution represents.
182. The Constitution recognises free speech as a fundamental right
in Article 19(1 )(a). A separate articulation of that right in Article 105(1)
shows how important the debates and expression of view in Parliament have
been viewed by the draftspersons. Article 105(1) is not a simple reiteration g
or for that matter, a surplusage. It embodies the fundamental value that
the free and fearless exposition of critique in Parliament is the essence of
democracy. Elected Members of Parliament represent the voices of the citizens.
In giving expression to the concerns of citizens, Parliamentary speech enhances
democracy. Article 105(1) emphasises free speech as an institutional value,
apart from it being a part of individual rights. Elected Members of the h
legislature continue to wield that fundamental right in their individual capacity.
628
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Collectively, their expression of opinion has an institutional protection since
the words which they speak are spoken within the portals of Parliament.
a This articulated major premise is however subject to the provisions of the
Constitution and is conditioned by the procedure of Parliament embodied in
its rules and standing orders. The recognition in clause (1) that there shall be
freedom of speech in Parliament is effectuated by the immunity conferred on
Members of Parliament against being liable in a court of law for anything said
or for any vote given in Parliament or a committee. Similarly, a person who
b publishes a report, paper, votes or proceedings under the authority of Parliament
is protected against liability in any court. In other respects - that is to say,
on matters other than those falling under clauses (1) and (2), Parliament has
been empowered to define the powers, privileges and immunities of each of its
Houses and of its Members and committees. Until Parliament does so, those
powers, privileges and immunities are such as existed immediately before the
C enforcement of the 44th amendment to the Constitution 11 8 • Clause (4) of Article
105 widens the scope of the protection by making it applicable "in relation
to persons" who have a right to speak in or to take part in the proceedings
before the House or its committees. The protection afforded to Members of
Parliament is extended to all such persons as well. Committees of the Houses
of Parliament are established by and under the authority of Parliament. They
d represent Parliament. They are comprised within Parliament and are as much,
Parliament.
183. Article 118 deals with the Rules of Procedure of Parliament:
"118. Rules ofprocedure.-(!) Each House of Parliament may make rules
for regulating, subject to the provisions of this Constitution, its procedure and
the conduct of its business.
e
(2) Until rules are made under clause (1), the rules of procedure and
standing orders in force immediately before the commencement of this
Constitution with respect to the legislature of the Dominion of India shall have
effect in relation to Parliament subject to such modifications and adaptations as
may be made therein by the Chairman of the Council of States or the Speaker
of the House of the People, as the case may be.
f
(3) The President, after consultation with the Chairman of the Council of
States and the Speaker of the House of the People, may make rules as to the
procedure with respect to joint sittings of, and communications between, the
two Houses.
(4) At a joint sitting of the two Houses the Speaker of the House of
the People, or in his absence such person as may be determined by rules of
g procedure made under clause (3), shall preside."
184. The procedure and conduct of business of Parliament are governed
by the rules made by each House. The rule-making authority is subject only
to the provisions of the Constitution. Until rules are framed, the procedure
of Parliament was to be governed by the rules of procedure and Standing
h Orders which applied to the legislature of the Dominion of India immediately
118 The Constitution (44th Amendment) Act, 1978 came into force from 20-6-1979.
629
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before the commencement of the Constitution (subject to adaptations and
modifications). Rules of procedure for joint sittings of the two Houses of
Parliament and in regard to communications between them are to be framed a
by the President in consultation with the Chairman of the Raj ya Sabha and the
Speaker of the Lok Sabha.
185. Article 119 provides for regulation by law of the procedure in
Parliament in relation to financial business. Article 119 provides thus:
"119. Regulation by law of procedure in Parliament in relation to
financial business .-Parliament may, for the purpose of the timely completion b
of financial business, regulate by law the procedure of, and the conduct of
business in, each House of Parliament in relation to any financial matter or to
any Bill for the appropriation of moneys out of the Consolidated Fund of India,
and, if and so far as any provision of any law so made is inconsistent with any
rule made by a House of Parliament under clause (1) of Article 118 or with
any rule or standing order having effect in relation to Parliament under clause C
(2) of that article, such provision shall prevail."
Article 119 thus embodies a special provision which enables Parliament to
regulate the procedure for and conduct of business in each House in relation to
financial matters or for appropriation of monies from the Consolidated Fund.
186. Article 122 contains a bar on courts inquiring into the validity of any d
proceedings of Parliament on the ground of an irregularity of procedure:
"122. Courts not to inquire into proceedings of Parliament.-(!) The
validity of any proceedings in Parliament shall not be called in question on the
ground of any alleged irregularity of procedure.
(2) No officer or Member of Parliament in whom powers are vested by or
under this Constitution for regulating procedure or the conduct of business, or e
Article 122 protects the proceedings in Parliament being questioned on the
ground of an irregularity or procedure. In a similar vein, a Member of
Parliament or an officer vested with authority under the Constitution to regulate
the procedure or the conduct of business (or to maintain order) in Parliament f
is immune from being subject to the jurisdiction of any court for the exercise
of those powers. Those who perform the task - sometimes unenviable - of
maintaining order in Parliament are also protected, to enable them to discharge
their functions dispassionately.
187. The provisions contained in Chapter II of Part V are mirrored, in the
g
case of the State Legislatures, in Chapter III of Part VI. The corresponding
provisions in regard to State Legislatures are contained in Articles 194, 208,
209 and 212.
188. The fundamental principle which the Constitution embodies is in
terms of its recognition of and protection to the freedom of speech in
Parliament. Freedom of speech has been entrenched by conferring an immunity h
against holding a Member of Parliament liable for what has been spoken
630
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in Parliament or for a vote which has been tendered. The freedom to speak
is extended to other persons who have a right to speak in or take part in
a the proceedings of Parliament. Parliament is vested with the authority to
regulate its procedures and to define its powers, privileges and immunities. The
same protection which extends to parliamentary proceedings is extended to
proceedings in or before the Committees constituted by each House. Parliament
has been vested with a complete and exclusive authority to regulate its own
procedure and the conduct of its business.
b 189. While making the above provisions, the Constitution has carefully
engrafted provisions to ensure institutional comity between Parliament and the
judiciary. Under Article 121, the conduct of a Judge of the Supreme Court or
of a High Court in the discharge of duties cannot be discussed in Parliament
(except upon a motion for removal). Article 211 makes a similar provision in
regard to the State Legislatures.
C
D. Parliamentary Standing Committees
190. Parliamentary Committees exist both in the Westminster form of
Government in the United Kingdom as well as in the Houses of Parliament
in India. In the UK, Select Committees have emerged as instmments through
which Parliament scmtinises the policies and actions of Government and
d enforces accountability of Government and its officers. Select Committees are
composed of specifically nominated Members of Parliament and exercise the
authority which the House delegates to them. The role of Select Committees has
been set forth in Erskine May's Treatise on The Law, Privileges, Proceedings
and Usage of Parliament 11 9:
"Select Committees are appointed by the House to perform a wide
e range of functions on the House's behalf. Most notably they have become
over recent years the principal mechanism by which the House discharges
its responsibilities for the scmtiny of government policy and actions.
Increasingly this scmtiny work has become the most widely recognised and
public means by which Parliament holds Government Ministers and their
departments to account."
f
191. The scope of deliberations or inquiries before a Select Committee
is defined in the order by which the committee is appointed. When a Bill is
referred to a Select Committee, the Bill constitutes the order of reference 120 .
Select Committees are a microcosm of the House. During the course of their
work, Select Committees rely upon documentary and oral evidence 121 :
g "Once received by the committee as evidence, papers prepared for
a committee become its property and may not be published without the
express authority of the committee. Some committees have agreed to a
119 Erskine May 's Trealise on The Law, Privileges, P1vceedings and Usag e of Parliamenl, (Lexis
h Nexis, 24th Edn. 2011) , 37.
120 Id, at pp. 805-806.
121 Id, at p. 818.
631
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resolution at the beginning of an inquiry authorising witnesses to publish
their own evidence."
192. Evidence which has been collected during the course of an inquiry is a
published with the report of the committee 122 :
"It is usual practice of committees to publish the evidence which
they have taken during the course of an inquiry with the report to which
the evidence is relevant. In the case of longer inquiries, the evidence
may be separately published during the course of the inquiry. In such b
cases, however, that evidence may be published again with the report.
Additionally, committees may take evidence with no intention of producing
a subsequent report and publish it without comment."
A Select Committee decides when to publish any report which it has agreed 123 .
193. Article 105 of the Indian Constitution recognises committees of the
C
Houses of Parliament. Rules of Procedure of the Lok Sabha and the Rajya
Sabha framed under Article 118(1) of the Constitution inter alia provide for the
organisation and working of these committees 124 .
194. The rules governing procedure and the conduct of business in the
Rajya Sabha provide for the constitution of the committees of the House.
Chapter IX of the Rules contains provisions relating to legislation. Provisions d
have been made for Bills which originate in the Rajya Sabha and for those
which originate in the Lok Sabha and are transmitted to the Rajya Sabha.
Under Rule 72, members of a Select Committee for a Bill are appointed by
the Rajya Sabha when a motion that the Bill be referred to a Select Committee
is made. Rule 84 empowers the Select Committee to require the attendance
of witnesses or the production of papers or records. The Select Committee e
can hear expert evidence and representatives of special interests affected by
the measure. Documents submitted to the Committee cannot be withdrawn
or altered without its knowledge and approval. The Select Committee, under
Rule 85, is empowered to decide upon its procedure and the nature of questions
which it may address to a witness called before it. Rule 86 provides for the
printing and publication of evidence and empowers the Committee to direct that f
the evidence or a summary be laid on the table. Evidence tendered before the
Select Committee can only be published after it has been laid on the table. The
Select Committee prepares its report on the Bill referred to it, under Rule 90.
Under Rule 91, the report of the Select Committee on a Bill, together with
minutes of dissent, is presented to the Rajya Sabha by the Chairperson of
the Committee. Under Rule 92, the Secretary General must print every report g
of a Select Committee. The report together with the Bill proposed by the
Select Committee has to be published in the Gazette. The rules contemplate
122 Erskine May's Treatise on The Law, Privileges, Proceedings and Usage of Parliament, (Lexis
Nexis, 24th Edn. 2011), 825.
123 Id, at p. 838.
124 Rules of Procedure and Conduct of Business in Lok Sabha, (Lok S abha Secretariat, 15th Edn. , h
April 2014 ). Rules of Procedure and Conduct of Business in the Council of States (Rajya Sabha),
(published by the Secretary General, 9th Edn., August 2016).
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the procedure to be followed in the Rajya Sabha for debating and discussing
the report and for considering amendments, leading up to the eventual passage
a of the Bill. In a manner similar to reference of Bills originating in the Rajya
Sabha to Select Committees, Bills which are transmitted from the Lok Sabha
to the Rajya Sabha may be referred to a Select Committee under Rule 125, if
a motion for that purpose is carried.
195. Chapter XXII of the Rules contains provisions in regard to Department
related Parliamentary Standing Committees. Rule 268 stipulates that there shall
b be Parliamentary Standing Committees related to Ministries/Departments. The
Third Schedule elucidates the name of each committee and the Ministries/
Departments which fall within its purview. Under Rule 269, each such
committee is to consist of not more than 31 members: 10 to be nominated by
the Chairperson from the Members of the Rajya Sabha and 21 to be nominated
by the Speaker from the Members of the Lok Sabha. Rule 270 specifies the
c functions of the Standing Committees:
(a) to consider the demands for grants of the related Ministries/
Departments and report thereon. The report shall not suggest anything of
d the nature of cut motions;
report thereon; and
e (d) to consider national basic long-term policy documents presented to
to-day administration of the related Ministries/Departments."
196. Rule 274 envisages that the report of the Standing Committee "shall be
f
based on broad consensus" though a member may record a dissent. The report
of the Committee is presented to the Houses of Parliament. Under Rule 275,
provisions applicable to Select Committees on Bills apply mutatis mutandis
to the Standing Committees. Rule 277 indicates that the report of a Standing
Committee is to have persuasive value and is treated as advice to the House:
g "277. Reports to have persuasive value .-The report of a Standing
197. Department related Parliamentary Standing Committees are
Committees of the Houses of Parliament. The Committees can regulate their
procedure for requiring the attendance of persons and for the production
h of documents. The Committees can hear experts or special interests. These
Committees ensure parliamentary oversight of the work of the ministries/
633
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departments of Government. As a part of that function, each Committee
considers demands for grants, examines Bills which are referred to it, considers
the annual reports of the ministry/department and submits reports on national a
long-term policy documents, when they have been referred for consideration.
The reports of these Committees are published and presented to the Houses
of Parliament. They have a persuasive value and are advice given by the
Committee to Parliament.
198. Besides the Department related Standing Committees, there is a
General Purposes Committee (Chapter XXIII) whose function is to consider b
and advise on matters governing the affairs of the House, referred by the
Chairperson. Chapter XXIV provides for the constitution of a Committee on
Ethics to oversee "the moral and ethical conduct" of members, prepare a code
of conduct, examine cases of alleged breach and to tender advise to members
on questions involving ethical standards.
C
E. Parliamentary privilege
E.1. UK decisions
199. In UK, a body of law has evolved around the immunity which is
afforded to conduct within or in relation to statements made to Parliament
against civil or criminal liability in a court of law. The common law also
affords protection against the validity of a report of a Select Committee being d
challenged in a court.
200. Article 9 of the Bill of Rights, 1688 declares that:
"... That the freedom of speech and debates or proceedings in
Parliament, ought not to be impeached or questioned in any court or place
out of Parliament .... " e
Construed strictly, the expression "out of Parliament" will effectively squelch
any discussion of the proceedings of Parliament, outside it. This would
compromise to the need for debate and discussion on matters of governance
in a democracy. Hence, there has been an effort to bring a sense of balance:
a balance which will ensure free speech within Parliament but will allow a
free expression of views among citizens. Both are essential to the health of f
democracy.
201. Article 9 has provided the foundation for a line of judicial precedent
in the English Courts. In 1884, the principle was formulated in Bradlaugh v.
Gossett 80 : (QBD p. 271)
"The House of Commons is not subject to the control of Her Majesty's g
Courts in its administration of that part of the statute law which has relation
to its internal procedure only. What is said or done within its walls cannot
be inquired into in a court of law.
A resolution of the House of Commons cannot change the law of the
land. But a court of law has no right to inquire into the propriety of a
h
80 (1884) LR 12 QBD 271 : 53 LJQB 290: 50 LT 620 (DC)
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resolution of the House restraining a member from doing within the walls
of the House itself something which by the general law of the land he had
a a right to do .... "
In Dingle v. Associated Newspapers Ltd. 125 , the above formulation was held to
constitute "a clear affirmation of the exclusive right of Parliament to regulate
its own internal proceedings". Applying that principle, the Queen's Bench
Division rnled that the report of a Select Committee of the House of Commons
could not be impugned outside Parliament. This principle was applied in
b Church of Scientology of California v. Johnson Smith 126 , when an action for
libel was brought against a Member of Parliament for a statement made during
the course of a television interview. In order to refute the defendants' plea of
fair comment, the plaintiff sought to prove malice by leading evidence of what
had taken place in Parliament. Rejecting such an attempt, the Court adverted
to the following statement of principle in Blackstone: (Johnson Smith case 126 ,
C
QB p. 528)
" '... "The whole of the law and custom of Parliament has its origin
from this one maxim, "that whatever matter arises concerning either House
of Parliament ought to be examined, discussed, and adjudged in that House
to which it relates, and not elsewhere"."' (Gossett case 8°, QBD p. 278)
d
Reiterating that principle, the Court held: (Johnson Smith case 126 , QB p. 529)
" ... what is said or done in the House in the course of any proceedings
there cannot be examined outside Parliament for the purpose of supporting
a cause of action even though the cause of action itself arises out of
something done outside the House."
e The decision involved a libel action brought against a Member of Parliament
for a statement made outside. The Court rejected an attempt to rely upon what
was stated in Parliament to establish a case of malice against the defendant.
202. In Pepper (Inspector of Taxes) v. Hart95 , Lord Browne-Wilkinson held
for the House of Lords that there was a valid reason to relax the conventional
rule of exclusion under which reference to Parliamentary material, as an aid to
f
statutory constrnction, was not permissible. The learned Law Lord held: (AC
p. 634)
"... In my judgment, subject to the questions of the privileges of
the House of Commons, reference to Parliamentary material should be
permitted as an aid to the constrnction of legislation which is ambiguous
g or obscure or the literal meaning of which leads to an absurdity. Even in
such cases references in court to Parliamentary material should only be
permitted where such material clearly discloses the mischief aimed at or
the legislative intention lying behind the ambiguous or obscure words."
125 (1960) 2 QB 405 : (1960) 2 WLR 430

h 126 (1972) 1 QB 522: (1971) 3 WLR 434
80 Bradlaugh v. Gossett, (1884) LR 12 QBD 271 : 53 LJQB 290: 50 LT 620 (DC)
95 1993 AC 593: (1992) 3 WLR 1032: 1992 UKHL 3 (HL)
635
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Holding that such a relaxation would not involve the Court criticising what has
been said in Parliament since the Court was only giving effect to the words used
by the Minister, the Court held that the exclusionary rule should be relaxed to a
permit reference to parliamentary materials where: (Hart case 95 , AC p. 640)
"(a) legislation is ambiguous or obscure, or leads to an absurdity;
(b) the material relied upon consists of one or more statements by a
Minister or other promoter of the Bill together if necessary with such other
Parliamentary material as is necessary to understand such statements and
their effect; (c) the statements relied upon are clear." b
203. The decision of the Privy Council in Richard William Prebble v.

Television New Zealand Ltd. 127 (Prebble) arose from a case where, in a
television programme transmitted by the defendant, allegations were levelled
against the Government of New Zealand, involving the sale of State-owned
assets to the private sector while the plaintiff was the Minister of the C
department. In his justification, the defendant alleged that the plaintiff had made
statements in the House calculated to mislead. Lord Browne-Wilkinson held
that the defendant was precluded from questioning a statement made by the
plaintiff before the House of Parliament. The principle was formulated thus:
(AC p. 332)
"In addition to Article 9 itself, there is a long line of authority which d
supports a wider principle, of which Article 9 is merely one manifestation
viz. that the courts and Parliament are both astute to recognise their
respective constitutional roles. So far as the courts are concerned they will
not allow any challenge to be made to what is said or done within the walls
of Parliament in performance of its legislative functions and protection
of its established privileges: Burdett v. Abbot 128 ; Stockdale v. Hansard 83 ; e
Bradlaugh v. Gossett80 ; British Railways Board v. Pickin 129 and Pepper
(Inspector of Taxes) v. Hart95 . As Blackstone said in his Commentaries on
the Laws of England, 17th Edn. (1830), Vol. 1, p. 163:
'the whole of the law and custom of Parliament has its origin from
this one maxim, "that whatever matter arises concerning either House f
of Parliament, ought to be examined, discussed, and adjudged in that
House to which it relates, and not elsewhere".' "
The Privy Council held that cross-examination based on the Hansard was
impermissible.
95 Pepper (Inspector of Taxes) v. Hart, 1993 AC 593 : (1992) 3 WLR 1032: 1992 UKHL 3 (HL)
127 (1995) 1 AC 321 : (1994) 3 WLR 970: (1994) 3 All ER 407 (PC)
128 (1811) 14 East 1 : 104 ER 501
83 (1839) 9 Ad & E 1 : 112 ER 1112 (QB) h
80 (1884) LR 12 QBD 271 : 53 LJQB 290: 50 LT 620 (DC)
129 1974 AC 765 : (1974) 2 WLR 208 (HL)
636
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204. In the course of its decision in Prebble 127 , the Privy Council adverted
to an Australian judgment of New South Wales Supreme Court in R. v.
a Murphy 130 (Murphy) which had allowed a witness to be cross-examined on
the basis of evidence given to a Select Committee on the ground that Article
9 did not prohibit cross-examination to show that the statement of the witness
before the committee was false. In order to overcome the situation created by
the decision, the Australian Legislature enacted the Parliamentary Privileges,
Act, 1987. Section 16(3) introduced the following provisions: (Prebble 127 , AC
b p. 333)
"16. (3) In proceedings in any court or tribunal, it is not lawful for evidence
to be tendered or received, questions asked or statements, submissions or
comments made, concerning proceedings in Parliament, by way of, or for the
purpose of:
C
(a) questioning or relying on the truth, motive, intention or good faith
of anything forming part of those proceedings in Parliament;
(b) otherwise questioning or establishing the credibility, motive,
intention or good faith of any person; or
(c) drawing, or inviting the drawing of, inferences or conclusions
wholly or partly from anything forming part of those proceedings in
d Parliament."
205. In Prebble 127 , the Privy Council held that Section 16(3) contains
"what, in the opinion of their Lordships, is the true principle to be applied".
The Privy Council held that the Australian view in Murphy 130 was not correct,
so far as the rest of the Commonwealth is concerned, because it was in conflict
with a long line of authority that courts will not allow any challenge to what
e is said or done in Parliament.
206. The Defamation Act, 1996 (UK) contained a provision in Section 13
under which an individual litigant in a defamation case could waive
parliamentary privilege. The report of the Joint Committee observed that the
provision "undermined the basis of privilege: freedom of speech was the
privilege of the House as a whole and not of the individual member in his
f
or her own right, although an individual member could assert and rely on it".
The waiver provision was deleted on the ground that the privilege belongs to
the House and not to an individual member. The impact of the provisions of
Section 13 of the Defamation Act, 1996 was dealt with in a 2011 decision
of the House of Lords in Hamilton v. Al Fayed76 (Hamilton). The defendant
had alleged that as a Member of Parliament, the plaintiff had accepted cash
g
from him for asking questions on his behalf in the House of Commons.
The plaintiff commenced an action for defamation against the defendant,
waiving his parliamentary privileges pursuant to Section 13 of the Defamation
127 Richard William Prebble v. Tele vision New Z ealand Ltd., (1995) 1 AC 321 : (1994) 3 WLR 970:
h (1994) 3 All ER 407 (PC)
130 (1986) 64 ALR 498: (1986) 5 NSWLR 18
76 (2001) 1 AC 395 : (2000) 2 WLR 609 (HL)
637
-----------------------------------------------------------------------------------------------------------------------------------------------------------

Act, 1996. Lord Browne-Wilkinson dwelt on parliamentary privileges, which
prohibit the court from questioning whether a witness before Parliament had
misled it. The House of Lords held that any attempt to cross-examine the a
defendant to the effect that he had lied to a Parliamentary Committee when
he had stated that he had paid money for questions would have infringed
parliamentary privileges. However, under Section 13, the plaintiff could waive
his own protection from parliamentary privilege. The consequence was thus:
(AC pp. 408-09)
" ... The privileges of the House are just that. They all belong to the b
House and not to the individual. They exist to enable the House to perform
its functions. Thus Section 13(1) accurately refers, not to the privileges
of the individual MP, but to "the protection of any enactment or rule of
law" which prevents the questioning of procedures in Parliament. The
individual MP enjoys the protection of parliamentary privilege. Ifhe waives
such protection, then under Section 13(2) any questioning of parliamentary C
proceedings (even by challenging "findings ... made about his conduct")

is not to be treated as a breach of the privileges of Parliament."
The effect of Section 13 was that if a Member of Parliament waived the
protection, an assail of proceedings before Parliament would not be regarded
as a breach of privilege. d
207. The decision in Hamilton 76 is significant for explaining precisely the
relationship between parliamentary privilege and proceedings in a court which
seek to challenge the truth or propriety of anything done in parliamentary
proceedings. As the Court holds: (AC p. 407)
" ... The normal impact of parliamentary privilege is to prevent the
court from entertaining any evidence, cross-examination or submissions e
which challenge the veracity or propriety of anything done in the course
of parliamentary proceedings. Thus, it is not permissible to challenge by
cross-examination in a later action the veracity of evidence given to a
Parliamentary Committee."
But for the provisions of Section 13, evidence by Hamilton 76 that he had f
not received money for questions would come into conflict with the evidence
tendered by Al Fayed which was accepted by the Parliamentary Committees.
Hence it would have been impermissible to cross-examine Al Fayed to the
effect that he had falsely stated before the Parliamentary Committees that he
had paid money for questions. Such a consequence was obviated by the waiver
provisions of Section 13. g
208. In Toussaint v. Attorney General of Saint Vincent and the
Grenadines 131 (Toussaint), the Privy Council dealt with a case where a claim
was brought against the Government by an individual claiming that the
acquisition of his land was unlawful. In support, he referred to a speech
of the Prime Minister in Parliament and a transcript taken from the video-
h
76 Hamilton v. Al Fayed, (2001) 1 AC 395: (2000) 2 WLR 609 (HL)
131 (2007) 1 WLR 2825 : 2007 UKPC 48 (PC)
638
-----------------------------------------------------------------------------------------------------------------------------------------------------------

tape of a televise d d e bate . The submission w as tha t the true r eason for the
acquisition of the land, as evide nt from the speech of the Prime Minister, was
a politica l. Adverting to Prebble 127 , Lord Mance, spe aking for the Privy Council,
noted that there w ere three principle s involved: the need to e nsure the free
exercise of powers by the legislature on behalf of the electors; the need to
protect the interest of justice; and the interest of justice in ensuring that all
relevant evidence is available to the courts. The Privy Council held that it was
permissible to rely upon the speech of the Prime Minister though the attempt
b was to demonstrate an improper exercise of power for extraneous purposes. As
Lord Mance observed: (Toussaint case 1 31 , WLR pp. 2832-33, para 17)
"17. In such cases, the minister's statement is relied upon to explain
the conduct occurring outside Parliament, and the policy and motivation
leading to it. This is unobjectionable although the aim and effect is
to show that such conduct involved the improper exercise of a power
C
"for an alien purpose or in a wholly unreasonable manner": Pepper
(lnspectorofTaxes) v. Hart95 ,perLordBrowne-Wilkinson atp. 639-A. The
Joint Committee expressed the view that Parliament should welcome this
development, on the basis that "Both parliamentary scrutiny and judicial
review have important roles, separate and distinct, in a modern democratic
society" (para 50) and on the basis that "The contrary view would have
d
bizarre consequences", hampering challenges to the "legality of executive
decisions ... by ring-fencing what ministers said in Parliament", and
making "ministerial decisions announced in Parliament . . . less readily
open to examination than other ministerial decisions": para 51. The Joint
Committee observed, pertinently, that:
e " 'That would be an ironic consequence of Article 9. Intended to
protect the integrity of the legislature from the executive and the courts,
Article 9 would become a source of protection of the executive from
the courts.' "
The Prime Minister's statement in the House was "re lie d on for what it says,
rather than que stione d or challenged". This was p ermissible.
f
209. Toussaint 131 is an important stage in the development of the law. A
stateme nt made in Parliame nt by a Minister could be relie d upon, not just
to explain the history of a law. Wher e ther e is a challe nge to the exercise of
governme ntal authority on the ground that it is actuate d by extrane ous reasons,
a statement by a Minister in Parliament could be used in court in regard
to conduct outside Parliament. The challe nge is not to a statement made in
g
Parliament but to gove rnmental action outside. The statement would be relevant
to question an abuse of power by Government.
127 Richard William Prebble v. Television New Zealand Ltd., (1995) 1 AC 321 : (1994) 3 WLR 970:
(1 994) 3 All ER 407 (PC)
h 131 Toussaint v. A ttorney General of Saint Vincent and the Grenadines, (2007) 1 WLR 2825 : 2007
UKPC 48 (PC)
95 1993 AC 593: (1992) 3 WLR 1032: 1992 UKHL 3 (HL)
639
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210. In R. (Bradley) v. Secy. of State for Work and Pensions 132 (Attorney
General intervening), the Court of Appeal visited the statement in Prebble 127
that Section 16(3) of the Parliamentary Privileges Act, 1987 in Australia a
declared the true effect of Article 9 of the Bill of Rights and that Section 16(3)
contained "the true principle to be applied" in the case. Holding that the dictum
in Prebble 127 appears to be too wide, it was held: [R. (Bradley) case 132 , QB
p. 160, para 32]
"32 . ... But paragraph (c), if read literally, is extremely wide. It would
b
seem to rule out reliance on or a challenge to a ministerial statement itself
on judicial review of the decision embodied in that statement (which was
permitted in R. v. Secy. of State for the Hom e D epartment, exp Brind 133 , and
to which no objection has been raised in the present case), or to resolve an
ambiguity in legislation [Pepper (Inspector of Taxes) v. Hart 95 ], or to assist
in establishing the policy objectives of an enactment [Wilson v. First County C
Trust Ltd. (No. 2 ) 134]. It would also prohibit reliance on report of the Joint
Committee on Human Rights, which, as Mr Lewis's submissions rightly
state, have been cited in a number of appellate cases in this jurisdiction:
a very recent example is R. v. F. 135 , QB para 11. As Lord Nicholls of
Birkenhead observed in Wilson case 134 , AC para 60: (Wilson case 134 , AC
p. 841) d
'60 . ... there are occasions when courts may properly have regard
to ministerial and other statements made in Parliament without in any
way "questioning" what has been said in Parliament, without giving
rise to difficulties inherent in treating such statements as indicative
of the will of Parliament, and without in any other way encroaching
upon parliamentary privilege by interfering in matters properly for e
consideration and regulation by Parliament alone.'
I therefore do not treat the text of paragraph (c) of the Australian statute as
being a rule of English law."
The report of a Select Committee, it was observed, is a written document
published after a draft report has been placed before and approved by the f
Committee. Hence, it was unlikely that the use of such a report in the
submissions of a party in civil litigation would have inhibited the Committee
from expressing its view. The freedom of speech in Parliament principle would
not be affected, since there would be no inhibition of that freedom.
132 2009 QB 114: (2008) 3 WLR 1059: 2007 EWHC 242 (Admin)
(1994) 3 All ER 407 (PC)
133 (1991) 1 AC 696: (1991) 2 WLR 588: (1991) 1 All ER 720 (HL)
95 1993 AC 593: (1992) 3 WLR 1032: 1992 UKHL 3 (HL) h
134 (2004) 1 AC 816: (2003) 3 WLR 568: 2003 UKHL 40 (HL)
135 2007 QB 960: (2007) 3 WLR 164 (CA)
640
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211. The d ecision of the Administrative Court in the UK in Office of Govt.
Comme rce v. Info rmation Commr. 136 involved a case where a department of
a Government had carried out reviews into an identity card programme . The case
involved a claim for the disclosure of information. The Court observed that
the law of parliamentary privilege is based on two principles: the need for free
speech in Parliament and separation of powers between the legislature and the
judiciary: (QB p. 115, paras 46 & 47)
"46 . ... the law of parliamentary privilege is essentially based on two
b principles. The first is the need to avoid any risk of interference with
free speech in Parliament. The second is the principle of the separation
of powers, which in our Constitution is restricted to the judicial function
of Government and requires the executive and the legislature to abstain
from interference with the judicial function, and conversely requires the
judiciary not to interfere with or to criticise the proceedings of the
C
legislature. These basic principles lead to the requirement of mutual respect
by the courts for the proceedings and decisions of the legislature and by
the legislature (and the executive) for the proceedings and decisions of the
courts.
47. Conflicts between Parliament and the courts are to be avoided.
The above principles lead to the conclusion that the courts cannot
d
consider allegations of impropriety or inadequacy or lack of accuracy
in the proceedings of Parliament. Such allegations are for Parliament to
address, if it thinks fit, and if an allegation is well founded any sanction
is for Parliament to determine. The proceedings of Parliament include
parliamentary questions and answers. These are not matters for the courts
to consider."
e
Yet, the Court also noticed the limitation of the above principles, when
proceedings in Parliament are relied upon simply as relevant historical facts
or to determine whether the legislation is incompatible with the European
Convention for the Protection of Human Rights which was embodied in the
Human Rights Act, 1998 ("HRA") in the UK. In that context the Court
f observed: (QB p. 116, para 49)
"49. However, it is also important to recognise the limitations of these
principles. There is no reason why the courts should not receive evidence
of the proceedings of Parliament when they are simply relevant historical
facts or events: no "questioning" arises in such a case .... Similarly, it is
of the essence of the judicial function that the courts should determine
g issues of law arising from legislation and delegated legislation. Thus, there
can be no suggestion of a breach of parliamentary privilege if the courts
decide that legislation is incompatible with the European Convention for
the Protection of Human Rights and Fundamental Freedoms: by enacting
the Human Rights Act, 1998 .... "
h
136 2010 QB 98: (2009) 3 WLR 627
641
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The Court held that the conclusions of the report of a committee that had led
to legislation could well be relied upon since the purpose of the reference is
either historical or made with a view to ascertaining the mischief at which the a
legislation was aimed. If the evidence given to a committee is uncontentious
- the parties being in agreement that it is true and accurate - there could
be no objection to it being taken into account. What the Tribunal could not do
was to refer to contentious evidence given to a Parliamentary Committee or the
finding of the Committee on an issue which the Tribunal had to determine.
212. The decision indicates a calibrated approach to parliamentary b
privilege consistent with the enactment of the HRA. The doctrine of
incompatibility envisages a role for courts in the UK to assess the consistency
of the provisions of law with reference to the standards of the European
Convention. Parliamentary supremacy does not allow the court to strike down
legislation. Yet the emergence of standards under the HRA has allowed for a
distinct adjudicatory role: to determine the compatibility of domestic law with C
reference to European Convention standards, adopted by the HRA. To hold that
this has not altered the role of courts vis-a-vis parliamentary legislation would
be to miss a significant constitutional development.
213. R. (Wheeler) v. Office of the Prime Minister 137 was a case where there
was a challenge to a decision brought by the Government to give notice of
the intention of UK to participate in the Council Framework Decision on the d
European arrest warrants. It was claimed that the Government was precluded
from issuing a notification of its intention without holding a referendum.
Holding that the plea would breach parliamentary privilege the Court held:
"... In substance, however, the claim is that, unless the House of
Commons organises its business in a particular way, and arranges for a vote e
in a particular form, the courts must intervene and either grant a declaration
or issue an order prohibiting the government from taking certain steps
unless and until there is such a vote. In my judgment, that would involve
the courts impermissibly straying from the legal into the political realm."
The plea, the Court ruled, would amount to the Court questioning things done
in Parliament and instead of facilitating the role of Parliament, the Court would f
be usurping it.
214. In Wilson v. First County Trust Ltd. (No. 2) 134 the House of Lords
observed that the Human Rights Act, 1998 had obligated the Court to exercise a
new role in respect of primary legislation. The courts were required to evaluate
the effect of domestic legislation upon rights conferred by the European
Convention and where necessary; to make a declaration of incompatibility. g
While doing so, the Court would primarily construe the legislation in question.
Yet, the practical effect of a statutory provision may require the Court to
look outside the statute. The Court would be justified in looking at additional
background information to understand the practical impact of a statutory
h
137 2014EWHC 3815 (Admin)
134 (2004) 1 AC 816: (2003) 3 WLR 568: 2003 UKHL 40 (HL)
642
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measure on a Convention right and decide upon the proportionality of a
statutory provision. In that context, the Court held: (AC pp. 842-43, paras 64
a & 65)
"64. This additional background material may be found in published
documents, such as a government white paper. If relevant information
is provided by a minister or, indeed, any other member of either House
in the course of a debate on a Bill, the courts must also be able to
take this into account. The courts, similarly, must be able to have regard
b to information contained in explanatory notes prepared by the relevant
government department and published with a Bill. The courts would
be failing in the due discharge of the new role assigned to them by
Parliament if they were to exclude from consideration relevant background
information whose only source was a ministerial statement in Parliament
or an explanatory note prepared by his department while the Bill was
C proceeding through Parliament. By having regard to such material, the
court would not be "questioning" proceedings in Parliament or intruding
improperly into the legislative process or ascribing to Parliament the views
expressed by a minister. The court would merely be placing itself in a better
position to understand the legislation.
65. To that limited extent there may be occasion for the courts, when
d
conducting the statutory "compatibility" exercise, to have regard to matters
stated in Parliament. It is a consequence flowing from the Human Rights
Act. The constitutionally unexceptionable nature of this consequence
receives some confirmation from the view expressed in the unanimous
report of the parliamentary Joint Committee on Parliamentary Privilege
(1999) (HL Paper 43-I, HC 214-I), p. 28, para 86, that it is difficult to see
e how there could be any objection to the court taking account of something
said in Parliament when there is no suggestion the statement was inspired
by improper motives or was untrue or misleading and there is no question
of legal liability."
Recourse to such background information would enable the court to better
f understand the law and would not amount to a breach of parliamentary
privilege.
215. The decision of the Privy Council in Buchanan v. Jennings 138 arose
from the Court of Appeal1 39 in New Zealand. The judgment recognises that
while the protection conferred by Article 9 of the Bill of Rights should not be
whittled away, yet as the Joint Committee on parliamentary privileges (Chaired
g by Lord Nicholls of Birkenhead) observed, freedom to discuss parliamentary
proceedings is necessary in a democracy: (AC p. 123, para 9)
"9 . ... 'Freedom for the public and the media to discuss parliamentary
proceedings outside Parliament is as essential to a healthy democracy as
the freedom of members to discuss what they choose within Parliament.' "
h
138 (2005) 1 AC 115: (2004) 3 WLR 1163: 2004 UKPC 36
139 Buchanan v. Jennings, (2002) 3 NZLR 145 (CA)
643
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Media reporting of parliamentary proceedings, the Court held, has been an
important instrument of public debate. Hence the freedom of the Members of
Parliament to discuss freely within its portals must be weighed with the freedom a
of the public to discuss and debate matters of concern to them: (AC p. 123,
para 9)
"9 . ... As it is, parliamentary proceedings are televised and recorded.
They are transcribed in Hansard. They are reported in the press, sometimes
less fully than parliamentarians would wish. They form a staple of current
b
affairs and news programmes on the radio and television. They inform and
stimulate public debate. All this is highly desirable, since the legislature is
representative of the whole nation. Thus, as the Joint Committee observed
in its executive summary (p. 1 ):
'This legal immunity is comprehensive and absolute. Article 9
should therefore be confined to activities justifying such a high degree C
of protection, and its boundaries should be clear.' "

These observations reflect a concern to define the boundaries of the immunities
under Article 9 in clear terms. While recognising the absolute nature of the
immunity, its boundaries must "be confined to activities justifying such a high
degree of protection". The right of Members of Parliament to speak their minds d
in Parliament without incurring a liability is absolute. However, that right is
not infringed if a member, having spoken and in so doing defamed another
person, thereafter chooses to repeat his statement outside Parliament. In such
circumstances, the privilege may be qualified. While it is necessary that the
legislature and the courts do not intrude into the spheres reserved to the other,
a reference to parliamentary records to prove that certain words were in fact e
uttered is not prohibited. (Jenn ings case 138 , AC p. 132, para 18)
"18. . . . In a case such as the present, however, reference is made
to the parliamentary record only to prove the historical fact that certain
words were uttered. The claim is founded on the later extra-parliamentary
statement. The propriety of the member's behaviour as a parliamentarian f
will not be in issue. Nor will his state of mind, motive or intention when
saying what he did in Parliament."
216. The evolution of the law in UK indicates the manner in which the
protection under Article 9 of the Bill of Rights has been transformed. There
are essentially three principles which underlie the debate. The first is the
g
importance of the freedom of speech in Parliament. The absolute protection
which is afforded to what is done or spoken by a Member of Parliament
in Parliament is an emanation of the need to protect freedom of speech in
Parliament. The second principle which is at work is the separation of powers
between Parliament and the courts. This principle recognises that liability for a
falsehood spoken in Parliament lies within the exclusive control of Parliament. h
138 Buchanan v. Jennings, (2005) 1 AC 115 : (2004) 3 WLR 1163: 2004 UKPC 36
644
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A Member of Parliament cannot be held to account in a court of law for anything
which is said or spoken in Parliament. A speech in Parliament would not
a attract either a civil or criminal liability enforceable in a court of law. The third
principle emphasises that debates in Parliament have a public element. Public
debate is the essence of and a barometer to the health of democracy. Though
the privilege which attaches to a speech in Parliament is absolute, the immunity
extends to those activities within Parliament, which justify a high degree of
protection. As parliamentary proceedings have come to be widely reported,
b published and televised, the common law has come to recognise that a mere
reference to or production of a record of what has been stated in Parliament
does not infringe Article 9 of the Bill of Rights.
217. In other words, a reference to parliamentary record to prove a
historical fact that certain words were spoken is not prohibited. What is
C
impermissible is to question the trnthfulness or veracity of what was stated
before Parliament in any fornm including a court, outside Parliament. Nor can a
Member of Parliament be cross-examined in a proceeding before the court with
reference to what was stated in Parliament. The validity of an Act of Parliament
or of the proceedings of a Parliamentary Committee cannot be questioned in a
court in UK. The enactment of the Human Rights Act has led to a recognition
d that in testing whether a statutory provision is incompatible with a Convention
right, it may become necessary for the court to adjudge the practical effects
of a law. To do so, the court may legitimately have reference to background
material which elucidates the rationale for the law, the social purpose which
it has sought to achieve and the proportionality of its imposition. In order to
understand the facets of the law which bear upon rights protected under the
e European Convention, the court may justifiably seek recourse to statements of
ministers, policy documents and white papers to find meaning in the words of
the statute. The law in UK has hence developed to recognise that free speech in
Parliament and separation of powers must be placed in a scale of interpretation
that is cognizant of the need to protect the democratic rights of citizens.
f E.2. India
218. The law in India has witnessed a marked degree of evolution. Indian
jurisprndence on the subject has recognised the importance of the freedom of
speech in Parliament, the principle of separation of powers and the concomitant
protection afforded to Members from being held liable for what is spoken in
Parliament. Principles grounded in the common law in UK have not remained
g just in the realm of common law. The Constitution, in recognising many of
those principles imparts sanctity to them in a manner which only the text
of a fundamental written charter for governance can provide. Separation of
powers is part of the basic structure. Our precedent on the subject notices
the qualitative difference between parliamentary democracy in UK and in
India. The fundamental difference arises from the supremacy of the Indian
h
645
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Constitution which subjects all constitutional authorities to the mandate of a
written Constitution.
219. The locus classicus on the subject of parliamentary privileges is the a
seven-Judge Bench decision in Powers, Privileges and Immunities of State
Legislatures, In re 22 . It was argued before this Court that the privilege of the
House to construe Article 194(3) and to determine the width of the privileges,
powers and immunities enables the House to determine questions relating to the
existence and extent of its powers and privileges, unfettered by the views of the
b
Supreme Court. Gajendragadkar, C.J. held that it was necessary to determine
whether even in the matter of privileges, the Constitution confers on the House
a sole and exclusive jurisdiction. The decision recognises that while in UK,
Parliament is sovereign, the Indian Constitution creates a federal structure and
the supremacy of the Constitution is fundamental to preserving the delicate
balance of power between constituent units: (AIR p. 762, para 39) C
"39 . ... it is necessary to bear in mind one fundamental feature of a
Federal Constitution. In England, Parliament is sovereign; and in the words
of Dicey, the three distinguishing features of the principle of Parliamentary
Sovereignty are that Parliament has the right to make or unmake any law
whatever; that no person or body is recognised by the law of England as
having a right to override or set aside the legislation of Parliament, and d
that the right or power of Parliament extends to every part of the Queen's
dominions*. On the other hand, the essential characteristic of federalism
is "the distribution of limited executive, legislative and judicial authority
among bodies which are coordinate with and independent of each other".
The supremacy of the Constitution is fundamental to the existence of a e
federal State in order to prevent either the legislature of the federal unit
or those of the member States from destroying or impairing that delicate
balance of power which satisfies the particular requirements of States
which are desirous of union, but not prepared to merge their individuality
in a unity. This supremacy of the Constitution is protected by the authority
of an independent judicial body to act as the interpreter of a scheme of f
distribution of powers. Nor is any change possible in the Constitution by
the ordinary process of federal or State legislation**. Thus the dominant
characteristic of the British Constitution cannot be claimed by a Federal
Constitution like ours."
While the legislatures in our country have plenary powers, they function g
within the limits of a written Constitution. As a result, the sovereignty which
Parliament can claim in UK cannot be claimed by any legislature in India "in
the literal absolute sense".
22 Powers, Privileges and lmmunilies of State Legislalures, In re, Special Reference No. 1 of
1964, AIR 1965 SC 745 : (1965) 1 SCR 413 h
* The Law of the Constitution by A.V. Dicey, p. 34.
** The Law of the Constitution by A.V. Dicey, p. 77.
646
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220. The immunity conferred on Members of Parliament from liability to
"any proceedings in any court in respect of anything said or any vote given
a by him in Parliament" [Article 105(2)] was deliberated upon in a judgment of
the Constitution Bench in P.V. Narasimha Rao v. State 140 . G.N. Ray, J. agreed
with the view of S.P. Bharucha, J. on the scope of the immunity under clauses
(2) and (3) of Article 105. The judgment of Bharucha, J. (for himself and
S. Rajendra Babu, J.) thus represents the view of the majority. The minority
view was of S.C. Agrawal and Dr A.S. Anand, JJ. In construing the scope
b of the immunity conferred by Article 105(2), Bharucha, J. adverted to the
judgments delivered by courts in the United Kingdom (including those of
the Privy Council noted earlier 141 ). Interpreting Article 105(2), Bharucha, J.
observed thus: (SCC p. 729, para 133)
"133. Broadly interpreted, as we think it should be, Article 105(2)
protects a Member of Parliament against proceedings in court that relate
C
to, or concern, or have a connection or nexus with anything said, or a vote
given, by him in Parliament."
In that case, the charge in a criminal prosecution for the offences under
Section 120-B of the Penal Code and the Prevention of Corruption Act, 1988
was that there was a criminal conspiracy between alleged bribe-givers and
d bribe-takers (who were Members of the legislature) to defeat a motion of no
confidence by obtaining illegal gratification in pursuance of which bribes were
given and accepted. The charge did not refer to the votes that the alleged
bribe-takers had actually cast upon the no-confidence motion. Nevertheless, the
majority held that the expression "in respect of'' in Article 105(2) must perceive
a "broad meaning". The alleged conspiracy and agreement had nexus in respect
e of those votes, and the proposed inquiry in the criminal proceedings was in
regard to its motivation.
221. The submission of the Attorney General for India that the protection
under Article 105(2) is limited to court proceedings and to a speech that is
given or a vote that is cast was not accepted by the Constitution Bench for the
following reasons: (P.V. Narasimha case 140 , SCC pp. 729-30, para 136)
f
"136. It is difficult to agree with the learned Attorney General that
though the words "in respect of'' must receive a broad meaning, the
protection under Article 105(2) is limited to court proceedings that impugn
the speech that is given or the vote that is cast or arises thereout or that
the object of the protection would be fully satisfied thereby. The object of
the protection is to enable Members to speak their mind in Parliament and
g
vote in the same way, freed of the fear of being made answerable on that
account in a court of law. It is not enough that Members should be protected
against civil action and criminal proceedings, the cause of action of which
140 (1998) 4 sec 626: 1998 sec (Cri) 1108

h 141 Bradlaugh v. Gossett, (1884) LR 12 QBD 271 : 53 LJQB 290: 50 LT 620 (DC); Richard William
Prebble v. Television New Zealand Ltd., (1995) 1 AC 321 : (1994) 3 WLR 970: (1994) 3 All ER
407 (PC); R. v. Currie, 1992 (unreported).
647
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is their speech or their vote. To enable Members to participate fearlessly
in parliamentary debates, Members need the wider protection of immunity
against all civil and criminal proceedings that bear a nexus to their speech a
or vote. It is for that reason that a Member is not "liable to any proceedings
in any court in respect of anything said or any vote given by him". Article
105(2) does not say, which it would have if the learned Attorney General
were right, that a Member is not liable for what he has said or how he has
voted. While imputing no such motive to the present prosecution, it is not
difficult to envisage a Member who has made a speech or cast a vote that b
is not to the liking of the powers that be being troubled by a prosecution
alleging that he had been party to an agreement and conspiracy to achieve
a certain result in Parliament and had been paid a bribe."
The view of the minority was that the offence of bribery is made out against
a bribe-taker either upon taking or agreeing to take money for a promise to
act in a certain manner. Following this logic, S.C. Agrawal, J. held that the C
criminal liability of a Member of Parliament who accepts a bribe for speaking

or giving a vote in Parliament arises independent of the making of the speech
or the giving of the vote and hence is not a liability "in respect of anything said
or any vote given" in Parliament. The correctness of the view in the judgment
of the majority does not fall for consideration in the present case. Should it
become necessary in an appropriate case in future, a larger Bench may have d
to consider the issue.
222. The judgment of the Constitution Bench in Raja Ram Pal v. Lok
Sabha 142 , has a significant bearing on the issues which arise in the present
reference. Y.K. Sabharwal, C.J. delivering the leading opinion on behalf of
three Judges dealt with the ambit of Article 105 in relation to the expulsion of
e
a Member and the extent to which such a decision of the Houses of Parliament
is amenable to judicial review. The judgment notices that "parliamentary
democracy in India is qualitatively distinct" from UK. In defining the nature
and extent of judicial review in such cases, Sabharwal, C.J. observed that it is
the jurisdiction of the court to examine whether a particular privilege claimed
by the legislature is actually available to it: (SCC p. 259, para 62)
f
"62. In view of the above clear enunciation of law by Constitution
Benches of this Court in case after case, there ought not be any doubt left
that whenever Parliament, or for that matter any State Legislature, claims
any power or privilege in terms of the provisions contained in Article
105(3), or Article 194(3), as the case may be, it is the Court which has
the authority and the jurisdiction to examine, on grievance being brought g
before it, to find out if the particular power or privilege that has been
claimed or asserted by the legislature is one that was contemplated by the
said constitutional provisions or, to put it simply, ifit was such a power or
privilege as can be said to have been vested in the House of Commons of the
Parliament of the United Kingdom as on the date of commencement of the
Constitution of India so as to become available to the Indian Legislatures." h
142 c2001) 3 sec 184
648
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While Parliament has the power to expel a member for a contempt committed,
the doctrine of "exclusive cognizance" adopted in UK has no application
a in India which is governed by a written Constitution. Though Parliament
is possessed of a plenitude of powers, it is subject to terms of legislative
competence and to the restrictions imposed by fundamental rights. Article
21 is attracted when the liberty of a Member of Parliament is threatened by
imprisonment in execution of a parliamentary privilege. Fundamental rights
can be invoked both by a Member and by a non-Member when faced by the
b exercise of parliamentary privilege.
223. Drawing the distinction between UK and India, Sabharwal, C.J.
observed: (Raja Ram Pal case 142 , SCC p. 348, para 363)
"363. That the English cases laying down the principle of exclusive
cognizance of Parliament, including Bradlaugh 80 , arise out of a jurisdiction
controlled by the constitutional principle of sovereignty of Parliament
C
cannot be lost sight of. In contrast, the system of governance in India
is founded on the norm of supremacy of the Constitution which is
fundamental to the existence of the Federal State."
Consequently, proceedings which are tainted as a result of a substantive
illegality or unconstitutionality (as opposed to a mere irregularity) would
d not be protected from judicial review. The doctrine of exclusive cognizance
was evolved in England as incidental to a system of governance based on
parliamentary sovereignty. This has no application to India, where none of the
organs created by the Constitution is sovereign, and each is subject to the checks
and controls provided by the Constitution.
224. The decision in Raja Ram Pa/1 42 holds that Article 122(1) embodies
e the twin test of legality and constitutionality. This Court has categorically
rejected the position that the exercise of powers by the legislature is not
amenable to judicial review: (SCC p. 360, para 389)
"389 . ... there is no scope for a general rule that the exercise of powers
by the legislature is not amenable to judicial review. This is neither the letter
f
nor the spirit of our Constitution. We find no reason not to accept that the
scope for judicial review in matters concerning parliamentary proceedings
is limited and restricted. In fact, this has been done by express prescription
in the constitutional provisions, including the one contained in Article
122(1 ). But our scrutiny cannot stop, as earlier held, merely on the privilege
being found, especially when breach of other constitutional provisions has
g been alleged."
The Court will not exercise its power of judicial review where there is merely
an irregularity of procedure, in view of the provisions of Article 122(1). But
judicial review is not "inhibited in any manner" where there is a gross illegality
or a violation of constitutional provisions. While summarising the conclusions
of the judgment, Sabharwal, C.J. emphasised the need for constitutional comity,
h
80 Bradlaugh v. Gossett, (1884) LR 12 QBD 271 : 53 LJQB 290: 50 LT 620 (DC)
649
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since Parliament being a coordinate constitutional institution. The expediency
and necessity for the exercise of the power of privilege are for the legislature to
determine. Yet, judicial review is not excluded for the purpose of determining a
whether the legislature has trespassed on the fundamental rights of its citizens.
225. Among the conclusions in the judgment, of relevance to the present
case, are the following: (Raja Ram Pal case 142 , SCC p. 372, para 431)
"431 . ... (k) There is no basis to the claim of bar of exclusive
cognizance or absolute immunity to the parliamentary proceedings in
b
Article 105(3) of the Constitution;
(l) The manner of enforcement of privilege by the legislature can result
in judicial scrutiny, though subject to the restrictions contained in the other
constitutional provisions, for example Article 122 or 212; and
(m) Article 122(1) and Article 212(1) displace the broad doctrine of
exclusive cognizance of the legislature in England of exclusive cognizance C
of internal proceedings of the House rendering irrelevant the case law that
emanated from courts in that jurisdiction; inasmuch as the same has no
application to the system of governance provided by the Constitution of
India;"
226. The decision in Raja Ram Pal 142 has been adverted to in the
subsequent judgment of the Constitution Bench in Amarinder Singh v. Punjab d
Vidhan Sabha 143 . Balakrishnan, C.J. speaking for the Constitution Bench, held
that all the privileges which have been claimed by the House of Commons
cannot be claimed automatically by legislative bodies in India. Legislatures in
India do not have the power of self-composition which is available to the House
of Commons. Indian legislatures are governed by a written Constitution.
e
227. The limits of comparative law must weigh in the analysis in this
area of constitutional law, when the Court is confronted by a copious attempt,
during the course of submissions, to find meaning in the nature and extent of
parliamentary privilege in India from decided cases in UK. The fundamental
difference between the two systems lies in the fact that parliamentary
sovereignty in the Westminster form of Government in UK has given way, in
f
the Indian Constitution, to constitutional supremacy. Constitutional supremacy
mandates that every institution of governance is subject to the norms embodied
in the constitutional text. The Constitution does not allow for the existence of
absolute power in the institutions which it creates. Judicial review as a part of
the basic features of the Constitution is intended to ensure that every institution
acts within its bounds and limits. The fundamental rights guaranteed to citizens
g
are an assurance of liberty and a recognition of the autonomy which inheres
in every person. Hence, judicial scrutiny of the exercise of parliamentary
privileges is not excluded where a fundamental right is violated or a gross
illegality occurs. In recognising the position of Parliament as a coordinate
institution created by the Constitution, judicial review acknowledges that
h
143 c2010) 6 sec 113: c2010) 2 sec (Cri) 1343
650
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Parliament can decide the expediency of asserting its privileges in a given
case. The Court will not supplant such an assertion or intercede merely on the
a basis of an irregularity of procedure. But where a violation of a constitutional
prescription is shown, judicial review cannot be ousted.
F. Separation of powers: A nuanced modern doctrine
228. The submission of the Attorney General is that the carefully structured
dividing lines between the judicial, executive and legislative wings of the
State would be obliterated if the court were to scrutinise or judicially review
b
reports of Parliamentary Committees. The principle of separation, it has
been submitted, interdicts the courts from scrutinising or reviewing reports
of Parliamentary Committees. Judicial review may well result in a conflict
between the two institutions of the State and is hence - according to the
submission - best eschewed.
C
229. Separation of powers between the legislature, the executive and the
judiciary covers a large swathe of constitutional history spanning the writings
of Montesquieu and Blackstone, to the work of Dicey and Jennings. Gerangelos
(2009) laments that in UK, parliamentary sovereignty has prevented the
principle of separation from emerging as a judicially enforceable standard 144 :
"Britain's unwritten constitution and the influence of Diceyian
d orthodoxy, emphasising parliamentary sovereignty and a fusion of powers
which did not countenance judicial invalidation of legislative action,
has meant that the separation of powers has not become a source of
judicially-enforceable constitutional limitations. The precise status of
the doctrine has varied from time to time and the extent to which the
doctrine nevertheless provides some restraint on legislative interference
e with judicial process cannot be determined with precision. It can be
said, however, that constitutional entrenchment of the separation doctrine
has not been part of the Westminster constitutional tradition; a tradition
which has not, in any event, placed much store by written constitutions
with their accompanying legalism and rigidities. The prevailing influence
from that quarter has been the maintenance of judicial independence in
f terms of institutional independence through the protection of tenure and
remuneration, and afforded statutory protection in the Act of Settlement
in 1701, as opposed to the protection of judicial power in a functional
sense." (emphasis in original)
The impact of the doctrine is seen best in terms of the institutional independence
of the judiciary from other organs of the State. The doctrine is stated to have
g
been overshadowed in UK "by the more dominant constitutional principles of
parliamentary sovereignty and the rule of law". For instance, in UK, Ministers
of Crown are both part of the executive and members of Parliament. Until the
Constitutional Reform Act, 2005 the Lord Chancellor was a member of the
Cabinet and was eligible to sit as a Judge in the Appellate Committee of the
h
144 Peter A. Gerangelos, The Separation of Powers and Legislative Interference in Judicial Process,
Constitutional Principles and Limitations (Hart Publishing, 2009).
651
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House of Lords. The Judicial Committee of the House of Lords was the highest
court, even though the House constituted the Upper House of the legislature.
In the enforcement of parliamentary privileges, the House exercises judicial a
functions. Delegated legislation enables the executive to exercise legislative
functions.
230. Many contemporary scholars have differed on the normative
importance of the doctrine of separation. One view is that while a distinct
legislature, executive and judiciary can be identified as a matter of practice,
this is not a mandate of the unwritten Constitution. The statement that there b
is a separation is construed to be descriptive and not normative 145 . On the
other hand, other scholars regard the doctrine as "a fundamental underlying
constitutional principle which informs the whole British constitutional
structure" 146 . Yet, even scholars who emphasise the importance of the
separation of powers in UK acknowledge that the Constitution does not strictly
observe such a separation. Courts in UK do not possess a direct power of C
judicial review to invalidate legislation though, with the enactment of the
Human Rights Act, the doctrine of incompatibility has become an entrenched
feature of the law.
231. Gerangelos (supra) states that "the most that can be said is that the
separation of powers does play an influential role as a constitutional principle,
d
but as a non-binding one". 147 He cites Professor Robert Stevens 148 :
"In modern Britain the concept of the separation of powers is cloudy
and the notion of the independence of the judiciary remains primarily a
term of constitutional rhetoric. Certainly its penumbra, and perhaps even
its core, are vague. No general theory exists, although practically the
English have developed surprisingly effective informal systems for the e
separation of powers; although it should never be forgotten that the system
of responsible Government is based on a co-mingling of the executive
with the legislature. The political culture of the United Kingdom, however,
provides protections for the independence of the judiciary, which are
missing in law."
232. The importance of the principle of separation essentially lies in the f
independence of the judiciary. The protections in the Act of Settlement, 1701
have now been reinforced in the Constitutional Reform Act, 2005. Though the
supremacy of Parliament is one of the fundamental features in UK and the
145 See A. Tomkins, Public Law (Oxford University Press, 2003) 37 (as cited by Gerangelos at
p. 274). g
146 E. Barendt, "Separating of Powers and Constitutional Government" [1995] Public Law 599 at
599-60, C. Munro, Studies in Constitutional L aw, 2nd Edn. (London, Butterworths, 1999) at
304, T.R.S. Allan, Law Liberty and Justice, The Legal Foundations of British Constitutionalism
(Oxford, Clarendon Press, 1993) Chs. 3 and 8, and T.R.S. Allan, Constitutional Justice, A Liberal
Theory of the Rule of Law (Oxford, Oxford University Press, 2001).
147 Peter A. Gerangelos, The Separation of Powers and Legislative Interf erence in Judicial Process,
Constitutional Principles and Limitations (Hart Publishing, 2009). h
148 R. Stevens, "A Loss oflnnocence?: Judicial Independence and the Separation of Powers" (1999)
19 Oxford Journal of Legal Studies 365.
652
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unwritten Constitution does not mandate a strict separation of powers, it would
be difficult to regard a State which has no control on legislative supremacy as
a a constitutional State founded on the rule of law 14 9. Consequently, where the
rule of law and constitutionalism govern society there may yet be fundamental
principles inhering in the nature of the polity, which can be enforced by the
judiciary even against Parliament, in the absence of a written Constitution 150 .
In other words, even in the context of an unwritten Constitution, the law has
a certain internal morality as a part of which it embodies fundamental notions
b of justice and fairness.
233. The interpretation of the doctrine of separation of powers has evolved
from being a "one branch - one function approach" 151 with limited exceptions,
to a concept which involves an integration of the "division of work" and
"checks and balances" 152. The primary aim of the doctrine today is to ensure
the accountability of each wing of the State, while ensuring concerted action
C in respect of the functions of each organ for good governance in a democracy.
The doctrine of separation of power has developed to fulfil the changing
needs of society and its growing necessities. Many of these considerations
are significantly different from those which were prevalent when Montesquieu
originally formulated the doctrine.
234. In 1967, M.J.C. Vile in his book titled Constitutionalism and the
d
Separation of Powers 153 defined the "pure doctrine" of separation of powers
thus:
"[a] "pure doctrine" of the separation of powers might be formulated
in the following way: It is essential for the establishment and maintenance
of political liberty that the Government be divided into three branches
e or departments, the legislature, the executive, and the judiciary. To each
of these three branches, there is a corresponding identifiable function
of Government, legislative, executive, or judicial. Each branch of the
Government must be confined to the exercise of its own function and not
allowed to encroach upon the functions of the other branches. Furthermore,
the persons who compose these three agencies of Government must be kept
f separate and distinct, no individual being allowed to be at the same time a
member of more than one branch. In this way, each of the branches will be
a check to the others and no single group of people will be able to control
the machinery of the State." 154
g
149 T.R.S. Allan, Law Liberty and Justice, The Legal Foundations of British Constitutionalism
(Oxford, Clarendon Press, 1993).
150 Gerangelos, at p. 277.
151 Aileen Kavanagh, The Constitutional Separation of Powers, Chapter 11 in David Dyzenhaus and
Malcolm Thorburn (eds.) Philosophical Foundations of Constitutional Law, (Oxford University
Press, 2016) 221 (hereinafter, "Philosophical Foundations of Constitutional Law").
h 152 See M.J.C. Vile, Constitutionalism and the Separation ofPowers (Oxford University Press, 1967).
153 Ibid.
154 Id, at p. 13.
653
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This d efinition become s important to facilitate an understanding of the
reconstructed and modern vie w on separa tion of powers vis-a-vis its traditional
understanding. Vile e sse ntially proposes that "division of labour" and "checks a
and b alances" are intrinsic to the theory of separation of powers. In his vie w, a
scheme of checks and balances would involve a degree of mutual supervision
among the branches of Government, and may therefore result in a certain
amount of interference by one branch into the functions and tasks of the
other. 155
235. Aileen Kavanagh, has presented a scholarly analysis of separation b
of powers in a chapter titled "The Constitutional Separation of Powers" . 156
She concurs with the view expressed by M.J.C. Vile that separation of
powers includes two components, that of "division of labour" and "checks
and balances". These two components are strengthened by the deep-rooted
ethos of coordinated institutional effort and joint activity between branches of
the Government in the interest of good governance. 157 Instead of an isolated C
compartmentalisation of branches of Government, she highlights the necessary

independence, interdependence, interaction and interconnection between these
branches in a complex interactive setting. 158
236. Kavanagh acknowledges that in view of the stronghold of the pure
doctrine over our understanding of separation of powers, the idea of a
d
collective enterprise between the branches of the Government for the purpose
of governing may seem jarring. However, she argues that this idea of "branches
being both independent and interdependent-distinct but interconnected-
also has some pedigree in canonical literature." 159 Kavanagh thus opines that
the tasks of law-making, law-applying and law-executing are collaborative in
nature, necessitating cooperation between the branches of the Government in
e
furtherance o f the common objective o f good governance. Kavanagh explains
this as follows:
"In some contexts, the interaction between the branches will be
supervisory, where the goal is to check, review and hold the other to
account. At other times, the interaction will be a form of cooperative
engagement where the branches have to support each other's role in the f
joint endeavor." 160
155 See, M.J.C. Vile, Constitutionalism and The Sep aration of Powers (Oxford University Press,
1967).
156 Aileen Kavanagh, The Constitutional Separation of Powers, Chapter 11 in David Dyzenhaus and
Malcolm Thorburn (eds.) Philosophical Foundations of Constitutional Law, (Oxford University g
P ress, 201 6) 221.
157 See, D . Kyritsis, "What is Good ab out Legal C onventionali sm?" (2008) 14 Legal Theory 135, 154
(as cited in Philosophical Foundations of Constitutional Law, at p. 235).
158 Ibid.
159 Philosophical Foundations of Constitutional Law, at p. 236.
160 K. Malleson, 'The Rehabilitation of S eparation of Powers in UK' in L. de Groot- van Leeuwen and
W. Rombouts, Sep aration of Powers in Theo ry and P ractice: A n International Perspective h
(Nijmegen: Wolf Publishing , 2010) 99-122, 115 (as cited in Philosophical Foundations of
Constitutional Law, at p. 237).
654
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237. Jeremy Waldron has dealt with the relationships among officials or
institutions in a State. He proposes that separation of powers is not just a
a principle involving the division of labour and the distribution of power but
also includes inter-institutional relationships between the three branches when
carrying out their distinct roles as part of a joint enterprise. This is in order to
facilitate, what Waldron called the "Principle of Institutional Settlement". 161
Further, inter-institutional comity, which is the respect that one branch of the
State owes to another, is also a significant factor, which calls for collaboration
b among branches of the Government to ensure that general public values such
as welfare, autonomy, transparency, efficiency and fairness are protected and
secured for the benefit of citizens. 162
238. Thus, in a comparative international context, authors have accepted
separation of powers to widely include two elements: "division of labour" and
"checks and balances". The recent literature on the subject-matter encourages
C inter-institutional assistance and aid towards the joint enterprise of good
governance. The current view on the doctrine of separation of powers also
seeks to incorporate mutual supervision, interdependence and coordination
because the ultimate aim of the different branches of the Government, through
their distinct functions is to ensure good governance and to serve public
interest, which is essential in the background of growing social and economic
d interests in a welfare State. This stands in contrast with the former and original
interpretation of the doctrine, which sought to compartmentalise and isolate
the different branches of the Government from one another, with limited
permissible exceptions.
239. Eoin Carolan's book titled The New Separation of Powers (2009)
reflects an attempt to reshape the traditional doctrine of separation, to make it
e relevant to the practical realities of modern Government. He notes that while the
tripartite separation of powers between the legislature, executive and judiciary
had "conceptual simplicity with an impeccable academic pedigree" 163 , the
doctrine has obvious limitations in the sense that it does not satisfactorily
explain the emergence and growth of the modern administrative State we see
today. The author contends that an institutional theory like the separation of
f powers can no longer be accepted in its original form ifit cannot account for this
"significant tranche of government activity". Among the characteristics of the
modern administrative State is that public power is exercised in a decentralised
manner and on an ever-growing discretionary basis. 164
g
161 J. Waldron, "Authority for Officials" in L. Meyer, S. Paulson and T. Pogge (eds.), Rights, Culture,
and the Law: Themes from the Legal and Political Philosophy of Jos eph Raz (Oxford University
Press, 2003) 45-70.
162 See, J. King, "Institutional Approaches to Judicial Restraint" (2008) 28 Oxford Journal of Legal
Studies 409,428; See also, Buckley v. Attorney General, 1950 Irish Reports 67, 80 (per O'Bryne,
J.) (as cited in Philosophical Foundations of Constitutional Law, at p. 235).
h 163 Eoin Carolan, The N ew Separation ofPowers-A Theory for the Modern State (Oxford University
Press, 2009) 253.
164 Ibid.
655
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240. The shared growth of administrative powers of the bureaucracy
in the modern State defies the tripartite division. Therefore, a realistic
modern application of the theory is necessary. The modern system of a
Government has grown in ways previously thought unfathomable, and now
encompasses a breadth and diversity previously unseen. The Government
today is characterised by the increase in powers of its agencies and the rapid
growth of organisations which can neither be classified as exclusively public
or private bodies. These modern systems of Government and the existence
and rapid rise of supranational organisations defy the traditional three-way b
division of powers. Administrative bodies are not defined by a uniform design,
and exercise institutional fluidity in a manner which has come to characterise
the administrative State's organisational complexity: in a single instance, they
exercise powers and perform functions that might have been formerly classified
as executive, judicial or legislative in nature. 165 In this view, the modern Stale is
distinctly different from Locke's seventeenth century Model and Montesquieu's C
eighteenth century ideas:
"The State is now dirigiste, discretionary, and broadly dispersed." 166
241. Carolan thus proposes that to be suitable, a theory of institutional
justice must be rooted in the principle of non-arbitrariness. He believes
that a more suitable approach of classification of institutions would be not d
by functions, but by constituencies, and the sole constituency in this legal
framework is the individual citizen. Carolan's proposed model places emphasis
on the exercise of power on the basis of inter-institutional dialogue which
ensures that a communicative process has taken place 167 . Carolan describes his
model thus:
"The prescribed institutional structure operates by inter-organ e
mingling instead of separation. Individual decisions are delivered at
the end of a multi-institutional process, the central concern of which
is to organise, structure, manage, and-crucially-ensure the input of
all relevant institutional interests. On this model, the government and
the courts are presented as providing an orienting framework within
which administrative decision-making will occur. These first-order organs f
function at the level of macro-social organisation, adopting general
measures which are expected to advance their constituent social interest.
The government specifies the actions it feels are required (or requested) to
enhance the position of the collective. The courts, for their part, insist on
the process precautions necessary to secure individual protection. Issues of
informational efficacy and non-arbitrariness combine to ensure, however, g
that these provisions are not particularized."
While the autonomy of the administration is respected as a vital institutional
process, corrective measures are required where an institution has strayed
165 Eoin Carolan, "The Problems with the Theory of Separation of Powers", SSRN, (2011) 26. h
166 Op cit fn 162 at p. 256.
167 Id, at p. 132.
656
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outside the rang e of pe rmissible outcome s. He spe aks of a collaborative proce ss
of exercising power, with the judiciary acting as a re straining influe nce on the
a arbitrary exercise of authority.
242. While the Indian Constitution has been h eld to have re cognised the
doctrine of separation of powers, it does not adopt a rigid separation. In Ram
Jawaya Kapur v. State of Punjab 13 , this Court held: (AIR p. 556, para 12)
"12 . ... The Indian Constitution has not indeed recognised the doctrine
of separation of powers in its absolute rigidity but the functions of the
b
different parts or branches of the Governme nt have been sufficie ntly
differentiated and consequently it can v ery well be said that our
Constitution does not contemplate assumption, by one organ or part of the
State, of functions that essentially belong to another."
R educe d to its core, separation e ntails that one organ or institution of the State
C cannot usurp the powers of another.
243. In Powers, Privileges and Immunities of State Legislatures, In re 22 ,
this Court held that whether or not the Constitution brings about a "distinct and
rigid separation of powers", judicial review is an inseparable part of the judicial
function. Whether legislative authority has extended beyond its constitutional
boundaries or the fundamental rights have been contravened cannot be decided
d by the legislature , but is a matter entrusted exclusively to judicial decision.
244. In Kesavananda Bharati v. State of Kerala 3 , separation of powers was
regarded as a feature of the basic structure of the Indian Constitution. Sikri,
C.J. held: (SCC p. 366, para 292)
"292. The learned Attorney General said that every provision of the
e Constitution is essential; otherwise it would not have been put in the
Constitution. This is true. But this does not place every provision of
the Constitution in the same position. The true position is that every
provision of the Constitution can be amended provided in the result the
basic foundation and structure of the Constitution remains the same. The
basic structure may be said to consist of the following features:
f Supremacy of the Constitution;
(J)
(2)
Republican and Democratic form of Governme nt;
(3)
Secular character of the Constitution;
Separation ofpowe rs between th e legislature, th e executive and
(4)
the judiciary;
g (5) Federal character of the Constitution." (emphasis supplied)
Shelat and Grover, JJ. emphasised the doctrine of separation as a part of the
checks and balances envisaged by the Constitution: (SCC p. 452, para 577)
13 (1 955) 2 SCR 225 : AIR 1955 SC 549

h 22 Powers, Privileges and Immunities of State Legislatures, In re, Special Ref erence No. 1 of
1964, AIR 1965 SC 745 : (1965) 1 SCR 413
3 (1973) 4 sec 225: AIR 1973 SC 1461
657
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"577 .... There is ample evidence in the Constitution itself to indicate
that it creates a system of checks and balances by reason of which powers
are so distributed that none of the three organs it sets up can become so pre- a
dominant as to disable the others from exercising and discharging powers
and functions entrusted to them. Though the Constitution does not lay down
the principle of separation of powers in all its rigidity as is the case in the
United States Constitution yet it envisages such a separation to a degree .... "
245. In Indira Nehru Gandhi v. Raj Narain 12 , Y.V. Chandrachud held that
while the Constitution does not embody a rigid separation of governmental b
powers, a judicial function cannot be usurped by the legislature: (SCC p. 261,
para 689)
"689. . .. the exercise by the legislature of what is purely and
indubitably a judicial function is impossible to sustain in the context even of
our cooperative federalism which contains no rigid distribution of powers C
but which provides a system of salutary checks and balances."
The 39th Amendment of the Constitution did precisely that and was held to
violate the basic structure.
246. In l.R. Coelho v. State of T.N. 5 , the Court underlined the functional
complementarity between equality, the rule of law, judicial review and
d
separation of powers: (SCC p. 105, para 129)
"129. Equality, rule of law, judicial review and separation of powers
form parts of the basic structure of the Constitution. Each of these concepts
are intimately connected. There can be no rule of law, ifthere is no equality
before the law. These would be meaningless if the violation was not subject
to the judicial review. All these would be redundant if the legislative, e
executive and judicial powers are vested in one organ. Therefore, the duty
to decide whether the limits have been transgressed has been placed on the
judiciary."
247. A Constitution Bench of this Court in State ofT.N. v. State of Kerala 15
ruled on the importance of separation as an entrenched constitutional principle.
The Court held: (SCC p. 771, para 126.1) f
"126. J. Even without express provision of the separation of powers,

the doctrine of separation of powers is an entrenched principle in the
Constitution of India. The doctrine of separation of powers informs the
Indian constitutional structure and it is an essential constituent of rule
of law. In other words, the doctrine of separation of power though not g
expressly engrafted in the Constitution, its sweep, operation and visibility
are apparent from the scheme of Indian Constitution. Constitution has
made demarcation, without drawing formal lines between the three organs
-legislature, executive and judiciary. In that sense, even in the absence
12 1975 Supp sec 1 h

5 c2007) 2 sec 1
15 (2014) 12 sec 696
658
-----------------------------------------------------------------------------------------------------------------------------------------------------------

of expre ss provision for separation of powers, the separation of powers
be twe en the legislature , ex ecutive and judiciary is not differe nt from
a the Constitutions of the countries which contain express provision for
separation of powers."
248. The doctrine of separation restrains the legislature from declaring a
judgment of a court to be void and of no effect. However, in the exercise of
its law-making authority, a legislature possessed of legislative competence can
enact validating law which remedies a defect pointed out in a judgment of a
b court. While the legislature cannot ordain that a decision rendered by the court
is invalid, it may by enacting a law, take away the basis of the judgment such
that the conditions on which it is based are so fundamentally altered that the
decision could not have been given in the altered circumstances. 168
249. In State of U.P v. f eet S. Bisht 169 , the Court held that the doctrine
of separation of powers limits the "active jurisdiction" of each branch of
C
Government. However, even when the active jurisdiction of an organ of the
State is not challenged, the doctrine allows for methods to be used to prod and
communicate to an institution either its shortfalls or excesses in discharging its
duty. The Court recognised that fundamentally, the purpose of the doctrine is
to act as a scheme of checks and balances over the activities of other organs.
The Court noted that the modern concept of separation of powers subscribes to
d
the understanding that it should not only demarcate the area of functioning of
various organs of the State, but should also, to some extent, define the minimum
content in that delineated area of functioning. S.B. Sinha, J. addressed the
need for the doctrine to evolve, as administrative bodies are involved in the
dispensation of socio-economic entitlements: (SCC p. 619, para 83)
e "83. If we notice the evolution of separation of powers doctrine,
traditionally the checks and balances dimension was only associated
with governmental excesses and violations. But in today's world of
positive rights and justifiable social and economic entitlements, hybrid
administrative bodies, private functionaries discharging public functions,
we have to perform the oversight function with more urgency and
f enlarge the field of checks and balances to include governmental inaction.
Otherwise we envisage the country getting transformed into a state of
repose. Social engineering as well as institutional engineering therefore
forms part of this obligation." (emphasis in original)
250. The constitutional validity of the Members of Parliament Local
Area Development ("MPLAD") Scheme, which allocates funds to MPs for
g development work in their constituencies was considered by a Constitution
Bench of this Court in Bhim Singh v. Union of India 16 . The challenge was
168 l.N. Saksena v. State of M.P., (1976) 4 SCC 750 : 1977 SCC (L&S) 36; Indian Aluminium Co.
v. State of Kerala, (1996) 7 SCC 637; S.S. Bola v. B.D. Sardana, (1997) 8 SCC 522; Shri Prithvi
Cotton Mills Ltd. v. Broach Bo rough Mun icipality , (1 969) 2 SCC 283; Supreme Cowt Ad vo cates-
h on-Record A ssn. v. Union of India, (2016) 5 SCC 1
169 (2007) 6 sec 586
16 (2010) 5 sec 538
659
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that by entrusting funds to MPs, the Scheme vests governmental functions in
legislators and violates the separation of powers. The Court held that while
the concept of separation of powers is not found explicitly in a particular a
constitutional provision, it "is inherent in the polity the Constitution has
adopted". The Constitution Bench perceived that there is a link between
separation and the need to ensure accountability of each branch of Government.
While the Constitution does not prohibit overlapping functions, what it
prohibits is the exercise of functions by a branch in a way which "results in
wresting away of the regime of constitutional accountability". The Court held b
that by allowing funds to be allocated to Members of Parliament for addressing
the development needs of their constituencies, the MPLAD Scheme does not
breach the doctrine of separation of powers. The administration of the scheme
was adequately supervised by district authorities.
251. In Supreme Court Advocates-on-Record Assn. v. Union of India 170 ,
Madan B. Lokur, J. observed that separation of powers does not envisage that C
each of the three organs of the State - the legislature, executive and judiciary
- work in a silo. The learned Judge held: (SCC p. 583, para 678)
"678. There is quite clearly an entire host of parliamentary and
legislative checks placed on the judiciary whereby its administrative
functioning can be and is controlled, but these do not necessarily violate
d
the theory of separation of powers or infringe the independence of the
judiciary as far as decision-making is concerned. As has been repeatedly
held, the theory of separation of powers is not rigidly implemented in our
Constitution, but if there is an overlap in the form of a check with reference
to an essential or a basic function or element of one organ of State as against
another, a constitutional issue does arise. It is in this context that the 99th
e
Constitution Amendment Act has to be viewed-whether it impacts on a
basic or an essential element of the independence of the judiciary, namely,
its decisional independence."
252. In State of W.B. v. Committee for Protection of Democratic Rights 17 1 ,
this Court held that the doctrine of separation of powers could not be invoked to
limit the Court's power to exercise judicial review, in a case where fundamental f
rights are sought to be breached or abrogated on the ground that exercise of the
power would impinge upon the doctrine.
253. In a more recent decision of a Bench of two learned Judges of
this Court in Common Cause v. Union of India 172 , the Court construed the
provisions of the Lokpal and Lokayuktas Act, 2013 under which a multi-
member selection committee for the appointment of the Lokpal is to consist, g
among others, of the Leader of the Opposition. A Bill for amending the
provisions of the Act was referred to a Parliamentary Committee which
proposed the inclusion of the leader of the largest opposition party in the Lok
Sabha as a member, in lieu of the Leader of the Opposition in the selection
170 c2016) 5 sec 1 h
171 c2010) 3 sec 571 : c2010) 2 sec (Cri) 401
1n c2017) 7 sec 158
660
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committee. The grievance of the petitioners was that despite the enactment of
the law, its provisions had not been implemented. It was urged that even if there
a is no recognised Leader of the Opposition in the Lok Sabha, the leader of the
single largest opposition party should be inducted as a part of the Selection
Committee. Ranjan Gogoi, J. speaking for this Court held thus: (SCC p. 173,
para 18)
"18. There can be no manner of doubt that the parliamentary wisdom of
seeking changes in an existing law by means of an amendment lies within
b the exclusive domain of the legislature and it is not the province of the Court
to express any opinion on the exercise of the legislative prerogative in this
regard. The framing of the Amendment Bill; reference of the same to the
Parliamentary Standing Committee; the consideration thereof by the said
Committee; the report prepared along with further steps that are required
to be taken and the time-frame thereof are essential legislative functions
C which should not be ordinarily subjected to interference or intervention
of the Court. The constitutional doctrine of separation of powers and the
demarcation of the respective jurisdiction of the executive, the legislature
and the judiciary under the constitutional framework would lead the Court
to the conclusion that the exercise of the amendment of the Act, which
is presently underway, must be allowed to be completed without any
d intervention of the Court. Any other view and any interference, at this
juncture, would negate the basic constitutional principle that the legislature
is supreme in the sphere of law-making. Reading down a statute to make
it workable in a situation where an exercise of amendment of the law is
pending, will not be justified either. A perception, however strong, of the
imminent need of the law engrafted in the Act and its beneficial effects on
e the citizenry of a democratic country, by itself, will not permit the Court to
overstep its jurisdiction. Judicial discipline must caution the Court against
such an approach."
254. While assessing the impact of the separation of powers upon the
present controversy, certain precepts must be formulated. Separation of powers
f between the legislature, the executive and the judiciary is a basic feature of the
Constitution. As a foundational principle which is comprised within the basic
structure, it lies beyond the reach of the constituent power to amend. It cannot
be substituted or abrogated. While recognising this position, decided cases
indicate that the Indian Constitution does not adopt a separation of powers in the
strict sense. Textbook examples of exceptions to the doctrine include the power
g of the executive to frame subordinate legislation, the power of the legislature to
punish for contempt of its privileges and the authority entrusted to the Supreme
Court and the High Courts to regulate their own procedures by framing rules.
In making subordinate legislation, the executive is entrusted by the legislature
to make delegated legislation, subject to its control. The rule-making power
of the higher judiciary has trappings of a legislative character. The power of
h the legislature to punish for contempt of its privileges has a judicial character.
These exceptions indicate that the separation doctrine has not been adopted in
661
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the strict form in our Constitution. But the importance of the doctrine lies in its
postulate that the essential functions entrusted to one organ of the State cannot
be exercised by the other. By standing against the usurpation of constitutional a
powers entrusted to other organs, separation of powers supports the rule of law
and guards against authoritarian excesses.
255. Parliament and the State Legislatures legislate. The executive frames
policies and administers the law. The judiciary decides and adjudicates upon
disputes in the course of which facts are proved and the law is applied. The
distinction between the legislative function and judicial functions is enhanced b
by the basic structure doctrine. The legislature is constitutionally entrusted with
the power to legislate. Courts are not entrusted with the power to enact law.
Yet, in a constitutional democracy which is founded on the supremacy of the
Constitution, it is an accepted principle of jurisprudence that the judiciary has
the authority to test the validity of legislation. Legislation can be invalidated
where the enacting legislature lacks legislative competence or where there c
is a violation of fundamental rights. A law which is constitutionally ultra
vires can be declared to be so in the exercise of the power of judicial review.
Judicial review is indeed also a part of the basic features of the Constitution.
Entrustment to the judiciary of the power to test the validity of law is an
established constitutional principle which co-exists with the separation of
powers. Where a law is held to be ultra vires there is no breach of parliamentary d
privileges for the simple reason that all institutions created by the Constitution
are subject to constitutional limitations. The legislature, it is well settled, cannot
simply declare that the judgment of a court is invalid or that it stands nullified.
If the legislature were permitted to do so, it would travel beyond the boundaries
of constitutional entrustment. While the separation of powers prevents the
legislature from issuing a mere declaration that a judgment is erroneous or e
invalid, the law-making body is entitled to enact a law which remedies the
defects which have been pointed out by the court. Enactment of a law which
takes away the basis of the judgment (as opposed to merely invalidating it) is
permissible and does not constitute a violation of the separation doctrine. That
indeed is the basis on which validating legislation is permitted.
256. This discussion leads to the conclusion that while the separation f
of powers, as a principle, constitutes the cornerstone of our democratic
Constitution, its application in the actual governance of the polity is nuanced.
The nuances of the doctrine recognise that while the essential functions of
one organ of the State cannot be taken over by the other and that a sense
of institutional comity must guide the work of the legislature, executive and
judiciary, the practical problems which arise in the unfolding of democracy g
can be resolved through robust constitutional cultures and mechanisms. The
separation doctrine cannot be reduced to its descriptive content, bereft of its
normative features. Evidently, it has both normative and descriptive features.
In applying it to the Indian Constitution, the significant precept to be borne
in mind is that no institution of governance lies above the Constitution. No
entrustment of power is absolute. h
662
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G. A functional relationship
257. What then does the above analysis tell us about the functional
a relationship of the work which is done by Parliamentary Committees and
the role of the court as an adjudicator of disputes? In assessing the issue,
it must be remembered, that Parliamentary Committees owe their existence
to Parliament. They report to Parliament. They comprise of the Members
of Parliament. Their work consists of tendering advice to the legislature. A
Parliamentary Committee does not decide a lis between contesting disputants
b nor does it perform an adjudicatory function. A committee appointed by the
House can undoubtedly receive evidence, including expert evidence, both oral
and documentary. A Select Committee may be appointed by the House to
scrutinise a Bill. When the committee performs its task, its report is subject to
further discussion and debate in the House in the course of which the legislative
body would decide as to whether the Bill should be enacted into law. The
C validity of the advice which is tendered by a Parliamentary Committee in
framing its recommendations for legislation cannot be subject to a challenge
before a court of law. The advice tendered is, after all, what it purports to be:
it is advice to the legislating body. The correctness of or the expediency or
justification for the advice is a matter to be considered by the legislature and
by it alone.
d 258. Department related S landing Committees are constituted by
Parliament to oversee the functioning of ministries/departments of
Government. It is through the work of these committees that Parliament exacts
the accountability of the executive. It is through the work of these committees
that Parliament is able to assess as to whether the laws which it has framed
are being implemented in letter and spirit and to determine the efficacy of
e government policies in meeting the problems of the day.
259. The contents of the report of a Parliamentary Committee may have
a bearing on diverse perspectives. It is necessary to elucidate them in order
to determine whether, and if so to what extent, they can form the subject-
matter of consideration in the course of adjudication in a court. Some of these
perspectives are enumerated below:
f
259.1. The report of a Parliamentary Committee may contain a statement
of position by Government on matters of policy;
259.2. The report may allude to statements made by persons who have
deposed before the Committee;
259.3. The report may contain inferences of fact including on the
g performance of Government in implementing policies and legislation;
259.4. The report may contain findings of misdemeanour implicating a
breach of duty by public officials or private individuals or an evasion of law; or
259.5. The report may shed light on the purpose of a law, the social problem
which the legislature had in view and the manner in which it was sought to be
remedied.
h
663
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260. The use of parliamentary history as an aid to statutory construction is
an area which poses the fewest problems. In understanding the true meaning
of the words used by the legislature, the court may have regard to the reasons a
which have led to the enactment of the law, the problems which were sought
to be remedied and the object and purpose of the law. For understanding this,
the court may seek recourse to background parliamentary material associated
with the framing of the law.
261. In his seminal work on the Interpretation of Statutes, Justice G.P.
Singh notes that the traditional rule of exclusion in English courts has over a b
period of time been departed from in India as well to permit the court to have
access to the historical background in which the law was enacted. Justice G.P.
Singh 173 notes:
"The Supreme Court, speaking generally, to begin with, enunciated the
rule of exclusion of Parliamentary history in the way it was traditionally C
enunciated by the English Courts, but on many an occasion, the court used
this aid in resolving questions of construction. The court has now veered
to the view 174 that legislative history within circumspect limits may be
consulted by courts in resolving ambiguities. But the courts still sometimes,
like the English courts, make a distinction between use of a material for
finding the mischief dealt with by the Act and its use for finding the d
meaning of the Act. As submitted earlier this distinction is unrealistic and
has now been abandoned by the House of Lords."
262. Reports of Parliamentary Committees may contain a statement of
position by the Government on matters of policy. There is no reason in principle
to exclude recourse by a court to the report of the committee at least as a e
reflection of the fact that such a statement was made before the committee.
Similarly, that a statement was made before the committee - as a historical
fact - may be taken note of by the court in a situation where the making of
the statement itself is not a contentious issue.
263. In matters involving public interest which come up before the court,
a grievance is often made of the violation of the fundamental rights of persons f
who by reason of poverty, ignorance or marginalised status are unable to seek
access to justice. Public interest litigation has been perceived as social action
litigation because a relaxation of the rules of standing has enabled constitutional
courts to reach out to those who have suffered discrimination and prejudice.
Whatever be the source of such discrimination - the feudal and patriarchal
structures of Indian society being among them - public interest litigation g
has enabled courts to develop flexible tools of decision-making and pursue
innovative remedies. The writ of continuing mandamus is one of them. In the
process, the violation of the fundamental rights of those groups of citizens
173 Justice G.P. Singh, Principles of Statuto ry Interpretation (14th Edn.) 253.
174 Kesavananda Bharati v. State of Kerala , (1973) 4 SCC 225; Tata Power Co. Ltd. v. Reliance h
Energy Ltd., (2009) 16 SCC 659; Narnit Sharma v. Union of India, (2013) 1 SCC 745 : (2013) 1
sec (Civ) 786 : (2013) 1 sec (Cri) 737 : (2013) 1 sec (L&S) 244
664
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who may not be able to see k access to justice is sought to be re m edied. Public
intere st litigation has emerged as a powerful tool to provide justice to the
a marginalised. In matters involving issue s of public intere st, courts have been
called upon to scrutinise the failure of the State or its agencie s to imple ment
law and to provide social welfare benefits to those for whom they are envisaged
under legislation. Courts have intervened to ensure the structural probity of the
system of democratic governance. Executive power has been made accountable
to the guarantee against arbitrariness (Article 14) and to fundamental liberties
b (principally Articles 19 and 21).
264. Committees of Parliament attached to ministries/departments of the
Government perform the function of holding the Government accountable
to implement its policies and its duties under legislation. The performance
of governmental agencies may form the subject-matter of such a report. In
other cases, the deficiencies of the legislative framework in remedying social
C
wrongs may be the subject of an evaluation by a Parliamentary Committee.
The work of a Parliamentary Committee may traverse the area of social welfare
either in terms of the extent to which existing legislation is being effectively
implemented or in highlighting the lacunae in its framework. There is no reason
in principle why the wide jurisdiction of the High Courts under Article 226
or of this Court under Article 32 should be exercised in a manner oblivious
d
to the enormous work which is carried out by Parliamentary Committees in
the field. The work of the committee is to secure alacrity on the part of the
Government in alleviating deprivations of social justice and in securing efficient
and accountable governance. When courts enter upon issues of public interest
and adjudicate upon them, they do not discharge a function which is adversarial.
e The constitutional function of adjudication in matters of public interest is in step
with the role of Parliamentary Committees which is to secure accountability,
transparency and responsiveness in the Government. In such areas, the doctrine
of separation does not militate against the court relying upon the report of a
Parliamentary Committee. The court does not adjudge the validity of the report
nor for that matter does it embark upon a scrutiny into its correctness. There
f is a functional complementarity between the purpose of the investigation by
the Parliamentary Committee and the adjudication by the court. To deprive the
court of the valuable insight of a Parliamentary Committee would amount to
excluding an important source of information from the purview of the court.
To do so on the supposed hypothesis that it would amount to a breach of
parliamentary privilege would be to miss the wood for the trees. Once the report
g of the Parliamentary Committee has been published it lies in the public domain.
Once Parliament has placed it in the public domain, there is an irony about the
executive relying on parliamentary privilege. There is no reason or justification
to exclude it from the purview of the material to which the court seeks recourse
to understand the problem with which it is required to deal. The court must
look at the report with a robust commonsense, conscious of the fact that it is
h not called upon to determine the validity of the report which constitutes advice
tendered to Parliament. The extent to which the court would rely upon a report
665
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must necessarily vary from case to case and no absolute rule can be laid down
in that regard.
265. There may, however, be contentious matters in the report of a a
Parliamentary Committee in regard to which the court will tread with
circumspection. For instance, the report of the committee may contain a
finding of misdemeanour involving either officials of the Government or private
individuals bearing on a violation of law. If the issue before the court for
adjudication is whether there has in fact been a breach of duty or a violation
of law by a public official or a private interest, the court would have to deal b
with it independently and arrive at its own conclusions based on the material
before it. Obviously in such a case the finding by a Parliamentary Committee
cannot constitute substantive evidence before the court. The Parliamentary
Committee is not called upon to decide a lis or dispute involving contesting
parties and when an occasion to do so arises before the court, it has to make its
determination based on the material which is admissible before it. An individual c
whose conduct has been commented upon in the report of a Parliamentary
Committee cannot be held guilty of a violation on the basis of that finding.
In Jyoti Harshad Mehta v. Custodian 175 , this Court held that a report of the
Janakiraman Committee could not have been used as evidence by the Special
Court. The Court held: (SCC pp. 582-83, para 57)
d
"57. It is an accepted fact that the reports of the Janakiraman
Committee, the Joint Parliamentary Committee and the Inter-Disciplinary
Group (IDG) are admissible only for the purpose of tracing the legal history
of the Act alone. The contents of the report should not have been used by
the learned Judge of the Special Court as evidence."
266. Section 57 of the Evidence Act, 1872 speaks of facts of which the e
court must take judicial notice. Section 57 is comprised in Part II (titled "On
proof''). Chapter III deals with facts which need not be proved. Section 57(4)
provides as follows:
"57. Facts of which Court must take judicial notice .-The Court shall
f
* * *
established under any law for the time being in force in a Province or in
the States."
267. In Lok Shikshana Trust v. CTJ99 , a three-Judge Bench of this Court, g
while construing Section 57(4) made a distinction between the fact that a
particular statement is made in Parliament and the correctness of what is stated
on a question of fact. The former could be relied upon. However, the truth of a
h
175 c2009) 10 sec 564 : c2010) 2 sec (Cri) 1494
99 (1976) 1 SCC 254 : 1976 SCC (Tax) 14
666
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disputable que stion of fact would have to be independe ntly prove d be fore the
court. H.R. Khanna, J. obse rved thus: (SCC p. 272, para 33)
a "33. We find that Section 57 clause (4) of the Evidence Act not
only enables but enjoins courts to take judicial notice of the course of
proceedings in Parliament assuming, of course, that it is relevant. It is true
that the correctness of what is stated, on a question of fact, in the course
of parliamentary proceedings, can only be proved by somebody who had
direct knowledge of the fact stated. There is, however, a distinction between
b the fact that a particular statement giving the purpose of an enactment was
made in Parliament, of which judicial notice can be taken as part of the
procee dings, and the truth of a disputable matter of fact stated in the course
of proceedings, which has to b e proved aliunde, that is to say, apart from
the fact that a state m ent about it w a s made in the course of proce edings
in Parliame nt (see Rt. Hon'ble G e rald Lord Strickland v. Ca rm e lo Mifsud
C Bonnici 176 ; and "The Englishman" Ltd. v. Lajpat Rai 177 ."
A statement made by the Finance Minister while proposing amendment could,
it was held, be taken judicial notice of. Judicial notice would be taken of the fact
that " such a statement of the reason was given in the course of such a speech".
268. In Onkar Nath v. State ( UT of Delhi) 178 , another Bench of three Judges
elaborated upon Section 57(4). Y.V. Chandrachud, J. speaking for the Court,
d h e ld thus: (SCC p. 614, para 6)
"6. One of the points urged before us is whether the courts below were
justified in taking judicial notice of the fact that on the date when the
appellants delivered their speeches a railway strike was imminent and that
such a strike was in fact launched on 8-5-1974. Section 56 of the Evidence
Act provides that no fact of which the Court will take judicial notice need b e
e proved. S ection 57 enumerates facts of which the Court "shall" take judicial
notice and state s that on all matters of public history, literature , scie nce or
art the Court may resort for its aid to appropriate books or documents of
reference. The list of facts mentioned in Section 57 of which the Court can
take judicial notice is not exhaustive and indeed the purpose of the section is
to provide that the Courts hall take judicial notice of certain facts rather than
f exhaust the category of facts of which the Court may in appropriate cases
take judicial notice. Recognition of facts without formal proof is a matter
of expediency and no one has ever questioned the need and wisdom of
accepting the existence of matters which are unquestionably within public
knowledge. (See Taylor, 11th Edu., pp. 3-12; Wigmore, Section 2571,
footnote; Steph en's Digest, notes to Article 58; Whitley Stokes ' Anglo-
g Indian Codes, Vol. II, p. 887.) Shutting the judicial eye to the existence of
such facts and matters is in a sense an insult to commonsense and would
tend to reduce the judicial process to a m e aningle ss and wasteful ritual.
No court therefore insists on formal proof, by evide nce , of notorious facts
of history, past or present. The date of poll, the passing away of a man of
h 176 1934 SCC OnLine PC 51 : AIR 1935 PC 34: 153 IC 1

177 1910 SCC OnLine Cal 224: ILR (1910) 37 Cal 760: 14 CWN 945 : 6 IC 81
178 (1977) 2 sec 611 : 1977 sec (Cri) 388
667
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eminence and events that have rocked the nation need no proof and are
judicially noticed. Judicial notice, in such matters, takes the place of proof
and is of equal force." (emphasis in original) a
269. InBaburao v. Union of India 179 , the Court observed thus: (SCC p. 414,
para 31)
"31. The Lok Sabha Debates and the Rajya Sabha Debates are the
journals or the reports of the two Houses of Parliament which are printed
and published by them. The court has to take judicial notice of the
proceedings of both the Houses of Parliament and is expected to treat the b
proceedings of the two Houses of Parliament as proved on the production
of the copies of the journals or the reports containing proceedings of the
two Houses of Parliament which are published by them."
These observations were in the context, specifically, of the provisions of the
Evidence Act, including Section 57(4). The Court held that the production
C
of debates of the Lok Sabha and Rajya Sabha containing the proceedings of
the two Houses of Parliament, relating to the period between the time when
the resolutions were moved in each of the two Houses and the time when the
resolutions were duly adopted amounted to proof of the resolutions. The Court
was required to take judicial notice under Section 57.
H. Conclusion d
270. The issue which has been referred to the Constitution Bench is
whether the report of a Parliamentary Standing Committee can be relied upon
in a proceeding under Article 32 or Article 136 of the Constitution. Allied
to this is whether parliamentary privileges and the doctrine of separation of
powers (shades of which find expression in the often-used phrase "the delicate
balance") impose restraints on the ability of the court to seek recourse to e
parliamentary reports.
271. In finding an answer to the questions in reference, this Court must
of necessity travel from a literal and perhaps superficial approach, to an
understanding of the essence of what the Constitution seeks to achieve.
At one level, our Constitution has overseen the transfer of political power
from a colonial regime to a regime under law of a democratic republic.
f
Legitimising the transfer of political power is one, but only one facet of the
Constitution. To focus upon it alone is to miss a significant element of the
constitutional vision. That vision is of about achieving a social transformation.
This transformation which the Constitution seeks to achieve is by placing the
individual at the forefront of its endeavours. Crncial to that transformation is
the need to reverse the philosophy of the colonial regime, which was founded
on the subordination of the individual to the State. Liberty, freedom, dignity g
and autonomy have meaning because it is to the individual to whom the
Constitution holds out an assurance of protecting fundamental human rights.
The Constitution is about empowerment. The democratic transformation to
which it aspires places the individual at the core of the concerns of governance.
For a colonial regime, individuals were subordinate to the law. Individuals were
h
179 1988 Supp SCC 401
668
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subject to the authority of the State and their w ell-being was governed by the
acceptance of a d e stiny wedded to its power. Those assumptions which lay at
a the foundation of colonial rule have undergone a fundamental transformation
for a nation of individuals governed by the Constitution. The Constitution
recognises their rights and entitlements. Empowerment of individuals through
the enforcement of their rights is the e ssence of the constitutional purpose.
Hence, in understanding the issues which have arisen before the Court in the
pre sent refere nce , it is well to r emind ourselve s that since the Constitution
is about transformation and its vision is about empowerment, our reading of
b
precepts drawn from a colonial past, including parliamentary privilege, must be
subjected to a nuance that facilitates the assertion of rights and access to justice.
We no longer live in a political culture based on the subordination of individuals
to the authority of the State. Our interpretation of the Constitution must reflect
a keen sense of awareness of the basic change which the Constitution has made
to the polity and to its governance.
C
272. A distinguished South African Judge, Albie Sachs has spoken of the
importance of understanding the value of constitutional transformation. In his
book titled The Strange Alchemy of Life and Law 180 , explaining the role of the
constitutional court, Sachs has this to say:
"It is difficult to analyse the impact that court decisions have on actual
d historical events. It m ay w ell be that the publicity given to the case, and
the evidence and arguments presented had more impact on public life than
did the actual decision. Yet any amount of forensic combat, however bitter
and prolonged, is better than a single bullet. Submitting the harsh conflicts
of our times to legal scrutiny-conducted transparently and in the light
of internationally accepted values of fairness and justice-was a telling
e rebuttal of mercenarism and violence, whether from or against the State.
It responded in a practical way to the immediate issues, and at the same
time induced Governments, judiciaries, and law-enforcement agencies in
three countries to engage with each other and carefully consider their
powers and responsibilities under the international law. It reaffirmed to the
South African public that we were living in a constitutional democracy in
f which all exercises of power were subject to constitutional control. It said
something important about the kind of country in which we lived and about
the importance of principled and reasoned debate. It underlined that we
had moved from a culture of authority and submission to the law, to one of
justification and rights under the law." (emphasis supplied)
273. In India, no less than in South Africa it is important to realise that
g citizens live in a constitutional democracy in which every exercise of power is
subject to constitutional control. Every institution of the State is subject to the
Constitution. None lies above it. The most important feature of Sachs' vision
relevant to our Constitution is that Indian society must move "from the culture
h
180 Justice Albie Sachs, The Strange Alchemy of Life and Law (Oxford University Press 2009)
pp. 32-33.
669
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of authority and submission to the law, to one of justification and rights under
the law".
274. Once we place the fulfilment of individual rights and human freedoms a
at the forefront of constitutional discourse, the resolution of the present
case presents no difficulty. Individuals access courts to remedy injustice. As
institutions which are committed to the performance of a duty to facilitate
the realisation of human freedom, the High Courts as well as this Court are
under a bounden obligation to seek and pursue all information on the causes
of injustice. Where the work which has been performed by a coordinate b
constitutional institution - in this case a Parliamentary Committee, throws
light on the nature of the injustice or its causes and effects, constitutional
theory which has to aid justice cannot lead us to hold that the court must act
oblivious to the content of the report. History and contemporary events across
the world are a reminder that blackouts of information are used as a willing
ally to totalitarian excesses of power. They have no place in a democracy. c
Placing reliance on the report of a Parliamentary Committee does not infringe
parliamentary privilege. No Member of Parliament is sought to be made liable
for what has been said or for a vote tendered in the course of a debate. The
correctness or validity of the report of a Parliamentary Committee is not a
matter which can be agitated before the Court nor does the Court exercise such
a function. Where an issue of fact becomes contentious, it undoubtedly has d
to be proved before a court independently on the basis of the material on the
record. In other words, where a fact referred to in the report of the Parliamentary
Committee is contentious, the court has to arrive at its own finding on the basis
of the material adduced before it.
275. Parliamentary Committees are an intrinsic part of the process by
which the elected legislature in a democracy exacts accountability on the part e
of the Government. Department related Parliamentary Standing Committees
undertake the meticulous exercise of scrntinising the implementation of law,
including welfare legislation and the performance of the departments of the
State. The purpose of law is to promote order for the benefit of the citizen and
to protect rights and entitlements guaranteed by the Constitution and by statute.
Access to justice as a means of securing fundamental freedoms and realising f
socio-economic entitlements is complementary to the work of other organs of
the State. The modern doctrine of separation of powers has moved away from
a "one organ - one function" approach, to a more realistic perspective which
recognises the complementarity in the work which is performed by institutions
of governance. Judicial review is founded on the need to ensure accountable
governance in the administration of law as an instrument of realising the rights g
guaranteed by the Constitution. If the function of judicial review in facilitating
the realisation of socio-economic rights is constrned in the context of the
modern notion of separation of powers, there is no real conflict between the
independence of the judicial process and its reliance on published reports
of Parliamentary Committees. Ultimately it is for the court in each case to
determine the relevance of a report to the case at hand and the extent to h
which reliance can be placed upon it to facilitate access to justice. Reports of
670
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KALPANA MEHTA v. UNION OF INDIA (Ashok Bhushan, J.) 135

Parliamentary Committees become part of the published record of the State.
As a matter of principle, there is no reason or justification to exclude them
a from the purview of the judicial process, for purposes such as understanding
the historical background of a law, the nature of the problem, the causes of a
social evil and the remedies which may provide answers to intractable problems
of governance. The court will in the facts of a case determine when a matter
which is contentious between the parties would have to be adjudicated upon
independently on the basis of the evidence adduced in accordance with law.
b 276. In the circumstances, the reference is answered by holding that:
276.1. As a matter of principle, there is no reason why reliance upon the
report of a Parliamentary Standing Committee cannot be placed in proceedings
under Article 32 or Article 136 of the Constitution;
276.2. Once the report of a Parliamentary Committee has been published,
reference to it in the course of judicial proceedings will not constitute a breach
C
of parliamentary privilege;
276.3. The validity of the report of a Parliamentary Committee cannot
be called into question in the court. No Member of Parliament or person can
be made liable for what is stated in the course of the proceedings before a
Parliamentary Committee or for a vote tendered or given; and
d 276.4. When a matter before the court assumes a contentious character, a
finding of fact by the court must be premised on the evidence adduced in the
judicial proceeding as explained in paras 265 and 27 4.
277. The issues framed for reference are accordingly answered.
278. The proceedings may now be placed before the Hon'ble Chief Justice
for assignment of the case for disposal.
e ASHOK BHUSHAN, J. (concurring)- This Constitution Bench is required
to answer some important constitutional issues which also involve issues
relating to delicate balance between Parliament and the Judiciary. The Hon'ble
Chief Justice has circulated his Lordships' judgment which has been carefully
read by me. Although I am in substantial agreement with the conclusions
arrived by my Lord the Chief Justice, but looking to the importance of the issues
f involved I have penned my own views and conclusions.
280. Whether acceptance and reliance on a Parliamentary Standing
Committee report by this Court while hearing a public interest writ petition
amount to breach of any privilege of Parliament, is the sum and substance
of the questions referred to this Constitution Bench. During the course of
hearing of these writ petitions, the learned Senior Counsel of Respondent 8
g [MSD Pharmaceuticals (P) Ltd.] raised objection regarding admissibility
and consideration of the Parliamentary Committee report, considering which
objections following two questions have been referred to be answered:
(Kalpana Mehta case 2 , SCC p. 322, para 73)
"73.J. (i) Whether in a litigation filed before this Court either under
h Article 32 or Article 136 of the Constitution of India, the Court can
671
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refer to and place reliance upon the report of the Parliamentary S landing
Committee?
73.2. (ii) Whether such a report can be looked at for the purpose of a
281. The background facts as disclosed by the two writ petitions giving rise
to the above two questions need to be noted now. b

282. The writ petition as a public interest litigation has been filed by three
petitioners, Petitioners 1 and 2 claim to be working for women health whereas
Petitioner 3 is a registered Society working with women organisations to help
them to improve their lives and livelihood and to seek justice for marginalised c
communities.
283. In July 2009, the petitioners became aware of a so-called
demonstration project work being carried out in the States of Andhra Pradesh
and Gujarat by PATH (Respondent 6), a US based NGO along with the Indian
Council of Medical Research (ICMR) and the Governments of Andhra Pradesh
and Gujarat. In the above project about 32,000 young adolescent girls in the d
age group of 10-14 years were to be administered HPV (human papilloma
virus) vaccines purported to be effective in preventing cervical cancer. HPV
vaccine, namely, "Gardasil" is manufactured by Respondent 7 Glaxosmithkline
Asia Pvt. Ltd. and "Cervarix" by Respondent 8 MSD Pharmaceuticals (P) Ltd.,
licensed in India only in July 2008 and September 2008 respectively by the
Drug Controller General of India. e
284. In July 2009 vaccine Gardasil in Khammam District in Andhra
Pradesh was administered. Few girl children died. Health activists wrote to the
Ministry of Health pointing out concern about irregularities and health risk of
the HPV vaccine. Women organisation sent representations and also conducted
a fact-finding enquiry. On 15-4-2010, the Government of India appointed a
f
committee to enquire into "alleged irregularities in the conduct of studies using
human papilloma virus (HPV) vaccine" by PATH in India. The final report of
the Committee was submitted on 15-2-2011. The Enquiry Committee noted
several discrepancies.
285. The Parliamentary Standing Committee of the Department of Health
Research, Ministry of Health and Family Welfare while examining the demand
g
for grants (2010-11) of Department of Health Research took up the issue of
trial ofHPV vaccine on children in the districts ofKhammam, Andhra Pradesh
and Vadodara, Gujarat. The Parliamentary Standing Committee (hereinafter
referred to as "PSC") deliberated on the subject and held various meetings. The
Committee heard the UOI, ICMR, Department of Drugs Controller General
of India and also took oral evidence. The Departmental Standing Committee
h
submitted its report (72nd Report) to the Rajya Sabha on 30-8-2013 which
672
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was also laid on the table of the Lok Sabha on 30-8-2013. The PSC found
various shortcomings and lapses of the government departments, ICMR as well
a as on part of Respondents 6 to 8. Various directions and recommendations were
issued by the Committee.
286. Again a detailed report, namely, 81st Report on "action taken by
the Government on the recommendations/observations contained in the 72nd
Report on the alleged irregularities in the conduct of studies using human
papilloma virus (HPV) vaccine by PATH" in India was submitted to the
b Rajya Sabha on 23-12-2014 and also laid on the table of the Lok Sabha on
23-12-2014. Both the reports have been brought on record.
287. The writ petition as a public interest litigation has been filed by the
petitioners of which Petitioners 1 and 2 are public trusts and Petitioners 3 and 4
C
are registered societies. The petitioners have questioned the methods in which
clinical trials for medicines including vaccines are taking place in this country
to the disadvantage of vulnerable groups in the society including the poor,
tribal, women and children. The facts and pleadings in the writ petition are on
the line of facts and pleadings as contained in Writ Petition (C) No. 558 of
2012, hence are not repeated for brevity.
d 288. The petitioners have prayed for various reliefs including declaration
that HPV Vaccine Observational Study Demonstration Project was a Phase
IV clinical trial within the meaning of various rules in the Drugs and
Cosmetics Rules, 1945. The petitioners have made several prayers including
the prayers for grant of compensation and direction for investigation by special
investigation team of various offences committed by Respondents 2 to 8.
e 289. In both the writ petitions, most of the materials including fact-finding
enquiry conducted by Petitioner 1 in Writ Petition (C) No. 921 of 2013 (PIL-
W), newspapers reports, articles, representations, correspondence have been
referred to and relied on. Apart from other materials, reference and reliance on
72nd Report presented on 30-8-2013 and 81st Report presented on 23-12-2014
to the Rajya Sabha have also been placed.
f 290. A two-Judge Bench of this Court while hearing the writ petitions has
posed several questions and issued various directions. In this context the Court
passed various directions on 12-8-2014 116 , 13-1-2015 181 and 17-11-2015 182 .
291. When the matter was heard on 18-11-2015 183 the two-Judge Bench of
this Court stated: (Kalpana Mehta case 183 , SCC p. 306, para 19)
g "19. Be it noted, a substantial issue in law has arisen in course of
hearing of this case which pertains to exercise of power of judicial review
when a report of the Parliamentary Standing Committee is filed before the
Court."
116 Kalpana M ehta v. Union of India, (2017) 7 SCC 295, paras 1 and 2.
h 181 Kalpana M ehta v. Union of India, (2017) 7 SCC 295 : (2017) 7 SCC 302
673
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After hearing the parties on 18-11-2015 183 the two-Judge Bench of this Court
by a detailed order dated 5-4-2017 2 has referred two questions as noted above
to be answered by a Constitution Bench. a
Submissions
292. We have heard Shri Colin Gonsalves, learned Senior Advocate for the
petitioner in Writ Petition (C) No. 558 of2012 and Shri Anand Grover, learned
Senior Advocate for the petitioner in Writ Petition (C) No. 921 of 2013. Shri
Harish Salve and Shri Gourab Banerji, learned Senior Advocates have appeared b
for Respondent 8 MSD Pharmaceuticals (P) Ltd. Shri Shyam Divan, learned
Senior Advocate has appeared for PATH International. We have also heard Shri
K.K. Venugopal, learned Attorney General for India.
293. Shri Salve submits that Parliamentary Committee report can neither
be looked into nor relied on by this Court. Shri Salve, however, submits that
there are two areas where Parliamentary Committee report can be relied i.e. (a) c
legislative history of a statute and (b) Minister's statement in the House. The
Members of Parliament as well as those who appear before the Parliamentary
Committee are fully protected by the legislative privileges of the Members
as well as of the Houses. Article 105 clause (2) of the Constitution of India
provides that no Member of Parliament shall be liable to any proceedings in
any court in respect of anything said or any vote given by him in Parliament d
or any committee thereof.
294. Shri Salve further submits that as per Article 105 clause (3) the
powers, privileges and immunities of each House of Parliament, and of the
Members and the committees of each House, is same as of those of the House
of Commons as it exists on 26-11-1950. Article 105 clause (4) extends the
privileges as referred to in clauses (1), (2) and (3) to all persons who have e
the right to speak in, and otherwise to take part in the proceedings of any
House of Parliament or any committee thereof. Evidence led in a court cannot
be criticised. Same principles can apply with regard to evidence taken by a
Parliamentary Committee. A committee of Parliament is part of Parliament.
295. The principal submission which has been canvassed by Shri Salve is
that there being legislative privilege of all acts done in Parliament including f
report of Parliamentary Committee, the report cannot be challenged in a court
of law. He submits that reliance on a Parliamentary Committee report also
involves a challenge to the report by other parties. No adjudication can be
entertained by this Court with regard to a Parliamentary Committee report,
hence reliance placed by the petitioner on the Parliamentary Committee report
is misplaced. g
296. Relying on Article IX of the Bill of Rights, 1688, Shri Salve
submits that it confers on "proceedings in Parliament" protection from being
"impeached or questioned" in any "court or place out of Parliament". He
submits that Indian Parliament is conferred the same privileges which are
h
674
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enjoyed by the House of Commons, hence Parliamentary Committee report
can neither be relied nor questioned in any court of law. Shri Salve referred
a to various English cases and several judgments of this Court which shall be
referred to while considering the submissions in detail.
297. Shri K.K. Venugopal, learned Attorney General also contends that
parliamentary reports cannot be relied on in Court. He submits that although
there is no rigid separation of powers in the three wings of States but each wing
of the States works in its own sphere. Parliament is supreme in its proceedings
b which proceedings cannot be questioned in any court of law. The parliamentary
reports cannot be made subject-matter of an issue in any proceeding of court
of law or even in a public interest litigation. He submits that all wings of the
States have to work in their own spheres so as not to entrench upon the sphere
allotted to other wing of the State. He submitted that referring to a report of
Parliamentary Committee is a sensitive issue of jurisdiction between the courts
C
and Parliament which should be avoided by this Court. When the courts cannot
adjudicate on Parliamentary Committee report, what is the use of looking into
it.
298. Referring to Section 57(4) of the Evidence Act, 1872 which provides
that the Court shall take judicial notice of the proceedings of Parliament and
d the legislature established under any law for the time being in force, the learned
Attorney General submits that the substitutions were made in clause (4) of
Section 57 by the Adaptation Order of 1950 which were orders issued by the
President and were not amendments made by Parliament in Section 57. He
submits that by the Adaptation Order various words which were earlier used in
the Evidence Act, 1872 were changed after adoption of the Constitution which
e cannot be treated to be an act done by conscious deliberation of the legislature.
299. Shri Venugopal submits that historical facts as well as the statement of
the Minister in Parliament can be used with which there cannot be any quarrel.
He, however, submits that inferences in Parliamentary Committee report are
not acceptable. He submits that when any litigant wants to prove a fact, he
f has to search material and produce evidence and he cannot be allowed to
take a shortcut by placing reliance on the Parliamentary Committee report.
Parliamentary Committee report, is, in a manner, a speech. Article 105 of the
Constitution does not make any distinction with reports which can be termed
to as Social Welfare Reports or other kinds of reports.
300. Shri Venugopal, learned Attorney General submits that there is total
g bar in looking into the Reports of Parliament based on separation of power
and express provisions of Articles 105(2) and 105(4) of the Constitution
of India. The very fact that the Speaker can say "no" with regard to any
parliamentary material, it has to be assumed that they operate as total bar on
use of parliamentary material as evidence. The protection which is extended
to a Member of Parliament is also extended to the parliamentary proceedings
h
and parliamentary reports.
675
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301. Shri Colin Gonsalves, learned Senior Counsel appearing for the
petitioner submits that the petitioner does not intend to challenge any part of
the Parliamentary Committee report. The writ petitioner seeks nothing which a
may give rise to any question of breach of parliamentary privileges. The writ
petitioner is not asking this Court to take any facts stated in Parliamentary report
to be conclusive except which is permissible under Section 57 of the Evidence
Act, 1872. As per the Evidence Act, 1872, the parliamentary proceedings are
public documents which are admissible in evidence. The petitioner does not ask
for issuing any mandamus to enforce the Parliamentary Committee report. The b
cases cited by Shri Harish Salve in support of his submissions relate to breach
of privileges of Members of Parliament whereas present is not a case involving
any breach of any privileges of a Member of Parliament. Neither any question
is being raised in the writ petition questioning any action or conduct of any
Member of Parliament nor the petitioner is asking to initiate any proceeding
against any Member of Parliament. C
302. Shri Gonsalves submits that facts noticed and stated in parliamentary
report can very well be relied. Parliament by its procedure permits the
committee report to be filed in the Court, hence there is no prohibition in the
Court in looking into the parliamentary report.
303. It is further submitted by Shri Gonsalves that in the present case, it is
the Executive, which is trying to protect itself taking shield of parliamentary d
privileges whereas Parliament does not take objection or offence of its reports
being relied and used. When the reports are published by Parliament the
process is over and thereafter there is no prohibition on reports being filed as
evidence and used by all concerned. This Court should follow the principles of
the comity of the institution instead of relying on principles of separation of
power and conflict of the institution. Under the Right to Information Act, the e
parliamentary reports can be sought for and used by all concerned. The present
is an age of transparency, in which period the respondent cannot be heard in
saying that benefits of report should be blacked out from the courts.
304. The 72nd and 81st Parliamentary Committee reports play a very
important role since they unearth the events of the illegal vaccination done
on poor and malnourished young tribal girls and further it has commented f
adversely on the role of government agencies such as ICMR and DGCI and the
State of Andhra Pradesh and Gujarat. The government officials had appeared
before the Parliamentary Committee and admitted several wrongdoings.
305. Shri Anand Grover, learned Senior Advocate appearing for the
petitioners in Writ Petition (C) No. 921 of 2013 has adopted most of
g
the submissions of Shri Colin Gonsalves but has raised certain additional
submissions. Shri Grover submits that the truth and contents of documents are
two entirely different things. When document is admitted what is proved is
document and contents and not the truth. He submits that there is no question
of challenging the findings of the Parliamentary Committee's report nor the
reports are being questioned in this Court.
h
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306. Shri Grover has also referred to several English cases as well as
judgments of the Australian High Court, the US Supreme Court and of this
a Court. Referring to Section 16(3) of the Australian Parliamentary Privileges
Act, 1987, Shri Grover submits that law as applicable in Australia by virtue of
Section 16(3) is not applicable in India nor has been accepted as law applicable
in the United Kingdom. He submits that Parliamentary Committee report which
is a measure of social protection should be looked into by the Court while
rendering justice to the common man especially in public interest litigation.
b 307. Shri Grover further submits that Parliamentary Committee reports can
be relied only when they are published and become a public document. He
submits that statements can be looked into from the Parliamentary Committee
report but not the inferences and findings. The Parliamentary Committee
reports have been obtained from the House and no kind of privilege is involved.
308. Shri Shyam Divan, learned Senior Advocate appearing for PATH
C submits that PATH is a non-profit body operating in the area of health.
Referring to Section 57 of the Evidence Act, Shri Divan submits that clause
(4) of Section 57 uses the phrase "course of proceeding". He submits that
the expression "course of proceeding" does not comprehend the parliamentary
reports. He submits that when in this Court anyone traverses or controverts a
Parliamentary Committee report, it is not in the interest of the comity of the
d institutions.
309. Shri Divan submits that references to parliamentary proceedings are
possible only in two areas i.e. in interpreting a legislation and statement
of a Minister. He submits that the entire report is to be examined as a
whole. The answering respondent in Writ Petition (C) No. 921 of 2013
in its counter-affidavit has challenged the veracity of the findings of the
e Parliamentary S landing Committee report. The Parliamentary Committee is the
functional organ of Parliament which also enjoys the privileges and immunity
provided under Article 105(2) of the Constitution of India. The reports of the
Parliamentary Committee are not amenable to judicial review. Parliamentary
Standing Committee reports are not to be relied in court proceedings inasmuch
as traversing or contesting the content of report, it may cause breach of
f parliamentary privileges under Article 105 and Article 122 of the Constitution
of India. Challenge to such reports may invite contempt proceedings by
Parliament for breach of privileges. The parliamentary reports cannot be basis
for any action in law both criminal and civil in any court including writ petition
or public interest litigation.
310. Shri Gourab Banerji, learned Senior Advocate, replying to the
g
submissions of Shri Colin Gonsalves and Shri Anand Grover, submits that
recommendations and conclusions of Parliamentary Committee reports cannot
be relied. A moment there is a fact finding in report, it cannot be looked into.
311. We have considered the above submissions and pernsed the record.
For answering the two questions referred to this Constitution Bench, as noted
h above, we need to consider the following issues:
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311.1. Whether by accepting on record a Parliamentary Standing
Committee's report by this Court in a case under Article 32 or 136, any privilege
of Parliament is breached. a
311.2. In the event, a Parliamentary Standing Committee's report can be
accepted as an evidence, what are the restrictions in its reference and use as per
the parliamentary privileges enjoyed by the legislature of this country.
311.3. Whether in traversing and questioning the reports, the private
respondents may invite a contempt of House.
311.4. The above issues being interconnected, we proceed to examine b
all the issues together. While considering the above issues, we have divided
our discussion in different sub-heads/topics for overall understanding of
parliamentary privileges enjoyed by the Indian Legislature.
A. Parliamentary privileges
312. The origin and evolution of parliamentary privilege is traceable from C
the High Court of British Parliament. In the early period of British History, the
High Court of Parliament assisted the Crown in his judicial functions. The High
Court of Parliament started sitting in two parts i.e. House of Lords and House of
Commons. Gradually, both the Houses claimed various privileges which were
recognised. Some of the privileges were claimed by both the Houses as rights
from ancient times and some of the privileges were statutorily recognised. d
A significant parliamentary privilege is recognised and declared by Article
IX. The Bill of Rights, 1688 which conferred on "proceedings in Parliament
protection from being "impeached" or "questioned" in any court or place out of
Parliament". By the end of 19th century most of the parliamentary privileges of
House of Commons were firmly established and recognised by the courts also.
313. Erskine May in his treatise Parliamentary Practice, 24th Edn. has e
elaborately dealt with the privileges of Parliament and all other related aspects.
In Chapter XII of the book, Erskine May states about what constitutes the
privilege:
"Parliamentary privilege is the sum of certain rights enjoyed by each
House collectively as a constituent part of the High Court of Parliament;
f
and by Members of each House individually, without which they could
not discharge their functions, and which exceed those possessed by other
bodies or individuals. Some privileges rest solely on the law and custom of
Parliament, while others have been defined by statute."
314. The term "parliamentary privilege" refers to the immunity and
powers possessed by each of the Houses of Parliament and by the Members g
of Parliament, which allow them to carry out their parliamentary functions
effectively. Enumerating few rights and immunities Erskine May states:
"Certain rights and immunities such as freedom from arrest or freedom
of speech belong primarily to individual Members of each House and exist
because the House cannot perform its functions without unimpeded use of
h
the services of its Members. Other rights and immunities, such as the power
678
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to punish for contempt and the power to regulate its own constitution,
belong primarily to each House as a collective body, for the protection
a of its Members and the vindication of its own authority and dignity.
Fundamentally, however, it is only as a means to the effective discharge
of the collective functions of the House that the individual privileges are
enjoyed by Members. The Speaker has ruled that parliamentary privilege
is absolute.
When any of these rights and immunities is disregarded or attacked,
b the offence is called a breach of privilege, and is punishable under the law
of Parliament. Each House also claims the right to punish contempts, that
is, actions which, while not breaches of any specific privilege, obstruct
or impede it in the performance of its functions, or are offences against
its authority or dignity, such as disobedience to its legitimate commands
or libels upon itself, its Members or its officers. The power to punish for
C contempt has been judicially considered to be inherent in each House of
Parliament not as a necessary incident of the authority and functions of a
legislature (as might be argued in respect of certain privileges) but by virtue
of their descent from the undivided High Court of Parliament and in right
of the lex et consuetudo parliamenti."
315. The Halsbury's Laws of England, 5th Edu. Vol. 78, while tracing the
d
"origin and scope of privileges", states the following:
"1076. Claim to rights and privileges.-The House of Lords and
the House of Commons claim for their members, both individually and
collectively, certain rights and privileges which are necessary to each
House, without which they could not discharge their functions, and which
e exceed those possessed by other bodies and individuals. In 1705 the House
of Lords resolved that neither House had power to create any new privilege
and when this was communicated to the Commons, that House agreed.
Each House is the guardian of its own privileges and claims to be the sole
judge of any matter that may arise which in any way impinges upon them,
and, ifit deems it advisable, to punish any person whom it considers to be
f guilty of a breach of privilege or a contempt of the House."
316. The privileges of the Indian Legislatures have also gradually
developed along with the progress in the constitutional development of the
country. The Government of India Acts, 1919 and 1935 constitute successive
milestone in the development of the legislative bodies in India. The Government
of India Act, 1935 has been referred to as the Constitution Act by the Privy
g Council.
317. Dr B.R. Ambedkar, the Chairman of the Drafting Committee while
debating on draft Article 85 (Article 105 of the Constitution of India) and
draft Article 169 (Article 194 of the Constitution of India) has referred to
Erskine May's Parliamentary Practice as a source book of knowledge with
regard to immunities, privileges of Parliament. The Constitution of India by
h
Article 105 and Article 194 gives constitutional recognition of parliamentary
679
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privileges. We now proceed to examine the constitutional provisions pertaining
to parliamentary privileges.
318. Article 105 of the Constitution oflndia deals with "powers, privileges a
and immunities" of Parliament and its Members whereas Article 194 deals with
the powers, privileges and immunities of State Legislatures and their Members.
Both the provisions are identical. To understand the constitutional scheme, it is
sufficient to refer to Article 105 of the Constitution of India.
319. Article 105 of the Constitution oflndia as it exists, provides as follows:
b
"105. Powers, privileges, etc., of the Houses of Parliament and of the
Members and committees thereof.-(!) Subject to the provisions of this
(2) No Member of Parliament shall be liable to any proceedings in any
C
so defined, shall be those of that House and of its Members and committees d
committee thereof as they apply in relation to Members of Parliament." e
320. Two amendments were made in Article 105 clause (3) i.e. by the
Constitution (Forty-second and Forty-fourth Amendments). Article 105 clause
(3) in its original form was as follows:
"105. (3) In other respects, the powers, privileges and immunities of
each House of Parliament, and of the Members and the committees of each f
House, shall be such as may from time to time be defined by Parliament by
law, and, until so defined, shall be those of the House of Commons of the
Parliament of the United Kingdom, and of its Members and committees, at the
commencement of this Constitution."
321. Clause (1) of Article 105 of the Constitution of India gives
constitutional recognition to "freedom of speech" in Parliament. Clause (2) g
of Article 105 enumerates the privileges and immunities of Members of
Parliament. There is absolute protection to a Member of Parliament against any
proceeding in any court, in respect of anything said or vote given by him in
Parliament or any committee thereof. In the present case, we are called upon
to examine the parliamentary privileges with regard to Parliamentary Standing
Committee's report. According to clause (2) of Article 105 of the Constitution h
of India no Member of Parliament can be held liable for anything said by
680
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him in Parliament or in any committee. The reports submitted by Members
of Parliament is also fully covered by protection extended under clause (2) of
a Article 105 of the Constitution of India. Present is not a case of any proceeding
against any Member of Parliament for anything which has been said in the
Parliament Committee's report.
322. We now proceed to clause (3) of Article 105 of the Constitution of
India. Clause (3) of Article 105 of the Constitution of India begins with the
words "in other respects". The words "in other respects" clearly refer to powers,
b privileges and immunities which are not mentioned and referred to in clauses
(1) and (2) of Article 105. Clause (3) of Article 105 makes applicable the
same powers, privileges and immunities which are not mentioned and referred
to in clauses (1) and (2) of Article 105. Clause (3) of Article 105 makes
applicable the same powers, privileges and immunities for Indian Parliament
which were enjoyed by the House of Commons at the time of enforcement of
c the Constitution of India.
323. The Constitution Bench in P. V. Narasimha Rao v. State 140 had
elaborately considered Article 105 of the Constitution of India. In para 28 and
para 29 of the judgment the following has been stated: (SCC pp. 662-63)
"28. Clause (2) confers immunity in relation to proceedings in courts.
d It can be divided into two parts. In the first part immunity from liability
under any proceedings in any court is conferred on a Member of Parliament
in respect of anything said or any vote given by him in Parliament or any
committee thereof. In the second part such immunity is conferred on a
person in respect of publication by or under the authority of either House of
Parliament of any report, paper, votes or proceedings. This immunity that
e has been conferred under clause (2) in respect of anything said or any vote
given by a Member in Parliament or any committee thereof and in respect of
publication by or under the authority of either House of Parliament of any
report, paper, votes or proceedings, ensures that the freedom of speech that
is granted under clause (1) of Article 105 is totally absolute and unfettered.
(See Legislative Privileges case 22 , SCR pp. 441, 442.)
f 2 9. Having secured the freedom of speech in Parliament to the
Members under clauses (1) and (2), the Constitution, in clause (3) of
Article 105, deals with powers, privileges and immunities of the House
of Parliament and of the Members and the committees thereof in other
respects. The said clause is in two parts. The first part empowers Parliament
to define, by law, the powers, privileges and immunities of each House
g of Parliament and of the Members and the committees of each House. In
the second part, which was intended to be transitional in nature, it was
provided that until they are so defined by law the said powers, privileges
and immunities shall be those of the House of Commons in the United
Kingdom and of its Members and committees at the commencement of
h 140 (1998) 4 sec 626 : 1998 sec (Cri) 1108

1964, AIR 1965 SC 745 : (1965) 1 SCR 413
681
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the Constitution. This part of the provision was on the same lines as
the provisions contained in Section 49 of the Australian Constitution and
Section 18 of the Canadian Constitution. Clause (3), as substituted by the a
Forty-fourth Amendment of the Constitution, does not make any change
in the content and it only seeks to omit future reference to the House
of Commons of Parliament in the United Kingdom while preserving the
position as it stood on the date of the coming into force of the said
amendment."
B. Privileges of the House of Commons b
324. What are the privileges of the House of Commons which are also
enjoyed by the Indian Parliament by virtue of clause (3) of Article 105 of the
Constitution of India need to be examined for answering the issues which have
arisen in the present case.
325. While dealing with the privileges of Parliament Erskine May in his C
treatise Parliamentary Practice enumerates the following privileges:
1. Freedom of speech.
2. Freedom from arrest.
3. Freedom of access.
4. Favourable construction.
d
5. Privileges with respect to membership of the House.
6. Power of commitment for breach of privilege or contempt.
326. Halsbury's Laws of England in 5th Edn. Vol. 78, while dealing with
the privileges, etc. claimed by both the Houses "enumerates privileges":
1. Exclusive cognizance of proceedings. e
2. Freedom of Speech and proceedings in Parliament.
3. Contempts.
4. Freedom from Arrest.
5. Protection of witnesses and others before Parliament.
6. Power to exclude the public.
f
327. The main privileges which are claimed by the House of Commons
were noticed by the Constitution Bench of this Court in Powers, Privileges and
Immunities of State Legislatures, In re 22 in paras 74 and 75 which are quoted
as below: (AIR p. 771)
"74. Amongst the other privileges are: the right to exclude strangers,
g
the right to control publication of debates and proceedings, the right to
exclusive cognizance of proceedings in Parliament, the right of each House
to be the sole judge of the lawfulness of its own proceedings, and the right
implied to punish its own members for their conduct in Parliament [May's
Parliamentary Practice, pp. 52-53].
h
1964, AIR 1965 SC 745 : (1965) 1 SCR 413
682
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75. Besides these privileges, both Houses of Parliament were possessed
of the privilege of freedom from arrest or molestation, and from being
a impleaded, which was claimed by the Commons on ground of prescription.
,,
328. M .N. Kaul and S .L. Shakdher in Practice & Procedure of Parliament,
7th Edu. published by Lok Sabha Secretariat have enumerated "Main privileges
of Parliament" to the following effect:
b "Main Privileges of Parliament
Some of the privileges of Parliament and of its Members and
committees are specified in the Constitution, certain statutes and the Rules
of Procedure of the House, while others continue to be based on precedents
of the British House of Commons and on conventions which have grown
in this country.
c Some of the more important of these privileges are:
(i) Privileges specified in the Constitution:
Freedom of speech in Parliament [Article 105(1)].
Immunity to a Member from any proceedings in any court in
respect of anything said or any vote given by him in Parliament or
d any committee thereof [Article 105(2)].
Immunity to a person from proceedings in any court in respect
of the publication by or under the authority of either House of
Parliament of any report, paper, votes or proceedings (Ibid).
Prohibition on the courts to inquire into proceedings of
Parliament (Article 122).
e
Immunity to a person from any proceedings, civil or criminal,
in any court in respect of the publication in a newspaper of a
substantially true report of any proceedings of either House of
Parliament unless the publication is proved to have been made with
malice. This immunity is also available in relation to reports or
matters broadcast by means of wireless telegraphy (Article 361-A).
f
(ii) Privileges specified in Statutes:
Freedom from arrest of Members in civil cases during the
continuance of the session of the House and forty days before
its commencement and forty days after its conclusion. CPS
Section 135 A-For further details, see sub-head 'Freedom from
g Arrest in Civil Cases' (infra).
(iii) Privileges specified in the Rules of Procedure and Conduct of
Business of the House:
Right of the House to receive immediate information of
the arrest, detention, conviction, imprisonment and release of a
h Member (Rules 229 and 230).
683
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Exemption of a Member from service of legal process and
arrest within the precincts of the House (Rules 232 and 233).
Prohibition of disclosure of the proceedings or decisions of a a
secret sitting of the House (Rule 252).
(iv) Privileges based upon precedents:
Members or officers of the House cannot be compelled to give
evidence or to produce documents in courts of law, relating to the
proceedings of the House without the permission of the House 1- R b
(CPR- lLS).
Members or officers of the House cannot be compelled to
attend as witness before the other House or a committee thereof
or before a House of State Legislature or a committee thereof
without the permission of the House and without the consent of the
Member whose attendance is required 6-R (CPR - 2LS). c
In addition to the abovementioned privileges and immunities, each
House also enjoys certain consequential powers necessary for the
protection of its privileges and immunities. These powers are:
to commit persons, whether they are members or not, for breach
of privilege or contempt of the House P.D., 1961, Vol. V-2, Pt. III, d
pp. 51-52 (Rajasthan Vidhan Sabha case, 10-4-1954) 1974, Vol. XIX-2,
pp. 42-43 and 197 5, Vol. XX-1, p. 78 (shouting of slogans and carrying
of arms by visitors to Lok Sabha); Homi D. Mistry v. Nafisul Hussan 184
- the Blitz case; Searchlight case 185 ; C. Subramaniam case 186 .
to compel the attendance of witnesses and to send for persons,
papers and records Rules 269 and 270, Harendra Nath Barua v. D ev e
Kanta Barua 187 .
to regulate its procedure and the conduct of its business [Article
118(1)]
to prohibit the publication of its debates and proceedings, the
Searchlight case 185 and to exclude strangers (Rule 387)." f
329. The privileges of Indian Parliament, which have been enumerated
above, are the privileges which were enjoyed by the British House of
Commons. From the parliamentary privileges as enumerated above, it is clear
that there is a complete immunity to the Members of Parliament from any
proceeding for anything said in any committee of Parliament. Present is
not a case where any proceedings are contemplated against any Member of g
Parliament for anything which has been said in a report of a committee,
184 1956 SCC OnLine Born 175 : ILR 1957 Born 218
185 M.S.M. Sharma v. Sri Krishna Sinha, AIR 1959 SC 395
186 C. Subramaniam v. Speaker of the Madras Legislative Assembly, 1968 SCC OnLine M ad 64 : h
AIR 1969 Mad 10
187 1958 SCC OnLine Gau 16: AIR 1958 Assam 160
684
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involving a breach of any privilege under clause (2) of Article 105 of the
Constitution of India.
a 330. The question to be considered, is as to whether, there is any breach of
privileges of Parliament in accepting, referring and relying on a Parliamentary
Committee report by this Court.
C. The Role of Parliamentary Committees
331. Parliament is legislative wing of the Union. The Council of Ministers
b headed by the Prime Minister is collectively responsible to the House of
the People. The role of Parliament is thus not confined to mere transacting
legislative business. In the representative parliamentary democracy, the role of
Parliament has immensely increased and is pivotal for the governance of the
country.
332. F.W. Maitland in the Constitutional History of England while writing
C on "The Work of Parliament" stated the following:
" ... But we ought to notice that the Houses of Parliament do a great
deal of important work without passing statutes or hearing causes. In the
first place they exercise a constant supervision of all governmental affairs.
The ministers of the king are expected to be in Parliament and to answer
questions, and the House may be asked to condemn their conduct .... "
d
333. Dr Subhash C. Kashyap in Parliamentary Procedure, 2nd Edn. while
discussing the functions of Parliament stated:
"Over the years, the functions of Parliament have no longer remained
restricted merely to legislating. Parliament has, in fact emerged as
a multi-functional institution encompassing in its ambit various roles
e viz. developmental, financial and administrative surveillance, grievance
ventilation and redressal, national integrational, conflict resolution,
leadership recrnitment and training, educational and so on. The
multifarious functions of Parliament make it the cornerstone on which the
edifice oflndian polity stands and evokes admiration from many a quarter."
334. The business of Parliament is transacted in accordance with the rules
f
of procedure as framed under Article 118 of the Constitution of India. Both
the Houses of Parliament have made rnles for regulating its procedure and
conduct of its business. The Rajya Sabha has framed rnles, namely, "The Rules
of Procedure and Conduct of Business in the Council of States (Rajya Sabha)",
which were brought into force w.e.f. 1-7-1964. The Rules of Procedure and
Conduct of Business in Lok Sabha were framed and published in the Gazette
g
of India Extraordinary on 17-5-1952.
335. Various committees of both Raj ya Sabha and Lok Sabha are entrusted
with enormous duties and responsibilities in reference to the functions of
Parliament. Maitland in Constitutional History of England while referring to
the committees of the Houses of British Parliament noticed the functions of the
h committees in the following words:
685
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" ... Then again by means of committees the Houses now exercise what
we may call an inquisitorial power. If anything is going wrong in public
affairs a committee may be appointed to investigate the matter; witnesses a
can be summoned to give evidence on oath, and if they will not testify
they can be committed for contempt. All manner of subjects concerning the
public have of late been investigated by parliamentary commissions; thus
information is obtained which may be used as a basis for legislation or for
the recommendation of administrative reforms."
336. Chapter IX of the Rajya Sabha Rules dealing with the legislation b
provides for Select Committees on Bills, procedure of the presentation after
report of the Select/Joint Committee. The Rules provide for various committees
including Committee on Subordinate Legislation, Committee on Government
Assurances and other committees. Chapter XXII deals with "Department
Related Parliamentary Standing Committees". Rule 268 which provides for
"Departmental Select Committees" is as follows: C
"268. Department related Standing Committees.-(!) There shall be

Parliamentary Standing Committees of the Houses (to be called the Standing
Committees) related to Ministries/Departments.
(2) Each of the Standing Committees shall be related to the Ministries/
Departments as specified in the Third Schedule: d
Provided that the Chairman and the Speaker, Lok Sabha (hereinafter
referred to as the Speaker), may alter the said Schedule from time to time in
consultation with each other."
337. Rule 270 deals with functions of the Standing Committees which are
to the following effect:
e
(a) to consider the demands for grants of the related Ministries/
Department and report thereon. The report shall not suggest anything of
(b) to examine Bills, pertaining to the related Ministries/Departments, f
report thereon; and
the Houses, if referred to the Committee by the Chairman or the Speaker, g
to-day administration of the related Ministries/Departments."
338. Rule 277 provides that the Report of the Standing Committee shall
have persuasive value. Schedule III to the Rules deals with the "Allocation of h
various Ministries/Departments related to Parliamentary Standing Committee".
686
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At Item 7 is "Committee on Health and Family Welfare" which relates to
Department of Health and Family Welfare.
a 339. Present is a case where Parliamentary Standing Committee which has
submitted the report is the Parliamentary S landing Committee on Health and
Family Welfare. M.N. Kaul and S.L. Shakdher in their treatise on Practice and
Procedure of Parliament published by Lok Sabha Secretariat, dealing with the
business of committees stated the following:
"Parliament transacts a great deal of its business through committees.
b These committees are appointed to deal with specific items of business
requiring expert or detailed consideration. The system of Parliamentary
Committees is particularly useful in dealing with matters which, on account
of their special or technical nature, are better considered in detail by a small
number of Members rather than by the House itself. Moreover, the system
saves the time of the House for the discussion of important matters and
C
prevents Parliament from getting lost in details and thereby losing hold on
matters of policy and broad principles."
340. The reports which are submitted by the Departmental Parliamentary
Standing Committees are reports of matters entrusted to it by Parliament,
by the Speaker. Parliament to which Council of Ministers are responsible,
d supervises the various works done by different Departments of the Government.
Apart from the supervision, the committees also make recommendations and
issue directions. Directions and recommendations are to be implemented
by different government departments and action taken reports are submitted
before Parliament to be considered by Departmental Standing Committees. The
functions of the committees thus, play an important role in functioning of the
e entire Government which is directly related to the welfare of the people of the
country.
D. Publication of Parliamentary Reports
341. The reports of the Parliamentary Standing Committees and other
decisions and resolutions of Parliament are published under the authority of
the House. Publication of proceedings of Parliament serves public purpose.
f
Members of British Parliament in earlier years had treated publication of its
proceedings as breach of privilege. However, subsequently, the Members of
British Parliament have permitted the publication of its proceedings in Hansard.
As early as, in the year 1868 Cockburn, C.J. in Wason v. Walter 188 held that
it is of paramount public and national importance that the proceedings of the
House of Parliament shall be communicated to the people.
g
342. Cockburn, C.J., at QB p. 89 held the following: (Walter case 188 )
" ... It seems to us impossible to doubt that it is of paramount public
and national importance that the proceedings of the Houses of Parliament
shall be communicated to the public, who have the deepest interest in
knowing what passes within their walls, seeing that on what is there
h
188 (1868) LR 4 QB 73
687
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said and done, the welfare of the community depends. Where would be
our confidence in the Government of the country or in the legislature
by which our laws are framed, and to whose charge the great interests a
of the country are committed-where would be our attachment to the
constitution under which we live-if the proceedings of the great council
of the realm were shrouded in secrecy and concealed from the knowledge
of the nation? How could the communications between the representatives
of the people and their constituents, which are so essential to the working
of the representative system, be usefully carried on, if the constituencies b
were kept in ignorance of what their representatives are doing? What would
become of the right of petitioning on all measures pending in parliament,
the undoubted right of the subject, if the people are to be kept in ignorance
of what is passing in either house? Can any man bring himself to doubt that
the publicity given in modern times to what passes in Parliament is essential
to the maintenance of the relations subsisting between the Government, the C
legislature, and the country at large? ... "
343. Further, it was held "no" subject of parliamentary discussion which
more requires to be made known than an inquiry relating to it. Cockburn,
C.J. further held that although each House by Standing Orders prohibits the
publication of its debate but each House not only permits, but also sanctions
and encourages the publication: (Walter case 188 , QB p. 95) d
" ... The fact, no doubt, is, that each House of Parliament does, by its
standing orders, prohibit the publication of its debates. But, practically,
each House not only permits, but also sanctions and encourages, the
publication of its proceedings, and actually gives every facility to those
who report them. Individual members correct their speeches for publication e
in Hansard or the public journals, and in every debate reports of former
speeches contained therein are constantly referred to. Collectively, as
well as individually, the members of both Houses would deplore as a
national misfortune the withholding their debates from the country at large.
Practically speaking, therefore, it is idle to say that the publication of
parliamentary proceedings is prohibited by parliament.... " f
344. Under Rule 379 of the Lok Sabha, the Secretary General is authorised
to prepare and publish the full report of the proceedings of the House under
the direction of the Speaker. Parliament has also passed a legislation, namely,
the "Parliamentary Proceedings (Protection of Publication) Act, 1977" which
provides that publication of reports of parliamentary proceedings is privileged.
Section 3 of the Act is as follows: g
"3. Publication of reports ofparliamentary proceedings privileged.-(!)
Save as otherwise provided in sub-section (2), no person shall be liable to any
proceedings, civil or criminal, in any court in respect of the publication in a
newspaper of a substantially true report of any proceedings of either House of
Parliament unless the publication is proved to have been made with malice.
h
188 Wason v. Walter, (1868) LR 4 QB 73
688
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(2) Nothing in sub-section (1) shall be construed as protecting the
publication of any matter, the publication of which is not for the public good."
a 345. By the Constitution (Forty-fourth Amendment) Act, 1978, Article
361-A was inserted in the Constitution providing for "protection of publication
of proceedings by Parliament and State Legislatures". Article 361-A is as
follows:
"361-A. Protection of publication of proceedings of Parliament and
b State Legislatures.-(!) No person shall be liable to any proceedings, civil
or criminal, in any court in respect of the publication in a newspaper of a
substantially true report of any proceedings of either House of Parliament
or the Legislative Assembly, or, as the case may be, either House of the
Legislature of a State, unless the publication is proved to have been made with
malice:
C Provided that nothing in this clause shall apply to the publication of any
report of the proceedings of a secret sitting of either House of Parliament or the
Legislative Assembly, or, as the case may be, either House of the Legislature,
of a State.
(2) Clause (1) shall apply in relation to reports or matters broadcast, by
means of wireless telegraphy as part of any programme or service provided by
d means of a broadcasting station as it applies in relation to reports or matters
published in a newspaper.
Explanation.-ln this article, "newspaper" includes a news agency report
containing material for publication in a newspaper."
346. The Rules framed under Article 118 of the Constitution of India
thus clearly permit the publication of parliamentary proceedings. Apart from
e publication of the proceedings of Parliament, including the reports of the
committees, now, they are also permitted to be broadcast on electronic media.
The publication of the reports not being only permitted, but also are being
encouraged by Parliament. The general public is keenly interested in knowing
about the parliamentary proceedings including parliamentary reports which are
steps towards the governance of the country.
f
347. At this juncture, it is relevant to note that as per the Rules framed
under Article 118 of the Constitution of India, both for Lok Sabha and Rajya
Sabha, the Parliamentary Standing Committees are to follow the procedure
after constitution of the committee and till the reports are submitted to the
Speaker. During the intervening period, when the preparation of reports is in
g process and it is not yet submitted to the Speaker and published, there is no right
to know the outcome of the reports. The learned counsel for both the petitioners
have submitted that the right to know about the reports only arises when they
have been published for use of the public in general. Thus, no exception can
be taken in the petitioners obtaining 72nd and 81st Reports of Parliamentary
S landing Committee.
h
689
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E. Rules and Procedures regarding permission for giving evidence in courts
regarding proceedings in Parliament
348. The papers and proceedings of Parliament have been permitted to be a
given in evidence in courts of law by Parliament. In this context, reference
is made to Practice and Procedure of Parliament by M.N. Kaul and S.L.
Shakdher, 7th Edn., published by Lok Sabha Secretariat, where on this subject
the following has been stated:
"Evidence in Courts Regarding Proceedings in Parliament b
Leave of the House is necessary for giving evidence in a court of law
in respect of the proceedings in that House or committees thereof or for
production of any document connected with the proceedings of that House
or Committees thereof, or in the custody of the officers of that House.
According to the First Report of the Committee of Privileges of the Second
Lok Sabha, "no Member or officer of the House should give evidence in a C
court of law in respect of any proceedings of the House or any Committees

of the House or any other document connected with the proceedings of the
House or in the custody of the Secretary-General without the leave of the
House being first obtained".
When the House is not in session, the Speaker may, in emergent d
cases, allow the production of relevant documents in courts of law in
order to prevent delays in the administration of justice and inform the
House accordingly of the fact when it reassembles or through the Bulletin.
However, in case the matter involves any question of privilege, especially
the privilege of a witness, or in case the production of the document appears
to him to be a subject for the discretion of the House itself, the Speaker e
may decline to grant the required permission without leave of the House.
Whenever any document relating to the proceedings of the House or
any committee thereof is required to be produced in a court of law, the Court
or the parties to the legal proceedings have to request the House stating
precisely the documents required, the purpose for which they are required
and the date by which they are required. It has also to be specifically stated f
in each case whether only a certified copy of the document should be sent
or an officer of the House should produce it before the court."
349. After the enforcement of the Right to Information Act, 2005, on the
basis of a report submitted by the Committee of Privileges, the procedure for
making available documents relating to the proceedings of the House has been g
modified. Kaul and Shakdher had noticed the detail in the above regard in
Chapter XI dealing with powers, privileges and immunities of Houses, their
Committees and Members to the following effect:
"The Committee of Privileges, Fourteenth Lok Sabha, felt that it
was about time that the procedure for dealing with the requests for h
documents relating to proceedings of the House, its Committees, etc.,
690
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received from courts of law and investigating agencies were given a fre sh
look, particularly in the light of the provisions of the Right to Information
a Act, 2005. The Committee, with the permission of the Speaker, took up the
examination of the matter. The Twelfth Report in the matter was presented
to the Speaker Lok Sabha on 28-4-2008 and laid on the Table of the House
on 30-4-2008. The Report was adopted by the House on 23-10-2008.
The Committee in their Report recommended the following procedure:
b (I) Procedure for making requests for documents relating to the

proceedings of the House or of any Committee of the House:
A. If request for documents relating to proceedings of the
House or of any Committee of the House is made by a Court or
by the parties to a legal proceedings before a court, the court or
the parties to the proceedings as the case may be, shall specify the
C
documents required, the purpose for which they are required and
the date by which they are required. It should also be specifically
stated in each case whether only certified copies or photocopies
of the documents should be sent or an officer of the House should
produce it before the court.
d * * *
(II) Procedure for dealing with requests for documents relating to
proceedings of the House or any Committee of the House.
* * *
III. Procedure for dealing with requests from courts or
e investigating agencies for documents other than those relating to the
proceedings of the House or any Committee of the House, which are
in the custody of the Secretary-General.
* * *
IV. The question whether a document relates to the proceedings
of the House or any Committee of the House shall be decided by the
f Speaker and his decision shall be final.
V. Documents relating to the proceedings of the House or any
Committee of the House which are public documents should be taken
judicial notice of and requests for certified cop ies thereof may not be
ordinarily made unless there are sufficient reasons for making such
g requests.
VI. Procedure after the Report of the Committee of Privileges has
been presented or laid on the Table of the House." (emphasis supplied)
350. The learned counsel for the respondents in his compilation has given
3rd Edn. (2017) of Rajya Sabha at Work, wherein at p. 257 the subject
"Production of documents before a Court" is mentioned. From p. 257 to p. 259
h
various instances have also been mentioned whereas on a request received from
691
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court for production of documents, due permission was granted and documents
were made available to the courts. At p. 259 reference of the request received
from the Sessions Judge, Cuddalore, for certified copy of Attendance Register a
of Rajya Sabha was made. The extract from the relevant file has been quoted
which is to the following effect:
"A request was received from the Sessions Judge, Cuddalore,
for certified extracts from the Attendance Register from 1-3-1963
to 15-3-1963, in the Rajya Sabha, showing the presence and attendance of b
Shri R. Gopalakrishnan, Member of the Rajya Sabha. As the House was
not in session when the said request was received, the Chairman granted
permission to send the relevant extracts from the Attendance Register duly
certified to the Sessions Judge. The extracts were sent on 30-1-1964, and
the Deputy Chairman informed the House accordingly.
As regards the production of printed/published debates of the House or C
reference to them in a court, a view was held that no leave of the House was
required for the purpose. Under Section 78 of the Evidence Act, 1872, the
proceedings of Legislatures could be proved by copies thereof, printed by
order of the Government. The question of obtaining the leave of the House
would arise only if a court required the assistance of any of the Members
or officers in connection with the proceedings of the House or production d
of documents in the custody of the Secretary-General of the House."
351. From the above discussion it is clear that as a matter of fact the
parliamentary materials including reports and other documents have been sent
from time to time by the permission of Parliament itself to be given as evidence
in courts of law. e
F. The applicability of the Evidence Act, 1872, in the context ofparliamentary
proceedings
352. The learned counsel for the petitioner has placed reliance on
Section 57 of the Evidence Act. Section 57 provides for "Facts of which Court
must take judicial notice". Section 57 clause (4) is relevant which is quoted as f
below:
"57. Facts of which Court must take judicial notice .-The Court shall
( 1) All laws in force in the territory oflndia;
* * * g
established under any laws for the time being in force in a Province or in
the States;
* * *
(13) h
* * *
692
-----------------------------------------------------------------------------------------------------------------------------------------------------------

In all these cases, and also on all matters of public history, literature,
science or art, the Court may resort for its aid to appropriate books or
a documents of reference.
If the Court is called upon by any person to take judicial notice of any fact,
it may refuse to do so unless and until such person produces any such book or
document as it may consider necessary to enable it to do so."
353. A plain reading of Section 57 clause (4) makes it clear that the course
of proceeding of Parliament and the Legislature, established under any law are
b
facts of which judicial notice shall be taken by the Court.
354. Shri Shyam Divan in reference to Section 57 submits that
Parliamentary Standing Committee reports are not covered by the expression
"course of proceeding of Parliament", hence no benefit can be taken by
the petitioner of this provision. The expression "course of proceeding of
C Parliament" is an expression of wide import. The "Parliamentary Committee"
is defined in Rule 2 of the Rules of Lok Sabha in the following manner:
"*2. (1)* ... "Parliamentary Committee" means a Committee which is
works under the direction of the Speaker and presents its report to the House
d
Secretariat;"
355. Article 118 clause (1) read with the Rules framed for conduct of
business in Lok Sabha and Rajya Sabha makes it clear that the proceedings of
Parliamentary Standing Committee including its Report are proceedings which
are covered by the expression "course of proceeding of Parliament". Thus, we
e do not find any substance in the above submission of Shri Shyam Divan.
356. Now the submission of the learned Attorney General in reference to
Section 57(4) needs to be considered.
357. The President exercises power under Article 372 clause (2) by way
of repeal or amendment of any law in force in the territory of India. The
f Adaptation Order issued by the President thus constitutionally has same effect
as the repeal or amendment of any law in force in the territory of India.
Under clause (3)(h) of Article 372 the competent legislature has also power
of repealing or amending any law adapted or modified by the President under
clause (2) of Article 372.
358. The Adaptation Order issued by the President under clause (2) of
g Article 372 thus has force of law and the competent legislature having not
made any amendment in the Adaptation Order of 1950, even after 77 years
of the enforcement of the Constitution indicates that law as adapted by the
Presidential Order, 1950 is continued in full force. The effect of Section 57(4)
in no manner is diminished by the fact that amendments were made in
Section 57(4) by the Presidential Adaptation Order.
h
693
-----------------------------------------------------------------------------------------------------------------------------------------------------------

359. One more provision of the Evidence Act which needs to be noted is
Section 74 which deals with the public documents. Section 74 of the Evidence
Act is as follows: a
"74. Public documents .-The following documents are public documents
( 1) Documents forming the acts or records of the acts-

( i) of the sovereign authority,
(ii) of official bodies and tribunals, and b
(iii) of public officers, legislative, judicial and executive, of any
part of India or of the Commonwealth, or of a foreign country;
(2) Public records kept in any State of private documents."
360. According to Section 7 4 documents forming the acts, or records of the
acts of legislature of any part of India is a public document. We have noticed C
above that Parliament has already adopted the report of the privilege committee
that for those documents which are public documents within the meaning of
the Evidence Act, there is no requirement of any permission of Speaker of Lok
Sabhafor producing such documents as evidence in court. We may, however,
hasten to add that mere fact that a document is admissible in evidence whether
a public or private document does not lead to draw any presumption that the d
contents of the documents also are true and correct.
361. In this context, reference is made to a judgment of the Privy Council in
Gerald Lord Strickland v. Carmelo Mifsud Bonnici 176 . In the above case reports
of the debates in the Legislative Assembly containing speeches of the appellant
and the publication were produced. The Privy Council in the above reference
has expressed opinion that debates can only be evidence of what was stated by e
the Speakers in the Legislative Assembly, and are not evidence of "any facts
contained in the speeches".
362. A judgment of the Bombay High Court dealing with Section 74 of
the Evidence Act in reference to Article 105 of the Constitution of India and
the Rules of Procedure and Conduct of Business in Lok Sabha has been cited,
f
namely, Standard Chartered Bank v. A.B.F.S.L. 189 In the above case, a report
of the Joint Parliamentary Committee was objected to by the learned counsel
for Standard Chartered Bank. In para 3 of the judgment, issue which has arisen
in the case was noticed to the following effect: (SCC OnLine Born)
"3 . ... Two points arise for determination. Firstly, whether the Report
of Joint Parliamentary Committee is a public document as defined under g
Section 7 4 of the Indian Evidence Act, 1872. Secondly, even if it is a public
document, whether the findings of the Joint Parliamentary Committee
constitute evidence as defined under Section 3 of the Indian Evidence Act."
h
176 1934 SCC OnLine PC 51 : AIR 1935 PC 34: 153 IC 1
189 2001 SCC OnLine Born 588: (2001) 4 Born LR 520
694
-----------------------------------------------------------------------------------------------------------------------------------------------------------

363. It was contended before the Bombay High Court that Joint
Parliamentary Committee report is a public document as defined in
a Section 74(1) of the Evidence Act. In paras 4 to 6 of the judgment arguments
have been noticed. The argument was opposed by the other side. The Bombay
High Court came to the conclusion that report of JPC is a public document
under Section 74 of the Evidence Act and the report was admissible as evidence.
S.H. Kapadia, J. ( as he then was) held that the correctness of the findings in
the JPC will ultimately depend on the entire view of the matter. The following
b was observed in para 8 of the judgment: (Standard Chartered Bank case 189 ,
SCC OnLine Born)
"8 . ... The Report of JPC has recorded that there was an arrangement
between the brokers and the Banks, including Standard Chartered Bank,
under which the Banks were assured of a return of 15%. It was something
C
like a minimum guaranteed return offered by the brokers to the Banks. As
stated above, the Report has given findings on certain banking and market
practices which led to the financial irregularities in security transactions.
In that context, the JPC examined various officers of the Banks and the
brokers. After recording their evidence, as stated above, JPC came to the
conclusion that there were certain practices followed by the Banks and the
d brokers like routing facilities, margin trading and 15% arrangement. To this
extent, the findings of JPC can be read as evidence in the present matter.
However, the question as to whether the suit transaction was a part of 15%
arrangement, has not been found by JPC. There is no finding to the effect
that the suit transaction was a part of such an arrangement. Therefore, I
am of the view that Canbank Mutual Fund is entitled to tender the Report
e of JPC as evidence only to establish that there was a 15% arrangement
between Standard Chartered Bank and HPD. The issue as to whether the
suit transaction was a part of such a practice/arrangement will have to be
established independently by Canbank Mutual Fund. However, in order
to prove that issue, the Report will be one of the important pieces of
evidence. At this stage, I am concerned with admissibility. The correctness
f of the findings will ultimately depend on the entire view of the matter. The
question as to what weight the Court should give to the findings of JPC
will ultimately depend on the totality of circumstances brought before the
Court."
364. In para 9 ultimately the Court held: (Standard Chartered Bank case 189,
g SCC OnLine Born)
"9. Accordingly, I hold that the Report of JPC is a public document
under Section 74(1)(iii) of the Evidence Act. Secondly, that the said Report
is admissible as evidence of the existence of 15% arrangement between
Standard Chartered Bank and HPD. That subject to above, CanbankMutual
Fund will have to prove whether the suit transaction took place under
h
189 Standard Chartered Bank v. A.B.F.S.L., 2001 SCC OnLine Born 588: (2001) 4 Born LR 520
695
-----------------------------------------------------------------------------------------------------------------------------------------------------------

such an arrangement as any other fact. At the request of Mr Cooper, it is
clarified that this ruling is subject to my earlier ruling dated 27-6-2001 on
the argument of Standard Chartered Bank on inadmissibility of documents a
under Sections 91 and 92 of the Evidence Act and also in view of the
provisions of the Benami Transactions Abolition Act."
G. Nature and extent of parliamentary privileges regarding reports of
committees of British Parliament
365. In the Constituent Assembly Debates on draft Article 85 (now Article b
105 of the Constitution of India) and draft Article 169 (now Article 194 of the
Constitution of India), various members have brought amendments and prayed
that privileges of the House of Parliament be enumerated and the Constitution
should not refer to House of Commons of the United Kingdom for referring
to its privileges. Dr B.R. Ambedkar in his reply in the Constituent Assembly
Debates on 3-6-1949 stated as follows: (CAD Vol. 8, p. 583) C
"It seems to me, if the proposition was accepted that the Act itself
should enumerate the privileges of Parliament, we would have to follow
three courses. One is to adopt them in the Constitution, namely, to set out
in detail the privileges and immunities of Parliament and its Members. I
have very carefully gone over May's Parliamentary Practice which is the
source book of knowledge with regard to the immunities and privileges of d
Parliament. I have gone over the index to May's Parliamentary Practice
and I have noticed that practically 8 or 9 columns of the index are devoted
to the privileges and immunities of Parliament. So that if you were to
enact a complete code of the privileges and immunities of Parliament based
upon what May has to say on this subject, I have not the least doubt
in my mind that we will have to add not less than twenty or twenty- e
five pages relating to immunities and privileges of Parliament. I do not
know whether the Members of this House would like to have such a large
categorical statement of privileges and immunities of Parliament extending
over twenty or twenty-five pages. That I think is one reason why we did
not adopt that course."
f
366. The draft Article was finally approved maintaining the reference to the
House of Commons in regard to other privileges. Thus, the privileges which our
Parliament and State Legislatures enjoy are privileges enjoyed by the House
of Commons of the United Kingdom at the time of commencement of the
Constitution.
367. In early period of history of British Parliament, at the commencement g
of every Parliament, it has been the custom, the Speaker sought by humble
petition the rights and privileges. The petitions were granted by Her Majesty ' s
by conferring upon the power, the privileges asked for. In subsequent period,
the Commons started insisting that the privileges are inherent in the House.
The first major recognition and acceptance of parliamentary privileges found
reflected in the Bill of Rights, 1688. The Bill of Rights, 1688 was an Act h
696
-----------------------------------------------------------------------------------------------------------------------------------------------------------

declaring the rights and liberties of the subject and settling the succession of
the Crown. Article IX of the Bill of Rights provides as follows:
a "Freedom of speech.-That the freedom of speech and debates or
proceedings in Parliament ought not to be impeached or questioned in any
court or place out of Parliament:"
368. The above declaration made in the Bill of Rights thereafter has been
firmly established and till date enjoyed by the House of Commons of the United
Kingdom. Erskine May in Parliamentary Practice, 24th Edn. while dealing
b
with privileges of freedom of speech says the following with regard to the Bill
of Rights:
"Article IX of the Bill of Rights, 1688 confers on 'proceedings in
Parliament' protection from being 'impeached or questioned' in any 'court
or place out of Parliament'. Except in the limited circumstances mentioned
C
below, none of these critical terms is defined, so that it has often fallen to the
courts to arrive at judgments about their meaning, against the background
of parliamentary insistence on the privilege of exclusive cognizance of
proceedings (see above) and concern that judicial interpretation should not
narrow the protection of freedom of speech which Article IX affords."
369. There is no doubt that reports of the Standing Committee of Parliament
d are also parliamentary proceedings. Participation of Members of Parliament in
normal course is usually by a speech but their participation in parliamentary
proceedings is not limited to speaking only. Participation of Members of
Parliament is also by various other recognised forms such as voting, giving
notice of a motion, presenting a petition or submitting a report of a committee,
the modern forms of expression by which the wish and will of Parliamentarians
e is expressed. The report submitted by Standing Committee of Parliament is
also another form of expression. Thus, the parliamentary privileges which are
contained in clause (2) of Article 105 to individual parliamentary Member
are also extended by virtue of clause (3) of Article 105 to the Parliamentary
Committee reports. The parliamentary privileges contained in Article IX of the
Bill of Rights thus also protect the Parliamentary Standing Committee reports.
In this context, references to few English cases is relevant.
f
370. The case of Stockdale v. Hansard 83 is referred. The case was an action
for a publication defaming the plaintiff's character by imputing that he had
published an obscene libel. The following was stated by Lord Denmen, C.J.:
(ER p. 1156)
"Thus the privilege of having their debates unquestioned, though
g denied when the members began to speak their minds freely in the time
of Queen Elizabeth, and punished in its exercise both by that princess and
her two successors, was soon clearly perceived to be indispensable and
universally acknowledged. By consequence, whatever is done within the
walls of either assembly must pass without question in any other place. For
speeches made in Parliament by a member to the prejudice of any other
h
83 (1839)9Ad&El :112ER1112(QB)
697
-----------------------------------------------------------------------------------------------------------------------------------------------------------

person, or hazardous to the public peace, that member enjoys complete
impunity.... "
371. Another judgment which needs to be noted is Bradlaugh v. Gossett80 . a
The plaintiff Bradlaugh was a duly elected burgess to serve in the House
of Commons. The House resolved that the Serjeant-at-arms shall exclude
Mr Bradlaugh from the House until he shall engage not further to disturb the
proceedings of the House. Lord Coleridge, C.J. stated as follows: (QBD p. 275)
"... What is said or done within the walls of Parliament cannot be
inquired into in a court of law. On this point all the judges in the two great b
cases which exhaust the learning on the subject-Burdett v. Abbot128 and
Stockdale v. Hansard 83 -are agreed, and are emphatic. The jurisdiction
of the Houses over their own members, their right to impose discipline
within their walls, is absolute and exclusive. To use the words of Lord
Ellenborough, "They would sink into utter contempt and inefficiency
C
without it"."
372. Another case in which question of parliamentary privilege with respect
to parliamentary report of a Select Committee of House of Commons was
involved was Dingle v. Associated Newspapers Ltd. 125 The plaintiff sued
for damages for libels appearing in the issues of the Daily Mail newspaper.
The plaintiff alleged that the defendants falsely and maliciously printed d
and published an article concerning the circumstances in which the shares
in Ardwick Cemetery Ltd. were acquired by Manchester Corporation. A
committee of the House of Commons has also submitted a report that the
Corporation obtained the shares by presenting a one-sided view, which failed
to disclose the true position of the company on a break-up.
373. Pearson, J. referring to the Bill of Rights, 1688 and Bradlaugh v. e
Gossett 80 said the following: (Dingle case 125 , QB pp. 409-10)
"Reference was made to the Bill of Rights, 1688, Section 1, Article 9,
on freedom of speech, which provides:
'That the freedom of speech and debates or proceedings in Parliament
ought not to be impeached or questioned in any court or place out of
Parliament.' f
Reference was also made to Bradlaugh v. Gossett 80 , and it is sufficient

to read a short portion of the headnote: (QBD p. 271)
'The House of Commons is not subject to the control of Her
Majesty's Courts in its administration of that part of the statute law
which has relation to its internal procedure only. What is said or done g
within its walls cannot be inquired into in a court of law.
80 (1884) LR 12 QBD 271 : 53 LJQB 290: 50 LT 620 (DC)

128 (1811) 14 E ast 1 : 104 ER 501 h
83 (1839)9Ad&El :112ER1112(QB)
125 (1960) 2 QB 405 : (1960) 2 WLR 430
698
-----------------------------------------------------------------------------------------------------------------------------------------------------------

A resolution of the House of Commons cannot change the law of
the land. But a court of law has no right to inquire into the propriety
a of a resolution of the House restraining a member from doing within
the walls of the House itself something which by the general law of the
land he had a right to do .... '
There is a clear affirmation of the exclusive right of Parliament to regulate
its own internal proceedings.
That was one of the points put forward and, in my view, it is quite clear
b that to impugn the validity of the report of a Select Committee of the House
of Commons, especially one which has been accepted as such by the House
of Commons by being printed in the House of Commons Journal, would be
contrary to Section 1 of the Bill of Rights. No such attempts can properly
be made outside Parliament."
C 374. Another judgment which also related to proceeding in Parliament is
Church of Scientology of California v. Johnson Smith 126 . Referring to earlier
judgment in Dingle v. Associated Newspapers Ltd. 125 , Browne, J. said the
following: (Johnson Smith case 126 , QB pp. 530-31)
"The most recent case to which I was referred was Ding le v. Associated
Newspapers Ltd. 125 The plaintiff's claim in that case was in respect of an
d
article which had appeared in a newspaper which he said was defamatory
of him. It was held in that case that the court could not inquire into the
validity of a Select Committee of the House of Commons on which the
article complained of had apparently been partly based. The invalidity
suggested in that case seems to have been a suggestion that there was some
sort of procedural defect in the proceedings of the committee, which of
e
course is quite a different set of facts from the present case. But it seems
to me that it really involved the same principle as is involved in this case.
As I understand it the plaintiff there was trying to question proceedings
in Parliament in order to support in certain respects his case based on a
libel published outside Parliament and was held not entitled to do that. By
analogy with this case it seems to me that the plaintiffs here are trying
f
to use what happened in Parliament in order to support a part of their
case in respect of this libel published outside Parliament in the television
broadcast.
I am quite satisfied that in these proceedings it is not open to either
party to go directly, or indirectly, into any question of the motives or
g intentions of the defendant or Mr Hordern or the then Minister of Health or
any other Member of Parliament in anything they said or did in the House.
,,
375. What was held in the above cases clearly establish that it is now
well settled that proceedings undertaken in Parliament including a report of
h
126 (1972) 1 QB 522: (1971) 3 WLR 434
125 (1960) 2 QB 405 : (1960) 2 WLR 430
699
-----------------------------------------------------------------------------------------------------------------------------------------------------------

the Standing Committee cannot be challenged before any court. The word
"challenge" includes both "impeaching" and "questioning" the Parliamentary
Committee reports. a
376. After having noticed the nature and extent of Article 9 of the Bill
of Rights (1688), we now proceed to consider the question, as to whether,
use of parliamentary materials including Standing Committee report in courts,
violates the parliamentary privilege as enshrined in Article 9 of the Bill of
Rights (1688).
377. The most important judgment to be noticed in the above regard is the b
judgment of the House of Lords in Pepper (Inspector of Taxes) v. Hart95 . A
seven-Member Committee of the House of Lords heard the case looking to
the importance of the issue raised. The opinion expressed by Lord Browne-
Wilkinson was concurred by all except one. The two questions which arose in
the case, were noticed in the following words by Lord Browne-Wilkinson: (AC
p. 621) C
"... However, in the circumstances which I will relate, the appeals

have also raised two questions of much wider importance. The first is
whether in construing ambiguous or obscure statutory provisions your
Lordships should relax the historic rule that the courts must not look at
the parliamentary history of legislation or Hansard for the purpose of d
construing such legislation. The second is whether, if reference to such
materials would otherwise be appropriate, it would contravene Article 9 of
the Bill of Rights (1688) or parliamentary privilege so to do."
378. Lord Wilkinson also considered Article 9 of the Bill of Rights (1688),
in the context that whether such use of parliamentary materials will contravene
the parliamentary privilege. The argument of the learned Attorney General that e
the use of parliamentary material by the courts shall amount to questioning of
the freedom of speech or debate, was repelled holding that the court would be
giving effect to what was said and done there. Considering the aforesaid the
following was stated by the House of Lords: (Hart case 95 , AC p. 638)
"Article 9 is a provision of the highest constitutional importance and
f
should not be narrowly construed. It ensures the ability of democratically
elected members of Parliament to discuss what they will (freedom of
debate) and to say what they will (freedom of speech). But, even given a
generous approach to this construction, I find it impossible to attach the
breadth of meaning to the word "question"; which the Attorney General
urges. It must be remembered that Article 9 prohibits questioning not
g
only "in any court" but also in any "place out of Parliament". If the
Attorney General's submission is correct, any comment in the media or
elsewhere on what is said in Parliament would constitute "questioning"
since all Members of Parliament must speak and act taking into account
what political commentators and others will say. Plainly Article 9 cannot
have effect so as to stifle the freedom of all to comment on what is said
h
95 1993 AC 593: (1992) 3 WLR 1032: 1992 UKHL 3 (HL)
700
-----------------------------------------------------------------------------------------------------------------------------------------------------------

in Parliament, even though such comment may influence members in what
they say.
a In my judgment, the plain meaning of Article 9, viewed against the
historical background in which it was enacted, was to ensure that Members
of Parliament were not subjected to any penalty, civil or criminal, for what
they said and were able, contrary to the previous assertions of the Stuart
monarchy, to discuss what they, as opposed to the monarch, chose to have
discussed. Relaxation of the rule will not involve the courts in criticising
b what is said in Parliament. The purpose of looking at Hansard will not be
to construe the words used by the minister but to give effect to the words
used so long as they are clear. Far from questioning the independence of
Parliament and its debates, the courts would be giving effect to what is said
and done there."
379. The House of Lords also observed that Hansard has frequently been
C
used in cases of judicial review and the following was stated in this context:
(Hart case9 5, AC pp. 638-39)
"Moreover, the Attorney General's contentions are inconsistent with
the practice which has now continued over a number of years in cases
of judicial review. In such cases, Hansard has frequently been referred to
d with a view to ascertaining whether a statutory power has been improperly
exercised for an alien purpose or in a wholly unreasonable manner. In R.
v. Secy. of State for the Hom e D epartment, exp Brind 133 it was the Crown
which invited the court to look at Hansard to show that the minister in that
case had acted correctly (see R. v. Secy. of State for the Home Department,
exp Brind 133 , AC at p. 741). This House attached importance to what the
e minister had said (see R. v. Secy. of State for the Home Department, exp
Brind 133 , AC at pp. 749, 755-56: All ER at pp. 724, 729-30). The Attorney
General accepted that references to Hansard for the purposes of judicial
review litigation did not infringe Article 9. Yet reference for the purposes of
judicial review and for the purposes of construction are indistinguishable.
In both type of cases, the minister's words are considered and taken into
f account by the court: in both, the use of such words by the courts might
affect what is said in Parliament."
380. In the end Lord Wilkinson held that reference to parliamentary
materials for the purpose of construing legislation does not breach Article 9 of
the Bill of Rights (1688). The following was held: (Hart case 95 , AC p. 644)
g " ... For the reasons I have given, as a matter of pure law this House
should look at Hansard and give effect to the parliamentary intention it
discloses in deciding the appeal. The problem is the indication given by
the Attorney General that, if this House does so, your Lordships may be
infringing the privileges of the House of Commons.
h
95 Pepper (Inspector of Taxes) v. Hart, 1993 AC 593 : (1992) 3 WLR 1032: 1992 UKHL 3 (HL)
133 (1991) 1 AC 696: (1991) 2 WLR 588: (1991) 1 All ER 720 (HL)
701
-----------------------------------------------------------------------------------------------------------------------------------------------------------

For the reasons I have given, in my judgment reference to
parliamentary materials for the purpose of construing legislation does not
breach Article 9 of the Bill of Rights .... " a
381. Again the House of Lords in Richard William Prebble v. Television
New Zealand Ltd. 127 observed that there can no longer be any objection to the
production of Hansard. The following was held by Lord Wilkinson: (AC p. 337)
"Since there can no longer be any objection to the production of
Hansard, the Attorney General accepted (in their Lordships' view rightly) b
that there could be no objection to the use of Hansard to prove what
was done and said in Parliament as a matter of history. Similarly, he
accepted that the fact that a statute had been passed is admissible in court
proceedings. Thus, in the present action, there cannot be any objection to
it being proved what the plaintiff or the Prime Minister said in the House
(particulars 8-2-2010 and 8-2-2014) or that the State-owned Enterprises C
Act, 1986 was passed (particulars 8-4-2001). It will be for the trial Judge to
ensure that the proof of these historical facts is not used to suggest that the
words were improperly spoken or the statute passed to achieve an improper
purpose.
It is clear that, on the pleadings as they presently stand, the defendant
intends to rely on these matters not purely as a matter of history but d
as part of the alleged conspiracy or its implementation. Therefore, in
their Lordships' view, Smellie, J. was right to strike them out. But their
Lordships wish to make it clear that if the defendants wish at the trial
to allege the occurrence of events or the saying of certain words in
Parliament without any accompanying allegation of impropriety or any
other questioning there is no objection to that course." e
382. R. v. Murphy 130 is another judgment where Article 9 of the Bill of
Rights was considered in the context of parliamentary proceedings. The tender
of Hansard in curial proceedings is not a breach of parliamentary privilege.
Hunt, J., stated the following:
"None of the cases to which reference has been made has caused me t
to alter the interpretation of the Bill of Rights, Article 9, which I have
proposed. I remain of the view that what is meant by the declaration
that "freedom of speech . . . in Parliament ought not to be impeached
or questioned in any court or place out of Parliament" is that no court
proceedings ( or proceedings of a similar nature) having legal consequences
against a Member of Parliament ( or a witness before a Parliamentary g
Committee) are permitted which by those legal consequences have the
effect of preventing that member (or committee witness) exercising his
freedom of speech in Parliament (or before a committee) or of punishing
him for having done so."
h
127 (1995) 1 AC 321 : (1994) 3 WLR 970: (1994) 3 All ER 407 (PC)
130 (1986) 64 ALR 498: (1986) 5 NSWLR 18
702
-----------------------------------------------------------------------------------------------------------------------------------------------------------

383. The ne xt judgme nt which needs to be note d is the judgme nt of the
House of Lords in Wilson v. First County Trust Ltd. (No. 2) 134 . The House of
a Lords in the above case has held that the de cision in Pepper (InspectorofTaxes)
v. Hart 95 removed from the law an irrational exception. Before the decision in
Pepper (Inspector of Taxes) v. Hart95 a self-imposed judicial rule excluded use
of parliamentary materials as an external aid. It was held that the Court may
properly use the ministerial and other statements made in Parliament without
in any way questioning what has been said in Parliament. The following was
b
laid down in para 60: (Wilson case 134 , AC pp. 841-42)
"60 . ... What is important is to recognise there are occasions when
courts may properly have regard to ministerial and other statements made
in Parliament without in any way "questioning" what has been said in
Parliament, without giving rise to difficulties inherent in treating such
C statem e nts as indicative of the will of Parliament, and without in any other
way encroaching upon parliame ntary privileg e by interfering in matters
properly for consideration and regulation by Parliament alone . The use
by courts of ministe rial and other promoters' statements as part of the
b ackground of legislation, pursuant to Peppe r (Insp ector of Taxes) v.
Hart 95 , is one instance. Another instance is the e stablished practice by
d which courts, when adjudicating upon an application for judicial review of
a ministerial de cision, may have regard to a ministerial statem ent made in
Parliame nt. The d ecision of your Lordships' House in R. v. Secy. of State
for the Hom e D ep artm ent, ex p Brind 133 is an example of this .... "
384. Toussaint v. Attorney General of Saint Vincent and the Grenadines 131
e
is another judgment of the House of Lords where Article IX of the Bill of Rights
and parliamentary privileges in the context of use in court of statement made
by the Prime Minister during parliamentary debate came for consideration. It
was held that Article IX of the Bill of Rights precludes the impeaching or
questioning in court or out of Parliament of the freedom of speech and debates
or proceedings in Parliament. It was held that giving a literal meaning will lead
f to absurd consequences. In para 10, the following was stated by the House of
Lords: (WLR pp. 2830-31)
"IO. Ag ainst this background, the Board turns to Article 9 of the
Bill of Rights and the wider common law principle identified in Prebble
case 127 • Article 9 precludes the impeaching or questioning in court or
out of Parliament of the freedom of speech and debates or proceedings
g
in Parliament. The Board is concerned with the proposed use in court of
a statement made during a parliamentary debate. But it notes in passing
134 (2004) 1 AC 816: (2003) 3 WLR 568: 2003 UKHL 40 (HL)

95 1993 AC 593: (1992) 3 WLR 1032: 1992 UKHL 3 (HL)
133 (1 99 1) 1 AC 696: (1 99 1) 2 WLR 588: (1 991) 1 All ER 720 (HL)
h 131 (2007) 1 WLR 2825 : 2007 UKPC 48 (PC)
127 Richard William Prebble v. Television New Zealand Ltd. , (1995) 1 AC 321 : (1994) 3 WLR 970:
(1994) 3 All ER 407 (PC)
703
-----------------------------------------------------------------------------------------------------------------------------------------------------------

that the general and somewhat obscure wording of Article 9 cannot on
any view be read absolutely literally. The prohibition on questioning
"out of Parliament" would otherwise have "absurd consequences" e.g. a
in preventing the public and media from discussing and criticising
proceedings in parliament, as pointed out by the Joint Committee on
Parliamentary Privilege, para 91 (United Kingdom, Session 1998-1999, HL
Paper 43-I, HC 214-I). On the other hand, Article 9 does not necessarily
represent the full extent of the parliamentary privilege recognised at
common law. As Lord Browne-Wilkinson said in Prebble case 127 at AC b
p. 332, there is in addition:
' ... a long line of authority which supports a wider principle, of
which Article 9 is merely one manifestation viz. that the courts and
Parliament are both astute to recognise their respective constitutional
roles. So far as the courts are concerned they will not allow any
C
challenge to be made to what is said or done within the walls of
Parliament in performance of its legislative functions and protection of
its established privileges .... ' "
385. The House of Lords also referred to report of the Joint Committee,
which welcome the use of the ministerial statement in Court. Para 17 of the
judgment is to the following effect: (Toussaint case 131 , WLR pp. 2832-33) d
"17. In such cases, the minister's statement is relied upon to explain
the conduct occurring outside Parliament, and the policy and motivation
leading to it. This is unobjectionable although the aim and effect is
to show that such conduct involved the improper exercise of a power
"for an alien purpose or in a wholly unreasonable manner": Pepper
( Insp ector of Taxes ) v. Hart 95 , per Lord Browne-Wilkinson at p. 639-A. The e
Joint Committee expressed the view that Parliament should w elcome this
development, on the basis that "both parliamentary scrutiny and judicial
review have important roles, separate and distinct, in a modern democratic
society" (para 50) and on the basis that "The contrary view would have
bizarre consequences", hampering challenges to the "legality of executive
decisions . . . by ring-fencing what ministers said in Parliament", and f
"making ministerial decisions announced in Parliament less readily open
to examination than other ministerial decisions" (para 51 ). The Joint
Committee observed, pertinently, that:
'That would be an ironic consequence of Article 9. Intended to
protect the integrity of the legislature from the executive and the courts, g
Article 9 would become a source of protection of the executive from
the courts.' "
(1994) 3 All ER 407 (PC)
131 Touss aint v. Attorney General of Saint Vincent and the Grenadines, (2007) 1 WLR 2825 : 2007 h
UKPC 48 (PC)
95 1993 AC 593: (1992) 3 WLR 1032: 1992 UKHL 3 (HL)
704
-----------------------------------------------------------------------------------------------------------------------------------------------------------

386. Office of Govt. Commerce v. Information Commr. 136 , was a case
where Stanley Burnton, J. held that receiving evidence of the proceedings of
a Parliament are relevant for historical facts or events and does not amount to
"questioning". In para 49, the following was stated: (QB p. 116)
"49. However, it is also important to recognise the limitations of
these principles. There is no reason why the courts should not receive
evidence of the proceedings of Parliament when they are simply relevant
historical facts or events: no "questioning" arises in such a case: see para 35
b above. Similarly, it is of the essence of the judicial function that the courts
should determine issues of law arising from legislation and delegated
legislation. Thus, there can be no suggestion of a breach of parliamentary
privilege if the courts decide that legislation is incompatible with the
European Convention for the Protection of Human Rights and Fundamental
Freedoms: by enacting the Human Rights Act, 1998, Parliament has
C
expressly authorised the court to determine questions of compatibility, even
though a minister may have made a declaration under Section 19 of his
view that the measure in question is compatible. The courts may consider
whether delegated legislation is in accordance with statutory authority, or
whether it is otherwise unlawful, irrespective of the views to that effect
expressed by ministers or others in Parliament: R. v. Secy. of State for Home
d
Department 190 : (QB p. 146, para 33)
'33 . ... Legislation is the function of Parliament, and an Act of
Parliament is immune from scrutiny by the courts, unless challenged
on the ground of conflict with European law. Subordinate legislation
derives its legality from the primary legislation under which it is made.
e Primary legislation that requires subordinate legislation to be approved
by each House of Parliament does not thereby transfer from the courts
to the two Houses of Parliament, the role of determining the legality
of the subordinate legislation.' "
387. Another judgment delivered by Stanley Burnton, J. in Federation of
Tour Operators v. HM Treasury 191 was a case where objection to receiving
f evidence report of Treasury Select Committee was raised. In para 5 of the
judgment, objection raised on behalf of the Speaker of the House was noticed.
Para 5 is to the following effect:
"The Speaker of the House of Commons intervened because of the
Claimants' reliance in these proceedings on evidence given to Committees
g of the House and on a report of the Treasury Select Committee. It was
submitted on his behalf that their reliance on these matters in these
proceedings involved a breach of Article 9 of the Bill of Rights and the
wider principle of Parliamentary privilege."
h 136 2010 QB 98: (2009) 3 WLR 627

190 2002 QB 129: (2001) 3 WLR 323: 2001 EWCA Civ 789
191 2007 EWHC 2062 (Admin): 2008 STC 547
705
-----------------------------------------------------------------------------------------------------------------------------------------------------------

388. The issue as to the admissibility of the parliamentary material was
considered in detail while referring to the judgment of the House of Lords
in Toussaint 131 . It was held that there is no basis for distinguishing between a
statement of minister in the House and statement made to a Select Committee.
The following was held in paras 11 7, 124 and 125 of the judgment:
"l 17. In my judgment, the first two of these propositions are too widely
stated. I see no basis for distinguishing between what a Minister says in
the House of Commons (or the House of Lords), which may be considered
by the Court in a case such as Toussaint 131 , and what he or she says to a b
Select Committee. Whether what is said by an official should be received
in evidence must depend on the circumstances: what he says, his authority,
and the reason for which it is sought to rely on it. In general, the opinion
of a Parliamentary Committee will be irrelevant to the issues before the
Court [as in R. (Bradley) v. Secy. of State for Work and Pensions 132 and, as
C
will be seen, the present case], and accordingly I do not think it sensible
to seek to consider the admissibility of such a report in a case in which its
contents are relevant.
* * *
124. The efficacy or otherwise of APD as an environmental measure
is also, in my judgment, a question which, if relevant, is to be determined d
on the basis of evidence and argument before the Court, and not on the
basis of the opinion of anyone whose evidence is not before the Court.
There is, however, no reason why the Claimants cannot take from what
has been said to or by a Select Committee points that can be put before
the Court. For example, what was said by the Financial Secretary to the
Treasury to the Select Committee on the Environment is not rocket science, e
but something that would be obvious to anyone who gave the matter some
thought. The points he made can be made independently, without reference
to his statement.
125. Thus, in the end, I do not think that the parliamentary material
referred to by the claimants, which I have looked at de bene esse, as such
advances their case." f
389. The learned counsel for the respondents has pleaded reliance on a
judgment of R. v. Secy. of State for Trade, exp Anderson Strathclyde Plc. 192 ,
Dunn, L.J. while delivering his opinion has observed that while using a report
in Hansard the Court would have to do more than take note of the fact that a
certain state ment was made in the House on a certain date. The Court had to g
consider the statement or statements with a view to determining what was the
true meaning of them, and what were the proper inferences to be drawn from
131 Toussaint v. Attorney General of Saini Vincenl and the Grenadines, (2007) 1 WLR 2825 : 2007
UKPC 48 (PC) h
132 2009 QB 114: (2008) 3 WLR 1059: 2007 EWHC 242 (Admin)
192 (1983) 2 All ER 233 (DC)
706
-----------------------------------------------------------------------------------------------------------------------------------------------------------

them. This, according to Dunn, L.J., would be contrary to Article 9 of the Bill
of Rights. The following was stated by the Court: (All ER p. 239b-d)
a "In my judgment there is no distinction between using a report in
Hansard for the purpose of supporting a cause of action arising out of
something which occurred outside the House, and using a report for the
purpose of supporting a ground for relief in proceedings for judicial review
in respect of something which occurred outside the House. In both cases
the court would have to do more than take note of the fact that a certain
b statement was made in the House on a certain date. It would have to
consider the statement or statements with a view to determining what was
the true meaning of them, and what were the proper inferences to be drawn
from them. This, in my judgment, would be contrary to Article 9 of the
Bill of Rights. It would be doing what Blackstone said was not to be done,
namely, to examine , discuss and adjudge on a matter which was being
C consider ed in Parliament. Moreover, it would be an invasion by the court of
the right of every M e mber of Parliame nt to free speech in the House with
the possible adverse e ffects referre d to by Browne , J."
390. It is relevant to note that the above opinion of Dunn, L.J. was
specifically disapproved by the House of Lords in Pepper (Insp ector of Taxes) v.
Hart 95 . The House of Lords by referring to the above opinion of Dunn, L.J. had
d held that the said case was wrongly decide d. It is useful to extract the following
observation of the House of Lords: (AC p. 639)
"In R. v. Secy. of State for Trade, exp Anderson Strathclyde Plc. 192 an
applicant for judicial review sought to adduce parliamentary materials to
prove a fact. The Crown did not object to the Divisional Court (see All ER
p. 237 g-h) looking at the materials but the court itself refused to do so on
e
the grounds that it would constitute a breach of Article 9 (at All ER pp. 237,
239 p er Dunn, L.J.). In view of the Attorne y General's conce ssion and the
d e cision of this House in Brind case 133 , in my judgment Exp Anderson
Strathclyde Plc. 192 was wrongly decided on this point."
391. Another case the learned counsel for the respondents relied on is Office
f of Govt. Commerce v. Information Commr. 136 Although, it was held by Stanley
Burnton, J. that there is no reason why the courts should not receive evidence
of the proceedings of Parliament when they are simply relevant historical facts
or events; no "questioning" arises in such a case. However, in para 58 of the
judgme nt the following was stated: (QB p. 118)
"58. In addition, in my judgment, there is substance in
g Mr Chamberlain's further submission, summarised at para 23(b )(i) above.
If a party to proceedings before a court ( or the Information Tribunal) seeks
to rely on an opinion expressed by a Select Committee, the other party,
95 1993 AC 593: (1992) 3 WLR 1032: 1992 UKHL 3 (HL)

192 (1 983) 2 All ER 233 (DC)
h 133 R. v. Secy. ofState forth e Home D ep a rtment, ex pBrind, (1991) 1 AC 696: (1 991) 2 WLR588:
(1991) 1 All ER 720 (HL)
136 2010 QB 98: (2009) 3 WLR 627
707
-----------------------------------------------------------------------------------------------------------------------------------------------------------

if it wishes to contend for a different result, must either contend that the
opinion of the Committee was wrong (and give reasons why), thereby at
the very least risking a breach of parliamentary privilege, if not committing a
an actual breach, or, because of the risk of that breach, accept that opinion
notwithstanding that it would not otherwise wish to do so. This would be
unfair to that party. It indicates that a party to litigation should not seek to
rely on the opinion of a Parliamentary Committee, since it puts the other
party at an unfair disadvantage and, if the other party does dispute the
correctness of the opinion of the Committee, would put the tribunal in the
b
position of committing a breach of parliamentary privilege if it were to
accept that the Parliamentary Committee's opinion was wrong. As Lord
Woolf, M.R. said in Hamilton v. Al Fayed76 , WLR p. 1586 G, the courts
cannot and must not pass judgment on any parliamentary proceedings."
392. In the same judgment subsequently, it was held that whether there
is any breach of parliamentary privilege in such a reference will depend on C
the purpose for which the reference is made. In para 62 of the judgment the
following has been held: (Information Commr. case 136 , QB p. 119)
"62. Generally, however, I do not think that inferences can be drawn
from references made by the court to the reports of parliamentary Select
Committees in cases where no objection was taken to its doing so. In
addition, as I said in Federation of Tour Operators v. HM Treasury 19 1 , d
whether there is any breach of parliamentary privilege in such a reference
will depend on the purpose for which the reference is made. For example, it
seems to me that there can be no objection to a reference to the conclusions
of a report that leads to legislation, since in such a case the purpose of
the reference is either historical or made with a view to ascertaining the
mischief at which the legislation was aimed; the reference is not made with e
a view to questioning the views expressed as to the law as at the date of
the report."
393. We are of the view that the law as broadly expressed in para 58 of
the above case cannot be accepted. All references to parliamentary proceedings
and materials do not amount to breach of privilege to invite contempt of
Parliament. When a party relies on any fact stated in the report as the matter f
of noticing an event or history, no exception can be taken on reliance on such
report. However, no party can be allowed to "question" or "impeach" report
of Parliamentary Committee. The parliamentary privilege that it shall not be
impeached or questioned outside Parliament shall equally apply both to a party
who files claim in the court and other who objects to it. Both parties cannot
impeach or question the report. Insofar as the question of unfair disadvantage g
is concerned, both the parties are free to establish their claim or objection by
leading evidence in the court and by bringing materials to prove their point.
The court has the right to decide the "lis" on the basis of the material and
evidence brought by the parties. Any observation in the report or inference of
76 (2001) 1 AC 395 : (2000) 2 WLR 609 (HL) h

136 Office of Govt. Commerce v. Information Commr., 2010 QB 98: (2009) 3 WLR 627
191 2007 EWHC 2062 (Admin): 2008 STC 547
708
-----------------------------------------------------------------------------------------------------------------------------------------------------------

the Committee cannot be held to be binding between the parties or prohibit
either of the parties to lead evidence to prove their stand in court of law. Unfair
a disadvantage stands removed in the above manner.
394. The above decisions categorically hold that parliamentary materials
including report of a Standing Committee of a Parliament can very well be
accepted in evidence by a court. However, in view of parliamentary privileges
as enshrined in Article IX of the Bill of Rights, the proceedings of Parliament
can neither be questioned nor impeached in court of law. The cases of judicial
b review have been recognised as another category where the courts examine
parliamentary proceedings to a limited extent.
395. This Court in a number of cases has also referred to and relied on
parliamentary proceedings including reports of the Standing Committee of
Parliament. The learned counsel for the petitioners have given reference to
several cases in this regard, namely, Catering Cleaners of Southern Railway
C v. Union of lndia 100 where the Court has taken into consideration report of a
Standing Committee of petitions. Another case relied on is Gujarat Electricity
Board v. Hind Mazdoor Sabha 105 . In State of Maharashtra v. Milind 101 , the
Court has referred to and relied on a Joint Parliamentary Committee report. In
Federation of Railway Officers Assn. v. Union of India 18 , the Court has referred
to a report of the Standing Committee of Parliament on Railways. In Aruna Roy
d v. Union of India 1° 2 , report of a Committee, namely, S.B. Chavan Committee,
which was appointed by Parliament was relied and referred. M.C. Mehta v.
Union of lndia 103 was again a case where report of a Standing Committee of
Parliament on Petroleum and Natural Gas has been referred to and relied. Other
judgments where Parliamentary Committee reports have been relied are Kishan
Lal Gera v. State of Haryana 107 , Modern Dental College and Research Centre
e
v. State of M.P. 106 and Lal Babu Priyadarshi v. Amritpal Singh 1°4 .
396. The learned counsel appearing for the respondents as well as the
learned Attorney General has submitted that it is true that in the above cases
this Court has referred to and relied on Parliamentary Committee reports but
the issue of privilege was neither raised nor considered.
f 397. We have already noticed that rules of Parliament, procedure permit
the production of parliamentary materials in a court of law as evidence. The
parliamentary materials which are public documents can be submitted before
the Court without taking any permission from Parliament. Thus, no exception
can be taken in producing reports of Parliament Committee before a court of
law. The Evidence Act, 1872, which regulates the admission of evidence in
g
100 (1987) 1 sec 100: 1987 sec (L&S) 77
105 (1995) 5 sec 27: 1995 sec (L&S) 1166
101 c2001) 1 sec 4 : 2001 sec (L&S) 111
18 (2003) 4 sec 289 : AIR 2003 SC 1344
102 (2002) 7 sec 368: 5 SCEC 310
103 c2017) 7 sec 243
h 101 c2011) 10 sec 529
106 (2016) 7 sec 353: 7 SCEC 1
104 (2015) 16 sec 795 : (2016) 3 sec (Civ) 649
709
-----------------------------------------------------------------------------------------------------------------------------------------------------------

court of law, also refers to proceedings in Parliament as a public document of
which the Court shall take judicial notice. All these factors lead us to conclude
that there is no violation of any parliamentary privilege in accepting reports of a
Parliamentary Committee in court.
398. Now we come to the question that when parliamentary reports cannot
be questioned or impeached in court of law for what use they may be looked
into by court of law. We have already noticed above ample authorities which
lay down that for events which take place in Parliament, the facts which were
stated before Parliament or a committee, are facts which can be looked into. b
Further when parliamentary reports can be looked into for few purposes as
has been conceded by the learned Attorney General as well as the respondents
themselves, we do not find any justification in reading any prohibition for use
of reports for other purposes which are legal and lawful, without breach of any
privilege.
H. Exclusionary rules how far applicable in the Indian context C
399. We have already noticed English cases dealing with exclusionary rules
and subsequent cases whittling down the exclusionary rules. We have noticed
above that in a large number of cases this Court has referred to and relied
on Parliamentary Standing Committee reports. In most of the said cases, the
objection relating to parliamentary privilege was neither raised nor gone into,
but there are few cases of this Court where the principles and cases pertaining to d
exclusionary rules were gone into and the Court considered the parliamentary
materials thereafter.
400. In State of Mysore v. R. V. Bidap 193 , the Constitution Bench of this
Court speaking through Krishna Iyer, J. stated that:
"Anglo-American jurisprudence, unlike other systems, has generally
e
frowned upon the use of parliamentary debates and press discussions as
throwing light upon the meaning of statutory provisions." (SCC p. 339,
para 5)
Krishna Iyer, J. opined that there is a strong case of whittling down the rule of
exclusion followed in the British courts. In para 5 of the judgment the following
was held: (SCC p. 341) f
"5. . .. The rule of exclusion has been criticised by jurists as
artificial. The trend of academic opinion and the practice in the European
system suggest that interpretation of a statute being an exercise in
the ascertainment of meaning, everything which is logically relevant
should be admissible. Recently, an eminent Indian jurist has reviewed
the legal position and expressed his agreement with Julius Stone and g
Justice Frankfurter. Of course, nobody suggests that such extrinsic
materials should be decisive but they must be admissible. Authorship and
interpretation must mutually illumine and interact. There is authority for
the proposition that resort may be had to these sources with great caution
and only when incongruities and ambiguities are to be resolved. There is a
strong case for whittling down the rule of exclusion followed in the British h
193 (1974) 3 sec 337: 1973 sec (L&S) 538
710
-----------------------------------------------------------------------------------------------------------------------------------------------------------

courts and for less apologetic reference to legislative proceedings and like
materials to read the meaning of the words of a statute."
a 401. Another Constitution Bench in R.S. Nayak v. A.R. Antulay 85 ,
considered the objection that debates in Parliament or the reports of the
Committee cannot be relied on as per the "exclusionary rules". In para 32 of the
judgment, Desai, J. speaking for the Constitution Bench noticed the detailed
objections. In para 33 this Court observed that the trend certainly seems to
be in the reverse gear, that is, use of report of Committee as external aids to
b construction. In para 33 the following was stated: (SCC p. 212)
"33. The trend certainly seems to be in the reverse gear in that in order
to ascertain the true meaning of ambiguous words in a statute, reference to
the reports and recommendations of the commission or committee which
preceded the enactment of the statute are held legitimate external aids to
C
construction. The modern approach has to a considerable extent eroded the
exclusionary rule even in England."
402. After considering certain other cases and B idap case 193 this Court held
that those exclusionary rules have been given a decent burial by this Court. It
is useful to extract the following from para 34 of the judgment: (A.R. Antu lay
case 85 , sec pp. 213-15)
d
"34 . ... Further even in the land of its birth, the exclusionary rule has
received a serious jolt in Black-Clawson International Ltd. v. Papierwerke
Waldhof-Aschaffenburg A. G. 194 Lord Simon of Glaisdale in his speech
while examining the question of admissibility of Greer Report observed as
under: (AC p. 647)
e '... At the very least, ascertainment of the statutory objective
can immediately eliminate many of the possible meanings that the
language of the Act might bear and if an ambiguity still remains,
consideration of the statutory objective is one of the means of resolving
it.
The statutory objective is primarily to be collected from the
f provisions of the statute itself. In these days, when the long title can
be amended in both Houses, I can see no reason for having recourse
to it only in case of an ambiguity-it is the plainest of all the guides
to the general objectives of a statute. But it will not always help as to
particular provisions. As to the statutory objective of these, a report
leading to the Act is likely to be the most potent aid; and, in my
g judgment, it would be more obscurantism not to avail oneself of it.
There is, indeed clear and high authority that it is available for this
purpose.'
h 85 (1984) 2 sec 183 : 1984 sec (Cri) 112

193 State of Mysore v. R. V. Bidap, (1974) 3 SCC 337: 1973 SCC (L&S) 538
194 1975 AC 591 : (1975) 2 WLR 513 (HL)
711
-----------------------------------------------------------------------------------------------------------------------------------------------------------

... A reference to Halsbury's Laws of England, 4th Edn., Vol. 44 Para 901,
would leave no one in doubt that 'reports of commissions or committees
preceding the enactment of a statute may be considered as showing the a
mischief aimed at and the state of the law as it was understood to be by the
legislature when the statute was passed'. In the footnote under the statement
of law cases quoted amongst others are R. v. Olugboja 195 , R. v. Bloxham 196 ,
in which Eighth Report of Criminal Law Revision Committee was admitted
as an extrinsic aid to construction. Therefore, it can be confidently said
that the exclusionary rule is flickering in its dying embers in its native land b
of birth and has been given a decent burial by this Court. ... Therefore,
departing from the earlier English decisions we are of the opinion that
reports of the committee which preceded the enactment of a legislation,
reports of Joint Parliamentary Committee, report of a commission set up
for collecting information leading to the enactment are permissible external
aids to construction .... The objection therefore of Mr Singh vi to our C
looking into the history of the evolution of the section with all its clauses,
the Reports of Mudiman Committee and K. Santhanam Committee and
such other external aids to construction must be overruled."
403. Thus, in the above two cases, this Court has accepted that
parliamentary materials can be looked into, that too after considering the
exclusionary rules which prohibited use of parliamentary materials in courts. d
As observed above, the learned Senior Counsel, Shri Harish Salve and
Shri K.K. Venugopal, learned Attorney General have not disputed that
parliamentary reports and materials can be used for the purposes of taking
into consideration legislative history for interpretation of statute as well as
for considering the statement made by a Minister. When there is no breach
of privilege in considering the parliamentary materials and reports of the e
Committee by the Court for the above two purposes, we fail to see any valid
reason for not accepting the submission of the petitioner that courts are not
debarred from accepting the parliamentary materials and reports as evidence
before it, provided the court does not proceed to permit the parties to question
or impeach the reports.
f
404. The learned counsel for the respondents have also referred to the
judgment of this Court in Jyoti Harshad Mehta v. Custodian 175 .
405. In the above case, the Court was considering an Enquiry Committee
Report, namely, Janakiraman Committee Report. In the above context the
following observations were made in para 57 of the judgment: (Jyoti Harshad
Mehta case 175) g
"57. It is an accepted fact that the reports of the Janakiraman
Committee, the Joint Parliamentary Committee and the Inter-Disciplinary
Group (IDG) are admissible only for the purpose of tracing the legal history
195 1982 QB 320: (1981) 3 WLR 585 (CA) h

196 (1983) 1 AC 109: (1982) 2 WLR 392 (HL)
175 c2009) 10 sec 564: c2010) 2 sec (Cri) 1494
712
-----------------------------------------------------------------------------------------------------------------------------------------------------------

of the Act alone. The contents of the report should not have been used by
the learned Judge of the Special Court as evidence."
a 406. In para 28(viii) of Jyoti Harshad Mehta case 175 , the arguments of the
appellants were noticed to the effect that the Judge, Special Court, committed a
serious illegality insofar as he relied upon the Janakiraman Committee Report,
which was wholly inadmissible in evidence. The learned Judge, Special Court,
had passed order on an application of the Custodian which was set aside by this
Court by remitting back the matter to the Special Court with some directions.
b The Special Court thereafter relying on the said Report passed order. In this
context, observations were made in para 57 that the report can be admissible
only for the purpose of tracing the legal history of the Act alone and the contents
of the report should not have been used by the learned Judge as evidence. This
Court also took view that various audit reports were relied which were not
considered. In para 58 the following was stated: (Jyoti Harshad Mehta case 175 ,
C
sec p. 583)
"58. It does not appear that the Special Judge had considered this aspect
of the matter in great detail. The learned Judge, Special Court, should
consider the aforementioned two audit reports so as to arrive at a positive
finding with regard to the liabilities and assets possessed by them so as to
d enable to pass appropriate orders."
407. The Special Court in Jyoti Harshad Mehta case 175 was deciding the
lis in which the party had filed the evidence. Ignoring the same reliance was
placed on the report with regard to which observation was made in para 57.
The Special Judge ought to have considered the evidence which were produced
by the appellants and only reliance placed on the evidence of Janakiraman
e Committee Report was rightly disapproved by this Court. The above was a
case where sole reliance was placed on the Report which was disapproved. The
observation made by the Court that the Report should not have been used by
the learned Judge as evidence was made in the above context which cannot be
treated to mean that the Report cannot be accepted by a court as evidence.
408. Another judgment which has been relied on by the respondents is SB/
f
v. National Housing Bank 197 . In the above case, this Court made the following
observation in para 50 of the judgment which has been relied: (SCC p. 558)
"50. It is well settled by a long line of judicial authority that the
findings of even a statutory commission appointed under the Commissions
of Inquiry Act, 1952 are not enforceable proprio vigore as held in Ram
g Krishna Dalmia v. S.R. Tendolkar 198 and the statements made before
such Commission are expressly made inadmissible in any subsequent
proceedings civil or criminal. The leading judicial pronouncements
[Madhava Singh v. Secy. of State for India in Council 199 , M. V. Rajwade
175 Jyoti Harshad Mehta v. Custodian, (2009) 10 SCC 564: (2010) 2 SCC (Cri) 1494
h 197 (2013) 16 sec 538: (2014) 5 sec (Civ) 523
198 AIR 1958 SC 538
199 1904 SCC OnLine PC 18 : (1903-04) 31 IA 239
713
-----------------------------------------------------------------------------------------------------------------------------------------------------------

v. S.M. Hassan 200 , Ram Krishna Dalmia v. S.R. Tendolkar 19 8 , State of
Karnataka v. Union of lndia 201 , Sham Kant v. State of Maharashtra 202 ] on
that question were succinctly analysed by this Court in T. T. Antony v. State a
of Kerala 203 , paras 29-34. Para 34 of the judgment inter alia reads: (SCC
p.204)
'34 . ... In our view, the courts, civil or criminal, are not bound
by the report or findings of the Commission of Inquiry as they have
to arrive at their own decision on the evidence placed before them in
b
accordance with law.' "
409. In the above case, the Court has relied on Janakiraman Committee
which was not a statutory body, authorised to collect evidence and was a body
set up by the Governor of Reserve Bank of India in exercise of its administrative
functions which has been noted by this Court in para 51. The observation made
by this Court in para 50 has to be read in the context of observations made by C
this Court in para 51 which is to the following effect: (National Housing Bank
case 197 , SCC p. 558)
"51. Therefore, courts are not bound by the conclusions and findings
rendered by such commissions. The statements made before such
commission cannot be used as evidence before any civil or criminal court. It
should logically follow that even the conclusions based on such statements d
can also not be used as evidence in any court. Janakiraman Committee is
not even a statutory body authorised to collect evidence in the legal sense.
It is a body set up by the Governor of Reserve Bank of India obviously in
exercise of its administrative functions,
' ... the Governor, RBI set up a Committee on 30-4-1992 to e
investigate into the possible irregularities in funds management by
commercial banks and financial institutions, and in particular, in
relation to their dealings in government securities, public sector bonds
and similar instruments. The Committee was required to investigate
various aspects of the transactions of SBI and other commercial banks
as well as financial institutions in this regard.' " f
The above judgment cannot be read to mean that Parliamentary Committee
reports cannot be adverted to. This Court has referred to the Commissions of
Inquiry Act, 1952. The observations were made in the light of law as contained
in Section 6 of the Commissions of Inquiry Act, 1952.
410. The next case relied on by the respondents is judgment of this Court
g
in Common Cause v. Union of India 172 .
200 1953 SCC OnLine MP 90: AIR 1954 Nag 71 : 1954 Cri LJ 366
198 AIR 1958 SC 538
201 (1977) 4 sec 608
202 1992 Supp (2) sec 521 : 1992 sec (Cri) 765
203 c2001) 6 sec 1s1 : 2001 sec (Cri) 1048 h
197 SBlv. National Housing Bank, (2013) 16 SCC 538: (2014) 5 SCC (Civ) 523
112 c2017) 7 sec 158
714
-----------------------------------------------------------------------------------------------------------------------------------------------------------

411. In the above judgment, this Court has referred to Parliamentary
Standing Committee report in paras 14 and 16. In para 21 it was held that the
a opinion of the Parliamentary Standing Committee would not be sacrosanct. In
para 21 the following observation was made: (Common Cause case 172 , SCC
pp. 174-75)
"21. . . . The view of the Parliamentary S landing Committee with
regard to the expediency of the Search/Selection Committee taking
decisions when vacancy/vacancies exists/exist is merely an opinion which
b the executive, in the first instance, has to consider and, thereafter, the
legislature has to approve. The said opinion of the Parliamentary Standing
Committee would therefore not be sacrosanct. The same, in any case, does
not have any material bearing on the validity of the existing provisions of
the Act."
C 412. The above judgments do not lend support to the submission of the
respondents that Parliamentary Standing Committee report cannot be taken as
evidence in the Court or it cannot be looked into by the Court for any purpose.
I. Separation of powers and maintaining a delicate balance between the
Legislature, Executive and Judiciary
413. The essential characteristic of a Federation is a distribution of
d
limited Executive, Legislative and Judicial authority and the supremacy of the
Constitution. B.K. Mukherjea, C.J., in Ram Jawaya Kapur v. State of Punjab 13
referred to the essential characteristics of separation of powers in the Indian
Constitution. In para 12, the following has been held: (AIR p. 556)
"12 . ... The Indian Constitution has not indeed recognised the doctrine
e of separation of powers in its absolute rigidity but the functions of the
different parts or branches of the Government have been sufficiently
differentiated and consequently it can very well be said that our
Constitution does not contemplate assumption, by one organ or part of the
State, of functions that essentially belong to another.... "
414. Separation of powers between the Legislative, Executive and Judiciary
f has been regarded as basic feature of our Constitution in Kesavananda Bharati
v. State of Kerala 3 . The Constitution does not envisage supremacy of any
of the three organs of the State. But, functioning of all the three organs is
controlled by the Constitution. Wherever, interaction and deliberations among
the three organs have been envisaged, a delicate balance and mutual respect are
contemplated. All the three organs have to strive to achieve the constitutional
g goal set out for "We the People". Mutual harmony and respect have to be
maintained by all the three organs to serve the Constitution under which we all
live. These thoughts were expressed by this Court time and again. Suffice it to
h 172 Common Cause v. Union of India, (2017) 7 SCC 158

13 (1955) 2 SCR 225 : AIR 1955 SC 549
3 (1973) 4 sec 225: AIR 1973 SC 1461
715
-----------------------------------------------------------------------------------------------------------------------------------------------------------

refer, the Constitution Bench of this Court in Special Refe rence No. I of 1964 22
where Gajendragadkar, C.J., laid down the following: (AIR p. 763, para 43)
"43 . ... In this connection it is necessary to remember that the status, a
Constitution. These two august bodies as well as the executive which is
antimony nor in a spirit of hostility, but rationally, harmoniously and in a b
415. The learned Attorney General has submitted that relying on the C
doctrine of "Separation of Powers", this Court may desist from taking into
consideration the Parliamentary Committee's report. As observed above, there
is no parliamentary privilege that Parliamentary Committee reports or other
parliamentary materials cannot be given in evidence in any court of law.
By accepting Parliamentary Report as an evidence, there is no breach of
any parliamentary privilege. It is also not out of place to mention that d
there is a vital difference between parliamentary sovereignty in England
and constitutional supremacy in this country. It is well settled that any law
made by Parliament, which violates the fundamental rights guaranteed under
Part III of the Constitution, can be set aside by this Court in exercise of
jurisdiction of judicial review which has been granted by the Constitution to
this Court. Parliamentary sovereignty, as enjoyed by the United Kingdom is e
not a parallel example in reference to functioning of different organs in this
country, as controlled by the Constitution oflndia. The parliamentary privilege,
as guaranteed under Article 9 of the Bill of Rights, 1688 that no proceeding of
Parliament can be questioned and impeached thus has to be applied, subject to
express constitutional provisions as contained in the Constitution of India.
416. We thus conclude that although, there is no rigid separation of powers f
under the Constitution of India, but functions of all the three wings have
been sufficiently differentiated and each has freedom to carry out its functions
unhindered by any other wing of the State. However, in functioning of all
the three organs, a delicate balance, mutual harmony and respect have to be
maintained for true working of the Constitution.
J. Article 121 & Article 122 of the Constitution of India g
417. Relying on Article 121 and Article 122 of the Constitution of India,
it has been contended by the learned Attorney General as well as other
learned counsel appearing for the respondents that the principle enshrined in
the abovementioned articles does suggest that the Court has to keep away
h
1964, AIR 1965 SC 745 : (1965) 1 SCR 413
716
-----------------------------------------------------------------------------------------------------------------------------------------------------------

from e ntertaining any challe nge to any parliame ntary proceeding, including a
Parliamentary Committee report.
a 418. Although, h e ading of Article 122 reads "Courts not to e nquire into
proceedings of Parliament" but substantive provision of the Constitution, as
contained in clause (1) of Article 122 debars the court from questioning
the validity of any parliamentary proceeding on the ground of any alleged
irregularity or procedure. The embargo on the court to question the proceeding
is thus limited on the aforesaid ground alone. There is no total prohibition from
b examining the validity of the proceeding if the proceedings are clearly in breach
of fundamental rights or other constitutional provisions.
419. The Constitution Bench in Special Reference No. 1 of 1964 22 ,
while considering the scope of Article 194 of the Constitution laid down the
following: (AIR p. 762, para 40)
C
"40. Our legislatures h ave undoubtedly plenary powers, but these
powers are controlled by the basic concepts of the written Constitution
itself and can be e xercised within the legislative fields allotted to their
jurisdiction by the three Lists under the Seventh Schedule; but beyond
the Lists, the legislatures cannot travel. They can no doubt exercise their
plenary legislative authority and discharge their legislative functions by
d virtue of the powers conferred on them by the relevant provisions of
the Constitution; but the basis of the power is the Constitution itself.
Besides, the legislative supremacy of our legislatures including Parliament
is normally controlled by the provisions contained in Part III of the
Constitution. If the legislatures step beyond the legislative fields assigned
to them, or acting within their respective fields, they trespass on the
e fundamental rights of the citizens in a manner not justified by the relevant
articles dealing with the said fundamental rights, their legislative actions
are liable to be struck down by courts in India. Therefore, it is necessary to
remember that though our legislatures have plenary powers, they function
within the limits prescribed by the material and relevant provisions of the
Constitution."
f 420. As observed above, the Constitution of India empowers this Court
in exercise of judicial review to annul the legislation of a Parliament if it
breaches the fundamental rights, guaranteed under Part III of the Constitution.
Thus, the privileges which are enjoyed by the Indian Legislature have to be
considered in light of the provisions of the Indian Constitution. These are the
clear exceptions to the parliamentary privileges, as applicable in the House
g of Commons on the strength of Article IX of the Bill of Rights, 1688. This
Court in Special Reference No. 1 of 1964 22 noticing the different constitutional
provisions referred to various privileges which although were enjoyed by the
House of Commons, but are no longer available to the Indian Legislature.
h
1964, AIR 1965 SC 745 : (1965) 1 SCR 413
717
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421. The power of judicial review enjoyed by this Court in reference to
legislation and some parliamentary proceedings are recognised exceptions,
when this Court can enter into parliamentary domain. In all other respects, a
parliamentary supremacy with regard to its proceedings, the procedure
followed has to be accepted.
422. In view of the above foregoing discussion, we are of the view that on
the strength of Article 122, it cannot be contended that Parliamentary Standing
Committee reports can neither be admitted in evidence in court nor the said
reports can be utilised for any purpose. b
K. Comments on reports of Parliamentary Committee whether breach of
privilege
423. The freedom of speech and expression is one of the most cherished
fundamental rights guaranteed and secured by the Constitution of India. As
early as in 1950 Patanjali Sastri, J., in Ramesh Thappar v. State of Madras 204 , C
stated: (AIR pp. 128-29, para 11)
"11. . . . freedom of speech and of the press lay at the foundation
of all democratic organisations, for without free political discussion no
public education, so essential for the proper functioning of the processes
of popular Government, is possible."
d
424. Again this Court in Bennett Coleman & Co. v. Union of India 205 , held:
(SCC p. 828, para 98)
"98 . ... 'Freedom of the Press is the Ark of the Covenant of Democracy
because public criticism is essential to the working of its institutions.' "
No organ of the State, be it Judicature, Executive or Legislature is immune
e
from public criticism; public criticism is an instrument to keep surveillance and
check on all institutions in a democracy.
425. In Wason v. Walter 188 Cockburn, C.J., stated: (QB p. 90)
" ... it may be further answered that there is perhaps no subject in which
the public have a deeper interest than in all that relates to the conduct
of public servants of the State-no subject of parliamentary discussion f
which more requires to be made known than an inquiry relating to it.
" (emphasis supplied)
426. It was further emphasised that deeper public interest is served in
making public, the conduct of a public servant or any inquiry public, Cockburn,
C.J., further held that there is a full liberty of public writers to comment on the
g
conduct and motives of public men. The recognition of making comment on
the conduct was noticed as of recent origin. It was further clearly laid down
that comments on Members of both the Houses of Parliament can also be made
204 1950 SCR 594: AIR 1950 SC 124: (1950) 51 Cri LJ 1514 h
205 (1972) 2 SCC 788: AIR 1973 SC 106 at p. 150
188 (1868) LR 4 QB 73
718
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by which comme nts, it is the public which is the gainer. The following w eighty
observations w ere made by Cockburn, C.J.: (Walter c ase 188 , QB pp. 93-94)
a " ... The full liberty of public writers to comment on the conduct and
motives of public men has only in very recent times been recognised.
Comments on Gove rnm ent, on ministe rs and office rs of State, on M e mbers
of both Houses of Parliament, on Judges and other public functionari es,
are now made every day, which half a century ago would have been the
subject of actions or ex officio information, and would have brought down
b fine and imprisonment on publishers and authors. Yet who can doubt that
the public are gainers by the change, and that, though injustice may often
be done, and though public men may often have to smart under the keen
sense of wrong inflicted by hostile criticism, the nation profits by public
opinion being thus freely brought to bear on the discharge of public duties?
" (emphasis supplied)
C
427. In reference to "parliamentary privilege", the House of Lords after due
consideration of Article 9 of the Bills of Rights, 1688 in Pepper (Insp ec tor of
Taxes) v. Hart 95 , laid down: (AC p. 638)
" ... Article 9 cannot have effect, so as to stifle the freedom o f all to
comment on what is said in Parliament, even though such comment may
d influence members in what they say."
What is said in Parliament is thus clearly subject to fair comments by all
including the Press.
428. A Constitution Bench of this Court in M.S.M. Sharma v. Sri Krishna
Sinha 185 , had occasion to consider parliamentary privileges in reference to
e publication of a speech delivered by a Member ofBihar Legislative Assembly,
commonly known as Search Light case 185 . In his speech, Member of Bihar
Legislative Assembly made critical reference to an ex-Minister of Bihar. The
Speaker, on a point of order raised by another Member directed expunging of
certain words stated with regard to ex-Minister. However, notwithstanding the
Speaker's direction of expunging the portion of the speech, the Search Light,
f in its issue dated 31-5-1957, published a complete report of the speech of the
Member including the portion which was directed to be expunged, a notice
was given to the Editor of the Search Light, Shri Sharma, to show cause as
to why appropriate action be not recommended for breach of privilege of the
Speaker and the Assembly in respect of the offending publication. Shri Sharma,
Editor filed writ petition under Article 32 contending that the said notice and
g the proposed action is in violation of his fundamental right to freedom of speech
and expression under Article 19(1)(a). This Court held that the principle of
harmonious construction must be adopted in considering Article 19(1)(a) and
Article 194(1) and the latter part of clause ( 3) of Article 194.
h 188 Wason v. Walter , (1868) LR 4 QB 73

95 1993 AC 593: (1992) 3 WLR 1032: 1992 UKHL 3 (HL)
185 AIR 1959 SC 395
719
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429. The Court further held that the publication of the speech by Search
Light in law has to be regarded as unfaithful report, prima facie, constituting a
breach of privilege, the following observations were made in para 32: (Search a
Light case 185 , AIR p. 412)
"32 . ... The effect in law of the order of the Speaker to expunge a
portion of the speech of a Member may be as if that portion had not
been spoken. A report of the whole speech in such circumstances, though
factually correct, may, in law, be regarded as perverted and unfaithful report
and the publication of such a perverted and unfaithful report of a speech i.e. b
including the expunged portion in derogation to the orders of the Speaker
passed in the House may, prima facie, be regarded as constituting a breach
of the privilege of the House arising out of the publication of the offending
news item and that is precisely the charge that is contemplated by the
Committee's resolution and which the petitioner is by the notice called
C
upon to answer. We prefer to express no opinion as to whether there has,
in fact, been any breach of the privilege of the House, for of that the House
alone is the judge."
430. The freedom of speech and expression as guaranteed under Article
19(1)(a) is available to a citizen to express his opinion and comment which
is also available with regard to court proceedings as well. In respect of d
parliamentary proceedings, the said right is not stifled unless the comment
amounts to reflection or personal attack on individual Member of Parliament
or to the House in general.
431. In this context reference is also made to a judgment of the House of
Lords in Adam v. Ward 206 , where proceedings of Parliament were published
containing a slander remark on a servant of the Crown. An enquiry was e
conducted with regard to imputation and report was published for vindication
of the honour of the servant. The following was laid down by Lord Atkinson
of the House of Lords: (AC p. 343)
"... I think it may be laid down as a general proposition that where
a man, through the medium of Hansard' s reports of the proceedings in
Parliament, publishes to the world vile slanders of a civil, naval, or military f
servant of the Crown in relation to the discharge by that servant of the duties
of his office he selects the world as his audience, and that it is the duty of
the heads of the service to which the servant belongs, if on investigation
they find the imputation against him groundless, to publish his vindication
to the same audience to which his traducer has addressed himself. In my
view the Army Council would have failed in their duty to General Scobell g
personally, and to the great service which they in a certain sense govern and
control, if they had not given the widest circulation to the announcement
of the General's vindication."
h
185 M.S.M. Shanna v. Sri Krishna Sinha, AIR 1959 SC 395
206 1917 AC 309 (HL)
720
-----------------------------------------------------------------------------------------------------------------------------------------------------------

432. In R. v. Murphy 130 , Hunt, J. held that what is said and done in
Parliament can without any breach of parliamentary privilege be impeached
a and questioned by the exercise by ordinary citize ns of their freedom of speech.
The following w as h eld:
"I have already pointed out that what is said and done in Parliament
can without any breach of parliamentary privilege be impeached and
questioned by the exercise by ordinary citizens of their freedom of speech
(whether or not in the media), notwithstanding the fear which such conduct
b may engender in members of Parliament (and committee witnesses) as to
the consequences of what they say or do. In those circumstances, it can
be neither necessary nor desirable in principle that what is said or done
in Parliament should not be questioned (in the wider sense) in courts or
similar tribunals where no legal consequences are to be visited upon such
members (or witnesses) by the proceedings in question."
C
433. The Privilege Committee of the Lok Sabha has also recognised the
right of fair comment in the following words:
"Nobody would deny the Members or as a matter o f fact, any citizen,
the right of fair comment. But if the comments contain personal attack
on individual Members of Parliament on account of their conduct in
d Parliament, or if the language of the comment is vulgar or abusive , they
cannot be deemed to come within the bounds of fair comment or justifiable
criticism."
(As quoted in "Press and Parliament" by A.N. Grover in J.C.P.S. VXIII 1984
at p. 141.)
e 434. Erskine May in Parliamentary Practice (24th Edn.) defines
"contempt" in the following words:
"Generally speaking , any act or omission which obstructs or impedes
either House of Parliament in the performance of its functions, or which
obstrncts or impedes any Member or officer of such House in the discharge
of his duty, or which has a tendency, directly or indirectly, to produce such
f results, may be treated as a contempt even though there is no precedent of
the offence."
435. Referring to a c ase , Burdett v. Abbot 128 , ER at p. 561, this Court in
Special R ef e rence No. 1 of 1964 22 , stated as follows: (Sp ecial R ef ere nce No. 1
of 1964 22 , AIR p. 763, para 43)
g "43 . ... In this connection it is necessary to remember that the status,
130 (1 986) 64 ALR 498: (1 986) 5 NSWLR 18
h 128 (1811) 14 E ast 1 : 104 ER 501
1964, AIR 1965 SC 745 : (1965) 1 SCR 413
721
-----------------------------------------------------------------------------------------------------------------------------------------------------------

Constitution. These two august bodies as w ell as the executive which is
antinomy nor in a spirit of hostility, but rationally, harmoniously and in a a
436. This Court in the Special Reference No. 1 of 1964 22 also had observed
that the caution and principle which are kept in mind by the courts while b
punishing for contempt are equally true to the Legislatures also. The following
observations were made by this Court: (AIR p. 791, para 142)
"142. Before we part with this topic, we would like to refer to one
aspect of the question relating to the exercise of power to punish for
contempt. So far as the courts are concerned, Judges always keep in mind C
the warning addressed to them by Lord Atkin in Andre Paul Terence
Ambard v. Attorney General of Trinidad and Tobago 207 . Said Lord Atkin,
"Justice is not a cloistered virtue; she must be allowed to suffer the scrutiny
and respectful even though outspoken comments of ordinary men". We
ought never to forget that the power to punish for contempt large as it
is, must always be exercised cautiously, wisely and with circumspection. d
Frequent or indiscriminate use of this power in anger or irritation would not
help to sustain the dignity or status of the court, but may sometimes affect it
adversely. Wise Judges never forget that the best way to sustain the dignity
and status of their office is to deserve respect from the public at large by the
quality of their judgments, the fearlessness, fairness and objectivity of their
approach, and by the restraint, dignity and decorum which they observe in e
their judicial conduct. We venture to think that what is true of the judicature
is equally true of the legislatures."
437. The power to punish for contempt is a privilege available to Parliament
which is defined as "keynote of parliamentary privileges".
438. From what has been stated above, we are of the view that fair f
comments on report of the Parliamentary Committee are fully protected under
the rights guaranteed under Article 19(1)(a). However, the comments when
turn into personal attack on the individual Member of Parliament or the House
or made in vulgar or abusive language tarnishing the image of Member or the
House, the said comments amount to contempt of the House and breach of
privilege. g
439. In the present case, the learned counsel for the respondents have
contended that in the event, they raise objections regarding Parliamentary
Committee report which has adversely commented on their role they shall
22 Powers, Privileges and Immunities of State Legislatures, In re, Special Reference No. I of h
1964, AIR 1965 SC 745 : (1965) 1 SCR 413
207 1936 SCC OnLine PC 15 : AIR 1936 PC 141
722
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be liable to be proceeded against for committing contempt of the House,
hence, this Court may neither permit the Parliamentary Committee report
a to be taken in evidence nor allow the petitioners to rely on the report. No
party is precluded in making fair comments on the Parliamentary Committee
report which comments remain within the bounds of fair comments and does
not transgress the limits prescribed for fair comments. The Parliamentary
Committee reports when published, the Press is entitled to make fair comments.
We fail to see any reason prohibiting the parties who were referred to in the
b Parliamentary Committee report to make such fair comments or criticism of
the Report as permissible under law without breach of privilege.
L. Adjudication in courts and Parliamentary Committee Report
440. "Adjudication" is the power of Court to decide and pronounce a
judgment and carry it into effect between the persons and parties who bring
C a cause before it for a decision. Both for civil and criminal cases people look
forward to courts for justice. To decide the controversy between its subject
had always been treated as a part of sovereign functions. Constitutional law
developments emphasised separation of powers of governmental functions for
protecting rights and liberties of people.
d
441. Montesquieu in L 'Esprit des Lois, 1748, the modern exponent of the
doctrine of separation of powers states:
"When the legislative and executive powers are united in the same
person, or on the same body or Magistrates, there can be no liberty. Again,
there is no liberty if the judicial power is not separated from the legislative
and executive powers. Were it joined with the legislative power, the life and
e liberty of the subject would be exposed to arbitrary control; for the Judge
would then be the legislator. Were it joined with the executive power, the
Judge might behave with violence and oppression. There would be an end
of everything were the same man or the same body to exercise these three
powers ... ".
f 442. In our Constitution although there is no strict separation of powers
of the three branches, that is, Legislature, Judicature and Executive but
constitutional provisions entrust separate functions of each organ with clarity
which makes it clear that our Constitution does not contemplate assumption by
one organ function which belongs to another organ of the State.
443. A nine-Judge Constitution Bench in l.R. Coelho v. State ofT.N. 5 , while
g
dealing with the separation of powers stated the following in paras 64, 65 and
67: (SCC pp. 86-87)
"64. In fact, it was settled centuries ago that for preservation of
liberty and prevention of tyranny it is absolutely essential to vest separate
powers in three different organs. In The Federalist 4 7, 48 and 51, James
h
s c2001) 2 sec 1
723
-----------------------------------------------------------------------------------------------------------------------------------------------------------

Madison details how a separation of powers preserves liberty and prevents
tyranny. In The Federalist 47, Madison discusses Montesquieu's treatment
of the separation of powers in Spirit of Laws (Book XI, Chapter 6). There a
Montesquieu writes,
'When the legislative and executive powers are united in the same
person, or in the same body of Magistrates, there can be no liberty ....
Again, there is no liberty, if the judicial power be not separated from
the legislative and executive.'
b
Madison points out that Montesquieu did not feel that different branches
could not have overlapping functions, but rather that the power of one
department of Government should not be entirely in the hands of another
department of Government.
65. Alexander Hamilton in The Federalist 78, remarks on the
C
importance of the independence of the judiciary to preserve the separation
of powers and the rights of the people:
'The complete independence of the courts of justice is peculiarly
essential in a limited Constitution. By a limited Constitution, I
understand one which contains certain specified exceptions to the
legislative authority; such, for instance, that it shall pass no bills of d
attainder, no ex post facto laws, and the like. Limitations of this
kind can be preserved in practice in no other way than through the
medium of courts of justice, whose duty it must be to declare all acts
contrary to the manifest tenor of the Constitution void. Without this,
all the reservations of particular rights or privileges would amount to
nothing.' (434) e
* * *
67. The Supreme Court has long held that the separation of powers
is part of the basic structure of the Constitution. Even before the basic
structure doctrine became part of constitutional law, the importance of
the separation of powers on our system of governance was recognised f
by this Court in Special Reference No. 1 of 1964 22 ."
444. Adjudication of rights of the people is a function not entrusted
to the Legislature of the country. Apart from legislation our Parliament
has become multi-functional institution performing various roles, namely,
inquisitorial, financial and administrative surveillance, grievance redressal
g
and developmental. Parliament, however, is not vested with any adjudicatory
jurisdiction which belongs to judicature under the constitutional scheme.
h
1964, AIR 1965 SC 745 : (1965) 1 SCR 413
724
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445. This Court in State of Karnataka v. Union of lndia 201 , while
considering Articles 105 and 194 of the Constitution of India laid down the
a following: (SCC p. 656, para 63)
"63 . ... Our Constitution vests only legislative power in Parliament as
well as in the State Legislatures. A House of Parliament or State Legislature
cannot try anyone or any case directly, as a Court of Justice can, but it can
proceed quasi-judicially in cases of contempt of its authority and take up
b motions concerning its "privileges" and "immunities" because, in doing
so, it only seeks removal of obstructions to the due performance of its
legislative functions. But, if any question of jurisdiction arises as to whether
a matter falls here or not, it has to be decided by the ordinary courts in
appropriate proceedings. For example, the jurisdiction to try a criminal
offence, such as murder, committed even within a House vests in ordinary
c criminal courts and not in a House of Parliament or in a State Legislature."
446. The function of adjudicating rights of the parties has been entrusted
to the constituted courts as per constitutional scheme, which adjudication has
to be made after observing the procedural safeguards which include the right
to be heard and the right to produce evidence.
d 447. In Dingle v. Associated N ewspapers Ltd. 125 in a case of damages for
libel where the defendants relied on Parliamentary Committee report published,
Pearson, J., laid down as follows: (QB pp. 410-11)
" ... in my view, this Court should make its own findings based on
the evidence adduced and on the arguments presented in this Court, and
e
that should be done without regard to any decisions reached or opinions
expressed or findings made by a different tribunal having a different
function, and, probably, different issues before it, and having received
different evidence and a different presentation of the case."
448. The apprehension of the respondents that their case shall be prejudiced
if this Court accepts the Parliamentary Committee report in evidence, in our
f opinion is misplaced. By acceptance of a Parliamentary Committee report in
evidence does not mean that facts stated in the Report stand proved. When
issues, facts come before a court of law for adjudication, the court is to decide
the issues on the basis of evidence and materials brought before it and in which
adjudication Parliamentary Committee report may only be one of the materials,
what weight has to be given to one or other evidence is the adjudicatory function
g
of the court which may differ from case to case. The Parliamentary Committee
reports cannot be treated as conclusive or binding of what has been concluded
in the Report. When adjudication of any claim fastening any civil or criminal
liability on an individual is up in a court of law, it is open for a party to rely
on all evidence and materials which is in its power and court has to decide
h
201 (1977) 4 sec 608
125 (1960) 2 QB 405 : (1960) 2 WLR 430
725
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the issues on consideration of the entire material brought before it. When the
Parliamentary Committee report is not adjudication of any civil or criminal
liability of the private respondents, their fear that acceptance of report shall a
prejudice their case is unfounded. We are, thus, of the opinion that by accepting
Parliamentary Committee report on the record in this case and considering
the Report by this Court, the respondents' right to dispel conclusions and
findings in the Report is not taken away and they are free to prove their case
in accordance with law.
b
449. Our Conclusions
449.1. According to clause (2) of Article 105 of Constitution of India no
Member of Parliament can be held liable for anything said by him in Parliament
or in any committee. The reports submitted by Members of Parliament are also
fully covered by protection extended under clause (2) of Article 105 of the
Constitution of India. C
449.2. The publication of the reports not being only permitted, but also
are being encouraged by Parliament. The general public is keenly interested in
knowing about the parliamentary proceedings including parliamentary reports
which are steps towards the governance of the country. The right to know about
the reports only arises when they have been published for use of the public in
d
general.
449.3. Section 57(4) of the Evidence Act, 1872 makes it clear that the
course of proceedings of Parliament and the Legislature, established under any
law are facts of which judicial notice shall be taken by the Court.
449.4. Parliament has already adopted a report of "privilege committee",
that for those documents which are public documents within the meaning of e
the Evidence Act, there is no requirement of any permission of the Speaker of
Lok Sabha for producing such documents as evidence in court.
449.5. That mere fact that document is admissible in evidence whether a
public or private document does not lead to draw any presumption that the
contents of the documents are also true and correct.
f
449.6. When a party relies on any fact stated in the Parliamentary
Committee report as the matter of noticing an event or history no exception
can be taken on such reliance of the report. However, no party can be
allowed to "question" or "impeach" report of Parliamentary Committee. The
parliamentary privilege, that it shall not be impeached or questioned outside
Parliament shall equally apply both to a party who files claim in the court g
and other who objects to it. Any observation in the report or inference of the
Committee cannot be held to be binding between the parties. The parties are at
liberty to lead evidence independently to prove their stand in a court of law.
449.7. Both the parties have not disputed that parliamentary reports can be
used for the purposes of legislative history of a statute as well as for considering
h
the statement made by a minister. When there is no breach of privilege in
726
-----------------------------------------------------------------------------------------------------------------------------------------------------------

considering the parliamentary materials and reports of the Committee by the
Court for the above two purposes, we fail to see any valid reason for not
a accepting the submission of the petitioner that courts are not debarred from
accepting the parliamentary materials and reports, on record, before it, provided
the court does not proceed to permit the parties to question and impeach the
reports.
449.8. The Constitution does not envisage supremacy of any of the three
organs of the State. But, functioning of all the three organs is controlled by the
b
Constitution. Wherever, interaction and deliberations among the three organs
have been envisaged, a delicate balance and mutual respect are contemplated.
All the three organs have to strive to achieve the constitutional goal set out for
"We the People". Mutual harmony and respect have to be maintained by all the
three organs to serve the Constitution under which we all live.
C 449.9. We are of the view that fair comments on report of the Parliamentary
Committee are fully protected under the rights guaranteed under Article 19(1)
(a). However, the comments when turn into personal attack on the individual
Member of Parliament or the House or made in vulgar or abusive language
tarnishing the image of the Member or the House, the said comments amount
to contempt of the House and breach of privilege.
d 449.10. The function of adjudicating rights of the parties has been entrusted
to the constituted courts as per constitutional scheme, which adjudication has
to be made after observing the procedural safeguards which include the right
to be heard and the right to produce evidence. Parliament, however, is not
vested with any adjudicatory jurisdiction which belongs to judicature under the
constitutional scheme.
e
449.11. Admissibility of a Parliamentary Committee report in evidence
does not mean that facts stated in the Report stand proved. When issues of facts
come before a court of law for adjudication, the court is to decide the issues on
the basis of evidence and materials brought before it.
450. The questions having been answered as above, let these writ petitions
f be listed before the appropriate Bench for hearing.
h
727
ANNEXURE P-19

भारत सरकार (कार्य आबंटन) ननर्म, 1961
(As amended upto Amendment Series no. 348, dated 5th February, 2019)
(संशोधन अवली सं 348, दिनांक 5 फरवरी, 2019 तक र्था संशोधधत)
CABINET SECRETARIAT
मंत्रिमंडल सधिवालर्
Government of India (Allocation of Business) Rules, 1961 728
Index
Subject Pg.No.
I. Order dated 14.01.1961 5
II. First Schedule 7
III. Second Schedule 12
Ministry/ Department
Ministry of Agriculture and Farmers Welfare
(Krishi Evam Kisan Kalyan Mantralaya)
1. (i) Department of Agriculture, Cooperation and Farmers Welfare (Krishi, Sahkarita 12
Evam Kisan Kalyan Vibhag)
2. (ii) Department of Agricultural Research and Education (Krishi Anusandhan aur 16
Shiksha Vibhag)
3. (iii) Department of Animal Husbandry and Dairying (Pashupalan aur Dairy Vibhag) 17
4. (iv) Department of Fisheries (Matsyapalan Vibhag) 19
5. Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy 20
(AYUSH) (Ayurveda, Yoga aur Prakratik Chikitsa, Unani, Siddha aur Homoeopathy
(AYUSH) Mantralaya)
Ministry of Chemicals and Fertilizers
(Rasayan aur Urvarak Mantralaya)
6. (i) Department of Chemicals and Petro-Chemicals (Rasayan aur Petro-Rasayan 22
Vibhag)
7. (ii) Department of Fertilizers (Urvarak Vibhag) 23
8. (iii) Department of Pharmaceuticals (Aushadh Vibhag) 24
9. Ministry of Civil Aviation (Nagar Vimanan Mantralaya) 25

10. Ministry of Coal (Koyala Mantralaya) 26
Ministry of Commerce and Industry

(Vanijya aur Udyog Mantralaya)
11. (i) Department of Commerce (Vanijya Vibhag) 27
12. (ii) Department for Promotion of Industry and Internal Trade (Udyog Samvardhan aur 30
Antarik Vyapar Vibhag)
Ministry of Communications
(Sanchar Mantralaya)
13. (i) Department of Telecommunications (Doorsanchar Vibhag) 33
14. (ii) Department of Posts (Dak Vibhag) 35
Ministry of Consumer Affairs, Food and Public Distribution
(Upbhokta Mamle, Khadya aur Sarvajanik Vitaran Mantralaya)
15. (i) Department of Consumer Affairs (Upbhokta Mamle Vibhag) 37
16. (ii) Department of Food and Public Distribution (Khadya aur Sarvajanik Vitaran 38
Vibhag)
17. Ministry of Corporate Affairs (Corporate Karya Mantralaya) 39

1
729
18. Ministry of Culture (Sanskriti Mantralaya) 40
Ministry of Defence
(Raksha Mantralaya)
19. (i) Department of Defence (Raksha Vibhag) 43
20. (ii) Department of Defence Production (Raksha Utpadan Vibhag) 45
21. (iii) Department of Defence Research and Development (Raksha Anusandhan aur 46
Vikas Vibhag)
22. (iv) Department of Ex-Servicemen Welfare (Poorva Senani Kalyan Vibhag) 48
23. Ministry of Development of North Eastern Region (Uttar Poorvi Kshetra Vikas 49
Mantralaya)
24. Ministry of Drinking Water and Sanitation (Peya Jal aur Swachchhata Mantralaya) 50
25. Ministry of Earth Sciences (Prithvi Vigyan Mantralaya) 51
26. Ministry of Electronics and Information Technology (Electroniki aur Soochana 52
Praudyogiki Mantralaya)
27. Ministry of Environment, Forest and Climate Change (Paryavaran, Van aur Jalvaayu 53
Parivartan Mantralaya)
28. Ministry of External Affairs (Videsh Mantralaya) 55
Ministry of Finance
(Vitta Mantralaya)
29. (i) Department of Economic Affairs (Arthik Karya Vibhag) 59
30. (ii) Department of Expenditure (Vyaya Vibhag) 64
31. (iii) Department of Revenue (Rajaswa Vibhag) 66
32. (iv) Department of Investment and Public Asset Management (DIPAM) (Nivesh aur 68
Lok Parisampatti Prabandhan Vibhag(DIPAM))
33. (v) Department of Financial Services (Vittiya Sewayen Vibhag) 69
34. Ministry of Food Processing Industries (Khadya Prasanskaran Udyog Mantralaya) 71

(Swasthya aur Parivar Kalyan Mantralaya)
35. (i) Department of Health and Family Welfare (Swasthya aur Parivar Kalyan Vibhag) 72
36. (iii) Department of Health Research (Swasthya Anusandhan Vibhag) 77
Ministry of Heavy Industries and Public Enterprises
(Bhari Udyog aur Lok Udyam Mantralaya)
37. (i) Department of Heavy Industry (Bhari Udyog Vibhag) 79
38. (ii) Department of Public Enterprises (Lok Udyam Vibhag) 82
Ministry of Home Affairs

(Grih Mantralaya)
39. (i) Department of Internal Security (Antarik Suraksha Vibhag) 83
40. (ii) Department of States (Rajya Vibhag) 87
41. (iii) Department of Official Language (Raj Bhasha Vibhag) 90
42. (iv) Department of Home (Grih Vibhag) 91
43. (v) Department of Jammu and Kashmir Affairs (Jammu tatha Kashmir Vibhag) 93
44. (vi) Department of Border Management (Seema Prabandhan Vibhag) 94
2
MINISTRY OF AYURVEDA, YOGA AND NATUROPATHY, UNANI, SIDDHA 730AND
HOMOEOPATHY (AYUSH) (AYURVEDA, YOGA AUR PRAKRATIK CHIKITSA, UNANI,
SIDDHA AUR HOMOEOPATHY (AYUSH) MANTRALAYA)1
I. UNION BUSINESS
1. Formulation of policy and policy issues for development and propagation of Ayurveda,
Siddha, Unani, Homoeopathy, Yoga and Naturopathy systems.
2. Development and implementation of programmes including Central schemes and Centrally
sponsored schemes for development and propagation of Ayurveda, Siddha, Unani,
3. Co-ordination and promotion of research and development including assistance therefor in
4. Setting up and maintenance of Central institutions for research and development, education
and standards relating to Ayurveda, Siddha, Unani, Homoeopathy, Yoga and Naturopathy
systems.
4A. Formulation of policy for development and propagation of Sowa Rigpa including
implementation of Central programmes / schemes, setting up and maintenance of Central
Institutions for research and development, education and standards relating to Sowa
Rigpa.2
(a) Pharmacopoeial Laboratory for Indian Medicine, Ghaziabad;
(j) Central Research Councils and National Institutes relating to Indian Systems of
Medicine and Homoeopathy.3
6. Education, Training and Research in all aspects of Indian Systems of Medicine including higher
training abroad.
7. Matters of cadre formation and control including framing and amendment of recruitment rules,
recruitment, promotion and all other service matters relating to Indian Systems of Medicine and
Homoeopathy doctors of Central Government Health Scheme and other Central Government
institutions requiring action at Government level.4
1
Inserted vide Amendment series no.310 dated 08.12.2014 (Earlier modified vide amendment series no.279
2
3
Substituted for (j) to (v) vide Amendment series no.339 dated 22.12.2017.
4
Modified vide Amendment series no.339 dated 22.12.2017.
20
Note.- Day-to-day administration and management will continue to be with the 731
Director,
8. Liaison with foreign countries and international bodies as regards matters relating to Indian
Systems of Medicine and Homoeopathy.
9. Matters relating to scientific societies/associations and charitable and religious endowments
relating to Indian Systems of Medicine and Homoeopathy.
11. Consultation and coordination with State Governments, Non-Government Organisations and
institutions for review of work and programmes in Indian Systems of Medicine and
Homoeopathy.
12. Undertaking surveys, evaluation, collection and publication of statistics relating to
various aspects of Indian Systems of Medicine and Homoeopathy.1
13. Proposals and matters concerning Union Territories requiring sanction and concurrence of
Government of India in regard to Indian Systems of Medicine and Homoeopathy.
15. All matters relating to the National Medicinal Plants Board; including promotion and
propagation of Medicinal Plants, and implementation of schemes therefor.2
16. Indian Medicines Pharmaceutical Corporation Limited.3
1
2
3
21
MINISTRY OF HEALTH AND FAMILY WELFARE 732
A. DEPARTMENT OF HEALTH AND FAMILY WELFARE1
I. UNION BUSINESS
1. Union agencies and institutes for research or for the promotion of special studies in medicine
and nutrition including all matters relating to -
(l) Jawaharlal Institute of Post-Graduate Medical Education and Research;
(m) Smt. Sucheta Kirpalani Medical College and Hospital and Kalawati Saran Children's
Hospital;
(q) National AIDS Control Organisation (NACO).2
1
2
Inserted vide Amendment series no.282 dated 12.01.2006; Omitted vide Amendment series no.294 dated 20.12.2008 and
re-inserted vide Amendment series no.307 dated 06.08.2014
72
(g) Regional Leprosy Training and Research Centre, Raipur (Uttar Pradesh), Aska (Orissa),
733
Gauripur(West Bengal), Teetulmari (Bihar).
(h) Port Quarantine (sea and air) seamen's and marine hospitals and hospitals connected
with port quarantine.
(l) World Health Organisation (WHO).
1
3 (a) The Food Safety and Standards Act, 2006 (34 of 2006)
(b) The Prevention of Food Adulteration Act, 1954 (37 of 1954) and the Central Food
Laboratory. 2
5. Coordination of work in respect of International Conferences in India and abroad in medical and
related fields.
(f) All National Programmes relating to control and eradication of communicable diseases.
8. Matters relating to epidemics - Problems connected with supply of medicines, effects of
malnutrition and shortage of drinking water leading to various diseases as a result of natural
calamities.
II. LIST OF BUSINESS FOR LEGISLATIVE AND EXECUTIVE PURPOSES IN
RESPECT OF UNION TERRITORIES.
10. Scientific societies and associations pertaining to subjects dealt with in the Department.
11. Charitable and religious endowments pertaining to subjects dealt with in the Department.
III. LIST OF BUSINESS WITH WHICH THE CENTRAL GOVERNMENT DEAL IN

A LEGISLATIVE CAPACITY ONLY FOR THE UNION AND IN BOTH
1
2
73
LEGISLATIVE AND EXECUTIVE CAPACITIES FOR ALL 734
UNION
TERRITORIES.
(e) Mental Health.
(h) Prevention of the extension from one State to another of infectious or contagious
diseases affecting human beings.
(j). Regulatory aspects namely quality, safety, labelling and performance of medical
devices1.
(a) The Medical Council of India.
14. Concession of medical attendance and treatment for Central Government servants other than (i)
those in Railway Service (ii) those paid from Defence Service Estimates (iii) officers governed
by the All India Services (Medical Attendance) Rules, 1954 and (iv) officers governed by the
Medical Attendance Rules, 1956.
controlled by the Department of Railways and those paid from Defence Services Estimates
excepting Civilian Services.].
15 A. Rashtriya Swasthya Bima Yojana.2
1
Inserted vide amendment series no.315 dated 5.8.2015.
2
Inserted vide amendment series no.313 dated 24.03.2015
74
735
(a) National Health Mission1.
21. Organisation and direction of education, training and research in all aspects of family welfare
23. Liaison with foreign countries and international bodies as regards matters relating to family
welfare.
26. Development and production of audiovisual aids, extensional education and information in
relation to population and family welfare.
29. Implementation of Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex
Selection) Act, 1994 (57 of 1994) – Medical Termination of Pregnancy Act, 1971 (34 of 1971).
____________
1
Amended vide series no.326 dated 21.5.2016
75
736
B. Omitted1
1
76
1
C. DEPARTMENT OF HEALTH RESEARCH (SWASTHYA ANUSANDHAN VIBHAG)
737
1. Promotion and co-ordination of basic, applied and clinical research including clinical trials and
operational research in areas related to medical, health, biomedical and medical profession and
education through development of infrastructure, manpower and skills in cutting edge areas and
management of related information thereto.
2. Promote and provide guidance on research governance issues, including ethical issues in
medical and health research.
3. Inter-sectoral coordination and promotion of public - private - partnership in medical, bio-
medical and health research related areas.
4. Advanced training in research areas concerning medicine and health, including grant of
fellowships for such training in India and abroad.
prevention.
8. Matters relating to Scientific societies and associations, Charitable and religious endowments in
medicine and health research areas.
9. Coordination between organizations and institutes under the Central and State Governments in
areas related to the subjects entrusted to the Department and for the promotion of special studies
in medicine and health.
1
77
D. Omitted1 738
1
Omitted vide Amendment series no.307 dated 06.08.2014 (earlier inserted vide amendment series no.294 dated
20.12.2008)
78
ANNEXURE P-20 739
Sj1d'ad~n ~ingh Oberoi Versus Union oflndia _

.
Present: Applicant m person. . es
!14RFB01-olo3G7-2oltl
ORDER:
The applicant submits as under:
l. The petitioner has today made a statement at bar that the controversy of
the jurisdiction of Human Rights Courts under Section 30 & 31 of the Protection
of Human Rights Act, 1993 (Act l O of 1994) involves substantial question of law
as to the interpretation of the Constitution of India.
2. The petitioner relies upon the judgment dated 22.03.2018 passed by the
Additional Sessions Judge, Gurgaon, in case titled Lt. Col. Sarvadaman Singh
Oberoi (Retd.) Versus State of Haryana and others (HR-GR-01-005629-2015)
and relevant extracts of which are as under:
"That an examination of Article 246 of The Constitutfon of India
read with Items 13, 14 and 95 of List I, Items 1,2 and 46 of List
III and Item 65 of List II suffice to establish that jurisdiction as
regards matters, which are the subject of any International
treaties, agreement and conventions lie strictly within the domain
of Union of India being matters in the Union List. It is, therefore,
reasoned contention of the petitioner that State Governments and
the Union Territories shall lack jurisdiction to legislate or make
Rules in the matters falling under the Protection of Human Rights
Act, 1993 in view of the fact that the Statement of O~jects and
Reasons of the Act itself states that "India is a party to the
International Covenant on Civil and Political Rights, 1966 and
the International Covenant on Economic, Social and Cultural
Rights, 1966 adopted by the General Assembly of the United
Nations on the I 6111 Decembe,~ I 966 and that taking into account
the views expressed in subsequent discussions on these
conventions, the said Act was brought before Parliament and
received the assent of the President on 8'" January, 1994.
xxxx.
-2-
740
·Moreover, there is presently no independent Public Prosecutor
appointed under Section 31 of the Act 10 of 1994 and the
Regulations thereof have also not been notified. Keeping in view
the above facts and law mentioned above, this Court is of the
considered opinion that no purpose will be served by hearing
these matters on day-to-day basis and the matter is, thus,
adjourned Sine die ...... "
3. The petitioner submits that the substantial question of law as to the
interpretation of the Constitution of India have been referred by the Hon'ble
Single Judge of the High Court of Punjab & Haryana in CRM-M-44361/17 titled
Sarvadaman Singh Oberoi Versus Union of India and others vide order dated
06.12.2017, which states:
"The petitioner who is present in person, prays that CWP-24079-
2015, involving similar questions of law, is pending adjudication
before a Division Bench of this Court on 29.01.2018, this petition
may be referred to the same Division Bench. To avoid any
multiplicity ofproceedings and conflicting views, be put up before
the same Division Bench, after obtaining appropriate orders,
from Hon'ble the ChiefJustice."
In CRM-M-34001 of 2012 titled Parvesh Kataria Vs. State of Haryana and
others, and CRM-M-5280 of 2015 titled Sarvadaman Singh Oberoi Vs.
Unknown with State of Haryana, our Hon'ble Punjab & Haryana High Court
vide order dated 10.12.2018 states :
"The petitioner submits that the petition bearing CRM-M-43361
(44361) of 2017 involving the point of law, upon which the
decision of the present case would be depending, is already.
pending before the Divsion Bench o.f this Court for 28.01.2019. It
is submitted by the counsel that either this petition be sent to the
Div;sion Bench, so that both the cases can be heard together or
this case may be taken up after the above said case is decided by
-3-
741
the Division Bench of this Court. Learned counsel for the State
has no objection if the present case is taken up after the above
said CRNJ-M-43361 of 2017 is decided by the Division Bench.
Adjourned sine die. To be taken up 'ajier the above said CRM-M-
43361 of 2017 is decided by the Division Bench of this Court."
4. The real matter is stated to be pending before the Hon'ble Division Bench
No.1 of Hon 'ble High Court of Punjab & Haryana in CWP 24079/15 titled Ram
Devi Versus National Human Rights Commission and CRM-M-44361/17 titled
Sarvadaman Singh Oberoi Versus Union of India and others pending for
23.07.2019.
5. It may take a few months or years to obtain closure in these constitutional
questions of law.
6. Keeping in view of the above facts and that this case is primarily about the
jurisdictional aspect itself, this court is of the considered opinion that no purpose
will be served by hearing these matters on day to day basis, and the matter is,
thus, adjourned sine-die with liberty to petitioner to move this court for taking up
these matters, as and when there is some progress in the above mentioned
matters.
7. The connected (disposed of) matters would need to be protected depending
on the final outcome of this case. These matters are as follows:
i) HRFB-03-005174-2014 titled Shriram Transport Co. Ltd. Vs. Sunil
decided on 30.09.2015;
ii) HRFB-03-005117-2014 titled Shriram Transport Co. Ltd. Vs. Sunil
iii) HRFB-01-008943-2015 titled Sunil Versus Sriram Transport Co. Ltd.
iv) HRFB-01-008942-2015 titled Sunil Versus Sriram Transpmi Co. Ltd.
-4-
L 742
v) HRFB-01-012326-2017 titled Sarvadaman Singh Oberoi Versus Union of
India decided on 01.08.2018;
vi) HRFB-0l-012372-2017 titled Sarvadarnan Singh Oberoi Versus Union of
India decided on 0 1.08.2018;
vii) HRFB-01-015154-2017 titled Shriram Transpmt Co. Ltd. Vs. Sunil
viii) HRFB-01-001413-2018 titled Shriram Transport Co. Ltd. Vs. Sunil
ix) HRFB-01-001414-2018 titled Shriram Transpo1t Co. Ltd. Vs. Sunil
8. All these case files be consfgned to record-room with a red ink note that its
record not to be weeded out without a specific permission for the same from this
cornt, with the libe1ty aforesaid to the petitioner.
9. Let copy of this order be given dasti to the petitioner and file be consigned
to the record-room.
Date of order : 06.04.2019. (Rajesh Malhotra)

Gautam Lal Addl. Sessions Judge,
Faridabad. 06.04.2019
UTD NoJ-1R0059.
GAUTAM ~.J,l~d by
LAL METHU.
Date: 2019.04.06
METHIL 17:15:09 +0530
743
ZIMNI
Lt. Col. Sarvadaman Singh Oberoi (Retd.) versus State
CNR number: HR-GR-01-005629 of 2015 CIS: 179/2015
Present: Petitioner Lt. Col. Sarvadaman Singh Oberoi (Retd.)

in person
Sh. S.S. Gulia, Public Prosecutor for State
Petitioner, in furtherance of statement at bar made on
20.02.2018 submitted documents substantiating certain important aspects of
human rights law. Petitioner has submitted seven documents today. Item
number 2 of these documents is an extract of Exh.A-1(i) which is letter
dated 05.03.2018 addressed to Union of India and nine others wherein at
pages 28 to 32 in para no.18 certain extracts of Article 246 and Schedule
VII have been reproduced. That an examination of Article 246 of The
Constitution of India read with Items 13, 14 and 95 of List I, Items 1,2 and
46 of List III and Item 65 of List II suffice to establish that jurisdiction as
regards matters which are the subject of any International treaties,
agreement and conventions lie strictly within the domain of Union of India
being matters in the Union List. It is, therefore, reasoned contention of the
petitioner that State Governments and the Union Territories shall lack
jurisdiction to legislate or make Rules in the matters falling under the
Protection of Human Rights Act, 1993 in view of the fact that the Statement
of Objects and Reasons of the Act itself states that "India is a a party to the
International Covenant on Civil and Political Rights,1966 and the
International Covenant on Economic, Social and Cultural Rights, 1966
adopted by the General Assembly of the United Nations on the 16th
December, 1966" and that taking into account the views expressed in
subsequent discussions on these Conventions, the said Act was brought

744
ZIMNI
before Parliament and received the assent of the President on 8th January,
1994. Petitioner has also produced certain other letters of Hon'ble High
Court of Delhi and Hon'ble Supreme Court of India and the Ministry of
Home Affairs in the Union of India at Items 3 to 5 which indicate that the
matter has been stated to be of judicial nature and the Ministry of Home
Affairs has referred the Delhi Human Rights matter to the Law Commission
Division in the Ministry of Law on 09.02.2018. According to the petitioner,
the matter would be coming up before the Special Judge, Human Rights,
Patiala House, New Delhi on 11.04.2018 and all these points would also be
agitated before that court in the complaint case no.20/2018 titled
"Sarvadaman Singh Oberoi versus Union of India and others" wherein
Union of India is a party.
It is noteworthy that the Union of India is not a party in any of
the human rights cases presently pending before this court. Petitioner
further states that it would take a few months before any out come can be
expected in the matter which is before the Special Judge, Human Rights,
Patiala House, New Delhi.
More over, there is presently no independent Public Prosecutor
appointed under Section 31 of the Act 10 of 1994 and the Regulations
thereof have also not been notified.
Keeping in view the above facts and law mentioned above, this
Court is of the considered opinion that no purpose will be served by hearing
these matters on day-to-day basis and the matter is, thus, adjourned Sine die
with liberty to petitioner to move this court for taking up the matters as and
when there is some progress in the above mentioned matters.
As six other connected petitions are also continuing before this

745
ZIMNI
court at the behest of petitioner, hence copy of present order be also pasted
in those connected matters for passing appropriate orders of the sine die
adjournment in those matters.
File be consigned to record room with a red ink note that its
record not to be weeded out without obtaining a specific permission for the
same from this court as the case is running adjourned sine die with liberty to
the petitioner to get it restored/revived.
Let copy of this order be given dasti to the petitioner under the
seal of the court for his record sake.
Date of Order: 22.03.2018 [ J.S. Kundu ]

yogesh stenographer-I Additional Sessions Judge,
Gurugram
[UID no. HR-0069]
746
ANNEXURE P-21
~ .:f 0 ~ 0 ~ 0 (1l;'J)04/0007/2003 19 REGISTERED NO. DL(N)04/0007/200319
EXTRAORDINARY
II 1
PART II Section 1
PUBLISHED BY AUTHORITY
49]
No. 49] NEW DELHI, THURSDAY, AUGUST 8, 2019/SHRAVANA 17, 1941 (SAKA)
Separate paging is given to this Part in order that it may be filed as a separate compilation.
MINISTRY OF LAW AND JUSTICE

(Legislative Department)
New Delhi, the 8th August, 2019/Shravana 17, 1941 (Saka)
The following Act of Parliament received the assent of the President on the
8th August, 2019, and is hereby published for general information:
THE NATIONAL MEDICAL COMMISSION ACT, 2019
NO. 30 OF 2019
[8th August, 2019.]
An Act to provide for a medical education system that improves access to
quality and affordable medical education, ensures availability of adequate
and high quality medical professionals in all parts of the country; that
promotes equitable and universal healthcare that encourages community
health perspective and makes services of medical professionals accessible
to all the citizens; that promotes national health goals; that encourages
medical professionals to adopt latest medical research in their work and
to contribute to research; that has an objective periodic and transparent
assessment of medical institutions and facilitates maintenance of a medical
register for India and enforces high ethical standards in all aspects of
medical services; that is flexible to adapt to changing needs and has an
effective grievance redressal mechanism and for matters connected
therewith or incidental thereto.
BE it enacted by Parliament in the Seventieth Year of the Republic of India as
follows:
CHAPTER I
PRELIMINARY
1. (1) This Act may be called the National Medical Commission Act, 2019. Short title,
extent and
(2) It extends to the whole of India. commencement.
747
2 THE GAZETTE OF INDIA EXTRAORDINARY [PART II
(3) It shall come into force on such date as the Central Government may, by
notification in the Official Gazette, appoint, and different dates may be appointed for
different provisions of this Act and any reference in any such provision to the
commencement of this Act shall be construed as a reference to the coming into force of
that provision.
Definitions. 2. In this Act, unless the context otherwise requires,
(a) "Autonomous Board" means any of the Autonomous Boards constituted
under section 16;
(b) "Chairperson" means the Chairperson of the National Medical
Commission appointed under section 5;
(c) "Commission" means the National Medical Commission constituted under
section 3;
(d) "Council" means the Medical Advisory Council constituted under
section 11;
(e) " Ethics and Medical Registration Board" means the Board constituted
under section 16;
(f) "health University" means a University specialised in affiliating
institutions engaged in teaching medicine, medical and health sciences and
includes a medical University and University of health sciences;
(g) "licence" means a licence to practice medicine granted under
sub-section (1) of section 33;
(h) "Medical Assessment and Rating Board" means the Board constituted
under section 16;
(i) "medical institution" means any institution within or outside India which
grants degrees, diplomas or licences in medicine and include affiliated colleges
and deemed to be Universities;
(j) "medicine" means modern scientific medicine in all its branches and
includes surgery and obstetrics, but does not include veterinary medicine and
surgery;
(k) "Member" means a Member of the Commission appointed under
section 5 and includes the Chairperson thereof;
(l) "National Board of Examination" means the body registered as such
under the Societies Registration Act, 1860 which grants broad-speciality and 21 of 1860.
super-speciality qualifications referred to in the Schedule;
(m) "National Register" means a National Medical Register maintained by
the Ethics and Medical Registration Board under section 31;
(n) "notification" means notification published in the Official Gazette and
the expression "notify" shall be construed accordingly;
(o) "Post -Graduate Medical Education Board" means the Board
constituted under section 16;
(p) "prescribed" means prescribed by rules made under this Act;
(q) "President" means the President of an Autonomous Board appointed
under section 18;
(r) "recognised medical qualification" means a medical qualification
recognised under section 35 or section 36 or section 37 or section 40, as the case
may be;
(s) "regulations" means the regulations made by the Commission under this Act;
748
SEC. 1] THE GAZETTE OF INDIA EXTRAORDINARY 3
(t) "Schedule" means the Schedule to this Act;

(u) "State Medical Council" means a medical council constituted under any
law for the time being in force in any State or Union territory for regulating the
practice and registration of practitioners of medicine in that State or Union territory;
(v) "State Register" means a register maintained under any law for the time
being in force in any State or Union territory for registration of practitioners of
medicine;
(w) "Under-Graduate Medical Education Board" means the Board constituted
under section 16;
(x) "University" shall have the same meaning as assigned to it in clause (f)
3 of 1956. of section 2 of the University Grants Commission Act, 1956 and includes a health
University.
CHAPTER II
THE N ATIONAL M EDICAL C OMMISSION
3. (1) The Central Government shall constitute a Commission, to be known as the Constitution
National Medical Commission, to exercise the powers conferred upon, and to perform of National
Medical
the functions assigned to it, under this Act. Commission.
(2) The Commission shall be a body corporate by the name aforesaid, having
perpetual succession and a common seal, with power, subject to the provisions of this
Act, to acquire, hold and dispose of property, both movable and immovable, and to
contract, and shall, by the said name, sue or be sued.
(3) The head office of the Commission shall be at New Delhi.
4. (1) The Commission shall consist of the following persons to be appointed by Composition
the Central Government, namely: of
Commission.
(a) a Chairperson;
(b) ten ex officio Members; and
(c) twenty-two part-time Members.
(2) The Chairperson shall be a medical professional of outstanding ability,
proven administrative capacity and integrity, possessing a postgraduate degree in any
discipline of medical sciences from any University and having experience of not less
than twenty years in the field of medical sciences, out of which at least ten years shall
be as a leader in the area of medical education.
(3) The following persons shall be the ex officio Members of the Commission,
namely:
(a) the President of the Under-Graduate Medical Education Board;
(b) the President of the Post-Graduate Medical Education Board;
(c) the President of the Medical Assessment and Rating Board;
(d) the President of the Ethics and Medical Registration Board;
(e) the Director General of Health Services, Directorate General of Health
Services, New Delhi;
(f) the Director General, Indian Council of Medical Research;
(g) a Director of any of the All India Institutes of Medical Sciences, to be
nominated by the Central Government;
749
(h) two persons from amongst the Directors of Postgraduate Institute of

Medical Education and Research, Chandigarh; Jawaharlal Institute of
Postgraduate Medical Education and Research, Puducherry; Tata Memorial
Hospital, Mumbai; North Eastern Indira Gandhi Regional Institute of Health and
Medical Sciences, Shillong; and All India Institute of Hygiene and Public Health,
Kolkata; to be nominated by the Central Government; and
(i) one person to represent the Ministry of the Central Government dealing
with Health and Family Welfare, not below the rank of Additional Secretary to the
Government of India, to be nominated by that Ministry.
(4) The following persons shall be appointed as part-time Members of the
Commission, namely:
(a) three Members to be appointed from amongst persons of ability, integrity
and standing, who have special knowledge and professional experience in such
areas including management, law, medical ethics, health research, consumer or
patient rights advocacy, science and technology and economics;
(b) ten Members to be appointed on rotational basis from amongst the
nominees of the States and Union territories, under clauses (c) and (d) of
sub-section (2) of section 11, in the Medical Advisory Council for a term of two
years in such manner as may be prescribed;
(c) nine members to be appointed from amongst the nominees of the States
and Union territories, under clause (e) of sub-section (2) of section 11, in the
Medical Advisory Council for a term of two years in such manner as may be
prescribed.
Explanation.For the purposes of this section and section 17, the term
"leader" means the Head of a Department or the Head of an organisation.
Search 5. (1) The Central Government shall appoint the Chairperson, part-time Members
Committee referred to in clause (a) of sub-section (4) of section 4 and the Secretary referred to in
for
appointment
section 8 on the recommendation of a Search Committee consisting of
of (a) the Cabinet SecretaryChairperson;
Chairperson
and Members. (b) three experts, possessing outstanding qualifications and experience of
not less than twenty-five years in the field of medical education, public health
education and health research, to be nominated by the Central Government
Members;
(c) one expert, from amongst the part-time Members referred to in clause (c)
of sub-section (4) of section 4, to be nominated by the Central Government in
such manner as may be prescribedMember;
(d) one person, possessing outstanding qualifications and experience
of not less than twenty-five years in the field of management or law or economics
or science and technology, to be nominated by the Central Government
Member; and
(e) the Secretary to the Government of India in charge of the Ministry of
Health and Family Welfare, to be the ConvenorMember.
(2) The Central Government shall, within one month from the date of occurrence
of any vacancy, including by reason of death, resignation or removal of the Chairperson
or a Member, or within three months before the end of tenure of the Chairperson or
Member, make a reference to the Search Committee for filling up of the vacancy.
(3) The Search Committee shall recommend a panel of at least three names for
every vacancy referred to it.
(4) The Search Committee shall, before recommending any person for appointment
as the Chairperson or a Member of the Commission, satisfy itself that such person
750
does not have any financial or other interest which is likely to affect prejudicially his
functions as such Chairperson or Member.
(5) No appointment of the Chairperson or Member shall be invalid merely by
reason of any vacancy or absence of a Member in the Search Committee.
(6) Subject to the provisions of sub-sections (2) to (5), the Search Committee may
regulate its own procedure.
6. (1) The Chairperson and the part-time Members, other than the part-time Term of
Members appointed under clauses (b) and (c) of sub-section (4) of section 4, shall hold office and
conditions of
office for a term not exceeding four years and shall not be eligible for any extension or
service of
re-appointment: Chairperson
and Members.
Provided that such person shall cease to hold office after attaining the age of
seventy years.
(2) The term of office of an ex officio Member shall continue as long as he holds
the office by virtue of which he is such Member.
(3) Where a Member, other than an ex officio Member, is absent from three
consecutive ordinary meetings of the Commission and the cause of such absence is
not attributable to any valid reason in the opinion of the Commission, such Member
shall be deemed to have vacated the seat.
(4) The salaries and allowances payable to, and other terms and conditions of
service of, the Chairperson and Member, other than an ex officio Member, shall be
such as may be prescribed.
(5) The Chairperson or a Member may,
(a) relinquish his office by giving in writing to the Central Government a
notice of not less than three months; or
(b) be removed from his office in accordance with the provisions of
section 7:
Provided that such person may be relieved from duties earlier than three months
or be allowed to continue beyond three months until a successor is appointed, if the
Central Government so decides.
(6) The Chairperson and every member of the Commission shall make declaration
of his assets and his liabilities at the time of entering upon his office and at the time of
demitting his office and also declare his professional and commercial engagement or
involvement in such form and manner as may be prescribed, and such declaration shall
be published on the website of the Commission.
(7) The Chairperson or a Member, ceasing to hold office as such, shall not accept,
for a period of two years from the date of demitting such office, any employment, in any
capacity, including as a consultant or an expert, in any private medical institution,
whose matter has been dealt with by such Chairperson or Member, directly or indirectly:
Provided that nothing herein shall be construed as preventing such person from
accepting an employment in a body or institution, including medical institution,
controlled or maintained by the Central Government or a State Government:
Provided further that nothing herein shall prevent the Central Government from
permitting the Chairperson or a Member to accept any employment in any capacity,
including as a consultant or expert in any private medical institution whose matter
has been dealt with by such Chairperson or Member.
751
Removal of 7. (1) The Central Government may, by order, remove from office the Chairperson
Chairperson or any other Member, who
and Member
of (a) has been adjudged an insolvent; or
Commission.
(b) has been convicted of an offence which, in the opinion of the Central
Government, involves moral turpitude; or
(c) has become physically or mentally incapable of acting as a Member; or
(d) is of unsound mind and stands so declared by a competent court; or
(e) has acquired such financial or other interest as is likely to affect
prejudicially his functions as a Member; or
(f) has so abused his position as to render his continuance in office prejudicial
to public interest.
(2) No Member shall be removed under clauses (e) and (f) of sub-section (1)
unless he has been given a reasonable opportunity of being heard in the matter.
Appointment 8. (1) There shall be a Secretariat for the Commission to be headed by a
of Secretary,
experts,
Secretary, to be appointed by the Central Government in accordance with the provisions
professionals, of section 5.
officers and
other (2) The Secretary of the Commission shall be a person of proven administrative
employees of capacity and integrity, possessing such qualifications and experience as may be
Commission. prescribed.
(3) The Secretary shall be appointed by the Central Government for a term of four
years and shall not be eligible for any extension or re-appointment.
(4) The Secretary shall discharge such functions of the Commission as are
assigned to him by the Commission and as may be specified by regulations made under
this Act.
(5) The Commission may, for the efficient discharge of its functions under this
Act, appoint such officers and other employees, as it considers necessary, against the
posts created by the Central Government.
service of, the Secretary, officers and other employees of the Commission shall be such
as may be prescribed.
(7) The Commission may engage, in accordance with the procedure specified by
regulations, such number of experts and professionals of integrity and outstanding
ability, who have special knowledge of, and experience in such fields, including medical
education, public health, management, health economics, quality assurance, patient
advocacy, health research, science and technology, administration, finance, accounts
and law, as it deems necessary, to assist the Commission in the discharge of its functions
under this Act.
Meetings, 9. (1) The Commission shall meet at least once every quarter at such time and
etc., of place as may be appointed by the Chairperson.
Commission.
(2) The Chairperson shall preside at the meeting of the Commission, and if, for
any reason, the Chairperson is unable to attend a meeting of the Commission, any
other Member, being the President of an Autonomous Board, nominated by the
Chairperson, shall preside at the meeting.
(3) Unless the procedure to be followed at the meetings of the Commission is
otherwise provided by regulations, one-half of the total number of Members of the
Commission including the Chairperson shall constitute the quorum and all the acts of
the Commission shall be decided by a majority of the members, present and voting and
752
in the event of equality of votes, the Chairperson, or in his absence, the President of
the Autonomous Board nominated under sub-section (2), shall have the casting vote.
(4) The general superintendence, direction and control of the administration of
the Commission shall vest in the Chairperson.
(5) No act done by the Commission shall be questioned on the ground of the
existence of a vacancy in, or a defect in the constitution of, the Commission.
(6) A person who is aggrieved by any decision of the Commission except the
decision rendered under sub-section (4) of section 30 may prefer an appeal to the
Central Government against such decision within thirty days of the communication of
such decision.
10. (1) The Commission shall perform the following functions, namely: Powers and
functions of
(a) lay down policies for maintaining a high quality and high standards in Commission.
medical education and make necessary regulations in this behalf;
(b) lay down policies for regulating medical institutions, medical researches
and medical professionals and make necessary regulations in this behalf;
(c) assess the requirements in healthcare, including human resources for
health and healthcare infrastructure and develop a road map for meeting such
requirements;
(d) promote, co-ordinate and frame guidelines and lay down policies by
making necessary regulations for the proper functioning of the Commission, the
Autonomous Boards and the State Medical Councils;
(e) ensure co-ordination among the Autonomous Boards;
(f) take such measures, as may be necessary, to ensure compliance by the
State Medical Councils of the guidelines framed and regulations made under this
Act for their effective functioning under this Act;
(g) exercise appellate jurisdiction with respect to the decisions of the
Autonomous Boards;
(h) lay down policies and codes to ensure observance of professional ethics
in medical profession and to promote ethical conduct during the provision of
care by medical practitioners;
(i) frame guidelines for determination of fees and all other charges in respect
of fifty per cent. of seats in private medical institutions and deemed to be
universities which are governed under the provisions of this Act;
(j) exercise such other powers and perform such other functions as may be
prescribed.
(2) All orders and decisions of the Commission shall be authenticated by the
signature of the Secretary.
(3) The Commission may delegate such of its powers of administrative and financial
matters, as it deems fit, to the Secretary.
(4) The Commission may constitute sub-committees and delegate such of its
powers to such sub-committees as may be necessary to enable them to accomplish
specific tasks.
753
CHAPTER III
THE MEDICAL ADVISORY COUNCIL
Constitution 11. (1) The Central Government shall constitute an advisory body to be known as
and
composition the Medical Advisory Council.
of Medical
Advisory
(2) The Council shall consist of a Chairperson and the following members, namely:
Council.
(a) the Chairperson of the Commission shall be the ex officio Chairperson
of the Council;
(b) every member of the Commission shall be the ex officio members of the
Council;
(c) one member to represent each State, who is the Vice-Chancellor of a
health University in that State, to be nominated by that State Government;
(d) one member to represent each Union territory, who is the Vice-Chancellor
of a health University in that Union territory, to be nominated by the Ministry of
Home Affairs in the Government of India;
(e) one member to represent each State and each Union territory from
amongst elected members of the State Medical Council, to be nominated by that
State Medical Council;
(f) the Chairman, University Grants Commission;
(g) the Director, National Assessment and Accreditation Council;
(h) four members to be nominated by the Central Government from amongst
persons holding the post of Director in the Indian Institutes of Technology,
Indian Institutes of Management and the Indian Institute of Science:
Provided that if there is no health University in any State or Union territory,
the Vice-Chancellor of a University within that State or Union territory having the
largest number of medical colleges affiliated to it shall be nominated by the State
Government or by the Ministry of Home Affairs in the Government of India:
Provided further that if there is no University in any Union territory, the
Ministry of Home Affairs shall nominate a member who possesses such medical
qualification and experience as may be prescribed.
Functions of 12. (1) The Council shall be the primary platform through which the States and
Medical
Advisory
Union territories may put forth their views and concerns before the Commission and
Council. help in shaping the overall agenda, policy and action relating to medical education and
training.
(2) The Council shall advise the Commission on measures to determine and
maintain, and to co-ordinate maintenance of, the minimum standards in all matters
relating to medical education, training and research.
(3) The Council shall advise the Commission on measures to enhance equitable
access to medical education.
Meetings of 13. (1) The Council shall meet at least twice a year at such time and place as may
Medical be decided by the Chairperson.
Advisory
Council. (2) The Chairperson shall preside at the meeting of the Council and if for any
reason the Chairperson is unable to attend a meeting of the Council, such other member
as nominated by the Chairperson shall preside over the meeting.
(3) Unless the procedure is otherwise provided by regulations, fifty per cent. of
the members of the Council including the Chairperson shall form the quorum and all
acts of the Council shall be decided by a majority of the members present and voting.
754
CHAPTER IV
NATIONAL EXAMINATION
14. (1) There shall be a uniform National Eligibility-cum-Entrance Test for National
admission to the undergraduate and postgraduate super-speciality medical education Eligibility-
cum-Entrance
in all medical institutions which are governed by the provisions of this Act:
Test.
Provided that the uniform National Eligibility-cum-Entrance Test for admission to
the undergraduate medical education shall also be applicable to all medical institutions
governed under any other law for the time being in force.
(2) The Commission shall conduct the National Eligibility-cum-Entrance Test in
English and in such other languages, through such designated authority and in such
manner, as may be specified by regulations.
(3) The Commission shall specify by regulations the manner of conducting
common counselling by the designated authority for admission to undergraduate and
postgraduate super-speciality seats in all the medical institutions which are governed
by the provisions of this Act:
Provided that the designated authority of the Central Government shall conduct
the common counselling for all India seats and the designated authority of the State
Government shall conduct the common counselling for the seats at the State level.
15. (1) A common final year undergraduate medical examination, to be known as National Exit
the National Exit Test shall be held for granting licence to practice medicine as medical Test.
practitioners and for enrolment in the State Register or the National Register, as the
case may be.
(2) The Commission shall conduct the National Exit Test through such designated
authority and in such manner as may be specified by regulations.
(3) The National Exit Test shall become operational on such date, within three
years from the date of commencement of this Act, as may be appointed by the Central
Government, by notification.
(4) Any person with a foreign medical qualification shall have to qualify National
Exit Test for the purpose of obtaining licence to practice medicine as medical practitioner
and for enrolment in the State Register or the National Register, as the case may be, in
such manner as may be specified by regulations.
(5) The National Exit Test shall be the basis for admission to the postgraduate
broad-speciality medical education in medical institutions which are governed under
the provisions of this Act or under any other law for the time being in force and shall
be done in such manner as may be specified by regulations.
(6) The Commission shall specify by regulations the manner of conducting
common counselling by the designated authority for admission to the postgraduate
broad-speciality seats in the medical institutions referred to in sub-section (5):
Provided that the designated authority of the Central Government shall conduct
the common counselling for All India seats and the designated authority of the State
Government shall conduct the common counselling for the seats at the State level.
CHAPTER V
AUTONOMOUS BOARDS
16. (1) The Central Government shall, by notification, constitute the following Constitution
Autonomous Boards, under the overall supervision of the Commission, to perform the of
Autonomous
functions assigned to such Boards under this Act, namely:
Boards.
(a) the Under-Graduate Medical Education Board;
755
(b) the Post-Graduate Medical Education Board;

(c) the Medical Assessment and Rating Board; and
(d) the Ethics and Medical Registration Board.
(2) Each Board referred to in sub-section (1) shall be an autonomous body which
shall carry out its functions under this Act subject to the regulations made by the
Commission.
Composition 17. (1) Each Autonomous Board shall consist of a President and two whole-time
of Members and two part-time Members.
Autonomous
Boards. (2) The President of each Autonomous Board, three Members (including one
part-time Member) of the Under-Graduate Medical Education Board and the
Post-Graduate Medical Education Board, and two Members (including one part-time
Member) each of the Medical Assessment and Rating Board and the Ethics and
Medical Registration Board shall be persons of outstanding ability, proven
administrative capacity and integrity, possessing a postgraduate degree in any
discipline of medical sciences from any University and having experience of not less
than fifteen years in such field, out of which at least seven years shall be as a leader in
the area of medical education, public health, community medicine or health research.
(3) The third Member of the Medical Assessment and Rating Board shall be a
person of outstanding ability and integrity, possessing a postgraduate degree in any
of the disciplines of management, quality assurance, law or science and technology
from any University, having not less than fifteen years experience in such field, out of
which at least seven years shall be as a leader.
(4) The third Member of the Ethics and Medical Registration Board shall be a
person of outstanding ability who has demonstrated public record of work on medical
ethics or a person of outstanding ability possessing a postgraduate degree in any of
the disciplines of quality assurance, public health, law or patient advocacy from any
University and having not less than fifteen years experience in such field, out of which
at least seven years shall be as a leader.
(5) The fourth Member of each Autonomous Boards, being a part-time Member,
shall be chosen from amongst the elected Members of the State Medical Council in
such manner as may be prescribed.
Search 18. The Central Government shall appoint the President and Members of the
Committee
Autonomous Boards, except Members referred to in sub-section (5) of section 17, on
for
appointment the recommendations made by the Search Committee constituted under section 5 in
of President accordance with the procedure specified in that section.
and Members.
Term of 19. (1) The President and Members (other than part-time Members) of each
office and Autonomous Board shall hold the office for a term not exceeding four years and shall
conditions of
service of
not be eligible for any extension or re-appointment:
President and Provided that part-time Members of each Autonomous Board shall hold the office
Members. for a term of two years:
Provided further that a Member shall cease to hold office after attaining the age
of seventy years.
service of the President and Members (other than part-time Members) of an Autonomous
Board shall be such as may be prescribed:
Provided that part-time Members of each Autonomous Board shall be entitled for
such allowances as may be prescribed.
(3) The provisions of sub-sections (3), (5), (6), (7) and (8) of section 6 relating to
other terms and conditions of service of, and section 7 relating to removal from the
office of, the Chairperson and Members of the Commission shall also be applicable to
the President and Members of the Autonomous Boards.
756
20. (1) Each Autonomous Board, except the Ethics and Medical Registration Advisory
Board, shall be assisted by such advisory committees of experts as may be constituted committees of
experts.
by the Commission for the efficient discharge of the functions of such Boards under
this Act.
(2) The Ethics and Medical Registration Board shall be assisted by such ethics
committees of experts as may be constituted by the Commission for the efficient
discharge of the functions of that Board under this Act.
21. The experts, professionals, officers and other employees appointed under Staff of
Autonomous
section 8 shall be made available to the Autonomous Boards in such number, and in Boards.
such manner, as may be specified by regulations by the Commission.
22. (1) Every Autonomous Board shall meet at least once a month at such time Meetings, etc.,
and place as it may appoint. of
Autonomous
(2) All decisions of the Autonomous Boards shall be made by majority of votes of Boards.
the President and Members.
(3) Subject to the provision of section 28, a person who is aggrieved by any
decision of an Autonomous Board may prefer an appeal to the Commission against
such decision within sixty days of the communication of such decision.
23. (1) The President of each Autonomous Board shall have such administrative Powers of
and financial powers as may be delegated to it by the Commission to enable such Board Autonomous
to function efficiently. Boards and
delegation of
(2) The President of an Autonomous Board may further delegate any of his powers powers.
to a Member or an officer of that Board.
24. (1) The Under-Graduate Medical Education Board shall perform the following Powers and
functions, namely: functions of
Under-
(a) determine standards of medical education at undergraduate level and Graduate
oversee all aspects relating thereto; Medical
Education
(b) develop competency based dynamic curriculum at undergraduate level Board.
in accordance with the regulations made under this Act;
(c) develop competency based dynamic curriculum for addressing the needs
of primary health services, community medicine and family medicine to ensure
healthcare in such areas, in accordance with the provisions of the regulations
made under this Act;
(d) frame guidelines for setting up of medical institutions for imparting
undergraduate courses, having regard to the needs of the country and the global
norms, in accordance with the provisions of the regulations made under this Act;
(e) determine the minimum requirements and standards for conducting
courses and examinations for undergraduates in medical institutions, having
regard to the needs of creativity at local levels, including designing of some
courses by individual institutions, in accordance with the provisions of the
regulations made under this Act;
(f) determine standards and norms for infrastructure, faculty and quality of
education in medical institutions providing undergraduate medical education in
accordance with the provisions of the regulations made under this Act;
(g) facilitate development and training of faculty members teaching
undergraduate courses;
(h) facilitate research and the international student and faculty exchange
programmes relating to undergraduate medical education;
(i) specify norms for compulsory annual disclosures, electronically or
otherwise, by medical institutions, in respect of their functions that has a bearing
on the interest of all stakeholders including students, faculty, the Commission
and the Central Government;
757
(j) grant recognition to a medical qualification at the undergraduate level.

(2) The Under-Graduate Medical Education Board may, in the discharge of its
duties, make such recommendations to, and seek such directions from, the Commission,
as it deems necessary.
Powers and 25. (1) The Post-Graduate Medical Education Board shall perform the following
functions of functions, namely:
Post-Graduate
Medical (a) determine the standards of medical education at the postgraduate level
Education and super-speciality level in accordance with the regulations made under this
Board. Act and oversee all aspects relating thereto;
(b) develop competency based dynamic curriculum at postgraduate level
and super-speciality level in accordance with the regulations made under this
Act, with a view to develop appropriate skill, knowledge, attitude, values and
ethics among postgraduates and super-specialists to provide healthcare, impart
medical education and conduct medical research;
(c) frame guidelines for setting up of medical institutions for imparting
postgraduate and super-speciality courses, having regard to the needs of the
country and global norms, in accordance with the regulations made under this
Act;
(d) determine the minimum requirements and standards for conducting
postgraduate and super-speciality courses and examinations in medical
institution, in accordance with the regulations made under this Act;
(e) determine standards and norms for infrastructure, faculty and quality of
education in medical institutions conducting postgraduate and super-speciality
medical education, in accordance with the regulations made under this Act;
(f) facilitate development and training of the faculty members teaching
postgraduate and super-speciality courses;
(g) facilitate research and the international student and faculty exchange
programmes relating to postgraduate and super-speciality medical education;
(h) specify norms for compulsory annual disclosure, electronically or
otherwise, by medical institutions in respect of their functions that has a bearing
on the interest of all stakeholders including students, faculty, the Commission
and the Central Government;
(i) grant recognition to the medical qualifications at the postgraduate level
and super-speciality level;
(j) promote and facilitate postgraduate courses in family medicine.
(2) The Post-Graduate Medical Education Board may, in the discharge of its
functions, make such recommendations to, and seek such directions from, the
Commission, as it deems necessary.
Powers and 26. (1) The Medical Assessment and Rating Board shall perform the following
functions of functions, namely:
Medical
Assessment (a) determine the procedure for assessing and rating the medical institutions
and Rating for their compliance with the standards laid down by the Under-Graduate Medical
Board. Education Board or the Post-Graduate Medical Education Board, as the case may
be, in accordance with the regulations made under this Act;
(b) grant permission for establishment of a new medical institution, or to
start any postgraduate course or to increase number of seats, in accordance with
the provisions of section 28;
(c) carry out inspections of medical institutions for assessing and rating
such institutions in accordance with the regulations made under this Act:
Provided that the Medical Assessment and Rating Board may, if it deems
necessary, hire and authorise any other third party agency or persons for carrying
out inspections of medical institutions for assessing and rating such institutions:
758
Provided further that where inspection of medical institutions is carried out

by such third party agency or persons authorised by the Medical Assessment
and Rating Board, it shall be obligatory on such institutions to provide access to
such agency or person;
(d) conduct, or where it deems necessary, empanel independent rating
agencies to conduct, assess and rate all medical institutions, within such period
of their opening, and every year thereafter, at such time, and in such manner, as
may be specified by the regulations;
(e) make available on its website or in public domain the assessment and
ratings of medical institutions at regular intervals in accordance with the
regulations made under this Act;
(f) take such measures, including issuing warning, imposition of monetary
penalty, reducing intake or stoppage of admissions and recommending to the
Commission for withdrawal of recognition, against a medical institution for failure
to maintain the minimum essential standards specified by the Under-Graduate
Medical Education Board or the Post-Graduate Medical Education Board, as the
case may be, in accordance with the regulations made under this Act.
(2) The Medical Assessment and Rating Board may, in the discharge of its
functions, make such recommendations to, and seek such directions from, the
Commission, as it deems necessary.
27. (1) The Ethics and Medical Registration Board shall perform the following Powers and
functions, namely: functions of
Ethics and
(a) maintain National Registers of all licensed medical practitioners in Medical
Registration
accordance with the provisions of section 31;
Board.
(b) regulate professional conduct and promote medical ethics in accordance
with the regulations made under this Act:
Provided that the Ethics and Medical Registration Board shall ensure
compliance of the code of professional and ethical conduct through the State
Medical Council in a case where such State Medical Council has been conferred
power to take disciplinary actions in respect of professional or ethical misconduct
by medical practitioners under respective State Acts;
(c) develop mechanisms to have continuous interaction with State Medical
Councils to effectively promote and regulate the conduct of medical practitioners
and professionals;
(d) exercise appellate jurisdiction with respect to the actions taken by a
State Medical Council under section 30.
(2) The Ethics and Medical Registration Board may, in the discharge of its duties,
make such recommendations to, and seek such directions from, the Commission, as it
deems necessary.
28. (1) No person shall establish a new medical college or start any postgraduate Permission for
course or increase number of seats without obtaining prior permission of the Medical establishment
Assessment and Rating Board. of new
medical
(2) For the purposes of obtaining permission under sub-section (1), a person may college.
submit a scheme to the Medical Assessment and Rating Board in such form, containing
such particulars, accompanied by such fee, and in such manner, as may be specified by
the regulations.
(3) The Medical Assessment and Rating Board shall, having due regard to the
criteria specified in section 29, consider the scheme received under sub-section (2) and
either approve or disapprove such scheme within a period of six months from the date
of such receipt:
759
Provided that before disapproving such scheme, an opportunity to rectify the

defects, if any, shall be given to the person concerned.
(4) Where a scheme is approved under sub-section (3), such approval shall be
the permission under sub-section (1) to establish new medical college.
(5) Where a scheme is disapproved under sub-section (3), or where no decision
is taken within six months of submitting a scheme under sub-section (1), the person
concerned may prefer an appeal to the Commission for approval of the scheme within
fifteen days of such disapproval or, as the case may be, lapse of six months, in such
manner as may be specified by the regulations.
(6) The Commission shall decide the appeal received under sub-section (5) within
a period of forty-five days from the date of receipt of the appeal and in case the
Commission approves the scheme, such approval shall be the permission under
sub-section (1) to establish a new medical college and in case the Commission
disapproves the scheme, or fails to give its decision within the specified period, the
person concerned may prefer a second appeal to the Central Government within thirty
days of communication of such disapproval or, as the case may be, lapse of specified
period.
(7) The Medical Assessment and Rating Board may conduct evaluation and
assessment of any medical institution at any time, either directly or through any other
expert having integrity and experience of medical profession and without any prior
notice and assess and evaluate the performance, standards and benchmarks of such
medical institution.
Explanation.For the purposes of this section, the term "person" includes a
University, trust or any other association of persons or body of individuals, but does
not include the Central Government.
Criteria for 29. While approving or disapproving a scheme under section 28, the Medical
approving or Assessment and Rating Board, or the Commission, as the case may be, shall take into
disapproving
scheme. consideration the following criteria, namely:
(a) adequacy of financial resources;
(b) whether adequate academic faculty and other necessary facilities have
been provided to ensure proper functioning of medical college or would be
provided within the time-limit specified in the scheme;
(c) whether adequate hospital facilities have been provided or would be
provided within the time-limit specified in the scheme;
(d) such other factors as may be prescribed:
Provided that, subject to the previous approval of the Central Government,
the criteria may be relaxed for the medical colleges which are set up in such areas
as may be specified by the regulations.
State Medical 30. (1) The State Government shall, within three years of the commencement of
Councils. this Act, take necessary steps to establish a State Medical Council if no such Council
exists in that State.
(2) Where a State Act confers power upon the State Medical Council to take
disciplinary actions in respect of any professional or ethical misconduct by a registered
medical practitioner or professional, the State Medical Council shall act in accordance
with the regulations made, and the guidelines framed, under this Act:
Provided that till such time as a State Medical Council is established in a State,
the Ethics and Medical Registration Board shall receive the complaints and grievances
760
relating to any professional or ethical misconduct against a registered medical

practitioner or professional in that State in accordance with such procedure as may be
specified by the regulations:
Provided further that the Ethics and Medical Registration Board or, as the case
may be, the State Medical Council shall give an opportunity of hearing to the medical
practitioner or professional concerned before taking any action, including imposition
of any monetary penalty against such person.
(3) A medical practitioner or professional who is aggrieved by any action taken

by a State Medical Council under sub-section (2) may prefer an appeal to the Ethics
and Medical Registration Board against such action, and the decision, if any, of the
Ethics and Medical Registration Board thereupon shall be binding on the State Medical
Council, unless a second appeal is preferred under sub-section (4).
(4) A medical practitioner or professional who is aggrieved by the decision of the

Ethics and Medical Registration Board may prefer an appeal to the Commission within
sixty days of communication of such decision.
Explanation.For the purposes of this Act,
(a) "State" includes Union territory and the expressions "State Government"
and "State Medical Council", in relation to a Union territory, shall respectively
mean the "Central Government" and "Union territory Medical Council";
(b) the expression "professional or ethical misconduct" includes any act of

commission or omission as may be specified by the regulations.
31. (1) The Ethics and Medical Registration Board shall maintain a National National
Register containing the name, address, all recognised qualifications possessed by a Register and
licensed medical practitioner and such other particulars as may be specified by the State Register.
regulations.
(2) The National Register shall be maintained in such form, including electronic
form, in such manner, as may be specified by the regulations.
(3) The manner in which a name or qualification may be added to, or removed
from, the National Register and the grounds for removal thereof, shall be such as may
be specified by the regulations.
(4) The National Register shall be a public document within the meaning of
1 of 1872. section 74 of the Indian Evidence Act, 1872.
(5) The National Register shall be made available to the public by placing it on the
website of the Ethics and Medical Registration Board.
(6) Every State Medical Council shall maintain and regularly update the State
Register in the specified electronic format and supply a physical copy of the same to
the Ethics and Medical Registration Board within three months of the commencement
of this Act.
(7) The Ethics and Medical Registration Board shall ensure electronic
synchronisation of the National Register and the State Register in such a manner that
any change in one register is automatically reflected in the other register.
(8) The Ethics and Medical Registration Board shall maintain a separate National
Register in such form, containing such particulars, including the name, address and all
recognised qualifications possessed by a Community Health Provider referred to in
section 32 in such manner as may be specified by the regulations.
761
Community 32. (1) The Commission may grant limited licence to practice medicine at
Health mid-level as Community Health Provider to such person connected with modern
Provider.
scientific medical profession who qualify such criteria as may be specified by the
regulations:
Provided that the number of limited licence to be granted under this sub-section
shall not exceed one-third of the total number of licenced medical practitioners registered
under sub-section (1) of section 31.
(2) The Community Health Provider who is granted limited licences under
sub-section (1), may practice medicine to such extent, in such circumstances and for
such period, as may be specified by the regulations.
(3) The Community Health Provider may prescribe specified medicine
independently, only in primary and preventive healthcare, but in cases other than
primary and preventive healthcare, he may prescribe medicine only under the supervision
of medical practitioners registered under sub-section (1) of section 32.
Rights of 33. (1) Any person who qualifies the National Exit Test held under section 15
persons to have shall be granted a licence to practice medicine and shall have his name and qualifications
licence to
practice and
enrolled in the National Register or a State Register, as the case may be:
to be enrolled Provided that a person who has been registered in the Indian Medical Register
in National
Register or
maintained under the Indian Medical Council Act, 1956 prior to the coming into force of 102 of 1956.
State Register this Act and before the National Exit Test becomes operational under sub-section (3) of
and their section 15, shall be deemed to have been registered under this Act and be enrolled in
obligations the National Register maintained under this Act.
thereto.
(2) No person who has obtained medical qualification from a medical institution
established in any country outside India and is recognised as a medical practitioner in
that country, shall, after the commencement of this Act and the National Exit Test
becomes operational under sub-section (3) of section 15, be enrolled in the National
Register unless he qualifies the National Exit Test.
(3) When a person whose name is entered in the State Register or the National
Register, as the case may be, obtains any title, diploma or other qualification for
proficiency in sciences or public health or medicine which is a recognised medical
qualification under section 35 or section 36, as the case may be, he shall be entitled to
have such title, diploma or qualification entered against his name in the State Register
or the National Register, as the case may be, in such manner as may be specified by the
regulations.
Bar to 34. (1) No person other than a person who is enrolled in the State Register or the
practice. National Register, as the case may be, shall
(a) be allowed to practice medicine as a qualified medical practitioner;
(b) hold office as a physician or surgeon or any other office, by whatever
name called, which is meant to be held by a physician or surgeon;
(c) be entitled to sign or authenticate a medical or fitness certificate or any
other certificate required by any law to be signed or authenticated by a duly
qualified medical practitioner;
(d) be entitled to give evidence at any inquest or in any court of law as an
expert under section 45 of the Indian Evidence Act, 1872 on any matter relating to 1 of 1872.
medicine:
Provided that the Commission shall submit a list of such medical professionals
to the Central Government in such manner as may be prescribed:
Provided further that a foreign citizen who is enrolled in his country as a medical
practitioner in accordance with the law regulating the registration of medical practitioners
in that country may be permitted temporary registration in India for such period and in
such manner as may be specified by the regulations.
762
(2) Any person who contravenes any of the provisions of this section shall be
punished with imprisonment for a term which may extend to one year, or with fine which
may extend to five lakh rupees or with both.
CHAPTER VI
RECOGNITION OF MEDICAL QUALIFICATIONS
35. (1) The medical qualification granted by any University or medical institution Recognition
in India shall be listed and maintained by the Under-Graduate Medical Education Board of medical
qualifications
or the Post-Graduate Medical Education Board, as the case may be, in such manner as granted by
may be specified by the regulations and such medical qualification shall be a recognised Universities or
medical qualification for the purposes of this Act. medical
institutions in
(2) Any University or medical institution in India which grants an undergraduate India.
or postgraduate or super-speciality medical qualification not included in the list
maintained by the Under-Graduate Medical Education Board or the Post-Graduate
Medical Education Board, as the case may be, may apply to that Board for granting
recognition to such qualification.
(3) The Under-Graduate Medical Education Board or the Post-Graduate Medical
Education Board, as the case may be, shall examine the application for grant of
recognition to a medical qualification within a period of six months in such manner as
may be specified by the regulations.
(4) Where the Under-Graduate Medical Education Board or the Post-Graduate
Medical Education Board, as the case may be, decides to grant recognition to a medical
qualification, it shall include such medical qualification in the list maintained by it and
also specify the date of effect of such recognition.
(5) Where the Under-Graduate Medical Education Board or the Post-Graduate
Medical Education Board, as the case may be, decides not to grant recognition to a
medical qualification, the University or the medical institution concerned may prefer an
appeal to the Commission for grant of recognition within sixty days of the communication
of such decision, in such manner as may be specified by the regulations.
(6) The Commission shall examine the appeal received under sub-section (5)
within a period of two months and if it decides that recognition may be granted to such
medical qualification, it may direct the Under-Graduate Medical Education Board or the
Post-Graduate Medical Education Board, as the case may be, to include such medical
qualification in the list maintained by that Board, in such manner as may be specified
by the regulations.
(7) Where the Commission decides not to grant recognition to the medical
qualification, or fails to take a decision within the specified period, the University or
the medical institution concerned may prefer a second appeal to the Central Government
within thirty days of the communication of such decision or lapse of specified period,
as the case may be.
(8) All medical qualifications which have been recognised before the date of
commencement of this Act and are included in the First Schedule and Part I of the Third
102 of 1956. Schedule to the Indian Medical Council Act, 1956, shall also be recognised medical
qualifications for the purposes of this Act, and shall be listed and maintained by the
Under-Graduate Medical Education Board or the Post-Graduate Medical Education
Board, as the case may be, in such manner as may be specified by the regulations.
36. (1) Where an authority in any country outside India, which by the law of that Recognition
country is entrusted with the recognition of medical qualifications in that country, of medical
qualifications
makes an application to the Commission for granting recognition to such medical granted by
qualification in India, the Commission may, subject to such verification as it may deem medical
necessary, either grant or refuse to grant recognition to that medical qualification: institutions
outside India.
763
Provided that the Commission shall give a reasonable opportunity of being heard
to such authority before refusing to grant such recognition.
(2) A medical qualification which is granted recognition by the Commission under
sub-section (1) shall be a recognised medical qualification for the purposes of this Act,
and such qualification shall be listed and maintained by the Commission in such manner
as may be specified by the regulations.
(3) Where the Commission refuses to grant recognition to the medical qualification
under sub-section (1), the authority concerned may prefer an appeal to the
Central Government against such decision within thirty days of communication thereof.
(4) All medical qualifications which have been recognised before the date of
commencement of this Act and are included in the Second Schedule and Part II of the
Third Schedule to the Indian Medical Council Act, 1956, shall also be recognised medical 102 of 1956.
qualifications for the purposes of this Act, and shall be listed and maintained by the
Commission in such manner as may be specified by the regulations.
Recognition 37. (1) The medical qualifications granted by any statutory or other body in India
of medical which are covered by the categories listed in the Schedule shall be recognised medical
qualifications
granted by qualifications for the purposes of this Act.
statutory or
other body in
(2) The Diplomate of National Board in broad-speciality qualifications and super-
India. speciality qualifications when granted in a medical institution with attached hospital
or in a hospital with the strength of five hundred or more beds, by the National Board
of Examinations, shall be equivalent in all respects to the corresponding postgraduate
qualification and the super-speciality qualification granted under this Act, but in all
other cases, senior residency in a medical college for an additional period of one year
shall be required for such qualification to be equivalent for the purposes of teaching also.
(3) The Central Government may, on the recommendation of the Commission, and
having regard to the objects of this Act, by notification, add to, or, as the case may be,
omit from, the Schedule any categories of medical qualifications granted by a statutory
or other body in India and on such addition, or as the case may be, omission, the
medical qualifications granted by such statutory or other body in India shall be, or
shall cease to be, recognised medical qualifications for the purposes of this Act.
Withdrawal of 38. (1) Where, upon receiving a report from the Medical Assessment and Rating
recognition Board under section 26, or otherwise, if the Commission is of the opinion that
granted to
medical (a) the courses of study and examination to be undergone in, or the
qualification
proficiency required from candidates at any examination held by, a University or
granted by
medical medical institution do not conform to the standards specified by the
institutions in Under-Graduate Medical Education Board or the Post-Graduate Medical Education
India. Board, as the case may be; or
(b) the standards and norms for infrastructure, faculty and quality of
education in medical institution as determined by the Under-Graduate Medical
Education Board or the Post-Graduate Medical Education Board, as the case may
be, are not adhered to by any University or medical institution, and such
University or medical institution has failed to take necessary corrective action to
maintain specified minimum standards, the Commission may initiate action in
accordance with the provisions of sub-section (2):
Provided that the Commission shall, before taking any action for suo motu
withdrawal of recognition granted to the medical qualification awarded by a University
or medical institution, impose penalty in accordance with the provisions of clause (f) of
sub-section (1) of section 26.
(2) The Commission shall, after making such further inquiry as it deems fit, and
after holding consultations with the concerned State Government and the authority of
764
the concerned University or medical institution, comes to the conclusion that the
recognition granted to a medical qualification ought to be withdrawn, it may, by order,
withdraw recognition granted to such medical qualification and direct the
Under-Graduate Medical Education Board or the Post-Graduate Medical Education
Board, as the case may be, to amend the entries against the University or medical
institution concerned in the list maintained by that Board to the effect that the recognition
granted to such medical qualification is withdrawn with effect from the date specified
in that order.
39. Where, after verification with the authority in any country outside India, the Derecognition
Commission is of the opinion that a recognised medical qualification which is included of medical
qualifications
in the list maintained by it is to be derecognised, it may, by order, derecognise such granted by
medical qualification and remove it from the list maintained by the Commission with medical
effect from the date of such order. institutions
outside India.
40. Where the Commission deems it necessary, it may, by an order published in Special
the Official Gazette, direct that any medical qualification granted by a medical institution provision in
certain cases
in a country outside India, after such date as may be specified in that notification, shall for
be a recognised medical qualification for the purposes of this Act: recognition of
medical
Provided that medical practice by a person possessing such qualification shall qualifications.
be permitted only if such person qualifies National Exit Test.
CHAPTER VII
GRANTS, AUDIT AND ACCOUNTS
41. The Central Government may, after due appropriation made by Parliament by Grants by
law in this behalf, make to the Commission grants of such sums of money as the Central Central
Government.
Government may think fit.
42. (1) There shall be constituted a fund to be called the National Medical National
Commission Fund which shall form part of the public account of India and there shall Medical
Commission
be credited thereto Fund.
(a) all Government grants, fees, penalties and charges received by the
Commission and the Autonomous Boards;
(b) all sums received by the Commission from such other sources as may be
decided by it.
(2) The Fund shall be applied for making payment towards
(a) the salaries and allowances payable to the Chairperson and Members of
the Commission, the Presidents and Members of the Autonomous Boards and
the administrative expenses including the salaries and allowances payable to the
officers and other employees of the Commission and Autonomous Boards;
(b) the expenses incurred in carrying out the provisions of this Act, including
in connection with the discharge of the functions of the Commission and the
Autonomous Boards.
43. (1) The Commission shall maintain proper accounts and other relevant records Audit and
and prepare an annual statement of accounts in such form as may be prescribed, in accounts.
consultation with the Comptroller and Auditor-General of India.
(2) The accounts of the Commission shall be audited by the Comptroller and
Auditor-General of India at such intervals as may be specified by him and any
expenditure incurred in connection with such audit shall be payable by the Commission
to the Comptroller and Auditor-General of India.
765
(3) The Comptroller and Auditor-General of India and any other persons appointed
by him in connection with the audit of the accounts of the Commission shall have the
same rights and privileges and authority in connection with such audit as the Comptroller
and Auditor-General generally has in connection with the audit of Government accounts
and in particular, shall have the right to demand the production of, and complete access
to, records, books, accounts, connected vouchers and other documents and papers
and to inspect the office of the Commission.
(4) The accounts of the Commission as certified by the Comptroller and
Auditor-General of India or any other person appointed by him in this behalf, together
with the audit report thereon, shall be forwarded annually by the Commission to the
Central Government which shall cause the same to be laid, as soon as may be after it is
received, before each House of Parliament.
Furnishing of 44. (1) The Commission shall furnish to the Central Government, at such time, in
returns and such form and in such manner, as may be prescribed or as the Central Government may
reports to
Central direct, such reports and statements, containing such particulars in regard to any matter
Government. under the jurisdiction of the Commission, as the Central Government may, from time to
time, require.
(2) The Commission shall prepare, once every year, in such form and at such time
as may be prescribed, an annual report, giving a summary of its activities during the
previous year and copies of the report shall be forwarded to the Central Government.
(3) A copy of the report received under sub-section (2) shall be laid by the Central
Government, as soon as may be after it is received, before each House of Parliament.
CHAPTER VIII
M ISCELLANEOUS
Power of 45. (1) Without prejudice to the foregoing provisions of this Act, the Commission
Central
Government
and the Autonomous Boards shall, in exercise of their powers and discharge of their
to give functions under this Act, be bound by such directions on questions of policy as the
directions to Central Government may give in writing to them from time to time:
Commission
and Provided that the Commission and the Autonomous Boards shall, as far as
Autonomous practicable, be given an opportunity to express their views before any direction is
Boards.
given under this sub-section.
(2) The decision of the Central Government whether a question is one of policy or
not shall be final.
Power of 46. The Central Government may give such directions, as it may deem
Central necessary, to a State Government for carrying out all or any of the provisions of this
Government
to give
Act and the State Government shall comply with such directions.
directions to
State
Governments.
Information 47. (1) The Commission shall furnish such reports, copies of its minutes, abstracts
to be of its accounts, and other information to the Central Government as that Government
furnished by
Commission may require.
and
(2) The Central Government may publish, in such manner as it may think fit, the
publication
thereof. reports, minutes, abstracts of accounts and other information furnished to it under
sub-section (1).
Obligation of 48. Every University and medical institution governed under this Act shall maintain
universities a website at all times and display on its website all such information as may be required
and medical
institutions.
by the Commission or an Autonomous Board, as the case may be.
766
49. (1) Notwithstanding anything contained in this Act, any student who was Completion of
courses of
studying for a degree, diploma or certificate in any medical institution immediately
studies in
before the commencement of this Act shall continue to so study and complete his medical
course for such degree, diploma or certificate, and such institution shall continue to institutions.
provide instructions and examination for such student in accordance with the syllabus
and studies as existed before such commencement, and such student shall be deemed
to have completed his course of study under this Act and shall be awarded degree,
diploma or certificate under this Act.
(2) Notwithstanding anything contained in this Act, where recognition granted
to a medical institution has lapsed, whether by efflux of time or by its voluntary surrender
or for any other reason whatsoever, such medical institution shall continue to maintain
and provide the minimum standards required to be provided under this Act till such
time as all candidates who are admitted in that medical institution complete their study.
50. (1) There shall be a joint sitting of the Commission, the Central Council of Joint sittings
Homoeopathy and the Central Council of Indian Medicine at least once a year, at such of
Commission,
time and place as they mutually appoint, to enhance the interface between Homoeopathy, Central
Indian Systems of Medicine and modern systems of medicine. Councils of
Homoeopathy
(2) The agenda for the joint sitting may be prepared with mutual agreement and Indian
between the Chairpersons of the Commission, the Central Council of Homoeopathy medicine to
and the Central Council of Indian Medicine or be prepared separately by each of them. enhance
interface
(3)The joint sitting referred to in sub-section (1) may, by an affirmative vote of all between their
members present and voting, decide on approving specific educational modules or respective
systems of
programmes that may be introduced in the undergraduate course and the postgraduate medicine.
course across medical systems and promote medical pluralism.
51. Every State Government may, for the purposes of addressing or promoting State
primary healthcare in rural area, take necessary measures to enhance the capacity of Government
to promote
the healthcare professionals.
primary
healthcare in
rural areas.
52.The Chairperson, Members, officers and other employees of the Commission Chairperson,
and the President, Members and officers and other employees of the Autonomous Members,
officers of
Boards shall be deemed, when acting or purporting to act in pursuance of any of the
Commission
provisions of this Act, to be public servants within the meaning of section 21 of the and of
45 of 1860. Indian Penal Code. Autonomous
Boards to be
public
servants.
53. No suit, prosecution or other legal proceeding shall lie against the Government, Protection of
the Commission or any Autonomous Board or a State Medical Council or any Committee action taken
thereof, or any officer or other employee of the Government or of the Commission in good faith.
acting under this Act for anything which is in good faith done or intended to be done
under this Act or the rules or regulations made thereunder.
54. No court shall take cognizance of an offence punishable under this Act except Cognizance of
offences.
upon a complaint in writing made in this behalf by an officer authorised by the
Commission or the Ethics and Medical Registration Board or a State Medical Council,
as the case may be.
55. (1) If, at any time, the Central Government is of opinion that Power of
Central
(a) the Commission is unable to discharge the functions and duties imposed Government
to supersede
on it by or under the provisions of this Act; or
Commission.
(b) the Commission has persistently made default in complying with any
767
direction issued by the Central Government under this Act or in the discharge of
the functions and duties imposed on it by or under the provisions of this Act,
the Central Government may, by notification, supersede the Commission for such period,
not exceeding six months, as may be specified in the notification:
Provided that before issuing a notification under this sub-section, the Central
Government shall give a reasonable opportunity to the Commission to show cause as
to why it should not be superseded and shall consider the explanations and objections,
if any, of the Commission.
(2) Upon the publication of a notification under sub-section (1) superseding the
Commission,
(a) all the Members shall, as from the date of supersession, vacate their
offices as such;
(b) all the powers, functions and duties which may, by or under the
provisions of this Act, be exercised or discharged by or on behalf of the
Commission, shall, until the Commission is re-constituted under sub-section (3),
be exercised and discharged by such person or persons as the Central Government
may direct;
(c) all property owned or controlled by the Commission shall, until the
Commission is re-constituted under sub-section (3), vest in the Central
Government.
(3) On the expiration of the period of supersession specified in the notification
issued under sub-section (1), the Central Government may,
(a) extend the period of supersession for such further term not exceeding
six months, as it may consider necessary; or
(b) re-constitute the Commission by fresh appointment and in such case
the Members who vacated their offices under clause (a) of sub-section (2) shall
not be deemed disqualified for appointment:
Provided that the Central Government may, at any time before the expiration of
the period of supersession, whether as originally specified under sub-section (1) or as
extended under this sub-section, take action under clause (b) of this sub-section.
(4 ) T he Central Government shall cause a notification issued under
sub-section (1) and a full report of any action taken under this section and the
circumstances leading to such action to be laid before both Houses of Parliament at the
earliest opportunity.
Power to make 56. (1) The Central Government may, by notification, make rules to carry out the
rules.
purposes of this Act.
(2) In particular, and without prejudice to the generality of the foregoing power,
such rules may provide for all or any of the following matters, namely:
(a) the manner of appointing six Members of the Commission on rotational
basis from amongst the nominees of the States and Union territories in the Medical
Advisory Council under clause (b) of sub-section (4) of section 4;
(b) the manner of appointing five members of the Commission under
clause (c) of sub-section (4) of section 4;
(c) the manner of nominating one expert by the Central Government under
768
(d) the salary and allowances payable to, and other terms and conditions of
service of the Chairperson and Members under sub-section (4) of section 6;
(e) the form and the manner of making declaration under sub-section (6) of
section 6;
(f) the qualifications and experience to be possessed by the Secretary of the
Commission under sub-section (2) of section 8;
(g) the salaries and allowances payable to, and other terms and conditions
of service of the Secretary, officers and other employees of the Commission under
(h) the other powers and functions of the Commission under clause (j) of
(i) the medical qualification and experience to be possessed by a member
under the second proviso to section 11;
(j) the manner of choosing part-time Members under sub-section (5) of
section 17;
(k) the salary and allowances payable to, and other terms and conditions of
service of the President and Members of an Autonomous Board under
sub-section (2), and the allowances payable to part-time Members under the
proviso thereunder, of section 19;
(l) the other factors under clause (d) of section 29;
(m) the manner of submitting a list of medical professionals under the
second proviso to sub-section (1) of section 34;
(n ) the form for preparing annual statement of accounts under
(o) the time within which, and the form and the manner in which, the reports
and statements shall be furnished by the Commission and the particulars with
regard to any matter as may be required by the Central Government under
(p) the form and the time for preparing annual report under sub-section (2)
of section 44;
(q) any other matter in respect of which provision is to be made by rules.
57. (1) The Commission may, after previous publication, by notification, make Power to
regulations consistent with this Act and the rules made thereunder to carry out the make
regulations.
provisions of this Act.
(2) In particular, and without prejudice to the generality of the foregoing power,
such regulations may provide for all or any of the following matters, namely:
(a) the functions to be discharged by the Secretary of the Commission
under sub-section (4) of section 8;
(b) the procedure in accordance with which experts and professionals may
be engaged and the number of such experts and professionals under
(c) the procedure to be followed at the meetings of Commission,
including the quorum at its meetings under sub-section (3) of section 9;
(d) the quality and standards to be maintained in medical education under
clause (a) of sub-section (1) of section 10;
(e) the manner of regulating medical institutions, medical researches and
medical professionals under clause (b) of sub-section (1) of section 10;
769
(f) the manner of functioning of the Commission, the Autonomous Boards

and the State Medical Councils under clause (d) of sub-section (1) of section 10;
(g) the procedure to be followed at the meetings of the Medical Advisory
Council, including the quorum at its meetings under sub-section (3) of
section 13;
(h) the other languages in which and the manner in which the National
Eligibility-cum-Entrance Test shall be conducted under sub-section (2) of
section 14;
(i) the manner of conducting common counselling by the designated
authority for admission to the undergraduate and postgraduate super-speciality
medical education under sub-section (3) of section 14;
(j) the designated authority, and the manner for conducting the National
Exit Test under sub-section (2) of section 15;
(k) the manner in which a person with foreign medical qualification shall
qualify National Exit Test under sub-section (4) of section 15;
(l) the manner in which admission to the postgraduate broad-speciality
medical education shall be made on the basis of National Exit Test under
(m) the manner of conducting common counselling by the designated
authority for admission to the postgraduate broad-speciality medical education
(n) the number of, and the manner in which, the experts, professionals,
officers and other employees shall be made available by the Commission to the
Autonomous Boards under section 21;
(o) the curriculum at undergraduate level under clause (b) of sub-section (1)
of section 24;
(p) the curriculum for primary medicine, community medicine and family
medicine under clause (c) of sub-section (1) of section 24;
(q) the manner of imparting undergraduate courses by medical institutions
under clause (d) of sub-section (1) of section 24;
(r) the minimum requirements and standards for conducting courses and
examinations for undergraduates in medical institutions under clause (e) of
(s) the standards and norms for infrastructure, faculty and quality of
education at undergraduate level in medical institutions under clause (f) of
(t) the standards of medical education at the postgraduate level and super-
speciality level under clause (a) of sub-section (1) of section 25;
(u) the curriculum at postgraduate level and super-speciality level under
clause (b) of sub-section (1) of section 25;
(v) the manner of imparting postgraduate and super-speciality courses by
medical institutions under clause (c) of sub-section (1) of section 25;
(w) the minimum requirements and standards for conducting postgraduate
and super-speciality courses and examinations in medical institutions under
clause (d) of sub-section (1) of section 25;
770
(x) the standards and norms for infrastructure, faculty and quality of
education in medical institutions conducting postgraduate and super-speciality
medical education under clause (e) of sub-section (1) of section 25;
(y) the procedure for assessing and rating the medical institutions under
(z) the manner of carrying out inspections of medical institutions for
assessing and rating such institutions under clause (c) of sub-section (1) of
section 26;
(za) the manner of conducting, and the manner of empanelling independent
rating agencies to conduct, assessment and rating of medical institutions under
clause (d) of sub-section (1) of section 26;
(zb) the manner of making available on website or in public domain the
assessment and ratings of medical institutions under clause (e) of sub-section (1)
of section 26;
(zc) the measures to be taken against a medical institution for its failure to
maintain the minimum essential standards under clause (f) of sub-section (1) of
section 26;
(zd) the manner of regulating professional conduct and promoting medical
ethics under clause (b) of sub-section (1) of section 27;
(ze) the form of scheme, the particulars thereof, the fee to be accompanied
and the manner of submitting scheme for establishing a new medical college or
for starting any postgraduate course or for increasing number of seats under
(zf) the manner of making an appeal to the Commission for approval of the
scheme under sub-section (5) of section 28;
(zg) the areas in respect of which criteria may be relaxed under the proviso
to section 29;
(zh) the manner of taking disciplinary action by a State Medical Council for
professional or ethical misconduct of registered medical practitioner or
professional and the procedure for receiving complaints and grievances by Ethics
and Medical Registration Board, under sub-section (2) of section 30;
(zi) the act of commission or omission which amounts to professional or
ethical misconduct under clause (b) of the Explanation to section 30;
(zj) other particulars to be contained in a National Register under
(zk) the form, including the electronic form and the manner of maintaining
the National Register under sub-section (2) of section 31;
(zl) the manner in which any name or qualification may be added to, or
removed from, the National Register and the grounds for removal thereof, under
(zm) the form and manner in which the National Register for registering
Community Health Provider is to be maintained under sub-section (8) of
section 31;
(zn) the criteria for granting limited licence to practice medicine under
(zo) the extent, the circumstances and the period under sub-section (2) of
section 32;
771
(zp) the manner of listing and maintaining medical qualifications granted by

a University or medical institution in India under sub-section (1) of section 35;
(zq) the manner of examining the application for grant of recognition under
(zr) the manner of preferring an appeal to the Commission for grant of
recognition under sub-section (5) of section 35;
(zs) the manner of including a medical qualification in the list maintained by
the Board under sub-section (6) of section 35;
(zt) the manner of listing and maintaining medical qualifications which
have been granted recognition before the date of commencement of this Act
under sub-section (8) of section 35.
Rules and 58. Every rule and every regulation made, and every notification issued, under
regulations to this Act shall be laid, as soon as may be after it is made, before each House of Parliament,
be laid before
while it is in session, for a total period of thirty days which may be comprised in one
Parliament.
session or in two or more successive sessions, and if, before the expiry of the session
immediately following the session or the successive sessions aforesaid, both Houses
agree in making any modification in the rule or regulation or notification; both Houses
agree that the rule or regulation or notification should not be made, the rule or regulation
or notification shall thereafter have effect only in such modified form or be of no effect,
as the case may be; so, however, that any such modification or annulment shall be
without prejudice to the validity of anything previously done under that rule or regulation
or notification.
Power to 59. (1) If any difficulty arises in giving effect to the provisions of this Act, the
remove
difficulties.
Central Government may, by order published in the Official Gazette, make such
provisions not inconsistent with the provisions of this Act, as may appear to it to be
necessary, for removing the difficulty:
Provided that no order shall be made under this section after the expiry of a
period of two years from the commencement of this Act.
(2) Every order made under this section shall be laid, as soon as may be after it is
made, before each House of Parliament.
Repeal and 60. (1) With effect from such date as the Central Government may appoint in this
saving. behalf, the Indian Medical Council Act, 1956 shall stand repealed and the Medical 102 of 1956.
Council of India constituted under sub-section (1) of section 3 of the said Act shall
stand dissolved.
(2) Notwithstanding the repeal of the Act referred to in sub-section (1), it shall
not affect,
(a) the previous operation of the Act so repealed or anything duly done or
suffered thereunder; or
(b) any right, privilege, obligation or liability acquired, accrued or incurred
under the Act so repealed; or
(c) any penalty incurred in respect of any contravention under the Act so
repealed; or
(d) any proceeding or remedy in respect of any such right, privilege,
obligation, liability, penalty as aforesaid, and any such proceeding or remedy
may be instituted, continued or enforced, and any such penalty may be imposed
as if that Act had not been repealed.
(3) On the dissolution of the Medical Council of India, the person appointed as
the Chairman of the Medical Council of India and every other person appointed as the
772
Member and any officer and other employee of that Council and holding office as such
immediately before such dissolution shall vacate their respective offices and such
Chairman and other Members shall be entitled to claim compensation not exceeding
three months' pay and allowances for the premature termination of term of their office
or of any contract of service:
Provided that any officer or other employee who has been, immediately before
the dissolution of the Medical Council of India appointed on deputation basis to the
Medical Council of India, shall, on such dissolution, stand reverted to his parent cadre,
Ministry or Department, as the case may be:
Provided further that any officer or other employee who has been, immediately
before the dissolution of the Medical Council of India, employed on regular or contractual
basis by the Medical Council of India, shall, on and from such dissolution, cease to be
the officer or employee of the Medical Council of India and his employment in the
Medical Council of India stand terminated with immediate effect:
Provided also that such officer or employee of the Medical Council of India shall
be entitled to such compensation for the premature termination of his employment,
which shall not be less than three months' pay and allowances, as may be prescribed.
(4) Notwithstanding the repeal of the aforesaid enactment, any order made, any
licence to practice issued, any registration made, any permission to start new medical
college or to start higher course of studies or for increase in the admission capacity
granted, any recognition of medical qualifications granted, under the Indian Medical
102 of 1956. Council Act, 1956, which are in force as on the date of commencement of this Act, shall
continue to be in force till the date of their expiry for all purposes, as if they had been
issued or granted under the provisions of this Act or the rules or regulations made
thereunder.
61. (1) The Commission shall be the successor in interest to the Medical Council Transitory
of India including its subsidiaries or owned trusts and all the assets and liabilities of provisions.
the Medical Council of India shall be deemed to have been transferred to the Commission.
102 of 1956. (2) Notwithstanding the repeal of the Indian Medical Council Act, 1956, the
educational standards, requirements and other provisions of the Indian Medical Council
Act, 1956 and the rules and regulations made thereunder shall continue to be in force
and operate till new standards or requirements are specified under this Act or the rules
and regulations made thereunder:
Provided that anything done or any action taken as regards the educational
standards and requirements under the enactment under repeal and the rules and
regulations made thereunder shall be deemed to have been done or taken under the
corresponding provisions of this Act and shall continue in force accordingly unless
and until superseded by anything done or by any action taken under this Act.
773
28 THE GAZETTE OF INDIA EXTRAORDINARY [PART IIS EC. 1]
THE SCHEDULE
[See section 37]
LIST OF CATEGORIES OF MEDICAL QUALIFICATIONS GRANTED BY
STATUTORY BODY OR OTHER BODY IN INDIA
Sl. No. Categories of medical qualifications
1. All medical qualifications granted by the Jawaharlal Institute of Postgraduate Medical
Education and Research, Puducherry.
2. All medical qualifications granted by All India Institutes of Medical Sciences.
3. All medical qualifications granted by the Postgraduate Institute of Medical Education
and Research, Chandigarh.
4. All medical qualifications granted by the National Institute of Mental Health and
Neuro-Sciences, Bangalore.
5. All medical qualifications granted by the National Board of Examination.

DR. G. NARAYANA RAJU,

Secretary to the Govt. of India.
UPLOADED BY THE MANAGER, GOVERNMENT OF INDIA PRESS, MINTO ROAD, NEW DELHI110002
AND PUBLISHED BY THE CONTROLLER OF PUBLICATIONS, DELHI110054. Dlgltallyslgnedby
BANSHI BANSHI OHAR
MGI PMRND-2590Gl(S3)--08-08-2019. DHAR DUBEY

Olite:2019.08.08
DUBEY 23.1)9:201-0S'lO'
ANNEXURE P-22
Immunization Division, MoHFW 774
Dated: 16 January 2020
Causality assessment report of 608 reported Serious Adverse Events

Following Immunization (AEFI) cases, approved by National AEFI
Committee
The Immunization Division of Ministry of Health & Family Welfare

has taken several steps to improve the National AEFI surveillance system,
both the quality of investigation of cases at state level and their causality
assessment at national level. Considering the importance and critical nature
of the task, SOPs for causality assessment (CA) have been laid down as
quality assurance. The CA subcommittee is housed at Lady Harding
Medical College which is also the National AEFI Technical Collaborating
Centre. The first round of Causality Assessment is undertaken by this sub-
committee.
AEFI deaths, attributed to the vaccine or programme error are

reviewed again by a specially constituted review panel comprising of the
chairs of the 4 subcommittees of the National AEFI Committee (i.e.
Causality assessment, investigation, media and laboratory subcommittees)
chaired by Chairman, National AEFI committee. The causality assessment
reports are presented to the National AEFI Committee.
The results of the Causality Assessment for 608 cases completed over
the past few months after thorough review, deliberation and approval by the
National AEFI Committee is placed below (The anonymized line list of the
causality assessment done by the National AEFI Committee as annexure).
Many of the reported serious AEFIs are Consistent Causal Relation

to Immunization (343) and Inconsistent Causal Relation to
Immunization (Coincidental) (204) and none have been found to be due to
quality defect in manufacturing vaccines.
775
CAUSALITY CLASSIFICATION OF 608 AEFI CASES REVIEWED AND APPROVED BY THE NATIONAL AEFI COMMITTEE
17th JUN 2019 - (NEW DELHI)
A1 - VACCINE PRODUCT RELATED REACTION
A2 - VACCINE QUALITY DEFECT RELATED REACTION
A3 - IMMUNIZATION ERROR RELATED REACTION
A4 - IMMUNIZATION ANXIETY RELATED REACTION
B1 - TEMPORAL RELATIONSHIP IS CONSISTENT BUT THERE IS INSUFFICIENT DEFINITIVE EVIDENCE FOR VACCINE CAUSING EVENT
B2 - REVIEWING FACTORS RESULT IN CONFLICTING TRENDS OF CONSISTENCY AND INCONSISTENCY WITH CAUSAL ASSOCIATION TO IMMUNIZATION
C - COINCIDENTAL - UNDERLYING OR EMERGING CONDITION(s), OR CONDITIONS CAUSED BY EXPOSURE TO SOMETHING OTHER THAN VACCINE
D - UNCLASSIFIABLE
DATE OF
AGE IN REASON FOR REPORTING / ROUTINE, SIA, CLASSIFICATION BY
S. NO. NATIONAL ID YEAR STATE SEX VACCINATION ANTIGENS
YEAR MONTHS DAYS OUTCOME CAMPAIGN & OTHERS NATIONAL AEFI COMMITTEE
(DD/MM/YYYY)
1 IND(AEFI)APCHT15002 2015 ANDHRA PRADESH 1 M 20 D M DEATH 19-08-15 OPV PENTA ROUTINE C
2 IND(AEFI)APGTR15001 2015 ANDHRA PRADESH 2M5D M DEATH 08-07-15 OPV PENTA ROUTINE C
3 IND(AEFI)APPKM15001 2015 ANDHRA PRADESH 1 M 16 D M DEATH 09-05-15 OPV PENTA ROUTINE D
4 IND(AEFI)APPKM15002 2015 ANDHRA PRADESH 3 M 21 D F DEATH 19-08-15 OPV PENTA ROUTINE D
5 IND(AEFI)APPKM15003 2015 ANDHRA PRADESH 1 M 14 D M HOSPITALIZED 19-12-15 OPV PENTA ROUTINE C
6 IND(AEFI)APSKM15001 2015 ANDHRA PRADESH 1 M 16 D M DEATH 12-09-15 OPV PENTA ROUTINE D
7 IND(AEFI)APVSM15001 2015 ANDHRA PRADESH 1 M 16 D F DEATH 13-05-15 OPV PENTA ROUTINE D
8 IND(AEFI)APVSM15002 2015 ANDHRA PRADESH 2 Y 11 M 14 D F HOSPITALIZED 18-01-15 OPV SIA C
9 IND(AEFI)APVSM15006 2015 ANDHRA PRADESH 2 M 25 D M HOSPITALIZED 05-08-15 PENTA ROUTINE C
10 IND(AEFI)ACKMY15001 2015 ARUNACHAL PR. 1Y6M2D M DEATH 08-11-15 DPT HEP-B ROUTINE D
11 IND(AEFI)ASCHR15001 2015 ASSAM 11Y F HOSPITALIZED 04-04-15 JE CAMPAIGN A1
12 IND(AEFI)ASCHR15002 2015 ASSAM 1 M 23 D M DEATH 07-10-15 OPV BCG PENTA ROUTINE C
13 IND(AEFI)ASGLT15001 2015 ASSAM 1M7D F DEATH 18-04-15 OPV PENTA ROUTINE C
14 IND(AEFI)ASKXJ15002 2015 ASSAM 1 M 17 D M HOSPITALIZED 09-06-15 OPV BCG PENTA ROUTINE B2
15 IND(AEFI)ASLKR15001 2015 ASSAM 5M7D F DEATH 18-01-15 OPV SIA C
16 IND(AEFI)ASNLB15001 2015 ASSAM 1 M 19 D F DEATH 20-05-15 OPV PENTA ROUTINE D
17 IND(AEFI)CGBIL15001 2015 CHHATTISGARH 1 M 16 D F DEATH 04-05-15 PENTA ROTA IPV PCV ROUTINE C
18 IND(AEFI)CGSRG15001 2015 CHHATTISGARH 1D M DEATH 14-09-15 BCG OPV HEP-B ROUTINE D
19 IND(AEFI)DLSWE15002 2015 DELHI 2 Y 3 M 10 D F HOSPITALIZED 21-06-15 OPV SIA C
20 IND(AEFI)GUAND15002 2015 GUJARAT 3D F DEATH 16-12-15 BCG ROUTINE D
21 IND(AEFI)GUBVN15002 2015 GUJARAT 8M2D M HOSPITALIZED 08-06-15 OPV PENTA MEASLES VIT-A ROUTINE A1
22 IND(AEFI)HAPAL15001 2015 HARYANA 1 M 17 D F DEATH 07-01-15 PENTA ROUTINE D
23 IND(AEFI)HASNP15003 2015 HARYANA 6M6D M DEATH 22-07-15 OPV PENTA ROUTINE C
24 IND(AEFI)JHDGH15001 2015 JHARKHAND 3M F DEATH 03-09-15 OPV PENTA ROUTINE D
25 IND(AEFI)KABEL15004 2015 KARNATAKA 7 M 21 D F HOSPITALIZED 12-09-15 OPV PENTA ROUTINE A1
26 IND(AEFI)KABLR15001 2015 KARNATAKA 1D F DEATH 25-05-15 BCG OPV HEP-B ROUTINE A3
27 IND(AEFI)KABLR15002 2015 KARNATAKA 1 M 26 D F DEATH 18-08-15 OPV PENTA ROUTINE C
28 IND(AEFI)KABLU15002 2015 KARNATAKA 5 M 14 D M HOSPITALIZED 15-06-15 OPV PENTA ROUTINE A1
29 IND(AEFI)KABLU15003 2015 KARNATAKA 1 M 15 D F DEATH 28-05-15 OPV PENTA ROUTINE C
30 IND(AEFI)KABLU15009 2015 KARNATAKA 1D M DEATH 25-05-15 BCG OPV HEP-B ROUTINE A3
31 IND(AEFI)KABLU15016 2015 KARNATAKA 1 M 15 D M HOSPITALIZED 16-12-15 OPV PENTA ROUTINE A1
32 IND(AEFI)KAKOL15001 2015 KARNATAKA 1Y5M5D M HOSPITALIZED 10-12-15 OPV DPT MEASLES JE ROUTINE A1
33 IND(AEFI)KAKPP15001 2015 KARNATAKA 15 Y 7 M F DEATH 30-07-15 TT ROUTINE D
34 IND(AEFI)KAMAN15003 2015 KARNATAKA 9M F DEATH 09-07-15 MEASLES JE ROUTINE C
35 IND(AEFI)KAMAN15005 2015 KARNATAKA 4M M HOSPITALIZED 17-09-15 OPV PENTA ROUTINE A1
36 IND(AEFI)KATUM15001 2015 KARNATAKA 2 M 23 D M DEATH 20-08-15 OPV PENTA ROUTINE D
37 IND(AEFI)KAUKN15002 2015 KARNATAKA 0D M HOSPITALIZED 08-12-15 OPV HEP-B ROUTINE A3
38 IND(AEFI)KEKLM15001 2015 KERALA 3 M 23 D M DEATH 22-04-15 OPV PENTA ROUTINE D
39 IND(AEFI)KEKLM15013 2015 KERALA 3 M 26 D M HOSPITALIZED 02-09-15 OPV PENTA ROUTINE C
40 IND(AEFI)KEKLM15015 2015 KERALA 3M M DEATH 16-12-15 OPV PENTA ROUTINE C
41 IND(AEFI)KEKNU15005 2015 KERALA 4 Y 3 M 26 D F DEATH 28-10-15 DPT ROUTINE B1
42 IND(AEFI)KEKOT15002 2015 KERALA 2 M 14 D F HOSPITALIZED 15-01-15 OPV PENTA ROUTINE A1
43 IND(AEFI)KEKOT15006 2015 KERALA 1 Y 6 M 22 D M HOSPITALIZED 07-05-15 QUADRAVAC (DTwP+Hib) ROUTINE A1
44 IND(AEFI)KEKOT15019 2015 KERALA 1 M 13 D F HOSPITALIZED 28-09-15 OPV PENTA ROUTINE A1
45 IND(AEFI)KEKZK15005 2015 KERALA 8 M 19 D F HOSPITALIZED 04-02-15 OPV PENTA ROUTINE A1
46 IND(AEFI)KEMPM15001 2015 KERALA 7 M 22 D M HOSPITALIZED 04-02-15 PENTA ROUTINE A1
47 IND(AEFI)KEMPM15003 2015 KERALA 1Y6M6D M HOSPITALIZED 15-05-15 DPT OPV ROUTINE A1
48 IND(AEFI)KEMPM15004 2015 KERALA 1 M 14 D F HOSPITALIZED 10-06-15 OPV PENTA ROUTINE A1
49 IND(AEFI)KEMPM15006 2015 KERALA 1 Y 5 M 14 D M HOSPITALIZED 20-10-15 OPV PENTA ROUTINE A1
50 IND(AEFI)KEPLK15002 2015 KERALA 9 M 19 D M DEATH 23-01-15 MEASLES ROUTINE C
51 IND(AEFI)KETHR15005 2015 KERALA 1 Y 6 M 14 D F HOSPITALIZED 19-03-15 OPV DPT VIT-A ROUTINE A1
52 IND(AEFI)KETHR15007 2015 KERALA 1 Y 6 M 23 D M HOSPITALIZED 27-03-15 OPV DPT ROUTINE A1
53 IND(AEFI)KETHR15011 2015 KERALA 1 M 26 D F HOSPITALIZED 25-05-15 OPV PENTA ROUTINE A1
54 IND(AEFI)KETHR15012 2015 KERALA 1Y6M5D F HOSPITALIZED 27-05-15 OPV DPT ROUTINE A1
55 IND(AEFI)MPANP15001 2015 MADHYA PRADESH 2M4D F DEATH 09-04-15 OPV PENTA ROUTINE C
56 IND(AEFI)MPBHD15001 2015 MADHYA PRADESH 1D M DEATH 09-04-15 OPV BCG HEP-B ROUTINE C
57 IND(AEFI)MPBHD15002 2015 MADHYA PRADESH 1 Y 5 M 25 D F HOSPITALIZED 26-06-15 DPT OPV VIT-A ROUTINE A1
58 IND(AEFI)MPBPL15001 2015 MADHYA PRADESH 3M M HOSPITALIZED 05-08-15 OPV PENTA ROUTINE A1
59 IND(AEFI)MPBTL15001 2015 MADHYA PRADESH 10 D M DEATH 01-12-15 OPV BCG ROUTINE C
60 IND(AEFI)MPIDR15001 2015 MADHYA PRADESH 11 M 19 D M HOSPITALIZED 23-06-15 MEASLES ROUTINE C
61 IND(AEFI)MPIDR15003 2015 MADHYA PRADESH 1 M 12 D M DEATH 20-11-15 OPV PENTA ROUTINE D
62 IND(AEFI)MPSTN15001 2015 MADHYA PRADESH 1D M DEATH 15-04-15 OPV BCG HEP-B ROUTINE D
63 IND(AEFI)MPTKM15001 2015 MADHYA PRADESH 1 M 20 D F DEATH 15-04-15 OPV PENTA ROUTINE C
64 IND(AEFI)MPVDS15004 2015 MADHYA PRADESH 2Y5M M HOSPITALIZED 09-07-15 OPV DPT MEASLES VIT-A ROUTINE A1
65 IND(AEFI)MPVDS15006 2015 MADHYA PRADESH 23D F HOSPITALIZED 21-08-15 BCG OPV HEP-B ROUTINE A3
66 IND(AEFI)MPVDS15009 2015 MADHYA PRADESH 9 M 12 D F DEATH 29-10-15 MEASLES VIT-A ROUTINE D
67 IND(AEFI)MHBMC15002 2015 MAHARASHTRA 6Y3D F HOSPITALIZED 09-01-15 DPT ROUTINE C
Page 1 of 10
776
D - UNCLASSIFIABLE
DATE OF
(DD/MM/YYYY)
68 IND(AEFI)MHBMC15009 2015 MAHARASHTRA 3M M DEATH 24-03-15 DPT OPV HEP-B ROUTINE C
69 IND(AEFI)MHNSK15005 2015 MAHARASHTRA 7 M 24 D F HOSPITALIZED 08-07-15 DPT HEP-B ROUTINE A1
70 IND(AEFI)MHTHN15003 2015 MAHARASHTRA 1D M DEATH 06-01-15 OPV BCG HEP-B ROUTINE D
71 IND(AEFI)MEJNH15001 2015 MEGHALAYA 2 M 17 D M DEATH 07-07-15 DPT OPV HEP-B ROUTINE D
72 IND(AEFI)MEJNH15002 2015 MEGHALAYA 1Y7M7D M CLUSTER 07-07-15 OPV DPT MEASLES VIT-A ROUTINE C
73 IND(AEFI)MEJNH15003 2015 MEGHALAYA 3M8D M CLUSTER 07-07-15 DPT OPV HEP-B ROUTINE C
74 IND(AEFI)MEJNH15004 2015 MEGHALAYA 10 M 23 D F CLUSTER 07-07-15 MEASLES VIT-A ROUTINE C
75 IND(AEFI)MEJNH15006 2015 MEGHALAYA 1 Y 4 M 11 D F CLUSTER 07-07-15 OPV DPT MEASLES VIT-A ROUTINE C
76 IND(AEFI)MZAZW15001 2015 MIZORAM 1 M 23 D F DEATH 04-02-15 DPT OPV HEP-B ROUTINE D
77 IND(AEFI)ORGJM15002 2015 ODISHA 1 M 15 D F DEATH 26-11-15 OPV PENTA ROUTINE B2
78 IND(AEFI)RJALW15001 2015 RAJASTHAN 7 M 14 D M DEATH 09-06-15 OPV BCG PENTA ROUTINE D
79 IND(AEFI)TNCNI15001 2015 TAMIL NADU 14 D F DEATH 07-01-15 OPV BCG ROUTINE C
80 IND(AEFI)TNCNI15006 2015 TAMIL NADU 2 M 22 D M HOSPITALIZED 28-01-15 OPV PENTA ROUTINE A3
81 IND(AEFI)TNCNI15022 2015 TAMIL NADU 1 Y 5 M 11 D M HOSPITALIZED 29-06-15 OPV DPT MEASLES ROUTINE A1
82 IND(AEFI)TNCNI15031 2015 TAMIL NADU 2 M 26 D F DEATH 23-09-15 OPV PENTA ROUTINE C
83 IND(AEFI)TNCNI15045 2015 TAMIL NADU 6Y1M1D M HOSPITALIZED 30-12-15 MEASLES CAMPAIGN C
84 IND(AEFI)TNCNI15046 2015 TAMIL NADU 2M4D F HOSPITALIZED 16-12-15 OPV PENTA ROUTINE A1
85 IND(AEFI)TNKPM15003 2015 TAMIL NADU 8M8D M HOSPITALIZED 18-03-15 OPV PENTA ROUTINE C
86 IND(AEFI)TNKPM15008 2015 TAMIL NADU 8M4D M HOSPITALIZED 17-09-15 INFLUENZA VACCINE ROUTINE A1
87 IND(AEFI)TNTLR15010 2015 TAMIL NADU 1 Y 5 M 23 D M HOSPITALIZED 24-06-15 OPV DPT MEASLES JE ROUTINE A1
88 IND(AEFI)TNVLR15008 2015 TAMIL NADU 3M7D F DEATH 21-10-15 OPV PENTA ROUTINE C
89 IND(AEFI)TSKMM15003 2015 TELANGANA 3 M 15 D F HOSPITALIZED 22-02-15 OPV SIA C
90 IND(AEFI)TSKMM15004 2015 TELANGANA 1 Y 4 M 28 D M DEATH 09-12-15 OPV DPT ROUTINE B2
91 IND(AEFI)TSMBR15001 2015 TELANGANA 2M4D M DEATH 19-09-15 OPV PENTA ROUTINE D
92 IND(AEFI)TSWRL15002 2015 TELANGANA 1 M 14 D M HOSPITALIZED 21-11-15 OPV PENTA ROUTINE A1
93 IND(AEFI)TSWRL15003 2015 TELANGANA 2 M 27 D M HOSPITALIZED 18-11-15 OPV PENTA ROUTINE A1
94 IND(AEFI)TRTRW15034 2015 TRIPURA 5Y F CLUSTER 01-06-15 JE CAMPAIGN B2
95 IND(AEFI)TRTRW15037 2015 TRIPURA 12Y F CLUSTER 29-05-15 JE CAMPAIGN C
96 IND(AEFI)TRTRW15052 2015 TRIPURA 2 M 13 D F HOSPITALIZED 30-12-15 OPV PENTA ROUTINE C
97 IND(AEFI)UPBLS15001 2015 UTTAR PRADESH 24 D F DEATH 08-07-15 BCG ROUTINE D
98 IND(AEFI)UPBRC15001 2015 UTTAR PRADESH 1 Y 11 M 27 D M DEATH 19-01-15 OPV SIA C
99 IND(AEFI)UPBRL15002 2015 UTTAR PRADESH 5 M 27 D M HOSPITALIZED 09-04-15 DPT OPV HEP-B ROUTINE C
100 IND(AEFI)UPGRP15001 2015 UTTAR PRADESH 11 D M DEATH 06-08-15 BCG OPV HEP-B ROUTINE D
101 IND(AEFI)UPHTR15001 2015 UTTAR PRADESH 2M1D M DEATH 04-11-15 DPT OPV HEP-B SIA D
102 IND(AEFI)UPJPN15004 2015 UTTAR PRADESH 6M6D F DEATH 16-07-15 DPT OPV HEP-B ROUTINE C
103 IND(AEFI)UPKAN15001 2015 UTTAR PRADESH 8M F HOSPITALIZED 13-08-15 DPT OPV HEP-B ROUTINE C
104 IND(AEFI)UPLLP15002 2015 UTTAR PRADESH 1 M 28 D F DEATH 06-11-15 DPT HEP-B ROUTINE D
105 IND(AEFI)UPLNO15001 2015 UTTAR PRADESH 3 M 14 D M DEATH 07-01-15 DPT OPV HEP-B ROUTINE C
106 IND(AEFI)UPMRD15001 2015 UTTAR PRADESH 1 M 17 D F DEATH 08-05-15 DPT OPV HEP-B ROUTINE D
107 IND(AEFI)UPMRT15001 2015 UTTAR PRADESH 2M F DEATH 04-11-15 BCG ROUTINE C
108 IND(AEFI)UPPIL15005 2015 UTTAR PRADESH 6Y1M F DEATH 13-08-15 JE CAMPAIGN B2
109 IND(AEFI)UPSBD15002 2015 UTTAR PRADESH 1 M 16 D F DEATH 12-12-15 DPT HEP-B BCG ROUTINE D
110 IND(AEFI)UPSHP15006 2015 UTTAR PRADESH 4 M 10 D F DEATH 20-03-15 OPV DPT BCG HEP-B ROUTINE D
111 IND(AEFI)UPSHP15012 2015 UTTAR PRADESH 7M4D F HOSPITALIZED 18-03-15 DPT OPV HEP-B ROUTINE A1
112 IND(AEFI)UPSTP15005 2015 UTTAR PRADESH 1 M 19 D M DEATH 14-03-15 DPT OPV HEP-B ROUTINE C
113 IND(AEFI)UPVRN15001 2015 UTTAR PRADESH 1M8D M DEATH 18-01-15 OPV SIA D
114 IND(AEFI)UPVRN15002 2015 UTTAR PRADESH 3 M 20 D F DEATH 19-09-15 DPT OPV HEP-B ROUTINE D
115 IND(AEFI)WBCAL15002 2015 WEST BENGAL 1D M HOSPITALIZED 23-06-15 OPV BCG HEP-B ROUTINE A3
116 IND(AEFI)WBCAL15003 2015 WEST BENGAL 9 M 12 D M HOSPITALIZED 05-08-15 MEASLES JE ROUTINE C
117 IND(AEFI)WBHRA15001 2015 WEST BENGAL 1 Y 8 M 23 D M DEATH 08-01-15 OPV DPT MEASLES JE ROUTINE C
118 IND(AEFI)WBKBR15001 2015 WEST BENGAL 0D M HOSPITALIZED 07-12-15 HEP-B ROUTINE A3
119 IND(AEFI)WBMLD15005 2015 WEST BENGAL 1 Y 9 M 13 D F DEATH 10-09-15 OPV DPT MEASLES JE ROUTINE C
120 IND(AEFI)WBPRL15001 2015 WEST BENGAL 7D F DEATH 18-01-15 BCG OPV HEP-B SIA C
121 IND(AEFI)WBPRL15002 2015 WEST BENGAL 1D M HOSPITALIZED 08-03-15 OPV BCG HEP-B ROUTINE A3
122 IND(AEFI)WBSPG15002 2015 WEST BENGAL 3 Y 7 M 10 D M HOSPITALIZED 23-11-15 OPV SIA C
123 IND(AEFI)WBSPG15007 2015 WEST BENGAL 13 Y 3 M 27 D F HOSPITALIZED 16-12-15 JE CAMPAIGN A4
124 IND(AEFI)WBSPG15009 2015 WEST BENGAL 13 Y 1 M 28 D F HOSPITALIZED 29-12-15 JE CAMPAIGN A1
125 IND(AEFI)WBSPG15011 2015 WEST BENGAL 1 M 11 D M HOSPITALIZED / DEATH 04-02-15 OPV PENTA ROUTINE C
126 IND(AEFI)WBTML15007 2015 WEST BENGAL 2 Y 5 M 13 D F HOSPITALIZED 05-11-15 OPV DPT MEASLES ROUTINE A1
127 IND(AEFI)WBTML15009 2015 WEST BENGAL 10 M M HOSPITALIZED 18-01-15 OPV SIA C
128 IND(AEFI)WBTML15010 2015 WEST BENGAL 1 Y 4 M 13 D M HOSPITALIZED 18-02-15 OPV DPT MEASLES ROUTINE A1
129 IND(AEFI)APEGV16003 2016 ANDHRA PRADESH 5M F DEATH 15-06-16 OPV PENTA ROTA ROUTINE C
130 IND(AEFI)APVSM16005 2016 ANDHRA PRADESH 2M8D M DEATH 05-10-16 OPV PENTA ROUTINE C
131 IND(AEFI)APVSM16006 2016 ANDHRA PRADESH 2 M 25 D M DEATH 02-11-16 BCG ROUTINE C
132 IND(AEFI)ACESI16001 2016 ARUNACHAL PR. 1 M 23 D M DEATH 24-05-16 OPV PENTA ROUTINE D
133 IND(AEFI)ASNLB16002 2016 ASSAM 2M1D M DEATH 05-10-16 OPV PENTA BCG ROUTINE C
134 IND(AEFI)ASNLB16003 2016 ASSAM 2M7D M DEATH 14-12-16 OPV PENTA ROUTINE C
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DATE OF
(DD/MM/YYYY)
135 IND(AEFI)CHCHD16008 2016 CHANDIGARH 1M15D M CLUSTER 06-07-16 OPV PENTA ROUTINE A3
136 IND(AEFI)DNDNV16001 2016 D&N HAVELI 0D M HOSPITALIZED 10-08-16 OPV HEP-B BCG ROUTINE A3
137 IND(AEFI)DNDNV16002 2016 D&N HAVELI 6M9D M HOSPITALIZED 14-09-16 OPV IPV PENTA ROUTINE A3
138 IND(AEFI)DLSOE16002 2016 DELHI 1 Y 5 M 14 D M SEVERE 07-06-16 OPV DPT ROUTINE C
139 IND(AEFI)GOGON16011 2016 GOA 0D M HOSPITALIZED 14-09-16 HEP-B ROUTINE A3
140 IND(AEFI)GOGON16012 2016 GOA 1 M 24 D F HOSPITALIZED 26-09-16 OPV IPV PENTA ROUTINE A3
141 IND(AEFI)GOGON16013 2016 GOA 1 M 17 D M HOSPITALIZED 24-10-16 OPV IPV PENTA ROUTINE C
142 IND(AEFI)GOGOS16011 2016 GOA 2 M 15 D F HOSPITALIZED 22-12-16 OPV IPV PENTA ROUTINE A1
144 IND(AEFI)GUVLD16001 2016 GUJARAT 1Y6M8D M HOSPITALIZED 05-10-16 OPV DPT MEASLES ROUTINE A1
145 IND(AEFI)HAKNL16001 2016 HARYANA 2 M 16 D M DEATH 23-11-16 OPV IPV PENTA ROTA ROUTINE C
146 IND(AEFI)KEKLM16004 2016 KERALA 4 Y 8 M 12 D F DEATH 15-03-16 DPT ROUTINE C
147 IND(AEFI)KEKNU16014 2016 KERALA 3 Y 5 M 13 D F CLUSTER 23-09-16 MMR ROUTINE A1
148 IND(AEFI)KEKNU16015 2016 KERALA 1 Y 5 M 22 D M CLUSTER 23-09-16 MMR ROUTINE A1
149 IND(AEFI)MHBMC16003 2016 MAHARASHTRA 2 M 17 D M DEATH 05-02-16 OPV DPT IPV Hib ROUTINE C
150 IND(AEFI)ORGJM16005 2016 ODISHA 1 M 23 D F DEATH 01-06-16 OPV PENTA ROTA ROUTINE D
151 IND(AEFI)TNMDU16002 2016 TAMIL NADU 9M F DEATH 07-10-16 MEASLES JE ROUTINE C
152 IND(AEFI)TNTPR16002 2016 TAMIL NADU 7 Y 14 D M HOSPITALIZED 06-10-16 DPT ROUTINE A1
153 IND(AEFI)UPFKB16002 2016 UTTAR PRADESH 2M3D F DEATH 04-05-16 PENTA ROUTINE C
154 IND(AEFI)UPKRI16001 2016 UTTAR PRADESH 4M5D F DEATH 27-08-16 PENTA ROUTINE B2
155 IND(AEFI)UPPSN16001 2016 UTTAR PRADESH 3M9D M SEVERE 10-01-16 OPV PENTA ROUTINE A1
156 IND(AEFI)UPSBD16002 2016 UTTAR PRADESH 3M9D M DEATH 02-07-16 OPV PENTA ROUTINE D
157 IND(AEFI)WBBKR16006 2016 WEST BENGAL 2D M DEATH 07-12-16 OPV BCG ROUTINE D
158 IND(AEFI)WBTML16025 2016 WEST BENGAL 2 M 11 D F DEATH 18-08-16 OPV PENTA ROUTINE C
159 IND(AEFI)WBTML16027 2016 WEST BENGAL 18 D M DEATH 07-09-16 BCG ROUTINE C
160 IND(AEFI)APAPR17001 2017 ANDHRA PRADESH 1 M 21 D F DEATH 01-02-17 IPV ROUTINE C
161 IND(AEFI)APGTR17003 2017 ANDHRA PRADESH 1 M 27 D F DEATH 04-03-17 OPV IPV PENTA ROTA ROUTINE C
162 IND(AEFI)APGTR17008 2017 ANDHRA PRADESH 2M4D M DEATH 16-12-17 OPV PENTA ROTA ROUTINE C
163 IND(AEFI)ASSPR17002 2017 ASSAM 1 M 16 D M DEATH 18-11-17 OPV PENTA BCG ROTA ROUTINE D
164 IND(AEFI)BIAGB17001 2017 BIHAR 1 M 26 D F DEATH 09-12-17 OPV IPV PENTA ROUTINE C
165 IND(AEFI)BIBGP17003 2017 BIHAR 1 M 21 D F DEATH 15-02-17 OPV PENTA ROUTINE C
166 IND(AEFI)BIBGP17004 2017 BIHAR 2M1D F DEATH 22-03-17 OPV IPV PENTA ROUTINE D
167 IND(AEFI)BIBGP17005 2017 BIHAR 2 M 24 D F DEATH 04-10-17 OPV IPV PENTA ROUTINE C
168 IND(AEFI)BIBGS17001 2017 BIHAR 1 M 18 D F DEATH 20-01-17 OPV PENTA ROUTINE C
169 IND(AEFI)BIBGS17002 2017 BIHAR 1 M 14 D F DEATH 27-01-17 BCG ROUTINE C
170 IND(AEFI)BIBGS17004 2017 BIHAR 1 M 23 D M DEATH 13-10-17 OPV IPV PENTA PCV ROUTINE C
171 IND(AEFI)BIBGS17005 2017 BIHAR 2 M 28 D F DEATH 11-10-17 OPV PENTA BCG PCV ROUTINE C
172 IND(AEFI)BIBGS17006 2017 BIHAR 3M1D F DEATH 02-11-17 OPV PENTA PCV ROUTINE D
173 IND(AEFI)BIBGS17007 2017 BIHAR 2M1D F DEATH 03-11-17 OPV PENTA PCV ROUTINE C
174 IND(AEFI)BIBGS17008 2017 BIHAR 1 M 15 D M DEATH 22-12-17 OPV IPV PENTA PCV ROUTINE C
175 IND(AEFI)BIBJR17001 2017 BIHAR 2D M DEATH 20-12-17 OPV BCG ROUTINE C
176 IND(AEFI)BIGYA17001 2017 BIHAR 3 M 18 D F DEATH 08-03-17 OPV PENTA ROUTINE C
177 IND(AEFI)BIMDP17001 2017 BIHAR 4M8D F DEATH 30-03-17 OPV PENTA ROUTINE C
178 IND(AEFI)BIMDP17002 2017 BIHAR 1 M 16 D M DEATH 20-05-17 OPV IPV PENTA ROUTINE C
179 IND(AEFI)BIMUN17001 2017 BIHAR 9 M 20 D F SEVERE 08-07-17 MEASLES ROUTINE C
180 IND(AEFI)BIMUN17002 2017 BIHAR 1Y4M6D M SEVERE 10-07-17 OPV DPT MEASLES ROUTINE C
181 IND(AEFI)BISAM17001 2017 BIHAR 2M F DEATH 07-01-17 OPV PENTA ROUTINE C
182 IND(AEFI)BISAM17004 2017 BIHAR 10 M 21 D F DEATH 04-10-17 MEASLES ROUTINE C
183 IND(AEFI)BIVSL17001 2017 BIHAR 2M1D F DEATH 02-01-17 OPV PENTA ROUTINE D
184 IND(AEFI)DLNOR17004 2017 DELHI 3M9D F HOSPITALIZED 03-11-17 OPV PENTA ROUTINE A1
185 IND(AEFI)DLSWE17001 2017 DELHI 2 M 28 D M DEATH 07-06-17 OPV PENTA ROUTINE C
186 IND(AEFI)GUJMC17001 2017 GUJARAT 3 M 18 D F DEATH 08-04-17 OPV IPV PENTA ROUTINE A1
187 IND(AEFI)HPKGR17004 2017 HIMACHAL PRADESH 8 Y 2 M 20 D M DEATH 13-09-17 MR CAMPAIGN C
188 IND(AEFI)HPSMR17002 2017 HIMACHAL PRADESH 5 Y 10 M 3 D M HOSPITALIZED 30-08-17 MR CAMPAIGN C
189 IND(AEFI)JKJAM17001 2017 JAMMU & KASHMIR 1 M 16 D M DEATH 01-02-17 OPV PENTA ROUTINE D
190 IND(AEFI)KEKLM17001 2017 KERALA 1 M 12 D F SEVERE 18-01-17 OPV IPV PENTA ROUTINE A3
191 IND(AEFI)KEKLM17011 2017 KERALA 1Y7M6D M SEVERE 29-07-17 OPV DPT VIT-A ROUTINE A3
192 IND(AEFI)KEKLM17013 2017 KERALA 1 Y 6 M 28 D M HOSPITALIZED 18-08-17 OPV DPT ROUTINE C
193 IND(AEFI)MPBPL17012 2017 MADHYA PRADESH 9 M 24 D M HOSPITALIZED 07-04-17 MEASLES ROUTINE C
194 IND(AEFI)MPVDS17006 2017 MADHYA PRADESH 9 M 12 D M HOSPITALIZED 27-10-17 MEASLES ROUTINE C
195 IND(AEFI)MEEKH17001 2017 MEGHALAYA 1 M 16 D F DEATH 19-04-17 OPV PENTA ROUTINE C
196 IND(AEFI)ORAGL17002 2017 ODISHA 2 Y 3 M 16 D M DEATH 02-04-17 OPV SIA C
197 IND(AEFI)ORBSR17001 2017 ODISHA 1M5D M DEATH 29-01-17 OPV SIA C
198 IND(AEFI)PDPNY17004 2017 PUDUCHERRY 13 Y M HOSPITALIZED 09-02-17 MR CAMPAIGN A1
199 IND(AEFI)PBJLD17001 2017 PUNJAB 1 M 17 D M HOSPITALIZED 14-07-17 OPV PENTA ROUTINE A1
200 IND(AEFI)PBMHL17001 2017 PUNJAB 1 Y 6 M 19 D M HOSPITALIZED 22-03-17 OPV DPT MEASLES VIT-A ROUTINE A1
201 IND(AEFI)RJKTA17001 2017 RAJASTHAN 3 M 13 D F DEATH 18-05-17 OPV IPV PENTA ROTA ROUTINE D
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D - UNCLASSIFIABLE
DATE OF
(DD/MM/YYYY)
202 IND(AEFI)RJPTH17001 2017 RAJASTHAN 1 M 12 D M DEATH 13-05-17 OPV PENTA BCG ROTA ROUTINE C
203 IND(AEFI)TNTPR17001 2017 TAMIL NADU 5 M 19 D F HOSPITALIZED 12-07-17 OPV IPV PENTA ROUTINE A1
204 IND(AEFI)UPAGR17002 2017 UTTAR PRADESH 2 M 26 D M DEATH 10-04-17 PENTA ROUTINE D
205 IND(AEFI)UPAGR17003 2017 UTTAR PRADESH 7D M DEATH 04-07-17 OPV SIA D
206 IND(AEFI)UPALG17001 2017 UTTAR PRADESH 2 M 16 D M DEATH 15-02-17 OPV PENTA ROUTINE A1
207 IND(AEFI)UPALG17002 2017 UTTAR PRADESH 4 M 13 D F DEATH 07-11-17 OPV IPV PENTA BCG ROUTINE C
208 IND(AEFI)UPDOR17001 2017 UTTAR PRADESH 2 Y 13 D F DEATH 15-12-17 OPV DPT MEASLES JE ROUTINE C
209 IND(AEFI)UPDOR17002 2017 UTTAR PRADESH 3 M 20 D M DEATH 16-12-17 OPV PENTA ROUTINE C
210 IND(AEFI)UPGZA17001 2017 UTTAR PRADESH 10 M 19 D F DEATH 20-04-17 MEASLES ROUTINE D
211 IND(AEFI)UPHDO17001 2017 UTTAR PRADESH 1 M 15 D M DEATH 14-01-17 OPV PENTA ROUTINE C
212 IND(AEFI)UPHDO17002 2017 UTTAR PRADESH 3M F DEATH 24-03-17 OPV PENTA ROUTINE C
213 IND(AEFI)UPKSN17001 2017 UTTAR PRADESH 6 M 19 D M HOSPITALIZED 09-05-17 OPV IPV PENTA ROUTINE A1
214 IND(AEFI)UPLLP17001 2017 UTTAR PRADESH 2M M DEATH 11-10-17 OPV IPV PENTA ROUTINE C
215 IND(AEFI)UPPSN17002 2017 UTTAR PRADESH 4 M 15 D F SEVERE 25-03-17 OPV IPV PENTA ROUTINE C
216 IND(AEFI)UPPSN17003 2017 UTTAR PRADESH 1 M 27 D F DEATH 18-08-17 OPV IPV PENTA BCG ROUTINE C
217 IND(AEFI)UPSDN17001 2017 UTTAR PRADESH 3M3D M DEATH 12-12-17 OPV IPV PENTA BCG PCV ROUTINE C
218 IND(AEFI)WBAPD17016 2017 WEST BENGAL 2 M 13 D M SEVERE 06-09-17 OPV IPV PENTA ROUTINE A1
219 IND(AEFI)WBBDN17004 2017 WEST BENGAL 3 M 11 D M DEATH 18-05-17 OPV PENTA ROUTINE D
220 IND(AEFI)WBCAL17008 2017 WEST BENGAL 6 M 14 D F DEATH 26-04-17 OPV PENTA ROUTINE D
221 IND(AEFI)WBCAL17025 2017 WEST BENGAL 2 M 10 D F DEATH 11-10-17 OPV IPV PENTA ROUTINE C
222 IND(AEFI)WBDDJ17019 2017 WEST BENGAL 2 M 12 D F DEATH 10-10-17 OPV IPV PENTA ROUTINE C
223 IND(AEFI)WBDDJ17025 2017 WEST BENGAL 1D M HOSPITALIZED 20-10-17 OPV HEP-B BCG ROUTINE A3
224 IND(AEFI)WBDDJ17026 2017 WEST BENGAL 1 Y 8 M 10 D M HOSPITALIZED 14-12-17 OPV DPT MEASLES JE ROUTINE C
225 IND(AEFI)WBDDJ17027 2017 WEST BENGAL 2D F HOSPITALIZED 17-12-17 OPV HEP-B BCG ROUTINE A3
226 IND(AEFI)WBHGL17005 2017 WEST BENGAL 7 M 22 D M HOSPITALIZED 03-11-17 OPV PENTA ROUTINE C
227 IND(AEFI)WBHGL17006 2017 WEST BENGAL 1Y5M6D F HOSPITALIZED 10-11-17 MEASLES JE VIT-A ROUTINE A3
228 IND(AEFI)WBHRA17033 2017 WEST BENGAL 1 M 16 D M HOSPITALIZED 02-11-17 OPV IPV PENTA ROUTINE A1
229 IND(AEFI)WBHRA17035 2017 WEST BENGAL 1 M 26 D M HOSPITALIZED 01-11-17 OPV IPV PENTA BCG ROUTINE C
230 IND(AEFI)WBMBD17007 2017 WEST BENGAL 4M8D M DEATH 02-07-17 OPV SIA C
231 IND(AEFI)WBMBD17010 2017 WEST BENGAL 1D M HOSPITALIZED 21-09-17 HEP-B ROUTINE A3
232 IND(AEFI)WBMBD17011 2017 WEST BENGAL 0D F HOSPITALIZED 01-10-17 OPV HEP-B ROUTINE A3
233 IND(AEFI)WBMBD17012 2017 WEST BENGAL 1D F HOSPITALIZED 13-10-17 OPV HEP-B BCG ROUTINE A3
234 IND(AEFI)WBNDA17006 2017 WEST BENGAL 5 M 24 D M DEATH 05-07-17 OPV IPV PENTA ROUTINE C
235 IND(AEFI)WBSPG17018 2017 WEST BENGAL 1 Y 1 M 28 D F CLUSTER 02-04-17 OPV SIA C
236 IND(AEFI)WBSPG17020 2017 WEST BENGAL 8D M DEATH 02-04-17 OPV SIA C
237 IND(AEFI)WBSPG17067 2017 WEST BENGAL 1D F SEVERE 09-10-17 OPV HEP-B BCG ROUTINE A3
238 IND(AEFI)WBSPG17079 2017 WEST BENGAL 5 Y 2 M 14 D M SEVERE 07-12-17 DPT ROUTINE C
239 IND(AEFI)WBSPG17088 2017 WEST BENGAL 1 M 19 D M HOSPITALIZED 06-12-17 OPV PENTA ROUTINE A3
240 IND(AEFI)WBTML17011 2017 WEST BENGAL 1 M 25 D M DEATH 17-05-17 OPV IPV PENTA ROUTINE C
241 IND(AEFI)WBTML17024 2017 WEST BENGAL 4M6D M SEVERE 14-09-17 OPV IPV PENTA ROUTINE A1
242 IND(AEFI)WBTML17025 2017 WEST BENGAL 4 M 11 D F SEVERE 05-07-17 OPV IPV PENTA ROUTINE A3
243 IND(AEFI)APAPR18001 2018 ANDHRA PRADESH 1 M 15 D M DEATH 07-02-18 OPV IPV PENTA ROTA ROUTINE D
244 IND(AEFI)APAPR18002 2018 ANDHRA PRADESH 3M1D F DEATH 08-02-18 OPV IPV PENTA ROTA ROUTINE C
245 IND(AEFI)APKRN18002 2018 ANDHRA PRADESH 11 M 17 D M CLUSTER 23-06-18 MR VIT-A ROUTINE A3
246 IND(AEFI)APKRN18003 2018 ANDHRA PRADESH 9 M 24 D M CLUSTER 23-06-18 MR JE VIT-A ROUTINE A3
247 IND(AEFI)APKRN18004 2018 ANDHRA PRADESH 10 M 11 D F CLUSTER 23-06-18 MR JE VIT-A ROUTINE A3
248 IND(AEFI)APKRN18005 2018 ANDHRA PRADESH 9 M 23 D F HOSPITALIZED 23-06-18 MR JE VIT-A ROUTINE C
249 IND(AEFI)ASSPR18001 2018 ASSAM 9D F DEATH 29-01-18 OPV SIA C
250 IND(AEFI)CHCHD18002 2018 CHANDIGARH 3 M 18 D M HOSPITALIZED 26-02-18 OPV IPV PENTA ROUTINE A1
251 IND(AEFI)CHCHD18003 2018 CHANDIGARH 2 M 24 D F DEATH 03-03-18 OPV PENTA ROUTINE C
252 IND(AEFI)CHCHD18004 2018 CHANDIGARH 3 M 27 D F HOSPITALIZED 03-01-18 OPV IPV PENTA ROUTINE A1
253 IND(AEFI)CHCHD18005 2018 CHANDIGARH 9 M 10 D F HOSPITALIZED 07-03-18 MR VIT-A ROUTINE C
254 IND(AEFI)CHCHD18006 2018 CHANDIGARH 1 M 18 D M HOSPITALIZED 25-04-18 OPV PENTA ROUTINE A1
255 IND(AEFI)CHCHD18007 2018 CHANDIGARH 4 M 23 D M HOSPITALIZED 20-06-18 OPV IPV PENTA ROUTINE A1
256 IND(AEFI)CHCHD18008 2018 CHANDIGARH 7 Y 4 M 20 D M HOSPITALIZED 21-07-18 TYPHOID ROUTINE A3
257 IND(AEFI)CHCHD18010 2018 CHANDIGARH 1D M HOSPITALIZED 25-08-18 OPV HEP-B BCG ROUTINE A3
258 IND(AEFI)CGBIL18001 2018 CHHATTISGARH 9Y9M7D F SEVERE 25-10-18 MR CAMPAIGN A1
259 IND(AEFI)CGBOD18001 2018 CHHATTISGARH 10 Y 10 M 13 D F SEVERE 06-10-18 MR CAMPAIGN A4
260 IND(AEFI)CGBOD18002 2018 CHHATTISGARH 6Y7M8D F SEVERE 13-10-18 MR CAMPAIGN A1
261 IND(AEFI)CGBOD18003 2018 CHHATTISGARH 13 Y 5 M 9 D F SEVERE 15-10-18 MR CAMPAIGN A4
262 IND(AEFI)CGJHP18001 2018 CHHATTISGARH 11 Y 4 M 19 D M SEVERE 06-10-18 MR CAMPAIGN A1
263 IND(AEFI)CGJHP18002 2018 CHHATTISGARH 6 Y 6 M 28 D M CLUSTER 29-10-18 MR CAMPAIGN A1
264 IND(AEFI)CGJHP18003 2018 CHHATTISGARH 6Y4M1D F CLUSTER 29-10-18 MR CAMPAIGN A1
265 IND(AEFI)CGJHP18004 2018 CHHATTISGARH 14 Y 5 M 18 D F SEVERE 10-10-18 MR CAMPAIGN A1
266 IND(AEFI)CGJHP18005 2018 CHHATTISGARH 4 Y 9 M 29 D M SEVERE 10-10-18 MR CAMPAIGN A1
267 IND(AEFI)CGJHP18006 2018 CHHATTISGARH 13 Y 8 M 5 D F HOSPITALIZED 29-10-18 MR CAMPAIGN A4
268 IND(AEFI)DNDNV18001 2018 D&N HAVELI 4M6D F HOSPITALIZED 09-05-18 OPV PENTA ROUTINE A1
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D - UNCLASSIFIABLE
DATE OF
(DD/MM/YYYY)
269 IND(AEFI)DNDNV18002 2018 D&N HAVELI 4M5D M HOSPITALIZED 10-10-18 OPV IPV PENTA ROUTINE A1
270 IND(AEFI)DLCEN18003 2018 DELHI 2 M 29 D M HOSPITALIZED 08-12-18 OPV PENTA ROUTINE A1
271 IND(AEFI)DLNOR18001 2018 DELHI 1 M 14 D M HOSPITALIZED 05-07-18 OPV IPV PETNA ROUTINE A1
272 IND(AEFI)DLNWE18002 2018 DELHI 1 M 20 D M DEATH 08-05-18 OPV IPV PENTA ROUTINE C
273 IND(AEFI)DLNWE18003 2018 DELHI 1 M 16 D F DEATH 18-06-18 OPV IPV PENTA ROUTINE B2
274 IND(AEFI)DLNWE18004 2018 DELHI 7 M 14 D F HOSPITALIZED 01-08-18 OPV IPV PENTA ROUTINE A1
275 IND(AEFI)DLNWE18005 2018 DELHI 3 M 29 D M DEATH 08-08-18 OPV PENTA ROUTINE C
276 IND(AEFI)DLSOE18002 2018 DELHI 3M3D M HOSPITALIZED 07-07-18 OPV PENTA ROUTINE A1
277 IND(AEFI)DLWES18001 2018 DELHI 1Y3M3D M HOSPITALIZED 16-04-18 OPV PENTA ROUTINE A1
278 IND(AEFI)DLWES18002 2018 DELHI 1 M 17 D F DEATH 10-04-18 OPV IPV PENTA ROUTINE C
279 IND(AEFI)GOGON18001 2018 GOA 5M7D F HOSPITALIZED 10-01-18 OPV IPV PENTA ROUTINE A1
280 IND(AEFI)GOGON18002 2018 GOA 1D M HOSPITALIZED 31-01-18 HEP-B ROUTINE A1
281 IND(AEFI)GOGON18003 2018 GOA 11 M 7 D F HOSPITALIZED 20-04-18 JE MR ROUTINE C
282 IND(AEFI)GOGON18004 2018 GOA 7M8D F SEVERE 17-05-18 PENTA ROUTINE A3
283 IND(AEFI)GOGOS18001 2018 GOA 5Y2D M HOSPITALIZED 22-01-18 DPT ROUTINE A1
284 IND(AEFI)GOGOS18002 2018 GOA 1 Y 8 M 16 D M HOSPITALIZED 09-01-18 OPV DPT ROUTINE A1
285 IND(AEFI)GOGOS18003 2018 GOA 5 Y 2 M 26 D F HOSPITALIZED 12-02-18 DPT ROUTINE A1
286 IND(AEFI)GOGOS18004 2018 GOA 1 Y 6 M 15 D M SEVERE 12-02-18 OPV DPT JE VIT-A ROUTINE A1
287 IND(AEFI)GOGOS18005 2018 GOA 1Y3M3D M HOSPITALIZED 12-02-18 MMR ROUTINE C
289 IND(AEFI)GOGOS18007 2018 GOA 2 M 19 D F HOSPITALIZED 19-03-18 OPV PENTA ROUTINE A1
290 IND(AEFI)GOGOS18008 2018 GOA 2M8D F HOSPITALIZED 17-05-18 OPV IPV PENTA ROUTINE C
292 IND(AEFI)GOGOS18010 2018 GOA 1 M 12 D M HOSPITALIZED 07-05-18 OPV IPT PENTA ROUTINE C
293 IND(AEFI)GOGOS18011 2018 GOA 11 M 1 D M HOSPITALIZED 26-04-18 MR JE ROUTINE A3
294 IND(AEFI)GOGOS18012 2018 GOA 9 M 28 D M HOSPITALIZED 27-09-18 MR JE VIT A ROUTINE A1
295 IND(AEFI)GOGOS18013 2018 GOA 1D F HOSPITALIZED 28-09-18 HEP-B ROUTINE A3
296 IND(AEFI)GOGOS18014 2018 GOA 1 M 17 D M HOSPITALIZED 08-11-18 OPV IPV PENTA ROUTINE A3
297 IND(AEFI)GOGOS18015 2018 GOA 2 M 26 D F HOSPITALIZED 29-11-18 OPV PENTA ROUTINE A3
298 IND(AEFI)GOGOS18017 2018 GOA 1 Y 2 M 21 D M HOSPITALIZED 26-11-18 OPV IPV PENTA ROUTINE A1
299 IND(AEFI)GOGOS18018 2018 GOA 5 Y 26 D M HOSPITALIZED 22-11-18 DPT VIT-A ROUTINE A1
300 IND(AEFI)GOGOS18019 2018 GOA 1 Y 2 M 13 D F HOSPITALIZED 11-12-18 MMR ROUTINE A1
301 IND(AEFI)GOGOS18020 2018 GOA 1Y5M3D M HOSPITALIZED 17-12-18 DPT JE ROUTINE A3
302 IND(AEFI)GUARV18001 2018 GUJARAT 6 Y 11 M 6 D M DEATH 18-07-18 MR CAMPAIGN C
303 IND(AEFI)GUBAN18001 2018 GUJARAT 3Y F DEATH 31-07-18 MR CAMPAIGN C
304 IND(AEFI)GUJMD18004 2018 GUJARAT 16 D F HOSPITALIZED 17-07-18 OPV BCG ROUTINE C
305 IND(AEFI)GUJMD18005 2018 GUJARAT 5 Y 10 M 19 D M HOSPITALIZED 20-07-18 MR CAMPAIGN A1
306 IND(AEFI)GUJMD18007 2018 GUJARAT 5 Y 11 M 6 D M SEVERE 23-07-18 MR CAMPAIGN A1
307 IND(AEFI)GUJMD18008 2018 GUJARAT 2 Y 4 M 28 D F HOSPITALIZED 02-08-18 MR CAMPAIGN C
308 IND(AEFI)GUJMD18009 2018 GUJARAT 3 Y 10 M 11 D M HOSPITALIZED 10-08-18 MR CAMPAIGN A1
309 IND(AEFI)GUJMD18010 2018 GUJARAT 2 Y 5 M 19 D M HOSPITALIZED 10-08-18 MR CAMPAIGN C
310 IND(AEFI)GUJMD18012 2018 GUJARAT 1 M 29 D M CLUSTER 06-11-18 IPV PENTA BCG OPV ROUTINE A1
311 IND(AEFI)GUJMD18013 2018 GUJARAT 2 M 16 D F CLUSTER 06-11-18 OPV IPV PENTA ROUTINE A1
312 IND(AEFI)GUNAV18001 2018 GUJARAT 9Y3M8D M HOSPITALIZED 16-07-18 MR CAMPAIGN A1
313 IND(AEFI)GUNAV18002 2018 GUJARAT 2M15D F DEATH 03-10-18 OPV IPV PENTA ROUTINE C
314 IND(AEFI)GUNMD18002 2018 GUJARAT 9 Y 7 M 25 D M HOSPITALIZED 01-09-18 MR CAMPAIGN C
315 IND(AEFI)HABWN18001 2018 HARYANA 14 Y 6 M 14 D F CLUSTER 27-04-18 MR CAMPAIGN A4
316 IND(AEFI)HABWN18002 2018 HARYANA 15 Y 3 M 7 D F CLUSTER 27-04-18 MR CAMPAIGN A4
317 IND(AEFI)HAJJR18003 2018 HARYANA 13 Y 10 M 21 D M HOSPITALIZED 01-05-18 MR CAMPAIGN A1
318 IND(AEFI)HAKKR18002 2018 HARYANA 1Y6M4D M HOSPITALIZED 28-05-18 MR CAMPAIGN C
319 IND(AEFI)HAKNL18003 2018 HARYANA 4M F DEATH 17-02-18 OPV IPV PENTA ROTA ROUTINE C
320 IND(AEFI)HAKNL18005 2018 HARYANA 13 Y 6 M 8 D M SEVERE 04-05-18 MR CAMPAIGN A4
321 IND(AEFI)HAKTL18002 2018 HARYANA 7Y3M3D F HOSPITALIZED 05-05-18 MR CAMPAIGN C
322 IND(AEFI)HAPKL18001 2018 HARYANA 6 Y 10 M F HOSPITALIZED 28-04-18 MR CAMPAIGN A4
323 IND(AEFI)HAPKL18002 2018 HARYANA 1 M 19 D M HOSPITALIZED 12-12-18 OPV IPV PENTA ROTA PCV ROUTINE A1
324 IND(AEFI)HASNP18004 2018 HARYANA 4M6D M HOSPITALIZED 12-12-18 OPV IPV PENTA ROTA PCV ROUTINE A1
325 IND(AEFI)JHGML18002 2018 JHARKHAND 1D F DEATH 11-04-18 OPV HEP-B BCG ROUTINE C
326 IND(AEFI)JHPLM18001 2018 JHARKHAND 1Y9M8D M DEATH 07-04-18 DPT MEASLES JE ROUTINE A3
327 IND(AEFI)JHPLM18002 2018 JHARKHAND 1 Y 4 M 23 D M DEATH 07-04-18 DPT MEASLES JE ROUTINE A3
328 IND(AEFI)JHPLM18003 2018 JHARKHAND 1 Y 17 D M DEATH 07-04-18 MEASLES JE ROUTINE A3
329 IND(AEFI)JHPLM18004 2018 JHARKHAND 1 Y 5 M 24 D F DEATH 07-04-18 DPT MEASLES JE ROUTINE A3
330 IND(AEFI)JHPLM18005 2018 JHARKHAND 2 M 25 D F CLUSTER 07-04-18 OPV IPV PENTA ROUTINE A4
331 IND(AEFI)JHPLM18006 2018 JHARKHAND 4M4D F CLUSTER 08-04-18 OPV PENTA ROUTINE A4
332 IND(AEFI)JHPLM18007 2018 JHARKHAND 1 Y 9 M 22 D M CLUSTER 07-04-18 OPV DPT JE VIT-A MEASLE ROUTINE A3
333 IND(AEFI)JHPLM18009 2018 JHARKHAND 4 M 27 D F CLUSTER 07-04-18 OPV IPV PENTA ROUTINE A4
334 IND(AEFI)JHPLM18010 2018 JHARKHAND 2M1D M CLUSTER 07-04-18 OPV IPV PENTA ROUTINE A4
335 IND(AEFI)JHPLM18011 2018 JHARKHAND 3M8D F CLUSTER 07-04-18 OPV IPV PENTA ROUTINE A4
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D - UNCLASSIFIABLE
DATE OF
(DD/MM/YYYY)
336 IND(AEFI)KABEL18003 2018 KARNATAKA 9D F SEVERE 01-03-18 BCG ROUTINE A1
337 IND(AEFI)KABLR18001 2018 KARNATAKA 3 M 29 D F DEATH 01-02-18 OPV PENTA ROUTINE D
338 IND(AEFI)KABLU18003 2018 KARNATAKA 5Y4M M HOSPITALIZED 17-05-18 DPT ROUTINE A1
339 IND(AEFI)KABLU18008 2018 KARNATAKA 1 M 15 D M DEATH 16-10-18 OPV IPV PENTA ROUTINE C
340 IND(AEFI)KABMP18004 2018 KARNATAKA 11 M 7 D F HOSPITALIZED 13-02-18 OPV IPV PENTA ROUTINE A1
341 IND(AEFI)KABMP18012 2018 KARNATAKA 1 M 21 D F DEATH 04-10-18 OPV IPV PENTA ROUTINE C
342 IND(AEFI)KABMP18015 2018 KARNATAKA 1 M 26 D M HOSPITALIZED 25-10-18 OPV IPV PENTA ROUTINE C
343 IND(AEFI)KADHA18005 2018 KARNATAKA 1 Y 6 M 12 D M HOSPITALIZED 05-07-18 OPV DPT ROUTINE A1
344 IND(AEFI)KADHA18007 2018 KARNATAKA 3 M 21 D M HOSPITALIZED 04-10-18 OPV PENTA ROUTINE A1
345 IND(AEFI)KADKN18006 2018 KARNATAKA 1 M 22 D F DEATH 26-10-18 OPV IPV PENTA ROUTINE C
346 IND(AEFI)KADKN18007 2018 KARNATAKA 1 M 22 D F CLUSTER 26-10-18 OPV IPV PENTA ROUTINE C
347 IND(AEFI)KAMAN18003 2018 KARNATAKA 1 M 20 D M DEATH 08-02-18 OPV PENTA ROUTINE B2
348 IND(AEFI)KAMAN18004 2018 KARNATAKA 1 M 19 D M DEATH 08-02-18 OPV PENTA ROUTINE C
349 IND(AEFI)KARMN18003 2018 KARNATAKA 1 M 18 D F HOSPITALIZED 17-05-18 OPV IPV PENTA ROUTINE A3
350 IND(AEFI)KARMN18004 2018 KARNATAKA 1 Y 6 M 19 D F HOSPITALIZED 28-06-18 OPV DPT MR ROUTINE A1
351 IND(AEFI)KARMN18006 2018 KARNATAKA 3M4D F HOSPITALIZED 15-09-18 PENTA ROUTINE C
352 IND(AEFI)KARMN18007 2018 KARNATAKA 2 M 15 D F HOSPITALIZED 16-10-18 OPV PENTA ROUTINE C
353 IND(AEFI)KATUM18001 2018 KARNATAKA 1 M 27 D F DEATH 08-02-18 OPV PENTA ROUTINE C
354 IND(AEFI)KAUKN18002 2018 KARNATAKA 6M3D F HOSPITALIZED 10-05-18 OPV IPV PENTA ROUTINE A1
355 IND(AEFI)KEKLM18008 2018 KERALA 6 Y 3 M 25 D M HOSPITALIZED 02-05-18 DPT ROUTINE A1
356 IND(AEFI)KEKLM18020 2018 KERALA 15 Y 20 D M HOSPITALIZED 25-09-18 TT ROUTINE A4
357 IND(AEFI)KEKLM18025 2018 KERALA 2 M 22 D F DEATH 17-10-18 OPV IPV PENTA ROUTINE C
358 IND(AEFI)KEKLM18027 2018 KERALA 3D M SEVERE 20-10-18 BCG ROUTINE A1
359 IND(AEFI)KEKLM18028 2018 KERALA 5 Y 5 M 28 D M HOSPITALIZED 07-11-18 DPT ROUTINE A1
360 IND(AEFI)KEKLM18029 2018 KERALA 1Y3M8D F SEVERE 14-11-18 MMR ROUTINE A1
361 IND(AEFI)KEKLM18030 2018 KERALA 1D F SEVERE 08-10-18 HEP-B ROUTINE A3
362 IND(AEFI)KEKLM18031 2018 KERALA 1D F HOSPITALIZED 15-11-18 HEP-B ROUTINE A1
363 IND(AEFI)KEKLM18032 2018 KERALA 2 M 18 D F SEVERE 16-11-18 OPV PENTA ROUTINE A1
364 IND(AEFI)KEKLM18033 2018 KERALA 9 M 13 D M HOSPITALIZED 16-11-18 MR ROUTINE C
365 IND(AEFI)KEKNU18018 2018 KERALA 3 M 21 D M HOSPITALIZED 15-10-18 IPV PENTA ROUTINE C
366 IND(AEFI)KEKZK18002 2018 KERALA 2M3D F SEVERE 17-01-18 OPV IPV PENTA ROUTINE A3
367 IND(AEFI)KEKZK18008 2018 KERALA 2M7D F HOSPITALIZED 02-05-18 OPV PENTA ROUTINE A1
368 IND(AEFI)KEKZK18009 2018 KERALA 1 M 24 D M HOSPITALIZED 14-05-18 OPV PENTA ROUTINE C
369 IND(AEFI)KEKZK18010 2018 KERALA 1 M 20 D F SEVERE 10-05-18 OPV PENTA ROUTINE A1
370 IND(AEFI)KEPLK18001 2018 KERALA 1 M 19 D M HOSPITALIZED 28-03-18 OPV IPV PENTA ROUTINE A1
371 IND(AEFI)KEPLK18002 2018 KERALA 1 M 16 D F SEVERE 11-04-18 OPV IPV PENTA ROUTINE A3
372 IND(AEFI)KETRM18001 2018 KERALA 1 M 16 D M HOSPITALIZED 24-07-18 PENTA ROUTINE A1
373 IND(AEFI)KETRM18003 2018 KERALA 1 Y 3 M 25 D M SEVERE 10-10-18 MMR ROUTINE C
374 IND(AEFI)KETRM18004 2018 KERALA 1 M 14 D F HOSPITALIZED 25-10-18 OPV IPV PENTA ROUTINE A1
375 IND(AEFI)KETRM18006 2018 KERALA 2D F SEVERE 24-10-18 OPV BCG ROUTINE C
376 IND(AEFI)KETRM18007 2018 KERALA 2 M 24 D M HOSPITALIZED 07-11-18 OPV PENTA ROUTINE A1
377 IND(AEFI)KETRM18008 2018 KERALA 1 M 13 D F DEATH 31-10-18 OPV IPV PENTA ROUTINE C
378 IND(AEFI)KETRM18009 2018 KERALA 5M2D F HOSPITALIZED 27-11-18 OPV IPV PENTA ROUTINE A1
379 IND(AEFI)KETRM18010 2018 KERALA 1 M 24 D M DEATH 10-10-18 OPV IPV PENTA ROUTINE C
380 IND(AEFI)KETRM18011 2018 KERALA 1 M 13 D F HOSPITALIZED 05-12-18 OPV IPV PENTA ROUTINE A1
381 IND(AEFI)KETRM18012 2018 KERALA 5 Y 3 M 22 D M HOSPITALIZED 26-12-18 DPT ROUTINE A1
382 IND(AEFI)KETRM18014 2018 KERALA 1Y3M M HOSPITALIZED 10-11-18 MMR ROUTINE A1
383 IND(AEFI)MHBMC18080 2018 MAHARASHTRA 9 M 21 D F HOSPITALIZED 01-09-18 MEASLES ROUTINE C
384 IND(AEFI)MHKLP18002 2018 MAHARASHTRA 1 Y 6 M 20 D M HOSPITALIZED 01-03-18 OPV DPT MEASLES VIT-A ROUTINE A1
385 IND(AEFI)MHKLP18003 2018 MAHARASHTRA 1 Y 6 M 26 D M HOSPITALIZED 17-07-18 OPV DPT MEASLES ROUTINE A1
386 IND(AEFI)MHKLP18004 2018 MAHARASHTRA 1 M 20 D F HOSPITALIZED 15-01-18 OPV PENTA ROUTINE A3
387 IND(AEFI)MHKLP18005 2018 MAHARASHTRA 1 Y 3 M 16 D F HOSPITALIZED 11-03-18 OPV SIA C
388 IND(AEFI)MHTHN18012 2018 MAHARASHTRA 4M M HOSPITALIZED 02-08-18 OPV IPV PENTA ROUTINE C
389 IND(AEFI)MHTHN18013 2018 MAHARASHTRA 2M M HOSPITALIZED 10-08-18 OPV IPV PENTA ROUTINE C
390 IND(AEFI)MHTHN18014 2018 MAHARASHTRA 10 M 7 D F HOSPITALIZED 09-08-18 MEASLES ROUTINE C
391 IND(AEFI)MHTHN18020 2018 MAHARASHTRA 5 M 18 D F HOSPITALIZED 05-12-18 OPV PENTA ROUTINE C
392 IND(AEFI)MHTHN18021 2018 MAHARASHTRA 1 M 20 D M HOSPITALIZED 26-12-18 OPV IPV PENTA ROUTINE A3
393 IND(AEFI)MNEIM18010 2018 MANIPUR 13 Y 27 D F CLUSTER 26-03-18 MR CAMPAIGN A4
394 IND(AEFI)MNEIM18011 2018 MANIPUR 13 Y 5 M 13 D F CLUSTER 26-03-18 MR CAMPAIGN A4
395 IND(AEFI)MNEIM18012 2018 MANIPUR 13 Y 5 M 13 D F CLUSTER 26-03-18 MR CAMPAIGN A4
396 IND(AEFI)NADPR18001 2018 NAGALAND 7Y7M6D F SEVERE 16-10-18 MR CAMPAIGN A1
397 IND(AEFI)NAPER18001 2018 NAGALAND 12 Y 2 M 27 D M SEVERE 03-10-18 MR CAMPAIGN A1
398 IND(AEFI)ORDNK18001 2018 ODISHA 3 M 25 D F DEATH 16-07-18 IPV ROUTINE C
399 IND(AEFI)ORGJM18001 2018 ODISHA 1 M 21 D M DEATH 03-01-18 OPV IPV PENTA ROTA ROUTINE C
400 IND(AEFI)ORGJM18002 2018 ODISHA 5Y M CLUSTER 29-01-18 MR CAMPAIGN A4
401 IND(AEFI)ORGJM18003 2018 ODISHA 5Y F CLUSTER 29-01-18 MR CAMPAIGN A4
402 IND(AEFI)ORGJM18004 2018 ODISHA 5Y F CLUSTER 29-01-18 MR CAMPAIGN A4
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D - UNCLASSIFIABLE
DATE OF
(DD/MM/YYYY)
403 IND(AEFI)ORGJM18005 2018 ODISHA 8 Y 2 M 15 D M HOSPITALIZED 30-01-18 MR CAMPAIGN C
404 IND(AEFI)ORGJM18006 2018 ODISHA 9Y2M M HOSPITALIZED 30-01-18 MR CAMPAIGN A1
405 IND(AEFI)ORGJM18007 2018 ODISHA 13 Y 25 D F CLUSTER 30-01-18 MR CAMPAIGN A1
406 IND(AEFI)ORGJM18008 2018 ODISHA 14 Y 12 D M CLUSTER 30-01-18 MR CAMPAIGN A4
407 IND(AEFI)ORGJM18009 2018 ODISHA 12 Y 4 M 17 D F CLUSTER 30-01-18 MR CAMPAIGN A4
408 IND(AEFI)ORGJM18010 2018 ODISHA 12Y M CLUSTER 30-01-18 MR CAMPAIGN A4
409 IND(AEFI)ORGJM18011 2018 ODISHA 11 Y 11 M 8 D F SEVERE 01-02-18 MR CAMPAIGN A4
410 IND(AEFI)ORGJM18015 2018 ODISHA 7Y M HOSPITALIZED 06-02-18 MR CAMPAIGN A1
411 IND(AEFI)ORJJP18001 2018 ODISHA 10 Y 10 M 13 D F HOSPITALIZED 15-02-18 MR CAMPAIGN C
412 IND(AEFI)ORJSP18001 2018 ODISHA 7Y 2D F HOSPITALIZED 30-01-18 MR CAMPAIGN C
413 IND(AEFI)ORJSP18003 2018 ODISHA 10 Y 1 M F HOSPITALIZED 05-02-18 MR CAMPAIGN C
414 IND(AEFI)ORJSP18007 2018 ODISHA 3Y6M F HOSPITALIZED 19-02-18 MR ROUTINE C
415 IND(AEFI)RJBTP18001 2018 RAJASTHAN 7M F SEVERE 11-03-18 OPV SIA C
416 IND(AEFI)RJKTA18001 2018 RAJASTHAN 1 M 26 D M HOSPITALIZED 01-08-18 OPV IPV PENTA ROTA ROUTINE A1
417 IND(AEFI)RJKTA18002 2018 RAJASTHAN 5 M 11 D F HOSPITALIZED 10-12-18 OPV IPV PENTA ROTA ROUTINE A1
418 IND(AEFI)RJKTA18003 2018 RAJASTHAN 9 M 23 D F HOSPITALIZED 20-09-18 OPV IPV PENTA MEASLES ROTA ROUTINE C
419 IND(AEFI)RJKTA18004 2018 RAJASTHAN 1 M 28 D F HOSPITALIZED 12-10-18 OPV IPV PENTA ROTA ROUTINE A1
420 IND(AEFI)TNCNI18004 2018 TAMIL NADU 1 M 12 D M HOSPITALIZED 02-01-18 OPV IPV PENTA ROTA ROUTINE C
421 IND(AEFI)TNCNI18005 2018 TAMIL NADU 3M F HOSPITALIZED 28-02-18 OPV PENTA ROTA ROUTINE A1
422 IND(AEFI)TNCNI18013 2018 TAMIL NADU 1 M 20 D M HOSPITALIZED 10-03-18 OPV IPV PENTA ROTA ROUTINE B2
423 IND(AEFI)TNCNI18016 2018 TAMIL NADU 3 M 21 D M DEATH 07-03-18 OPV IPV PENTA ROTA ROUTINE C
424 IND(AEFI)TNCNI18020 2018 TAMIL NADU 2 M 15 D M HOSPITALIZED 13-06-18 OPV PENTA ROTA ROUTINE A1
425 IND(AEFI)TNCNI18021 2018 TAMIL NADU 9M7D F HOSPITALIZED 20-06-18 MR ROUTINE C
426 IND(AEFI)TNCNI18030 2018 TAMIL NADU 6 M 27 D F HOSPITALIZED 04-07-18 OPV IPV PENTA BCG ROTA ROUTINE C
427 IND(AEFI)TNCNI18035 2018 TAMIL NADU 9 M 20 D M HOSPITALIZED 11-07-18 MR ROUTINE C
428 IND(AEFI)TNCNI18051 2018 TAMIL NADU 1 Y 5 M 20 D M HOSPITALIZED 19-09-18 OPV DPT MR ROUTINE C
429 IND(AEFI)TNCNI18052 2018 TAMIL NADU 0D F DEATH 21-08-18 OPV HEP-B ROUTINE C
430 IND(AEFI)TNCNI18053 2018 TAMIL NADU 1 Y 5 M 25 D F HOSPITALIZED 29-08-18 OPV DPT MR ROUTINE A1
431 IND(AEFI)TNCNI18054 2018 TAMIL NADU 1 M 15 D F HOSPITALIZED 16-07-18 OPV IPV PENTA ROTA ROUTINE A1
432 IND(AEFI)TNKPM18003 2018 TAMIL NADU 1Y6M8D M HOSPITALIZED 18-04-18 OPV DPT MR ROUTINE A1
433 IND(AEFI)TNKPM18005 2018 TAMIL NADU 3 M 10 D F HOSPITALIZED 25-04-18 OPV IPV PENTA ROTA ROUTINE C
434 IND(AEFI)TNKPM18010 2018 TAMIL NADU 1 M 13 D M HOSPITALIZED 19-09-18 OPV IPV PENTA ROTA ROUTINE A1
435 IND(AEFI)TNKPM18014 2018 TAMIL NADU 1 M 23 D M HOSPITALIZED 29-08-18 OPV IPV PENTA ROTA ROUTINE A1
436 IND(AEFI)TNSLM18004 2018 TAMIL NADU 9 M 25 D F HOSPITALIZED 04-07-18 MR ROUTINE A1
437 IND(AEFI)TNTLR18001 2018 TAMIL NADU 10 M 2 D F HOSPITALIZED 17-01-18 JE ROUTINE A1
438 IND(AEFI)TNTLR18002 2018 TAMIL NADU 4 M 11 D F HOSPITALIZED 17-01-18 OPV IPV PENTA ROTA ROUTINE B2
439 IND(AEFI)TNTLR18003 2018 TAMIL NADU 1 M 22 D F DEATH 10-01-18 OPV IPV PENTA ROTA ROUTINE C
440 IND(AEFI)TNTLR18011 2018 TAMIL NADU 1 Y 5 M 28 D F HOSPITALIZED 09-05-18 OPV DPT JE MR ROUTINE C
441 IND(AEFI)TNTNJ18002 2018 TAMIL NADU 1 M 25 D F HOSPITALIZED 04-07-18 OPV IPV PENTA ROTA ROUTINE A1
442 IND(AEFI)TNTVM18002 2018 TAMIL NADU 1 Y 8 M 12 D M HOSPITALIZED 08-06-18 MR JE ROUTINE C
443 IND(AEFI)TNVLR18001 2018 TAMIL NADU 2M2D M HOSPITALIZED 24-01-18 OPV IPV PENTA ROTA ROUTINE C
444 IND(AEFI)TNVLR18003 2018 TAMIL NADU 10 M 7 D M HOSPITALIZED 11-04-18 MR ROUTINE C
445 IND(AEFI)TNVLR18007 2018 TAMIL NADU 8 M 15 D M HOSPITALIZED 14-09-18 MR ROUTINE B1
446 IND(AEFI)TNVPM18001 2018 TAMIL NADU 1 Y 6 M 29 D M HOSPITALIZED 11-04-18 OPV DPT MR JE ROUTINE A1
447 IND(AEFI)TNVPM18002 2018 TAMIL NADU 8 M 28 D M HOSPITALIZED 11-04-18 MR JE ROUTINE A1
448 IND(AEFI)TNVPM18003 2018 TAMIL NADU 1Y7M8D M HOSPITALIZED 13-06-18 OPV DPT MR JE ROUTINE A1
449 IND(AEFI)TNVPM18004 2018 TAMIL NADU 4 M 16 D M HOSPITALIZED 28-06-18 OPV PENTA ROUTINE C
450 IND(AEFI)TSBHK18002 2018 TELANGANA 1 M 13 D F DEATH 24-10-18 OPV IPV PENTA ROUTINE C
451 IND(AEFI)TSJSB18001 2018 TELANGANA 11 M 15 D M HOSPITALIZED 17-03-18 MR JE VIT-A ROUTINE C
452 IND(AEFI)TSKDY18001 2018 TELANGANA 1 M 21 D F DEATH 26-09-18 IPV PENTA ROUTINE C
453 IND(AEFI)TSPDP18001 2018 TELANGANA 1 M 29 D M DEATH 23-05-18 OPV IPV PENTA ROUTINE C
454 IND(AEFI)TSRJS18005 2018 TELANGANA 1 M 21 D M DEATH 01-08-18 OPV IPV PENTA ROUTINE C
455 IND(AEFI)TSSGY18001 2018 TELANGANA 3M M HOSPITALIZED 16-06-18 OPV PENTA ROUTINE A1
456 IND(AEFI)TSSYP18003 2018 TELANGANA 6M4D F HOSPITALIZED 20-06-18 OPV IPV PENTA ROUTINE C
457 IND(AEFI)TSWRU18004 2018 TELANGANA 2 Y 29 D M HOSPITALIZED 04-04-18 OPV DPT VIT A ROUTINE A1
458 IND(AEFI)TSWRU18005 2018 TELANGANA 4 M 19 D M HOSPITALIZED 02-04-18 OPV IPV PENTA ROUTINE A1
459 IND(AEFI)TSWRU18006 2018 TELANGANA 4 M 22 D F HOSPITALIZED 14-11-18 MR JE ROUTINE A3
460 IND(AEFI)TSWRU18007 2018 TELANGANA 1 M 27 D M HOSPITALIZED 21-04-18 OPV IPV PENTA ROUTINE A1
461 IND(AEFI)TRTRN18003 2018 TRIPURA 10 Y 6 M 23 D M CLUSTER 28-09-18 MR CAMPAIGN A1
462 IND(AEFI)TRTRN18004 2018 TRIPURA 13 Y 8 M 4 D F CLUSTER 28-09-18 MR CAMPAIGN A1
463 IND(AEFI)TRTRN18005 2018 TRIPURA 13 Y 1 M 10 D M CLUSTER 28-09-18 MR CAMPAIGN A1
464 IND(AEFI)UPALG18001 2018 UTTAR PRADESH 1 M 11 D F DEATH 12-01-18 OPV IPV PENTA ROUTINE C
465 IND(AEFI)UPALG18005 2018 UTTAR PRADESH 14Y F HOSPITALIZED 29-11-18 MR CAMPAIGN A4
466 IND(AEFI)UPALG18008 2018 UTTAR PRADESH 7Y M HOSPITALIZED 03-12-18 MR CAMPAIGN C
467 IND(AEFI)UPALG18019 2018 UTTAR PRADESH 11 Y 4 M 14 D F CLUSTER 29-11-18 MR CAMPAIGN A4
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D - UNCLASSIFIABLE
DATE OF
(DD/MM/YYYY)
473 IND(AEFI)UPALG18025 2018 UTTAR PRADESH 8Y F CLUSTER 06-12-18 MR CAMPAIGN A4
474 IND(AEFI)UPALG18026 2018 UTTAR PRADESH 6Y M CLUSTER 06-12-18 MR CAMPAIGN A4
479 IND(AEFI)UPALG18048 2018 UTTAR PRADESH 11 Y 11 M 5 D M CLUSTER 06-12-18 MR CAMPAIGN A4
480 IND(AEFI)UPALG18049 2018 UTTAR PRADESH 8Y9M4D F CLUSTER 06-12-18 MR CAMPAIGN A4
487 IND(AEFI)UPALG18056 2018 UTTAR PRADESH 8Y4M1D F CLUSTER 06-12-18 MR CAMPAIGN A4
491 IND(AEFI)UPBAD18010 2018 UTTAR PRADESH 11Y M CLUSTER 13-12-18 MR CAMPAIGN A4
492 IND(AEFI)UPBAD18011 2018 UTTAR PRADESH 10Y F CLUSTER 13-12-18 MR CAMPAIGN A4
497 IND(AEFI)UPBAD18016 2018 UTTAR PRADESH 13 Y 4 M F CLUSTER 11-12-18 MR CAMPAIGN A4
514 IND(AEFI)UPBLS18008 2018 UTTAR PRADESH 10 Y 6 M F CLUSTER 26-11-18 MR CAMPAIGN A4
515 IND(AEFI)UPBLS18009 2018 UTTAR PRADESH 11 Y 4 M 19 D F CLUSTER 26-11-18 MR CAMPAIGN A4
516 IND(AEFI)UPBLS18010 2018 UTTAR PRADESH 11 Y 8 M 14 D F CLUSTER 26-11-18 MR CAMPAIGN A4
517 IND(AEFI)UPBLS18011 2018 UTTAR PRADESH 10 Y 1 M 6 D M SEVERE 26-11-18 MR CAMPAIGN A4
518 IND(AEFI)UPBLS18027 2018 UTTAR PRADESH 11 Y 2 D F SEVERE 06-12-18 MR CAMPAIGN A4
519 IND(AEFI)UPMRT18001 2018 UTTAR PRADESH 1 M 24 D F DEATH 16-01-18 OPV IPV PENTA ROUTINE C
520 IND(AEFI)UPMRT18002 2018 UTTAR PRADESH 4M3D F HOSPITALIZED 04-07-18 OPV PENTA ROUTINE C
521 IND(AEFI)UPMZP18001 2018 UTTAR PRADESH 3Y6M6D F HOSPITALIZED 05-08-18 OPV SIA C
522 IND(AEFI)UPPSN18009 2018 UTTAR PRADESH 0D M SEVERE 03-09-18 OPV HEP-B ROUTINE A3
523 IND(AEFI)UPSHA18002 2018 UTTAR PRADESH 9Y F CLUSTER 06-12-18 MR CAMPAIGN A4
524 IND(AEFI)UPSHA18003 2018 UTTAR PRADESH 14Y M CLUSTER 06-12-18 MR CAMPAIGN A4
Page 8 of 10
783
D - UNCLASSIFIABLE
DATE OF
(DD/MM/YYYY)
539 IND(AEFI)UPSTP18001 2018 UTTAR PRADESH 2 M 19 D M DEATH 15-01-18 OPV PENTA ROUTINE C
540 IND(AEFI)UPSTP18003 2018 UTTAR PRADESH 12 Y 2 M 11 D F CLUSTER 27-11-18 MR CAMPAIGN A4
541 IND(AEFI)UPSTP18004 2018 UTTAR PRADESH 13Y F CLUSTER 27-11-18 MR CAMPAIGN A4
544 IND(AEFI)UPSTP18007 2018 UTTAR PRADESH 13 Y 3 M 24 D M CLUSTER 27-11-18 MR CAMPAIGN A4
556 IND(AEFI)WBAPD18001 2018 WEST BENGAL 3 M 27 D F HOSPITALIZED 03-01-18 OPV PENTA ROUTINE C
557 IND(AEFI)WBAPD18010 2018 WEST BENGAL 1D M HOSPITALIZED 07-08-18 OPV HEP-B BCG ROUTINE A3
558 IND(AEFI)WBCAL18013 2018 WEST BENGAL 1 M 15 D F HOSPITALIZED 18-07-18 OPV IPV PENTA ROUTINE C
559 IND(AEFI)WBCAL18019 2018 WEST BENGAL 1M 15D M HOSPITALIZED 03-11-18 DTaP+IPV+HIB+HEP B PCV ROTA ROUTINE A1
560 IND(AEFI)WBCAL18020 2018 WEST BENGAL 7 M 14 D F HOSPITALIZED 14-11-18 OPV IPV PENTA ROUTINE C
562 IND(AEFI)WBDDJ18004 2018 WEST BENGAL 4 M 29 D M HOSPITALIZED 05-09-18 PENTA ROUTINE A3
564 IND(AEFI)WBHGL18002 2018 WEST BENGAL 12 D F DEATH 28-01-18 OPV SIA D
565 IND(AEFI)WBHGL18003 2018 WEST BENGAL 3 M 13 D F DEATH 10-01-18 OPV PENTA ROUTINE C
566 IND(AEFI)WBHGL18012 2018 WEST BENGAL 1Y5M5D F HOSPITALIZED 05-09-18 OPV DPT MR JE ROUTINE A1
567 IND(AEFI)WBHGL18013 2018 WEST BENGAL 2 M 24 D M HOSPITALIZED 05-09-18 OPV PENTA ROUTINE A1
568 IND(AEFI)WBHRA18003 2018 WEST BENGAL 9 M 26 D M HOSPITALIZED 15-02-18 MEASLES JE VIT-A ROUTINE B2
569 IND(AEFI)WBHRA18010 2018 WEST BENGAL 1 Y 8 M 10 D M HOSPITALIZED 09-08-18 OPV DPT ROUTINE A1
570 IND(AEFI)WBHRA18011 2018 WEST BENGAL 2M F HOSPITALIZED 14-08-18 OPV IPV PENTA ROUTINE C
571 IND(AEFI)WBHRA18012 2018 WEST BENGAL 1 Y 5 M 14 D M CLUSTER 05-09-18 OPV DPT MR ROUTINE A1
572 IND(AEFI)WBHRA18013 2018 WEST BENGAL 1 Y 5 M 14 D M CLUSTER 05-09-18 OPV DPT MR ROUTINE A1
573 IND(AEFI)WBHRA18015 2018 WEST BENGAL 4M M HOSPITALIZED 01-11-18 IPV PENTA ROUTINE A1
574 IND(AEFI)WBJHG18002 2018 WEST BENGAL 1 M 18 D M HOSPITALIZED 09-08-18 OPV IPV PENTA ROUTINE A1
575 IND(AEFI)WBNDA18001 2018 WEST BENGAL 3 M 22 D M HOSPITALIZED 26-07-18 OPV PENTA ROUTINE A1
576 IND(AEFI)WBNPG18011 2018 WEST BENGAL 1D F SEVERE 22-07-18 OPV HEP-B BCG ROUTINE A3
577 IND(AEFI)WBNPG18013 2018 WEST BENGAL 1D M HOSPITALIZED 04-08-18 OPV HEP-B BCG ROUTINE A3
578 IND(AEFI)WBNPG18014 2018 WEST BENGAL 1 Y 3 M 21 D F HOSPITALIZED 19-09-18 OPV DPT MR JE ROUTINE A1
579 IND(AEFI)WBNPG18015 2018 WEST BENGAL 2 M 25 D F DEATH 27-09-18 OPV PENTA ROUTINE C
580 IND(AEFI)WBNPG18017 2018 WEST BENGAL 1 M 16 D M HOSPITALIZED 30-10-18 OPV IPV PENTA ROUTINE A1
581 IND(AEFI)WBNPG18018 2018 WEST BENGAL 9D M SEVERE 01-11-18 OPV BCG ROUTINE A3
582 IND(AEFI)WBSPG18010 2018 WEST BENGAL 3M4D M SEVERE 07-02-18 OPV PENTA ROUTINE A1
583 IND(AEFI)WBTML18003 2018 WEST BENGAL 1 M 26 D M HOSPITALIZED 04-07-18 OPV IPV PENTA ROUTINE A1
584 IND(AEFI)WBTML18004 2018 WEST BENGAL 3M1D F HOSPITALIZED 08-08-18 OPV PENTA ROUTINE A3
585 IND(AEFI)WBTML18009 2018 WEST BENGAL 1D M HOSPITALIZED 26-08-18 OPV HEP-B BCG ROUTINE A3
586 IND(AEFI)APCHT19001 2019 ANDHRA PRADESH 4 Y 3 M 10 D M HOSPITALIZED 17-01-19 DPT VIT-A ROUTINE A1
587 IND(AEFI)BISAM19001 2019 BIHAR 13 Y F CLUSTER 21-01-19 MR CAMPAIGN A4
588 IND(AEFI)BISAM19002 2019 BIHAR 8Y3M3D F CLUSTER 21-01-19 MR CAMPAIGN A4
589 IND(AEFI)BISAM19003 2019 BIHAR 11 Y 6 M 14 D M CLUSTER 21-01-19 MR CAMPAIGN A4
591 IND(AEFI)BISAM19005 2019 BIHAR 12 Y F CLUSTER 21-01-19 MR CAMPAIGN A4
593 IND(AEFI)BISAM19007 2019 BIHAR 11 Y 10 M 9 D F CLUSTER 21-01-19 MR CAMPAIGN A4
594 IND(AEFI)DLCEN19001 2019 DELHI 2 M 10 D M HOSPITALIZED 08-01-19 OPV IPV PENTA ROUTINE C
595 IND(AEFI)GOGON19001 2019 GOA 2 M 17 D F HOSPITALIZED 21-01-19 PENTA ROUTINE A1
597 IND(AEFI)KARMN19001 2019 KARNATAKA 4 M 13 D F HOSPITALIZED 17-01-19 OPV IPV PENTA ROUTINE A1
598 IND(AEFI)KEKNU19001 2019 KERALA 4 M 12 D F HOSPITALIZED 16-01-19 OPV PENTA ROUTINE A1
599 IND(AEFI)KEKNU19002 2019 KERALA 1 M 18 D M SEVERE 09-01-19 OPV IPV PENTA ROUTINE A3
600 IND(AEFI)KEKNU19003 2019 KERALA 7 M 27 D M HOSPITALIZED 17-01-19 OPV PENTA ROUTINE A1
601 IND(AEFI)KEPLK19001 2019 KERALA 3 M 26 D F HOSPITALIZED 02-01-19 OPV IPV PENTA ROUTINE A1
602 IND(AEFI)MPBLG19001 2019 MADHYA PRADESH 14 Y 1 M 16 D F HOSPITALIZED 17-01-19 MR CAMPAIGN A4
603 IND(AEFI)MPNMC19001 2019 MADHYA PRADESH 12 Y 3 M M DEATH 19-01-19 MR CAMPAIGN C
Page 9 of 10
784
D - UNCLASSIFIABLE
DATE OF
(DD/MM/YYYY)
604 IND(AEFI)MHBMC19002 2019 MAHARASHTRA 14 Y 4 M 17 D F SEVERE 07-01-19 MR CAMPAIGN A1
605 IND(AEFI)MHTHN19001 2019 MAHARASHTRA 2M4D F HOSPITALIZED 10-01-19 OPV IPV PENTA ROUTINE A3
606 IND(AEFI)MHTHN19004 2019 MAHARASHTRA 3M7D F SEVERE 11-01-19 OPV PENTA ROUTINE A1
607 IND(AEFI)MHTHN19007 2019 MAHARASHTRA 1 M 24 D F HOSPITALIZED 01-01-19 OPV IPV PENTA ROUTINE A3
608 IND(AEFI)MZKLS19001 2019 MIZORAM 2 M 22 D F HOSPITALIZED 09-01-19 OPV IPV PENTA ROUTINE C
Page 10 of 10
785
ANNEXURE P-23
MANU/SC/0531/2020
Equivalent Citation: 2021(2)ABR488, AIR2021SC 843, 2021(1)ALLMR799, 2020 (5) SC J 94
IN THE SUPREME COURT OF INDIA

Transferred Case (Civil) Nos. 213-227 of 2020 (Transfer Petitions (Civil) Nos. 87-101
of 2014), C.A. Nos. 2024-27 of 2020 (SLP (C) No. 4124-4127 of 2016), C.A. Nos.
2028-31 of 2020 (SLP (C) No. 26480-26483 of 2017), C.A. No. 2032 of 2020 (SLP
(C) No. 25160 of 2017), C.A. No. 2035 of 2020 (SLP (C) No. 608 of 2018), C.A. No.
2036 of 2020 (SLP (C) No. 606 of 2018), C.A. No. 2033 of 2020 (SLP (C) No. 9547 of
2018), C.A. No. 2034 of 2020 (SLP (C) No. 9546 of 2018), C.A. No. 2037 of 2020
(SLP (C) No. 9572 of 2018), C.A. No. 2039 of 2020 (SLP (C) No. 1171 of 2018), C.A.
No. 2038 of 2020 (SLP (C) No. 1151 of 2018), C.A. No. 2040 of 2020 (SLP (C) No.
36434 of 2017), C.A. No. 2041 of 2020 (SLP (C) No. 26391 of 2018), Writ Petition
(C) No. 926 of 2018, C.A. No. 2042 of 2020 (SLP (C) No. 26373 of 2018), C.A. No.
2043 of 2020 (SLP (C) No. 15328 of 2019) and Writ Petition (C) No. 1501 of 2019
(Petitions Filed Under Article 139A(1) with Order XXXVI-A Part IVA)
Decided On: 05.03.2020
Appellants: The Pharmacy Council of India
Vs.
Respondent: Dr. S.K. Toshniwal Educational Trusts, Vidarbha Institute of
Pharmacy and Ors.
Hon'ble Judges/Coram:
Arun Mishra, Vineet Saran and M.R. Shah, JJ.
Counsels:
For Appearing Parties: Pinky Anand, ASG, Maninder Singh, P.N. Ravindran, Deepak
Nagalkar, Vinay Navare, Sr. Advs., Amit Sharma, Gopal Jha, G.S. Makker, Saudamini
Sharma, Hemant Arya, Chakitan V.S. Papta, Zoheb Hossain, Prabhas Bajaj, Piyush
Goyal, Ashita Chawla, Atul Shankar, Dileep Pillai, M.P. Vinod, P.S. Sudheer, Rishi
Maheshwari, Bharat Sood, Anne Mathew, Shruti Jose, Rituraj Biswas, Amitesh Kumar,
Binisa Mohanty, Priti Kumari, Mritunjay Kumar Sinha, Adil Muneer Andrabi, Mohd.
Imran P., Amir Yousuf W., Sadam Hussain, Advs., S.M. Jadhav and Company,
Sudhanshu S. Choudhari, Yogesh Colte, Mahesh P. Shinde, Gwen Karthika, Abha R.
Sharma, Amol Nirmalkumar Suryawanshi, Qurratulain, Shivaji M. Jadhav, Brij Kishor
Sah, Nicholas Choudhary, Shivam Singh, Ravi Kant, Mayank Manish, Chandra Shekhar
Singh, Rozer Willsan Mathew, Hitesh Kumar Sharma, Akhileshwar Jha, Willson
Thomas, Advs. for M.K. Sinha, Adv., Sachin Patil, Preshit Vilas Surshe, Nishant
Ramakantrao Katneshwarkar, Saurav Agrawal, Vibhu Anshuman, Suhas Kadam, Advs.
for Lemax Lawyers & Co., Gaurav Agrawal, Bijoy Kumar Jain, Sridhar Potaraju,
Shweta Parihar, Shiwani Tushir, G. Ushasri, Vishnu Thulasi Menon, Rajiv Ranjan
Dwivedi, Anil Soni, Harish Pandey, Aniruddha Deshmukh, Chandra Prakash, AOR and
Ashish Kumar Tiwari, Advs.
For Respondents/Defendant: Party-in-Person
JUDGMENT
M.R. Shah, J.
25-08-2021 (Page 1 of 23) www.manupatra.com SARVADAMAN OBEROI

786
1. Transfer Petitions (Civil) Nos. 87-101 of 2014 are allowed and Writ Petition Nos.
3783 of 2013 - Dr. S.K. Toshniwal Educational Trust's Vidarbha Institute of Pharmacy
v. The State of Maharashtra and Ors., W.P. No. 3945 of 2013 - Young Engineer's
Education Society v. The State of Maharashtra and Ors. pending in the High Court of
Judicature at Bombay, Nagpur Bench, Nagpur, W.P. No. 4992 of 2013 - The Shirpur
Education Society and Anr. v. The State of Maharashtra and Ors., W.P. No. 5104 of
2013 - Shri Bhagwan College of Pharmacy v. The State of Maharashtra and Ors., W.P.
No. 5150 of 2013 - Kiran and Ors. v. The State of Maharashtra and Ors., W.P. No.
5681 of 2013 - Yashodabai Dagadu Saraf Charitable Trust and Anr. v. The State of
Maharashtra and Ors., W.P. No. 5914 of 2013 -Nagaon Education Society's Institute
of Pharmacy, Nagaon v. The State of Maharashtra and Ors. pending in the High Court
of Judicature at Bombay Bench at Aurangabad, W.P. No. 19253 of 2013 - Aldel
Education Trust v. All India Council for Technical Education, W.P. 19254 of 2013 -
Shikshan & Krushi Vikas Pratishthan Medshingi v. All India Council for Technical
Education and Ors., W.P. 19255 of 2013 - K.B.H.S.S. Trust v. All India Council for
Technical Education and Ors. pending in the High Court of Judicature at Bombay,
W.P. No. 19887 of 2013 - The Shirpur Education Society and Anr. v. The State of
Maharashtra pending in the High Court of Judicature at Bombay Bench at Aurangabad,
W.P. No. 25857 of 2013 - St. Mary's Group of Institutions Hyderabad v. The
Pharmacy Council of India and Ors., W.P. No. 26077 of 2013 - B. Sridhar and Ors. v.
The Pharmacy Council of India and Ors., W.P. No. 26286 of 2013 - St. Mary's Group
of Institutions Guntur v. The Pharmacy Council of India and Ors. pending in the High
Court of Judicature at Andhra Pradesh at Hyderabad and W.P. 1388 of 2013 - Kashi
Institute of Pharmacy v. Union of India and Ors. pending in the High Court of
Judicature at Allahabad, Lucknow Bench, Lucknow are transferred to this Court.
2. Leave granted in the Special Leave Petitions.
3. As common question of law and facts arise in this group of cases, all these cases
are being decided together by this common judgment and order.
4 . In all these petitions, respective Respondent-Colleges approached the respective
High Courts with the grievance regarding actions of approval of the second shift by
the Pharmacy Council of India (hereinafter referred to as the PCI) and restriction on
increasing the intake capacity of students for various pharmacy courses. Since the
respective Respondent Colleges increased the intake of students, based upon the
requisite permission/approval obtained from the All India Council of Technical
Education (hereinafter referred to as the AICTE), the respective HighCourts have
allowed the colleges to increase/continue with the increase in intake. The respective
High Courts have concluded that AICTE is the supreme authority between the two
bodies, namely, AICTE and PCI and the decision of AICTE will prevail over the
decision of PCI. That, by the interim orders, the High Court allowed the Institutions to
continue with the increased number of intake as approved/permitted by AICTE. That,
in some of the cases, such interim orders have been made absolute. Therefore, the
issue involved in the present batch of cases is regarding the applicability of the
Pharmacy Act, 1948 (hereinafter referred to as the Pharmacy Act) or the All India
Council of Technical Education Act, 1987 (hereinafter referred to as the AICTE Act) in
relation to the subject of Pharmacy, including approval of courses of study, minimum
standards of education required for qualification as a Pharmacist, registration as a
Pharmacist, Regulation of future professional conduct etc.
SUBMISSIONS OF PCI

787
5 . Shri Maninder Singh, learned Senior Advocate appearing on behalf of PCI has
vehemently submitted the following arguments:
5.1 That having regard to the statutory scheme contained in the Pharmacy
Act, which is a complete code by itself dealing with the subject of pharmacy,
the jurisdiction for regulating the standards of education in the subject of
pharmacy and subsequent professional conduct of pharmacists vests entirely
in the PCI and AICTE does not have any jurisdiction or power in this behalf.
5.2 That, as such, the issue involved in the present batch of cases is now not
res integra and is clearly covered by the decision of this Court in the case of
AICTE v. Shri Prince Shivaji Maratha Boarding House's College of
Architecture MANU/SC/1534/2019 : (2019) 16 SCALE 421. It is submitted
that, in the said case, while dealing with an identical statutory scheme in the
case of Council of Architecture constituted under the Architects Act, 1972,
this Court has held that even when the definition of "technical education" in
Section 2(g) of the AICTE Act also uses the word "architecture", the said
word would have to be dropped from the definition of "technical education"
and shall be treated as inapplicable in cases where AICTE imports its
regulatory framework. It is further submitted that, in that case, it is held that
insofar as recognition of degrees and diplomas of architecture education is
concerned, the Architecture Act, 1972 would prevail and that AICTE shall not
be entitled to impose any regulatory measure in connection with the degrees
and diplomas in the subject of architecture. Heavy reliance has been placed
upon paragraphs 67 to 70 of the said decision.
That, in the said decision, this Court considered the entirely identical
statutory scheme contained in the Architects Act, 1972 and therefore the
same would squarely apply for interpretation of the Pharmacy Act as well. It
is submitted that even in the case of pharmacy, the stand of AICTE is based
solely upon the user of the word "pharmacy" in the definition of "technical
education" in Section 2(g) of the AICTE Act. It is submitted that having
regard to the law laid down by this Court in the aforesaid decision, as well as
the statutory scheme under the Pharmacy Act, the said word "pharmacy"
would deserve to be dropped from the definition of "technical education"
Under Section 2(g) of the AICTE Act and would deserve to be held to be
inapplicable in relation to the regulatory measures for prescribing minimum
standards for education in the field of pharmacy.
5.3 That even otherwise and having regard to the statutory scheme under the
Pharmacy Act, which is a complete code and a special law in relation to
subject of pharmacy, PCI is empowered to not only regulate the profession of
Pharmacy, but also the educational institutions from which persons may
obtain the qualification as a pharmacist and that AICTE does not have any
jurisdiction in that behalf.
5.4 That pharmacy is the profession of preparing, preserving, compounding
and dispensing medical drugs. It is submitted that, under the Pharmacy Act,
the PCI has been constituted as a body empowered to regulate the education
and profession of Pharmacy in India. It is submitted that PCI has been
empowered to determine and enforce the qualifications required for a person
to practice as Pharmacist in India, including approving courses of study and
institutions which may offer such courses of study to enable one to practice

788
the profession of a pharmacist. Relying upon the Statement of Objects and

Reasons of the Pharmacy Act, it is vehemently submitted by the learned
Senior Advocate appearing for PCI that PCI is supposed to prescribe the
minimum standards of education and approve courses of study for
pharmacists.
5 . 5 That pharmacy is one of the several disciplines/subjects where the
Legislature has laid down that for imparting education in that subject, the
minimum standards are to be prescribed by an autonomous statutory body
comprising of eminent professionals in the field. It is submitted that they not
only prescribe the standard of education of different courses in the
discipline/subject, they also lay down eligibility conditions for students as
well as teachers, course content, standards for evaluation of examination etc.
It is submitted that they also approve the courses in the subject in
colleges/institutions on the basis of the laid down norms by verification by
inspections. It is submitted that the law also deals with the registration of the
professionals in that discipline as well as their subsequent conduct as
registered professionals.
5.6 That it is very much important and/or necessary that the autonomous
statutory authority which is made obliged to supervise and monitor the
conduct of professionals by the Legislature in a particular discipline is also
given a free hand to decide about the standards of education, approval of
courses/institutions evaluation of standards of examination and thereafter
grant of registration.
5 . 7 That the Legislature has clearly envisaged only one autonomous
statutory authority to undertake all these integrated functions and it is
impossible to conceive that in the same very occupied field, another statutory
authority, seeks to assume/usurp jurisdiction thereby creating unsavory
practical problems, conflicts and inconsistencies, thereby defeating the entire
objective sought to be achieved by the Special Law.
5.8 That subject of Pharmacy is a special and not a general subject. It is
submitted that it has been exhaustively dealt with by the Parliament through
the Pharmacy Act which exhaustively covers all areas inclusive of approval of
courses, laying down course content, eligibility conditions for students as
well as teachers, evaluation of standards of examination, grant of
registration, taking action for any infamous conduct etc. It is submitted that
this entire legislative objective is achieved through the Pharmacy Act and the
statutory Rules and Regulations made thereunder.
5 . 9 That Section 10 of the Pharmacy Act empowers the PCI to frame
Education Regulations prescribing the minimum standards of education
required for qualification as a pharmacist. It is submitted that as per Section
10(2), such Education Regulations may prescribe -
(a) the nature and period of study and of practical training to be
undertaken before admission to an examination;
(b) the equipment and facilities to be provided for students
undergoing approved courses of study;
(c) the subjects of examination and the standards therein to be

789
attained;
(d) any other conditions of admission to examinations.
5 . 1 0 That the power to approve courses of study and examination is
contained in Section 12 of the Pharmacy Act. It is submitted that under this
provision, any "authority" in a State that is empowered to conduct a course
of study in pharmacy may apply to the Central Council for approval of the
course in accordance with the Education Regulations. It is further submitted
that likewise, any authority which conducts an examination in a State for
pharmacy may apply to the PCI for approval of such examination. It is
submitted that a student who has passed/completed an approved course and
passed an approved examination may therefore be registered as a
Pharmacist, subject to meeting other requirements. It is submitted that
therefore, under the Pharmacy Act, the approval of PCI in conducting any
course of pharmacy is mandatory and, in the absence of the same, no
student can be awarded the degree or diploma for such a course which
makes him entitled for registration as a pharmacist to practice the profession
of pharmacy in the country. It is submitted that Section 12(1) of the
Pharmacy Act empowers the PCI to grant approval to an Institution which
conducts a "course of study" for pharmacist. It is submitted that, as per
Section 12, an application has to be made to the Central Council seeking
approval which after such enquiry, as it thinks fit to make, that the said
course of study is in conformity with the Education Regulations envisaged
Under Section 10 prescribing the minimum standard of education required for
qualification as a pharmacist, shall declare the said course of study for the
purpose of admission to be an approved examination for pharmacists.
5.10.1 That Section 13 of the Pharmacy Act also empowers the Central
Council to withdraw approval accorded to the 'course of study' and
'examination' for failure to comply with the prescribed norms.
5.10.2 That Section 16 empowers the Executive Committee to appoint
inspectors to inspect any institution which provides an approved course of
study or those institutions which apply for approval of course of study or
examination.
5.10.3 That Section 29 deals with the preparation and maintenance of a
register of pharmacists. Section 35 provides for entry of additional
qualifications in the register in relation to any registered pharmacist. Section
36 provides for the removal of any person from the register, either
permanently or for a temporary period. That it is evident therefore that PCI
does not just regulate the provisions itself, but also plays a vital role in
regulating entry into the profession by approving the courses and
examination which constitute appropriate qualifications to be registered as a
pharmacist Under Section 32(2). It is submitted that Under Section 42 of the
Pharmacy Act, a person may not practice the profession of pharmacy unless
he or she is registered as a pharmacist in accordance with the Pharmacy Act
and Section 42(2) is a penal provision which states that any person who is
not a registered pharmacist and contravenes Section 42(1) shall be
punishable with imprisonment for a term which may extend to six months, or
with fine not exceeding one thousand rupees or with both.

790
5.11 That in exercise of powers vested in it under the Pharmacy Act, the PCI
has framed a number of Regulations for prescribing minimum standards of
education as well as regulating the subject of pharmacy in India, including:
a. Education Regulations, 1991;
b. Pharm. D. Regulations, 2008;
c. Minimum Qualifications for Teachers in Pharmacy Institutions
Regulations, 2014;
d. Bachelor of Pharmacy (B. Pharm) Course Regulations, 2014;
e. Master of Pharmacy (M. Pharm) Course Regulations, 2014;
f. Bachelor of Pharmacy (Practice) Regulations, 2014;
g. Pharmacy Practice Regulations, 2015.
5.12 That the aforesaid statutory scheme clearly demonstrates that the field
of Pharmacy is fully occupied with all details and is all pervasive. It is
submitted that it is fully covered and governed not only by the provisions of
the Pharmacy Act, but also supplemented by the statutory Rules and statutory
Regulations made thereunder; thereby providing a complete code on the
subject of Pharmacy.
5.13 That the legislative intent in enacting the Pharmacy Act was to ensure
that there is seamless Regulation of the profession, both in terms of the
qualifications required to be registered as a pharmacist and the actual
practice of pharmacy as a profession. It is submitted that the same scheme
has been adopted by the Parliament with respect to, inter alia, the legal
profession (Bar Council of India), medical profession (Medical Council of
India), architects (Architecture Council of India), nursing (Nurses Council of
India) and dentistry (Dental Council of India). It is submitted that therefore
the Pharmacy Act is a special law dealing with the subject/field of pharmacy.
5.14 That, on the other hand, the AICTE Act is merely to ensure that the
standards are maintained in the area of technical education and that it is not
intended to take over all aspects of the Regulation of specialized education in
India for which specialized regulatory bodies already operate under their
respective laws. It is submitted that a perusal of the Statement of Objects
and Reasons of the AICTE Act demonstrates that AICTE had been for assisting
and guiding the Central Government in relation to policies on the subject of
engineering and similar technical subjects. That it has not been created to
dilute, in any manner whatsoever, the autonomy and authority of other
statutory bodies. It is submitted that it does not oversee any course which
requires registration of professionals and their conduct. That it has no
jurisdiction whatsoever on the subject of medicine, dentistry, architecture as
well as pharmacy.
5.15 That the scope of powers of the AICTE and the legislative intent behind
the AICTE Act has been explained by this Court in the case of
Bharathidasan University v. All-India Council for Technical Education
MANU/SC/1689/2001 : (2001) 8 SCC 676. Heavy reliance has been placed on

791
Paragraphs 8 and 10.

5.16 That therefore the legislative intent behind the AICTE Act is therefore
clear. It is not intended to replace or supersede existing regulatory bodies,
but rather was intended to focus on coordinating and improving the
standards of technical education across the country in an advisory capacity.
It is submitted that therefore in the Regulation of Pharmacy education, PCI
continues to be the regulator of the educational institutions under the
Pharmacy Act. That in relation to Regulation of educational institutions in the
field of Pharmacy, the provisions of the Pharmacy Act being a Special Law
dealing with the subject of "Pharmacy" would prevail over the AICTE Act,
being a General Law for "technical education".
5 .1 7 That even otherwise the Pharmacy Act being a special law on the
subject of Pharmacy would prevail over the AICTE Act. It is submitted that it
is a settled position of law that a special law dealing with any subject would
prevail over the general law which may be dealing with the said subject only
incidentally. That this principle of law is also enshrined in the maxim
generalia specialibus non derogant. It is submitted that it is an exception to
the principle that a latter statute would prevail over an earlier statute. It is
submitted that therefore an earlier Special Law would prevail over a later
General Law. In support of the above submissions, heavy reliance has been
placed upon the decisions of this Court in the cases of UPSEB v. Hari
Shanker Jain MANU/SC/0500/1978 : (1978) 4 SCC 16;LIC of India v.
D.J. Bahadur MANU/SC/0305/1980 : (1981) 1 SCC 315 andYakub Abdul
Razak Memon v. State of Maharashtra MANU/SC/0268/2013 : (2013) 13
SCC 1.
5.18 Relying upon the above decisions, it is urged that even in case of any
conflict, the Pharmacy Act being a special law dealing with the special
subject of pharmacy would prevail over the AICTE Act being a general law in
the field of technical education.
5.19 That even the submission on behalf of the Respondents based on the
principle of 'implied repeal' are entirely misconceived and erroneous. It is
submitted that it has been held by this Court in the case of Municipal
Council v. T.J. Joseph MANU/SC/0032/1963 : (1964) 2 SCR 87 that when
two laws are made by the Legislature at different points of time, dealing with
the same subject matter, there is no presumption that the later law impliedly
repeals the earlier law. Heavy reliance is also placed upon the decision of
this Court in Byram Prestonji Gariwala v. Union Bank of India
MANU/SC/0485/1991 : (1992) 1 SCC 31. That in the aforesaid decision, it is
held by this Court that any fundamental change/alteration in law cannot be
presumed by applying the principle of "implied repeal". That it is held that
any fundamental change/alteration in law, can only be carried out by explicit
words, and not "by a sidewind". That therefore, in the aforesaid decision, the
contention based on the principle of "implied repeal" has been rejected.
5.19.1 That therefore having regard to the Statement of Objects and Reasons
as well as the scheme of the AICTE Act, as also explained in para 8 of the
judgment in Bharthidarsan case (supra), it is abundantly clear that the
Parliament has not intended to fundamentally alter the existing regime where
- from the stage of prescribing the minimum standards of education,

792
approving the courses of study to the stage of registration and future

monitoring of professional conduct of pharmacist the Pharmacy Act vests the
PCI with such jurisdiction and power.
5.19.2 That as such the AICTE Act cannot be treated to have, in any manner
whatsoever, affected the jurisdiction and power of the PCI in this behalf. It is
submitted that therefore AICTE Act cannot be held to have "implied repealed"
the Pharmacy Act and any contention to the contrary would deserve to be
rejected by this Court.
5.19.3 That in the absence of any express or implied legislative intent, the
AICTE Act cannot be held to have repealed the Pharmacy Act and on the
contrary, the provisions of the Pharmacy Act, being a special law dealing
comprehensively with the subject of Pharmacy, would prevail over the AICTE
Act.
5 .2 0 This Court while disposing of SLP (c) Diary No. 24798 of 2018 -
Progressive Education Society's College of Pharmacy v. State of
Maharashtra (dated 24.07.2018) has observed that "it is desirable that the
Government of India should revisit the definition in Section 2(g) of the AICTE
Act. Whether there could have been inclusion of pharmacy when it was
already converted by the Pharmacy Act". It is submitted that in fact thereafter
in a inter-Ministerial meeting held on 30.09.2019 between the Minister of
Health and Family Welfare, Government of India and Minister of HRD,
Government of India, a decision has been taken that the word "pharmacy"
would be deleted from the definition of "technical education" under the
AICTE Act. However, the said amendment is still to be carried out. It is
submitted that even the proposed Higher Education Commission of India Bill,
2019, which seeks to repeal the UGC and AICTE Acts and the Allied and
Healthcare Professions Bill, 2018, which seeks to bring into existence a
regulatory mechanism for 53 allied and healthcare professions such as
physiotherapists, radiologists, nutritionists etc., have no relation whatsoever
with the PCI. It is submitted that all the four Councils dealing with Medicine,
Dentistry, Pharmacy and Nursing would continue to discharge their respective
duties and activities under special enactments.
5.21 That the submission of the Respondent Colleges and the AICTE Act to
the effect that PCI can regulate only the grant of Diploma in Pharmacy and
not the further courses/qualifications, is absolutely erroneous, misconceived
and unsustainable in law in view of the specific provisions Under Sections 12
and 35 of the Pharmacy Act. It is submitted that Sections 12 and 35 makes it
abundantly clear that it is all courses in relation to pharmacy which get
covered by the scheme of the Pharmacy Act.
5.22 That the primary reason of conflict between the AICTE and PCI was on
account of AICTE permitting colleges to double the intake capacity for
courses where the intake capacity had been fixed by the PCI, and also on
account of AICITE permitting the second shift (evening classes) contrary to
the Regulations of PCI.
5.23 That even recently a public notice has been issued by the AICTE which
informs that AICTE is still inviting applications for grant of approval for
courses of Architecture, despite the decision of this Court in Shri Prince

793
Shivaji Maratha Boarding House's College of Architecture (supra).

That therefore even the said public notice is in the teeth of this Court's
judgment and order and the same is nothing but deliberate disobedience of
the decision of this Court.
5.24 Making the above submissions and relying upon the above decisions, it
is prayed to allow the present petitions and hold that the PCI possesses the
jurisdiction and power to regulate the education as well as practice of
profession of pharmacy in relation to all its aspects and AICTE would not
have any jurisdiction or power in that regard. It is also prayed to hold that
the word "pharmacy" in Section 2(g) of the AICTE Act deserves to be treated
as inapplicable in relation to the Regulation of education and practice of
profession in pharmacy.
SUBMISSIONS OF AICTE
6. Shri Harish Panday, learned Counsel appearing on behalf of the AICTE has raised
the following submissions:
6 .1 That AICTE was originally set up in the year 1945 by a Government
resolution as a National Expert Body to advise Central and State Government
for ensuring the coordinated development and technical education in
accordance with approved standards and was playing effective role. It is
submitted that taking into account the growing erosion of standard and
pursuant to recommendation, a National Working Group was set up in
November 1985 to look into the role of AICTE. In order to enable the AICTE
to play its role effectively, it was recommended that council should be given
the statutory power. The National Policy of Education 1986 also stipulated
that Council will be vested with statutory power. A Bill was introduced to
ensure proper planning and coordinated development of Technical Education
system in the country. It is submitted that the AICTE Act has been enacted
with an object to provide for the establishment of an AICTE with a view to
proper planning and coordinated development of the technical education
system throughout the country; the promotion of qualitative improvement of
such education in relation to planned quantitative growth and the Regulation
and proper maintenance of norms and standards in the technical education
system and for matters connected therewith. It is submitted that the power
and functions assigned to AICTE is not only to prescribe norms and standards
but to inspect, approve and withhold recognition of programmes and
institutes.
6.2 That Section 2(g) of the AICTE Act defines 'technical education" and it
includes "pharmacy". Learned Counsel on behalf of AICTE has taken us
through various provisions of the AICTE Act and it is submitted that therefore
the AICTE Act has been enacted for regulating and fixing minimum standard
for technical education and education institutions in the field of technical
education, as defined in Section 2(g) of the AICTE Act. It is submitted that
the AICTE Act has been given all powers for fixing the minimum qualification
and standards and regulating institutions and in case of failure to comply
with its Rules and Regulations, power to take action, including withdrawal of
the approval.
6.3 That so far as the Pharmacy Act is concerned it is a pre-Constitution Act

794
which was enacted in the year 1948 with the primary object to make better
provisions for Regulation of the profession and practice of pharmacy and for
that purpose to constitute Pharmacy Council. It is submitted that perusal of
the object, aim and provisions of the Pharmacy Act makes it clear that the
Pharmacy Act which is a prior Act has been primarily enacted to regulate the
professionals only. It is submitted that in the year 1987, AICTE has been
given the statutory status with the sole authority to regulate and prescribe
minimum norms and standard for Technical Education and technical
instructions as defined under the AICTE Act. It is submitted that after coming
into AICTE Act, it is entirely within the domain of the AICTE Council to grant
approval to a new course or to recognize a new institute.
6.4 That the Legislature in its own wisdom has included Pharmacy in the
definition of 'technical education' in the AICTE Act and given AICTE powers to
maintain the norms and standard of technical education for proper and
coordinated development of technical education.
6.5 That the language of AICTE Act is plain and unambiguous and therefore
the court shall not interpret the same in a different manner only because a
harsh consequence arising therefrom. Reliance is placed upon the case of
Nasiruddin v. Sita Ram Agarwal MANU/SC/0100/2003 : (2003) 2 SCC
577.
6.6 That deleting the word "Pharmacy" from AICTE Act which has specifically
been incorporated by the Legislature will amount to legislate which is not
permissible, as held by this Court in the case of Union of India v. Deoki
Nandan Aggarwal MANU/SC/0013/1992 : (1992) Supp. 1 SCC 323. It is
submitted that, as held by this Court, the courts cannot rewrite, recast or
reframe the legislation.
6.7 That as held by this Court in the case of Ajeet Singh Singhvi v. State
of Rajasthan MANU/SC/0652/1991 : 1991 Suppl. (1) SCC 343, the courts
should always presume that the Legislature inserted every part of the statute
for a purpose and the legislative intention is that every part of the statute
should have effect. It is further submitted that as held by this Court in the
case of Ajoy Kumar Banerjee v. Union of India MANU/SC/0263/1984 :
(1984) 3 SCC 127, the later law will prevail. It is submitted that therefore the
AICTE Act, which is a later Act, shall prevail over the Pharmacy Act.
6.8 That Article 372 of the Constitution provides that notwithstanding the
repeal by the Constitution of the enactments referred to in Article 395, all the
laws that were in force in the territory of India immediately before the
commencement of the Constitution shall continue to remain in force until
altered or repealed or amended by a competent Parliament under Entry-66 of
List-I (Union List). It is submitted that AICTE Act has been enacted by the
Parliament under the Union List, which covers the same field which was
earlier covered by the 1948 Act, namely, to lay down norms and standards
for studies in the field of pharmacy. It is submitted that therefore in terms of
Article 372 of the Constitution, the 1987 Act to the extent it covers the same
field as covered by the existing law i.e. 1948 Act, will prevail and the
provisions of the 1948 Act to that extent stand repealed/altered.
7. So far as the reliance placed upon by the learned Counsel for the Petitioner on the

795
decision of this Court in the case of Bharthidarsan (supra) is concerned, it is

submitted that the said decision shall not be applicable at all to the facts of the case
on hand. It is submitted that the dispute was with regard to the powers of UGC and
AICTE vis-a-vis the Universities and in the definition of 'technical institution' Under
Section 2(h) of the AICTE Act, Universities have been excluded and therefore this
Court held that AICTE has no jurisdiction over the Universities. It is submitted that
whereas Pharmacy has been purposely included in the definition and under various
Sections of AICTE Act.
7.1. So far as the reliance placed upon the decision of this Court in the case of Shri
Prince Shivaji Maratha Boarding House's College of Architecture (supra) by
the learned Senior Advocate appearing on behalf of PCI is concerned, it is submitted
that the reliance placed on the said decision is mis-placed as it primarily relies on the
decision of this Court in the case of Association of Management of Private
Colleges v. All Indian Council for Technical Education MANU/SC/0436/2013 :
(2013) 8 SCC 385 without appreciating the fact that the issue involved in that
aforesaid judgment has been referred to a larger Bench.
7.2. That even otherwise there is a difference in the provisions between the Architect
Act and the Pharmacy Act.
7.3. That the AICTE Act, 1987 is a later Act than the Pharmacy Act, 1948 and is a
special enactment for laying down norms and standards for courses, curriculum,
physical and instructional facilities, staff pattern, staff qualification, quality
instructions, assessment and examination in technical education as well as granting
approval for starting new technical institution, introduction of new courses or
variation in intake in the existing courses. It is submitted that therefore on the
principle of "implied repeal" the provisions of AICTE Act would prevail over the
Pharmacy Act.
7.4. That pursuant to order passed by this Court in the case of Progressive
Education Society's College of Pharmacy (supra) in a meeting between Minister
of Health and Family Welfare and Minister of Human Resource Development it was
decided to revisit the definition of 'technical education' in the AICTE Act by deleting
"Pharmacy" from the definition of 'technical education contained in Section 2(g) of
the AICTE Act. It is submitted that, however, it was decided that till the time it was
amended both councils will inspect jointly for the purpose of grant of Approval and
both parties will withdraw cases filed by them. It is submitted that both councils will
regulate simultaneously.
7.5. Making the above submissions, it is prayed to answer the questions/issue
involved in favour of AICTE and hold that the provisions of AICTE Act would prevail
over the Pharmacy Act.
OTHER SUBMISSIONS
8. Learned Counsel appearing on behalf of Respondent No. 5 in SLP (C) Nos. 4124-
4127 of 2016, as such, supported the stand of AICTE. It is submitted that attempts
should be made that both the Pharmacy Act and AICTE Act are harmoniously
construed and the attempts should be made to reconcile both the provisions.
8.1. Learned Counsel appearing on behalf of Respondent No. 5 has submitted that
Respondent No. 5 does not dispute the authority of PCI to prescribe, approve and
regulate the course of study and examination prescribed to register as pharmacist. It

796
is submitted that, however, the PCI has limited role and powers and also its powers
are limited to the Diploma in Pharmacy and not other courses. It is submitted that the
Pharmacy Act does not give direct control to the PCI over the Institutions. It is
submitted that such a lacuna is filled by the AICTE Act.
8.2. It is further submitted that insofar as the seat intake is concerned, the Education
Regulation, 1991 lays down some of the infrastructural facilities required for the
diploma courses in Pharmacy course. It is submitted that AICTE is empowered to
decide on seat intake increase on fulfillment of infrastructural requirements. It is
submitted that therefore when there will be full compliance on the infrastructural
requirements laid down in the Education Regulations, still AICTE can insist on any
other compliance as per its own norms. It is submitted that for the purpose of
regulating the profession of pharmacy, course for study and examination, PCI will
have supremacy and on other matters AICTE and its Regulations would prevail. It is
submitted that insofar as the profession of pharmacy is concerned, the Pharmacy Act
is a Special Act. It is submitted that insofar as regulating the technical institution,
AICTE is the Special Act and therefore the same shall prevail.
8.3. Making the above submissions, it is prayed that the intake of the seats approved
by the AICTE in respect of Respondent No. 5 Institution may kindly be protected.
9 . Learned Counsel appearing on behalf of the respective Institutions have further
submitted that by interim orders which in some cases were final, the respective
institutions are permitted to increase intake as per the decision of AICTE and the
students have studied and the interim orders were passed by the High Courts in the
interest of students, therefore, whatever be the outcome of the respective cases, the
interest of the students and the institutions may be protected.
10. In rejoinder, it is submitted by the learned Senior Advocate appearing on behalf
of the PCI that as such the provisions of the Architects Act, 1972 and the provisions
of the Pharmacy Act, 1948 are similar and para materia, except the non-obstinate
Clause in Section 17. It is submitted that, however, a bare perusal of Section 17 of
the Architects Act makes it abundantly clear that the said provision does not have any
relation or bearing whatsoever with the power of the Council of Architecture to
prescribe the minimum standards of education in the field of architecture and the said
non-obstinate provision is only with regard to the registration i.e. to say for
practicing architecture, registration under the Architects Act would be mandatory. It is
submitted that therefore non-existence of any such similar provision in the Pharmacy
Act is of no consequence or impact for adjudication of the issue involved in the
present case.
11. Now, so far as reliance placed upon Article 372 of the Constitution by the learned
Advocate appearing on behalf of the AICTE, it is vehemently submitted by Shri
Maninder Singh, learned Senior Advocate appearing on behalf of the PCI that even as
per Article 372 of the Constitution, unless a pre-constitutional statute is specifically
repealed, it continues to remain in operation. That, in the present case, in the
absence of any repeal of the Pharmacy Act, 1948, it continues to remain in operation
in India.
OUR CONSIDERATION:
1 2 . As observed hereinabove, the issue involved in the present batch of cases is
regarding the applicability of the Pharmacy Act, 1948 or the AICTE Act, 1987 in
relation to subject of pharmacy including the approval of courses of study, minimum

797
standards of education required for qualification as a pharmacist, registration as a

pharmacist, Regulation of future professional conduct etc. In other words, the
question is as to whether the mandate of the PCI or that of the AICTE would prevail
on the question of granting approval and related matters to any institution for
conducting pharmacy education course, if there is any conflict/contradictions in the
opinions of these two bodies. The issue is as to which body, i.e. AICTE or PCI would
primarily be responsible for Regulation of pharmaceutical Regulation in India.
13. While answering the issues/questions involved in the present batch of petitions,
first of all, what is required to be considered is whether the Pharmacy Act which is a
prior Act to that of AICTE Act can be said to be a special Act with special provisions
in the field of Pharmacy? The Statement of Objects and Reasons for the Pharmacy Act
is as under:
It is desirable that, as in most other countries, only persons who have
attained a minimum standard of professional education should be permitted
to practise the Profession of Pharmacy. It is accordingly proposed to
establish a Central Council of Pharmacy, which will prescribe the minimum
standards of education and approve courses of study and examinations for
Pharmacists, and Provincial Pharmacy Councils, which will be responsible for
the maintenance of provincial registers of qualified pharmacists. It is further
proposed to empower Provincial Governments to prohibit the dispensing of
medicine on the prescription of a medical practitioner otherwise than by, or
under the direct and personal supervision of, a registered pharmacist.
As per the Preamble of the Pharmacy Act, 1948, the Pharmacy Act has been enacted
to make better provision for the Regulation of the profession and practice of
Pharmacy and for that purpose to constitute Pharmacy Councils. If we consider the
relevant provisions of the Pharmacy Act, it covers all areas inclusive of approval of
courses, laying down course content, eligibility conditions for students as well as
teachers, evaluation of standards of examination, grant of registration, entry of
higher qualification, taking action for any infamous conduct etc. The relevant
provisions in the Pharmacy Act are Sections 10, 12, 13, 16, 29, 32, 35, 36 and 42.
13.1. Section 10 of the Pharmacy Act empowers the PCI to frame Education
Regulations prescribing the minimum standard of education required for qualification
as a pharmacist. As per Sub-section (2) of Section 10, such Education Regulations
may prescribe:
a) the nature and period of study and of practical training to be undertaken
before admission to an examination;
b) the equipment and facilities to be provided for students undergoing
approved courses of study;
c) the subjects of examination and the standards therein to be attained;
d) any other conditions of admission to examinations.
As per Section 12 of the Pharmacy Act, any "authority" in a State that is empowered
to conduct a course of study in pharmacy may apply to the Central Council for
approval of the course in accordance with the Education Regulations. Likewise, any
authority which conducts an examination of a State for pharmacy may apply to the
PCI for approval of such examination. A student who has passed/completed an

798
approved course and passed an approved examination can only be registered as a

Pharmacist subject to meeting other requirements. Section 13 of the Pharmacy Act
empowers the Central Council to withdraw approval accorded to the 'course of study'
and 'examination' for failure to comply with the prescribed norms. Section 16 of the
Pharmacy Act empowers the Executive Committee to appoint inspectors to inspect any
institution which provides an approved course of study or those institutions which
apply for approval of course of study or examination. Section 29 deals with
preparation and maintenance of a register of pharmacists. Section 35 provides for
entry of additional qualifications in the register in relation to any registered
pharmacist. Section 36 provides for the removal of any person from the register,
either permanently or for a temporary period. As per Section 42 of the Pharmacy Act,
a person may not practice the profession of pharmacy unless he or she is registered
as a pharmacist in accordance with the Pharmacy Act. Sub-section (2) of Section 42
is a penal provision which states that any person who is not a registered pharmacist
and contravenes Sub-section (1) of Section 42 shall be punishable with imprisonment
for a term which may extend to six months, or with fine not exceeding one thousand
rupees or with both.
13.2. In exercise of powers vested in the Pharmacy Act, PCI has framed a number of
Regulations for prescribing minimum standards of education as well as regulating the
subject of pharmacy in India, including:
a. Education Regulations, 1991;
b. Pharm. D Regulations, 2008;
c. Minimum Qualifications for Teachers in Pharmacy Institutions Regulations,
2014;
d. Bachelor of Pharmacy (B. Pharm) Course Regulations, 2014;
e. Master of Pharmacy (M. Pharm) Course Regulations, 2014;
f. Bachelor of Pharmacy (Practice) Regulations, 2014;
g. Pharmacy Practice Regulations, 2015.
Thus, considering the various provisions of the Pharmacy Act and the Regulations
made therein, it can be said that the Pharmacy Act is a complete Code in itself in the
subject of pharmacy. The PCI has been constituted as a body empowered to regulate
the education and profession of pharmacy in India. It cannot be disputed that the
subject of pharmacy is a special and not a general subject. From the relevant
provisions of the Pharmacy Act, more particularly, the provisions referred to
hereinabove, the Pharmacy Act exclusively covers all areas inclusive of approval of
courses, laying down course content, eligibility conditions for students as well as
teachers, evaluation standards of examination, grant of registration, entry of higher
qualifications in the same discipline, taking action for infamous conduct etc. It also
contains a penal provision. Thus, the legislative intent in enacting the Pharmacy Act
seems to be to ensure that there is seamless Regulation of the profession. To carry
out the objective and purpose for enacting the Pharmacy Act, the Legislature has
established under the Statute the autonomous statutory authority i.e. Pharmacy
Council of India. Thus it can be said that in the field of pharmacy, the Pharmacy Act
is a special law.

799
13.3. On the other hand, the AICTE Act can be said to be a general law applicable to
the technical institutions and technical education. If we consider the Statement of
Objects and Reasons for the AICTE Act, it is specifically stated that the AICTE Act was
originally set up by a Government Resolution as a National Expert Body to advise the
Central and State Government for ensuring the coordinated development of technical
education in accordance with the approved standards. It is as under:
1. The All India Council for Technical Education (AICTE) was set up in 1945
by a Government resolution as a National Expert body to advice the Central
and the State Governments for ensuring the co-ordinated development of
technical education in accordance with approved standards. During the first
three decades the Council functioned quite effectively and there was
phenomenal development of technical education in this period. However, in
recent years, a large number of private engineering colleges and polytechnics
have come up in complete disregard of the guidelines, laid down by the
AICTE. Most of these institutions have serious deficiencies in terms of even
the rudimentary infrastructure necessary for imparting proper education and
training. Barring some exceptions, there is scant regard for maintenance of
educational standards.
2 . Taking into account the growing erosion of standards, the Council at its
meeting held in 1981 came to the conclusion that a stage had been reached
when it should be vested with statutory powers to regulate and maintain
standards of technical education in the country. In pursuance of these and
other recommendations, a National Working Group was set up in November,
1985 to look into the role of the AICTE. The National Working Group
recommended that in order to enable the AICTE to play its role effectively, it
shall have to be vested with necessary statutory authority. The National
Policy on Education, 1986, also stipulated that the AICTE will be vested with
statutory authority for planning, formulation and the maintenance of norms
and standards, accreditation, funding of priority areas, monitoring and
evaluation, maintaining parity of certificates and awards and ensuring the co-
ordinated and integrated development of technical and management
education.
3 . The Bill seeks to provide statutory powers to the All India Council for
Technical Education to ensure:
(i) proper planning and co-ordinated development of the technical
education system throughout the country;
(ii) promotion of qualitative improvement of technical education in
relation of planned quantitative growth, and
(iii) Regulation of the system and proper maintenance of norms and
standards.
Accordingly, the powers and functions assigned to the AICTE, inter alia,
provide laying down norms and standards for programmes and institutions,
giving approval for setting up of technical institutions, prescribing guidelines
for admission of students and the charging of fees, and inspecting and
evaluating institutions periodically with a view to maintaining standards and
to provide recognition or withhold recognition of programmes and
institutions. As part of this overall co-ordination and development

800
responsibilities, the AICTE will also give grants to institutions for identified
developmental purposes. In addition, the AICTE will promote innovation,
research and development, linkages with industry and greater access to
technical education by women, handicapped, and the weaker Sections of the
society.
The preamble of the AICTE Act is as under:
An Act to provide for the establishment of an All India Council for Technical
Education with a view to the proper planning and co-ordinated development
of the technical education system throughout the country, the promotion of
qualitative improvements of such education in relation to planned
quantitative growth and the Regulation and proper maintenance of norms and
standards in the technical education system and for matters connected
therewith.
Thus, it can be said that the AICTE Act can be said to be a general law with respect to
the technical education. It is true that in the definition, as per Section 2(g) of the
AICTE Act, "technical education" also means "pharmacy". However, the same shall be
dealt with hereinbelow.
14. Now having held that the Pharmacy Act is a special Act dealing with the special
subject of pharmacy, the next question which is posed for consideration of this Court
is whether in the field of pharmacy, the Pharmacy Act would prevail or the AICTE Act?
The next question is whether in the profession of pharmacy, the PCI shall have the
exclusive jurisdiction or the AICTE?
14.1. While answering the question whether the Pharmacy Act which is a special Act
(as held hereinabove) shall prevail or the AIOCTE Act which is a general law (as held
hereinabove) and the submissions on behalf of AICTE that as the AICTE Act is
subsequent law and in the definition of "technical education" contained in Section
2(g), it includes "pharmacy" also, therefore, being a subsequent law, the same shall
prevail as there will be a implied repeal of the Pharmacy Act, few decisions of this
Court are required to be referred to and considered.
14.2. In the case of Hari Shankar Jain (supra), this Court had an occasion to
consider the maxim "Generalia specialibus non derogant". The relevant portions of
paragraphs 8 and 9 are as under:
8. The maxim "Generalia specialibus non derogant" is quite well-known. The
Rule flowing from the maxim has been explained in Mary Seward v. Owner of
the "Vera Cruz" [(1884) 10 AC 59, 68] as follows:
Now if anything be certain it is this, that where there are general
words in a later Act capable of reasonable and sensible application
without extending them to subjects specially dealt with by earlier
legislation, you are not to hold that earlier and special legislation
indirectly repealed, altered, or derogated from merely by force of
such general words, without any indication of a particular intention
to do so.
xxx xxx xxx
9. The reason for the Rule that a general provision should yield to a specific

801
provision is this: In passing a special Act, Parliament devotes its entire

consideration to a particular subject. When a general Act is subsequently
passed, it is logical to presume that Parliament has not repealed or modified
the former Special Act unless it appears that the Special Act again received
consideration from Parliament. Vide London and Blackwall Railway v.
Limehouse District Board of Works [26 L J Ch 164: 69 ER 1048], and Thorpe
v. Adams [(1871) LR 6 CP 125]. In J. & K. Cotton Spinning and Weaving Mills
Co. Ltd. v. State of U.P. [MANU/SC/0287/1960 : AIR 1961 SC 1170 : (1961)
3 SCR 185 : (1961) 1 LL J 540 : (1960-61) 19 FJR 43], this Court observed
(at p. 1174):
The Rule that general provisions should yield to specific provisions is
not an arbitrary principle made by lawyers and Judges but springs
from the common understanding of men and women that when the
same person gives two directions, one covering a large number of
matters in general and another to only some of them his intention is
that these latter directions should prevail as regards these while as
regards all the rest the earlier direction should have effect.
14.3. In the case of D.J. Bahadur (supra), this Court had an occasion to consider
the conflict between the general legislation and the special legislation and argument
of 'implied repeal'. In the said decision, this Court took note of the following extracts
from the Craies on Statute Law [1963 Edn., pp. 376-77]:
49. xxx xxx xxx
The general rule, that prior statutes are held to be repealed by implication by
subsequent statutes if the two are repugnant, is said not to apply if the prior
enactment is special and the subsequent enactment is general, the Rule of
law being, as stated by Lord Selbourne in Sewards v. Vera Cruz [Mary
Sewards v. Owner of the "Vera Cruz", (1884) 10 AC 59, 68], 'that where
there are general words in a later Act capable of reasonable and sensible
application without extending them to subjects specially dealt with by earlier
legislation, you are not to hold that earlier and special legislation indirectly
repealed, altered, or derogated from merely by force of such general words,
without any indication of a particular intention to do so. There is a well-
known Rule which has application to this case, which is that a subsequent
general Act does not affect a prior special Act by implication. That this is the
law cannot be doubted, and the cases on the subject will be found collected
in the third edition of Maxwell is generalia specialibus non derogant -- i.e.
general provisions will not abrogate special provisions.' When the legislature
has given its attention to a separate subject and made provision for it, the
presumption is that a subsequent general enactment is not intended to
interfere with the special provision unless it manifests that intention very
clearly. Each enactment must be construed in that respect according to its
own subject-matter and its own terms.
In the said decision, it is observed that an 'implied repeal' is the last judicial refuge
and unless driven to that conclusion, is rarely resorted to. It is further observed that
in determining whether a statute is a special or a general one, the focus must be on
the principal subject-matter plus the particular perspective. It is observed that for
certain purposes, an Act may be general and for certain other purposes it may be
special and we cannot blur distinctions when dealing with finer points of law. It is

802
further observed that what is special or general is wholly a creature of the subject
and context and may vary with situation, circumstances and angle of vision. Law is
no abstraction but realizes itself in the living setting of actualities. Which is a special
provision and which general, depends on the specific problem, the topic for decision,
not the broad rubric nor any Rule of thumb.
14.4. In the case of Yakub Abdul Razak Memon (supra), this Court again had an
occasion to consider the conflict between the general statue and the special statute.
After considering the various decisions of this Court on the point, it is observed and
concluded in paragraphs 1518 to 1522 as under:
1518. The principle that the latter Act would prevail the earlier Act has
consistently been held to be subject to the exception that a general provision
does not derogate from a special one. It means that where the literal
meaning of the general enactment covers a situation for which specific
provision is made by another enactment contained in the earlier Act, it would
be presumed that the situation was intended to continue to be dealt with by
the specific provision rather than the later general one.
1519. The basic Rule that a general provisions should yield to the specific
provisions is based on the principle that if two directions are issued by the
competent authority, one covering a large number of matters in general and
another to only some of them, his intention is that these latter directions
should prevail as regards these while as regards all the rest the earlier
directions must be given effect to.
1520. It is a settled legal proposition that while passing a special Act, the
legislature devotes its entire consideration to a peculiar subject. Therefore,
when a general Act is subsequently passed, it is logical to presume that the
legislature has not repealed or modified the former special Act unless an
inference may be drawn from the language of the special Act itself.
1521. In order to determine whether a statute is special or general one, the
court has to take into consideration the principal subject-matter of the statute
and the particular perspective for the reason that for certain purposes an Act
may be general and for certain other purposes it may be special and such a
distinction cannot be blurred.
1522. Thus, where there is inconsistency between the provisions of two
statutes and both can be regarded as special in nature, the conflict has to be
resolved by reference to the purpose and policy underlying the two
enactments and the clear intendment of the legislature conveyed by the
language of the relevant provisions therein. (Vide Ram Narain v. Simla
Banking and Industrial Co. Ltd. [MANU/SC/0003/1956 : AIR 1956 SC 614],
J.K. Cotton Spg. & Wvg. Mills Co. Ltd. v. State of U.P. [MANU/SC/0287/1960
: AIR 1961 SC 1170], Kumaon Motor Owners' Union Ltd. v. State of U.P.
[MANU/SC/0059/1965 : AIR 1966 SC 785],Sarwan Singh v. Kasturi Lal
[MANU/SC/0071/1976 : (1977) 1 SCC 750],U.P. SEB v. Hari Shankar Jain
[MANU/SC/0500/1978 : (1978) 4 SCC 16: 1978 SCC (L&S) 481],LIC v. D.J.
Bahadur [MANU/SC/0305/1980 : (1981) 1 SCC 315: 1981 SCC (L&S) 111],
Ashoka Mktg. Ltd. v. Punjab National Bank [MANU/SC/0198/1991 : (1990) 4
SCC 406: AIR 1991 SC 855] andT.M.A. Pai Foundation v. State of Karnataka
[MANU/SC/0905/2002 : (2002) 8 SCC 481].

803
14.5. In the case of R.S. Raghunath v. State of Karnataka MANU/SC/0012/1992

: (1992) 1 SCC 335, this Court was considering the enforceability of special law on
the subject in spite of the general law. This Court noted the following paragraph in
Maxwell on the Interpretation of Statutes:
A general later law does not abrogate an earlier special one by mere
implication. Generalia specialibus non derogant, or, in other words, 'where
there are general words in a later Act capable of reasonable and sensible
application without extending them to subjects specially dealt with by earlier
legislation, you are not to hold that earlier and special legislation indirectly
repealed, altered, or derogated from merely by force of such general words,
without any indication of a particular intention to do so. In such cases it is
presumed to have only general cases in view, and not particular cases which
have been already otherwise provided for by the special Act.
That, thereafter it is further observed and held as under:
I n Maharaja Pratap Singh Bahadur v. Thakur Manmohan Dey
[MANU/SC/0202/1966 : AIR 1966 SC 1931: (1966) 3 SCR 663] applying this
principle it is held that general law does not abrogate earlier special law by
mere implication. In Eileen Louise Nicolle v. John Winter Nicolle [(1922) 1 AC
284], Lord Phillimore observed as under:
It is no doubt a sound principle of all jurisprudence that a prior
particular law is not easily to be held to be abrogated by a posterior
law, expressed in general terms and by the apparent generality of its
language applicable to and covering a number of cases of which the
particular law is but one. This as a matter of jurisprudence, as
understood in England, has been laid down in a great number of
cases, whether the prior law be an express statute ... or be the
underlying common or customary law of the country.
... Where there are general words in a later Act capable of
reasonable and sensible application without extending them to
subjects specially dealt with by earlier legislation ... that earlier and
special legislation is not to be held indirectly repealed, altered or
derogated from merely by force of such general words, without any
indication of a particular intention to do so'. [Ed.: Quoting from Vera
Cruz case, (1884) 10 AC 59, 68]
I n Justiniano Augusto De Piedade Barreto v. Antonio Vicente Da Fonseca
[MANU/SC/0382/1979 : (1979) 3 SCC 47 : AIR 1979 SC 984] this Court
observed that a law which is essentially general in nature may contain special
provisions on certain matters and in respect of these matters it would be
classified as a special law. Therefore unless the special law is abrogated by
express repeal or by making provisions which are wholly inconsistent with it,
the special law cannot be held to have been abrogated by mere implication.
1 5 . Applying the law laid down by this Court in the aforesaid decisions and as
observed hereinabove, the Pharmacy Act is a Special Act in the field of pharmacy and
it is a complete code in itself in the field of pharmacy, the Pharmacy Act shall prevail
over the AICTE Act which, as observed hereinabove, is a general statute dealing with
technical education/institutions. Therefore, the submission on behalf of AICTE and/or
concerned educational institutions that the AICTE Act is a subsequent law and in the

804
definition of "technical education" it includes the "pharmacy" and therefore it can be

said to be an "implied repeal", cannot be accepted. At his stage, it is required to be
noted that as such in the AICTE Act there is no specific repeal of the Pharmacy Act,
more particularly when, as observed hereinabove, the Pharmacy Act is a Special Act
and the subsequent enactment of AICTE Act is general and therefore the Pharmacy
Act being a Special Act must prevail. Apart from that, with regard to several aspects,
there is no provision made in AICTE Act which are exclusively within the domain of
PCI. Thus, it cannot be accepted that there is 'implied repeal' of the Pharmacy Act.
16. Now the next question which is required to be considered is whether in the field
of pharmacy, PCI would have the jurisdiction or AICTE constituted under the AICTE
Act which is held to be a general law. The Constitution and Composition of Central
Council under the Pharmacy Council of India is as under:
3. Constitution and composition of Central Council.-The Central
Government shall, as soon as may be, constitute a Central Council consisting
of the following members, namely:
(a) Six members, among whom there shall be at least one teacher of
each of the subjects, pharmaceutical chemistry, pharmacy,
pharmacology and pharmacognosy elected by the University Grants
Commission from among persons on the teaching staff of an Indian
University or college affiliated thereto which grants a degree or
diploma in pharmacy;
(b) Six members, of whom at least four shall be persons possessing
a degree or diploma in, and practicing pharmacy or pharmaceutical
chemistry nominated by the Central Government;
(c) One member elected from amongst themselves by the members
of the Medical Council of India.
(d) the Director General, Health Services, ex officio or if he is unable
to attend any Meeting, a person authorized by him in writing to do
so;
The Drugs Controller, India, ex officio or if he is unable to attend any
meeting, a person authorized by him in writing to do so;
(e) the Director of the Central Drugs Laboratory, ex officio;
(f) a representative of the University Grants Commission and a
representative of the all India Council for Technical Education;
(g) one member to represent each State elected from amongst
themselves by the members of each State Council, who shall be a
registered pharmacist;
(h) One member to represent each State nominated by the State
Government, who shall be a registered pharmacist:
Therefore, PCI consists of experts in the field of pharmacy and related subjects
connected with the education of pharmacy. Therefore, under the statute, specialized
persons in the field of pharmaceutical, pharmacy etc. shall be the members of the
PCI.

805
16.1. On the other hand, so far as AICTE is concerned, only one member would be
from the field of pharmacy and that too representative of PCI. Under the
circumstances, the PCI is the body of experts connected with the subject of pharmacy
and related subjects and therefore it will be in the larger interest and more
particularly in the interest of education of pharmacy that PCI shall alone have the
Jurisdiction in the field of pharmacy, rather than AICTE.
17. The aforesaid question is also required to be viewed from another angle. Both,
the PCI and AICTE are the creature of the statute. Therefore, it is not at all healthy
that the two regulators, both being Central authorities, can be permitted to fight for
supremacy. The fight of supremacy between both the regulators is unhealthy for the
education sector as well as the institutions to permit two regulators to function in the
same field. Therefore also and more particularly when the PCI is consisting of the
experts in the field of pharmacy and other related subjects, it is in the larger interest
in the field of pharmacy that the PCI must be given the power to regulate in the field
of pharmacy.
17.1. An identical question came to be considered by this Court in the case of Shri
Prince Shivaji Maratha Boarding House's College of Architecture (supra). In
that case, this Court was considering the similar provisions in the field of architecture
and whether the mandate of the Council of Architecture or that of AICTE would
prevail on the question of granting approval and related matters to the institution for
conducting architecture education course, if there is contradiction in the opinions of
these two bodies. At this stage, it is required to be noted that in the definition of
'technical education' in Section 2(g), 'architecture' is also included like 'pharmacy'. In
that case also, the Architecture Act was enacted prior to the AICTE Act, 1987, i.e. in
the year 1972. After considering the scheme of the Architecture Act and the powers
and function of the Council of Architecture, this Court observed and held that the
Architecture Act is a Special Act and shall prevail over the AICTE Act being a general
Act, in case of conflict/contradictions in the opinions of the aforesaid two bodies.
After considering the similar submissions made on behalf of AICTE in the case of
Shri Prince Shivaji Maratha Boarding House's College of Architecture
(supra), it is ultimately observed and held in paragraphs 63 and 64 as under:
63. We are of the opinion that in respect of the provisions of Section 2(g) of
the 1987 Act, the definition of "technical education" would have to be given
such a construction and the word "architecture" should be treated to have
been inapplicable in cases where the AICTE imports its regulatory framework
for institutions undertaking technical education. There would however be no
substitution because the context would not demand it. This construction of
the definition Clause is necessary as the external context requires it to
prevent an unworkable outcome in implementation of the 1987 Act. The
principle of implied repeal cannot apply so far as the provisions relating to
architecture education is concerned, on the basis of the 1987 Act having
become operational. One of the dominant purposes of the 1972 Act is
recognition of qualifications on architecture. The registration of an architect
is dependent upon acquisition of such recognised qualification. The said Act
cannot be held to have been repealed by implication for the sole reason of
inclusion of the word "architecture" in the definition of technical education.
AICTE has failed to discharge its onus to establish the 71 said provisions of
the 1972 Act was repealed by implication.

806
64. We accordingly hold that so far as recognition of degrees and diplomas

of architecture education is concerned, the 1972 Act shall prevail. AICTE will
not be entitled to impose any regulatory measure in connection with the
degrees and diplomas in the subject of architecture. Norms and Regulations
set by CoA and other specified authorities under the 1972 Act would have to
be followed by an institution imparting education for degrees and diplomas
in architecture.
18. We are in complete agreement with the view taken by this Court in Shri Prince
Shivaji Maratha Boarding House's College of Architecture (supra). Otherwise
on merits also, as observed and held hereinabove, the Pharmacy Act which is a
Special Act in the field of pharmacy shall prevail and consequently so far as the
recognition of degrees and diplomas of pharmacy education is concerned, the
Pharmacy Act shall prevail. As observed hereinabove, PCI constituted under the
provisions of the Pharmacy Act which is consisting of the experts in the field of
pharmacy and/or related subjects shall prevail. Consequently, the norms and
Regulations set by the PCI and other specified authorities under the Pharmacy Act
would have to be followed by an institution imparting education for degrees and
diplomas in pharmacy.
19. Now, so far as reliance placed upon Article 372 of the Constitution by learned
Advocate appearing on behalf of AICTE is concerned, at the outset, it is required to
be noted that even as per Article 372 of the Constitution, unless a pre-constitutional
statute is specifically repealed it continues to remain in operation. In the present
case, even in the AICTE Act there is no specific repeal of the Pharmacy Act, 1948. As
observed hereinabove, there is not even 'implied repeal'. Therefore, reliance placed
upon Article 372 of the Constitution is misconceived.
20. At this stage, it is required to be noted that having realized the difficulties in
view of dual Regulations of pharmacy education under the PCI and AICTE, a
ministerial level meeting between the Minister of Health and Family Welfare and the
Minister of HRD, Union of India was held on 03.10.2018 to end the dual Regulations
on pharmacy education under PCI and AICTE. In the counter-affidavit filed by the
AICTE itself, it is stated that during the meeting it was noted and even it is submitted
by Ms. Pinki Anand, learned ASG appearing on behalf of the Union of India that
during the meeting it was noted that, both the Pharmacy Act, 1948 and the AICTE
Act, 1987, contain the provisions regarding pharmacy education leading to
duplication of Regulations and considerable confusion at the field level, it was
unanimously agreed that this dual Regulation should be ended forthwith and the
AICTE Act governing the general technical education would be amended deleting
'pharmacy' from its mandate and the pharmacy education would thereafter be
governed by the Pharmacy Act, 1948. It is submitted that the amendment in Section
2(g) of the AICTE Act was proposed, but thereafter there is no further progress in the
wake of formation of newly proposed Higher Education Council of India and
finalization of NEP, which as such has nothing to do with the Pharmacy Act.
Therefore, even according to the Union of India, the word 'pharmacy' is to be deleted
from the definition of 'technical education' contained in Section 2(g) of the AICTE
Act.
21. In view of the above and for the reasons stated above, it is held that in the field
of Pharmacy Education and more particularly so far as the recognition of degrees and
diplomas of Pharmacy Education is concerned, the Pharmacy Act, 1948 shall prevail.
The norms and Regulations set by the PCI and other specified authorities under the

807
Pharmacy Act would have to be followed by the concerned institutions imparting

education for degrees and diplomas in Pharmacy, including the norms and
Regulations with respect to increase and/or decrease in intake capacity of the
students and the decisions of the PCI shall only be followed by the institutions
imparting degrees and diplomas in Pharmacy. The questions are answered
accordingly.
2 2 . Now the next question which is required to be considered is with respect to
students already admitted pursuant to the orders passed by this Court and the
concerned High Courts. The conflict and the dispute arose because despite refusal by
the PCI, the AICTE increased the intake capacity in the respective institutions, which
were not approved by the PCI. By the interim orders, this Court and the respective
High Courts have directed to allow those students to appear in the examinations and
to register them as pharmacists. Such Interim Orders are also made final. Therefore,
the present decision shall not affect those students admitted in the increased intake
capacity and/or pursuant to the interim orders passed by this Court and/or final
judgments and orders passed by the respective High Courts. PCI is therefore directed
to give consequential benefit of registration to such students. However, at the same
time, all pending applications for increase in intake capacity and/or for recognition
and/or approval of course/institutions in the pharmacy shall be as per the provisions
of the Pharmacy Act, 1948 and the Regulations, if any, thereunder and as per the
norms and Regulations fixed by the PCI. It is further directed the concerned
institutions who increased their intake capacity as approved by AICTE and their
increase in intake capacity was not approved by PCI, shall apply afresh for increase in
intake capacity and/or evening shift for the next academic year within a period of
four weeks from today and their cases for increase in intake capacity and/or
applications for recognition and/or applications for approval of the course or evening
shift shall be considered by the PCI in accordance with the Pharmacy Act, 1948 and
Rules and Regulations framed therein and the norms prescribed by the PCI.
23. All these Transferred Cases/Appeals/Writ Petitions stand disposed of accordingly.
© Manupatra Information Solutions Pvt. Ltd.

ANNEXURE P-24
com;>re.bcnslvc frame is inherenc808 in our Cutrenc
knowledge &)-Stems. which progress tbrougb e\o-er·
incre•asing speciaJisalion and f()(..'US on the micro.
abs.iractio,g rrom the macro. '111e big plc-.rure. the
awarene,;softbe myriad Uu-cads lbatbind the planers
fragile ecology together, that a small disturt>a.nce in
one parr oftbis ecology maytriggtr large disruptions
in0thcq10ns, tblscompcUlogtruth ha$ been in<:ress-
lngJy obscured and is now being denied in a fit of
coUccrh~ blindn~ The reason is nOL ha.rd ro find.
Acknowledgil'4! the truth \\111 demand Lhat we aJter
our llfeSL)'les,_ change ourvatue sysrem$-lntl rccon•
nect humanityY.ith natw·e- Man in ~ature, not Man
Against Nature. which has bl<tn the credo or our
industrial age.
·rhe report of the I nt.er•GovernmentaJ Panel on
Climate Change (IPCC) has looked at the implica-
tions of the aspii:atlonal goal, i:ocorporated in the
Paris Qima,e Agreemem. ro Umitglob:tl tempera-
ture rise co only 1,5 degrees ceotigrade compi,red
Covid-19is sign of
with whar it was at th-e beginning of che industrial
revolution. ll has come 10 the conclusion thal we
arc aJread)•wellon tb<t w,:; 1oreachiogthe l.S degree
range and this will already be enough to unlea$h
ell mare mayhem. More significantly the reporrcon•
eludes that Nthe.pathwaystoa.voiding an evtn honer
an ecological crisis wo,dd require a S\Vi.ft and complete transfonna1Jon

not just or the global economy but of society too",
SOcictal change is tmpossiblc wiU,out effecrlng a
civilisational response.
Outs lsan age of technologlcaJ hubrls. There is a
Dealing with itas if itwere a singular phenomenon occurring in pcr,..asive betief th.'lt somehow technology will find
the solutions we need 10 resolve the multiple crises
a single domain will notwo rk we confront without having-to change QUr pattc.rns
o!li\•ing. There is a n<~v ...1orld ofarciOcial h1teUig,nce
he coronavirus (Covid~l9) epidemic oontinues adverse health consc-quences. The indu~alis.."tcion and machine learning waltin3 round the corner.
T to •))read a,Toss the world and is already a or agricul1ure and animal husbandry may have
major bcaJtb ens!$. rt has begun co spill °""r eoba,nced food secu1i1y but lhls trcate~ a nega1jvc
intolheecooomicdomain. causingcasca<iing(tisrup- feedback loop in heaJtb security.
There arc Lhe wonder,, or quantum computing and
gene1 le en,glnceri.ngwbose poientiol isalready b:iJ'\g
actualised. 1l'lereisa sense. in the words ofonescien·
tlons 10 the dense ncrworks of pro- rn reality. mulrlpl.e crlscsconf1--om tiSI, t.ha1 •rb.courcomeoffucuretechnologicalevolu•
duction and investment, travel and humanity today, such a$ climate tion coukl surpass humans by as much as Y..-e. intel·
trade. ll is possible t.ha~ wit.bin a yc.ar change. environmental degradation, lectuallys,upass Slime mou1c1s.•
or so, an effective vaccine may be declining waler. food and energy Maybe.But will our planet and lifeoneanhsur•
developed l)tlt that mil,lhtbe too Jato security and social and economic iW long(mOUgh 10 SIN lhe \\'Onders Of this te<:bn~
\1
in preventing a full scale pandemic. in-equaJil)'· These are alJ densely logjca1 advancement?CouJdlhere. rorexample. con~
Whi\efocusiogon 1he immcdJaxe imcr•conoecied. some-thn.cs ceivably b,c a so_rain of vlllLS whose vlruleoc:e
crisis one..s.houkt consider its deeper muwally reinforcing. while at other decimates lhe wOJ'ld·s p0pu.lalion before an antidote
implicatlOIJ$. TheCoYid-19isasymp- timesmuluallyotT-scuiog. Tbeyore is fou rxl? TheCOvid·t9 is perhaps a timely portent of
tom of a deeper ecological crisis thar ......., S}'ntptoms o( a deeper civillsational an ecological disaster which we ignore at our peril.
·endangers lhe surv'hial of humanity mAlaise eml>C4ded inourwll)•of Hfe, What is the ciVilisationat response need<'<! to,;iave
itself. It is the in°'itable outcome of SHYAM SARAN ourvalue system. our understarntin.g offllle loomingecologlcaJcrlsis? We mus, look upon
thegrowingindusoiallsationoragti- - - - - - - - - - of the pasiamtoura.wirationsforthc Nature as a 1"1ngsourceofnunute from whichooe
cultureanctanlmalhusbandry~ future. Dealing with each crisis as if mustncvcrexuac1 mo.re than neccssal')'forltsicgei'l:•
on standardisation ofspecies at LhecOSt ofbio-diver· it w-ere a..s:i ngular phenomenon occurring in a single eraclon. Biodi-tersjty is fundamental to tbe mainte,..
slt;y, rhe s,cady loss of wild babltats, which COO\pels domal n w!U n0t ,vo!l< because Ir Is Unked through nanccofau llfeonoutplanct'and mustbe preserved.
wildlife to intrude into l\uman setllements and the feedb:lck loops to multiple dOmains. A crisis in one The cross-domain nature or the challenges we
unintended e.xposu.re of human communities 10 part of our planet's ecology such as the outtireak of confront require a comprehensl\'e and collaborative.
organisi:ns to which they have oo immunity. In our Covid·l9, may be linked to phenomena occurring in response 01 the gtobaJ levcJ. There is no alternative
own cities, we see banas or marauding mon.l:eys. otherdomains. although l)lis may n0tbc immediarcly co muJtUa,eral processes thr'O<lgh empowered Inter•
Leopards ond elephants often stray inlovilloges Md obvious. There was an interdependent causal chain oa.t ional.goverrumce insl,itutions.
urban sctOerocnts berouse fores,s ,-,.e being denuded. arwork bcre. The Covld•t9was ll virus hosted by• Abo\1call, we need a newde.fi.nirJonofaffiuence
Industrial f.echniquesor mass p.rodUClion have been species normally resident in t.he ,vtld. in lhis case which vaJues clean air to breathe. fresh wa,ter to
bi'ot)ght into lhe animaJhusbandl)' domafo wirh ani- wild bats. These bots were brought into close prox- drink and a green earth to walk on above all else.
mals and paukry packed together in cramped spaces. imi(Y "'"'iilh industriaJly raised animals pa-eked and does nor squander ihe inheritance of succeed-
Asl)' infection Ia one animal spread$ qulc:JW to Qlhers. lO{l<!ther at a food market in Wuhan, China. hcighL· loggenemrions.
Examples are.swine nu and avian flu.and these then cniJlS' the risk of conm.gion. Toe risk is inherent in
cross-owrtoltuman hOsts. In o(derto mlnimiSe such cb<t oature or pt'O<Csses dcvclopod 10 enhance food 'flit' wriuT lsnf on11erfi>"J~pr s«iwa,yonda stuior fr{low
risl\S, anlmatsareromlnely 1:umped full ofantil>iotlcs. security wlrhour ~gatd to consequences in Olhcr CPR. He\mi prime mlnl.stw't $p.vit1lt1nV([yfer,:lhrim~
This then gets into the rood-chain with its own dOlll3ins.This inabilil}' (0 k>ok at Our challenges in a dl(rtlg(' ~2010
ANNEXURE P-25
The Corona Crisis in Light of the Law-as-Culture Paradigm 809
http://www.recht-als-kultur.de/de/aktuelles/
International Law and Covid-19 Jurisprudence

Upendra Baxi
The deadly Covid-19 virus has now enveloped the globe and generated new forms of
governmentality and bio-legitimation practises in its wake. But only new forms of human
compassion and solidarity can help us overcome this lethal and formidably grim challenge.
Even amidst the disease and death caused by the pandemic, theoretical discourse rages: on the
one hand, our focus rests on the intensification of state of exception in combatting Covid-19.
On the other, we explore the projection of the crisis as an opportunity for building a new future
for global politics, one that is marked by empathy, fraternity, justice, and rights as fidelity to
establish novel forms of sources of self in society.
Here, we engage only one facet of the new developments: How can international law discourse
be read as we step into the future? Respect for norms and standards of international law is
among the paramount constitutional duties of the Indian State under Article 51 of the
Constitution, regardless of the quibbles of whether the language only refers to treaty-
obligations or also to customary international law. It is an egregious error to think that
international norms, standards, and doctrines are irrelevant to making policy and law regarding
disasters or pandemics.
A threshold distinction of the United Nations, as a site of normative discursivity and of

exercising global power politics, is sadly manifest even during this ever-accelerating pandemic.
President Donald Trump’s insistence on calling Covid-19 the ‘Chinese virus’ renders it
extremely unlikely that the pandemic will be discussed during China’s current monthly
presidency of the Council. And the threat of veto, both by China and Russia, will always loom
large whenever the matter is raised for discussion.
But the UN also illustrates systems of norm enunciation. Responsible for the progressive
codification of law (along with the International Law Commission, ILC), the UN system has
developed a web of lawmaking and framework treaties as well as provided auspices for systems
of ‘soft’ law that may eventually become binding. Some robust norms, standards, and doctrines
have emerged. For example, the peremptory jus cogens – a few fundamental, overriding
principles of international law, such as crimes against humanity, genocide, and human
trafficking – apply to all states. And Article 53 of the Vienna Convention on the Law of Treaties
goes so far as to declare that a “treaty is void if, at the time of its conclusion, it conflicts with a
peremptory norm of general international law”. And even when ingredients of genocide remain
difficult to prove, the International Court of Justice has held, for example in 2007, that states
1
have a duty to prevent and punish acts and omissions that eventually furnish elements for
committing the crime of genocide.
There also exists an erga omens rule prescribing specifically determined obligations that states
owe to the international community as a whole. This was enunciated by the World Court in
1970 when it enumerated four ‘situations’ of obligations: the outlawing of acts of aggression,
the outlawing of genocide, protection from slavery, and protection from racial discrimination.
A great significance of this judicial dictum is that it imposes obligations which transcend
consensual relations among states.
Justice Prasana Varale (of the Aurangabad Bench of the Bombay High Court) suggested on
April 8, 2020, that the administration can create several centres across districts to avoid large
gatherings, thereby recognizing the need of vegetables, medicines, and other essential goods as
well as the emphasized role of the fundamental duties of all Indian citizens under Article 51-A
of the Constitution. He admirably stated that “while it expects effective measures from the state
government for migrants and health workers”, the Covid-19 pandemic requires citizens, who
are “always protective about their fundamental rights” to “remind themselves and discharge the
fundamental duties”. In doing so, he invoked Article 51-A of the Indian Constitution, which
calls on all citizens to “promote harmony and the spirit of common brotherhood amongst all the
people of India” and transcend “religious, linguistic and regional to renounce practices
derogatory to the dignity of women”.
In this context, we should also remember the American Declaration of the Rights and Duties of
Man, also known as the Bogota Declaration, the inaugural international human rights
instrument that preceded the Universal Declaration of Human Rights (UDHR) by less than a
year. And on December 9, 1998, the eve of the 70th anniversary of the UDHR, the UN General
Assembly adopted a resolution declaring the Right and Responsibility of Individuals, Groups
and Organs of Society to Promote and Protect Universally Recognized Human Rights and
Fundamental Freedoms. It asserts in Article 18, Section 1 that: “Everyone has duties towards
and within the community, in which alone the free and full development of his or her personality
is possible”. And Article 18, Section 3 states that: “Individuals, groups, institutions and non-
governmental organizations also have an important role and a responsibility in contributing, as
appropriate, to the promotion of the right of everyone to a social and international order in
which the rights and freedoms set forth in the Universal Declaration of Human Rights and other
human rights instruments can be fully realized.”
It is eminently arguable to maintain that this Declaration has become an aspect of customary
international law binding on all states – and further that it remains particularly relevant to the
global Covid-19 situation, which unites the state and civil society actors to care for the concrete
suffering of others. In this connection, the “morality of aspiration” (to recall the phrase of
lamented Professor Lon Fuller) is crucial because, as Professor John Finnis reminds us,
“universalist and agent-neutral” duties make moral sense even if these “moral duties regarding
people’s well-being are not impartial, and if they are agent-relative”.
2
In addition, there are three other sets of international law obligations. These are primarily
derived from the no-harm principles crystallized in the ILC 2001 Draft Articles on the
Prevention of Transboundary Harm (DAPTH) and the 2015 Paris Framework Agreement on
Climate Change. DAPTH has carefully developed norms of due diligence, stressing entirely
that these may be adapted to contextual exigencies. But due diligence obligations may not be
gainsaid altogether when the environmental invasions have a transboundary impact. Each state
is obliged to observe these standards in the fight against Covid-19 as a matter of international
law.
The second set of obligations relate to other core human rights measures: no law or policy to
combat epidemics or pandemics can go against the rights of migrant workers, internally
displaced peoples, refugees, and asylum seekers. In combating Covid-19, respect is owed to the
inherent dignity of individuals, the rights of equal health for all, and the duties of non-
discrimination. And the norms of human dignity further reinforce the accountability and
transparency of the state and other social actors. Panicky and sadist policing endeavours to
maintain lockdown regimes and shoot at sight orders in collective migrant labour exodus
situations – and militaristic responses to food riots instantly de-justify public health lockouts
and curfews.
The third set of obligations arise out of international humanitarian law. The Biological and
Toxin Weapons Convention (BTWC) must be mentioned in this context. Without joining any
conspiracy or racist theory about the origins of Covid-19, the Foreign Minister of India rightly
affirmed the BTWC obligations on March 26, 2020, the 40th anniversary of that Convention.
Surely, this first global and non-discriminatory disarmament convention is worthy of applause
because it outlawed a range of weapons of mass destruction. India rightly again called for a
“high priority” to enable “full and effective implementation by all states parties”.
Moreover, multinational and domestic corporations are also liable before an increasing number
of domestic courts. In an illustration of this, the Canadian Supreme Court ruled on February 28,
2020, in Nevsun Resources Ltd. v Araya et al., 2020 SCC 5, that customary international law
can give rise to a direct claim in Canada if obligations of avoiding and eliminating forced labour,
slavery, cruel, inhumane and degrading treatment, and crimes against humanity are violated.
The metaphor of ‘war’ is often invoked in a determined fight against Covid-19; even when there
are some pacific conscientious objections to the starting point, this has to be based on a full-
throated repudiation of an ancient Latin maxim Inter arma enim silent lēgēs (popularly rendered
as “In times of war, the law falls silent.”) Combating this fierce and fearsome pandemic calls
for a re-dedication to existing international law obligations and frameworks, not in their
violation or denial.
What illustrious thinkers of the pre-Covid-19 era, such as Sir Wilfred Jenks, called the
“common law of Mankind”, and what Professor John Rawls later christened the “Law of
Peoples”, is a code of summoning and sustainability nested obligations for all states and peoples
that must now be fully upheld. Put differently, the innate morality of post-Westphalian
3
international law provides the necessary conditions of the “cultural validity” (as Professor
Werner Gephart develops this notion) governing anti-Covid-19 platforms of action.
Professor em. Upendra Baxi is one of the most renowned contemporary Indian legal scholars.
His academic career led him to the universities of Delhi, Durham (Duke University), Sydney,
Surat, New York, Toronto, and Warwick. He was Fellow at the Käte Hamburger Center for
Advanced Study in the Humanities “Law as Culture” from April to November 2011 and from
July to December 2012.
4
813
ANNEXURE P-26
814
815
816
817
818
SOP TEMPLATE FOR ETHICS REVIEW OF
BIOMEDICAL AND HEALTH RESEARCH
DURING COVID-19 PANDEMIC
ANNEXURE P-27
ICMR Bioethics Unit

National Centre for disease Informatics and Research
Indian Council of Medical research
Kannamangala Post, Bengaluru- 562110
http://ethics.ncdirindia.org/
email: icmr.bioethics@gmail.com
819
Institute Logo SOP for Review of Biomedical and Health Research during COVID-19 SOP No: __/ V01
Pandemic Effective Date: dd/mm/yyyy
1. Purpose:
The purpose of this Standard Operating Procedure (SOP) is to describe how the EC will function and conduct ethics review
in an emergency situation with restrictions as imposed by social distancing requirements during the COVID-19 outbreak.
2. Procedures & Responsibilities:

SN Procedure Responsibility
Submission and initial review
a. Submit research proposal (electronically) Researchers
b. Receive, record, verify completeness and allot reference no. Secretariat/ Member Secretary
c. Categorize depending on risk (Exempt/ Expedited, Full committee), identify Member Secretary in
need for review by experts/ independent consultants/ patient /others, consultation with Chairperson
designate reviewers
d. Perform Initial review of documents as described in Table 4.3 of ICMR Primary/ secondary Reviewers
National Ethical Guidelines, fill study evaluation form
e. Schedule virtual Meeting, Prepare Agenda, invite members (Independent Secretariat / Member Secretary
Consultants/Subject Experts/ PI/ Member secretary of local EC/ in
consultation with Chairperson).
Virtual EC meeting
f. Open the meeting, determine quorum (Section 4.8.4 of ICMR National Ethical Chairperson
Guidelines), COI declaration, Summaries Agenda
g. Brief presentation and/or address queries on the research proposal and Researchers/ subject experts
leave meeting prior to decision (optional)
h. Present observations on item reviewed Primary/ secondary Reviewers
i. Discuss further on the item and reach consensus EC members
j. Record Decision and rejoin member who had declared COI before moving on Secretariat / Member Secretary
to subsequent item on agenda
k. Record minutes of meeting, ratify approved decisions of Member Secretary/ Chairperson
exemption/expedited review before closing meeting
Post meeting activities
l. Communication of decision and maintaining records. Secretariat/ Member Secretary
m. Follow up/monitoring/ analysis of SAE/ handling of issues related to non- Member Secretary in
compliance, violation, complaints etc. consultation with Chairperson
3. Detailed Instructions:
 The Research Proposal should be submitted electronically in ICMR Common Forms for Ethics Review
(http://ethics.ncdirindia.org/Common_forms_for_Ethics_Committee.aspx) with supporting documents (Informed Consent,
Brief CV of PI/ Co PIs, Questionnaire/ Case report form, Approval/ Comments of scientific committee, CTRI/ CDSCO/ HMSC/
MTA/ MoU/ insurance coverage) as applicable.
 Once received, the secretariat will verify protocol for completeness (if not ask PI) and number.
 Member Secretary to categorise research into full review, expedited review or exemption from review.
 Member Secretary (in consultation with Chairperson) will identify need for review by subject experts, independent
consultants, special invitees, patient representatives, others for prior review or to present views during the meeting.
 The project for full review will be included in agenda of virtual full-committee meeting to be scheduled at the earliest (48
hrs) by the Member Secretary in consultation with the Chairperson.
 The members will be briefed about the technological requirements and virtual platform used for the conduct of the meeting.
 Quorum requirements for review will be applicable as per Section 4.8.4 ICMR National Ethical Guidelines, 2017.
 Review procedures as per ICMR National Ethical Guidelines will also hold good for the virtual web ethics meeting.
4. Annexures: if any
5. References: ICMR National Ethical Guidelines for Biomedical and Health Research involving Human Participants
Prepared by Reviewed by Approved by Accepted by

Page _ of _
Signature with date Signature with date Signature with date Signature with date
820
ANNEXURE P-28
GUIDELINES
for
HOMOEOPATHIC
PRACTITIONERS
for
COVID 19
821
GUIDELINES
for
HOMOEOPATHIC
PRACTITIONERS
for
COVID 19
Design: Kamleshwar Singh 9810316649

822
Definition
COVID-19 is an infectious disease caused
by the “novel corona virus”. Common
symptoms are fever, dry cough, breathing
difficulty. Some patients also have aches and
pains, nasal congestion, runny nose, sore
throat, nausea, vomiting or diarrhoea.
Historical Background
On 31 December 2019, World Health Organization (henceforth
referred as WHO) was alerted about an outbreak of several cases
of pneumonia in Wuhan City, Central Hubei Province of China
raising concern since the affected patients were geographically
linked with a local wet market as a potential source with 12% risk
of death(1). As on 4th April 2020, globally 205 countries are
affected. There are 1,051,635 cases diagnosed out of which
56,985, died(2).
Current Status of Covid19 in India

In India, the first case was detected on 30th January 2020,
thereafter day by day the number of cases of COVID19 infection
are increasing. With the spread over more than 28 states
isolation and social distancing is the general measures taken up
by the public promoted by the government in the form of lock
down since 24thMarch 2020. Among the confirmed cases 60-65%
of the subjects belong to eight states viz., Kerala, Maharashtra,
Delhi, Andhra Pradesh, Rajasthan, Tamil Nadu, Uttar Pradesh and
Telangana with more than 200 cases detected(3).
823
Diagnosis
Clinical presentation
Patients with COVID19 infection exhibit a wide range of
symptoms. Most cases reported have mild disease, and nearly
20% appear to progress to severe disease, including pneumonia,
respiratory failure and in some cases death(4). Fever (98%),
cough (82%), shortness of breath(55%),fatigue
(70%),myalgia(44%)and sputum production (33%) are most
common symptoms reported whereas less common symptoms
include headache (13%), diarrhoea (10%), nausea and vomiting
(10%) and haemoptysis(5%)(5).
Case definition
Term Case definition xii,xiii xiv,
A patient with acute respiratory illness {fever and at least one
Suspect Case sign/symptom of respiratory disease (e.g. cough, shortness of
breath or diarrhoea), AND a history of travel to or residence in
a country/area or territory reporting transmission of COVID-19
disease during the 14 days prior to symptom onset.
A patient/Health care worker with any acute respiratory illness
AND having been in contact with a confirmed COVID-19 in the
last 14 days prior to onset of symptoms
A patient with severe acute respiratory infection {fever and at
least one sign/symptom of respiratory disease (e.g. cough,
shortness breath)} AND requiring hospitalization AND with no
other etiology that fully explains the clinical presentation
A case for whom testing for COVID-19 is inconclusive
Lab confirmed Case A person with laboratory confirmation of COVID-19 infection,

irrespective of clinical signs and symptoms.
824
The description of term 'Contact' is given below:
Term Case definition xii,xiii xiv,
Contact A contact is a person that is involved in any of the following:
Ÿ Providing direct care without proper personal protective

equipment (PPE) for COVID-19 patient
Ÿ Staying in the same close environment of a COVID-19 patient

(including workplace, classroom, household, gatherings)
Ÿ Travelling together in close proximity (within 1 m) with a

symptomatic person who later tested positive for COVID-19
Contact with a confirmed case of COVID-19

High risk contact
Travel to a province where COVID-19 LOCAL TRANSMISSION is
being reported as per WHO daily situation report
Touched body fluids of patients (respiratory tract secretions,

blood, vomitus, saliva, urine, faeces)
Touched or cleaned the linens, clothes or dishes of the patient
Close contact, within 3 feet (1 metre) of the confirmed case
Co-passengers in an airplane/vehicle seated in the same row, 3

rows in front and behind of a confirmed COVID-19 case
Shared the same space (same classroom/same room for work) or

similar activity and not having high risk exposure to the
Low risk Contact
confirmed/suspected case
Travel in the same environment (bus/train/flight/any mode of

transit) but not having high risk exposure as cited above
Any traveller from abroad not satisfying high risk criteria

825
Warning Signs
Ÿ Pre-existing underlying serious illness such as
cardiovascular disease, diabetes, end stage renal disease,
vacuities
Ÿ Greater severity of pneumonia at presentation
Ÿ Radio opacity and/or pulmonary infiltrates in chest X-ray
Ÿ Older age group
Ÿ Immunocompromised medical condition
Ÿ Organ failure
Homoeopathic Approach
It is advised that before taking up for
homoeopathic medicines for prophylaxis,
Amelioration and mitigation, physician must
acquaint himself of above sections.
In case of epidemics or pandemics, first approach is to follow preventive

measures and educate people about general measures and to provide such
interventions which will keep their immunity enhanced. Homeopathy therefore
recommends issuing of public notice for Genus epidemicus identified by the
designated experts for immunity enhancement and practitioners may suggest
the same to the people and as per the Advisory issued by Ministry of AYUSH(6).
Second approach is to provide homoeopathic symptomatic mitigation to

affected persons. Homoeopathic medicines are also useful in the treatment of
communicable diseases like Influenza Like Illness(7)(8), dengue(9), acute
encephalitis syndrome(10). Several studies are also published which shows the
immune modulatory potential of homoeopathic medicines in preclinical
studies(11)(12)(13)(14)(15)(16). These medicines can be prescribed in an
integrated manner or standalone depending on the severity on a case to case
826
Therapeutic Aid
As a system with wholistic approach
medicine were selected based on the
presenting signs and symptoms of each
patients(17)(18)(19)(20). The medicines
given here are suggestive based on their
use and studies in the past in diseases of
similar presentation like COVID-19 (21)
(22) (23). Patients of COVID-19 are to be
treated with adjuvant Homoeopathic
medicines with the permission from local
health authorities and Medical
Superintendent of the Hospital.
Homoeopathic doctors must follow all
preventive measures (using PPEs) as are
required for dealing with COVID 19
patients.
The remedies according to different

stages of disease are given below:
Mild Disease (Symptomatic Amelioration
and Mitigation Approach):
Medicines like Aconite napellus,
Arsenicum album, Bryonia alba,
Gelsemium sempervirens, Rhus tox.
Eupatorium perfoliatum, Ipecacaucunha,
Belladonna, Camphora,may be used
depending upon the symptoms
similarities.
Severe disease but not in critical

condition:
It is defined by following criteria
(Dyspnoea, respiratory frequency ≥ 30/min,
blood oxygen saturation (SpO2) ≤ 93%,
PaO2/FiO2 ratio < 300, and/or lung
infiltrates > 50% within 24 to 48 hours)/)
827
Ÿ Suggested medicines are as adjuvant to Standard

Management guidelines in the hospital setting only with
the approval of authorities and willingness of the
patient/guardian.
Ÿ The prescription is to be given only by institutionally

qualified practitioner.
Ÿ Medicines like Phosphorus, Chelidonium, Veratrum Viride,

Iodum, Camphora, Cinchona officinalis, Lycopodium, Ars.
iod., Antim ars., Stannum met, Carbo veg., can be
prescribed on symptomatic indication.
Posology
The medicine selected for each patient is tailored to person specific, taking into
consideration, his/her mental make-up, physical symptoms, and characteristic
particulars etc. In case of long term illness, besides the above mentioned factors,
age, occupation, previous illnesses and life circumstance unique to that individual
irrespective of the disease which he/she is suffering from, are also taken into
consideration; thus the dictum “Homoeopathy treats the patient but not the
disease”.
After the appropriate medicine is selected, it is essential to decide the requisite
potency, dose and repetition which is imperative for optimum response and faster
recovery in each case. Different types of potencies such as decimal or centesimal
potencies can be employed for treatment as are required for acute diseases.
However, selection of potency of the remedy is dependent on various factors like
susceptibility of the patient (high or low), type of disease (acute/chronic), seat/
nature and intensity of the disease, stage and duration of the disease and also the
previous treatment of the disease(24).
828
References
i. Mizumoto K, Chowell G. Estimating risk for death from 2019 novel coronavirus
disease, China, January–February 2020. Emerg Infect Dis. 2020 Jun. Available from:
https://doi.org/10.3201/eid2606.200233. Accessed on: 18 March 2020.
ii. World Health Organization, Situation update [accessed 4th April 2020] available
at: https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200404-
sitrep-75-covid-19.pdf?sfvrsn=99251b2b_2
iii. https://www.covid19india.org/ [accessed 4 April 2020]
iv. World Health Organisation. Novel Coronavirus (2019-nCoV). Situation Report-8
*As reported by 28 January 2020. Available from: https://www.who.int/docs/default-
source/coronaviruse/situation-reports/20200128-sitrep-8-ncov-
cleared.pdf?sfvrsn=8b671ce5_2. Accessed on: 29 January 2020.
v. United States of America. Centres for Disease Control and Prevention. 2019
Novel Coronavirus (2019-nCoV) Outbreak Information. Available from:
https://www.cdc.gov/coronavirus/about/symptoms.html. Accessed on: 29 January 2020.
vi. Jacobs J. Homeopathic Prevention and Management of Epidemic Diseases.
Homeopathy. 2018 Aug; 107(3):157-160.
vii. Mathie RT, Baitson ES, Frye J, Nayak C, Manchanda RK, Fisher P. Homeopathic
treatment of patients with influenza-like illness during the 2009 A/H1N1 influenza
pandemic in India. Homeopathy (2013) 102, 187-192.
viii. Chakraborty PS, Lamba CD, Nayak D, John MD, Sarkar DB et al. Effect of
individualized homoeopathic treatment in influenza like illness: A multicenter, single
blind, randomized, placebo-controlled study. Indian Journal of Research in
Homoeopathy. 7 (1); Jan-Mar 2013.
ix. Nayak D, Chadha V, Jain S, Nim P, Sachdeva J, Sachdeva G, Vivekanand K,
Khurana A, Raheja SM, Manchanda RK. Effect of Adjuvant Homeopathy with Usual Care
in Management of Thrombocytopenia Due to Dengue: A Comparative Cohort Study.
Homeopathy. 2019 Aug;108(3):150-157.
x. Oberai P, Varanasi R, Padmanabhan M, Upadhyaya A, Singh S, Singh SP.
Effectiveness of Homeopathic Medicines as Add-on to Institutional Management
Protocol for Acute Encephalitis Syndrome in Children: An Open-Label Randomized
Placebo-Controlled Trial. Homeopathy. 2018 Aug; 107(3):161-171. doi: 10.1055/s-0038-
1656715.
xi. Cajueiroa APB, Gomaa EP, Santosa HAM, Rodriguesa IA, Tomaa HK, Araújob SM
et al. Homeopathic medicines cause Th1 predominance and induce spleen and
megakaryocytes changes in BALB/c mice infected with Leishmaniainfantum. Cytokine.
2017; 95: Available from:
https://www.sciencedirect.com/science/article/pii/S1043466617300467. Accessed on: 1
April 2020.
xii. Santana FRD, Coelho CP, Cardoso TN, Hurtado ECP, Benites NR, Laurenti MD et
829
al. Modulation of inflammation response to murine cutaneous Leishmaniasis by

homeopathic medicines: Antimoniumcrudum 30cH. Homeopathy. 2014; 103 : Available
from: https://doi.org/10.1016/j.homp.2014.08.006. Accessed on: 1 April 2020.
xiii. Santana FRD, Coelho CDP, Cardoso TN, Laurenti MD, Hurtado ECP, Bonamin LV.
Modulation of inflammation response to murine cutaneous Leishmaniosis by homeopathic
medicines: Thymulin 5cH. Homeopathy. 2014; 103: Available from: DOI:
10.1016/j.homp.2014.08.002. Accessed on 1 April 2020.
xiv. Sandri PF, Portocarrero AR, Ciupa L, Veiga FK, Sanchez Falkowski GJ, Benvenutti
MJ et al. Clinical and parasitological assessment in mice treated with highly diluted Atropa
belladonna. Int J High Dilution. 2014. 13; Available from:
http://www.highdilution.org/index.php/ijhdr/article/view/734. Accessed on: 1 April 2020.
xv. Jonas WB, Dillner DK. Protection of mice from Tularemia infection with ultra-low,
serial agitated dilutions prepared from Francisellatularensis-infected tissue. Journal of
Scientific Exploration. 2000. 14; Available from:
http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.543.2578&rep=rep1&type=pdf.
Accessed on: 1 April 2020.
xvi. Singh LM, Gupta G. Antiviral efficacy of homoeopathic drugs against animal
viruses. 1985; 7: Available from: https://doi.org/10.1016/S0007-0785(85)80063-6. Accessed
on: 1 April 2020.
xvii. Boericke W. Pocket manual of Homoeopathic MateriaMedica& Repertory. 9th
edition. Reprint edition.1998. B. Jain Publishers. New Delhi.
xviii. Allen H.C. Allen's key Notes& characteristics of the Materia Medical with
Nosodes.8th edition. Reprint 1986. B Jain Publishers Pvt. Ltd. New Delhi.
xix. Dewey W.A. Practical Homoeopathic Therapeutics. 3rd edition revised and
enlarged. B Jain Publishers Pvt. Ltd. New Delhi.
xx. Tylor M.L. Homoeopathic Drug Pictures. B Jain Publishers Pvt. Ltd. New Delhi.
xxi. Dewey WA. Homeopathy in Influenza—A chorus of fifty in harmony. Journal of the
American Institute of Homeopathy 1920-21; 13: 1038-1043.
xxii. Borland D M. Pneumonia. B Jain Publishers Pvt. Ltd. New Delhi.
xxiii. Borland D M. Influenza. B Jain Publishers Pvt. Ltd. New Delhi.
xxiv. Close S. The Genius of Homeopathy: Lectures and Essays on Homeopathic
Philosophy. New Delhi; B Jain Publishers; 183-211
830
Disclaimer
These guidelines are in addition to the standard treatment guidelines of
Ministry of Health and Family Welfare, Govt of India and also vetted by the
Interdisciplinary AYUSH Research and Development Task Force setup by
Ministry of AYUSH, Govt of India
831
GUIDELINES for
HOMOEOPATHIC PRACTITIONERS for COVID 19
In case of epidemics or pandemics, first approach is to follow preventive

measures and educate people about general measures and to provide such
interventions which will keep their immunity enhanced. Homeopathy
therefore recommends issuing of public notice for Genus epidemicus
identified by the designated experts for immunity enhancement and
practitioners may suggest the same to the people and as per the Advisory
issued by Ministry of AYUSH.
http://ayush.gov.in | www.facebook.com/moayush | twitter.com/moayush
MINISTRY OF AYUSH
AYUSH BHAWAN, B Block, GPO Complex, INA, NEW DELHI - 110023
832
ANNEXURE P-29
1
833
Compiled and Edited by:
Dr Roli Mathur, Scientist F & Head, ICMR Bioethics Unit, NCDIR, Bengaluru
Secretariat: Dr Kalyani Thakur & Dr Deepika Rathna M
Cover page design: Ms Ankita Pardhi
Published by:
ICMR - National Centre for Disease Informatics & Research, Bengaluru
for Director General, Indian Council of Medical Research, New Delhi
April 2020
Indian Council of Medical Research
i
834
Contents
Foreword ...................................................................................................................................... i
Preface ........................................................................................................................................ ii
1. Statement of General Principles ............................................................................................ 1
2. General Ethical Issues ........................................................................................................... 1
2.1 Benefit-risk assessment ......................................................................................................................... 1
2.2 Privacy Confidentiality ........................................................................................................................... 1
2.3 Distributive Justice. ............................................................................................................................... 1
2.4 Payment for participation. .................................................................................................................... 1
2.5 Compensation for research-related harm ............................................................................................. 1
2.6 Conflict of interest ................................................................................................................................. 2
2.7 Community Engagement ....................................................................................................................... 2
2.8 Post research access and benefit sharing ............................................................................................. 2
2.9 Storage of Biological Material/ datasets .............................................................................................. 2
2.10 Collaboration in research ...................................................................................................................... 2
2.11 Public health and socio behavioral research ......................................................................................... 3
2.12 Role of Agencies/ Sponsors & Governance of Research ........................................................................ 3
2.13 Biosafety in laboratories and hospitals ................................................................................................. 4
3. Ethical Review Procedures .................................................................................................... 4
3.1 Categories of Research .......................................................................................................................... 4
3.2 Ethics Committee (EC) ........................................................................................................................... 4
3.3 Special Situations .................................................................................................................................. 5
3.4 Ethics Review ......................................................................................................................................... 5
3.5 Review of Multicentre Research ............................................................................................................ 6
3.6 Continuing Review & Monitoring .......................................................................................................... 6
3.7 Decisions Regarding Ongoing Studies ................................................................................................... 6
3.8 Review of new non-COVID Research ..................................................................................................... 7
4. Informed Consent ................................................................................................................. 7
4.1 Informed Consent Process ..................................................................................................................... 7
4.2 Electronic Consent ................................................................................................................................. 8
4.3 Waiver of Consent ................................................................................................................................. 8
5. Vulnerability......................................................................................................................... 8
5.1 Vulnerable Persons ................................................................................................................................ 8
5.2 Additional Safeguards ........................................................................................................................... 9
5.3 Safety of Health Care Workers (HCW) involved in research .................................................................. 9
5.4 Psychological needs and mental health ................................................................................................ 9
References................................................................................................................................... 9
Annexure I: SOP Template for Ethics Review of during COVID-19 Pandemic ................................. 11
ii
835
1. F
ore
wor
d
i
836
Preface
Indian Council of Medical Research has always been on the forefront to develop ethical guidance for
biomedical and health research in the country since 1980 and responded to ethical changes with the
emerging times and ICMR National Ethical Guidelines is widely respected and recognised. In the
ongoing COVID-19 pandemic situation, research has to take the front stage in order to tackle the novel
challenges that have come to the fore in an unprecedented manner. There is need for extensive
research to explore therapeutic options, deal with clinical challenges related to patient management
and care, undertake epidemiological studies, fast track development of new diagnostic tools,
identifying and tackling challenges impacting socio behavioural well-being, ways of reducing
stigmatisation, need for quick research without compromising scientific integrity, sharing the samples,
data transfer etc while protecting the rights, safety and well-being of research participants. The need
for social distancing and nationwide lockdown has led to people from all strata of society being left in
a vulnerable situation whether they are affected population, patients, family members, care givers or
health care workers. Many have been forced to remain for long periods in isolation or quarantine,
restricting their freedom of movement, psycho-social responses and autonomous decision making.
Section 12 on “Research during humanitarian emergencies and disasters” and several other sections
of ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants,
2017 directly provide ethical guidance to conduct research in humanitarian emergencies. The relevant
portions are being extracted and put together with additional new guidance points relevant to the
COVID-19 situation in this document to facilitate easy understanding. The structure of the document
is kept similar to the original guidelines for easy reference. Readers are encouraged to go through the
full guidelines for details.
The role of ECs is very important in reviewing protocols prepared for such emergency situation(s).
Responsiveness to the situation include, use of expedited or fast track processes but ensuring robust
ethics review, as well as for monitoring conduct of research. During this pandemic and restricted
environment of research, even non-COVID health research needs to be ongoing. There are provisions
in the guidelines to facilitate them. It is expected that this guideline will be useful not only for ethics
committees but for all stakeholders in research including researchers, sponsors and even public at
large to inform them about the ethical conduct and review of research for ensuring participant safety
and right at all time.
We are grateful to Prof. Balram Bhargava Secretary, DHR & DG, ICMR for his constant support and
guidance. We thank the experts for reviewing the document and providing valuable inputs, viz., Dr NK
Arora, Dr BT Kaul, Dr Bikash Medhi, Dr Shuba Kumar and Rv Dr Christopher Vimalraj. We deeply
acknowledge the support extended by Dr Prashant Mathur, Director NCDIR, Bengaluru for fast track
creation of this document. We also thank Dr Kalyani Thakur and Dr Deepika Rathna, staff of ICMR
Bioethics Unit, NCDIR, Bengaluru for their assistance in developing this document.
Dr Vasantha Muthuswamy Dr Roli Mathur

Chairperson Member Secretary
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1. Statement of General Principles
1.1 The four basic principles namely; respect for persons (autonomy), beneficence, non-
maleficence and justice must guide research in order to protect the dignity, rights, safety and
well-being of research participants while conducting Biomedical and Health Research.
1.2 These basic principles have been further expanded into 12 general principles:
i. Principle of Essentiality ii. Principle of Professional Competence

iii. Principle of Voluntariness iv. Principle of Maximization of Benefit
v. Principle of Non-exploitation vi. Principle of Institutional Arrangements
vii. Principle of Social Responsibility viii. Principle of Transparency & Accountability
ix. Principle of Ensuring Privacy & Confidentiality x. Principle of Totality of Responsibility
xi. Principle of Risk Minimization xii. Principle of Environmental Protection
2. General Ethical Issues

2.1 Benefit-risk assessment: The EC must decide about the type of review required (exempted,
expedited, full committee) based on the type of risk involved.
Table 1: Types of risk
Type of risk Definition/description
Less than minimal Probability of harm or discomfort is nil or not expected.
Minimal risk Probability of harm or discomfort anticipated in the research is not greater than
encountered in routine life activities/ serious harm or adverse event is unlikely
Minor increase Increment in probability of harm or discomfort is only a little more than the minimal risk
over minimal threshold. Such research should have a social value. Social risks, psychological harm and
risk or Low risk discomfort may also fall in this category.
More than Probability of harm or discomfort anticipated in the research is invasive and greater than
Minimal/high risk minimal risk or interventional study.
2.2 Privacy Confidentiality: Information related to COVID-19 infection may be highly sensitive in
nature with a lot of scope for stigmatization, discrimination, violence etc. Maintaining
confidentiality of research related data and its publication is important to protect the privacy
of individuals and avoid any discrimination against them.
2.3 Distributive Justice: Individuals or communities invited for research should be selected in such
a way that the benefits and burdens of research are equitably distributed without leading to
social, racial or ethnic inequalities.
2.4 Payment for participation: Participants should not be made to pay for any expenses incurred
beyond routine clinical care and wherever possible may be given a reasonable amount to
cover incidental expenses.
2.5 Compensation for research-related harm:
2.5.1 Research participants who suffer direct physical, psychological, social, legal or economic harm
as a result of participating in the research are entitled to free health care and referrals as
needed. However, for research related Serious Adverse Events (SAE), appropriate financial
compensation and insurance coverage be provided as per norms.
2.5.2 Sponsor to include insurance coverage/other provision within budget. In investigator initiated
research, investigator/institution must provide through insurance, corpus funds or grants.
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2.5.3 SAEs should be reported to EC (including on non-working days) within 24 hours and a report
on SAE relatedness (causality assessment) within 14 days for EC review regarding quantum
and type of assistance.
2.6 Conflict of interest:

2.6.1 Implement procedures to declare and management conflict of interest (financial/non-
financial) of researchers, EC members, institution, sponsor.
2.7 Community Engagement:

2.7.1 Engaging with the community in a culturally sensitive manner can improve public trust, help
improve design, conduct and responsiveness to health needs.
2.7.2 Various measures to educate the public or communities about pandemic (COVID-19
infection), proposed research, risks and benefits, persons to be contacted etc. should be
undertaken.
2.7.3 Efforts must also be made to prevent the infodemic or spread of fake information, or to
sensationalize, make false promises or claims, or spread negativity or create a scare.
2.8.2 Wherever possible, community representatives (e.g., Community advisory board) be involved
in conceptualization, review, research, dissemination of results in such settings.
2.8 Post research access and benefit sharing:

2.8.1 Efforts be made to communicate the research findings to the individuals/communities.
2.8.2 EC should consider the need for an a priori agreement between researchers and sponsors
regarding post-research access of the community to successful interventions and benefit
sharing if relevant.
2.9 Storage of Biological Material/ datasets:

2.9.1 In COVID-19, samples may be in the form of expectorated sputum, endotracheal aspirate, or
Broncho alveolar lavage (BAL) etc. besides other body fluids, such as blood, plasma, dried
blood spots, body fluids, urine, stool, tissues, organs - stored or prospectively collected.
Storage of infectious samples requires adequate safeguards.
2.9.2 A dataset is an organized collection of data and information maintained in physical and/or
electronic/digital form ranging from small numbers to large numbers or whole population.
2.9.3 Samples/ datasets may be classified as anonymous (unidentified), anonymized or identifiable.
2.9.4 It may be useful to have repository of samples/ registry which can be further used to generate
forecasts of trends and identify hotspots.
2.9.5 Provide clarity on custodianship, obtain approval of the EC/ governance committee,
appropriate written consent, maintain individual confidentiality and privacy.
2.10 Collaboration in research:

2.8.1 Existing guidelines on collaboration for sharing biological samples, data and intellectual
property including publication related issues will be applicable. Collaborations to address
possible inequity of expertise, access between partnering institutions /funding relationships.
2.8.2 Rapid data sharing while safeguarding the above is critical during public health emergency.
2.8.3 An appropriate MoU and/or MTA to safeguard the interests of participants and ensure
compliance (addressing issues of confidentiality, sharing of data, joint publications, etc).
2.8.4 Biomedical and health research proposals involving foreign assistance and/or collaboration
be submitted to Health Ministry’s Screening Committee (HMSC) for approval before initiation.
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2.11 Public health and socio behavioral research:
2.9.1 Health system preparedness is critical to control spread of COVID-19 and focused research
and public health interventions are needed to prevent, delay, or contain the spread.
2.9.2 Isolation, quarantine, segregation from families during the COVID-19 disaster has given a new
dimension to risk to individual dignity, psychological/ emotional harm, social harm,
informational risk.
2.9.3 Emergency circumstances have rendered participants vulnerable to be coerced to participate.
They may not have access to formal or informal support during these times e.g. families,
counselling centers, rehabilitation centers, police protection, etc.
2.9.4 The social distancing norms may not facilitate conventional methods of data collection and
alternative study designs may be required such as online or remote methods to conduct
interviews, focus groups, surveys or questionnaires. Social media research using data in public
domain may still be evaluated for potential privacy threats.
2.9.5 Stakeholders are to consider the fact that technological requirements of the study design may
exclude participants without access to the technology.
2.9.6 For obtaining quality data, verification of identity of research participant is required. However,
exchanging confidential information electronically is prone to security threats. The privacy
and security features of the virtual tool used must be assessed to a reasonable extent.
2.9.7 Collection of identifying information, GPS location, IP address tracking, etc. should be
reviewed by EC on case-case basis.
2.12 Role of Agencies/ Sponsors & Governance of Research:

2.12.1 Humanitarian emergencies lead to fragile political environments, disruption of health
systems, challenging social situations, resource constraints for fast track conduct of research.
2.12.2 Need to ensure appropriate safety, funds, care and compensation, including insurance
coverage as well as training at individual, societal and/or community levels for patients, health
care workers and others engaged in COVID-19 research.
2.12.3 Setting up community consultations and preparation of public educational material.
2.12.4 Support for extensive expert group consultations, review of existing national and international
experience, adequacy of data from preclinical or previous clinical evidence, public private
involvement, ensuring best minds get together to guide research in-spite of limited scientific
evidence, ensure robust research protocols and outcomes.
2.12.5 Central regulatory authority to undertake expeditious review process for clinical trials for new
drugs/ compassionate use and ensure safety/efficacy monitoring processes.
2.12.6 In case of an outbreak of infectious diseases, monitored emergency use of unregistered and
experimental interventions (MEURI) may be approved with the following precautions:
 Thorough scientific review followed by an ethics review / locally or by national level EC
 Tackle public concerns and ensure oversight by a local EC.
 Use GMP products, make rescue medicines/supportive treatment accessible.
 Meticulous documentation of therapeutic processes including adverse events
 Fast track research and possible sharing of data on safety and efficacy for further research
 Consent process is important and must be carried out with care.
 Community engagement and ensuring fair distribution of scarce supply
2.12.7 Facilitate post-trial access of the successful investigational drug/ vaccine free of cost to the
trial participants till the same is available in the market.
2.12.8 Media must also play a responsible role in facilitating dissemination of useful information and
not creating panic through spread of unauthenticated information.
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2.13 Biosafety in laboratories and hospitals:
2.13.1 There are four biosafety levels from BSL-1 to BSL-4 with specific controls for containment of
microbes and biological agents. Virus isolation in cell culture and initial characterization of
infectious viral particles recovered in cultures of SARS-CoV-2 specimens should only be
conducted in a Biosafety Level 3 (BSL-3) laboratory or BSL-4 laboratories which offer highest
safety environments.
2.13.2 The lab must ensure proper labelling and handling of specimens (suspected or confirmed for
COVID-19) and relevant biosafety precautions and relevant regulatory standards to protect
individuals and the environment/ testing in National Accreditation Board for Testing &
Calibration Laboratories (NABL) certified labs. Regulatory requirements for biosafety labs
should be strictly followed as prescribed by Department of Biotechnology (DBT) and Min. of
Environment and Forests, Govt. of India.
2.13.3 Personnel must be trained about additional precautions, decontamination with appropriate
disinfectants, hand hygiene, use of personal protective equipment (PPE), or other physical
barriers, biomedical waste handling to reduce the risk of exposure.
2.13.4 Every effort should be made to limit contact with patients at triage, cohort of patients with
COVID-19, limit the numbers of staff providing care.
2.13.5 Ensure that active screening of all staff at the hospitals is done daily and implement cleaning
and disinfection protocol.
2.13.6 Telemedicine can be used for research when possible. Patient consent is necessary for any
telemedicine consultation for research.
3. Ethical Review Procedures

3.1 Categories of Research:
3.1.1 There are 3 categories of research during COVID that may require ethics review.
 New research directly related to COVID-19
 Ongoing non-COVID research
 New non-COVID research
3.1.2 EC must prioritize research review based on urgency and take needful steps to facilitate the
review of new research and conduct ongoing research with needful amendments as per need
in the view of social distancing norms.
3.2 Ethics Committee (EC):

3.2.1 EC to ensure a thorough scientific and ethical review of research as per national guidelines
and regulations to safeguard the dignity, rights, safety and well-being of research participants.
3.2.2 EC to be registered with appropriate agencies – DHR for biomedical and health research and
CDSCO for regulatory clinical trials as per New Drug and Clinical Trial Rules, 2019.
3.2.3 EC to ensure that all COVID-19 related research (all clinical trials as well as biomedical and
health research) be registered on Clinical Trial Registry of India (CTRI) and seek approvals as
per relevant guidelines and applicable regulations.
3.2.4 Member Secretary to categorise proposals into exempt/expedited/ or full review category as
per National Ethical Guidelines and plan next steps for fast track review.
3.2.5 Research during emergencies can be reviewed through expedited review/unscheduled full
committee meetings on a case-to-case basis depending on the urgency and need. If an
expedited review is done, full ethical review can follow whenever next possible.
3.2.6 Quorum for decision-making should have a minimum of five members, including both
medical/non-medical or technical/non-technical members with one non-affiliated member.
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3.2.7 Measures such as virtual or tele/web conferences should be attempted and face-to-face
meetings can be avoided to observe social distancing norms.
3.2.8 In exceptional and emergency situations, preliminary research procedures including but not
restricted to data/ biological sample collection that are likely to rapidly deteriorate or perish
may be allowed while the ethics review process is still underway.
3.2.9 Available protocol templates could be reviewed to expedite the process and interim review/
re-review can be done if the emergency situation changes.
3.2.10 In situations where members of local ECs are unavailable, the review may be conducted by
any other EC within India for initiating the study, until the local EC is able to convene its
meeting.
3.2.11 ECs should develop procedures to ensure timely review and monitoring of the approved
research. On a case-by-case basis, may require re-review with time and circumstances.
Table 2: Ethical issues related to reviewing a protocol

Social values Scientific design and conduct of Review of informed consent
study process
Benefit–risk assessment Selection and recruitment of Qualification & adequacy of study
participants sites
Payment for participation Disclosure of conflict of interest Plans for medical management
Community considerations Protection of privacy and and compensation for study
confidentiality related injury
3.3 Special Situations:

3.3.1 Institutions can have multiple ECs as per need or may utilize services of another institution
with mutual agreement and agree to be overseen by it.
3.3.2 Registered Independent ECs (Ind EC) can review protocols of researchers who have no
institutional attachments or of institutions without their own ethics committees.
3.3.3 Institutions could have subcommittees such as SAE subcommittee or expedited review
committee which report to the main EC. These comprise Chairperson/ Member Secretary and
one to two designated members of the main EC as defined in the SOPs.
3.4 Ethics Review:

3.4.1 Researchers should submit research proposals in the ICMR Common Forms for Ethics Review
as soft or hard copies enclosing required documents.
(http://ethics.ncdirindia.org/Common_forms_for_Ethics_Committee.aspx)
3.4.2 The EC should adopt/ include an SOP for Emergency Research review.
3.4.3 Submission of e-copy of research protocol and relevant documents followed by their
screening by Secretariat for completeness and categorization as exempt/ expedited review/
emergency full committee review depending on the urgency and need.
3.4.4 Electronic documents may be accepted for review and timelines shortened for accelerated
procedures.
3.4.5 Virtual or Tele/Video conferences should be attempted to ensure social distancing as face-to
face meetings may not be suitable. Use suitable virtual software platform, preferably a video
conference to enable face to face discussion or teleconference if connectivity is an issue.
3.4.6 Agenda of virtual meetings should be kept short, however, EC may meet more frequently for
fast track review within in 24-48 hrs.
3.4.7 The EC may plan a prior review by subject experts/obtain clarifications from researchers
before the meeting or/ invite independent consultants (non-voting) or representative from a
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specific patient group as special invitee. The special invitees invited for the web-meeting may
be asked to leave the meeting before final decision making.
3.4.8 During the review process, the Ethics Committees should consider the following:
 If written consent is not possible (e.g., physical isolation/severe COVID-19 patients),
consent could be given orally/ use electronic methods to document and record.
 Due to inability of the participant to attend the site (for e.g., social distancing), the
contact/communication can be made via phone, to enquire and identify adverse events,
serious adverse events and ensure medical care and oversight with documentation.
 In an ongoing study, if the designated principal investigator (PI) is indisposed for a period,
she/he may need delegate parts of her/his duties temporarily to others/ co-investigator
and the same should be documented and reported to EC at the earliest.
3.4.9 Withholding information in Public Health emergencies may be a threat to national security,
and therefore the right balance must be maintained to protect individual privacy and
confidentiality, and relevant disclosure to public health authorities.
3.4.10 Suggest steps to protect participants of researchers from possible stigma or discrimination.
3.4.11 EC members present during the virtual meeting should decide through consensus or cast
online vote expressing their decision. Any disagreement to be recorded with reasons.
3.4.12 Meeting could be digitally recorded (audio/video) with permission of members and
secretariat is responsible to note the attendance/ participation in the online meeting.
3.5 Review of Multicentre Research:

3.5.1 Common review of multicentre research in India can be carried out by one main designated
EC for fast track decision making.
3.5.2 The local ECs are free to accept the decision of designated committee or to do an expedited
or full committee review expeditiously. They must ensure ethics review of local site specific
issues or concerns, informed consent translations, local study implementation and
monitoring.
3.5.3 Common review is generally carried out for research involving low or minimal risk, survey or
multicentric studies using anonymized samples or data or those that are public health
research studies determined to have low or minimal risk.
3.5.4 However, in an emergency situation like the current one, for all types of research including
high risk studies or those involving vulnerable population can be taken up for fast track
common review while ensuring strict monitoring and oversight by registered local ethics
committees.
3.6 Continuing Review & Monitoring:

3.6.1 The EC should continually evaluate progress of ongoing proposals, monitor approved study
site for compliance, review SAE reports, protocol deviations/violations/ non-compliance/
DSMB reports/ any new information/assess final reports.
3.6.2 For protocol deviations/violations the EC should examine the corrective actions. If the
violations are serious the EC may halt the study.
3.6.3 Compensation must be given for research-related injuries if applicable, as determined by the
EC and as per regulatory requirement (if applicable).
3.7 Decisions Regarding Ongoing Studies:

3.7.1 The impact of COVID-19 on ongoing and existing studies, ongoing recruitment and continued
involvement of participants needs to be considered.
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3.7.2 Secretariat in consultation with Chairperson, must carefully evaluate need for other non
COVID-19 research studies that are ongoing/ near term/ have direct benefit(s) and if stopped,
may pose risk to participants. These may be continued/suggest mechanisms for continuation.
3.7.3 Following measures can be taken in consideration such as, extension of study duration;
temporary halt of study at some/all sites; Suspension/ Postponement of study or activation of
sites that have not yet been initiated without compromising safety and well-being of patients;
Continuation of study with limited parameters; conversion of physical visits into phone or
video visits, postponement or complete cancellation of visits to ensure that only strictly
necessary visits are performed at sites; ongoing study may need to take re-consent of already
enrolled participants to implement urgent changes; it can be done via phone or video-calls
and obtaining oral consents supplemented with email confirmation.
3.7.4 Further, travel restrictions, confinement of study participants and staff to perform visits
should be taken into account.
3.8 Review of new non-COVID Research:

3.8.1 If priority for ethics review in a defined timeframe is given to COVID-19 related research, non-
COVID research must not suffer due to ‘covidisation’. Studies evaluating treatments for
chronic conditions or other communicable diseases or injuries or others may also be
considered for review by EC as these may also be important.
3.8.2 EC should review and assess if a planned study may have a negative impact on participants’
safety or increase risk to participants (as a result of the ongoing COVID-19 pandemic), and
make a decision to allow or not allow it so. It may also make relevant suggestions for additional
safeguards for conducting research in such emergency.
3.8.3 The review of these studies may be done through virtual EC meeting ensuring appropriate
scientific and ethical review and fulfilling the quorum requirements.
4. Informed Consent
4.1 Informed Consent Process:
4.1.1 Obtaining valid informed consent in humanitarian emergencies such as COVID-19 is a
challenge due to practical difficulties in reaching out to a patient, who may be in a COVID
ward, isolation or quarantine facility. In addition, the decisional capacity of the hospitalised
patient with moderate or critical disease condition would be very low and it may not be
possible to differentiate between reliefs offered and research components.
4.1.2 Informed consent is a continuous process involving three main components – providing
relevant information, ensuring competence, ensuring comprehension and voluntariness.
Table 3: Elements of an ICD
Elements of an ICD Additional elements (optional)
1. Statement mentioning that it is research 1. Alternative procedures or treatment
2. Purpose of research and methods 2. Insurance coverage
3. Duration, frequency, methods 3. Possible stigmatizing condition
4. Benefits to participant, community or others 4. Biological material and data, including
5. Foreseeable risks, discomfort or inconvenience i. Current and future uses
6. Confidentiality of records ii. Period of storage, secondary use, sharing
7. Payment/reimbursement for participation iii. Right to prevent use of biological sample
8. Treatment and/or compensation for injury iv. Provisions to safeguard confidentiality
9. Freedom to participate/withdraw v. Post-research plan/benefit sharing
10. Identity of research team and contact persons vi. Publication plan/photographs/pedigrees
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4.1.3 Needful procedure be followed as discussed in National ethical guidelines for involving
children (assent) or legally authorized representative (LAR) in case a participant is
incompetent (medically or legally), illiterate participant/LAR should be witnessed by an
impartial literate witness.
4.1.4 Broad consent with an individual informed opt-out option may be used for research on
residual clinical samples.
4.1.5 The Informed Consent Document (ICD) has two parts – patient/participant information sheet
(PIS) and the informed consent form (ICF) and can be prepared preferably utilizing electronic
formats or plan methods to obtain consent maintaining adequate social distancing.
4.2 Electronic Consent:

4.2.1 In light of COVID-19 infection control measures, the alternative procedures to avoid direct
interaction with the patient in isolation must be explored.
4.2.2 Technology should be utilized to prepare interactive formats and using electronic tools such
as text, graphics, audio, video, podcasts, interactive website, platforms to explain information
related to a study and to electronically document informed assent/consent the same.
4.2.3 Electronic methods (e.g. digital signature) must be reviewed and approved by the EC a priori.
4.2.4 Process can be documented through audio or video recording (if required).
4.3 Waiver of Consent:

4.3.1 For seeking waiver of consent, the researchers should give the rationale justifying the waiver
which EC can approve a waiver after careful discussion in the following situations:
 research cannot practically be carried out without the waiver and the waiver is
scientifically justified like, cluster randomization trials.
 retrospective studies, where the participants are de-identified or cannot be contacted
 research on anonymized biological samples/data
 certain types of public health studies/surveillance programs/program evaluation studies
 research on data available in the public domain; or
 research during humanitarian emergencies and disasters, when the participant may not
be in a position to give consent.
 When consent of the participant/LAR/assent is not possible due to the emergency
situation, informed consent can be administered at a later stage, when the situation
allows for it, and if it is so envisaged, prior permission must be obtained from the EC.
5. Vulnerability
5.1 Vulnerable Persons are individuals/ belonging to certain groups of persons who are relatively
or absolutely incapable of protecting their own interests such as:
5.1.1 COVID-19 patients may be additionally vulnerable of being stigmatized due to the contagious
nature of the disease. Also at risk are health care workers in COVID-19 hospitals including
doctors, nurses, ward staff, sanitation workers, security personnel, food suppliers, or others.
5.1.2 Socially, economically or politically disadvantaged individuals such as the stranded migrant
workers who are susceptible to being exploited;
5.1.3 Incapable of making a voluntary informed decision or whose autonomy is compromised
temporarily or permanently;
5.1.4 Able to give consent, but voluntariness/understanding compromised due to their situation;
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5.1.5 Unduly influenced either by the expectation of benefits or fear of retaliation in case of refusal
to participate which may lead them to give consent
5.1.6 Terminally ill patients ready to consent in search of new interventions.
5.2 Additional Safeguards: Participants may be under duress and traumatized, therefore,
additional safeguards are required for participants and it should be ensured that,
5.2.1 Research to address the needs of participants and justify inclusion of vulnerable persons.
5.2.2 Benefits and risks carefully determined and the risk minimization strategies are examined.
5.2.3 There is no coercion, force, undue influence, threat or misrepresentation or incentives.
5.2.4 Informed consent process is conducted in a respectful manner.
5.2.5 Efforts to set up support systems to deal with associated medical and social problems.
5.2.6 Protection of their privacy, confidentiality and rights is required at all times.
5.2.7 Whenever possible, ancillary care may be provided.
5.3 Safety of Health Care Workers (HCW) involved in research:

5.3.1 In wake of the pandemic, safety of researchers must get due attention as transmission of
infection to one member in a lab or clinical setting could jeopardize the entire program.
5.3.2 Ensuring safety is the responsibility of the institution, sponsors and local authorities, since
research team may be subjected to disturbing instances (trauma, humiliation and threats of
violence) while conducting research.
5.3.3 Additional precautions such as; Prioritize research and schedules to prevent overcrowding,
adequate training, appropriate biosafety precautions, expose minimum number of
researchers, communication using electronic platforms, due protection gear/PPE and facilities
to undertake research, safety against any assault from public or others, insurance cover etc.
5.4 Psychological needs and mental health:

5.4.1 Persons tested positive for COVID-19, their families, health workers who get in contact with
COVID positive cases must be provided due psychosocial support wherever possible.
5.4.2 There is need to show respect, empathy and compassion and not subject them to any kind of
stigma or discrimination.
5.4.3 Persons in isolation or quarantine may face enormous stress and anxiety. Managing the
mental health and psychosocial well-being is important.
5.4.4 The institutions must ensure access to psychosocial and emotional support, good
communication, flexible working hours, and ways to ensure physical as well as psychological
well-being and mental health of those going through the crisis.
References
1. National Ethical Guidelines for Biomedical and Health Research Involving Human Participants. New Delhi: Indian
Council of Medical Research; 2017. Available
from: (http://ethics.ncdirindia.org//asset/pdf/ICMR_National_Ethical_Guidelines.pdf). (Last accessed on 28th April
2020)
2. ICMR Common Forms for Ethics Review. Available from:
(http://ethics.ncdirindia.org/Common_forms_for_Ethics_Committee.aspx). (Last accessed on 28th April 2020)
3. Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services Ministry of Health &
Family Welfare, Government of India, New Delhi. Available from: https://cdsco.gov.in/opencms/opencms/en/Home/
(Last accessed on 28th April 2020)
4. New Drugs and Clinical Trials Rules 2019 G.S.R. 227(E). CDSCO. Available from:
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id
=NDI2MQ==. (Last accessed on 28th April 2020)
5. National Accreditation Board for Hospitals & Healthcare Providers (NABH), Information Brochure for Ethics Committee
Accreditation Program, Dec 2016 Available from: https://www.nabh.co/Images/PDF/CT_Brochure.pdf (Last accessed
on 28th April 2020)
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6. Clinical Trial Registry-India (CTRI), ICMR National Institute of Medical Statistics. Available from:
http://ctri.nic.in/Clinicaltrials/login.php (Last accessed on 28th April 2020)
7. Department of Health Research (DHR), MOHFW, Government of India, National Ethics Committee Registry for
Biomedical and Health Research (NECRBHR). Available from https://naitik.gov.in/DHR/Homepage (Last accessed on
28th April 2020)
8. Matt Richtel San Fransisco W.H.O. Fights a Pandemic Besides Coronavirus: an ‘Infodemic’ Available from:
https://www.nytimes.com/2020/02/06/health/coronavirus-misinformation-social-media.html (Last accessed on 28th
April 2020)
9. Guidelines for International Collaboration /Research Projects in Health Research; MoUs & HMSC procedure Available
from: https://www.icmr.nic.in/content/guidelines (Last accessed on 28th April 2020)
10. ICMR Bioethics Unit NCDIR, National Centre for Disease Informatics and Research (Indian Council of Medical Research),
Bangalore. Available from: http://ethics.ncdirindia.org/ (Last accessed on 28th April 2020).
11. UNESCO. Ethics in research in times of pandemic COVID-19, dated 26th March 2020 Available from:
https://en.unesco.org/news/ethics-research-times-pandemic-covid-19. (Last accessed on 28th April 2020).
12. World Health Organization Ethical standards for research during public health emergencies: distilling existing guidance
to support COVID-19 R&D. 21st March 2020. https://apps.who.int/iris/bitstream/handle/10665/331507/WHO-RFH-
20.1-eng.pdf?sequence=1&isAllowed=y (Last accessed on 28th April 2020)
13. World Health Organization. (2016). Guidance for Managing Ethical Issues in Infectious Disease Outbreaks.
https://apps.who.int/iris/bitstream/handle/10665/250580/9789241549837-eng.pdf?sequence=1&isAllowed=y (Last
accessed on 28th April 2020).
14. Council for International Organizations of Medical Sciences (CIOMS) - 2016. International Ethical Guidelines for Health‐
Related Research Involving Humans. Available from: https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-
EthicalGuidelines.pdf (Last accessed on 28th April 2020).
15. Nuffield Council on Bioethics. (2020). Rapid Policy Briefing. Ethical considerations in responding to the COVID-19
pandemic. 17th March 2020. Available from:
https://www.nuffieldbioethics.org/assets/pdfs/Ethical-considerations-in-responding-to-the-COVID-19-pandemic.pdf
(Last accessed on 28th April 2020).
16. Nuffield Council on Bioethics. (2020). Research in Global Health Emergencies: Ethical Issues.
https://www.nuffieldbioethics.org/publications/research-in-global-health-emergencies (Last accessed on 28th April
2020).
17. COVID-19 Clinical Research Coalition. Global coalition to accelerate COVID-19 clinical research in resource-limited
settings. The Lancet. Vol 395 April 25, 2020. Pg1322-25. Available from: https://www.dndi.org/wp-
content/uploads/2020/04/Coalition-Accelerate-COVID19-Clinical-Research-Resource-Limited-Settings-TheLancet-
2020.pdf (Last accessed on 28th April 2020).
18. WHO Laboratory biosafety guidance related to coronavirus disease (COVID-19). Interim guidance 19 March 2020.
https://apps.who.int/iris/bitstream/handle/10665/331138/WHO-WPE-GIH-2020.1-
eng.pdf?sequence=1&isAllowed=y (Last accessed on 28th April 2020).
19. Guidance for sample collection, packaging and transportation. Ministry of Health and Family Welfare.
https://www.mohfw.gov.in/pdf/5Sample%20collection_packaging%20%202019-nCoV.pdf (Last accessed on 28th April
2020).
20. Novel Coronavirus Disease 2019 (COVID-19): Guidelines on rational use of Personal Protective Equipment. Ministry of
Health and Family Welfare.
https://www.mohfw.gov.in/pdf/GuidelinesonrationaluseofPersonalProtectiveEquipment.pdf (Last accessed on 28th
April 2020).
21. Katharine Wright. COVID-19 and the ethical imperative of preparedness. Nuffield Council of Bioethics
https://www.nuffieldbioethics.org/blog/covid-19-and-the-ethical-imperative-of-preparedness. (Last accessed on 28th
April 2020)
22. Guidelines for Good Clinical Laboratory Practices (GCLP). Indian Council of Medical Research. 2008.
https://www.icmr.gov.in/sites/default/files/guidelines/GCLP.pdf. (Last accessed on 28th April 2020)
23. Madhukar Pai. 'Covidisation' of academic research: opportunities and risks. Available from:
https://naturemicrobiologycommunity.nature.com/users/20892-madhukar-pai/posts/65638-covidisation-of-
academic-research-opportunities-and-risks. (Last accessed on 28th April 2020)
24. Regulations and Guidelines on Biosafety of Recombinant DNA Research and Biocontainment, 2017, Department of
Biotechnology, Min. of Science and technology, Govt. of India. Available from:
http://dbtindia.gov.in/sites/default/files/uploadfiles/Regulations_%26_Guidelines_for_Reocminant_DNA_Research_
and_Biocontainment%2C2017.pdf (Last accessed on 28th April 2020).
25. Psychosocial Issues among Migrants during COVID-19, Ministry of Health and Family Welfare, Govt. of India.
https://www.mohfw.gov.in/pdf/RevisedPsychosocialissuesofmigrantsCOVID19.pdf (Last accessed on 4th May 2020)
26. Review Committee on Genetic Manipulation, Department of Biotechnology, Govt. of India.
https://ibkp.dbtindia.gov.in/Content/Commitee (Last accessed on 4th May 2020)
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Annexure I: SOP Template for Ethics Review of Biomedical and Health Research during
COVID-19 Pandemic
Institute Logo SOP for Review of Review of Biomedical and Health Research during SOP No: __/ V01
COVID-19 Pandemic Effective Date: dd/mm/yyyy
1. Purpose:
The purpose of this Standard Operating Procedure (SOP) is to describe how the EC will function and conduct ethics review
in an emergency situation with restrictions as imposed by social distancing requirements during the COVID-19 outbreak.
2. Procedures & Responsibilities:

SN Procedure Responsibility
Submission and initial review
a. Submit research proposal (electronically) Researchers
b. Receive, record, verify completeness and allot reference no. Secretariat/ Member Secretary
c. Categorize depending on risk (Exempt/ Expedited, Full committee), identify Member Secretary in
need for review by experts/ independent consultants/ patient /others, consultation with Chairperson
designate reviewers
d. Perform Initial review of documents as described in Table 4.3 of ICMR Primary/ secondary Reviewers
National Ethical Guidelines, fill study evaluation form
e. Schedule virtual Meeting, Prepare Agenda, invite members (Independent Secretariat / Member Secretary
Consultants/Subject Experts/ PI/ Member secretary of local EC/ in
consultation with Chairperson).
Virtual EC meeting
f. Open the meeting, determine quorum (Section 4.8.4 of ICMR National Ethical Chairperson
Guidelines), COI declaration, Summaries Agenda
g. Brief presentation and/or address queries on the research proposal and Researchers/ subject experts
leave meeting prior to decision (optional)
h. Present observations on item reviewed Primary/ secondary Reviewers
i. Discuss further on the item and reach consensus EC members
j. Record Decision and rejoin member who had declared COI before moving on Secretariat / Member Secretary
to subsequent item on agenda
k. Record minutes of meeting, ratify approved decisions of Member Secretary/ Chairperson
exemption/expedited review before closing meeting
Post meeting activities
l. Communication of decision and maintaining records. Secretariat/ Member Secretary
m. Follow up/monitoring/ analysis of SAE/ handling of issues related to non- Member Secretary in
compliance, violation, complaints etc. consultation with Chairperson
3. Detailed Instructions:
 The Research Proposal should be submitted electronically in ICMR Common Forms for Ethics Review
(http://ethics.ncdirindia.org/Common_forms_for_Ethics_Committee.aspx) with supporting documents (Informed Consent,
Brief CV of PI/ Co PIs, Questionnaire/ Case report form, Approval/ Comments of scientific committee, CTRI/ CDSCO/ HMSC/
MTA/ MoU/ insurance coverage) as applicable.
 Once received, the secretariat will verify protocol for completeness (if not ask PI) and number.
 Member Secretary to categorise research into full review, expedited review or exemption from review.
 Member Secretary (in consultation with Chairperson) will identify need for review by subject experts, independent
consultants, special invitees, patient representatives, others for prior review or to present views during the meeting.
 The project for full review will be included in agenda of virtual full-committee meeting to be scheduled at the earliest (48
hrs) by the Member Secretary in consultation with the Chairperson.
 The members will be briefed about the technological requirements and virtual platform used for the conduct of the meeting.
 Quorum requirements for review will be applicable as per Section 4.8.4 ICMR National Ethical Guidelines, 2017.
 Review procedures as per ICMR National Ethical Guidelines will also hold good for the virtual web ethics meeting.
4. Annexures: if any
5. References: ICMR National Ethical Guidelines for Biomedical and Health Research involving Human Participants
Prepared by Reviewed by Approved by Accepted by

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Signature with date Signature with date Signature with date Signature with date
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ANNEXURE P-30
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ANNEXURE P-31
THE NATIONAL COMMISSION FOR HOMOEOPATHY ACT, 2020

______________
ARRANGEMENT OF SECTIONS
Last updated: 6-7-2021
_________
CHAPTER I
PRELIMINARY
SECTIONS
1. Short title, extent and commencement.
2. Definitions.
CHAPTER II
NATIONAL COMMISSION FOR HOMOEOPATHY
3. Constitution of National Commission for Homoeopathy.
4. Composition of Commission.
5. Search committee for appointment of Chairperson and Members.
6. Term of office and conditions of service of Chairperson and Members.
7. Removal of Chairperson and Members of Commission.
8. Appointment of secretary experts, professionals officers and employees of Commission.
9. Meeting of Commission.
10. Power and functions of Commission.
CHAPTER III
ADVISORY COUNCIL FOR HOMOEOPATHY
11. Constitution and composition of Advisory council for Homoeopathy.
12. Functions of Advisory Council for Homoeopathy.
13. Meetings of Advisory Council for Homoeopathy.
CHAPTER IV
14. National Eligibility cum-Entrance Test.
15. National Exit Test.
16. Post-Graduate National Entrance Test.
17. National Teachers’ Eligibility Test for Homoeopathy.
CHAPTER V
AUTONOMOUS BOARDS
18. Constitution of Autonomous Boards.

19. Composition of Autonomous Boards.
20. Search Committee for appointment of President and Members.
21. Term of office and conditions of service of President and Members.
22. Advisory committees of experts.
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SECTIONS
23. Staff of Autonomous Boards.
24. Meetings of Autonomous Boards.
25. Delegation of powers.
26. Powers and functions of Homoeopathy Education Board.
27. Powers and functions of Board of Ethics and Registration for Homoeopathy.
28. Powers and functions of Medical Assessment and Rating Board for Homoeopathy.
29. Permission for establishment of new medical institution.
30. Criteria for approving or disapproving scheme.
31. State Medical Councils.
32. National Register and State Register of Homoeopathy.
33. Rights of persons to be enrolled in National Register and their obligations thereto.
34. Rights of persons to practice.
CHAPTER VI
RECOGNITION OF QUALIFICATIONS OF HOMOEOPATHY
35. Recognition of qualifications granted by Universities or medical institutions in India.
36. Recognition of qualifications granted by medical institutions outside India.
37. Withdrawal of recognition or de-recognition of qualification.
38. Special provision in certain cases for recognition of qualifications.
CHAPTER VII
39. Grants by Central Government.
40. National Commission Fund for Homoeopathy.
41. Audit and accounts.
42. Furnishing of returns and reports to Central Government.
CHAPTER VIII
MISCELLANEOUS
43. Power of Central Government to give directions to Commission and Autonomous Boards.
44. Power of Central Government to give directions to State Governments.
45. Information to be furnished by Commission and publication thereof.
46. Obligation of Universities and medical institutions.
47. Completion of courses of studies in medical institutions.
48. Chairperson, Members, officers of Commission, Autonomous Boards to be public servants.
49. Protection of action taken in good faith.
50. Cognizance of offences.
51. Power of Central Government to supersede Commission.
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SECTIONS
52. Joint sittings of Commission, National Commission for Indian Systems of Medicine and National
Medical Commission.
53. State Government to promote public health.
54. Power to make rules.
55. Power to make regulations.
56. Rules and regulations to be laid before Parliament.
57. Power to remove difficulties.
58. Repeal and saving.
59. Transitory provisions.
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THE NATIONAL COMMISSION FOR HOMOEOPATHY ACT, 2020

ACT NO. 15 OF 2020
[20th September, 2020.]
An Act to provide for a medical education system that improves access to quality and affordable
medical education, ensures availability of adequate and high quality Homoeopathy medical
professionals in all parts of the country; that promotes equitable and universal healthcare that
encourages community health perspective and makes services of Homoeopathy medical
professionals accessible and affordable to all the citizens; that promotes national health goals; that
encourages Homoeopathy medical professionals to adopt latest medical research in their work and
to contribute to research; that has an objective periodic and transparent assessment of medical
institutions and facilitates maintenance of a Homoeopathy medical register for India and enforces high
ethical standards in all aspects of medical services; that is flexible to adapt to the changing needs and
has an effective grievance redressal mechanism and for matters connected therewith or incidental
thereto.
BE it enacted by Parliament in the Seventy-first Year of the Republic of India as follows:—
CHAPTER I
PRELIMINARY
1. Short title, extent and commencement.—(1) This Act may be called the National Commission for
Homoeopathy Act, 2020.
(2) It extends to the whole of India.
(3) It shall come into force on such date1 as the Central Government may, by notification in the Official
Gazette, appoint:
Provided that different dates may be appointed for different provisions of this Act and any reference in
any such provision to the commencement of this Act shall be construed as a reference to the coming into
force of that provision.
2. Definitions.—In this Act, unless the context otherwise requires,—
(a) “Autonomous Board” means any of the Autonomous Boards constituted under section 18;
(b) “Board of Ethics and Registration for Homoeopathy” means the Board constituted under
section 18;
(c) “Chairperson” means the Chairperson of the National Commission for Homoeopathy
appointed under section 5;
(d) “Commission” means the National Commission for Homoeopathy constituted under section 3;
(e) “Council” means the Advisory Council for Homoeopathy constituted under section 11;
(f) “Homoeopathy” means the Homoeopathic System of Medicine and includes the use of
biochemic remedies supplemented by such modern advances, scientific and technological development
as the Commission may, in consultation with the Central Government, declare by notification from time
to time;
(g) “Homoeopathy Education Board” means the Board constituted for Homoeopathy
education under section 18;
(h) “licence” means a licence to practice Homoeopathy granted under sub-section (1) of
section 33;
1. 7th October, 2020 - S. 3, 4, 5, 6, 8,11, 18, 19, 20,21, 54 and 55, vide notification No. S.O. 3475(E), see Gazette of India,
Extraordinary, Part II, sec. 3(ii).
5th July, 2021- S. 2, 7, 9, 10, 12, 13, 14, 15, 16, 17, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41,
42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 56, 57, 58, and 59, vide notification No. S.O. 2693(E), see Gazette of India,
Extraordinary, Part II, sec. 3(ii).
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(i) “Medical Assessment and Rating Board for Homoeopathy” means the Board for assessment and
rating of medical institutions constituted under section 18;
(j) “medical institution” means any institution within or outside India which, grants degrees,
diplomas or licences in Homoeopathy and includes affiliated colleges and deemed to be Universities;
(k) “Member” means a Member of the Commission referred to in section 4 and includes the
Chairperson thereof;
(l) “National Register” means a National Medical Register for Homoeopathy maintained by the
Board of Ethics and Registration for Homoeopathy under section 32;
(m) “notification” means a notification published in the Official Gazette and the expression “notify”
shall be construed accordingly;
(n) “prescribed” means prescribed by rules made under this Act;
(o) “President” means the President of an Autonomous Board appointed under section 20;
(p) “regulations” means the regulation made by the Commission under this Act;
(q) “State Medical Council” means a State Medical Council of Homoeopathy constituted under
any law for the time being in force in any State or Union territory for regulating the practice and
registration of practitioners of Homoeopathy;
(r) “State Register” means a State register for Homoeopathy maintained under any law for the time
being in force in any State or Union territory for registration of practitioners of Homoeopathy;
(s) “University” shall have the same meaning as assigned to it in clause (f) of section 2 of the
University Grants Commission Act, 1956 (3 of 1956) and includes a health university.
CHAPTER II
NATIONAL COMMISSION FOR HOMOEOPATHY
3. Constitution of National Commission for Homoeopathy.—(1) The Central Government shall, by
notification, constitute a Commission, to be known as the National Commission for Homoeopathy, to
exercise the powers conferred upon, and to perform the functions assigned to it, under this Act.
(2) The Commission shall be a body corporate by the name aforesaid, having perpetual succession and a
common seal, with power, subject to the provisions of this Act, to acquire, hold and dispose of property,
both movable and immovable, and to contract, and shall, by the said name, sue or be sued.
4. Composition of Commission.—(1) The Commission shall consist of the following persons,
namely:––
(a) a Chairperson;
(b) seven ex officio Members; and
(c) nineteen part-time Members.
(2) The Chairperson shall be a person of outstanding ability, proven administrative capacity and
integrity, possessing a postgraduate degree in Homoeopathy from a recognised University and having
experience of not less than twenty years in the field of Homoeopathy, out of which at least ten years shall be
as a leader in the area of healthcare delivery, growth and development of Homoeopathy or its education.
(3)The following persons shall be appointed by the Central Government as ex officio Members of the
Commission, namely:––
(a) the President of the Homoeopathy Education Board;
(b) the President of the Medical Assessment and Rating Board for Homoeopathy;
(c) the President of the Board of Ethics and Registration for Homoeopathy;
(d) Advisor (Homoeopathy) or Joint Secretary to the Government of India in-charge of
Homoeopathy, in the Ministry of AYUSH;
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(e) the Director, National Institute of Homoeopathy, Kolkata;

(f) the Director, North Eastern Institute of Ayurveda and Homoeopathy, Shillong; and
(g) the Director-General, Central Council for Research in Homoeopathy, Janakpuri, New Delhi.
(4) The following persons shall be appointed by the Central Government as part-time Members of the
Commission, namely:—
(a) three Members to be appointed from amongst persons of ability, integrity and standing, who
have special knowledge and professional experience in the areas of Homoeopathy, management, law,
health research, science and technology and economics;
(b) ten Members to be appointed on rotational basis from amongst the nominees of the States and
Union territories in the Advisory Council for a term of two years in such manner as may be
prescribed.
(c) six members to be appointed from amongst the nominees of the States and Union territories,
under clause (d) of sub-section (2) of section 11, of the Advisory Council for a term of two years in
such manner as may be prescribed:
Provided that no Member shall either himself or through any of his family members, directly or indirectly,
own or be associated with or have any dealings with the managing body of a private or non-government
medical institution which is regulated under this Act.
Explanation.––For the purpose of this section and section 19, the term “leader” means the Head of a
Department or the Head of an Organisation.
5. Search committee for appointment of Chairperson and Members.—(1) The Central
Government shall appoint the Chairperson referred to in section 4 and the President of the Autonomous
Boards referred to in section 20 on the recommendation of a Search Committee consisting of—
(a) the Cabinet Secretary—Chairperson;
(b) two experts, possessing outstanding qualifications and experience of not less than twenty-five
years in the field of Homoeopathy, to be nominated by the Central Government—Members;
(c) one expert, from amongst the members as referred to in clause (c) of sub-section (4) of section
4, to be nominated by the Central Government in such manner as may be prescribed—Member;
(d) one person, possessing outstanding qualifications and experience of not less than twenty-five
years in the field of health research, management, law, economics or science and technology, to be
nominated by the Central Government—Member;
(e) the Secretary to the Government of India incharge of the AYUSH, to be the Convenor—
Member:
Provided that for selection of part-time members of the Commission referred to in clause (a) of sub-
section (4) of section 4, the Secretary referred to in section 8 and other Members of the Autonomous
Boards referred to in section 20, the Search Committee shall consist of members specified in clauses
(b) to (d) and Joint Secretary to the Government of India in the Ministry of AYUSH as Convenor—
Member and chaired by Secretary to the Government of India in-charge of the Ministry of AYUSH.
(2) The Central Government shall, within one month from the date of occurrence of any vacancy,
including by reason of death, resignation or removal of the Chairperson or a Member, or within three
months before the end of tenure of the Chairperson or Member, make a reference to the Search Committee
for filling up of the vacancy.
(3) The Search Committee shall recommend a panel of at least three names for every vacancy referred
to it.
(4) Before recommending any person for appointment as the Chairperson or a Member of the
Commission, the Search Committee shall satisfy itself that such person does not have any financial or other
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interest which is likely to affect prejudicially his functions as such Chairperson or Member.
(5) No appointment of the Chairperson or Member shall be invalid merely by reason of any vacancy or
absence of a Member in the Search Committee.
(6) Subject to the provisions of sub-sections (2) to (5), the Search Committee may regulate its own
procedure.
6. Term of office and conditions of service of Chairperson and Members.—(1) The Chairperson
and Members (other than ex officio Members) and Members appointed under clauses (b) and (c) of sub-
section (4) of section 4 shall hold office for a term not exceeding four years and shall not be eligible for
any extension or re-appointment:
Provided that such person shall cease to hold office after attaining the age of seventy years.
(2) The term of office of an ex officio Member shall continue as long as he holds the office by virtue of
which he is such Member.
(3) Where a Member, other than an ex officio Member, is absent from three consecutive ordinary
meetings of the Commission and the cause of such absence is not attributable to any valid reason in the
opinion of the Commission, such Member shall be deemed to have vacated the seat.
(4) The salary and allowances payable to, and other terms and conditions of service of, the
Chairperson and Member, other than an ex officio Member, shall be such as may be prescribed.
(5) The Chairperson or a Member may––
(a) relinquish his office by giving in writing a notice of not less than three months to the Central
Government; or
(b) be removed from his office in accordance with the provisions of section 7:
Provided that such person may be relieved from duties earlier than three months or allowed to
continue beyond three months until a successor is appointed, if the Central Government so decides.
(6) The Chairperson and every Member of the Commission shall make declaration of his assets and
liabilities at the time of entering upon his office and at the time of demitting his office and also declare his
professional and commercial engagement or involvement, in such form and manner as may be prescribed,
and such declaration shall be published on the website of the Commission.
(7) The Chairperson or a Member, ceasing to hold office as such, shall not accept, for a period of two
years from the date of demitting such office, any employment, in any capacity, including as a consultant or an
expert, in any private Medical institution of Homoeopathy or, whose matter has been dealt with by such
Chairperson or Member, directly or indirectly:
Provided that nothing contained herein shall be construed as preventing such person from accepting an
employment in a body or institution including Medical institution of Homoeopathy, controlled or
maintained by the Central Government or a State Government.
(8) Nothing in sub-section (7) shall prevent the Central Government from permitting the Chairperson
or a Member to accept any employment in any capacity, including as a consultant or an expert, in any
private Medical Institution of Homoeopathy, whose matter has been dealt with by such Chairperson or
Member.
7. Removal of Chairperson and Members of Commission.—(1) The Central Government may, by
order, remove from office the Chairperson or any other Member, who—
(a) has been adjudged an insolvent; or
(b) has been convicted of an offence which, in the opinion of the Central Government, involves
moral turpitude; or
(c) has become physically or mentally incapable of acting as the Chairperson or a Member; or
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(e) has acquired such financial or other interest as is likely to affect prejudicially his functions as a
Member; or
(f) has so abused his position as to render his continuance in office prejudicial to public interest.
(2) No Member shall be removed under clauses (e) and (f) of sub-section (1) unless he has been given a
reasonable opportunity of being heard in the matter.
8. Appointment of secretary experts, professionals officers and employees of Commission.—(1)
There shall be a Secretariat for the Commission to be headed by a Secretary, to be appointed by the Central
Government in accordance with the provisions of section 5.
(2) The Secretary of the Commission shall be a person of proven administrative capacity and integrity,
possessing such qualifications and experience as may be prescribed.
(3) The Secretary shall be appointed by the Central Government for a term of four years and he shall
not be eligible for any extension or re-appointment.
(4) The Secretary shall discharge such functions of the Commission as are assigned to him by the
Commission and as may be specified by regulations made under this Act.
(5) The Commission may appoint such officers and other employees, as it considers necessary, against
the posts created by the Central Government for the efficient discharge of its functions under this Act.
(6) The salaries and allowances payable to, and other terms and conditions of service of the Secretary,
officers and other employees of the Commission shall be such as may be prescribed.
(7) The Commission may engage, in accordance with the procedure specified by regulations, such
number of experts and professionals of integrity and outstanding ability, who have special knowledge of
Homoeopathy and experience in fields including medical education in Homoeopathy, public health,
management, economics, accreditation, patient advocacy, health research, science and technology,
administration, finance, accounts or law as it deems necessary, to assist the Commission in the discharge of
its functions under this Act.
9. Meeting of Commission.—(1) The Commission shall meet at least once every quarter at such time
and place as may be appointed by the Chairperson.
(2) The Chairperson shall preside at the meeting of the Commission and if, for any reason, the
Chairperson is unable to attend a meeting of the Commission, any Member being the President of the
Autonomous Boards, nominated by the Chairperson shall preside at the meeting.
(3) Unless the procedure to be followed at the meetings of the Commission is otherwise provided by
regulations, one-half of the total number of Members of the Commission including the Chairperson shall
constitute the quorum and all decisions of the Commission shall be taken by a majority of the members,
present and voting and in the event of equality of votes, the Chairperson or in his absence, the President of
the Autonomous Board nominated under sub-section (2), shall have the casting vote.
(4) The general superintendence, direction and control of the administration of the Commission shall
vest in the Chairperson.
(5) No act or proceeding of the Commission shall be invalid merely by reason of—
(a) any vacancy in, or any defect in the constitution of, the Commission; or
(b) any defect in the appointment of a person acting as a Chairperson or as a Member.
(6) A person who is aggrieved by any decision of the Commission, except the decision rendered under
sub-section (4) of section 31, may prefer an appeal to the Central Government against such decision within
fifteen days of the communication of such decision.
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858
10. Power and functions of Commission.—(1) The Commission shall perform the following
functions, namely:—
(a) lay down policies for maintaining a high quality and high standards in education of
Homoeopathy and make necessary regulations in this behalf;
(b) lay down policies for regulating medical institutions, medical researches and medical
professionals and make necessary regulations in this behalf;
(c) assess the requirements in healthcare, including human resources for health and healthcare
infrastructure and develop a road map for meeting such requirements;
(d) frame guidelines and lay down policies by making such regulations as may be necessary for the
proper functioning of the Commission, the Autonomous Boards and the State Medical Councils of
Homoeopathy;
(e) ensure coordination among the Autonomous Boards;
(f) take such measures, as may be necessary, to ensure compliance by the State Medical Councils
of Homoeopathy of the guidelines framed and regulations made under this Act for their effective
functioning under this Act;
(g) exercise appellate jurisdiction with respect to decisions of the Autonomous Boards;
(h) make regulations to ensure observance of professional ethics in Medical profession and to
promote ethical conduct during the provision of care by medical practitioners;
(i) frame guidelines for determination of fees and all other charges in respect of fifty per cent. of
seats in private medical institutions and deemed to be Universities which are governed under the
provisions of this Act.
(j) exercise such other powers and perform such other functions as may be prescribed.
(2) All orders and decisions of the Commission shall be authenticated by signature of the Secretary and
the Commission may delegate such of its powers on administrative and financial matters, as it deems fit,
to the Secretary.
(3) The Commission may constitute sub-committees and delegate such of its powers to them as may be
necessary to enable them to accomplish specific tasks.
CHAPTER III
ADVISORY COUNCIL FOR HOMOEOPATHY
11. Constitution and composition of Advisory council for Homoeopathy.—(1) The Central
Government shall, by notification, constitute an advisory body to be known as the Advisory Council for
Homoeopathy.
(2) The Council shall consist of a Chairperson and the following Members, namely:—
(a) the Chairperson of the Commission shall be the ex officio Chairperson of the Council;
(b) every Member of the Commission shall be ex officio member of the Council;
(c) one Member, to represent each State, who is the Vice-Chancellor of a University in that State,
possessing qualifications in Homoeopathy, to be nominated by that State Government, and one
member to represent each Union territory, who is the Vice- Chancellor of a University in that Union
territory, possessing qualifications in Homoeopathy, to be nominated by the Ministry of Home Affairs
in the Government of India:
Provided that where the Vice-Chancellor possessing qualifications in Homoeopathy is not
available, a Dean or Head of Faculty possessing qualifications in Homoeopathy shall be nominated;
(d) one member to represent each State and each Union territory from amongst elected members of
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the State Homoeopathy Medical Council, to be nominated by that State Medical Council;
(e) the Chairman, University Grants Commission;
(f) the Director, National Assessment and Accreditation Council;
(g) four Members to be nominated by the Central Government from amongst persons holding the
post of Director in the Indian Institutes of Technology, Indian Institutes of Management and the Indian
Institute of Science;
(h) the terms of non-ex officio Members in the Council shall be four years.
12. Functions of Advisory Council for Homoeopathy.—(1) The Council shall be the primary
platform through which the States and Union territories may put forth their views and concerns before the
Commission and help in shaping the overall agenda, policy and action relating to medical education,
training, research and development of Homoeopathy.
(2) The Council shall advise the Commission on measures to determine and maintain, and to coordinate
maintenance of the minimum standards in all matters relating to medical education, training, research and
development.
(3) The Council shall advise the Commission on measures to enhance equitable access to medical
education.
13. Meetings of Advisory Council for Homoeopathy.—(1) The Council shall meet at least twice in a
year at such time and place as may be decided by the Chairperson.
(2) The Chairperson shall preside at the meeting of the Council and if for any reason the Chairperson is
unable to attend a meeting of the Council, such other member as nominated by the Chairperson shall preside
over the meeting.
(3) Unless the procedure is otherwise provided by regulations, one-half of the Members of the Council
including the Chairperson shall form the quorum and all acts of the Council shall be decided by a majority
of the Members present and voting.
CHAPTER IV
14. National Eligibility cum-Entrance Test.—(1) There shall be a uniform National Eligibility-cum-
Entrance Test, for admission to the undergraduate in Homoeopathy in all medical institutions governed
under this Act.
(2) The Commission shall conduct the National Eligibility-cum-Entrance Test in English and in such other
languages, through such designated authority and in such manner, as may be specified by regulations.
(3) The Commission shall specify by regulations the manner of conducting common counselling by the
designated authority for admission to all the medical institutions governed under this Act:
Provided that the common counselling shall be conducted by the designated authority of ––
(i) the Central Government, for All India seats; and
(ii) the State Government, for the remaining seats at the State level.
15. National Exit Test.—(1) A Commission final year undergraduate medical examination, to be
known as the national Exit Test, shall be held for granting licence to practice as medical practitioner of
Homoeopathy and for enrolment in the State Register or National Register, as the case may be.
(2) The Commission shall conduct the National Exit Test for Homoeopathy in English and in such other
languages, through such designated authority and in such manner as may be specified by regulations.
(3) The National Exit Test shall become operational on such date, within three years from the date on
which this Act comes into force, as may be appointed by the Central Government, by notification.
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(4) Any person with a foreign medical qualification shall have to qualify National Exit Test for the
purpose of obtaining licence to practice Homoeopathy as medical practitioner of Homoeopathy and for
enrolment in the State Register or the National Register, as the case may be, in such manner as may be
specified by regulations.
16. Post-Graduate National Entrance Test.—(1) A uniform Post-Graduate National Entrance Test
shall be conducted for admission to post-graduate courses in Homoeopathy in all medical institutions
governed under this Act.
(2) The Commission shall conduct the National Entrance Test for admission to postgraduate courses
in English and in such other languages, through such designated authority and in such manner, as may be
(3) The Commission shall specify by regulations the manner of conducting common counselling by the
designated authority for admission to the post-graduate seats in all medical institutions governed under
this Act.
17. National Teachers’ Eligibility Test for Homoeopathy.—(1) A National Teachers’ Eligibility Test
shall be conducted separately for the postgraduates of Homoeopathy who desire to take up teaching
profession in that discipline.
(2) The Commission shall conduct the National Teachers’ Eligibility Test for Homoeopathy
through such designated authority and in such manner as may be specified by regulations.
(3) The National Teachers’ Eligibility Test for Homoeopathy shall become operational on such date,
within three years from the date on which this Act comes into force, as may be notified by the Central
Government:
Provided that nothing contained in this section shall apply to the teachers appointed prior to the date
notified under sub-section (3).
CHAPTER V
AUTONOMOUS BOARDS
18. Constitution of Autonomous Boards.—(1) The Central Government shall, by notification,

constitute the following Autonomous Boards, under the overall supervision of the Commission, to
perform the functions assigned to such Boards under this Act, namely:—
(a) the Homoeopathy Education Board;
(b) the Medical Assessment and Rating Board for Homoeopathy; and
(c) the Board of Ethics and Registration for Homoeopathy.
(2) Each Board referred to in sub-section (1) shall be an autonomous body which shall carry out its
functions under this Act in accordance with the regulations made by the Commission.
19. Composition of Autonomous Boards.—(1) The composition of the Autonomous Boards shall be
as under, namely:––
(a) the Homoeopathy Education Board shall consist of a President and four Members from the
discipline of Homoeopathy;
(b) the Medical Assessment and Rating Board for Homoeopathy shall consist of a President from
the discipline of Homoeopathy and two Members, out of whom one Member shall be from the
discipline of Homoeopathy and the other Member shall be an acceditation expert;
(c) the Board of Ethics and Registration for Homoeopathy shall consist of a President from the
discipline of Homoeopathy and two Members, out of whom one Member shall be from the discipline
of Homoeopathy and the other Member shall be a person who has demonstrated public record of work
on medical ethics or chosen from any of the disciplines of quality assurance, public health, law or patient
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advocacy.
(2) The President and Members of the Autonomous Boards to be chosen under sub-section (1) shall
be persons of outstanding ability, proven administrative capacity and integrity, possessing post-graduate
degree in respective disciplines from a recognised University and having experience of not less than
fifteen years in respective fields, out of which at least seven years shall be as a leader:
Provided that seven years as leader in the case of the President and Member from Homoeopathy shall
be in the area of health, growth and development of education in Homoeopathy.
20. Search Committee for appointment of President and Members.—The Central Government
shall appoint the President and Members of the Autonomous Boards on the basis of the
recommendations made in accordance with the procedure specified in section 5 by the Search Committee
constituted thereunder.
21. Term of office and conditions of service of President and Members.—(1) The President and
Members of each Autonomous Board shall hold the office for a term not exceeding four years and shall
(2) The salary and allowances payable to, and other terms and conditions of service of the President and
Members of an Autonomous Board shall be such as may be prescribed.
(3) The provisions contained in sub-sections (3), (5), (6), (7) and (8) of section 6 relating to other
terms and conditions of service of, and in section 7 relating to removal from office, the Chairperson and
Members of the Commission shall also be applicable to the President and Members of the Autonomous
Boards.
22. Advisory committees of experts.—(1) Each Autonomous Board, except the Board of Ethics and
Registration for Homoeopathy, shall be assisted by such advisory committees of experts, as may be constituted
by the Commission, for the efficient discharge of the functions of such Boards under this Act.
(2) The Board of Ethics and Registration for Homoeopathy shall be assisted by such ethics committees
of experts, as may be constituted by the Commission, for the efficient discharge of the functions of that
Board under this Act.
23. Staff of Autonomous Boards.—The experts, professionals, officers and other employees appointed
under section 8 shall be made available to the Autonomous Boards in such number and in such manner, as
may be specified by regulations made by the Commission.
24. Meetings of Autonomous Boards.—(1) Every Autonomous Board shall meet at least once a month
at such time and place as it may appoint.
(2) Subject to such regulations as may be made in this behalf, all decisions of the Autonomous Boards
shall be made by consensus and if consensus is not possible, decision shall be made by majority of votes of
the President and Members.
(3) A person who is aggrieved by any decision of an Autonomous Board may prefer an appeal to the
Commission against such decision within thirty days of the communication of such decision.
25. Delegation of powers.—(1) The Commission may delegate all or any of its administrative and
financial powers to the President of each Autonomous Board to enable such Board to function smoothly
and efficiently.
(2) The President of an Autonomous Board may further delegate any of his powers to a Member or
officer of that Board.
26. Powers and functions of Homoeopathy Education Board.—(1) The Homoeopathy Education
Board shall perform the following functions, namely:––
(a) determine the standards of education at the undergraduate, post-graduate and super-speciality
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levels and oversee all aspects of relating thereto;

(b) develop a competency based dynamic curriculum for Homoeopathy at all levels in accordance
with the regulations made under this Act, in such manner that it develops appropriate skill, knowledge,
attitude, values and ethics among the postgraduate and super-speciality students and enables them to
provide healthcare, to impart medical education and to conduct medical research;
(c) frame guidelines on setting up of medical institutions for imparting undergraduate, post-
graduate and super-speciality courses in Homoeopathy, having regard to the needs of the country, the
global norms and the regulations made under this Act;
(d) determine minimum requirements and standards for conducting of courses and examinations in
medical institutions, having regard to the needs of creativity at local levels and the regulations made
under this Act;
(e) determine standards and norms for infrastructure, faculty and quality of education and
research in medical institutions of Homoeopathy, in accordance with the regulations made under this
Act;
(f) specify norms for compulsory annual disclosure, electronically and otherwise, by medical
institutions of Homoeopathy in respect of their functions that has a bearing on the interest of various
stakeholders including students, faculty, the Commission and the Government;
(g) facilitate development and training of faculty Members;
(h) facilitate research programmes;
(i) grant recognition to medical qualifications of Homoeopathy at all levels.
(2) The Homoeopathy Education Board may, in the discharge of its functions, make such
recommendations to, and seek such directions from, the Commission, as it deems necessary.
27. Powers and functions of Board of Ethics and Registration for Homoeopathy.—(1) The Board
of Ethics and Registration for Homoeopathy shall perform the following functions, namely:—
(a) maintain a National Register of all licensed practitioners of Homoeopathy in accordance with
the provisions of section 32;
(b) regulate professional conduct and promote medical ethics in accordance with the regulations
made under this Act:
Provided that the Board of Ethics and Registration for Homoeopathy shall ensure compliance with
the code of professional and ethical conduct through the State Medical Council, in a case where such State
Medical Council has been conferred power to take disciplinary actions in respect of professional or
ethical misconduct by medical practitioners under respective State Acts;
(c) develop mechanisms to have continuous interaction with State Medical Councils of
Homoeopathy to effectively promote and regulate the conduct of medical practitioners of
Homoeopathy;
(d) exercise appellate jurisdiction with respect to the actions taken by a State Medical Council
under section 31.
(2) The Board of Ethics and Registration for Homoeopathy may, in the discharge of its functions, make
such recommendations to, and seek such directions from, the Commission, as it deems necessary.
28. Powers and functions of Medical Assessment and Rating Board for Homoeopathy.—(1) The
Medical Assessment and Rating Board for Homoeopathy shall perform the following functions, namely:–
(a) determine the process of assessment and rating of medical institutions on the basis of their
compliance with the standards laid down by the Homoeopathy Education Board, in accordance with
the regulations made under this Act;
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(b) grant permission for establishment of a new medical institution or to start any post-graduate
course or to increase number of seats, in accordance with the provisions of section 29;
(c) carry out inspections of medical institutions for assessing and rating such institutions in
accordance with the regulations made under this Act:
Provided that the Medical Assessment and Rating Board for Homoeopathy may, if it deems
necessary, hire and authorise any other third party agency or persons for carrying out inspections of
medical institutions for assessing and rating such institutions:
Provided further that where inspection of medical institutions is carried out by such third party
agency or persons authorised by the Medical Assessment and Rating Board for Homoeopathy, it shall
be obligatory on such institutions to provide access to such agency or person;
(d) conduct, or where it deems necessary, empanel independent rating agencies to conduct, assess
and rate all medical institutions, within such period of their opening, and every year thereafter, at such
time, and in such manner, as may be specified by regulations;
(e) make available on its website or in public domain, the assessment and ratings of medical
institutions at regular intervals, in accordance with the regulations made under this Act;
(f) take such measures, including issuing warning, imposition of monetary penalty, reducing
intake or stoppage of admissions and recommending to the Commission for withdrawal of
recognition, against a medical institution for its failure to maintain the minimum essential standards
specified by the Homoeopathy Education Board, in accordance with the regulations made under this
Act.
(2) The Medical Assessment and Rating Board for Homoeopathy may, in the discharge of its functions,
make such recommendations to, and seek such directions from, the Commission, as it deems necessary.
29. Permission for establishment of new medical institution.—(1) No person shall establish a new
medical institution or start any post-graduate course or increase number of seats without obtaining prior
permission of the Medical Assessment and Rating Board for Homoeopathy.
Explanation.––For the purpose of this sub-section, the term “person” includes any University or a
trust or any other body but does not include the Central Government.
(2) For the purpose of obtaining permission under sub-section (1), a person may submit a scheme to
the Medical Assessment and Rating Board for Homoeopathy in such form, containing such particulars,
accompanied by such fee, and in such manner, as may be specified by regulations.
(3) While considering the scheme received under sub-section (2), the Medical Assessment and
Rating Board for Homoeopathy shall have regard to the standards of education and research, the standards
and norms for infrastructure and faculty, the guidelines on setting up of medical institutions and other
requirements determined by the Homoeopathy Education Board, and pass an order either approving or
disapproving the scheme within three months from the date of receipt of such scheme:
Provided that before disapproving such scheme, an opportunity to rectify the defects, if any, shall be
given to the person concerned.
(4) Where a scheme is approved under sub-section (3), such approval shall be the permission under
sub-section (1) to establish a new medical institution.
(5) Where a scheme is disapproved under sub-section (3) or where no order is passed within three
months of submitting a scheme under sub-section (2), the person concerned may prefer an appeal to the
Commission within fifteen days of such disapproval or, as the case may be, after lapse of three months, in
(6) Where the Commission has disapproved the scheme or no order has been passed within fifteen
days from the date of preferring appeal under sub-section (5), the person concerned may prefer a second
appeal to the Central Government within seven days of communication of such disapproval or, as the case
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may be, lapse of specified period of fifteen days.

(7) The Medical Assessment and Rating Board for Homoeopathy may conduct evaluation and
assessment of any University or medical institution at any time, either directly or through any other expert,
having integrity and experience in medical profession without any prior notice and assess and evaluate the
performance, standards and benchmarks of such University or medical institution.
30. Criteria for approving or disapproving scheme.—While approving or disapproving a scheme
under section 29, the Medical Assessment and Rating Board for Homoeopathy, or the Commission, as the
case may be, shall take into consideration the following criteria, namely:—
(a) dequacy of infrastructure and financial resources;
(b) whether adequate academic faculty, non-teaching staff and other necessary facilities have been
provided to ensure proper functioning of medical institution or would be provided within the time-
limit specified in the scheme;
(c) whether adequate hospital facilities have been provided or would be provided within the time-
Provided that, subject to the previous approval of the Central Government, the criteria may be
relaxed for the medical institutions which are set up in such areas as may be specified by the
regulations.
31. State Medical Councils.—(1) The State Government shall, by notification, within three years of
the commencement of this Act, establish a State Medical Council for Homoeopathy in that State if no such
Council exists in that State.
(2) Where a State Act confers power upon the State Medical Council to take disciplinary actions in respect
of any professional or ethical misconduct by a registered practitioner of Homoeopathy, the State Medical
Council shall act in accordance with the regulations made, and the guidelines framed, under this Act:
Provided that till such time as a State Medical Council for Homoeopathy is established in a State, the
Board of Ethics and Registration for Homoeopathy shall receive the complaints and grievances relating to
any professional or ethical misconduct against a registered practitioner of Homoeopathy in that State in
accordance with such procedure as may be specified by regulations:
Provided further that the Board of Ethics and Registration for Homoeopathy or, as the case may be, the
State Medical Council shall give an opportunity of hearing to such practitioner before passing any order
or taking any action, including imposition of any monetary penalty, against such person.
(3) A practitioner of Homoeopathy who is aggrieved by the order passed or the action taken by––
(a) the State Medical Council under sub-section (2) may prefer an appeal to the Board of Ethics
and Registration for Homoeopathy and the decision, if any, of the Board of Ethics and Registration
for Homoeopathy thereupon shall be binding on such State Medical Council, unless a second appeal is
preferred under sub-section (4);
(b) the Board of Ethics and Registration for Homoeopathy under the first proviso to sub-section (2)
may prefer an appeal to the Commission.
(4) A medical practitioner of Homoeopathy who is aggrieved by the decision of the Board of Ethics
and Registration for Homoeopathy, may prefer an appeal to the Commission within sixty days of
communication of such decision.
Explanation.—For the purposes of this Act:—
(a) “State” includes Union territory and the expressions “State Government’’ and “State
Medical Council for Homoeopathy”, in relation to a Union territory, shall respectively mean the
“Central Government” and “Union Territory Medical Council for Homoeopathy”;
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(b) the expression “professional or ethical misconduct” includes any act of commission or
omission, as may be specified by regulations;
32. National Register and State Register of Homoeopathy.—(1) The Board of Ethics and
Registration for Homoeopathy shall maintain a National Register containing the name, address, all recognised
qualifications possessed by a licensed medical practitioner of Homoeopathy and such other particulars as
may be specified by regulations.
(2) The National Register shall be maintained in such form, including in electronic form and in such
manner as may be specified by regulations.
(3) The manner in which any name or qualification may be added to, or removed from, the National
Register and the grounds for removal thereof, shall be such as may be specified by the regulations.
(4) The National Register shall be made available in the public by placing it on the website of the
Board of Ethics and Registration for Homoeopathy.
(5) Every State Medical Council shall maintain and regularly update the State Register in the specified
electronic format and supply a physical copy of the same to the Board of Ethics and Registration for
Homoeopathy within three months of the commencement of this Act.
(6) The Board of Ethics and Registration for Homoeopathy shall ensure electronic synchronisation of
the National Register and the State Register in such a manner that any change in one such register is
automatically reflected in the other register.
33. Rights of persons to be enrolled in National Register and their obligations thereto.—(1)
Any person who has a recognised medical qualification in Homoeopathy under this Act and qualifies the
National Exit Test held under section 15 shall have a licence to practice Homoeopathy and shall have his
name and qualifications enrolled in the National Register or a State Register, as the case may be:
Provided that a person who has been registered in the Central Register of Homoeopathy maintained under
the Homoeopathy Central Council Act, 1973 (59 of 1973) prior to the coming into force of this Act and
before the National Exit Test becomes operational under sub-section (3) of section 15, shall be deemed to
have been registered under this Act and be enrolled first in the State Register and subsequently in the
National Register maintained under this Act.
(2) No person who has obtained a qualification in Homoeopathy from a medical institution
established in any country outside India and is recognised as a medical practitioner of Homoeopathy in that
country, shall, after the commencement of this Act and the National Exit Test for Homoeopathy becomes
operational under sub-section (3) of section 15, be enrolled in the National Register for Homoeopathy,
unless he qualifies the National Exit Test for Homoeopathy.
(3) When a person whose name is entered in the State Register or the National Register, as the case may
be, obtains any title, diploma or qualification for proficiency in sciences or medicine which is a recognised
qualification under section 34 or section 35, as the case may be, he shall be entitled to have such title,
diploma or qualification entered against his name in the State Register or the National Register, in such
34. Rights of persons to practice.—(1) No person other than a person who is enrolled in the State
Register or the National Register, as the case may be, shall—
(a) be allowed to practice Homoeopathy as a qualified practitioner;
(b) hold office as a physician or a surgeon or any other office, by whatever name called, which is
meant to be held by a physician or surgeon, as the case may be;
(c) be entitled to sign or authenticate a medical or fitness certificate or any other certificate required
by any law to be signed or authenticated by a duly qualified medical practitioner;
(d) be entitled to give evidence at any inquest or in any court of law as an expert under section 45 of
the Indian Evidence Act, 1872 (1 of 1872) on any matter relating to Homoeopathy:
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Provided that the Commission shall submit a list of such practitioners to the Central Government in
such manner as may be prescribed:
Provided further that a foreign citizen who is enrolled in his country as a practitioner of Homoeopathy
in accordance with the law regulating the registration of such practitioners in that country may be permitted
temporary registration in India for such period and in such manner as may be specified by regulations.
(2) Any person who acts in contravention of the provisions of this section shall be punished with
imprisonment for a term which may extend to one year, or with fine which may extend to five lakh rupees, or
with both.
(3) Nothing contained in sub-section (2) shall affect,—
(a) the right of a person enrolled on a State Register as practitioner of Homoeopathy to practice
in any State merely on the ground that he does not possess, as on the date of commencement of this
Act, a recognised medical qualification in Homoeopathy;
(b) the right of a person who has been practicing Homoeopathy for not less than five years in a
State, to continue to practice in that State in which a State Register of Homoeopathy is not maintained
as on the date of commencement of this Act.
CHAPTER VI
RECOGNITION OF QUALIFICATIONS OF HOMOEOPATHY
35. Recognition of qualifications granted by Universities or medical institutions in India.—(1)
The medical qualifications in Homoeopathy at undergraduate or postgraduate or super-speciality level
granted by any University or medical institution in India shall be listed and maintained by the
Homoeopathy Education Board, in such manner as may be specified by regulations and such medical
qualification shall be a recognised qualification for the purposes of this Act.
(2) Any University or medical institution in India which grants an undergraduate or postgraduate or
super-speciality qualification in Homoeopathy not included in the list maintained by the Homoeopathy
Education Board, may apply to that Board for granting recognition to such qualification.
(3) The Homoeopathy Education Board shall examine the application for grant of recognition
within period of six mnths in such manner as may be specified by regulations.
(4) Where the Homoeopathy Education Board decides to grant recognition to the qualification in
Homoeopathy, it shall include such qualification in the list maintained by it and shall also specify therein
the date of effect of such recognition, otherwise it shall communicate its decision not to grant
recognition to the concerned University or medical institution.
(5) The aggrieved University or the medical institution may prefer an appeal to the Commission
within a period of sixty days from the date of communication of the decision of Homoeopathy Education
Board in such manner as may be specified by regulations.
(6) The Commission shall examine the appeal received under sub-section (5) within a period of two
months and if it decides that recognition may be granted to such medical qualification, it may direct the
concerned Board to include such qualification in the list maintained by that Board in such manner as
(7) Where the Commission decides not to grant recognition under sub-section (6) or fails to decide
within the specified period, the aggrieved University or medical institution concerned may prefer a
second appeal to the Central Government within a period of thirty days of the communication of such
decision or lapse of specified period, as the case may be.
(8) All medical qualifications which have been recognised before the date of commencement of
this Act and are included in the Second Schedule to the Homoeopathy Central Council Act, 1973
(59 of 1973), shall also be listed and maintained by the Homoeopathy Education Board, in such manner as
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36. Recognition of medical qualifications granted by medical institutions outside India.—(1)

Where an authority in any country outside India which, by the law of that country, is entrusted with the
recognition of qualifications of Homoeopathy in that country, makes an application to the Commission
for granting recognition to such qualification in India, the Commission may, subject to such verification
as it deems necessary, either grant or refuse to grant recognition to that medical qualification.
(2) Where the Commission grants recognition to any medical qualification under sub-section (1),
such qualification shall be a recognised qualification for the purposes of this Act and shall be included
in the list maintained by the Commission in such manner as may be specified:
Provided that in case the Commission decides not to grant recognition to any qualification, the
Commission shall give a reasonable opportunity of being heard to such authority before refusing to
grant such recognition.
(3) Where the Commission refuses to grant recognition to a medical qualification under sub-section
(2), the authority concerned may prefer an appeal to the Central Government for grant of recognition.
(4) All qualifications which have been recognised before the date of commencement of this Act and are
included in the Third Schedule to the Homoeopathy Central Council, Act, 1973 (59 of 1973) shall also be
recognised medical qualifications for the purposes of this Act and shall be listed and maintained by the
Commission in such manner as may be specified by regulations.
37. Withdrawal of recognition or de-recognition of qualification.—(1) Where, upon a report
received from the Medical Assessment and Rating Board for Homoeopathy or otherwise, it appears to
the Commission that—
(a) the courses of study and examination to be undergone in, or the proficiency required from
candidates at any examination held by, a University or medical institution do not conform to the
standards specified by Homoeopathy Education Board; or
(b) the standards and norms for infrastructure, faculty and quality of education in medical
institutions as determined by the Homoeopathy Education Board are not adhered to by any
University or medical institution, and such University or medical institution has failed to take necessary
corrective action to maintain specified minimum standards,
the Commission may initiate action in accordance with the provisions of sub-section (2):
Provided that the Commission shall, before, taking any action for suo motu withdrawal of recognition
granted to the medical qualification awarded by a University or medical institution, impose penalty in
accordance with the provisions of clause (f) of sub-section (1) of section 28.
(2) The Commission shall, after making such further inquiry as it deems fit, and after holding
consultations with the State Government and the authority of the concerned University or medical
institution, comes to the conclusion that the recognition granted to a medical qualification ought to be
withdrawn, it may, by order, withdraw recognition granted to such medical qualification and direct the
Homoeopathy Education Board to amend the entries against the University or medical institution
concerned in the list maintained by that Board to the effect that the recognition granted to such
qualification is withdrawn with effect from the date specified in that order.
(3) If the Commission, after verification with the authority in any country outside India, is of the
opinion that a recognised medical qualification which is included in the list maintained by it is to be de-
recognised, it may, by order, de-recognise such medical qualification and remove it from the list maintained by
the Commission with effect from the date of such order.
38. Special provision in certain cases for recognition of qualifications.—Where the Commission
deems it necessary so to do, it may, by notification, direct that any qualification in Homoeopathy granted by
a medical institution outside India, after such date, as may be specified in that notification, shall be
recognised qualification for the purposes of this Act:
Provided that medical practice by a person possessing such qualification shall be permitted only if
such person has been enrolled as a medical practitioner in accordance with the law regulating the
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registration of medical practitioner for the time being in force in that country:
Provided further that medical practice by a person possessing such qualification shall be limited to such
period as may be specified in that order:
Provided also that medical practice by a person possessing such qualification shall be permitted only if
such person qualifies National Exit Test.
CHAPTER VII
39. Grants by Central Government.—The Central Government may, after due appropriation made by
Parliament by law in this behalf, make to the Commission grants of such sums of money as the Central
40. National Commission Fund for Homoeopathy.—(1) There shall be constituted a fund to be
called “the National Commission Fund for Homoeopathy” and there shall be credited thereto—
(a) all Government grants, fees, penalties and charges received by the Commission and the Autonomous
Boards;
(b) all sums received by the Commission from such other source as may be decided by it.
(2) The fund shall be applied for making payment towards—
(a) The salaries and allowances payable to the Chairperson and Members of the Commission,
Presidents and Members of the Autonomous Boards and administrative expenses including the salaries
and allowances payable to the officers and other employees of the Commission and the Autonomous
Boards;
(b) the expenses incurred or to be incurred in carrying out the provisions of this Act including in
connection with the discharge of the functions of the Commission and the Autonomous Boards.
41. Audit and accounts.—(1) The Commission shall maintain proper accounts and other relevant
records and prepare an annual statement of accounts in such form as may be prescribed, in consultation
with the Comptroller and Auditor-General of India.
(2) The accounts of the Commission shall be audited by the Comptroller and Auditor- General of India
at such intervals as may be specified by him and any expenditure incurred in connection with such audit
shall be payable by the Commission to the Comptroller and Auditor-General of India.
(3) The Comptroller and Auditor-General of India and any other persons appointed by him in connection
with the audit of the accounts of the Commission shall have the same rights and privileges and authority
in connection with such audit as the Comptroller and Auditor-General generally has in connection with the
audit of Government accounts and in particular, shall have the right to demand the production of, and
complete access to, records, books, accounts, connected vouchers and other documents and papers and to
inspect the office of the Commission.
(4) The accounts of the Commission as certified by the Comptroller and Auditor- General of India or
any other person appointed by him in this behalf, together with the audit report thereon, shall be forwarded
annually by the Commission to the Central Government which shall cause the same to be laid, as soon as
may be after it is received, before each House of Parliament.
42. Furnishing of returns and reports to Central Government.—(1) The Commission shall furnish
to the Central Government, at such time, in such form and in such manner, as may be prescribed or as the
Central Government may direct, such reports and statements and such particulars in regard to any matter
under the jurisdiction of the Commission, as the Central Government may, from time to time, require.
(2) The Commission shall prepare, once every year, in such form and at such time as may be
prescribed, an annual report, giving a summary of its activities during the previous year and copies of the
report shall be forwarded to the Central Government.
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(3) A copy of the report received under sub-section (2) shall be laid by the Central Government, as
soon as may be after it is received, before each House of Parliament.
CHAPTER VIII
MISCELLANEOUS
43. Power of Central Government to give directions to Commission and Autonomous
Boards.—(1) Without prejudice to the foregoing provisions of this Act, the Commission and the
Autonomous Boards shall, in exercise of their powers and discharge of their functions under this Act be
bound by such directions on questions of policy as the Central Government may give in writing to them from
time to time:
Provided that the Commission and the Autonomous Boards shall, as far as practicable, be given an
opportunity to express their views before any direction is given under this sub-section.
(2) The decision of the Central Government whether a question is one of policy or not shall be final.
44. Power of Central Government to give directions to State Governments.—The Central
Government may give such directions, as it may deem necessary, to a State Government for carrying out all
or any of the provisions of this Act and the State Government shall comply with such directions.
45. Information to be furnished by Commission and publication thereof.—(1) The Commission
shall furnish such reports, copies of its minutes, abstracts of its accounts and other information to the
Central Government as that Government may require.
(2) The Central Government may publish, in such manner as it may think fit, the reports, minutes,
abstracts of accounts and other information furnished to it under sub-section (1).
46. Obligation of Universities and medical institutions.—Every University and medical
institutions covered under this Act shall maintain a website at all times and display in its website all such
information as may be required by the Commission or an Autonomous Board, as the case may be.
47. Completion of courses of studies in medical institutions.—(1) Notwithstanding anything
contained in this Act, any student who was studying for a degree or diploma in any medical institution
immediately before the commencement of this Act shall continue to so study and complete his course for
such degree or diploma, and such institution shall continue to provide instructions and hold examination for
such student in accordance with the syllabus and studies as existed before such commencement, and such
student shall be deemed to have completed his course of study under this Act and shall be awarded degree
or diploma under this Act.
(2) Notwithstanding anything contained in this Act, where recognition granted to a medical institution
has lapsed, whether by efflux of time or by its voluntary surrender or for any other reason whatsoever, such
medical institution shall continue to maintain and provide the minimum standards as approved by the
Commission till such time as all the candidates are able to complete their study in that institution.
48. Chairperson, Members, officers of Commission, Autonomous Boards to be public
servants.—The Chairperson, Members, officers and other employees of the Commission, President and
Members of Autonomous Boards shall be deemed, when acting or purporting to act in pursuance of any of
the provisions of this Act, to be public servants within the meaning of section 21 of the Indian Penal Code
(45 of 1860).
49. Protection of action taken in good faith.—No suit, prosecution or other legal proceeding shall
lie against the Government, the Commission or any Autonomous Board or a State Medical Council or any
Committee thereof, or any officer or other employee of the Government or of the Commission acting
under this Act for anything which is in good faith done or intended to be done under this Act or the rules or
regulations made thereunder.
50. Cognizance of offences.—No Court shall take cognizance of an offence punishable under this
Act except upon a complaint in writing made in this behalf by an officer authorised by the Commission or
the Ethics and Registration Board or a State Medical Council, as the case may be.
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51. Power of Central Government to supersede Commission.—(1) If, at any time, the Central
Government is of opinion that––
(a) the Commission is unable to discharge the functions and duties imposed on it by or under the
provisions of this Act; or
(b) the Commission has persistently made default in complying with any direction issued by the
Central Government under this Act or in the discharge of the functions and duties imposed on it by or
under the provisions of this Act,
the Central Government may, by notification in the Official Gazette, supersede the Commission for such period,
not exceeding six months, as may be specified in the notification:
Provided that before issuing a notification under this sub-section, the Central Government shall
give a reasonable opportunity to the Commission to show cause as to why it should not be superseded and
shall consider the explanations and objections, if any, of the Commission.
(2) Upon the publication of a notification under sub-section (1) superseding the Commission,––
(a) all the Members shall, as from the date of supersession, vacate their offices as such;
(b) all the powers, functions and duties which may, by or under the provisions of this Act, be
exercised or discharged by or on behalf of the Commission, shall, until the Commission is re-
constituted under sub-section (3), be exercised and discharged by such person or persons as the
Central Government may direct;
(c) all property owned or controlled by the Commission shall, until the Commission is re-
constituted under sub-section (3), vest in the Central Government.
(3) On the expiration of the period of supersession specified in the notification issued under sub-section
(1), the Central Government may,—
(a) extend the period of supersession for such further term not exceeding six months, as it may
consider necessary; or
(b) re-constitute the Commission by fresh appointment and in such case the Members who
vacated their offices under clause (a) of sub-section (2) shall not be deemed disqualified for
appointment:
Provided that the Central Government may, at any time before the expiration of the period of
supersession, whether as originally specified under sub-section (1) or as extended under this sub-
section, take action under clause (b) of this sub-section.
(4) The Central Government shall cause a notification issued under sub-section (1) and a full report of
any action taken under this section and the circumstances leading to such action to be laid before both
Houses of Parliament at the earliest opportunity.
52. Joint sittings of Commission, National Commission for Indian Systems of Medicine and
National Medical Commission.—(1) There shall be a joint sitting of the Commission, the National
Commission for Indian System of Medicine and the National Medical Commission, at least once a year, at
such time and place as they mutually appoint, to enhance the interface between Homoeopathy, Indian System
of Medicine and modern system of medicine.
(2) The Agenda for the joint sitting may be placed with mutual agreement by the Chairpersons of the
Commissions concerned.
(3) The joint sitting may, by an affirmative vote of all members present and voting, decide on
approving specific educational and medical modules or programmes that could be introduced in the
undergraduate and postgraduate courses across medical systems, and promote medical pluralism.
53. State Government to promote public health.—Every State Government may, for the purposes of
addressing or promoting public health, take necessary measures to enhance the capacity of the healthcare
professionals.
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54. Power to make rules.—(1) The Central Government may, by notification in the Official Gazette,
make rules to carry out the purposes of this Act.
(2) In particular, and without prejudice to the foregoing power, such rules may provide for all or any of
the following matters, namely:––
(a) the manner of appointing ten Members of the Commission on rotational basis from amongst
the nominees of the States and Union territories in the Advisory Council under clause (b) of
(b) the manner of appointing members under clause (c) of sub-section (4) of section 4;
(c) the manner of nominating one expert by the Central Government under clause (c) of
(d) the salary and allowances payable to, and other terms and conditions of service of, the
Chairperson and Members under sub-section (4) of section 6;
(e) the form and the manner of making declaration under sub-section (6) of section 6;
(f) the qualifications and experience to be possessed by Secretary under sub-section (2) of
section 8;
(g) the salaries and allowances payable to, and other terms and conditions of the Secretary,
officers and other employees of the Commission under sub-section (6) of section 8;
(h) the other powers to be exercised and other functions to be performed by the Commission under
clause (j) of sub-section (1) of section 10;
(i) the salary and allowances payable to, and other terms and conditions of service of, the
President and Members of an Autonomous Board under sub-section (2) of section 21;
(j) the other factors under clause (d) of section 30;
(k) the manner of submitting list of practitioners under the first proviso to sub-section (1) of
section 34;
(l) the form for preparing annual statement of accounts under sub-section (1) of section 41;
(m) the time within which, and the form and the manner in which, the reports and statements shall be
furnished by the Commission and the particulars with regard to any matter as may be required by the
Central Government under sub-section (1) of section 42;
(n) the form and the time for preparing annual report under sub-section (2) of section 42;
(o) the compensation for the premature termination of employment under the second proviso to
(p) any other matter in respect of which provision is to be made by rules.
55. Power to make regulations.—(1) The Commission may, by notification, make regulations
consistent with this Act and the rules made thereunder to carry out the provisions of this Act.
(2) In particular, and without prejudice to the generality of the foregoing power, such regulations may
provide for all or any of the following matters, namely:—
(a) the functions to be discharged by the Secretary of the Commission under sub-section (4) of
section 8;
(b) the procedure in accordance with which experts and professionals may be engaged and the
number of such experts and professionals under sub-section (7) of section 8;
(c) the procedure to be followed at the meetings of Commission, including the quorum at its
meetings under sub-section (3) of section 9;
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(d) the quality and standards to be maintained in education of Homoeopathy under clause (a) of
(e) the manner of regulating medical institutions, medical researches and medical professionals
under clause (b) of sub-section (1) of section 10;
(f) the manner of regulating functioning of the Commission, the Autonomous Boards and the
State Medical Councils under clause (d) of sub-section (1) of section 10;
(g) the procedure to be followed at the meetings of the Medical Advisory Council, including the
quorum at its meetings under sub-section (3) of section 13;
(h) the other languages in which, the designated authority through which, and the manner in
which the National Eligibility-cum-Entrance Test shall be conducted under sub-section (2) of section
14;
(i) the manner of conducting common counselling by the designated authority for admission to
medical institutions under sub-section (3) of section 14;
(j) the other languages in which, the designated authority through which, and the manner in
which, the National Exit Test shall be conducted under sub-section (2) of section 15;
(k) the manner in which a person with foreign medical qualification shall qualify National Exit Test
(l) the other languages in which, the designated authority through which, and the manner in which
admission to postgraduate courses shall be conducted under sub-section (2) of section 16;
(m) the manner of conducting common counselling by the designated authority for admission to
the postgraduate seats in all medical institutions under sub-section (3) of section 16;
(n) the manner of conducting the National Teachers’ Eligibility Test for Homoeopathy and the
designated authority through whom such test shall be conducted under sub-section (2) of section
17;
(o) the number of, and the manner in which, experts, professionals, officers and other employees
shall be made available by the Commission to the Autonomous Boards under section 23;
(p) the manner in which decisions of the Autonomous Boards shall be made under sub-section (2)
of section 24;
(q) the competency based dynamic curriculum at all levels under clause (b) of sub-section (1) of
section 26;
(r) the manner of setting up of medical institutions for imparting undergraduate, postgraduate and
super-speciality courses in Homoeopathy under clause (c) of sub-section (1) of section 26;
(s) the minimum requirements and standards for conducting courses and examinations in
medical institutions under clause (d) of sub-section (1) of section 26;
(t) the standards and norms for infrastructure, faculty and quality of education and research in
medical institutions of Homoeopathy under clause (e) of sub-section (1) of section 26;
(u) the manner of regulating professional conduct and promoting medical ethics under clause (b) of
(v) the procedure for assessment and rating of the medical institutions under clause (a) of sub-
section (1) of section 28;
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(w) the manner of carrying out inspections of medical institutions for assessing and rating under
(x) the manner of conducting, and the manner of empanelling independent rating agencies to
conduct, assess and rate all medical institutions under clause (d) of sub-section (1) of section 28;
(y) the manner of making available on website or in public domain the assessment and ratings
of medical institutions under clause (e) of sub-section (1) of section 28;
(z) the measures to be taken against a medical institution for failure to maintain the minimum
essential standards under clause (f) of sub-section (1) of section 28;
(za) the form of scheme, the particulars thereof, the fee to be accompanied and the manner of
submitting scheme for establishing new medical college under sub-section (2) of section 29;
(zb) the manner of preferring an appeal to the Commission for approval of the scheme under sub-
(zc) the areas in respect of which criteria may be relaxed under the proviso to section 30;
(zd) the manner of taking disciplinary action by a State Medical Council for professional or ethical
misconduct of registered medical practitioner and the procedure for receiving complaints and
grievances by the Board of Ethics and Registration for Homoeopathy, under sub-section (2) of section
31;
(ze) the act of commission or omission which amounts to professional or ethical misconduct under
clause (b) of the Explanation to section 31;
(zf) other particulars to be contained in a National Register under sub-section (1) of
section 32;
(zg) the form, including the electronic form and the manner of maintaining the National Register
(zh) the manner in which any name or qualification may be added to, or removed from, the
National Register and the grounds for removal thereof, under sub-section (3) of section 32;
(zi) the manner of entering the title, diploma or qualification in the State Register or the National
Register under sub-section (3) of section 33;
(zj) the manner in which, and the period for which temporary registration may be permitted to a
foreign citizen under the second proviso to sub-section (1) of section 34;
(zk) the manner of listing and maintaining medical qualifications granted by a University or
medical institution in India under sub-section (1) of section 35;
(zl) the manner of examining the application for grant of recognition under sub-section (3) of
section 35;
(zm) the manner of preferring an appeal to the Commission for grant of recognition under sub-section
(5) of section 35;
(zn) the manner of including a medical qualification in the list maintained by the Board under sub-
(zo) the manner in which the Homoeopathy Education Board shall list and maintain the medical
qualifications which have been granted recognition before the date of commencement of this Act,
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(zp) the manner in which the Commission shall list and maintain the medical qualifications which
have been granted recognition before the date of commencement of this Act, under sub-section (4) of
section 36.
56. Rules and regulations to be laid before Parliament.—Every rule and every regulation made
under this Act shall be laid, as soon as may be after it is made, before each House of Parliament, while it is in
session, for a total period of thirty days which may be comprised in one session or in two or more
successive sessions, and if, before the expiry of the session immediately following the session or the
successive sessions aforesaid, both Houses agree in making any modification in the rule or regulation or
both Houses agree that the rule or regulation should not be made, the rule or regulation.
57. Power to remove difficulties.—(1) If any difficulty arises in giving effect to the provisions of this
Act, the Central Government may, by order, published in the Official Gazette, make such provisions not
inconsistent with the provisions of this Act as may appear to it to be necessary, for the removing of the
difficulty:
Provided that no order shall be made under this section after the expiry of a period of two years from
the commencement of this Act.
58. Repeal and saving.— (1) With effect from such date as the Central Government may, by
notification, appoint in this behalf, the Homoeopathy Central Council Act, 1973 (59 of 1973) shall stand
repealed and the Central Council of Homoeopathy constituted under section 3 of the said Act shall stand
dissolved.
(2) Notwithstanding the repeal of the Act referred to in sub-section (1), it shall not affect,––
(a) the previous operation of the Acts so repealed or anything duly done or suffered thereunder;
or
(b) any right, privilege, obligation or liability acquired, accrued or incurred under the Act so
repealed; or
(c) any penalty incurred in respect of any contravention under the Act so repealed; or
(d) any proceeding or remedy in respect of any such right, privilege, obligation, liability, penalty as
aforesaid, and any such proceeding or remedy may be instituted, continued or enforced, and any such
penalty may be imposed as if that Act had not been repealed.
(3) On the dissolution of the Central Council of Homoeopathy, the person appointed as the Chairman
of that Council and every other person appointed as the Member and any officer and other employees of
the Council and holding office as such immediately before such dissolution shall vacate their respective
offices and such Chairman and other Members shall be entitled to claim compensation not exceeding three
months’ pay and allowances for the premature termination of term of their office or of any contract of
service:
Provided that any officer or other employee who has been, immediately before the dissolution of the
Central Council of Homoeopathy appointed on deputation basis to the Central Council of Homoeopathy,
shall, on such dissolution, stand reverted to their parent cadre, Ministry or Department, as the case may
be:
Provided further that any officer, expert, professional or other employee who has been, immediately
before the dissolution of the Central Council of Homoeopathy employed on regular basis or on contractual
basis by the Council, shall cease to be such officer, expert, professional or other employees of the Central
Council and shall be entitled to such compensation for the premature termination of his employment, which
shall not be less than three months’ pay and allowances, as may be prescribed.
(4) Notwithstanding the repeal of the aforesaid enactment, any order made, any licence to practice
issued, any registration made, any permission to start new medical institution or to start higher course of
studies or to increase in the admission capacity granted, any recognition of medical qualifications granted,
under the Homoeopathy Central Council Act, 1973 (59 of 1973) which are in force as on the date of
commencement of this Act shall continue to be in force till the date of their expiry for all purposes, as if
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they had been issued or granted under the provisions of this Act or the rules or regulations made
thereunder.
59. Transitory provisions.—(1) The Commission shall be the successor in interest to the Central
Council of Homoeopathy including its subsidiaries or owned trusts and all the assets and liabilities of the
Central Council of Homoeopathy shall be deemed to have been transferred to the Commission.
(2) Notwithstanding the repeal of the Homoeopathy Central Council Act 1973, the educational and
medical standards, requirements and other provisions of the Homoeopathy Central Council Act, 1973 and
the rules and regulations made thereunder shall continue to be in force and operate till new standards or
requirements are specified under this Act or the rules and regulations made thereunder:
Provided that anything done or any action taken as regards the educational and medical standards and
requirements under the enactment under repeal and the rules and regulations made thereunder shall be
deemed to have been done or taken under the corresponding provision of this Act and shall continue in
force accordingly unless and until superseded by anything or by any action taken under this Act.
(3) The Central Government may take such measures, as may be necessary, for the smooth transition
of the dissolved Central Council of Homoeopathy to the corresponding to new Commission under this Act.
____
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ANNEXURE P-32
THE NATIONAL COMMISSION FOR INDIAN SYSTEM OF MEDICINE ACT, 2020
_______
ARRANGEMENT OF SECTIONS
Last updated: 14-6-2021
CHAPTER I
PRELIMINARY
SECTIONS
1. Short title, extent and commencement.
2. Definitions.
CHAPTER II
NATIONAL COMMISSION FOR INDIAN SYSTEM OF MEDICINE
3. Constitution of National Commission for Indian System of Medicine.
4. Composition of Commission.
5. Search Committee for appointment of Chairperson and Members.
6. Term of office and conditions of service of Chairperson and Members.
7. Removal of Chairperson and Members of Commission.
8. Appointment of Secretary, experts, professionals, officers and other employees of Commission.
9. Meetings of Commission.
10. Power and functions of Commission.
CHAPTER III
ADVISORY COUNCIL FOR INDIAN SYSTEM OF MEDICINE
11. Constitution and composition of Advisory Council for Indian System of Medicine.
12. Functions of Advisory Council for Indian System of Medicine.
13. Meetings of Advisory Council for Indian System of Medicine.
CHAPTER IV
14. National Eligibility-cum-Entrance Test.
15. National Exit Test.
16. Post-Graduate National Entrance Test.
17. National Teachers’ Eligibility Test for Indian System of Medicine.
CHAPTER V
AUTONOMOUS BOARDS
18. Constitution of Autonomous Boards.
19. Composition of Autonomous Boards.
20. Search Committee for appointment of President and Members.
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SECTIONS
21. Term of office and conditions of service of President and Members.
22. Advisory Committees of experts.
23. Staff of Autonomous Boards.
24. Meetings, etc., of Autonomous Boards.
25. Delegation of powers.
26. Powers and functions of Autonomous Boards.
27. Powers and functions of Board of Ethics and Registration for Indian System of Medicine.
28. Powers and functions of Medical Assessment and Rating Board for Indian System of
Medicine.
29. Permission for establishment of new medical institution.
30. Criteria for approving or disapproving scheme.
31. State Medical Council.
32. National Register and State Register of Indian System of Medicine.
33. Rights of persons to be enrolled in National Register and their obligations thereto.
34. Rights of persons to practice.
CHAPTER VI
RECOGNITION OF QUALIFICATIONS OF INDIAN SYSTEM OF MEDICINE
35. Recognition of qualifications granted by Universities or medical institutions in India.
36. Recognition of medical qualifications granted by medical institutions outside India.
37. Withdrawal of recognition or de-recognition of qualification.
38. Special provision in certain cases for recognition of qualifications.
CHAPTER VII
39. Grants by Central Government.
40. National Commission Fund for Indian System of Medicine.
41. Audit and accounts.
42. Furnishing of returns and reports to Central Government.
CHAPTER VIII
MISCELLANEOUS
43. Power of Central Government to give directions to Commission and Autonomous Boards.
44. Power of Central Government to give directions to State Governments.
45. Information to be furnished by Commission and publication thereof.
46. Obligation of Universities and medical institutions.
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SECTIONS
47. Completion of courses of studies in medical institutions.
48. Chairperson, Members, officers of Commission and of Autonomous Boards to be public
servants.
49. Protection of action taken in good faith.
50. Cognizance of offences.
51. Power of Central Government to supersede Commission.
52. Joint sittings of Commission, National Commission for Homoeopathy and National Medical
Commission.
53. State Government to promote public health.
54. Power to make rules.
55. Power to make regulations.
56. Rules and regulations to be laid before Parliament.
57. Power to remove difficulties.
58. Repeal and saving.
59. Transitory provisions.
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THE NATIONAL COMMISSION FOR INDIAN SYSTEM OF MEDICINE ACT, 2020

ACT NO. 14 OF 2020
[20th September, 2020.]
An Act to provide for a medical education system that improves access to quality and affordable
medical education, ensures availability of adequate and high quality medical professionals of Indian
System of Medicine in all parts of the country; that promotes equitable and universal healthcare that
encourages community health perspective and makes services of such medical professionals accessible
and affordable to all the citizens; that promotes national health goals; that encourages such medical
professionals to adopt latest medical research in their work and to contribute to research; that has an
objective periodic and transparent assessment of medical institutions and facilitates maintenance of a
medical register of Indian System of Medicine for India and enforces high ethical standards in all aspects
of medical services; that is flexible to adapt to the changing needs and has an effective grievance redressal
mechanism and for matters connected therewith or incidental thereto.
BE it enacted by Parliament in the Seventy-first Year of the Republic of India as follows:—
CHAPTER I
PRELIMINARY
1. Short title, extent and commencement.—(1) This Act may be called the National Commission
for Indian System of Medicine Act, 2020.
(2) It extends to the whole of India.
(3) It shall come into force on such date1 as the Central Government may, by notification in the
Official Gazette, appoint:
Provided that different dates may be appointed for different provisions of this Act and any reference
in any such provision to the commencement of this Act shall be construed as a reference to the coming
into force of that provision.
2. Definitions.—In this Act, unless the context otherwise requires,—
(a) “Autonomous Board” means any of the Autonomous Boards constituted under section 18;
(b) “Board of Ayurveda” means the Board constituted under section 18;
(c) “Board of Ethics and Registration for Indian System of Medicine” means the Board
(d) “Board of Unani, Siddha and Sowa-Rigpa” means the Board constituted under section 18;
(e) “Chairperson” means the Chairperson of the National Commission for Indian System of
Medicine appointed under section 5;
(f) “Commission” means the National Commission for Indian System of Medicine constituted
under section 3;
(g) “Council” means the Advisory Council for Indian System of Medicine constituted under
section 11;
1. 7th October, 2020— S. 3,4,5,6,8,11,18,19,20,21,54 and 55 vide notification No. S.O. 3483(E), dated 7th October, 2020, see
Gazette of India, Extraordinary, Part II, sec. 3 (ii).
11th June, 2021— (All the remaining provisions) vide notification No. S.O. 2278(E), dated 11 th June, 2021. see
Gazette of India, Extraordinary, Part II, sec. 3 (ii).
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(h) “Indian System of Medicine” means the Ashtang Ayurveda, Unani, Siddha and Sowa-Rigpa
Systems of Medicine supplemented by such modern advances, scientific and technological
development as the Commission may, in consultation with the Central Government, declare by
notification from time to time;
(i) “licence” means a licence to practice any of the Indian System of Medicine granted under
(j) “Medical Assessment and Rating Board for Indian System of Medicine” means the Board
(k) “medical institution” means any institution within or outside India which, grants degrees,
diplomas or licences in Indian System of Medicine and includes affiliated colleges and deemed to be
Universities;
(l) “Member” means a Member of the Commission referred to in section 4 and includes the
Chairperson thereof;
(m) “National Register” means a National Medical Register for Indian System of Medicine
maintained by the Board of Ethics and Registration for Indian System of Medicine under section 32;
(n) “notification” means a notification published in the Official Gazette and the expression
“notify” shall be construed accordingly;
(o) “prescribed” means prescribed by rules made under this Act;
(p) “President” means the President of an Autonomous Board appointed under section 20;
(q) “regulations” means the regulations made by the Commission under this Act;
(r) “State Medical Council” means a State Medical Council of Indian System of Medicine
constituted under any law for the time being in force in any State or Union territory for regulating the
practice and registration of practitioners of Indian System of Medicine in that State or Union territory;
(s) “State Register” means a State Register for Indian System of Medicine maintained under any
law for the time being in force in any State or Union territory for registration of practitioners of
Indian System of Medicine;
(t) “University” shall have the same meaning as assigned to it in clause (f) of section 2 of the
University Grants Commission Act, 1956 (3 of 1956) and includes a health university.
CHAPTER II
NATIONAL COMMISSION FOR INDIAN SYSTEM OF MEDICINE
3. Constitution of National Commission for Indian System of Medicine.—(1) The Central
Government shall, by notification, constitute a Commission, to be known as the National Commission for
Indian System of Medicine, to exercise the powers conferred upon, and to perform the functions assigned
to it, under this Act.
(2) The Commission shall be a body corporate by the name aforesaid, having perpetual succession
and a common seal, with power, subject to the provisions of this Act, to acquire, hold and dispose of
property, both movable and immovable, and to contract, and shall, by the said name, sue or be sued.
4. Composition of Commission.—(1) The Commission shall consist of the following persons,
namely:––
(a) a Chairperson;
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881
(b) fifteen ex officio Members; and

(c) twenty-three part-time Members.
(2) The Chairperson shall be a person of outstanding ability, proven administrative capacity and
integrity, possessing a postgraduate degree in any of the disciplines of Indian System of Medicine from a
recognised University and having experience of not less than twenty years in any field of Indian System
of Medicine, out of which at least ten years shall be as a leader in the area of healthcare delivery, growth
and development of Indian System of Medicine or its education.
(3) The following persons shall be appointed by the Central Government as ex officio Members of the
(a) the President of the Board of Ayurveda;
(b) the President of the Board of Unani, Siddha and Sowa-Rigpa;
(c) the President of the Medical Assessment and Rating Board for Indian System of Medicine;
(d) the President of the Board of Ethics and Registration for Indian System of Medicine;
(e) Advisor (Ayurveda) or Joint Secretary to the Government of India in-charge of Ayurveda and
Advisor (Unani) or Joint Secretary to the Government of India in-charge of Unani, in the Ministry of
AYUSH;
(f) the Director, All India Institute of Ayurveda, New Delhi;
(g) the Director General, Central Council for Research in Ayurvedic Sciences, New Delhi;
(h) the Director General, Central Council for Research in Unani Medicine, New Delhi;
(i) the Director General, Central Council for Research in Siddha, Chennai;
(j) the Director, National Institute of Siddha, Chennai;
(k) the Director, National Institute of Unani, Bengaluru;
(l) the Director, North Eastern Institute on Ayurveda and Homoeopathy, Shillong;
(m) the Director, Institute of Post Graduate Teaching and Research in Ayurveda, Jamnagar; and
(n) the Director, National Institute of Ayurveda, Jaipur.
(4) The following persons shall be appointed by the Central Government as part-time Members of the
(a) four Members to be appointed from amongst persons of ability, integrity and standing, who
have special knowledge and professional experience in any of the disciplines of Indian System of
Medicine, Sanskrit, Urdu, Tamil, management, law, health research, science and technology and
economics;
(b) ten Members to be appointed on rotational basis from amongst the nominees of the States and
Union territories in the Advisory Council for Indian System of Medicine for a term of two years in
such manner as may be prescribed;
(c) six members from Ayurveda, one member each from Siddha, Unani and Sowa-Rigpa, to be
appointed from amongst the nominees of the States and Union territories, under clause (d) of
sub-section (2) of section 11, in the Advisory Council for Indian System of Medicine, for a term of
two years in such manner as may be prescribed:
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882
Provided that no Member shall either himself or through any of his family members, directly or
indirectly, own or be associated with or have any dealings with the managing body of a private or non-
government medical institution which is regulated under this Act.
Explanation.––For the purpose of this section and section 19, the term “leader” means the Head of a
Department or the Head of an Organisation.
5. Search Committee for appointment of Chairperson and Members.—(1) The Central
Government shall appoint the Chairperson, referred to in section 4 and the President of the Autonomous
Boards referred to in section 20 on the recommendation of a Search Committee consisting of—
(a) the Cabinet Secretary—Chairperson;
(b) two experts, possessing outstanding qualifications and experience of not less than twenty-five
years in any of the fields of Indian System of Medicine, to be nominated by the Central
Government—Members;
(c) one expert, from amongst the Members referred to in clause (c) of sub-section (4) of section 4,
to be nominated by the Central Government in such manner as may be prescribed—Member;
(d) one person, possessing outstanding qualifications and experience of not less than twenty-five
years in the field of Sanskrit, Urdu, Tamil, health research, management, law, economics or science
and technology, to be nominated by the Central Government—Member;
(e) the Secretary to the Government of India in charge of the Ministry of AYUSH, to be the
Convenor—Member:
Provided that for selection of part-time Members of the Commission referred to in clause (a) of sub-
section (4) of section 4, the Secretary referred to in section 8 and other Members of the Autonomous
Boards referred to in section 20, the Search Committee shall consist of Members specified in the clauses
(b) to (d) and Joint Secretary to the Government of India in the Ministry of AYUSH as Convenor-
Member and chaired by Secretary to the Government of India in charge of the Ministry of AYUSH.
(2) The Central Government shall, within one month from the date of occurrence of any vacancy,
including by reason of death, resignation or removal of the Chairperson or a Member, or within three
months before the end of tenure of the Chairperson or Member, make a reference to the Search
Committee for filling up of the vacancy.
(3) The Search Committee shall recommend a panel of at least three names for every vacancy referred
to it.
(4) Before recommending any person for appointment as the Chairperson or a Member of the
Commission, the Search Committee shall satisfy itself that such person does not have any financial or
other interest which is likely to affect prejudicially his functions as such Chairperson or Member.
(5) No appointment of the Chairperson or Member shall be invalid merely by reason of any vacancy
or absence of a Member in the Search Committee.
(6) Subject to the provisions of sub-sections (2) to (5), the Search Committee may regulate its own
procedure.
6. Term of office and conditions of service of Chairperson and Members.––(1) The Chairperson
and Members (other than ex officio Members) and Members appointed under clauses (b) and (c) of
sub- section (4) of section 4 shall hold office for a term not exceeding four years and shall not be eligible
for any extension or re-appointment:
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(2) The term of office of an ex officio Member shall continue as long as he holds the office by virtue
of which he is such Member.
(3) Where a Member, other than an ex officio Member, is absent from three consecutive ordinary
meetings of the Commission and the cause of such absence is not attributable to any valid reason in the
opinion of the Commission, such Member shall be deemed to have vacated the seat.
(4) The salary and allowances payable to and other terms and conditions of service of the Chairperson
and Member, other than an ex officio Member, shall be such as may be prescribed.
(5) The Chairperson or a Member may,––
(a) relinquish his office by giving in writing a notice of not less than three months to the Central
Government; or
(b) be removed from his office in accordance with the provisions of section 7:
Provided that such person may be relieved from duties earlier than three months or allowed to
continue beyond three months until a successor is appointed, if the Central Government so decides.
(6) The Chairperson and every Member of the Commission shall make declaration of his assets and
liabilities at the time of entering upon his office and at the time of demitting his office and also declare his
professional and commercial engagement or involvement, in such form and manner as may be prescribed,
and such declaration shall be published on the website of the Commission.
(7) The Chairperson or a Member, ceasing to hold office as such, shall not accept, for a period of two
years from the date of demitting such office, any employment, in any capacity, including as a consultant
or an expert, in any private Medical institution of Indian System of Medicine or, whose matter has been
dealt with by such Chairperson or Member, directly or indirectly:
Provided that nothing contained herein shall be construed as preventing such person from accepting
an employment in a body or institution including Medical institution of Indian System of Medicine,
controlled or maintained by the Central Government or a State Government.
(8) Nothing in sub-section (7) shall prevent the Central Government from permitting the Chairperson
or a Member to accept any employment in any capacity, including as a consultant or an expert, in any
private Medical institution of Indian System of Medicine, whose matter has been dealt with by such
Chairperson or Member.
7. Removal of Chairperson and Members of Commission.––(1) The Central Government may, by
order, remove from office, the Chairperson or any other Member, who—
(a) has been adjudged an insolvent; or
(b) has been convicted of an offence which, in the opinion of the Central Government, involves
moral turpitude; or
(c) has become physically or mentally incapable of acting as the Chairperson or a Member; or
(e) has acquired such financial or other interest as is likely to affect prejudicially his functions as
a Member; or
(f) has so abused his position as to render his continuance in office prejudicial to public interest.
(2) No Member shall be removed under clauses (e) and (f) of sub-section (1) unless he has been
given a reasonable opportunity of being heard in the matter.
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8. Appointment of Secretary, experts, professionals, officers and other employees of

Commission.––(1) There shall be a Secretariat for the Commission to be headed by a Secretary, to be
appointed by the Central Government in accordance with the provisions of section 5.
(2) The Secretary of the Commission shall be a person of proven administrative capacity and
integrity, possessing such qualifications and experience as may be prescribed.
(3) The Secretary shall be appointed by the Central Government for a term of four years and he shall
not be eligible for any extension or re-appointment.
(4) The Secretary shall discharge such functions of the Commission as are assigned to him by the
Commission and as may be specified by regulations made under this Act.
(5) The Commission may appoint such officers and other employees, as it considers necessary,
against the posts created by the Central Government for the efficient discharge of its functions under this
Act.
(6) The salaries and allowances payable to, and other terms and conditions of service of the Secretary,
officers and other employees of the Commission shall be such as may be prescribed.
(7) The Commission may engage, in accordance with the procedure specified by regulations, such
number of experts and professionals of integrity and outstanding ability, who have special knowledge of
Indian System of Medicine, and experience in fields including medical education in Indian System of
Medicine, public health, management, economics, accreditation, patient advocacy, health research,
science and technology, administration, finance, accounts or law as it deems necessary, to assist the
Commission in the discharge of its functions under this Act.
9. Meetings of Commission.––(1) The Commission shall meet at least once every quarter at such
time and place as may be appointed by the Chairperson.
(2) The Chairperson shall preside at the meeting of the Commission and if, for any reason, the
Chairperson is unable to attend a meeting of the Commission, any Member being the President of the
Autonomous Boards, nominated by the Chairperson shall preside at the meeting.
(3) Unless the procedure to be followed at the meetings of the Commission is otherwise provided by
regulations, one-half of the total number of Members of the Commission including the Chairperson shall
constitute the quorum and all decisions of the Commission shall be taken by a majority of the members,
present and voting and in the event of equality of votes, the Chairperson or in his absence, the President
of the Autonomous Board nominated under sub-section (2), shall have the casting vote.
(4) The general superintendence, direction and control of the administration of the Commission shall
vest in the Chairperson.
(5) No act or proceeding of the Commission shall be invalid merely by reason of—
(a) any vacancy in, or any defect in the constitution of, the Commission; or
(b) any defect in the appointment of a person acting as a Chairperson or as a Member.
(6) A person who is aggrieved by any decision of the Commission, except the decision rendered
under sub-section (4) of section 31, may prefer an appeal to the Central Government against such decision
within fifteen days of the communication of such decision.
10. Power and functions of Commission.––(1) The Commission shall perform the following
functions, namely:—
(a) lay down policies for maintaining a high quality and high standards in education of Indian
System of Medicine and make necessary regulations in this behalf;
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(b) lay down policies for regulating medical institutions, medical researches and medical
professionals and make necessary regulations in this behalf;
(c) assess the requirements in healthcare, including human resources for health and healthcare
infrastructure and develop a road map for meeting such requirements;
(d) frame guidelines and lay down policies by making such regulations as may be necessary for
the proper functioning of the Commission, the Autonomous Boards and the State Medical Councils of
Indian System of Medicine;
(e) ensure coordination among the Autonomous Boards;
(f) take such measures, as may be necessary, to ensure compliance by the State Medical Councils
of Indian System of Medicine of the guidelines framed and regulations made under this Act for their
effective functioning under this Act;
(g) exercise appellate jurisdiction with respect to decisions of the Autonomous Boards;
(h) ensure observance of professional ethics in Medical profession and to promote ethical conduct
during the provision of care by medical practitioners;
(i) frame guidelines for determination of fees and all other charges in respect of fifty per cent. of
seats in private medical institutions and deemed to be Universities which are governed under the
provisions of this Act;
(j) exercise such other powers and perform such other functions as may be prescribed.
(2) All orders and decisions of the Commission shall be authenticated by signature of the Secretary
and the Commission may delegate such of its powers on administrative and financial matters, as it deems
fit, to the Secretary.
(3) The Commission may constitute sub-committees and delegate such of its powers to them as may
be necessary to enable them to accomplish specific tasks.
CHAPTER III
ADVISORY COUNCIL FOR INDIAN SYSTEM OF MEDICINE
11. Constitution and composition of Advisory Council for Indian System of Medicine.––(1) The
Central Government shall, by notification, constitute an advisory body to be known as the Advisory
Council for Indian System of Medicine.
(2) The Council shall consist of a Chairperson and the following members, namely:—
(a) the Chairperson of the Commission shall be the ex officio Chairperson of the Council;
(b) every Member of the Commission shall be ex officio member of the Council;
(c) one member, to represent each State, who is the Vice-Chancellor of a University in that State,
possessing qualifications in the Indian System of medicine, to be nominated by that State
Government, and one member to represent each Union territory, who is the Vice-chancellor of a
University in that Union territory, possessing qualifications in the Indian System of Medicine, to be
nominated by the Ministry of Home Affairs in the Government of India:
Provided that where the Vice-Chancellor possessing qualifications in the Indian System of
Medicine is not available, a Dean or a Head of Faculty possessing qualifications in the Indian System
of Medicine shall be nominated;
(d) one member to represent each State and each Union territory from amongst elected members
of the State Medical Council of Indian System of Medicine, to be nominated by that State Medical
Council;
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(e) the Chairman, University Grants Commission;

(f) the Director, National Assessment and Accreditation Council;
(g) four Members to be nominated by the Central Government from amongst persons holding the
post of Director in the Indian Institutes of Technology, Indian Institutes of Management and the
Indian Institutes of Science.
12. Functions of Advisory Council for Indian System of Medicine.—(1) The Council shall be the
primary platform through which the States and Union territories may put forth their views and concerns
before the Commission and help in shaping the overall agenda, policy and action relating to medical
education, training, research and development.
(2) The Council shall advise the Commission on measures to determine and maintain, and to
coordinate maintenance of, the minimum standards in all matters relating to medical education, training,
research and development.
(3) The Council shall advise the Commission on measures to enhance equitable access to medical
education.
13. Meetings of Advisory Council for Indian System of Medicine.—(1) The Council shall meet
atleast twice a year at such time and place as may be decided by the Chairperson.
(2) The Chairperson shall preside at the meeting of the Council and if for any reason the Chairperson
is unable to attend a meeting of the Council, such other member as nominated by the Chairperson shall
preside over the meeting.
(3) Unless the procedure is otherwise provided by regulations, one-half of the members of the
Council including the Chairperson shall form the quorum and all acts of the Council shall be decided by a
majority of the members present and voting.
CHAPTER IV
14. National Eligibility-cum-Entrance Test.—(1) There shall be a uniform National Eligibility-
cum-Entrance Test for admission to the undergraduate courses in each of the disciplines of the Indian
System of Medicine in all medical institutions governed under this Act:
Provided that National Eligibility-cum-Entrance Test shall be exempted for students who have taken
admission in––
(i) Pre-tib for Bachelor of Unani Medicine and Surgery; and
(ii) Pre-Ayurveda for Bachelor of Ayurvedic Medicine and Surgery.
(2) The Commission shall conduct the National Eligibility-cum-Entrance Test in English and in such
other languages, through such designated authority and in such manner, as may be specified by
regulations.
(3) The Commission shall specify by regulations the manner of conducting common counselling by
the designated authority for admission to all the medical institutions governed under this Act:
Provided that the common counselling shall be conducted by the designated authority of––
(i) the Central Government, for All India seats; and
(ii) the State Government, for the remaining seats at the State level.
(4) The Commission shall specify by regulations the manner of admission of students to
undergraduate courses who are exempted under sub-section (1).
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15. National Exit Test.—(1) A common final year undergraduate medical examination, to be known
as the National Exit Test, shall be held for granting licence to practice as medical practitioner of
respective disciplines of Indian System of Medicine and for enrollment in the State Register or National
Register, as the case may be.
(2) The Commission shall conduct the National Exit Test for Indian System of Medicine in English
and in such other languages, through such designated authority and in such manner as may be specified
by regulations.
(3) The National Exit Test shall become operational on such date, within three years from the date on
which this Act comes into force, as may be appointed by the Central Government, by notification.
(4) Any person with a foreign medical qualification shall have to qualify national Exist Test for the
purpose of obtaining licence to practice as medical practitioner of Indian System of Medicine and for
enrollment in the State Register or the National Register, as the case may be, in such manner as may be
16. Post-Graduate National Entrance Test.—(1) A uniform Post-Graduate National Entrance Test
shall be conducted separately for admission to postgraduate courses in each discipline of the Indian
System of Medicine in all medical institutions governed under this Act.
(2) The Commission shall conduct the National Entrance Test for admission to postgraduate courses
in English and in such other languages, through such designated authority and in such manner, as may be
(3) The Commission shall specify by regulations the manner of conducting common counselling by
the designated authority for admission to the postgraduate seats in all medical institutions governed under
this Act.
17. National Teachers’ Eligibility Test for Indian System of Medicine.—(1) A National Teachers’
Eligibility Test shall be conducted separately for the postgraduates of each discipline of Indian System of
Medicine who desire to take up teaching profession in that discipline.
(2) The Commission shall conduct the National Teachers’ Eligibility Test for Indian System of
Medicine through such designated authority and in such manner as may be specified by regulations.
(3) The National Teachers’ Eligibility Test for Indian System of Medicine shall become operational
on such date, within three years from the date on which this Act comes into force, as may be notified by
the Central Government:
Provided that nothing contained in this section shall apply to the teachers appointed prior to the date
notified under sub-section (3).
CHAPTER V
AUTONOMOUS BOARDS
18. Constitution of Autonomous Boards.—(1) The Central Government shall, by notification,
constitute the following Autonomous Boards, under the overall supervision of the Commission, to
perform the functions assigned to such Boards under this Act, namely:—
(a) the Board of Ayurveda;
(b) the Board of Unani, Siddha and Sowa-Rigpa;
(c) the Medical Assessment and Rating Board for Indian System of Medicine; and
(d) the Board of Ethics and Registration for Indian System of Medicine.
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(2) Each Board referred to in sub-section (1) shall be an autonomous body which shall carry out its
functions under this Act in accordance with the regulations made by the Commission.
19. Composition of Autonomous Boards.—(1) The composition of the Autonomous Boards shall be
as under, namely:––
(a) the Board of Ayurveda shall consist of a President and four Members from the Ayurveda
discipline of Indian System of Medicine;
(b) the Board of Unani, Siddha and Sowa-Rigpa shall consist of a President and two Members
from each of the Unani, Siddha and Sowa-Rigpa disciplines of Indian System of Medicine;
(c) the Medical Assessment and Rating Board for Indian System of Medicine shall consist of a
President and eight Members:
Provided that the President and six out of eight Members shall be chosen from the Ayurveda, Siddha,
Sowa-Rigpa and Unani disciplines of Indian System of Medicine in such manner that at least one Member
represents each such discipline separately, and the remaining two Members shall be accreditation experts;
(d) the Board of Ethics and Registration for Indian System of Medicine shall consist of a
President and eight Members:
Provided that the President and six out of eight Members shall be chosen from the Ayurveda, Siddha,
Sowa-Rigpa and Unani disciplines of Indian System of Medicine in such manner that at least one Member
represents each such discipline separately, and the remaining two Members shall be chosen from any of
the disciplines of quality assurance, public health, law or patient advocacy.
(2) The President and Members of the Autonomous Boards to be chosen under sub-section (1) shall
be persons of outstanding ability, proven administrative capacity and integrity, possessing postgraduate
degree in respective disciplines from a recognised University and having experience of not less than
fifteen years in respective fields, out of which at least seven years shall be as a leader:
Provided that seven years as leader in the case of the President and Member from Indian System of
Medicine shall be in the area of health, growth and development of education in Indian System of
Medicine.
20. Search Committee for appointment of President and Members.—The Central Government
shall appoint the President and Members of the Autonomous Boards on the basis of the recommendations
made in accordance with the procedure specified in section 5 by the Search Committee constituted
thereunder.
21. Term of office and conditions of service of President and Members.—(1) The President and
Members of each Autonomous Board shall hold the office for a term not exceeding four years and shall
(2) The salary and allowances payable to, and other terms and conditions of service of, the President
and Members of an Autonomous Boards shall be such as may be prescribed.
(3) The provisions contained in sub-sections (3), (5), (6), (7) and (8) of section 6 relating to the terms
and conditions of service of, and in section 7 relating to removal from office, the Chairperson and
Members of the Commission shall also be applicable to the President and Members of the Autonomous
Boards.
22. Advisory Committees of experts.—(1) Each Autonomous Board, except the Board of Ethics and
Registration for Indian System of Medicine, shall be assisted by such advisory Committees of experts, as
may be constituted by the Commission, for the efficient discharge of the functions of such Boards under
this Act.
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(2) The Board of Ethics and Registration for Indian System of Medicine shall be assisted by such
ethics committees of experts, as may be constituted by the Commission, for the efficient discharge of the
functions of that Boards under this Act.
23. Staff of Autonomous Boards.—The experts, professionals, officers and other employees
appointed under section 8 shall be made available to the Autonomous Boards in such number and in such
manner, as may be specified by regulations made by the Commission.
24. Meetings, etc., of Autonomous Boards.—(1) Every Autonomous Board shall meet at least once
a month at such time and place as it may appoint.
(2) Subject to such regulations as may be made in this behalf, all decisions of the Autonomous Boards
shall be made by consensus and if consensus is not possible, decision shall be made by majority of votes
of the President and Members.
(3) A person who is aggrieved by any decision of an Autonomous Board may prefer an appeal to the
Commission against such decision within thirty days of the communication of such decision.
25. Delegation of powers.—(1) The Commission may delegate all or any of its administrative and
financial powers to the President of each Autonomous Board to enable such Board to function smoothly
and efficiently.
(2) The President of an Autonomous Board may further delegate any of his powers to a Member or
officer of that Board.
26. Powers and functions of Autonomous Boards.—(1) The Board of Ayurveda, in respect of the
discipline of Ayurveda, and the Board of Unani, Siddha and Sowa-Rigpa, in respect of the disciplines of
Unani, Siddha and Sowa-Rigpa, of the Indian System of Medicine, shall perform the following functions
in respect of their respective disciplines, namely:—
(a) determine the standards of education at the undergraduate, postgraduate and super-speciality
levels and oversee all aspects relating thereto;
(b) develop a competency based dynamic curriculum at all levels in accordance with the
regulations made under this Act, in such manner that it develops appropriate skill, knowledge,
attitude, values and ethics among the postgraduate and superspeciality students and enables them to
provide healthcare, to impart medical education and to conduct medical research;
(c) frame guidelines on setting up of medical institutions for imparting undergraduate,
postgraduate and super-speciality courses in Ayurveda, Unani, Siddha and Sowa-Rigpa, having
regard to the needs of the country, the global norms and the regulations made under this Act;
(d) determine minimum requirements and standards for conducting of courses and examinations
in medical institutions, having regard to the needs of creativity at local levels and the regulations
(e) determine standards and norms for infrastructure, faculty and quality of education and
research in medical institutions of Indian System of Medicine, in accordance with the regulations
(f) specify norms for compulsory annual disclosure, electronically or otherwise, by medical
institutions of Indian System of Medicine in respect of their functions that has a bearing on the
interest of various stakeholders including students, faculty, the Commission and the Government;
(g) facilitate development and training of faculty members;
(h) facilitate research programmes;
(i) grant recognition to medical qualifications at all levels.
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(2) The Board of Ayurveda and the Board of Unani, Siddha and Sowa-Rigpa may, in the discharge of
their functions, make such recommendations to, and seek such directions from, the Commission, as it
deems necessary.
27. Powers and functions of Board of Ethics and Registration for Indian System of Medicine.—
(1) The Board of Ethics and Registration for Indian System of Medicine shall perform the following
functions, namely:––
(a) maintain a National Register of all licensed practitioners of Indian System of Medicine in
accordance with the provisions of section 32;
(b) regulate professional conduct and promote medical ethics in accordance with the regulations
made under this Act:
Provided that the Board of Ethics and Registration for Indian System of Medicine shall ensure
compliance with the code of professional and ethical conduct through the State Medical Council, in a
case where such State Medical Council has been conferred power to take disciplinary actions in
respect of professional or ethical misconduct by medical practitioners under respective State Acts;
(c) develop mechanisms to have continuous interaction with State Medical Councils of Indian
System of Medicine to effectively promote and regulate the conduct of medical practitioners of Indian
System of Medicine;
(d) exercise appellate jurisdiction with respect to the actions taken by a State Medical Council
under section 31.
(2) The Board of Ethics and Registration for Indian System of Medicine may, in the discharge of its
functions, make such recommendations to, and seek such directions from, the Commission, as it deems
necessary.
28. Powers and functions of Medical Assessment and Rating Board for Indian System of
Medicine.––(1) The Medical Assessment and Rating Board for Indian System of Medicine shall perform
the following functions, namely:––
(a) determine the procedure for assessment and rating of medical institutions on the basis of their
compliance with the standards laid down by the Board of Ayurveda or, as the case may be, the Board
of Unani, Siddha and Sowa-Rigpa, in accordance with the regulations made under this Act;
(b) grant permission for establishment of a new medical institution or to start any postgraduate
course or to increase number of seats, in accordance with the provisions of section 29;
(c) carry out inspections of medical institutions for assessing and rating such institutions in
accordance with the regulations made under this Act:
Provided that the Medical Assessment and Rating Board for Indian System of Medicine may, if it
deems necessary, hire and authorise any other third party agency or persons for carrying out
inspections of medical institutions for assessing and rating such institutions:
Provided further that where inspection of medical institutions is carried out by such third party
agency or persons authorised by the Medical Assessment and Rating Board for Indian System of
Medicine, it shall be obligatory on such institutions to provide access to such agency or person;
(d) conduct, or where it deems necessary, empanel independent rating agencies to conduct, assess
and rate all medical institutions, within such period of their opening, and every year thereafter, at such
time, and in such manner, as may be specified by regulations;
(e) make available on its website or in public domain, the assessment and ratings of medical
institutions at regular intervals, in accordance with the regulations made under this Act;
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(f) take such measures, including issuing warning, imposition of monetary penalty, reducing
intake or stoppage of admissions and recommending to the Commission for withdrawal of
recognition, against a medical institution for its failure to maintain the minimum essential standards
specified by the Board of Ayurveda or, as the case may be, the Board of Unani, Siddha and Sowa-
Rigpa, in accordance with the regulations made under this Act.
(2) The Medical Assessment and Rating Board for Indian System of Medicine may, in the discharge
of its functions, make such recommendations to, and seek such directions from, the Commission, as it
deems necessary.
29. Permission for establishment of new medical institution.––(1) No person shall establish a new
medical institution or start any postgraduate course or increase number of seats without obtaining prior
permission of the Medical Assessment and Rating Board for Indian System of Medicine.
Explanation.–– For the purpose of this sub-section, the term “person” includes any University, trust
or any other body, but does not include the Central Government.
(2) For the purpose of obtaining permission under sub-section (1), a person may submit a scheme to
the Medical Assessment and Rating Board for Indian System of Medicine in such form, containing such
particulars, accompanied by such fee, and in such manner, as may be specified by regulations.
(3) While considering the scheme received under sub-section (2), the Medical Assessment and Rating
Board for Indian System of Medicine shall have regard to the standards of education and research, the
standards and norms for infrastructure and faculty, the guidelines on setting up of medical institutions and
other requirements determined by the Board of Ayurveda or, as the case may be, the Board of Unani,
Siddha and Sowa-Rigpa under section 26, and pass an order either approving or disapproving the scheme
within three months from the date of receipt of such scheme:
Provided that before disapproving such scheme, an opportunity to rectify the defects, if any, shall be
given to the person concerned.
(4) Where a scheme is approved under sub-section (3), such approval shall be the permission under
sub-section (1) to establish a new medical institution.
(5) Where a scheme is disapproved under sub-section (3), or where no order is passed within three
months of submitting a scheme under sub-section (2), the person concerned may prefer an appeal to the
Commission within fifteen days of such disapproval or, as the case may be, after lapse of three months, in
(6) Where the Commission has disapproved the scheme or no order has been passed within fifteen
days from the date of preferring appeal under sub-section (5), the person concerned may prefer a second
appeal to the Central Government within seven days of communication of such disapproval or, as the case
may be, lapse of specified period of fifteen days.
(7) The Medical Assessment and Rating Board for Indian System of Medicine may conduct
evaluation and assessment of any University or medical institution at any time, either directly or through
any other expert, having integrity and experience in medical profession, without any prior notice and
assess and evaluate the performance, standards and benchmarks of such University or medical institution.
30. Criteria for approving or disapproving scheme.––While approving or disapproving a scheme
under section 29, the Medical Assessment and Rating Board for Indian System of Medicine, or the
Commission, as the case may be, shall take into consideration the following criteria, namely:—
(a) adequacy of infrastructure and financial resources;
(b) whether adequate academic faculty, non-teaching staff, and other necessary facilities have
been provided to ensure proper functioning of medical institution or would be provided within the
time-limit specified in the scheme;
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(c) whether adequate hospital facilities have been provided or would be provided within the time-
Provided that, subject to the previous approval of the Central Government, the criteria may be
relaxed for the medical institutions which are set up in such areas as may be specified by the
regulations.
31. State Medical Council.––(1) The State Government shall, by notification, within three years of
the commencement of this Act, establish a State Medical Council for Indian System of Medicine in that
State if no such Council exists in that State.
(2) Where a State Act confers power upon the State Medical Council to take disciplinary actions in
respect of any professional or ethical misconduct by a registered practitioner of Indian System of
Medicine, the State Medical Council shall act in accordance with the regulations made, and the guidelines
framed, under this Act:
Provided that till such time as a State Medical Council for Indian System of Medicine is established
in a State, the Board of Ethics and Registration for Indian System of Medicine shall receive the
complaints and grievances relating to any professional or ethical misconduct against a registered
practitioner of Indian System of Medicine in that State in accordance with such procedure as may be
specified by regulations:
Provided further that the Board of Ethics and Registration for Indian System of Medicine or, as the
case may be, the State Medical Council shall give an opportunity of hearing to such practitioner before
passing any order or taking any action, including imposition of any monetary penalty, against such
person.
(3) A practitioner of Indian System of Medicine who is aggrieved by the order passed or the action
taken by––
(a) the State Medical Council under sub-section (2) may prefer an appeal to the Board of Ethics
and Registration for Indian System of Medicine and the decision, if any, of the Board of Ethics and
Registration for Indian System of Medicine thereupon shall be binding on such State Medical
Council, unless a second appeal is preferred under sub-section (4);
(b) the Board of Ethics and Registration for Indian System of Medicine under the first proviso to
sub-section (2) may prefer an appeal to the Commission.
(4) A medical practitioner of Indian system of medicine who is aggrieved by the decision of the
Board of Ethics and Registration for Indian System of Medicine, may prefer an appeal to the Commission
within sixty days of communication of such decision.
Explanation.—For the purposes of this Act,—
(a) “State” includes Union territory and the expressions “State Government” and “State Medical
Council for Indian System of Medicine”, in relation to a Union territory, shall respectively mean the
“Central Government” and “Union Territory Medical Council for Indian System of Medicine”;
(b) the expression “professional or ethical misconduct” includes any act of commission or
omission, as may be specified by regulations.
32. National Register and State Register of Indian System of Medicine.––(1) The Board of Ethics
and Registration for Indian System of Medicine shall maintain a National Register containing the name,
address, all recognised qualifications possessed by a licensed medical practitioner of the Indian System of
Medicine and such other particulars as may be specified by regulations.
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(2) The National Register shall be maintained in such form, including in electronic form and in such
(3) The manner in which any name or qualification may be added to, or removed from, the National
Register and the grounds for removal thereof, shall be such as may be specified by the regulations.
(4) The National Register shall be made available to the public by placing it on the website of the
Board of Ethics and Registration for Indian System of Medicine.
(5) Every State Medical Council shall maintain and regularly update the State Register in the
specified electronic format and supply a physical copy of the same to the Board of Ethics and Registration
for Indian System of Medicine within three months of the commencement of this Act.
(6) The Board of Ethics and Registration for Indian System of Medicine shall ensure electronic
synchronization of the National Register and the State Register in such a manner that any change in one
such register is automatically reflected in the other register.
33. Rights of persons to be enrolled in National Register and their obligations thereto.––(1) Any
person who has a recognised qualification in Indian System of Medicine under this Act and qualifies the
National Exit Test held under section 15 shall be granted a licence to practice Indian System of Medicine
and shall have his name and qualifications enrolled first in the State Register and subsequently in the
National Register maintained under this Act:
Provided that a person who has been registered in the Central Register of Indian System of Medicine
maintained under the Indian Medicine Central Council Act, 1970 (48 of 1970) prior to the coming into
force of this Act and before the National Exit Test becomes operational under sub-section (3) of section
15, shall be deemed to have been registered under this Act and be enrolled in the National Register
maintained under this Act.
(2) No person who has obtained a qualification in Indian System of Medicine from a medical
institution established in any country outside India and is recognised as a medical practitioner of Indian
System of Medicine in that country, shall, after the commencement of this Act and the National Exit Test
for Indian System of Medicine becomes operational under sub-section (3) of section 15, be enrolled in the
National Register for Indian System of Medicine, unless he qualifies the National Exit Test for Indian
System of Medicine.
(3) When a person whose name is entered in the State Register or the National Register, as the case
may be, obtains any title, diploma or qualification for proficiency in sciences or medicine which is a
recognised qualification under section 35 or section 36, as the case may be, he shall be entitled to have
such title, diploma or qualification entered against his name in the State Register or the National Register,
in such manner as may be specified by regulations.
34. Rights of persons to practice.–– (1) No person other than a person who is enrolled in the State
Register or the National Register, as the case may be, shall—
(a) be allowed to practice Indian System of Medicine as a qualified practitioner;
(b) hold office as a physician or surgeon or any other office, by whatever name called, which is
meant to be held by a physician or surgeon, as the case may be;
(c) be entitled to sign or authenticate a medical or fitness certificate or any other certificate
required by any law to be signed or authenticated by a duly qualified medical practitioner;
(d) be entitled to give evidence at any inquest or in any court of law as an expert under section 45
of the Indian Evidence Act, 1872 (1 of 1872) on any matter relating to Indian System of Medicine:
Provided that the Commission shall submit a list of such practitioners to the Central Government
in such manner as may be prescribed:
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Provided further that a foreign citizen who is enrolled in his country as a practitioner of Indian
System of Medicine in accordance with the law regulating the registration of such practitioners in that
country may be permitted temporary registration in India for such period and in such manner as may
be specified by regulations.
(2) Any person who acts in contravention of the provisions of this section shall be punished with
imprisonment for a term which may extend to one year, or with fine which may extend to five lakh
rupees, or with both.
(3) Nothing contained in this section shall affect––
(a) the right of a person enrolled in a State Register as practitioner of Indian System of Medicine
to practice in any State merely on the ground that he does not possess, as on the date of
commencement of this Act, a recognised medical qualification in the Indian System of Medicine;
(b) the privileges, including the right to practice any system of medicine, conferred by or under
any law for the time being in force in a State on the practitioners of Indian System of Medicine
enrolled in the State register of that State;
(c) the right of a person who has been practicing Indian System of Medicine for not less than five
years in a State, to continue to practice in that State in which a State Register of Indian System of
Medicine is not maintained as on the date of commencement of this Act.
CHAPTER VI
RECOGNITION OF QUALIFICATIONS OF INDIAN SYSTEM OF MEDICINE
35. Recognition of qualifications granted by Universities or medical institutions in India.––(1)
The medical qualifications in Indian System of Medicine at undergraduate or postgraduate or
super-speciality level granted by any University or medical institution in India shall be listed and
maintained by the Board of Ayurveda or the Board of Unani, Siddha and Sowa-Rigpa, as the case may be,
in such manner as may be specified by regulations and such medical qualification shall be a recognised
medical qualification for the purposes of this Act.
(2) Any University or medical institution in India which grants an undergraduate or postgraduate or
super-speciality qualification in Indian System of Medicine not included in the list maintained by the
Board of Ayurveda or the Board of Unani, Siddha and Sowa-Rigpa, as the case may be, may apply to that
Board for granting recognition to such qualification.
(3) The Board of Ayurveda or the Board of Unani, Siddha and Sowa-Rigpa, as the case may be, shall
examine the application for grant of recognition to a qualification in Indian System of Medicine within a
period of six months in such manner as may be specified by regulations.
(4) Where the Board of Ayurveda or the Board of Unani, Siddha and Sowa-Rigpa, as the case may be,
decides to grant recognition to the qualification in Indian System of Medicine, it shall include such
qualification in the list maintained by it and shall also specify therein the date of effect of such
recognition, otherwise it shall communicate its decision not to grant recognition to the medical
qualification to the concerned University or medical institution.
(5) The aggrieved University or the medical institution may prefer an appeal to the Commission
within a period of sixty days from the date of communication of the decision of the Board of Ayurveda or
the Board of Unani, Siddha and Sowa-Rigpa, as the case may be, in such manner as may be specified by
regulations.
(6) The Commission shall examine the appeal received under sub-section (5) within a period of two
months and if it decides that recognition may be granted to such medical qualification, it may direct the
concerned Board to include such qualification in the list maintained by that Board in such manner as may
be specified by regulations.
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(7) Where the Commission decides not to grant recognition under sub-section (6) or fails to decide
within the specified period, the aggrieved University or medical institution may prefer a second appeal to
the Central Government within a period of thirty days from the date of communication of such decision or
lapse of specified period, as the case may be.
(8) All medical qualifications which have been recognised before the date of commencement of this
Act and are included in the Second Schedule and Third Schedule to the Indian Medicine Central Council
Act, 1970 (48 of 1970), shall also be listed and maintained by the Board of Ayurveda or the Board of
Unani, Siddha and Sowa-Rigpa, as the case may be, in such manner as may be specified by regulations.
36. Recognition of medical qualifications granted by medical institutions outside India.––(1)
Where an authority in any country outside India which, by the law of that country is entrusted with the
recognition of qualifications of Indian System of Medicine in that country, makes an application to the
Commission for granting recognition to such qualification in India, the Commission may, subject to such
verification as it deems necessary, either grant or refuse to grant recognition to that medical qualification.
(2) Where the Commission grants recognition to any medical qualification under sub-section (1), such
qualification shall be a recognised qualification for the purposes of this Act and shall be included in the
list maintained by the Commission in such manner as may be specified:
Provided that in case the Commission decides not to grant recognition to any qualification, the
Commission shall give a reasonable opportunity of being heard to such authority before refusing to grant
such recognition.
(3) Where the Commission refuses to grant recognition to a medical qualification under
sub-section (2), the Authority concerned may prefer an appeal to the Central Government for grant of
recognition.
(4) All qualifications which have been recognised before the date of commencement of this Act and
are included in the Fourth Schedule to the Indian Medicine Central Council Act, 1970 (48 of 1970) shall
also be recognised medical qualifications for the purposes of this Act and shall be listed and maintained
by the Commission in such manner as may be specified by the regulations.
37. Withdrawal of recognition or de-recognition of qualification.––(1) Where, upon a report
received from the Medical Assessment and Rating Board for Indian System of Medicine or otherwise, it
appears to the Commission that—
(a) the courses of study and examination to be undergone in, or the proficiency required from
candidates at any examination held by, a University or medical institution do not conform to the
standards specified by the Board of Ayurveda or the Board of Unani, Siddha and Sowa-Rigpa, as the
case may be; or
(b) the standards and norms for infrastructure, faculty and quality of education in medical
institutions as determined by the Board of Ayurveda or the Board of Unani, Siddha and Sowa-Rigpa,
as the case may be, are not adhered to by any University or medical institution, and such University
or medical institution has failed to take necessary corrective action to maintain specified minimum
standards,
the Commission may initiate action in accordance with the provisions of sub-section (2):
Provided that the Commission shall, before, taking any action for suo motu withdrawal of recognition
granted to the medical qualification awarded by a University or medical institution, impose penalty in
accordance with the provisions of clause (f) of sub-section (1) of section 28.
(2) The Commission shall, after making such further inquiry as it deems fit, and after holding
consultations with the State Government and the authority of the concerned University or medical
institution, comes to the conclusion that the recognition granted to a medical qualification ought to be
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withdrawn, it may, by order, withdraw recognition granted to such medical qualification and direct the
Board of Ayurveda or the Board of Unani, Siddha and Sowa-Rigpa, as the case may be, to amend the
entries against the University or medical institution concerned in the list maintained by that Board to the
effect that the recognition granted to such qualification is withdrawn with effect from the date specified in
that order.
(3) If the Commission, after verification with the authority in any country outside India, is of the
opinion that a recognised medical qualification which is included in the list maintained by it is to be
de-recognised, it may, by order, de-recognise such medical qualification and remove it from the list
maintained by the Commission with effect from the date of such order.
38. Special provision in certain cases for recognition of qualifications.––Where the Commission
deems it necessary so to do, it may, by notification, direct that any qualification in Indian System of
Medicine granted by a medical institution outside India, after such date, as may be specified in that
notification, shall be recognised qualification for the purposes of this Act:
Provided that medical practice by a person possessing such qualification shall be permitted only if
such person has been enrolled as a medical practitioner in accordance with the law regulating the
registration of medical practitioner for the time being in force in that country:
Provided further that medical practice by a person possessing such qualification shall be limited to
such period as may be specified in that order:
Provided also that medical practice by a person possessing such qualification shall be permitted only
if such person qualifies National Exit Test.
CHAPTER VII
39. Grants by Central Government.––The Central Government may, after due appropriation made
by Parliament by law in this behalf, make to the Commission grants of such sums of money as the Central
40. National Commission Fund for Indian System of Medicine.––(1) There shall be constituted a
fund to be called “the National Commission Fund for Indian System of Medicine” and there shall be
credited thereto—
(a) all Government grants, fees, penalties and charges received by the Commission and the
Autonomous Boards;
(b) all sums received by the Commission from such other source as may be decided by it.
(2) The fund shall be applied for making payment towards––
(a) the salaries and allowances payable to the Chairperson and Members of the Commission, the
Presidents and Members of the Autonomous Boards and the administrative expenses including the
salaries and allowances payable to the officers and other employees of the Commission and
Autonomous Boards;
(b) the expenses incurred or to be incurred in carrying out the provisions of this Act including in
connection with the discharge of the functions of the Commission and the Autonomous Boards.
41. Audit and accounts.––(1) The Commission shall maintain proper accounts and other relevant
records and prepare an annual statement of accounts in such form as may be prescribed, in consultation
with the Comptroller and Auditor-General of India.
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(2) The accounts of the Commission shall be audited by the Comptroller and Auditor-General of India
at such intervals as may be specified by him and any expenditure incurred in connection with such audit
shall be payable by the Commission to the Comptroller and Auditor-General of India.
(3) The Comptroller and Auditor-General of India and any other persons appointed by him in
connection with the audit of the accounts of the Commission shall have the same rights and privileges and
authority in connection with such audit as the Comptroller and Auditor-General generally has in
connection with the audit of Government accounts and in particular, shall have the right to demand the
production of, and complete access to, records, books, accounts, connected vouchers and other documents
and papers and to inspect the office of the Commission.
(4) The accounts of the Commission as certified by the Comptroller and Auditor-General of India or
any other person appointed by him in this behalf, together with the audit report thereon, shall be
forwarded annually by the Commission to the Central Government which shall cause the same to be laid,
as soon as may be after it is received, before each House of Parliament.
42. Furnishing of returns and reports to Central Government.––(1) The Commission shall
furnish to the Central Government, at such time, in such form and in such manner, as may be prescribed
or as the Central Government may direct, such reports and statements and such particulars in regard to
any matter under the jurisdiction of the Commission, as the Central Government may, from time to time,
require.
(2) The Commission shall prepare, once every year, in such form and at such time as may be
prescribed, an annual report, giving a summary of its activities during the previous year and copies of the
report shall be forwarded to the Central Government.
(3) A copy of the report received under sub-section (2) shall be laid by the Central Government, as
soon as may be after it is received, before each House of Parliament.
CHAPTER VIII
MISCELLANEOUS
43. Power of Central Government to give directions to Commission and Autonomous Boards.––
(1) Without prejudice to the foregoing provisions of this Act, the Commission and the Autonomous
Boards shall, in exercise of their powers and discharge of their functions under this Act be bound by such
directions on questions of policy as the Central Government may give in writing to them from time to
time:
Provided that the Commission and the Autonomous Boards shall, as far as practicable, be given an
opportunity to express their views before any direction is given under this sub-section.
(2) The decision of the Central Government whether a question is one of policy or not shall be final.
44. Power of Central Government to give directions to State Governments.––The Central
Government may give such directions, as it may deem necessary, to a State Government for carrying out
all or any of the provisions of this Act and the State Government shall comply with such directions.
45. Information to be furnished by Commission and publication thereof.––(1) The Commission
shall furnish such reports, copies of its minutes, abstracts of its accounts and other information to the
Central Government as that Government may require.
(2) The Central Government may publish, in such manner as it may think fit, the reports, minutes,
abstracts of accounts and other information furnished to it under sub-section (1).
46. Obligation of Universities and medical institutions.––Every university and medical institutions
covered under this Act shall maintain a website at all times and display in its website all such information
as may be required by the Commission or an Autonomous Board, as the case may be.
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47. Completion of courses of studies in medical institutions.––(1) Notwithstanding anything

contained in this Act, any student who was studying for a degree or diploma in any medical institution
immediately before the commencement of this Act shall continue to so study and complete his course for
such degree or diploma, and such institution shall continue to provide instructions and hold examination
for such student in accordance with the syllabus and studies as existed before such commencement, and
such student shall be deemed to have completed his course of study under this Act and shall be awarded
degree or diploma under this Act.
(2) Notwithstanding anything contained in this Act, where recognition granted to a medical institution
has lapsed, whether by efflux of time or by its voluntary surrender or for any other reason whatsoever,
such medical institution shall continue to maintain and provide the minimum standards as approved by
the Commission till such time as all the candidates are able to complete their study in that institution.
48. Chairperson, Members, officers of Commission and of Autonomous Boards to be public
servants.––The Chairperson, Members, officers and other employees of the Commission and the
President and Members of Autonomous Boards shall be deemed, when acting or purporting to act in
pursuance of any of the provisions of this Act, to be public servants within the meaning of section 21 of
the Indian Penal Code (45 of 1860).
49. Protection of action taken in good faith.–– No suit, prosecution or other legal proceeding shall
lie against the Government, the Commission or any Autonomous Board or a State Medical Council or any
Committee thereof, or any officer or other employee of the Government or of the Commission acting
under this Act for anything which is in good faith done or intended to be done under this Act or the rules
or regulations made thereunder.
50. Cognizance of offences.––No Court shall take cognizance of an offence punishable under this
Act except upon a complaint in writing made in this behalf by an officer authorised by the Commission or
the Ethics and Registration Board or a State Medical Council for Indian System of Medicine, as the case
may be.
51. Power of Central Government to supersede Commission.––(1) If, at any time, the Central
Government is of opinion that––
(a) the Commission is unable to discharge the functions and duties imposed on it by or under the
provisions of this Act; or
(b) the Commission has persistently made default in complying with any direction issued by the
Central Government under this Act or in the discharge of the functions and duties imposed on it by or
under the provisions of this Act,
the Central Government may, by notification, supersede the Commission for such period, not exceeding
six months, as may be specified in the notification:
Provided that before issuing a notification under this sub-section, the Central Government shall give a
reasonable opportunity to the Commission to show cause as to why it should not be superseded and shall
consider the explanations and objections, if any, of the Commission.
(2) Upon the publication of a notification under sub-section (1) superseding the Commission,––
(a) all the Members shall, as from the date of supersession, vacate their offices as such;
(b) all the powers, functions and duties which may, by or under the provisions of this Act, be
exercised or discharged by or on behalf of the Commission, shall until the Commission is
re-constituted under sub-section (3), be exercised and discharged by such person or persons as the
Central Government may direct;
(c) all property owned or controlled by the Commission shall, until the Commission is
re-constituted under sub-section (3), vest in the Central Government.
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(3) On the expiration of the period of supersession specified by the notification issued under
sub-section (1), the Central Government may,—
(a) extend the period of supersession for such further term not exceeding six months, as it may
consider necessary; or
(b) re-constitute the Commission by fresh appointment and in such case the Members who
vacated their offices under clause (a) of sub-section (2) shall not be deemed disqualified for
appointment:
Provided that the Central Government may, at any time before the expiration of the period of
supersession, whether as originally specified under sub-section (1) or as extended under this
sub-section, take action under clause (b) of this sub-section.
(4) The Central Government shall cause a notification issued under sub-section (1) and a full report of
any action taken under this section and the circumstances leading to such action to be laid before both
Houses of Parliament at the earliest opportunity.
52. Joint sittings of Commission, National Commission for Homoeopathy and National Medical
Commission.––(1) There shall be a joint sitting of the Commission, the National Commission for
Homoeopathy, and the National Medical Commission, at least once a year, at such time and place as they
mutually appoint, to enhance the interface between Indian System of Medicine, Homoeopathy and
modern system of medicine.
(2) The Agenda for the joint sitting may be placed with mutual agreement by the Chairpersons of the
Commissions concerned.
(3) The joint sitting may, by an affirmative vote of all members present and voting, decide on
approving specific educational and medical modules or programme that could be introduced in the
under-graduate and post-graduate courses across medical systems, and promote medical pluralism.
53. State Government to promote public health.––Every State Government may, for the purposes
of addressing or promoting public health, take necessary measures to enhance the capacity of the
healthcare professionals.
54. Power to make rules.––(1) The Central Government may, by notification in the Official Gazette,
make rules to carry out the purposes of this Act.
(2) In particular, and without prejudice to the foregoing power, such rules may provide for all or any
of the following matters, namely:––
(a) the manner of appointing ten Members of the Commission on rotational basis from amongst
the nominees of the States and Union territories in the Advisory Council under clause (b) of
(b) the manner of appointing members under clause (c) of sub-section (4) of section 4;
(c) the manner of nominating one expert by the Central Government under clause (d) of
(d) the salary and allowances payable to, and other terms and conditions of service of, the
Chairperson and Members under sub-section (4) of section 6;
(e) the form and the manner of making declaration under sub-section (6) of section 6;
(f) the qualifications and experience to be possessed by Secretary under sub-section (2) of
section 8;
(g) the salaries and allowances payable to, and other terms and conditions of the Secretary,
officers and other employees of the Commission under sub-section (6) of section 8;
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(h) the other powers to be exercised and other functions to be performed by the Commission
under clause (j) of sub-section (1) of section 10;
(i) the salary and allowances payable to, and other terms and conditions of service of, the
President and Members of an Autonomous Board under sub-section (2) of section 21;
(j) the other factors under clause (d) of section 30.
(k) the manner of submitting a list of practitioners under the first proviso to sub-section (1) of
section 34;
(l) the form for preparing annual statement of accounts under sub-section (1) of section 41;
(m) the time within which, and the form and the manner in which, the reports and statements shall
be furnished by the Commission and the particulars with regard to any matter as may be required by
the Central Government under sub-section (1) of section 42;
(n) the form and the time for preparing annual report under sub-section (2) of section 42;
(o) the compensation for the premature termination of employment under the second proviso to
(p) any other matter in respect of which provision is to be made by rules.
55. Power to make regulations.––(1) The Commission may, by notification, make regulations
consistent with this Act and the rules made thereunder to carry out the provisions of this Act.
(2) In particular, and without prejudice to the generality of the foregoing power, such regulations may
provide for all or any of the following matters, namely:—
(a) the functions to be discharged by the Secretary of the Commission under sub-section (4) of
section 8;
(b) the procedure in accordance with which experts and professionals may be engaged and the
number of such experts and professionals under sub-section (7) of section 8;
(c) the procedure to be followed at the meetings of Commission, including the quorum at its
meetings under sub-section (3) of section 9;
(d) the quality and standards to be maintained in education of Indian System of Medicine under
(e) the manner of regulating medical institutions, medical researches and medical professionals
under clause (b) of sub-section (1) of section 10;
(f) the manner of functioning of the Commission, the Autonomous Boards and the State Medical
Councils under clause (d) of sub-section (1) of section 10;
(g) the procedure to be followed at the meetings of the Medical Advisory Council, including the
quorum at its meetings under sub-section (3) of section 13;
(h) the other languages in which, the designated authority through which, and the manner in
which the National Eligibility-cum-Entrance Test shall be conducted under sub-section (2) of section
14;
(i) the manner of conducting common counselling by the designated authority for admission to
medical institutions under sub-section (3) of section 14;
(j) the manner of admission of students to undergraduate courses under sub-section (4) of section
14;
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(k) the other languages in which, the designated authority through which, and the manner in
which, the National Exit Test shall be conducted under sub-section (2) of section 15;
(l) the manner in which a person with foreign medical qualification shall qualify National Exist
Test under sub-section (4) of section 15;
(m) the other languages in which, the designated authority through which, and the manner in
which admission to postgraduate courses shall be conducted under sub-section (2) of section 16;
(n) the manner of conducting common counselling by the designated authority for admission to
the postgraduate seats in all medical institutions under sub-section (3) of section 16;
(o) the manner of conducting the National Teachers’ Eligibility Test for Indian System of
Medicine and the designated authority through whom such test shall be conducted under sub-section
(2) of section 17;
(p) the number of, and the manner in which, experts, professionals, officers and other employees
shall be made available by the Commission to the Autonomous Boards under section 23;
(q) the manner in which decisions of the Autonomous Boards shall be made under sub-section (2)
of section 24;
(r) the competency based dynamic curriculum at all levels under clause (b) of sub-section (1) of
section 26;
(s) the manner of imparting undergraduate, postgraduate and super-speciality courses in
Ayurveda, Unani, Siddha and Sowa-Rigpa under clause (c) of sub-section (1) of section 26;
(t) the minimum requirements and standards for conducting courses and examinations in medical
institutions under clause (d) of sub-section (1) of section 26;
(u) the standards and norms for infrastructure, faculty and quality of education and research in
medical institutions of Indian System of Medicine under clause (e) of sub-section (1) of section 26;
(v) the manner of regulating professional conduct and promoting medical ethics under clause (b)
of sub-section (1) of section 27;
(w) the procedure for assessment and rating of the medical institutions under clause (a) of
(x) the manner of carrying out inspections of medical institutions for assessing and rating under
(y) the manner of conducting, and the manner of empanelling independent rating agencies to
conduct, assess and rate all medical institutions under clause (d) of sub-section (1) of section 28;
(z) the manner of making available on website or in public domain the assessment and ratings of
medical institutions under clause (e) of sub-section (1) of section 28;
(za) the measures to be taken against a medical institution for failure to maintain the minimum
essential standards under clause (f) of sub-section (1) of section 28;
(zb) the form of scheme, the particulars thereof, the fee to be accompanied and the manner of
submitting scheme for establishing new medical college under sub-section (2) of section 29;
(zc) the manner of preferring an appeal to the Commission for approval of the scheme under
(zd) the areas in respect of which criteria may be relaxed under the proviso to section 30;
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(ze) the manner of taking disciplinary action by a State Medical Council for professional or
ethical misconduct of registered medical practitioner and the procedure for receiving complaints and
grievances by the Board of Ethics and Registration for Indian System of Medicine, under
(zf) the act of commission or omission which amounts to professional or ethical misconduct under
clause (b) of the Explanation to section 31;
(zg) other particulars to be contained in a National Register under sub-section (1) of section 32;
(zh) the form, including the electronic form and the manner of maintaining the National Register
(zi) the manner in which any name or qualification may be added to, or removed from, the
National Register and the grounds for removal thereof, under sub-section (3) of section 32;
(zj) the manner of entering the title, diploma or qualification in the State Register or the National
Register under sub-section (3) of section 33;
(zk) the manner in which, and the period for which temporary registration may be permitted to a
foreign citizen under the second proviso to sub-section (1) of section 34;
(zl) the manner of listing and maintaining medical qualifications granted by a University or
medical institution in India under sub-section (1) of section 35;
(zm) the manner of examining the application for grant of recognition under sub-section (3) of
section 35;
(zn) the manner of preferring an appeal to the Commission for grant of recognition under
(zo) the manner of including a medical qualification in the list maintained by the Board under
(zp) the manner in which the Board of Ayurveda or the Board of Unani, Siddha and Sowa-Rigpa
shall list and maintain the medical qualifications which have been granted recognition before the date
of commencement of this Act, under sub-section (8) of section 35;
(zq) the manner in which the Commission shall list and maintain the medical qualifications which
have been granted recognition before the date of commencement of this Act, under sub-section (4) of
section 36.
56. Rules and regulations to be laid before Parliament.––Every rule and every regulation made
under this Act shall be laid, as soon as may be after it is made, before each House of Parliament, while it
is in session, for a total period of thirty days which may be comprised in one session or in two or more
successive sessions, and if, before the expiry of the session immediately following the session or the
successive sessions aforesaid, both Houses agree in making any modification in the rule or regulation or
both Houses agree that the rule or regulation should not be made, the rule or regulation shall thereafter
have effect only in such modified form or be of no effect, as the case may be; so, however, that any such
modification or annulment shall be without prejudice to the validity of anything previously done under
that rule or regulation.
57. Power to remove difficulties.––(1) If any difficulty arises in giving effect to the provisions of
this Act, the Central Government may, by order published in the Official Gazette, make such provisions
not inconsistent with the provisions of this Act as may appear to it be necessary, for the removing the
difficulty:
Provided that no order shall be made under this section after the expiry of a period of two years from
the commencement of this Act.
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(2) Every order made under this section shall be laid, as soon as may be after it is made, before each
house of Parliament.
58. Repeal and saving.––(1) With effect from such date as the Central Government may, by
notification, appoint in this behalf, the Indian Medicine Central Council Act, 1970 (48 of 1970) shall
stand repealed and the Central Council of Indian Medicine constituted under section 3 of the said Act
shall stand dissolved.
(2) Notwithstanding the repeal of the Act referred to in sub-section (1), it shall not affect,––
(a) the previous operation of the Act so repealed or anything duly done or suffered thereunder;
(b) any right, privilege, obligation or liability acquired, accrued or incurred under the Act so
repealed;
(c) any penalty incurred in respect of any contravention under the Act so repealed; or
(d) any proceeding or remedy in respect of any such right, privilege, obligation, liability, penalty
as aforesaid, and any such proceeding or remedy may be instituted, continued or enforced, and any
such penalty may be imposed as if that Act had not been repealed.
(3) On the dissolution of the Central Council of Indian Medicine, the person appointed as the
Chairman of that Council and every other person appointed as the Member and any officer and other
employees of the Council and holding office as such immediately before such dissolution shall vacate
their respective offices and such Chairman and other Members shall be entitled to claim compensation not
exceeding three months’ pay and allowances for the premature termination of term of their office or of
any contract of service:
Provided that any officer or other employee who has been, immediately before the dissolution of the
Central Council of Indian Medicine appointed on deputation basis to the Central Council of Indian
Medicine, shall, on such dissolution, stand reverted to their parent cadre, Ministry or Department, as the
case may be:
Provided further that any officer, expert, professional or other employee who has been, immediately
before the dissolution of the Central Council of Indian Medicine employed on regular basis or on
contractual basis by the Council, shall cease to be such officer, expert, professional or other employees of
the Central Council and shall be entitled to such compensation for the premature termination of his
employment, which shall not be less than three months’ pay and allowances, as may be prescribed.
(4) Notwithstanding the repeal of the aforesaid enactment, any order made, any licence to practice
issued, any registration made, any permission to start new medical institution or to start higher course of
studies or to increase in the admission capacity granted, any recognition of medical qualifications granted,
under the Indian Medicine Central Council Act, 1970 (48 of 970) which are in force as on the date of
commencement of this Act shall continue to be in force till the date of their expiry for all purposes, as if
they had been issued or granted under the provisions of this Act or the rules or regulations made
thereunder.
59. Transitory provisions.––(1) The Commission shall be the successor in interest to the Central
Council of Indian Medicine including its subsidiaries or owned trusts and all the assets and liabilities of
the Central Council of Indian Medicine shall be deemed to have been transferred to the Commission.
(2) Notwithstanding the repeal of the Indian Medicine Central Council Act, 1970 (48 of 1970), the
Medical standards, requirements and other provisions of the Indian Medicine Central Council Act, 1970
and the rules and regulations made thereunder shall continue to be in force and operate till new standards
or requirements are specified under this Act or the rules and regulations made thereunder:
Provided that anything done or any action taken as regards the medical standards and requirements
under the enactment under repeal and the rules and regulations made thereunder shall be deemed to have
28
904
been done or taken under the corresponding provision of this Act and shall continue in force accordingly
unless and until superseded by anything or by any action taken under this Act.
(3) The Central Government may take such appropriate measure as may be necessary for smooth
transition of the dissolved Central Council of Indian Medicine to the corresponding to new Commission
under this Act.
-----------------------
29
ANNEXURE P-33 905
$~24
* IN THE HIGH COURT OF DELHI AT NEW DELHI
+ W.P.(C) 7213/2020 & CM APPLs. 6419/2021, 6431/2021
PRASHANT REDDY T ..... Petitioner
Through: Mr. Sanjay Hegde, Sr. Advocate with
Mr. Harsh Parashar and Mr.
Chanakya Sharma, Advocates.
versus
DRUGS CONTROLLER GENERAL OF

INDIA & ORS. ..... Respondents
Through: Mr. Rahul Sharma, Sr. Panel Counsel
for R-1 to R-3 with Mr. C.K. Bhatt,
Advocate.
CORAM:
JUSTICE PRATHIBA M. SINGH
ORDER
% 17.02.2021
1. This hearing has been done through hybrid mode (physical and virtual
hearing).
2. CM APPL.6419/2021 has been moved by the Petitioner seeking a
direction to members of the T.N. Mahapatra Committee to be called in
Court, as also to the Joint Secretary in charge of the Drug Regulation
Section in the Ministry of Health and Family Welfare (hereinafter,
‘MoHFW’). CM APPL.6431/2021 is for directions for streamlining and
digitisation of records of the Drugs Controller General of India (hereinafter,
‘DCGI’).
3. The matter relates to the T.N. Mahapatra Committee’s Report
(hereinafter, ‘Report’) which Committee was constituted by the DCGI on
26th March, 2013. The said Report is stated to be have been constituted as a
W.P.(C) 7213/2020 Page 1 of 3

906
result of the 59th Parliamentary Standing Committee Report in respect of

clinical trial approvals for certain drugs.
4. The Petitioner is an RTI applicant who has repeatedly made attempts
to obtain a copy of the said Report. However, despite repeated requests, the
Report could not be obtained. Finally, when the matter reached the Central
Information Commission (hereinafter, ‘CIC’), a copy of the Report was
supplied to the Petitioner, however, the same was without any annexures.
Under such circumstances, the present writ petition was filed seeking
production of the complete Report and also seeking directions for
digitisation of all the records of the DCGI in respect of clinical trials etc.
Notice was issued in this writ petition on 29th September, 2020 when the
DCGI was duly represented before this Court.
5. Despite notice having been issued in September, 2020, till date, the
counter affidavit has not been placed on record. Mr. Rahul Sharma, ld.
Counsel appearing for the DGCI, submits that the counter affidavit has been
filed on 12th February, 2021. However, the same is not record. Mr. Hegde,
ld. Sr. counsel, submits that he has not received a copy of the counter
affidavit.
6. Considering that crucial files relating to the T.N. Mahapatra
Committee’s Report appear to be completely missing and the fact that there
is a delay in filing the counter affidavit, it is directed that the counter
affidavit be taken on record, subject to payment of Rs.10,000/- as costs
within one week. The present costs shall be in addition to the costs of
Rs.15,000/- imposed on 21st December, 2020. If the counter affidavit is not
filed and/or costs are not paid, the DCGI shall depute a senior official to
appear in Court on the next date of hearing.
W.P.(C) 7213/2020 Page 2 of 3

907
7. In addition, considering the fact that one of the members of the

Committee - Dr. Shailendra Kumar, was the Chief Vigilance Officer of the
MoHFW, it is requested that Dr. Shailendra Kumar remain present on the
next date of hearing. The present order be communicated by Mr. Rahul
Sharma, ld. Counsel appearing for the DCGI to Dr. Shailendra Kumar, to
enable him to join the hearing on the next date of hearing.
8. In addition, a status report shall be filed by the DCGI in respect of the
steps taken for streamlining and digitisation of its records, at least five days
before the next date of hearing with advance copy to the Counsel for the
Petitioner.
9. List on 19th March, 2021, i.e., the date already fixed.
PRATHIBA M. SINGH, J.
FEBRUARY 17, 2021
dj/T
W.P.(C) 7213/2020 Page 3 of 3

ANNEXURE P-34 908
Signature valid
Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:23.02.2021
22:43:48
$~48, 49 & 52
+ W.P.(C) 5315/2020 & CM APPL. 19189/2020
MASTER ARNESH SHAW ..... Petitioner
Through: Mr. Vivek Chib, Mr. Rahul Malhotra,
Mr. Asif Ahmed & Mr. Manas
Tripathi, Advocates.
versus
UNION OF INDIA & ANR. ..... Respondents

Through: Mr. Ripudaman Bhardwaj, CGCS
with Mr. Kushagra Kumar along with
Dr. Pulkesh Kumar, Deputy
Secretary, MoHFW.
Mr. Satvik Varma & Mr. Tanveer
Oberoi, Advocates for R-2/AIIMS.
49 WITH
+ W.P.(C) 322/2021 & CM APPL. 812/2021
KESHAV SHARMA AGE 12 YEARS THROUGH HIS NEXT
FRIEND AND NATURAL FATHER SANJEEV
KUMAR ..... Petitioner
Through: Mr. Ashok Agarwal & Mr. Kumar
Utkarsh, Advocates
versus

Through: Mr. Ajay Digpaul, CGSC with Mr.
Kamal R. Digpaul, Advocate for UOI.
52 AND
+ W.P.(C) 1611/2021 & CM APPL. 4600/2021
LAKSHYA KUMAR GOYAL, 8 YRS OLD, THROUGH HIS NEXT
FRIEND AND NATURAL FATHER SH. VIPIN
KUMAR ..... Petitioner
Through: Mr. Ashok Aggarwal and Kumar
Signature valid
Digitally Signed
By:PRATHIBA M SINGH W.P.(C) 5315/2020 & connected matters Page 1 of 4
Signing Date:23.02.2021 21:42
909
Signature valid
SINGH NAYAL
22:43:48
Utkarsh, Advocates
versus

Through: Mr. Shankar Kumar Jha, Senior Panel
Counsels (M-9811706171)
CORAM:
JUSTICE PRATHIBA M. SINGH
ORDER
% 22.02.2021
1. This hearing has been done through video conferencing.
2. In these three petitions, the Petitioners suffer from Duchenne
Muscular Dystrophy (hereinafter ‘DMD’).
3. The matters are being heard from time to time and orders have been
passed even in the past in respect of the policy for rare diseases and to find
ways to obtain treatment/drugs from the company - M/s Sarepta
Therapeutics. On 12th January, 2021, the Government was directed to
contact M/s Sarepta Therapeutics, which advertises on its website that it
provides financial support/ medication in deserving cases. The said
Company has now informed the Petitioners on 19th February, 2021 that it
tried to contact one Mr. K. Balasubramanian in the Ministry of Health &
Family Welfare, however, they have not received any response in respect
thereof.
4. Dr. Pulkesh Kumar, Deputy Secretary, Ministry of Health & Family
Welfare, who has joined the Court proceedings through video conferencing,
submits that Mr. Balasubramanian is currently on leave. Be that as it may,
Signature valid
Digitally Signed
Signing Date:23.02.2021 21:42
910
Signature valid
SINGH NAYAL
22:43:48
there is no reason for not taking the discussion forward with M/s Sarepta
Therapeutics.
5. Mr. Ashok Aggarwal, ld. Counsel appearing for two of the
Petitioners, has placed on record certain documents which show that some
of the treatments and medicines for DMD are available in India and even
generic versions of treatments have been developed. The documents placed
on record show that one Indian Association for the Cultivation of Science,
2A & 2B, Raja S C Mullick Road, Jadavpur, Kolkata 700032 has already
developed the generic version of the drug for treatment of DMD and the cost
for the same would be much less.
6. Ideally, the Government ought to have had this data available with it.
However, since the said data has now been placed on record, the
Government is directed to contact the relevant parties and to place on record
a comprehensive affidavit, one day before the next date of hearing, on the
following aspects:
i) What is the development with M/s Sarepta Therapeutics after
discussion with them?;
ii) Availability of generic and other versions of drugs in India, either
approved or under trial, for treatment of DMD and the cost for the
same;
iii) Discussions shall be held with organizations in India providing
treatment for DMD, in order to ascertain the time by which the
medicines/therapy can be obtained;
iv) The Government shall also explore crowd funding options for the
Petitioners and place a concrete proposal before this Court;
Signature valid
Digitally Signed
Signing Date:23.02.2021 21:42
911
Signature valid
SINGH NAYAL
22:43:48
7. Considering the nature of the matter, the following parties are

impleaded in the present matters:
i) Department of Biotechnology through its Secretary, Dr. Renu
Swarup.;
ii) Indian Association for the Cultivation of Science (Address: 2A &
2B Raja S C Mullick Road, Jadavpur, Kolkata 700032);
iii) Dr. Apurba Ghosh from the Institute of Child Health (ICH),
Kolkata;
iv) Mr. Arun Shastry from Dystrophy Annihilation Research Trust
(DART), Bengaluru;
v) Drugs Controller General of India (DCGI).
8. Amended memo of parties be filed by the ld. Counsel for the
Petitioners in their respective petitions within three days.
9. The Department of Biotechnology shall inform the Court as to
whether there are any therapies currently being developed in respect of
DMD and if so, which are the organizations who are developing the same;
10. Dr. Pulkesh Kumar shall contact all the above-mentioned
organizations and file his status report independently. The said parties shall
be served by ld. Counsel for the Petitioners, as also through the Registry of
this Court, so that they can appear on the next date of hearing.
11. All parties are directed to bring on record, the documents which they
relied upon during today’s hearing.
12. List on 2nd March, 2021.
PRATHIBA M. SINGH, J.
FEBRUARY 22, 2021/Rahul/T
Signature valid
Digitally Signed
Signing Date:23.02.2021 21:42
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https://ndma.gov.in/sites/default/files/PDF/covid/MoHFWOrder-25.4.21.pdf ANNEXURE P-36
914
Annexure to Ministry of Health & Family Welfare (MoHFW) DO no.
Z.28015/85/2021-DM Cell dated 25th April 2021
Annexure - A
Implementation Framework for community containment/large containment areas
Understanding the virus transmission dynamics:
The virus transmits through the human host. It is imperative to understand that in order to
contain the transmission of the virus, the strategies involve not just containing the virus but
also the human host.
Broadly, the strategies are:
1. Individual actions such as wearing of masks, maintaining a distance of 6 feet from

others, sanitizing one’s hands frequently and not attending any mass gathering; and
2. Public Health measures to contain the virus by:
• quarantining and testing individuals suspected to be positive including contacts of

SARS-CoV-2 positive persons, SARI cases, persons with flu like symptoms etc.
and ensuring that they are not mobile and thus able to spread the infection
• isolating all those who are positive, tracing their contacts, quarantining and testing
them.
• where there are clusters of cases, simply quarantining individuals or families will not
help. In that case, containment zones with clear boundaries and stringent controls
will be required to ensure that the infection does not spread outside. This is in line
with the containment strategy followed worldwide and also already enumerated in
SOPs of the Ministry of Health. This would mean a large geographical area like a
city or district or well defined parts thereof, where cases are high and spiraling up,
gets contained physically, However, regulated movement of public transport would
be permitted.
3. Evidence Based Decision: The decision on where and when to go for large Containment
Zone (CZ) has to be evidence based and done at the State/UT level after proper analysis
of the situation, such as; the population affected, the geographical spread, the hospital
infrastructure, manpower, the ease of enforcing boundaries etc.
4. However, in order to facilitate objective, transparent, and epidemiologically sound decision

making, the following broad-based framework is provided to aid States UTs in selection of
districts/areas:
s.
Parameter Thresholds
No.
Test positivity of 10% or more in the last one
1 Test positivity
week
OR
Bed occupancy of more than 60% on either
2 Bed occupancy
oxygen supported or ICU beds
contd /-
915
: 2 :
5. The areas requiring Intensive action and local containment connotes specific and well
defined geographical units such as cities/town/part of the towns/district
headquarters/semi-urban localities/municipal wardsIpanchayat areas etc.
6. The areas so identified for intensive action and local containment will primarily focus on
the following strategic areas of intervention:
A. Containment
i. Focus will be on containment as a major approach to flatten the current curve

of the epidemic.
ii. Night curfew: Movement of individuals shall be strictly prohibited during night
hours, except for essential activities. Local administration shall decide the
duration of the night curfew hours and issue orders, in the entire area of their
jurisdiction, under appropriate provisions of law, such as under Section 144 of
CrPC, and ensure strict compliance.
iii. The spread of the infection has to be controlled through restricting the
intermingling amongst people, the only known host for the COVID-19 virus.
iv. Social/ political / sports / entertainment / academic / cultural / religious / festival-
related and other gathering and congregations shall be prohibited.
v. Marriages (attended by up to 50 persons) and funerals/ last rites (attended
by up to 20 persons) may be allowed.
vi. All shopping complexes, cinema halls, restaurants & bars, sports complexes,
gym, spas, swimming pool and religious places should remain closed.
vii. Essential services and activities such as healthcare services, police, fire,
banks, electricity, water and sanitation, regulated movement of public
transport including all incidental services and activities needed for a smooth
functioning of these activities shall continue. Such services shall continue in
both public and private sector.
viii. Public transport (railways, metros, buses, cabs) to operate at a maximum
capacity of 50%.
ix. There shall be no restrictions on inter-state and intra-state movement
including transportation of essential goods.
x. All offices, both government and private, to function with a maximum staff
strength of 50%.
xi. All industrial and scientific establishments, both government and private
may be allowed subject to the workforce following physical distancing
norms. They shall also be tested through RAT (in case of individuals identified
with flu like symptoms) from time to time.
xii. The SOPs already issued by MoHFW, including training manuals for
surveillance teams and supervisors are available on the website & must be
followed.
xiii. However, these are indicative activities, and States/ UTs should make a
careful analysis of the local situation, areas to be covered, and probability
of transmission and then take a decision.
.....contd/-
916
: 3 :
xiv. The restrictions as above shall continue for a period of 14 days.

xv. Before declaring a containment area, make a public announcement,
outlining the rationale for the same and the kind of restrictions that will be
in place (a leaflet in local language may be distributed highlighting the
gravity of the situation and restrictions to be followed)
xvi. Community volunteers, civil society organizations, ex- servicemen, and
members of the local NYK/NSS centers etc. should be involved for
sustainable management of containment activities, translating the
aforementioned leaflets and for encouraging people in the community for
sustained behavior change as well as vaccination.
B. Testing and Surveillance
Districts will continue with the strategy of ‘Test-Track-Treat-Vaccinate’ and

implementation of Covid Appropriate Behavior across the district as the ongoing
strategy for the management of COVID-19.
i. Ensure adequate testing and door to door case search in the area through
adequate number of teams formed for such purpose.
ii. Plan for testing of all clinically resembling cases of Influenza like illness (ILI)
& SARI through RAT. All symptomatic individuals turning out to be negative for
SARS-CoV-2 infection with RAT need to be retested through RT PCR.
iii. Ensuring compliance of COVID Appropriate Behaviour aggressively both
through creation of awareness through involvement of the community based
organizations and through stringent regulatory framework.
C. Clinical Management
i. Analysis to be undertaken with respect to requirement of health

infrastructure so as to manage the present and projected cases (next one
month) and necessary action initiated to ensure sufficient oxygen-supported
beds, ICU beds, ventilators, ambulances including creation of makeshift
hospitals, as needed. Sufficient quarantine facilities shall also be re-activated.
ii. Leverage government, private health facilities including hospital facilities
available with central ministries, railway coaches, temporary field
hospitals etc.
iii. Ensure that people satisfying protocol for home isolation only are allowed
under home isolation. Create a mechanism for their regular monitoring
through Call Centres along with regular visit of surveillance teams to such
houses.
iv. Provision of a customized kit for all patients under home isolation, including
detailed dos and don’ts to be followed by them.
v. Specific monitoring shall be done for high risk cases and their timely shifting
to the health facility. Similarly, elderly and co-morbid contacts of positive
cases shall be shifted to quarantine centres and monitored.
contd /-
917
: 4 :
vi. Appoint senior district officials as In-charge for all Covid dedicated hospitals
and create a mechanism for seamless shifting of patients (including home
isolation cases) as per their symptom to the relevant facilities.
vii. Ensure availability of sufficient ambulances for such purpose.
viii. Coordinate availability of oxygen, other related logistics, drugs etc. in
collaboration with state officials and ensure their rational use.
ix. Oxygen therapy for the admitted cases shall follow the guidelines issued by
Ministry of Health on the rational use of oxygen
x. Use of investigative drugs (Remdesivir / Tocilizumab etc.) shall also strictly
follow the clinical management protocol/advisories issued by Ministry of
Health.
xi. Facility wise cases and deaths shall be analyzed on daily basis by the
Incident Commander/District Collector/Municipal Commissioner. Death-
audit shall be undertaken for all deaths in the hospitals and in the community
to provide supportive supervision to field staff/hospitals.
D. Vaccination
100% vaccination for the eligible age-groups shall be undertaken duly creating
additional vaccination centres and optimal capacity utilization of existing
Centres.
E. Community Engagement
i. Ensure adequate advance information to community, also highlighting the

need for stringent containment actions so as to win their involvement and
support.
ii. Provide enough time for people movement for essential requirements etc.
before announcing the large scale containment
iii. Take necessary actions to avoid misinformation & panic in the community.
iv. Involve local level NGOs/CBOs/CSOs, Opinion Makers and subject experts
to create a positive environment and for sustained dialogue with the community.
v. Create wide publicity on early warning signals and self-reporting so as to
identify cases early and to prevent avoidable deaths among home isolation
patients.
vi. Give wide publicity on the mechanism whereby people can get themselves
tested, details o f available health facilities, requisitioning an am bulance etc
(community based organizations should be encouraged to create WhatsApp
groups for quick dissemination of information so that the individuals in need of
prevention and/or care services do not suffer delay).
vii. Ensure that details of hospital beds and their vacancy status is made
available on-line and also released to media on a daily basis.
viii. Details on availability of oxygen, drugs, vaccine and vaccination centres;
including the guidelines related with use of Remdesivir/Tocilizumab etc. be also
widely publicized so as to create confidence in the community.
contd/-
918
: 5 :
ix. Community should be oriented about the feasibility of managing mild COVID-19
cases at home with appropriate monitoring of vital parameters such as
temperature and oxygen saturation with the help of pulse oxymeter.
x. Need for COVID Appropriate Behaviour including regulatory framework for
enforcement should be widely publicized.
xi. Build confidence in community duly highlighting the nature of disease, the fact
that early identification helps in early recovery and more than 98% people
recover to remove fear as well as stigma related with Covid-19. Involvement
of civil society organizations to hold such orientations go a long way in this
regard.
919
1235675 59 ANNEXURE P-37

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924
ANNEXURE P-38
$~11–30.
(11)
+ W.P.(C) 5315/2020 & CM APPL. 19189/2020
MASTER ARNESH SHAW ..... Petitioner
versus

(12)
+ W.P.(C) 10782/2020 & CM APPL. 33828/2020
AVIRAJ GARG, AGE 4 YEARS, THROUGH HIS NEXT FRIEND
AND NATURAL FATHER SH. ABHINAV GARG ..... Petitioner
versus
UNION OF INDIA & ANR. .... Respondents

(13)
+ W.P.(C) 322/2021 & CM APPL. 812/2021
KESHAV SHARMA AGE 12 YEARS THROUGH HIS NEXT
FRIEND AND NATURAL FATHER SANJEEV KUMAR
..... Petitioner
versus

(14)
+ W.P.(C) 1491/2021 & CM APPL. 4291/2021
MASTER MEDHANSH JHAWAR @ MADHAV ..... Petitioner
versus

(15)
+ W.P.(C) 1511/2021, CM APPL. 4331/2021 & CM APPL. 4332/2021
MASTER KENIT JHAWAR @ KESHAV ..... Petitioner
Signature valid
Signed By:GARIMA MADAN
Location:
13:57:59
925
versus

(16)
+ W.P.(C) 1611/2021 & CM APPL. 4600/2021
LAKSHYA KUMAR GOYAL, 8 YRS OLD, THROUGH HIS NEXT
FRIEND AND NATURAL FATHER SH. VIPIN KUMAR
..... Petitioner
versus

(17)
+ W.P.(C) 3662/2021, CM APPL. 11103/2021, CM APPL. 11104/2021
& CM APPL. 11105/2021
PAYEL BHATTACHARYA ..... Petitioner
versus
UNION OF INDIA & ORS. ..... Respondents

(18)
+ W.P.(C) 3682/2021 & CM APPL. 11153/2021
HARSHIT SONI, 16 YEARS OLD, THROUGH HIS NEXT
FRIEND AND NATURAL FATHER SH. TIKAM CHAND SONI
..... Petitioner
versus

(19)
+ W.P.(C) 3689/2021 & CM APPL. 11179/2021
DHANANJAY BHARDWAJ, 11 YEARS OLD, THROUGH HIS
NEXT FRIEND AND NATURAL FATHER SH. AMIT KUMAR
..... Petitioner
versus
Signature valid
Location:
13:57:59
926

(20)
+ W.P.(C) 3706/2021 & CM APPL. 11229/2021
KHUSHWANT BHARDWAJ, 7 YEARS OLD, THROUGH HIS
NEXT FRIEND AND NATURAL FATHER SH. NIKHIL
BHARDWAJ ..... Petitioner
versus

(21)
+ W.P.(C) 3707/2021 & CM APPL. 11230/2021
AARAV GARG, 5 YEARS OLD, THROUGH HIS NEXT FRIEND
AND NATURAL FATHER SH. VIVEK ..... Petitioner
versus

(22)
+ W.P.(C) 3729/2021 & CM APPL. 11269/2021
MANISH, 8 YEARS OLD, THROUGH HIS NEXT FRIEND AND
NATURAL FATHER SH. PHOOL CHAND JAT & ANR.
..... Petitioners
versus

(23)
+ W.P.(C) 3737/2021 & CM APPL. 11277/2021
SHOURYA MARU, 7 YEARS OLD, THROUGH HIS NEXT
FRIEND AND NATURAL FATHER SH. KAMAL KUMAR
MARU ..... Petitioner
versus
Signature valid
Location:
13:57:59
927

(24)
+ W.P.(C) 3859/2021 & CM APPL. 11647/2021
SIDDHARTH SWARNKAR, 9 YEARS OLD, THROUGH HIS
NEXT FRIEND AND NATURAL FATHER SH. DINESH KUMAR
SWARNKAR ..... Petitioner
versus

(25)
+ W.P.(C) 4045/2021 & CM APPL. 12213/2021
UTKARSH INDRAJIT PAWAR, 10 YEARS OLD, THROUGH HIS
NEXT FRIEND AND NATURAL FATHER SH. INDRAJIT
DAMAR PAWAR ..... Petitioner
versus

(26)
+ W.P.(C) 4067/2021 & CM APPL. 12306/2021
ANSHU, 10 YEARS OLD, THROUGH HIS NEXT FRIEND AND
NATURAL FATHER SH. NARENDRA KUMAR YADAV
..... Petitioner
versus

(27)
+ W.P.(C) 4259/2021 & CM APPL. 12948/2021
ISHAAN, 10 YEARS OLD, THROUGH HIS NEXT FRIEND AND
NATURAL FATHER SH. RAJVIR SINGH ..... Petitioner
versus
Signature valid
Location:
13:57:59
928

(28)
+ W.P.(C) 4304/2021 & CM APPL. 13108/2021
TANAV HANDOO, 6 YEARS OLD, THROUGH HIS NEXT
FRIEND AND NATURAL FATHER SH. AMIT HANDOO
..... Petitioner
versus

(29)
+ W.P.(C) 4551/2021 & CM APPL. 13949/2021
SHAURYA DAHIYA, 7 YEARS OLD, THROUGH HIS NEXT
FRIEND AND NATURAL FATHER SH. SATBIR DAHIYA
..... Petitioner
versus
(30)
+ W.P.(C) 4812/2021 & CM APPL. 14844/2021
NIKHIL YOGENDERSINGH CHOUDARY, 17 YEARS OLD,
THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.
YOGENDERSINGH P CHOUDARY ..... Petitioner
versus
Through: Mr. Rahul Malhotra & Mr. Asif Ahmed, Advs. for
petitioner in W.P.(C) 5315/2020, W.P.(C) 322/2021 & W.P.(C)
1491/2021
Mr. Satvik Verma, Sr. Adv. alongwith Mr. Tanveer Obewan, Adv.
for AIIMS.
Signature valid
Location:
13:57:59
929
Mr. Ripudaman Bhardwaj, CGSC with Mr. T.P. Singh, Adv. for R-1
in W.P.(C) 5315/2020
Mr. Anuj Aggarwal, ASC, GNCTD with Ms. Ayushi Bansal, Adv.
for R-2 in W.P.(C) 3662/2021
Mr. Asif Ahmed, Adv. for petitioner in W.P.(C) 3662/2021
Mr. N.K. Srivastava, Adv. for R-1 in W.P.(C) 3859/2021
Mr. Ranvir Singh, CGSC for R-1 in W.P.(C) 3737/2021, W.P.(C)
4812/2021
Mr. Prakash Kumar, Adv. for R-1 in W.P.(C) 1511/2021
Mr. Harish Kumar Garg and Ms. Payal Agrawal, Advs. for R-1 in
W.P.(C) 4045/2021
Ms. Nidhi Raman, CGSC for R-1 in W.P.(C) 5287/2021
Mr. Shankar Kumar Jha, Adv. for R-1 in W.P.(C) 1611/2021 &
W.P.(C) 3682/2021
Ms. Anju Gupta, Adv. for R-1 in W.P.(C) 3662/2021
Mr. Siddharth Khatana, Adv. for R-1 in W.P.(C) 3707/2021
Mr. Sanjeev Sabharwal, Adv. for UOI in W.P.(C) 4067/2021
Mr. Satya Ranjan Swain & Mr. Kautilya Birat, Advs. for UOI in
W.P.(C) 4304/2021
Mr. Amrita Prakash, CGSC in W.P.(C) 10782/2020
Mr. Nawal Kishore Jha, Adv. for UOI in W.P.(C) 1491/2021
Mr. Ajay Digpaul, CGSC with Mr. Kamal R Digpaul, Adv. for R-1
in W.P.(C) 10782/2020
CORAM:
HON'BLE MS. JUSTICE REKHA PALLI
ORDER
% 20.05.2021
1. In purported compliance of the orders dated 23.03.2021 and
19.04.2021, respondent no.1 has filed an affidavit, however the said affidavit
does not deal with various issues of concern that were noted by the Court in
these orders.
2. Learned counsel for respondent no.1 prays for and is granted 10 days’
time, by way of last opportunity, to file an additional affidavit in this regard.
3. In this additional affidavit, the respondent no.1 will specifically deal
Signature valid
Location:
13:57:59
930
with the issue regarding the prescribed limit of Rs. 20 lakh per patient, as
noted in paragraph 5 of the order dated 19.04.2021, as also state its detailed
response in respect of the ‘crowd-funding option’ that the Government was
expected to explore as an alternative option to finance the treatment of such
patients. It is made clear that no further time will be granted to respondent
no.1 to file this affidavit.
4. List on 03.06.2021.
REKHA PALLI, J
MAY 20, 2021

kk
Signature valid
Location:
13:57:59
1/11/22, 3:56 PM Doctor's message about low pediatric deaths from COVID blocked by Facebook
ANNEXURE P-39 931
•
~
~
'¥'
THENET
_(httP-s://reclajmthenet.org).
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Issue: May 22, 2021
Doctor's message about low pediatric deaths

from COVID blocked by Facebook
The comment was removed.
By Christina Maas(https://reclaimthenet.org/author/christina-maas/) Posted 8:58 am
Share()
If you're tired of censorship, cancel culture, and the erosion of civil liberties
subscribe to Reclaim The Net. (h:ttP-s: //reclaimthenet.org/subscribe}
Facebook removed a comment by a doctor on the number of COVID-19 pediatric deaths.

Facebook claimed the comment violated it "Community Standards on Spam."
A Facebook user asked about the number of COVID-19 pediatric deaths in the month of April.
Dr. Tracy H0eg, a sports, spine, and regenerative medicine doctor, responded with factual
information from the CDC and American Academy of Pediatrics (AAP), and even included a
https://reclaimthenet.org/dr-tracy-hoeg-censored/ 1/9
932
graph.
"Part of the reason I have (for the most part) left Facebook is they delete my post/responses
that are factual, which I triple check," Dr. Tracy H0eg wrote in a May 20 Facebook post. "I
was responding to a question about what the number of pediatric deaths were due to COVID
in April. I don't feel like directly citing numbers from CDC and AAP should be deleted as
spam, but maybe that is just me. I have moved to Twitter FYI."
Tracy H0eg
20 May at 02:33 · 0
Part of the reason I have (for the most part) left Facebook is they delete my
posts/responses that are factua l, which I triple check. I was responding to a question about
what the number of ped iatric deaths were due to COVID in April. I don't feel like directly
citing numbers from CDC and AAP shou ld be deleted as spam, but maybe that is just me . I
have moved to Twitter FYI.
• AT&T LTE 6 :26 PM
Your comment goes against our

Community Standards on spam
No one else can see your comment.
We have these standards to prevent things like
fa lse advertising, fraud and security breaches.
Tracy H"eg
In the month of April there were 19
pediatric deaths due to covid. https://
services .aap .org/en/pages/2019-novel-
coronavirus-covid-19-infections/
children-a nd-covid-19-state-level-data-
report/. Graph also shows how rapid ly
cases among kids are declining.
Facebook's standards on spam are supposed "to prevent things like false advertising, fraud,
and security breaches." None of those things seem to describe Dr. Tracy H0eg comment.
933
Dr. Tracy H0eg recently testified in a hearing_(httP-s://news.wbfo.orgLP-ost/judge-calls-full-
P-erson-return-school-orchard-P-ark-and-williamsville), where a judge ordered the temporary
resumption of full in-person learning in schools in the Orchard Park and Williamsville school
districts in the state of New York. In her testimony, the orthopedics specialist said that kids
were more likely to get the virus in the community than at school.
If you're tired of censorship, cancel culture, and the erosion of civil liberties
subscribe to Reclaim The Net. (https: //reclaimthenet.org/subscribe)
Defend free speech and individual liberty online.
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1 Comment Sort By Best ...,
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g rayfu r 7 months ago
Like Twitter is any better? She will

soon enough make that discovery....
Reply
by Hyvor Talk
934
Chip-makers want 2022 to be the year of the "always-on" camera

(https://reclaimthenet.org/chip-makers-want-2022-to-be-the-year-of-
the-always-on-camera/)
READ » (HTTPS://RECLAIMTHENET.ORG/CHIP-MAKERS-WANT-2022-TO-BE-THE-VEAR-OF-THE-ALWAVS-ON-CAMERA/)
January 1, 2022
India investigates Apple's App Store practices on antitrust grounds

(https://recl a imthenet.o rg/i nd ia-i nvesti gates-a pp Ies-a pp-store-practices-
o n-a ntitru st-grounds/)
READ» (HTTPS://RECLAIMTHENET.ORG/INDIA-INVESTIGATES-APPLES-APP-STORE-PRACTICES-ON-ANTITRUST-
GROUNDS/)
January 1, 2022
CBP reviews secret division that kept databases on journalists and

politicians (https://reclaimthenet.org/cbp-reviews-secret-division-that-
kept-databases-on-journalists-and-politicians/)
935
READ » (HTTPS://RECLAI MTH EN ET.ORG/CBP-REVIEWS-SECRET-DIVISION-THAT-KEPT-DATABASES-ON-JOURNALISTS-AND-
t"ULI 11\.IAN:)IJ
January 1, 2022
Twitter locked out Grabien Media account for quoting a congressman

Andy Briggs (https://reclaimthenet.org/twitter-locked-out-grabien-
media-account-for-quoting-a-congressman-andy-briggs/)
READ» (HTTPS://RECLAIMTHENET.ORG/TWITTER-LOCKED-OUT-GRABIEN-MEDIA-ACCOUNT-FOR-QUOTING-A-
CONGRESSMAN-ANDY-BRIGGSn
January 1, 2022
Dr. Robert Malone responds to Big Tech censoring "inconvenient"

scientific facts (https://reclaimthenet.org/dr-robert-malone-responds-to-
big-tech-censoring/)
READ» (HTTPS://RECLAIMTHENET.ORG/DR-ROBERT-MALONE-RESPONDS-TO-BIG-TECH-CENSORINGn
January 1, 2022
936
The Illinois Holocaust Museum wants to introduce vaccine passports

(https://reclaimthenet.org/illinois-holocaust-museum-vaccine-passports/)
READ» (HTTPS://RECLAIMTHENET.ORG/ILLINOIS-HOLOCAUST-MUSEUM-VACCINE-PASSPORTS/)
January 1, 2022
Big Tech alternatives:
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Private search engines (https://reclaimthenet.org/private-search-engines/)
937
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Free speech friendly Discord alternatives (https://reclaimthenet.org/free-

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Free speech friendly and privacy-focused social networks

(https://reclaimthenet.org/free-speech-friendly-and-privacy-focused-social-
networks/)
938
.(httf,1s:llreclaimthenet.org/free-sf,1eech-friendly-video-sharing:.P-latforms/).
Free speech friendly video sharing platforms

(https://recla i mthenet.org/free-speech-friend ly-video-sha ring-platforms/)
.(httP-s:Ureclaimthenet.org/f,lrivate-and-encryP-ted-cloud-storag§:.f,lrOViders/).
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Light Dark
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940
ANNEXURE P-40
https://www.dnaindia.com/india/report-baba-ramdev-fires-25-questions-at-ima-asks-is-there-any-allopathic-medicine-to-turn-cruel-person-into-kind-2891795
Home »
India
Baba Ramdev fires 25 questions at IMA, asks 'is there

any allopathic medicine to turn cruel person into kind?’
The Yoga guru asked if allopathy offered permanent relief from hypertension (BP) and type-1 and 2 diabetes.
SHARE
941

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
WRITTEN BY
DNA Web Team

SOURCE
DNA webdesk
Updated: May 25, 2021, 09:17 AM IST
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After withdrawing his statement questioning the efficacy of allopathy medicines, yoga guru Ramdev on Monday
(May 24) posted an "open letter" directed to the Indian Medical Association (IMA), on his Twitter handle. He asked
25 questions to the IMA which included a question if allopathy offered permanent relief for ailments such as
hypertension and diabetes.
IMA had objected to his video clip running down allopathy treatment for COVID-19 and sent him a legal notice.
The Yoga guru asked if allopathy offered permanent relief from hypertension (BP) and type-1 and 2 diabetes. He
also listed several other ailments such as fatty liver, liver cirrhosis, colitis, constipation and bloating amnesia and
asked the IMA and pharma companies if they have any treatment for them without side effects.
ALSO READ
Baba Ramdev issues apology after 'extremely unfortunate' remarks on allopathy, here's what he said
942
स्वा मी रामदेव
@yogrishiramdev
मैं इंडियन मेडिकल एसोसिएशन व फार्मा कं पनियों से विनम्र ता के

साथ सीधे 25 सवाल पूछता हूँ-
6:15 PM · May 24, 2021
56K 9.3K Share this Tweet
"Does the pharma industry have permanent treatment for thyroid, arthritis, colitis and asthma?" he asked.
ALSO READ
943
IMA sends legal notice to yoga guru Ramdev over viral video, Patanjali reacts
Ramdev went on to ask, "Like you found a cure for TB and chickenpox, look for treatments for liver ailments. After
All, allopathy is now 200 years old."
Top rated School in Gurgaon. GPS Enabled
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He also asked what non-surgical cure does the pharma industry have for heart blockage. "What treatment is there
for cholesterol." "Does the pharma industry have treatment for migraine?" he asked.
ALSO READ
Baba Ramdev makes big statement on Centre's farm laws, says THIS
Ramdev also went on to list modern-day ailments such as Parkinson's disease and wondered if allopathy had any
painless cure to treat infertility as well as to reverse ageing and increase hemoglobin.
"Doctors should not fall ill at all if allopathy is all-powerful and 'sarvagun sampanna' (having all good qualities),"
he remarked.
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The yoga guru also asked if there is any medicine in allopathy to turn a violent and cruel person into a kind
human and if pharma companies have any medicine to end the tussle between allopathy and Ayurveda.
On Sunday (May 23), Harsh Vardhan had asked Baba Ramdev to withdraw his remark, saying it disrespects
'corona warriors' and can break the morale of healthcare workers.
For the unversed, in a video circulated on social media, Ramdev was heard saying allopathy is "a stupid science"
and medicines such as Remdesivir, Faviflu, and other drugs approved by the Drugs Controller General of India
944
have failed to treat COVID-19 patients.
In a letter to Ramdev, Harsh Vardhan said, "The statement disrespects the corona warriors and hurts the
sentiments of the country. Your statement on allopathy can break the morale of healthcare workers and weaken
our fight against COVID-19. "
The development comes after the Indian Medical Association (IMA) Saturday condemned Ramdev's remarks and
demanded action against him.
"The IMA demands and resolves if the minister (Harsh Vardhan) is not taking suo moto action, we will be forced
to resort to democratic means of struggle to propagate the truth to the common man and knock the doors of the
judiciary to get due to justice," IMA had said in its statement.
ANNEXURE P-40
945
इंडियन मेडिकल एसोससएशन (IMA) और फामाा कम्पननयों की

स्वामी रामदे व का खल
ु ा-पत्र और सीधे 25 सवाल
1. ऐलोपैथी के पास हाईपरटें शन (बी.पी.) व उसके कम््लीकेशन्स के सलए ननदोष स्थायी समाधान क्या है ?
2. ऐलोपैथी के पास टाईप-1 व टाईप-2 िायबबटीज व उसके कम््लीकेशन्स के सलए परमानेन्ट साल्यश
ू न क्या है?
3. फामाा इंिस्री के पास थायरायि, आथाराइटटस, कोलाइटटस, अस्थमा की समस्या का ननदोष स्थायी समाधान क्या
है ?
4. एलोपैथी के पास फैटी सलवर और लीवर ससरोससस, हेपट
े ाइटटस को क्योर करने के सलए मेडिसन क्या है ? जैसे
आपने टी.बी. व चेचक आटद का स्थायी समाधान खोजा है , वैसे ही सलवर की बीमाररयों का समाधान खोजजये, अब
तो एलोपैथी को शुरू हुए 200 साल हो गये, जरा बताइये।
5. फामाा इंिस्री में हाटा के ब्लॉकेज को ररवसा करने का उपाय क्या है , बबना बाईपास के, बबना ऑपरे शन के व
इंजो्लाजस्ट के स्थायी समाधान क्या है ?
6. फामाा इंिस्री में इनलाजा हाटा और इजेक्शन-फेक्शन (ई.एफ.) कम होने पर बबना पेसमेकर लगाये, कौन सा
इलाज है जजससे हाटा का साइज और फंक्शन नॉमाल हो जाये। कैसे उसे ररवसा कर सकते हो, बबना पेसमेकर के
उसका ननदोष इलाज क्या है?
7. कोलेस्रॉल के रोगगयों में कोलेस्रॉल राइजललसराइड्स कम करने का और लीवर पर साइि इफेक्ट रटहत ऐलोपैथी
में क्या इलाज है ?
8. क्या फामाा इंिस्री के पास ससरददा , और माईग्रेन का कोई परमानेन्ट साल्यूशन है? जजसके बार-बार ससरददा और
माईग्रेन न हो। एक बार दवा खायें और परमानेन्ट ससरददा, माईग्रेन बन्द हो जाये।
9. फामाा इंिस्री में आँखों का चश्मा उतारने का और हीयररंग ऐि हट जाये, इसका कोई ननदोष इलाज बता दें ?
10. पायररया होने पर, जजससे कक दाँत टहलने बन्द हो जाये, मसूडे मजबत
ू हो जाये, ऐसी कोई ननदोष दवाई बतायें?
जजससे करोडों लोग दुःु खी हैं।
1।. एक आदमी का रोज कम से कम आधा से | ककलो वजन कम जाये बबना सजारी के बैररयाटरक सजारी और
लाईपोसेक्शन के, बबना ककसी छे डछाड के, दवाई खाये, और वजन घट जाये, क्या फामाा इंिस्री में ऐसी कोई दवाई
है ?
12. सोरायससस, सोरायटटक अथारायटटस व सफेद दाग का कोई ननदोष स्थायी समाधान बतायें?
13. माड्ान मेडिकल साईन्स में एंक्लोजजंग स्पोंडिलोससस का स्थायी समाधान क्या है ? ९.५ फैक्टर पॉजजटटव को
नेगेटटव करने का उपाय क्या है ?
14. ऐलोपैथी के पास पाककिंसन का ननदोष स्थायी समाधान क्या है ?
15, साईि इफेक्ट रटहत कब्ज, गैस, एसीडिटी का फामाा इंिस्री के पास इसका स्थायी समाधान क्या है?
16. अननद्रा, (इन्सोमननया) लोगों को नींद नहीं आती है , क्योंकक आपकी दवा 4 से 6 घंटे ही असर करती हैं, वह
भी साइि इफेक्ट के साथ, ऐलोपैथी में इसका कोई परमानेन्ट सॉल्यूशन दे दें ?
17. स्रे स हामोंस कम करने के सलए और है्पी या गि
ु हामोंस बढाने के सलए, जजससे आदमी तनावमुक्त और
प्रसन्न हो जाये। फामाा इंिस्री में इसकी कोई दवाई बता दें ?
18. इन्फटटा सलटी में बबना कृबत्रम साधनों (टे स्ट रयब
ू बेबी, IVF) जो बहुत पेनफुल होती है , एलोपैथी में ऐसी कोई
दवाई बतायें जजससे समस्या का समाधान हो जाये?
जजससे बबना (टे स्ट ट्यब
ू बेबी, IVF) के नेचुरल तरीके से संतान हो जायें, और व्यजक्त लाखों रुपये की लूट से बच
जायें, ऐसी कोई ननदोष दवाई बताऐँ ?
19. फामाा इंिस्री में ऐजजंग प्रोसेस को ररवसा करने वाली कोई ननदोष दवाई बता दें ।
20. एलोपैथी में बबना साईि इफेक्ट के टहमोललोबबन बढाने का ननदोष तरीका बता दें ?
21. आदमी बहुत टहंसक, क्रूर और है वाननयत कर रहा है, उसके इंसान बनाने वाली एलोपैथी में कोई दवाई बताएं।
22. आदमी के सारे ड्रलस एडिक्शन, नशा छूट जायें, ऐसी कोई एलोपैथी में दवाई बता दें ?
23. एलोपैथी और आयव
ु द
े के आपस में झगडे खत्म करने की, फामाा इंिस्री के पास कोई दवाई है तो बता दें ?
24. फामाा इंिस्री में कोरोना पैसेन्ट को बबना ऑक्सीजन ससलेण्िर के ऑक्सीजन बढाने का कोई उपाय बताऐँ ?
25. एलोपैथी सवाशजक्तमान एवं सवागुण सम्पन्न है तो कफर एलोपैथी के िॉक्टर तो बीमार होने ही नहीं चाटहए?
946
Swami Ramdev's open letter and 25 straight questions to

Indian Medical Association (IMA) and Pharma companies
1. What is the perfect permanent solution to Hypertension (BP) and its complications in
Allopathy?
2. What is the permanent solution in Allopathy for type-1 and type-2 diabetes and its
complications?
3. What is the flawless permanent solution to the problem of Thyroid, Arthritis, Colitis, Asthma
with the pharma industry?
4. What is the medicine to cure fatty liver and liver cirrhosis, hepatitis in allopathy? As you have
found a permanent solution for T.B. and have smallpox etc. similarly, find a solution for liver
diseases, now that it has been 200 years since Allopathy started, kindly inform.
5. What is the solution to reverse heart blockage in pharma industry, without bypass, without
operation and without angioplasty. What is the permanent solution?
6. In the pharma industry, in case of enlarged heart and low ejection-faction (EF) without the use
of pacemaker, what is the treatment, so that the size and function of the heart becomes normal.
How can you reverse it, what is the flawless treatment without a pacemaker?
7. What is the treatment for lowering cholesterol, triglycerides in patients with cholesterol in
allopathy free of adverse side effects on liver?
8. Does the pharma industry have a permanent solution for headache and migraine? Use of which
relieves repetitive headaches and migraines, by taking medicine once to permanently relieve
headache, migraine..
9. In the pharma industry, is there any safe treatment to remove the eye glasses and remove the
hearing aid?
10. In case of pyorrhoea, so that the teeth stop moving, the gums become strong, suggest any
such innocent medicine? Due to which millions of people are unhappy.
11. A man may shed half to one kilo weight in a day without surgery, without bariatric surgery
and liposuction, without any manipulation, without taking medicine, and lose weight, is there
any such medicine in the pharma industry?
12. Suggest any flawless permanent solution for psoriasis, psoriatic arthritis and white spots?
13. What is the permanent solution for Ankylosing Spondylosis in Modern Medical Science?
What is the remedy for making RA Factor from positive to negative?
14. What is the safe permanent solution to Parkinson's in Allopathy?
15, What is the permanent solution for constipation, gas, acidity free of side effects?
16. Insomnia, (Insomnia) people do not sleep, because your medicine works only for 4 to 6 hours,
that too with side effects, give any permanent solution for this in allopathy?
17. To reduce stress hormones and to increase happy or good hormones, so that man becomes
relaxed and happy. Tell me any medicine for this in the pharma industry?
18. In Infertility without artificial means (test tube baby, IVF) which is very painful, inform about
any medicine in allopathy which can solve the problem?
By which children can be born naturally without (test tube baby, IVF), and a person can be saved
from the robbery of lakhs of rupees, inform any such innocent medicine?
19. Tell me any safe medicine that can reverse the aging process available from the pharma
industry.
20. Tell me the safe way to increase haemoglobin without any side effects in allopathy?
21. Man is becoming very violent, cruel and malevolent, inform about any medicine in allopathy
to alleviate cruelty in man.
22. Inform about any medicine in allopathy to free man from drug addiction?
23.Inform about any medicine with the pharma industry to end the conflict between allopathy
and Ayurveda?
24. In the pharma industry is there any method to increase oxygen in the corona patient without
oxygen cylinder?
25. If Allopathy is omnipotent and full of all virtues, then the doctors of Allopathy should not fall
sick at all?
947
ANNEXURE P-42
$~8
+ W.P.(C) 7213/2020
PRASHANT REDDY T ..... Petitioner
Through Mr.Sanjay R Hegde, Sr.Adv. with
Mr.Harsh Parashar, Mr.Chanakya Sharma, Advs.
versus
DRUGS CONTROLLER GENERAL OF INDIA & ORS.
..... Respondent
Through Mr.Swathi Sukumar, Adv for
Intervenor.
CORAM:
HON'BLE MS. JUSTICE REKHA PALLI
ORDER
% 23.07.2021
CM APPL.10914/2021
1. This is an application filed by one Mr.Dinesh Thakur, claiming to be a
professional working in pharmaceutical industry, seeking
intervention. It is the case of the applicant that in order to ensure
transparency in the process by which the pharmaceutical industry is
regulated in India the applicant, like the petitioner, has also been
making efforts to obtain a copy of the T M Mahapatra Committee
report.
2. Issue notice. Learned counsel for the petitioner accepts notice.
3. Learned senior counsel for the petitioner submits that the petitioner
has no objection to the application being allowed.
4. In the light of the aforesaid stand taken by the petitioner and for the
reasons stated in the application, the same is allowed and Mr.Dinesh
Signature valid
948
Thakur is impleaded as an intervenor and will be permitted to make

submissions at the time of hearing.
5. The application stands disposed of.
W.P.(C) 7213/2020
6. Vide order dated 17.02.2021, this Court while issuing certain

directions had also requested Dr.Shailendra Kumar, Chief Vigilance
Officer, Ministry of Health and Family Welfare to remain present in
Court on the next date. The matter could, however, not be taken up on
the said date i.e 19.03.2021, whereafter the same was not listed on
account of the limited functioning of this Court.
7. Though none appears on the behalf of the respondents, in the light of
the aforesaid circumstances, while not passing any adverse orders
against the respondents, it is directed that in terms of the order dated
17.02.2021, Dr.Shailendra Kumar will remain present in Court on the
next date.
8. List on 16.11.2021.
REKHA PALLI, J
JULY 23, 2021
sr
Signature valid
949
ANNEXURE P-43
Reserved on: 16th June, 2021

% Pronounced on: 27th July, 2021
+ FAO 153/2021, CM APPL.18660/2021 (by the appellant u/S 151

CPC for interim directions/stay)
DR. J.A. JAYALAL, NATIONAL PRESIDENT, INDIAN

MEDICAL ASSOCIATION .....Appellant
Through: Mr. Mukul Gupta, Sr. Advocate
with Mr. Tanmaya Mehta and Mr.
Nitesh Jain, Advocates
Versus
ROHIT JHA .....Respondent
Through: Mr. Sanjeev Uniyal and Mr.
Dhawal Unial, Advocates
CORAM:
HON'BLE MS. JUSTICE ASHA MENON
JUDGMEN T
[VIA VIDEO CONFERENCING]
1. The present appeal has been preferred against the order of the
learned Vacation Judge, Dwarka Courts, New Delhi dated 3rd June, 2021
whereby an application under Order XXXIX Rules 1 and 2 of the Code of
Civil Procedure, 1908 (³CPC´, for short) was disposed of in CS
No.1492/2021 filed by the respondent/plaintiff.
2. The facts, as are relevant for the disposal of this appeal, are,
briefly, that the appellant is the current National President of the Indian
Medical Association (³IMA´, for short), which is a society registered
under the Societies Registration Act, 1860. On 30th March, 2021, the
Signature validFAO 153/2021 Page 1 of 9

Signed By:MANJEET KAUR
22:24:19
950
appellant had allegedly given an interview to Mr. Morgan Lee of

³Christianity Today´, which was published on the website of
³Christianity Today´. Certain other articles and interviews were also
published, which, according to the respondent/plaintiff, were derogatory
of Ayurveda and Hindus. On 29th May, 2021, the respondent/plaintiff
filed a suit for damages and defamation and sought a permanent
injunction against the appellant on the ground of public nuisance and
misleading the nation and its citizens, including the respondent/plaintiff.
An application under Order XXXIX Rules 1 & 2 CPC was also filed
along with the said plaint, which was disposed of by the learned Vacation
Judge vide the impugned order dated 3rd June, 2021, placed as Annexure
A-1 of the record.
3. Mr. Mukul Gupta, learned Senior Counsel for the appellant
submitted that the learned Vacation Judge had made erroneous
observations as the interviews on which the respondent/plaintiff relied on
were fake. Moreover, the very suit was not maintainable and therefore,
the appellant had filed an application under Order VII Rule 11 CPC read
with Order XII Rule 6 and Section 151 CPC, which the learned Vacation
Judge had not considered. The main grievance, as voiced by the learned
Senior Counsel, was that the learned Vacation Judge had to consider
whether there was any prime facie case disclosed, before granting an
injunction, and which it had failed to do.
4. It was further argued that the learned Vacation Judge, despite the
protestations of the appellant that he had not made the controversial
statements attributable to him and on which the entire case of the
respondent/plaintiff was based, and had produced documents to establish

22:24:19
951
this claim, did not consider the same and assumed that the appellant had
made remarks attributed to him of wanting to use the IMA to propagate
Christianity and had belittled Ayurveda, and had shown the Hindus in
poor light. The appellant is also aggrieved by the observations made by
the learned Vacation Judge to the effect that the interview, which was
admitted to by the appellant and the copy of which was placed on the
record, was not harmonious with the provisions of the Constitution of
India and that the interview itself was in poor taste.
5. In the written submissions that have been filed, it is further
submitted that the learned Vacation Judge while passing the injunction
under Order XXXIX Rules 1 & 2 CPC had failed to satisfy itself on the
pre-requirements of the existence of a ³prima facie case´, ³the balance of
convenience´ being in favour of the respondent/plaintiff and against the
appellant, and ³the irreparable loss and injury´ being caused to the
respondent/plaintiff, in the absence of an injunction order. According to
the appellant, since no damages for defamation, through a class, is
maintainable and no injunction can be issued in such matters, the
impugned order is liable to be set aside.
6. It was also submitted that the suit was barred under Section 41(f)
of the Specific Relief Act, 1963 on the ground of ³nuisance´, as final
adjudication would be required to determine whether the act of the
appellant was in actual fact a ³nuisance´. Thus, a final relief seemed to
have been granted to the respondent/plaintiff by the impugned order.
7. It was further submitted that there was no material available on the
record to suggest that the appellant had ever used the platform of IMA for
propagating any religion or was misusing his position as the National

22:24:19
952
President of IMA. The document relied upon by the respondent/plaintiff

was not even accompanied with a Certificate under Section 65B of the
Indian Evidence Act, 1872 and no reliance could have been placed on
that so called interview. The appellant also placed reliance on an email
from the ³Haggai International´ that the screenshot placed on the record
by the respondent/plaintiff with the heading ³In the Name of the Great
Physician´, was fake and that a cyber complaint had also been lodged by
the appellant. In the absence of any prima facie case, no injunction ought
to have been granted. Moreover, relying on the decisions of this Court as
well the Supreme Court in Ashutosh Dubey v. Netflix, 2020 SCC OnLine
Del 625; Frank Finn Management v. Subhash Motwani, 2008 SCC
OnLine Del 1049; A.C. Muthiah v. Board of Control for Cricket in
India, (2011) 6 SCC 617; Laxmi Raj Shetty v. State of T.N., (1988) 3
SCC 319 and State of U.P. v. Ram Sukhi Devi, (2005) 9 SCC 733, it was
submitted, (i) that no reliance could be placed on a newspaper report; (ii)
defamation, through a class of Hindus, was not maintainable in law; (iii)
no leave of the court was sought for institution of the suit under Section
91 CPC; (iv) final relief could not have been granted; and, (v) therefore,
no injunction could have been granted.
8. It was further claimed that the impugned order was violative of
Article 21 of the Constitution of India as ³it had taken away the freedom
of life to live freely with reputation that the appellant has´.
9. Learned Senior Counsel also submitted that the learned Vacation
Judge in the impugned order had failed to point out which part of the
interview was not in good taste and was not in harmony with the
Constitution of India and that every person had a right to praise his or her

22:24:19
953
religion. It was also submitted that the learned Vacation Judge had made
unfair observations without any material to justify them.
10. In these circumstances, the learned Senior Counsel submitted that
that impugned order suffered from prejudices and was based on forged
documents for which the appellant could not be held responsible and
accordingly, the same be set aside.
11. On the other hand, Mr. Sanjeev Uniyal, learned counsel for the
respondent submitted that the learned Vacation Judge had made
observations with reference to the article in ³Nation World News´ dated
30th March, 2021. As regards the publications on the Christian Website,
³Haggai International´ and ³Christianity Today´, these were a matter of
evidence which the respondent would lead and prove the allegations
against the appellant. Learned counsel pointed out that on the Christian
Website itself, the deletion of the IMA Interview was mentioned. Learned
counsel also submitted that the Editor¶s note on page 54 of the e-file of
this case records that ³this interview has been edited for clarity´ and
therefore, this document did not reflect the original interview.
12. Moreover, the appellant kept describing himself as a Christian
Doctor in the interview, which was dealing with ³Servant Leadership´. In
fact, learned counsel pointed to various remarks in the document placed
on the record by the appellant as Annexure A-3, to support these
contentions. Additionally, he has filed documents that were filed before
the learned Vacation Judge as Annexures R-1 to R-5. On the basis of
these documents, he has submitted that there was enough material for the
learned Vacation Judge to make observations as it did. As regards the
Certificate under Section 65B of the Indian Evidence Act, 1872, the

22:24:19
954
learned counsel pointed out that it was the same situation for the
appellant. Hence, the learned counsel prayed that the appeal be dismissed.
13. I have heard the learned Senior Counsel for the appellant and the
learned counsel for the respondent and have perused the written
submissions as well as the material on record.
14. Several arguments have been advanced on the maintainability of
the suit, but since this Court is only considering the orders passed by the
learned Vacation Judge disposing of the application under Order XXXIX
Rules 1 & 2 CPC, and apparently, the application under Order VII Rule
11 CPC read with Order XII Rule 6 CPC and Section 151 CPC filed by
the appellant has yet not been disposed of, these submissions are not
being considered while disposing of the present appeal. The argument of
the learned Senior Counsel for the appellant on the truthfulness of the
version of the interview as filed by the respondent/plaintiff to submit that
there was no prima facie case, has been met by the argument of learned
counsel for the respondent/plaintiff that the documents relied upon by the
appellant are themselves doctored.
15. This question of which version is the correct one is to be proved
during trial. The version and claim of the appellant cannot be accepted in
the face of these counter-claims. At this juncture, reference may be made
to the judgment of the Supreme Court in Arjun Panditrao Khotkar v.
Kailash Kushanrao Gorantyal (2020) 7 SCC 1, to note that the learned
Trial Court has not even commenced the trial and can still permit both
sides to file their certificates under Section 65B of the Indian Evidence
Act, 1872, if they have not already done so. There are no grounds to hold
that there was no case disclosed for the learned Vacation Judge, now the

22:24:19
955
Trial Court, to have considered the matter.

16. A perusal of the impugned order reveals that in fact no injunction
has actually been issued. The learned Vacation Judge has passed the
following orders in paragraph No. 20 of the impugned order: -
³In view of the observation made herein above,
at this stage, accepting the submissions of defendant
though no injunction is required to be passed on the
assurance given during arguments by defendant to the
court that he shall not indulge in such kind of activity.
It is expected from him that he will not give any such
occasion so that people may believe otherwise or
indulge in any activity contrary to the principles
enshrined in constitution and shall maintain the dignity
of position chaired by him. He shall not use the
platform of IMA for propagating any religion and
rather shall concentrate for welfare of medical
fraternity and progress in medical field.´
17. Initially, the arguments were sought to be raised to the effect that
no such assurance had been given to the learned Vacation Judge. This
Court will have to proceed on the basis of what is recorded by the court
and if the learned Vacation Judge had misunderstood the submissions, the
appropriate means would have been to move an application for review.
18. What stands out is that paragraph No. 20, reproduced hereinabove,
is in the nature of an ³advisory´ and not a ³restraint order´. Even in the
other paragraphs of the impugned order, the observations that seem to
have irked the appellant are only in the nature of general comments, with
the court expecting that the parameters of such conduct would be kept in
mind by the appellant as he was a person, who was holding a high

22:24:19
956
position amongst the doctors. It has been submitted that there are about 3
lakhs doctor members of the IMA.
19. The specific grievances have been pointed out in paragraphs
No.13, 14, 15 and 16. The learned Vacation Judge on going through the
article dated 30th March, 2021, published in ³Christianity Today´, felt
constrained to note that the same was not in good taste. The appellant has
sought an explanation from the learned Vacation Judge as to what he
found distasteful. There is no merit in such a prayer. It is the judgment of
the court that explains the opinion of the court and no Judge can be called
upon personally to explain his observations.
20. The submission of learned Senior Counsel for the appellant that
paragraphs No. 14 to 16 reflected poorly on the appellant, appears to be
too sensitive a response, that does not appear to be justified on the part of
the appellant. Even the observations of the court in paragraph No.17, after
observing that the appellant had denied having made any comments
against Ayurveda and that his remarks were only against ³Mixopathy´,
that any kind of unguarded or loose comment was not expected from a
person chairing a responsible post in IMA, which was a prestigious
institution, seems to be a comment which prima facie cannot be held to
be an ³absurd´ comment. Any comment, even on ³Mixopathy´, as coined
by the appellant, may be taken seriously by many of the other members of
the medical fraternity and therefore, an expectation of the court that the
appellant would be cautious and sensitive to the reactions to his
statements, can hardly form the basis of a grievance.
21. On the other hand, in paragraph No.18, the learned Vacation Judge
has observed that when the appellant was asked specifically whether the

22:24:19
957
interview given by him was in his individual capacity or in the capacity

of IMA President, an evasive reply seems to have been given. In other
words, the appellant himself seemed to be unwilling to take an
unequivocal stand before the court, which invited the observations that
the appellant is now complaining about.
22. Finally, since no injunction has been issued on the basis of the
assurance given by the appellant that he will not indulge in any such
activity and that the court expected him to refrain from activity that may
become controversial and do everything to maintain the dignity of the
position he held, there is nothing for this Court to rectify. The
observations of the learned Vacation Judge that everybody should be
conscious of the constitutional provisions, is an expectation that is not
limited only to the appellant, but is of every citizen of this country.
23. Ultimately, the grievance of the appellant appears to be on the style
of the learned Vacation Judge in writing the impugned order and upon the
inferences that the appellant seeks to draw, particularly in view of certain
media coverage, that the learned Senior Counsel for the appellant alluded
to in the course of arguments.
24. There is no merit in the present appeal. The same is dismissed
along with the pending application.
25. The judgment be uploaded on the website forthwith.
(ASHA MENON)
JUDGE
JULY 27, 2021/s

22:24:19
Page No.#
958 1/3
GAHC020002332021
ANNEXURE P-44
THE GAUHATI HIGH COURT

(HIGH COURT OF ASSAM, NAGALAND, MIZORAM AND ARUNACHAL PRADESH)
KOHIMA BENCH
Case No. : PIL(Suo Moto) 1/2021
1:IN-RE
KOHIMA, NAGALAND
VERSUS
1:THE STATE OF NAGALAND AND 5 ORS

REPRESENTED BY THE CHIEF SECRETARY TO THE GOVT. OF NAGALAND
AND CHAIRMAN OF THE NAGALAND STATE DISASTER MANAGEMENT
AUTHORITY, NAGALAND
2:THE PRINCIPAL SECRETARY

HEALTH AND FAMILY WELFARE DEPARTMENT
NAGALAND
KOHIMA
3:THE PRINCIPAL DIRECTOR

HEALTH AND FAMILY WELFARE DEPARTMENT
GOVT. OF NAGALAND
NAGALAND
KOHIMA
4:THE DISTRICT TASK FORCE HEADED BY THE DEPUTY COMMISSIONER

OF ALL THE DISTRICTS
NAGALAND
5:THE CHIEF MEDICAL OFFICERS OF ALL THE DISTRICT

NAGALAND
6:THE UNION OF INDIA

REPRESENTED BY THE SECRETARY TO THE GOVT. OF INDIA
MINISTRY OF HEALTH AND FAMILY WELFARE

NIRMAN BHAVAN
NEW DELH
Advocate for the Petitioner : TAKA MASA, SR. ADV(AMICUS CURIAE)

Page No.#
959 2/3
Advocate for the Respondent : GOVT ADV NL
BEFORE
HON'BLE MR. JUSTICE SONGKHUPCHUNG SERTO
HON'BLE MR. JUSTICE S. HUKATO SWU
ORDER
Date : 28-07-2021
(Serto, J)
The Principal Secretary Home, Government of Nagaland has filed an
affidavit placing the two SOPs for re-opening of schools for students of
class 11 and 12 and for re-opening of colleges and technical institutions as
directed in our order dated 20/7/2021. However, regarding our direction to
file an affidavit showing the progress made in the vaccination on willing
shop keepers and vegetable vendors on priority Mr. N. Mozhui submitted
that a comprehensive affidavit covering almost all the directions given in
our order dated 20/7/2021 have been filed only today. The same has not
been placed before us. Therefore, the matters stated in the affidavit would
be taken up on the next date. Further, in paragraph 8 of our order passed
on 20/7/2021 while taking note of the high positivity rate in 5 districts of
the State, we have directed respondent No.1 to take some more special
steps to contain the spread of the virus and for treatment of people who
are already infected in those districts and file an affidavit showing the
steps taken in that regard. But no affidavit has been filed. Therefore, the
respondent No.1 is directed to file the same on or before the next date of
hearing.
At the same time a PIL has been filed today which is registered as
PIL 8/2021 challenging a portion of paragraph 2 of the two SOPs issued by
the Home Department for opening of schools for students of class 11 and
Page No.#
960 3/3
12 and for re-opening of colleges and technical institutes. The PIL has
been taken up along with the pending PIL (Suo Moto) 1/2021 since the
subject matters are more or less the same.
We have heard Ms. Nuksungtila, learned counsel appearing for the
petitioner in the PIL and we have also heard all the learned counsels
representing the other parties. The limited prayer of the petitioner in the
PIL 8/2021 is that the conditions given at paragraph 2 of the two SOPs for
opening of schools and colleges i.e. teaching and non-teaching staffs
should be fully vaccinated or should have taken the 1 st dose of vaccine at
least 15 days prior to the opening of schools or colleges be modified so
that those who choose not to be vaccinated may be given the option of
being compulsorily tested every 15 days. After considering the submissions
of the learned counsel on this and taking into account of the fact that no
one can be compulsorily vaccinated, we are of the view that the option
prayed for can be granted. Therefore, the Principal Secretary Home is
directed to modify paragraph 2 of the 2 SOP so as to provide such option
to the teaching and non teaching staff of schools and colleges.
With this the PIL 8/2021 is disposed.
List the PIL (Suo Moto)1/2021 along with PIL 6/2021 and PIL 7/2021
on 18/8/2021.
Sd/- Sd/-
JUDGE JUDGE
Comparing Assistant
961
ANNEXURE P-45
MANU/SC/0519/2021
Equivalent Citation: 2021(5)ALD56, 2021(5)BLJ472, 2021(5)BomC R431, 2021 (3) C C C 442 , 2021(3)RC R(C ivil)815
IN THE SUPREME COURT OF INDIA

Civil Appeal No. 4627 of 2021 (Arising out of SLP (Civil) No. 24735 of 2014)
Appellants: Ratul Mahanta
Vs.
Respondent: Nirmalendu Sana
Hemant Gupta and A.S. Bopanna, JJ.
JUDGMENT
A.S. Bopanna, J.
1. The Appellant instituted title suit No. 334 of 2011 in the Court of learned Munsif
No. 2, Kamrup Guwahati against the Respondent herein seeking for a declaration that
on the western boundary of the suit Schedule properties A, B and C there is a
common public drain which can be used by the Plaintiff. A declaration is also sought
to the affect that the public drain on the boundary of the Schedule 'C' property of the
D efendant, connected to the Plaintiff's property cannot be obstructed by the
Defendant at any point of time. As an ancillary relief, the Appellant has also sought
for permanent injunction against the Defendant so as to allow free flow of water in
the said drain upto the main GMC drain.
2. The Respondent having appeared, disputed the claim put forth by the Plaintiff on
merits. In addition, the Respondent raised the issue of jurisdiction for the civil court
to entertain the suit in view of the provisions contained in the Guwahati Municipal
Corporation Act, 1971 ('GMC Act for short). In the said suit, since the Appellant had
also prayed for temporary injunction, on consideration it was granted by the trial
court, of course without reference to the objection regarding jurisdiction. The
Respondent had therefore assailed the order of injunction by filing an appeal before
the Lower Appellate Court Under Section 96(1) read with Order 43 Rule 1 of the Code
of Civil Procedure ('CPC for short). In the said appeal, the Respondent herein who
was the Appellant had contended that the order dated 30.09.2011 passed by the
learned Munsif was not justified since the issue relating to the maintainability of the
suit vis-à-vis the provisions of the GMC Act barring the jurisdiction of the civil court
goes to the root of the case. It was contended that the same was required to be
considered and decided, before considering any other relief prayed in the suit. The
lower appellate court in the said miscellaneous application No. 33/2011 through its
order dated 21.09.2012 arrived at the conclusion that the jurisdiction aspect is to be
decided at the outset by the learned Munsif. Therefore, without going into the merits,
the lower appellate court remanded the matter by setting aside the order impugned in
the said appeal for deciding the question of jurisdiction before considering grant of
any other relief.
3. The Appellant herein claiming to be aggrieved by the said order preferred revision
petition in CRP No. 260/2013 before the Gauhati High Court. The learned Judge while

962
taking note of the rival contentions, through its order dated 29.08.2013 had agreed
with the decision of the lower appellate court that the jurisdiction of the civil court to
entertain the suit was to be decided at the outset. The revision petition was
accordingly disposed of. The parties were allowed to urge their contentions in the
court of the learned Munsif.
4 . Pursuant thereto the learned Munsif has considered the issue relating to
jurisdiction and has by its order dated 16.11.2013 arrived at the conclusion that the
bar contemplated under the GMC Act does not apply to the fact situation, keeping in
view the nature of the relief prayed. Accordingly, the learned Munsif has held that the
civil court has jurisdiction to try the suit between the parties. The Respondent herein
claiming to be aggrieved by the said order dated 16.11.2013 preferred revision
petition in CRP No. 128/2018 before the Gauhati High Court. The learned Judge,
through the order dated 06.06.2014 has held that the jurisdiction of this civil court
would stand ousted by implication and the party can claim relief under the procedure
prescribed under the GMC Act only. In that background, the order dated 16.11.2013
impugned in the revision petition was set aside, the suit was held not maintainable
and liberty was reserved to the Appellant to ventilate his grievance under the relevant
provisions of the GMC Act, if so advised. Accordingly, the plaint in title suit No.
334/2011 was ordered to be rejected. The Appellant therefore claiming to be
aggrieved by the order dated 08.04.2014 passed by the Gauhati High Court is before
this Court in appeal.
5 . Mr. Parthiv K. Goswami, learned Counsel for the Petitioner while assailing the
order impugned has contended that the lower appellate court in the first instance and
the High Court in the present round have erred in arriving at the conclusion that the
suit is not maintainable. It is contended that the reasoning adopted by the High Court
to consider the present case to be covered Under Order VII Rule 11(d) of the Code of
Civil Procedure and to bar the civil suit is not justified. It is contended that there is
no bar contemplated to approach the civil court for the nature of relief sought in the
suit, either under the GMC Act or under any other law for the time being in force. In
that regard, the learned Counsel has referred to Section 341 of the GMC Act which
contemplates for a bar of jurisdiction and would point out that the same is restricted
to the relief under the part to which the bar is made applicable. In that regard,
reference is made to Part VI of the Act to contend that if at all, a civil suit is barred, it
is only in respect of the nature of activities which are stated in Section 322 and the
other provisions which appear in Part VI of the Act. It is argued that the relief sought
in the instant suit is in respect of a drain which had existed on the western side of
the suit Schedule Properties and to protect the right of free flow of water which had
been enjoyed from the time the Plaintiff had purchased the property. Such right
sought to be protected is within the domain of the civil court. It is contended that
even though the provisions contained in Section 246, 247 and 248 of the GMC Act,
refer to the power of the Commissioner, any right available to the Plaintiff under the
said provisions can only be in aid of the relief to be sought by the Plaintiff, but in any
event cannot be construed as a bar to maintain the suit. It is therefore contended that
the order passed by the High Court is not sustainable and the suit should be allowed
to be proceeded on its merit.
6. Mr. Arunabh Chowdhury, learned Counsel for the Respondent seeks to sustain the
order passed by the High Court. The contention is that the GMC Act contemplates a
bar against the civil court entertaining the matters relating to the facilities which are
to be considered by the Commissioner, under the Act. Even assuming that Section
341 of GMC Act contemplates an express bar only in respect of Part VI, the provisions

963
contained in Section 246, 247 and 248 of the GMC Act provide the forum to a
property owner seeking for right relating to drain to approach the Commissioner, who
shall decide the said issue. In that context, it is contended that though Section 341 is
not made applicable to Part V, by necessary implication, the suit would stand barred.
It is his contention that in this case the Plaintiff is seeking for a right in respect of the
public drain and in such circumstance when the remedy is provided under the Act, the
consideration of the same under the Common law does not arise. He contends that
the High Court was justified in invoking the provision contained in Order VII Rule
11(d) of the Code of Civil Procedure to hold that the civil court did not have
jurisdiction to entertain the instant suit. In that view, the rejection of the plaint
ordered is justified. The Appellant is not left without a remedy and the alternate
forum is allowed to be invoked. In such circumstance, the order impugned does not
call for interference.
7 . In the background of the above contentions, the nature of the suit and the relief
prayed for therein requires to be noticed only to the limited extent to arrive at a
conclusion as to whether the civil court had jurisdiction to proceed with the suit or as
to whether a bar with regard to jurisdiction as provided in the GMC Act will apply.
Before adverting to that aspect, it is necessary to take note of the contents in para 9
of Code of Civil Procedure which provides for exercise of jurisdiction by civil court. It
reads as hereunder:
9 . The Courts shall (subject to the provisions herein contained) have
jurisdiction to try all suits of a civil nature excepting suits of which their
cognizance is either expressly or impliedly barred.
Explanation I-
A suit in which the right to property or to an office is contested is a suit of a
civil nature, notwithstanding that such right may depend entirely on the
decision of questions as to religious rites or ceremonies.
Explanation II.-
For the purposes of this section, it is immaterial whether or not any fees are
attached to the office referred to in Explanation I or whether or not such
office is attached to a particular place.
A bare perusal of the same indicates that the courts shall have jurisdiction to try all
suits of civil nature excepting suits of which their cognizance is either expressly or
impliedly barred. In that background, though in the instant case, the issue had not
arisen before the learned Munsif while considering an application Under Order VII
Rule 11(d) of Code of Civil Procedure, taking note of the fact that the High Court has
invoked the said provision to consider as to whether the suit is barred and has
thereafter held that the civil court has no jurisdiction and ordered rejection of plaint,
it would be appropriate to take note of the provision contained in Order VII Rule
11(d) which reads as hereunder:
Order VII Rule 11
Rejection of plaint-The plaint shall be rejected in the following cases:
(a) xx xx xx xx

964
(b) xx xx xx xx
(c) xx xx xx xx
(d) where the suit appears from the statement in the plaint to be
barred by any law.
(e) xx xx xx xx
(f) xx xx xx xx
The perusal of the above noted provision would indicate that there would be a bar for
the civil court to entertain the suit, if such suit is barred either expressly or impliedly
by any law. Further, Order VII Rule 11(d) contemplates that from the statement
contained in the plaint the suit should appear to be barred by any law, in which case
the plaint shall be rejected.
8. In that backdrop, a perusal of the plaint in the instant suit would disclose that the
case pleaded by the Appellant is that he along with one Mr. Dhan Chandra Mahanta
purchased 'schedule 'A' property measuring 15 lessas on 08.12.1997 from Mr.
Sailendra Medhi and others. Mr. Dhan Chandra Mahanta relinquished his right in
favour of the Appellant. The Appellant has thus become the sole owner of the suit
Schedule 'A' property. It is contended that the sale deed indicates that the last part of
the western boundary contained a water exhaust drain which was also passing along
the western boundary of the property belonging to Ms. Suwola Devi and would join
the public drain maintained by Guwahati Municipal Corporation ('GMC' for short).
Another adjacent land owner purchased Schedule 'B' property under sale deed dated
08.12.1997 wherein also the western boundary traverses through the water drain
which connected the public drain of GMC.
9 . It is further averred in the plaint that the Respondent who owns the property on
the southern side of the Appellant's property, had purchased the extent of 13 lessa
under sale deed dated 24.04.1984 wherein the western boundary is shown as public
drain. Though the said common drain had existed at the time of purchase and was
being used, the Defendant is alleged to have blocked the same by dumping RCC
material and therefore the water had overflowed into the Appellant's property. It is in
that light, the Appellant had prayed for the relief to declare that the western boundary
of Schedule A, B and C properties contained a common public drain which can be
used and the further prayer made in the plaint indicates that, injunction sought is for
the peaceful enjoyment of the drain facility to allow the free flow of water upto the
main GMC drain.
10. The question therefore is as to whether the nature of the relief prayed in the
plaint falls exclusively within the domain of the GMC Act and as to whether the case
put forth and the relief prayed is barred by any provision contained in the GMC Act so
as to disentitle the civil court to entertain the suit as contemplated Under Section 9 of
the Code of Civil Procedure, if so, whether a plaint of the present nature was liable to
be rejected as envisaged Under Order VII Rule 11(d) of Code of Civil Procedure.
11. At the outset it is necessary to take note of Section 341 of the GMC Act which
provides for the bar of jurisdiction of civil court which reads as hereunder:
341- Bar of jurisdiction-Save as otherwise expressly provided no civil court
shall have jurisdiction to settle, decide or deal with any question, which is by

965
or under this part required to be settled, decided or dealt with by the

Commissioner.
On perusal of the contents, it indicates that no civil court shall have jurisdiction to
settle, decide or deal with any question which is under that part wherein Section 341
is placed and is required to be settled, decided or dealt with by the Commissioner.
The Part VI under which a bar is imposed relates to Land, Buildings and Streets.
Therefore, on the face of it, it indicates that the issue relating to a common drain
between two private individuals residing within the limits of the Municipal
Corporation is not an issue regarding which a specific bar is contemplated against
approaching the civil court for relief.
12. The GMC Act no doubt makes provision to empower the Commissioner under
certain circumstances to regulate the manner in which the use of the drain connected
with the municipal drain is to be used. The provisions to that effect are contained in
Sections 246, 247 and 248, in Part V of GMC Act. The said provisions read as
hereunder:
246. Obligation of owner or joint owner of drain to allow the uses of it to
other:
Every owner of a drain connected with a municipal drain or other place set
apart by the Commissioner for drainage shall be bound to allow the use of it
to other persons, or to admit other persons as joint owners, thereof, on such
terms as may be prescribed Under Section 248.
247. How right of use of a drain may be obtained by a person other than the
owner: Any person desiring to drain his premises into a municipal drain
through a drain of which he is not an owner may make a private arrangement
with the owner for permission to use his drain, or may apply to the
Commissioner for authority to use such drain.
248. Commissioner may authority person other than the owner of a drain to
use the same or declare him to be a joint user thereof: (1) Where the
Commissioner is of opinion whether on receipt of an application or
otherwise, that the most convenient means by which the owner or occupier
of any premises can drain such premises is through a drain belonging to
some person other than the said owner or occupier the Commissioner shall,
give the owner of the drain a reasonable opportunity of stating his objection
thereto, and if no objection is raised or if the objection appears to him
invalid or insufficient, may, by an order in writing authorise the said owner
or occupier to use the drain or declare the said user to be a joint owner
thereof on such conditions as may appear to him equitable with regard to the
payment of rent or compensation and to connecting the drain of the said
premises with the communicating drain and to the responsibilities of the
parties for maintaining, repairing, flushing and clearing the joint drain. (2) In
respect of the execution of any work Under Sub-section (1) the person in
whose favour the Commissioner's order is made shall be subject to the same
restriction and liabilities as are specified in Sub-section (4) of Section 245.
13. Perusal of the above noted provisions would indicate that the Commissioner is
empowered by granting the authority under GMC Act to compel the owner or joint
owner of a drain to permit a person who is not the owner of such drain to use that
drain. In effect, the Commissioner is given the authority to create a right in favour of

966
the property owner to drain out the water through the drain owned by any other
property owner. In the instant case the Appellant is not seeking for creation of such
right. The case as pleaded and noticed above indicates that the Appellant is asserting
about a right which existed and is seeking to safeguard and continue to exercise such
right. The case pleaded is not to the effect that any of them own the drain but it is
contended that it existed as the western boundary of all the properties in the vicinity
and the Respondent is seeking to alter that position and is therefore to be restrained.
Whether the Appellant will succeed or not will depend on the evidence that will be
produced to support the pleading.
14. The point for consideration is as to whether the existence of such provision in
GMC Act would impliedly bar a civil suit. For answering the said question, it would be
appropriate to refer to the decision in the case of Shiv Kumar Chadha v. Municipal
Corporation of Delhi and Ors. MANU/SC/0522/1993 : (1993) 3 SCC 161 which in fact
was also taken note by the learned Munsif. The relevant consideration made therein is
as hereunder:
11. In the olden days the source of most of the rights and liabilities could be
traced to the common law. Then statutory enactments were few. Even such
enactments only created rights or liabilities but seldom provided forums for
remedies. The result was that any person having a grievance that he had
been wronged or his right was being affected, could approach the ordinary
civil court on the principle of law that where there is a right there is a
remedy -- ubi jus ibi remedium. As no internal remedy had been provided in
the different statutes creating rights or liabilities, the ordinary civil courts
had to examine the grievances in the light of different statutes. With the
concept of the welfare State, it was realised that enactments creating
liabilities in respect of payment of taxes, obligations after vesting of estates
and conferring rights on a class of citizens, should be complete codes by
themselves. With that object in view, forums were created under the Acts
themselves where grievances could be entertained on behalf of the persons
aggrieved. Provisions were also made for appeals and revision to higher
authorities.
12. Then a question arose as to where a particular Act had created a right or
liability and had also provided a forum for enforcement of such right or for
protection from enforcement of a liability without any authority in law,
whether a citizen could approach a court. It may be pointed out that many
statutes have created certain rights or liabilities and have also provided the
remedial measures in respect thereof. But such statutes have not touched the
common law rights of the citizen. But there are some statutes, which in
public interest affect even the common law rights or liabilities of the citizen,
which were in the nature of existing rights. The distinction between the two
types of rights or liabilities is subtle in nature but at the same time very vital.
2 3 . With the increase in the number of taxing statutes, welfare legislations and
enactments to protect a class of citizens, a trend can be noticed that most of such
legislations confer decision making powers on various authorities and they seek to
limit or exclude court's power to review those decisions. The result is that the power
of the court Under Section 9 of the Code is being denuded and curtailed by such
special enactments, in respect of liabilities created or rights conferred. This Court in
the judgments referred to above has upheld the ouster of the jurisdiction of the court
on examination of two questions -- (1) whether the right or liability in respect

967
whereof grievance has been made, had been created under an enactment and it did
not relate to a pre-existing common law right? (2) Whether the machinery provided
for redressal of the grievance in respect of infringement of such right or imposition of
a liability under such enactment, was adequate and complete? The ouster of the
jurisdiction of the court was upheld on the finding that the rights or liabilities in
question had been created by the Act in question and remedy provided therein was
adequate.
24. But the situation will be different where a statute purports to curb and curtail a
pre-existing common law right and purports to oust the jurisdiction of the court so
far remedy against the orders passed under such statute are concerned. In such
cases, the courts have to be more vigilant, while examining the question as to
whether an adequate redressal machinery has been provided, before which the
person aggrieved may agitate his grievance. In the case of Katikara Chintamani Dora
v. Guntreddi Annamanaidu [MANU/SC/0336/1973 : (1974) 1 SCC 567 : AIR 1974 SC
1069] this Court after referring to the case of Addanki Tiruvenkata Thata Desika
Charyulu v. State of A.P. [MANU/SC/0281/1963 : AIR 1964 SC 807] observed: (SCC
p. 579, para 35)
It was pertinently added that this exclusion of the jurisdiction of the civil
court would be subject to two limitations. First, 'the Civil Courts have
jurisdiction to examine into cases where the provisions of the Act have not
been complied with or the statutory tribunal has not acted in conformity with
the fundamental principles of judicial procedure. The second is as regards
the exact extent to which the powers of statutory tribunals are exclusive'. The
question as to whether any particular case falls under the first or the second
of the above categories would depend on the purpose of the statute and its
general scheme, taken in conjunction with the scope of the enquiry entrusted
to the tribunal set up and other relevant factors.
It was held that a suit for declaration that the decision of the Settlement
Officer/Tribunal holding certain properties to be an 'estate' Under Section 3(2)(d) of
the 1908 Act was void, was maintainable on the ground that the suit property was not
an 'inam village'. In Pyx Granite Co. Ltd. v. Ministry of Housing and Local
Government [(1960) AC 260] the Appellants sought a declaration of their common
law right to quarry their land without the need to obtain planning permission under
the Town and Country Planning Act, 1947. In that connection it was said:
The Appellant-company are given no new right of quarrying by the Act of
1947. Their right is a common-law right and the only question is how far it
has been taken away. They do not uno flatu claim under the Act and seek a
remedy elsewhere. On the contrary, they deny that they come within its
purview and seek a declaration to that effect.
25. In spite of the bar placed on the power of the court, orders passed under such
statutes can be examined on "jurisdictional question". To illustrate: a special
machinery has been provided for removal of the encroachments from 'public land'
under different enactments in different States and the jurisdiction of the court has
been barred in respect of the orders passed by such special tribunals or authorities
constituted under such Acts. Still a suit will be maintainable before a court on a plea
that the land in question shall not be deemed to be a public land within the meaning
of the definition of 'public land' given in the Act in question, and as such provisions
thereof shall not be applicable.

968
15. Further, this Court in the case of Ramesh Gobindram v. Sugra Humayun Mirza
Wakf MANU/SC/0659/2010 : (2010) 8 SCC 726 while examining the bar of civil court
as contemplated Under Section 85 of the Wakf Act, 1995 had drawn a distinction that
such power would apply only in respect of the issues arising under certain provisions
of Act i.e., Section 6, 7 and 83 of the Wakf Act, 1995 and had held that a suit before
a civil court would be maintainable for other reliefs notwithstanding the creation of
the Wakf tribunal under the Act, unless the dispute falls within the four corners of the
powers vested in the Tribunal. Therefore, despite there being the bar of jurisdiction
of the civil courts under the Act, as noted, except for the disputes arising to the
limited extent all other issues were held to be maintainable before the civil court. The
relevant consideration is as hereunder:
8. Wakfs and matters relating thereto were for a long time governed by the
Wakf Act, 1954. The need for a fresh legislation on the subject was,
however, felt because of the deficiencies noticed in the working of the said
earlier enactment especially those governing the Wakf Boards, their power of
superintendence and control over the management of individual wakfs.
Repeated amendments to the 1954 Act, having failed to provide effective
answers to the questions that kept arising for consideration, Parliament had
to bring a comprehensive legislation in the form of the Wakf Act, 1995 for
better administration of wakfs and matters connected therewith or incidental
thereto.
16. In the above circumstance, while adverting to the present case it is seen that
Sections 246, 247 and 248 though referred to the ownership and the manner in which
the drains connected to municipal drain are to be used and the Commissioner is given
the authority to compel the owner of a drain to permit another property owner to use
the same, the said provisions cannot be considered either as an express or an implied
bar on the civil court to entertain a suit relating to the declaration of an existing right
to use of the drain as asserted in the plaint.
17. In fact, the existence of a drain as claimed by the Appellant in the plaint as on
the date of purchase of the property and the same being used throughout is an issue
which is to be proved based on the evidence that would be tendered in the suit. The
provisions contained in Section 246, 247 and 248 of the GMC Act would be the
provisions which would come to the aid of the Appellant if ultimately the Respondent
establishes his ownership right over the drain, despite the Appellant proving the
existence of the drain. No doubt, the Appellant could have also filed an application to
the Commissioner seeking the relief to which the Commissioner could exercise his
authority but that would have arisen only if the Appellant had conceded to the
position that the Respondent is the owner of the drain. Even in such circumstance, if
relief was not made available to the Appellant by the Commissioner and if he was
dissatisfied with the manner in which such authority was exercised by the
Commissioner it would still have been open to approach the court for relief. The
learned Advocate for Respondent has in this regard contended that an appeal is
provided Under Section 438 of GMC Act. However, we do not consider it as an
alternate and efficacious remedy in a case of the present nature. The relief sought in
the instant suit is in the nature of declaratory relief in an inter se dispute between the
parties. The consideration by the statutory authority as provided under GMC Act is of
summary nature. Further, the appeal provided is in respect of any notice issued or
action taken or proposed to be taken by the Commissioner, which in effect provides
the appeal remedy only to the owner of the drain against whom action is proposed.

969
1 8 . Further as already noted, in the instant case the averments contained in the
plaint and the prayer made would disclose that the Appellant is not seeking for
creation of a right over the drain owned by the Defendant nor is any issue raised with
regard to the drain of GMC. But the case as put forth is that the property of the
Appellant, Ms. Suwola Devi and the Defendant are contiguous to one another which
are shown as suit Schedule 'A', 'B' and 'C' properties and on the western side of the
property starting from the Appellant's property, there is a drain, which is shown as
the boundary and it facilitates the water to flow into the GMC drain. Such relief is to
be considered in the suit based on the evidence that would be tendered. Therefore,
such relief is not barred under any law.
19. In view of the above, it is clear that the High Court without taking note of these
aspects of the matter has wrongly invoked the provisions contained in Order VII Rule
11(d) of the Code of Civil Procedure to reject the plaint, when in the instant facts
there is neither express nor implied bar under any law. On the other hand, the
learned Munsif was justified in passing the order dated 16.11.2013 in T.S. No.
334/2011 holding the suit to be maintainable.
20. In the result, the order dated 06.06.2014 passed by the Gauhati High Court at
Guwahati in CRP No. 128/2014 is set aside. The plaint in title suit No. 334/2011 is
restored to the file of the learned Munsif No. 2 Kamrup Guwahati. The parties herein
shall appear before the learned Munsif on 01.09.2021 as the first date for appearance
without further notice, whereafter the suit shall be considered on its merits.
21. The appeal is accordingly allowed with no order as to costs.
22. Pending applications, if any, shall stand disposed of.

ANNEXURE P-46 970
124567 1
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UNIWORLD: UNITED WE LIVE, DIVIDED WE DIE 974
ANNEXURE P-47
CUSTOMARY INTERNATIONAL LAW NOTICE UNDER SECTION 80 CPC
THE MEDICAL CASE II

Gurugram, India
11.09.2021
If an alien from Planet X were to land in the midst of the Earth Vaccine Dispute her fair comment
may be:
“Never in history has so much blood money been earned from experimental scientific
medical procedure (the 200 year old practice of vaccinations), unproven in its life-long or
even long-term efficacy in verifiable placebo controlled double blind long term medical
trials, legally declared on 22.02.2011 to be ‘unavoidably unsafe’; suspected to be at least
a contributory cause in maiming or killing millions of neonates, girls and boys, men and
women across the World, yet vaccine majors earn blood money from vaccine sales fooling
gullible Governments to use ordinary taxpayers money for vaccine injury claims; adding
insult to injury, WHO waives ethical ban to advertise experimental vaccines in the medical
space; net result is vaccine majors, less than truthfully, advertise vaccines as safe and
effective without any legal liability to demonstrate in courts of law the rule mandated safety/
efficacy records; US CDC #20-02002-FOIA dt. 29.07.2020 admits no vaccinated versus
unvaccinated (double blind placebo controlled) children safety/ efficacy records exist.
There are no CDC safety/ efficacy records for 1995 varicella vaccine. [New York,. South
District, Case 1:19-cv-10235, Informed Consent Action Network v. United States Food and
Drug Administration, 04.11.2019, 30.04.2021]”
From:
Lt Col Sarvadaman Singh Oberoi (Retd) s/o late Capt HS Oberoi, Flat No. 1102,
Tower 1, Uniworld Garden I, Sector 47, Gurugram 122018, Haryana, India Mob:
9818768349 Email: manioberoi@gmail.com on Behalf of A, B, C, D… In Womb
Representing All Future Humanity
To,
1. The Cabinet Secretary of India, Union Cabinet, Government of India, Rashtrapati
Bhawan, New Delhi 110004, India Fax: +91-11-2301-1241 Email: cabinetsy@nic.in
[RESPONDENT] WITH ADATA UV250 USB FLASH DRIVE CLASSIC 32GB
2. The Foreign Secretary, Ministry of External Affairs, Government of India, South
Block, New Delhi-110011, India Tel: +91-11-2301-2318, +91-11-2301-2196 Fax: +91-11-
2301-6781 E-mail: psfs@mea.gov.in [RESPONDENT] WITH ADATA UV250 USB
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3. The Secretary, Ministry of Ayush, Government of India, Ayush Bhawan, B-Block,
GPO Complex, INA, New Delhi 110023, India Tel: +91-11-2465-1950 Fax: +91-11-2465-
1937 Email: secy-ayush@nic.in [RESPONDENT] WITH ADATA UV250 USB FLASH
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4. The Secretary, Ministry of Health & Family Welfare, Government of India, Nirman
Bhavan, New Delhi 110011, India Fax: +91-11-2306-3221 Email: secyhfw@nic.in
ARMED FORCES OF THE WORLD HELP PRESERVE THE PEACE

5. The Secretary, Ministry of Defence, Government of India, South Block, New Delhi
110001 India Tel: 91-11-2301-2380 Fax: 91-11-2301-0044, Email: defsecy@nic.in
6. The Director General Armed Forces Medical Services, O/o The Directorate General
Armed Forces Medical Services, Ministry of Defence, Government of India, Room No. 10,
'M' Block, New Delhi 110001, India Tel: 91-11-2309-3331 Fax: +91-11-2309-3279 Email
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Organization, Directorate General of Health Services, Ministry of Health & Family
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Tel: 91-11-2323-6973 Email dci@nic.in [RESPONDENT] WITH ADATA UV250 USB
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160001, India Tel: +91-172-274-0860, Fax: +91-172-274-0156 Email: cs@punjab.gov.in
9. The Chief Secretary, State of Haryana, Haryana Secretariat, Sector 1, Chandigarh
160001, India Tel: +91-172-274-0118, Fax: +91-172-274-0317 Email: cs@hry.nic.in
10. The Chief Secretary, State of Orissa, Lok Seva Bhawan, Sachivalaya Marg,
Bhubaneswar 751001, Odisha, India Tel: 91-674-253-6700 Fax: 91-674-253-6660, Email:
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22025042 Fax: 91- 22- 22028594, Email: cs@maharashtra.gov.in [RESPONDENT]
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12. The Chief Secretary, State of Himachal Pradesh, Secretariat, Shimla 171001, H.P.,
India Tel: +91-177-2621022 Fax: +91-177-2621813, Email: cs-hp@nic.in
13. The Chief Secretary, State of West Bengal, Nabanna, 325, Sarat Chatterjee Road,
Shibpur, Howrah 711102, West Bengal, India Tel: +91-33-22145858 Fax: 91-33-
22144328, Email: cs-westbengal@nic.in [RESPONDENT] WITH ADATA UV250 USB
14. The Chief Secretary, Govt of NCT of Delhi (U.T.), Delhi Secretariat, IP Estate,
New Delhi 110054, India Fax: 91-11-23392102, Email: csdelhi@nic.in [RESPONDENT]
15. The Secretary, Delhi Gymkhana Club Limited, 2 Safdarjung Road, New Delhi 110011,
India Tel: +91-11-23010617 Email: secretary@delhigymkhana.org.in
secydgc@gmail.com [RESPONDENT] WITH ADATA UV250 USB FLASH DRIVE
CLASSIC 32GB

16. The Director, PATH International India, 15th Floor, Dr. Gopal Das Bhawan, 28,
Barakhamba Road, Connaught Place, New Delhi 110001, India Tel: +91-11-40640000 Fax:
+91-11-40640099 Email: info@path.org [RESPONDENT] WITH ADATA UV250 USB
17. The Secretary, Ministry of Home Affairs Government of India, North Block, New
Delhi 110001 India Fax: 91-11-2309-3003, Email: hshso@nic.in [RESPONDENT]
18. The Secretary General, The National Human Rights Commission, Manav Adhikar
Bhawan Block-C, GPO Complex, INA, New Delhi 110023, India Fax: +91-11-2465-1329
Email: sgnhre@nic.in [RESPONDENT BY INFORMED CONSENT] WITH ADATA
UV250 USB FLASH DRIVE CLASSIC 32GB
19. Ms. Medha Patkar, Narmada Bachao Andolan, Narmada-Ashish, Off Kasravad Road,
Navalpura, Badwani 451551, Madhya Pradesh, India Mobile : 9589662666, 9179617513
E-mail: nba.badwani@gmail.com, medha.narmada@gmail.com [RESPONDENT BY
INFORMED CONSENT] WITH ADATA UV250 USB FLASH DRIVE CLASSIC
32GB
20. The Managing Trustee, Sama Resource Group for Women and Health, B-45, Second
Floor, Shivalik Main Road, Malviya Nagar, New Delhi 110017 India Tel: +91-11-
26692730, 40666255 Email: samaforhealth@gmail.com [RESPONDENT BY
32GB
21. The Board of Trustees, Patanjali Yog Peeth (UK) Trust, (An International Yog teaching
body of Patanjali Yog Peeth Trust, Haridwar, India), Charity Registration No: 1115370
(England and Wales), Charity Registration No: SC041991 (Scotland), 40 Lambhill Street,
Kinning Park, Glasgow, G41 1AU, Scotland, U.K., Tel: +44 141 4277510 Fax: +44 141
419 0348 Email: Tel: +44 141 4277510 Fax: +44 141 419 0348 Email: Tel: +44 141
4277510 Fax: +44 141 419 0348 Email: info@pypt.org through, The Board of Trustees,
Patanjali Yogpeeth (Yog Gram), Maharshi Dayanand Gram, Delhi-Haridwar National
Highway, Near Bahardrabad, Haridwar 249405 Uttarakhand, India Mob: 08954890120,
07456900734, 07456900735 E-mail: onlineyoggram@divyayoga.com
legalcell@patanjaliayurved.org [RESPONDENT BY INFORMED CONSENT]
22. The Chief Operating Officer, Informed Consent Action Network, Informed Consent
Action Network, 2025 Guadalupe Street, Suite 260 Austin, Texas 78705, The United States
of America, Tel: +1-512-522-8739 Fax: +1-512-233-0814 Email:
whistleblower@icandecide.org info@icandecide.org [RESPONDENT BY INFORMED
CONSENT] WITH ADATA UV250 USB FLASH DRIVE CLASSIC 32GB
23. The WHO Representative to India, Office of the WHO Representative to India, 537,
A Wing, Nirman Bhawan, Maulana Azad Road, New Delhi 110011, India, India Tel: +91-
11-6656-4800 Fax: +91-11-2616-2996 E-mail: wrindia@who.int [RESPONDENT BY
32GB

24. The Registrar General, The High Court of Meghalaya, MG Road, Shillong 793001
Meghalaya, India Fax: +91-3642-500064 Email: highcourtmeghalaya@gmail.com
[RESPONDENT BY INFORMED CONSENT] WITH ADATA UV250 USB FLASH
DRIVE CLASSIC 32GB
25. The Registrar General, National Green Tribunal, Faridkot House, Copernicus Marg,
New Delhi 110001 India, Tel : +91-11-2304-3528 Fax : +91-11-2307-7931 Email :
rg.ngt@nic.in [RESPONDENT BY INFORMED CONSENT] WITH ADATA UV250
USB FLASH DRIVE CLASSIC 32GB
26. The Member Secretary, Central Empowered Committee, (Constituted by Hon'ble
Supreme Court of India), 2nd Floor, Chanakya Bhawan, Chanakya Puri, New Delhi 110021
India Tel: +91-11-2161-0612, 2161-0613, Fax: +91-11-2410-1925 Email:
[RESPONDENT BY INFORMED CONSENT] WITH SANDISK CRUZER BLADE
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27. The Commissioner or in the alternate The Director General, Directorate-General for
Health and Food Safety (SANTÉ), European Commission, B 1049 Brussels, Belgium, Tel:
+32-2-299-1111 Email: relex-sanctions@ec.europa.eu [RESPONDENT BY
INFORMED CONSENT] WITH SANDISK CRUZER BLADE USB 2.0 FLASH
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28. Ms. Michelle Bachelet Jeria, United Nations High Commissioner for Human Rights,
Office of the United Nations High Commissioner for Human Rights, OHCHR, Palais des
Nations, CH-1211 Geneva 10, Switzerland Tel: +41-22-917-92-20 Fax: +41-22-917-90-08
Email: civilsociety@ohchr.org [RESPONDENT BY INFORMED CONSENT] WITH
SANDISK CRUZER BLADE USB 2.0 FLASH DRIVE 32GB
29. Office of the Prosecutor, The International Criminal Court, Post Office Box 19519,
2500 CM The Hague, The Netherlands, Fax: +31-70-515-8555 Email:
otp.informationdesk@icc-cpi.int [NON-RESPONDENT] WITH SANDISK CRUZER
BLADE USB 2.0 FLASH DRIVE 32GB
30. The Rt Hon Alok Sharma MP, President-Designate for COP 26, The 26th United
Nations Climate Change Conference, Cabinet Office, 70 Whitehall, London SW1A 2AS
United Kingdom, Email: publiccorrespondence@cabinetoffice.gov.uk
COP26Media@cabinetoffice.gov.uk Tel: +44-20-7276-1234 [NON-RESPONDENT]
WITH SANDISK CRUZER BLADE USB 2.0 FLASH DRIVE 32GB
31. H.E. The Ambassador Extraordinary & Plenipotentiary, Head of Delegation,
Delegation of the European Union to India, 5/5, Shanti Niketan, New Delhi 110021, India,
Tel: +91-11-4949-6565 E-mail: delegation-india@eeas.europa.eu Fax: +91-11-4949-6555
[NON-RESPONDENT] WITH SANDISK CRUZER BLADE USB 2.0 FLASH
DRIVE 32GB
32. H.E. The High Commissioner, High Commission for Great Britain, Shantipath,
Chanakyapuri, New Delhi-110021, India, Tel: +91-11-2687-2161, 2419-2100, Fax: +91-
11-2687-0068, 2687-2882, 2687-0062, 2687-0060 E-mail: postmaster.nedel@fco.gov.uk
[NON-RESPONDENT] WITH SANDISK CRUZER BLADE USB 2.0 FLASH
DRIVE 32GB

33. H.E. The Chargé d'Affaires, Embassy of the People’s Republic of China, 50 D,
Shantipath, Chanakyapuri, New Delhi 110021, India Tel: +91-11-2611-2345, Fax: +91-11-
2688-5486 E-mail: chinaemb-in@mfa.gov.cn [NON-RESPONDENT] WITH SANDISK
CRUZER BLADE USB 2.0 FLASH DRIVE 32GB
34. H.E. The Ambassador, or in the alternate, The Chargé D’Affaires, The Embassy of
the United States of America, Chanakyapuri, New Delhi 110021, India Tel: +91-11-2419-
8000 Fax: +91-11-2419-0017 Email: protocolnewdelhi@state.gov [NON-
RESPONDENT] WITH SANDISK CRUZER BLADE USB 2.0 FLASH DRIVE 32GB
35. H.E. Penpa Tsering, Sikyong, Central Tibetan Administration (Tibetan
Government-in-Exile) established since 31.03.1959, and presently at Kashag Secretariat,
McLeod Ganj, Dharamshala-176215 H.P., India through its Secretary, Tel: +91-1892-
222218, 222713, 223546 Fax: +91-1892-224914 E-mail: kadrung@tibet.net [NON-
36. The Registrar General, The High Court of Delhi, Sher Shah Road New Delhi
110003, India Fax:+91-11-23073485 Email: rg.dhc@nic.in [NON-RESPONDENT]
37. The Registrar General, The High Court of Gujarat, Sola, Ahmedabad 380060, India
Tel: +91-79-2766-2860 Fax: +91-79-2766-5554 E-mail: rg-hc-guj@nic.in [NON-
38. Mrs. Marialena Tsirli, The Registrar of the Court, European Court of Human
Rights, Council of Europe, F-67075 Strasbourg CEDEX, France Tel : +33 3 88 41 20 18
Fax : +33 3 88 41 27 30 +33 3 90 21 43 10 Email: echrpress@echr.coe.int [NON-
39. Mr. Pablo Saavedra Alessandri, The Secretary of the Court, Inter American Court
of Human Rights, 10th Av, between Street 45 and Street 47, Los Yoses, San Pedro, PO Box
6906-1000 San José, Costa Rica, Tel : +506-2527-1600 Fax : 506-22890-5074 Email:
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40. Dr. Robert Eno, The Registrar of the Court, The African Court on Human and
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6274 Arusha, Tanzania Tel : +255-27 2970430 Email: registrar@african-court.org [NON-
41. The Secretary General, The Supreme Court of India, Tilak Marg, New Delhi
110001, India, Tel : +91-11-2338-4661 Fax: +91-11- 2338-6178 Email:
supremecourt@nic.in [NON-RESPONDENT] WITH SANDISK CRUZER BLADE
42. The Registrar of the Court, International Court of Justice, Peace Palace,
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information@icj-cij.org [NON-RESPONDENT] WITH SANDISK CRUZER BLADE

43. Mr. Fali Sam Nariman, Senior Counsel of the Supreme Court of India and President
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India Tel: +91-11-2686-2980 Email: fnariman@hathway.com WITH SANDISK
CRUZER BLADE USB 2.0 FLASH DRIVE 32GB
44. Sh Kottayan Katankot Venugopal, Attorney General for India, A-144, Neeti Bagh,
New Delhi, 110049 India Tel: +91-11-2924-4466 / 2924-3366 Email: kkvenu@outlook.in
45. Ms. Suruchi Mittal, Advocate, I-1728, LGF, CR Park, New Delhi 110019, India
Mob: +91-98110-00519 Email: suruchi.m14@gmail.com WITH SANDISK CRUZER
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46. The Secretary, Socio-Legal Information Center, Human Rights Law Network, 576,
Masjid Road, Jungpura, New Delhi 110014 India Tel:+91-11-24374501, +91-11-
24379855, Fax: +91-11-24374502 Email: contact@hrln.org WITH EVM USB 2.0
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47. Dr. John Balbus/ Mr. Arsenio Mataka, The Interim Director/ Sr. Advisor to OASH,
OCCHE (The Office of Climate Change and Health Equity), The Office of the Assistant
Secretary for Health, U.S. Department of Health & Human Services, 200 Independence
Avenue, S.W. Room 715-G, Washington, D.C. 20201 United States of America Tel: +1-
202-690-7694 Fax: +1-202-208-7607 Email: ASH@hhs.gov WITH EVM USB 2.0
ENSTORE DRIVE 32GB
48. The Board of Directors, Infosys Limited, No. 44, Infosys Avenue, Hosur Road,
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49. The Board of Directors, Tata Consultancy Services Limited, 9th Floor, Nirmal
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50. The Board of Directors, Wipro Limited, Doddakannelli Sarjapur Road, Bengaluru
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SHORT TITLE: THE MEDICAL CASE II

LONG TITLE: “ULTERIOR” “COERCION” WITH “ELEMENTS OF FORCE, FRAUD,
DECEIT, DURESS, OVER-REACHING” IN “UNAVOIDABLY UNSAFE” “MEDICAL
OR SCIENTIFIC EXPERIMENTATION” TANTAMOUNT TO EGREGIOUS CRIMES
AGAINST HUMANITY BY CONTINUING TO PERSEVERE IN OMISSION OF
INTERNATIONAL RULE OF LAW MANDATED "VOLUNTARY CONSENT"
PROVISION IN INDIA'S NATIONAL VACCINE POLICY, APRIL 2011
COMPOUNDED BY THE CONTINUING DELIBERATE PRE-MEDITATED
VIOLATION OF THE INTERNATIONAL COVENANT ON CIVIL AND POLITICAL
RIGHTS, ICCPR, ARTICLE 7(a)(ii) & PRINCIPLE 1 OF THE TEN POINT
NUREMBERG CODE/ KODEX 1947, PERMISSIBLE MEDICAL EXPERIMENTS

["THE MEDICAL CASE" 20.08.1947/ 16.02.1948 "TRIALS OF WAR CRIMINALS

BEFORE THE NÜREMBERG MILITARY TRIBUNALS UNDER CONTROL
COUNCIL LAW NO. 10", VOL. 2, PP. 181-182. WASHINGTON, D.C.: U.S.
GOVERNMENT PRINTING OFFICE, 1949 IN VIOLATION OF ARTICLE 21 OF THE
CONSTITUTION OF INDIA READ WITH ARTICLES 21, 51, 73 AND 253 THEREOF
AND CUSTOMARY INTERNATIONAL LAW, AS ACCEDED TO BY INDIA AND
DULY NOTED IN MEMORIAL OF THE REPUBLIC OF INDIA DATED 17.09.2017,
INDIA V. PAKISTAN (JADHAV CASE) AT THE INTERNATIONAL COURT OF
JUSTICE.
EDCCE: Earth Destroying Climate Change Emergency
Most respectfully state:
1. Res Ipsa Loquitur, EDCCE, causation land degradation/ fossil fuel related CO2 (a
xenobiotic & a near-IR heat absorbent-See Document No. 259A), forcing experimental
vaccine for Pandemics such as COVID-19, a Crime Against Humanity per settled
Customary International Law, inimical to the Intergenerational Genetic Outcome of the
Human Genome and violates the Principle of Intergenerational Equity (on Behalf of
A, B, C, D… In Womb Representing All Future Humanity)
2. This is a deliberate, well-considered & detailed follow-up, with all documentation, to
the earlier notice dated 28.06.2021, not to all, copy at Document No. 557 &
“2021.06.29 Non Domestic VAERS DATA, US CDC 187MB” (Document No. 558 –
only soft copy .xls file), appealing under the Principle of Intergenerational Equity to
assist the parties by listing the documents relied upon under Customary International
Law as applied by the Courts in India and contained in accompanying 32 GB USB Flash
Drive, Date Wise Documents (1-616) / Full Documents** (Document No. 614, 28GB
only soft copy). That the grave short term side effects caused by declared and
undeclared heavy metals/ vaccine adjuvants (Aluminum, Antimony, Barium, Beryllium,
Bismuth, Bromine, Calcium, Cerium, Chloride, Chromium, Cobalt, Copper,
Ferrochrome, Gold, Hydrogen Fluoride, Iron, Lead, Magnesium, Manganese,
Mercury, Molybdenum, Palladium, Platinum, Nickel, Selenium, Silicon, Silver,
Stainless steel, Strontium, Sulfur, Tin, Titanium, Vanadium, Zinc & Zirconium) and
other toxins routinely injected as experimental/ not fully verified prophylactic or
therapeutic or preventive inoculation/ immunisation/ vaccination directly into the
bloodstream might be acceptable to the regulators, but can no longer be justified as a
necessary toxic evil to curb pandemics in the face of emerging evidence of genetic
damage to the Human Genome cascading through successive generations from 1948 to
2021 and beyond (Refer to Document No. 317 p.149, pp.386-387, p.389, p.393, p.647,
p.772, p.1112, p.1271 & p.1280 & Document No. 319 p.14, p.40, p.45,pp.275-276,

p.279, p.290 & pp.1124-1125,) is inimical to the Intergenerational Genetic Outcome of

the Human Genome and violates the Principle of Intergenerational Equity, being a
Crime Against Humanity per settled Customary International Law. [Refer para 18 at
pp.34-36 and para 32 at pp.91-92 below]
3. That an exhaustive study of international law reveals, and this notice amply
demonstrates, India is the one nation where since 15.08.1947/ 26.01.1950/ 13.09.2017/
26.08.2020 (Refer paras 32-42 at pp.91-119 below) the supremacy of Customary
International Law in all of India, under Articles 21, 51, 73 and 253 of the Constitution
of India has been placed at the highest pedestal by the Supreme Court of India, the
Parliament of India and by the Executive Branches (Jadhav Case, 13.09.2017
Submission – Document No. 378). See also para 39 at pp.114-115 below. Therefore,
Customary International Law, in the Republic of India, stands in solitary splendour, as
an exemplar for all the World to envy and emulate. This has only been made possible
because India voluntarily surrendered a place on the Security Council to China even as
it has since 1947 been the World’s largest democracy, exhibiting a rare multi-cultural
solidarity among its hundreds of disparate local communities. Indian Courts are
therefore best suited to resolve the 200 year riddle of the Earth Vaccine Dispute. There
is of course scope for a caveat. India (particularly the Executive) has faltered grievously
in its implementation of inviolate protection to land belonging to Indigenous/ Tribals/
Aboriginals/ Adivasis deprivation of which was made non-negotiable and was
guaranteed by the Constituent Assembly of India as substantiated in Samatha v. State
of A.P. and others, (1997) 8 SCC 191 an immutable right which, per incuriam,
escaped the court’s eagle eye (even as executive was fully cognizant but withheld this
knowledge from this different Bench as its SECRET NOTE dt. 10.07.2000 proves
conclusively and beyond any manner of doubt leading to gross violation of Customary
International Law & the Constitution of India, as well as short shrift to the intent of the
Constituent Assembly, Document No. 164) in Narmada Bachao Andolan v. Union
of India and others (2000) 10 SCC 664 (Refer Document Nos. 101, 104-105, 107
[1949.01.08 Constituent Assembly Debates Volume VII 4 Nov 1948 to 8 Jan 1949
“p.147 ‘He also expressed the opinion that the salvation of the aboriginal lay in
protecting him from exploitation by the moneylenders who were gradually depriving
him of his land, .....In the Warli areas of the Thana District visited by us practically all
the land had been taken up by non-tribals and the tribals were reduced to the condition

of landless serfs. The Bombay Government have in fact now found it necessary to pass
special legislation to prevent alienation of land. On account of the acquisition of all the
land by a few people, the land system in this tract has been virtually transformed from
a ryotwari system to a system similar to the malguzari system of the Central
Provinces.... The partially excluded areas are, with hardly any exception, administered
in the same manner as the other districts. The C. P. Land Alienation Act of 1916 is the
only notable legislation enacted specially for the protection of the aboriginals and
restricts the transfer of agricultural land from aboriginal to non-aboriginal classes.
....A special enquiry into the problems of the aboriginals was ordered by the C. P.
Government and a report was submitted by Mr. W. V. Grigson in 1942. Among the
points made by Mr. Grigson were the weakness of the tribal representatives in the local
boards and the need for provisions to prevent the application of legislation to
aboriginal areas except after special consideration. Mr. Grigson was also examined by
us as a witness and expressed himself in favour of a system of indirect election for the
aboriginals. Opinion of a number of C.P. witnesses was not in favour of reserved
representation for the aboriginals in proportion to their population. Some witnesses
preferred nomination out of a panel submitted by the District Officers. At present there
are three tribal members in the Legislature although only one seat is reserved. pp.155-
156 (a) Areas to be Scheduled. - The provisions for partially excluded and excluded
areas in the 1935 Constitution are designed to prevent the application of unsuitable
legislation, to permit the making of special rules and regulations required for any
different system of administration needed in the aboriginal areas, and for the provision
of funds at the discretion of the Governor for the totally excluded areas. Although in
most of the Provinces, there has been a good deal of assimilation of the tribal people
of the plains, yet the social system of the tribes is different from that of the plains people
in a number of the partially excluded areas. In the excluded areas, of course as already
pointed out, there are people like Tibetans, the Chakma, Miro and Mogh of the
Chittagong Hill Tracts, the islanders of the Laccadive Islands and so on. In the partially
excluded areas, the tribes of Orissa and Chhota Nagpur and even the Gonds of the C.
P. and the Bhils of Bombay who have assimilated the life of the plains to a greater
extent than others have different social customs.....Even in the more advanced tracts of
the Central Provinces of Bombay, the tribal is at a serious disadvantage on account of
his poverty and ignorance and the procrastination of courts and officials and is easily

victimized. ... An alternative mechanism is therefore necessary. We have considered the

question in all its aspects and come to the conclusion that in respect of certain subjects,
laws passed by the Provincial Legislature should not be applied to the Scheduled Areas
if the Tribes Advisory Council does not consider them suitable for those areas. We have
also provided that in other subjects the Provincial Government should have the power
to withhold or modify legislation on the advice of the Tribes Advisory Council.(Para*.
15).’ p.160 ‘The importance of protection for the land of the tribals has been
emphasised earlier. All tenancy legislation which has been passed hitherto with a view
to protecting the aboriginal has tended to prohibit the alienation of the tribals land to
non-tribals. Alienation of any kind, even to other tribals, may have to be prohibited or
severely restricted in different stages of advancement are concerned......as we have
made special provision to see that land laws are not altered to the disadvantage of the
tribal in future, we do not consider additional restrictions necessary. As regards the
allotment of new land for cultivation or residence however, we are of the view that the
interests of the tribal need to be safeguarded in view of the increasing pressure on land
everywhere. We have provided accordingly that the allotment of vacant land, belonging
to the State in Scheduled Areas should not be made except in accordance with special
regulations made by the Government on the advice of the Tribes Advisory Council.’
p.185 ‘15. The alienation of land belonging to tribals to non-tribals should be
prohibited. Allotment of new land in Scheduled Areas should not be made to non-
tribals’ p.737 ‘Shri Jaipal Singh (Bihar: General): Mr. Vice-President, Sir. So far as I
am concerned, this particular article in no way frightens me, although the various
fundamental rights have been hedged in by so many exceptions. To me it is obvious that
whatever we put into the Constitution, its value, its use to us will depend upon the way
we work all these things. But there are one or two things on which I would like Dr.
Ambedkar to enlighten me. The first point on which I would like his clarification is in
regard to the amendment which he has moved, amendment No. 491, where in he seeks
to substitute the word "aboriginal" by the word "scheduled". Sir, I am always at a
disadvantage whenever anything affecting aboriginals has to be discussed at this stage
for the obvious reason that the two reports of the Tribal sub-committees have not been
fully discussed on the floor of this House, with the result that the House has not been
able to obtain its collective view point or arrive at a collective decision as has been the
case with all the other articles, that is to say, articles which affect the non tribals of our

country. Take the question of this word 'tribal'. As far as I know neither of the sub-
committees had gone into the work of scheduling. I know it for a fact that the sub-
committee of which I was a member did nothing of the sort and, in fact, bodily the
Drafting Committee has just put into the Draft Constitution whatever obtained in the
Government of India Act. Now, look at the list. My second point that I want to have
clarified is whether the advisory councils or the regional councils, which are envisaged
in the recommendations of the two subcommittees, will operate outside the so-called
scheduled areas. If they do not, then I want to know from Dr. Ambedkar what is going
to happen to the Adibasis, who are in millions, outside those scheduled areas. As far as
I can understand the language of the Constitution, the regional councils and the
advisory councils are to advise the Governor to participate as it were in the legislation
of the State only in regard to the scheduled areas. Well, once it is accepted that the
regional councils and the advisory councils may operate also outside the scheduled
areas then my point is met.’ ”], 112, 114, 116, 120-121, 136, 158, 162-165, 167, 173,
178-179 [Document Nos. 178: “30.01.2002 Shekhar Singh Report - Nearly 60% of the
exploitable forests (excluding the tribal reserve and protected areas) in South
Andamans, Mayabandar and Baratang, have already been “worked” and exploited
and, consequently, their natural profile significantly changed and their biodiversity
value compromised, perhaps forever. …. The most significant of the remaining natural
forests in Andamans are those within the Jarawa Reserve in South and Middle
Andaman and the Onge Reserve in Little Andaman. In recent years the Andaman Trunk
Road has been opened and passes contiguous to and in some cases through the tribal
reserve. This road, and the increased access to the Jarawas, poses a major threat not
only to the Jarawa tribals but also to the forests that they have protected for so many
years…. if the local requirement of timber and other forest produce is more than what
could be obtained by felling of plantations and sustainably extracting trees from worked
areas, as specified in 5 above, the same may be met by bringing timber in from other
parts of the country…. The existing plantations of oil palm, rubber and teak are
reportedly no longer viable and should be phased out. The land so released should, in
so far as it is forestland, be regenerated as specified earlier. No exotic species of fauna
or flora should be introduced into the islands…. The Andaman Trunk Road should be
closed to all vehicular traffic from Miletilak in South Andaman to the northern
boundary of the S. Andaman Island. Similarly, it should be closed to all traffic from

Kadamtala (corresponding to Prolobjig camp No.3) in Middle Andaman up to

Kaushalya Nagar (corresponding to Porlobjig camp No. 15). This should be done
within three months. Further, no person except for the Jarawas living in the Reserve
should be allowed to enter the Reserve ……… The deer, reportedly brought for
aesthetic purposes, have proliferated widely due to the absence of any natural predator
in the Islands and have significantly retarded forest regeneration. The elephants were
brought to the Islands by a timber logging company, which subsequently abandoned
them. Reportedly about sixty of them have become feral and are seriously impacting on
the forests in the regions that they are found. The introduction of dogs and cats, many
of which have turned feral, also pose a great threat to turtle breeding and other
indigenous species There has also been infestation by various exotic species of weeds,
which could prove to be a major deterrent to the regeneration of degraded forest areas,
especially areas freed from encroachment. The introduction of oil palms in Little
Andaman and of teak in various parts of the islands has also had a significant negative
impact. In fact, the areas in Little Andaman where oil palms were introduced show up
clearly as degraded forests in the remote sensing map prepared by the Forest Survey
of India (FSI) (maps at annex 19).” Document No. 179: SC ORDER 18.02.2002 “A
copy of the Report of Prof. Shekhar Singh be given to Shri Altaf Ahmed appearing on
behalf of the Andaman & Nicobar Administration and a copy be also given to the
MoEF. The responses to the Report and in particular to the recommendations made
should be given within four weeks” ], 182-184 [Document Nos. 183: “SC ORDER
07.05.2002 - After hearing the learned Amicus Curiae, counsel for the parties and
taking into consideration the affidavit of the Union of India ... learned Amicus Curiae
has made certain suggestions. There does not seem to be any objection to this Court in
accepting the Report of Shri Shekhar Singh that some modifications have been
suggested. We therefore, in the first instance, accept the Report of Shri Shekhar
Singh…. (12) Regularisation of encroachments on forest land in any form, including
allotment/use of forest land for agricultural or horticultural purposes, shall be strictly
prohibited…… (20) Specific actions shall be undertaken by Ministry of Environment &
Forests/Andaman & Nicobar Islands Administration on the other recommendations of
Shri Shekhar Singh Report which are not specifically dealt with in above orders.
Ministry of Environment & forests and the Andaman & Nicobar Islands Administration
shall file an affidavit within three months giving details of action taken by them on each

of such recommendations..”], 186-190 [Document Nos. 187: “SC ORDER 12.08.2002

- Re: Report of Central Empowered Committee ...Recommendations of the Central
Empowered Committee .. received…parties may file their response to the
Reports/Recommendations within three weeks. ... Notice to issue to the Union of India
and the various State Governments/U.Ts. who will address arguments on this aspect on
the next date of hearing and will also file the written submissions. … To come up on 9th
September, 2002. Compliance report of Andaman & Nicobar is already on record]
192, 194, 197-198, 201 [Document No. 201:03.11.2003 “Report of CEC
“Administration had sought one year's time to fully comply with Hon'ble Court's
orders…….even after more than a year, this Hon'ble Court's order has not been fully
complied…… The A & N Administration informed the Committee that it is moving an
application before the Hon'ble Court seeking permission to use deemed forest land for
the purpose of rehabilitation of encroachers and for other development activities. The
Committee informed the A&N Island Administration that as per the Hon'ble Court's
order dated 12.12.1996 these areas fall within the definition of “forest” for the purpose
of the FC Act and therefore use of such area for rehabilitation of encroachers is neither
permissible nor desirable…… A substantial number of the post-78 encroachments have
not been removed from the forest land. With the passage of time, the people will get
more and more convinced that they will not be evicted. The delay in implementing the
orders will further complicate the situation……. During the meeting, the Committee
also shared its perception about ATR, closure of Forest Corporation, issue of Inner
Line Permits use of deemed forest for rehabilitation of encroachers etc. It was
reiterated that since Shekhar Singh Report has been accepted by the Hon'ble Court all
recommendations made by him in the report including in respect of ATR stand approved
by the Hon'ble Court. Chairman, CEC requested the Administration to consider
implementing effective measures to ensure that the influx of persons from other parts
of the country to the island is effectively regulated as the carrying capacity of the island
has already exceeded… practical difficulties faced by them about closure of Andaman
Trunk Road, deemed forest, closure of the Forest Corporation and related issues ... At
the same time, they assured the Committee that the Administration is committed to
implement the Hon'ble Court's order in letter as well as spirit.”- 205, 209, 211,
212A&B, 213, 216A&B, 224, 240-241, 243, 246, 249, 255, 259B, 378, 386 & 609 –
“Palm-oil plan for Andamans came after many steps to skirt legal hurdles, Zia Haq,

HT New Delhi, August 22, 2021 - Edible-oil plantations tend to replace natural tropical
forests, depleting biodiversity. Environmental case studies in forested belts of Sumatra,
Borne and the Malay Peninsula - which produce 90% of global palm oil - have found
cultivation had eliminated pristine forests, pushing out wildlife, from orangutans to
birds. The new push will likely require additional clearances from the Supreme Court,
which had on May 7 2002 ordered phasing out all "exotic plantations" to conserve the
islands' ecology, an official with the knowledge of the matter said.”). In Fifty Years of
the Supreme Court, Chapter. 18 International Law ISBN 9780195662559 (Document
No. 163), Hon’ble CJI, S.K. Verma gave a panoramic view of the uncertain status of
Customary International Law in India as on 26.01.2000. It is the duty of this informant
to point out an erroneous statement made in Chapter 18 ” Regarding human rights, the
court has drawn heavily from international instruments on human rights to interpret
and expand the ambit of constitutional provisions despite the fact that none of these
instruments has been legislated, though some of them have been ratified or acceded by
India. India acceded to the 1966 International Covenants on Civil and Political Rights
(ICCPR) and International Covenants on Economic, Social and Cultural Rights
(ICESCR) on 27 March 1979. India also ratified the 1979 Convention on Elimination
of All Forms of Discrimination Against Women (CEDAW) on 25 June 1993. But none
of these instruments has been legislated by Parliament, nor do all the rights mentioned
therein find a place in the Constitution of India. As such, they are not enforceable in a
court of law in India.” The learned author had perhaps not noticed that both Houses of
Parliament had on 08.01.1994 (wef 28.09.1993), sitting jointly, unanimously legislated
1966 International Covenants on Civil and Political Rights (ICCPR) and International
Covenants on Economic, Social and Cultural Rights (ICESCR) on 27 March 1979 as
law of the land vide Section 2(f) of Central Act No. 10 of 1994. That the uncertain state
of Customary International Law in India has since been rectified on 26.08.2020 in
Union of India and Ors v. Agricas LLP and Ors MANU-SC-0614-2020 (Document
No. 459). That Parliament vide Section 2(a) of Act 43 of 2006 permitted addition to
Section 2(f) of Act 10 of 1994, (in addition to existing UN GA Resolution 2200 (XXI)
16.12.1966 ICESCR, ICCPR) such other Covenant or Convention adopted by the UN
General Assembly as the Central Government may by notification specify. [After this
S.O. 2397(E) dt. 18.09.2000 CEDAW & CRC; S.O. 2339(E) dt. 21.09.2010 CERD
were notified] However the lawful implementation of Sections 30 & 31 of the

Protection of Human Rights Act, 1993 has not taken place for nearly 28 years which is
a shame and a disgrace and in and of itself constitutes a Crime Against Humanity.
There is not even one lawfully functional Human Rights Court in India and the matter
is pending for 23.09.2021 before Hon’ble High Court of Delhi (CWP 1851 of 2021) as
also awaiting reply of the Union of India in a Section 80 CPC (60 days time limited
mandatory reply) Notice dt. 26.06.2021 which limit expires by 01.09.2021. That one
more human rights issue of property rights (Article 1 ICESCR, Articles 31C &
39(b)&(c) of the Constitution of India) remains unaddressed only because of excessive
delay in decision of the matter. (Refer Document Nos. 120, 152, 166, 170, 180, 274,
351, 393, 430-431 & 552)
4. That as this notice was readying to a final shape, the linkage between vaccination,
COVID-19 (causation EDCCE), air pollution, 2030-2050 CO2 caused likely losses in
human cognitive ability, global health and EDCCE was indicated in a PLOS ONE
article (Document No. 583) published by Richard Marcantonio et al on 21.07.2021.
[For more on harm caused by CO2, a xenobiotic, refer to Document Nos. 226, 324,
449, 469 & 537 and para 42 at pp.118-119 below] The authors noted the impossibility
of resolving these issues unless both India and China take strong concerted actions
with robust technical and financial assistance from the developed world. The
authors rightly noted “Given that a large portion of the world’s population lives in
countries at higher toxic pollution and climate impacts risk, understanding where and
how to target in pollution risk mitigation is critical to maximizing reductions of
potential human harm. Our Target results indicate that the countries facing the highest
toxic pollution and climate impacts risk also often lack institutional Readiness to
address these problems. This does not mean that efforts to support these countries or
to improve their conditions should be abandoned—or that efforts to restrict the external
factors acting upon them should be altered—but rather that focusing on and bolstering
institutional capacity development is likely the initial, and primary, focus of effort.
However, many other countries could benefit from direct efforts towards pollution risk
reduction. Two of the countries in our top 5 highest Target results, China and India,
are substantially economically developed and hold prominent geopolitical power. They
are the largest countries on the planet, together representing over 2.5 billion people,
and both have relatively high Proportion Mortality ranks, ranking 13th and 5th (17.9%
and 23.5% of annual deaths are associated with toxic pollution, equaling 1.9 and 2.3

million premature deaths annually, respectively) [9]. Despite these high rates, recently
developed national policies and their resultant impacts suggest that the benefits of
augmenting facilitation of such changes (via targeted policy efforts and incentives) are
large and achievable. For example, as a result of China’s Air Pollution and Prevention
and Control Action Plan enacted in 2013 and targeting PM2.5 specifically, Han et al.
[117] find that annual average PM2.5 levels reduced substantially between 2013–
2017—from 101.7 μg m-3 to 58.6 μg m-3, a 40% reduction. The improved air quality
resulted in significant corresponding reductions in respiratory disease and
cardiovascular disease mortality rates—both of which have been demonstrated to be
strongly linked to toxic air pollution [30,31,84]. Interestingly, if global annual average
PM2.5 emissions could be reduced even half the amount that China achieved—i.e.
20%—the estimated corresponding effect would be 1.4 million fewer premature deaths
annually worldwide [31]. Han et al. caution that air pollution remains severe across
China and further regulatory restrictions and mitigation efforts are much needed.
Importantly, while our results indicate that targeting these countries will likely produce
positive reductions in human suffering domestically, as China is the world’s leading
total GHG emitter and India is on track to join it at the top in the future, both emit high
rates of toxic pollution (Eco-health) that also can travel outside of their borders.”
5. “Vaccination management has also been important in this crisis. As early as June 2020,
the Commission put forward 2.7 billion Euros to speed up the development,
manufacturing, and deployment of vaccines on behalf of member states……. The
quality, safety, and efficacy of vaccines were the main concerns…… By January 2021,
the Commission adopted a Communication stating that at least 80% of the European
population should have already been vaccinated by the end of March 2021……
Agreements have not been comprehensive enough…… Notwithstanding, plans have
not gone as predicted and citizens feel frustrated…... This means that the crisis
prompted new solutions. Notwithstanding, the vaccination experience has not been a
success story. What the future holds is yet to be seen. The success of the former
European Union agenda entangled in the new targets remains a mystery.” [The
European Unions response to the pandemic, Fernanda Neutel, July 2021-
Document No. 593] "Information on the Delta variant from several states and other
countries indicates that, on rare occasions, some vaccinated people infected with the
Delta variant after vaccination may be contagious and spread the virus to others,"

Walensky said during a press call on Tuesday. "This new science is worrisome and
unfortunately warrants an update to our recommendations." Walensky said CDC
investigations have found that the amount of virus present in vaccinated people infected
with Delta is similar to the levels found in unvaccinated people with Delta infections.
That's an indication that vaccinated people can easily transmit the virus - even if they're
less likely to get sick on the whole. Still, Walensky added, "the vast majority of
transmission, the vast majority of severe disease, hospitalization, and death is almost
exclusively happening among unvaccinated people." [CDC says fully vaccinated
people spread the Delta variant Business Insider India, 28.07.2021- Document No.
588] That, for coronaviruses and other infectious diseases, there are traditional systems
of medicine, that are safer and more effective in the long run, which are available in
traditional Chinese,-Japanese, Indian, Tibetan, North & South American Natural
Remedies etc. (Document Nos. 72, 94B, 110, 148, 150, 161, 174, 176, 204, 217, 220,
244A, 244B, 245, 251, 275, 336, 356, 359, 412, 415 & 441) The German homoeopathic
system has, since long, shown its strength in handling pandemic situations
(homoeopathic nosodes); not for nothing has it spread across India, Brazil, U.S., U.K.,
Europe, Switzerland, France, Germany, Romania, Russia, Australia etc. India is the first
country in the world to pass laws during 2019-2020 [Document Nos. 399, 400, 401,
428, 463 & 464] for the Modern System, Indian Systems (Ayurveda, Yoga and
Naturopathy, Unani, Siddha, Sowa Rigpa) and Homoeopathic System mandating
togetherness in work and to hold a minimum of one annual joint sitting of the Councils
of these different health systems to harmonize and maximise the health benefits from
all the medical/ health systems working jointly for the health of the people. The
National Health Policy 1983 ordained an ultimate united functioning of existing
disparate health systems, Ayurveda, Yoga and Naturopathy, Unani, Siddha,
Homoeopathy, Sowa Rigpa (a later addition) and Allopathy. Within the MoHFW a
Department of ISM&H (renamed AYUSH in November 2003) was set up in March
1995, even as ISM&H was granted recognition in 1941 by the British after 61 years of
struggle since 1880 by moffusil doctors (including many converts from allopathy) at
Calcutta, (102 years after Johann Martin Honigberger miraculously cured Maharajah
Ranjit Singh's paralysed vocal chords with homeopathy learnt from Christian Friedrich
Samuel Hahnemann during his 1834-1838 trip to Germany from Punjab. [Document
No. 365 at pp.76-77]“CALCUTTA NATIVE HOMOEOPATHIC HOSPITAL.

Physician-Dr. Tonnerre. This Hospital was opened on the 17th March, 1852; it
contains ten beds.”) [Document No. 40 at pp.118-119]. “In Nov. 1851, by the earnest
endeavour of some dignified persons in Calcutta and under the patronage of the
Hon’ble Sir John Hunter Littler, Deputy Governor of Bengal and President of the
Council of India, a ‘Native Homoeopathic Hospital and Free Dispensary’ was founded
in Calcutta. C Fabre Tonner, M. D., a French allopath converted to homoeopath, was
appointed health officer of the hospital.” [See Document No. 365 at p.77 &
Vernacular Medicine in Colonial India Family, Market and Homoeopathy,
Shinjini Das, 2019, Document No. 415] On 09.11.2014 an independent Ministry of
AYUSH was established by amendment to the Allocation of Rules of Business
[Government of India Allocation of Business Rules,. 1961 (updated 05.02.2019)
pp.21-22]. In fact, as far back as 2006/2010 Patanjali Yog Peeth (UK) Trust, (An
International Yog teaching body of Patanjali Yog Peeth Trust, Haridwar, India)
declared as its charitable objects: “The preservation and protection of health and relief
of mental and physical illness by the promotion and development of the ancient Indian
sciences of Ayurveda and Pranayama Yoga and by supporting the aims and work of the
Patanjali Yog Peeth (charity registered in India) in order to further the foregoing and
such other objectives that are charitable under the law of England and Wales.
Throughout this trust deed "charitable" means charitable in accordance with the law
of England and Wales provided that it will not include any purpose which is not
charitable in accordance with section 7 of the Charities and Trustee Investment
(Scotland) Act 2005.” [Declaration Of Trust Dated 1 July 2006 As Amended By
Supplemental Deed Dated 6 December 2010, Charity Registration No: 1115370
(England and Wales)] That the 2012 Annual Report of the then Department of
AYUSH issued under the aegis of MoHFW is very categorical of the proper direction
needed to be taken in global health - at pages 2-4 of the 2012 AYUSH Annual Report
[Document No. 307B] published under the aegis of the then undivided MoHFW it was
decided “-To propagate and promote AYUSH systems outside the country and to ensure
their global acceptance as systems of medicine; -To collaborate with international
bodies, e.g. World Health Organisation for cross disciplinary standardization, global
recognition and propagation of AYUSH systems; -Global legal recognition of
qualification and practice of AYUSH; -To promote collaborative research and
education in AYUSH with other countries; -Protection of Traditional Knowledge.

DRUG ADMINISTRATION -To accelerate the Pharmacopoeial/ standardization

work on AYUSH drugs. -To ensure availability of high quality AYUSH drugs. -To
ensure enabling legal framework for production and distribution of safe and quality
AYUSH drugs. -To strengthen regulatory infrastructure in Central and State
Governments. -To encourage AYUSH drug industry to produce high quality AYUSH
medicines for national and international needs. 1.3 National Health Policy, 1983**
observed that the country has a large stock of health manpower comprising of private
practitioners in various systems. This resource has not so far been adequately utilized.
The practitioners of AYUSH systems enjoy high local acceptance and respect and
consequently exert considerable influence on health beliefs and practices. It is,
therefore, necessary to initiate organised measures to enable each of these systems of
medicine and health care to develop in accordance with their strengths.
Simultaneously, planned efforts should be made to dovetail the functioning of the
practitioners and integrate their service, at the appropriate levels, within specified
areas of responsibility and functioning, in the overall health care delivery system,
especially with regard to the preventive, promotive and public health objectives. Well-
considered steps would also be required to be taken to move towards a meaningful
phased integration of the indigenous and the modern systems. The significance of the
Alternative Systems of Medicine was further emphasized in the National Health Policy,
2002***, which stated that Ayurveda, Siddha, Unani and Homoeopathy have a
substantial role because of the inherent advantages, such as diversity, modest cost, low
level of technological input and the growing popularity of natural plant based products,
especially in the under-served, remote and tribal areas. The Policy also envisage the
consolidation of documentary knowledge contained in these systems to protect it
against attack from foreign commercial entities by way of malafide action under the
Patent laws in other countries. 1.4 The National Policy on Indian Systems of Medicine
& Homoeopathy, 2002 enunciated following as its objectives: (i) To promote good
health and expand the outreach of health care to our people, particularly those not
provided with health cover, through preventive, promotive, mitigating and curative
intervention through ISM&H; (ii) To improve the quality of teachers and clinicians by
revising curricula to contemporary relevance and researches by creating model
institutions and Centres of Excellence and extending assistance for creating
infrastructural facilities; (iii) To ensure affordable ISM&H services and drugs, which

are safe and efficacious; (iv) To facilitate availability of raw drugs, which are authentic
and contain essential components as required under pharmacopoeial standards to help
improve quality of drugs, for domestic consumption and export; (v) Integrate ISM&H
in health care delivery system and National Programmes and ensure optimal use of the
vast infrastructure of hospitals, dispensaries and physicians; (vi) Re-orient and
prioritize research in ISM&H to gradually validate drugs and therapies to address in
particular the chronic and new emerging life style related diseases; (vii) Create
awareness about the strengths of these systems in India and abroad and sensitize other
stakeholders and providers of health; and (viii) To provide full opportunity for the
growth and development of these systems and utilization of the potentiality, strength
and revival of their glory. 1.5 The Policy outlines the following strategies to achieve
the objectives: (a) Legislative measures to check mushroom growth of substandard
colleges; (b) Course curricula to be reinforced to raise the standards of medical
training and to equip trainees for utilization in national health programmes; (c)
Priority to research covering clinical trials, pharmacology, toxicology, standardization
and study of pharmaco-kinetics in respect of identified areas of strength; (d) The
National Medicinal Plants Board to address all issues connected with conservation and
sustainable use of medicinal plants leading to remunerative farming, regulation of
medicinal farms and conservation of bio-diversity; (e) National Medicinal Plants
Board to acquire statutory status to be able to regulate registration of farmers and
cooperative societies, transportation, marketing of medicinal plants and proper
procurement and supply of raw materials to pharmaceutical industry; (f) Protection of
India’s traditional medicinal knowledge to be undertaken through a progressive
creation of a Digital Library for each system and eventually the codified knowledge
leading to innovation and good health outcomes; (g) Effort to integrate and mainstream
ISM&H in health care delivery system and in National Programmes; (h) A range of
options for utilization of ISM&H manpower in the health care delivery system to be
developed by assigning specific goal oriented role and responsibility to the ISM&H
work force; (i) Allopathic hospitals to be encouraged to set up AYUSH health facilities;
(j) Government to assist allopathic hospitals to establish Panchkarma and Ksharsutra
facilities for the treatment of neurological disorders, musculo-skeletal problems as well
as ambulatory treatment of fistula-inano, bronchial asthma and dermatological
problems; (k) States to be encouraged to consolidate the ISM&H infrastructure and

health services; (l) Pharmacopoeial work related to Ayurveda, Unani, Siddha and
Homoeopathy Drugs to be expedited; (m) Industry to be encouraged to make use of
quality certification and acquisition of GMP and ISO 9000 certification; (n) Quality
Control Centers would be set up on regional basis to standardize the in process quality
control of ISM products and to modernize traditional processes without changing the
concepts of ISM; (o) States to be advised and supported to augment facilities for drug
manufacture and testing; (p) Operational use of ISM in Reproductive & Child Health
(RCH) to be encouraged in eleven identified areas, where the Indian Systems of
Medicine would be useful for antenatal, intra-natal, post-natal and neonatal care; (q)
North Eastern States, rich in flora and fauna, to be supported to develop infrastructure
and awareness of ISM; (r) Keeping in view the global interest in understanding ISM
concepts and practices, modules to be formulated for introducing Ayurveda and Yoga
to medical schools and institutions abroad and to expose medical graduates; (s)
Awareness programmes on the utility and effectiveness of ISM&H to be launched
through electronic and print media.” On 29.05.2020 as Document No. 453
[HOMEOGuidlines_v2a.cdr, (PDF) Advisory issued by Ministry of AYUSH dt.
29.05.2020 duly vetted by its Interdisciplinary AYUSH Research and Development
Task Force: Author: Kam Singh] substantiates, India adopted a holistic COVID-19
approach at p.6, p.7, p.8, pp.9-10 & p.11: p.6 “…provide homoeopathic symptomatic
mitigation to affected persons. Homoeopathic medicines are also useful in the treatment
of communicable diseases like Influenza Like Illness(7)(8), dengue(9), acute
encephalitis syndrome(10). Several studies are also published which shows the immune
modulatory potential of homoeopathic medicines in preclinical
studies(11)(12)(13)(14)(15)(16)….” p.7 “…As a system with wholistic approach
medicine were selected based on the presenting signs and symptoms of each patients
(17)(18)(19)(20). The medicines given here are suggestive based on their use and
studies in the past in diseases of similar presentation like COVID-19 (21) (22) (23).
Patients of COVID-19 are to be treated with adjuvant Homoeopathic medicines with
the permission from local health authorities and Medical Superintendent of the
Hospital…… The remedies according to different stages of disease are given below:
Mild Disease (Symptomatic Amelioration and Mitigation Approach): Medicines like
Aconite napellus, Arsenicum album, Bryonia alba, Gelsemium sempervirens, Rhus tox.
Eupatorium perfoliatum, Ipecacaucunha, Belladonna, Camphora,may be used

depending upon the symptoms similarities. Severe disease but not in critical condition:
It is defined by following criteria (Dyspnoea, respiratory frequency ≥ 30/min, blood
oxygen saturation (SpO2) ≤ 93%, PaO2/FiO2 ratio < 300, and/or lung infiltrates >
50% within 24 to 48 hours)/)” p.8 “* Suggested medicines are as adjuvant to Standard
Management guidelines in the hospital setting only with the approval of authorities and
willingness of the patient/guardian. * The prescription is to be given only by
institutionally qualified practitioner. * Medicines like Phosphorus, Chelidonium,
Veratrum Viride, Iodum, Camphora, Cinchona officinalis, Lycopodium, Ars. iod.,
Antim ars., Stannum met, Carbo veg., can be prescribed on symptomatic indication.
Posology. The medicine selected for each patient is tailored to person specific, taking
into consideration, his/her mental make-up, physical symptoms, and characteristic
particulars etc. In case of long term illness, besides the above mentioned factors, age,
occupation, previous illnesses and life circumstance unique to that individual
irrespective of the disease which he/she is suffering from, are also taken into
consideration; thus the dictum “Homoeopathy treats the patient but not the disease”.
After the appropriate medicine is selected, it is essential to decide the requisite potency,
dose and repetition which is imperative for optimum response and faster recovery in
each case. Different types of potencies such as decimal or centesimal potencies can be
employed for treatment as are required for acute diseases. However, selection of
potency of the remedy is dependent on various factors like susceptibility of the patient
(high or low), type of disease (acute/chronic), seat/nature and intensity of the disease,
stage and duration of the disease and also the previous treatment of the disease(24).
pp.9-10 “References. (1). Mizumoto K, Chowell G. Estimating risk for death from 2019
novel coronavirus disease, China, January–February 2020. Emerg Infect Dis. 2020
Jun. Available from:https://doi.org/10.3201/eid2606.200233. Accessed on: 18 March
2020. xxxxx (24). Close S. The Genius of Homeopathy: Lectures and Essays on
Homeopathic Philosophy. New Delhi; B Jain Publishers; 183-211” p.11 “These
guidelines are in addition to the standard treatment guidelines of Ministry of Health
and Family Welfare, Govt of India and also vetted by the Interdisciplinary AYUSH
Research and Development Task Force setup by Ministry of AYUSH, Govt of India”
6. The Earth Vaccine Dispute has become an emergent global flashpoint after the recent
“Opportunistic Textualism Style” clearly visible in the recent ECHR judgement,
Vavřička v. the Czech Republic, ECHR No. 47621/13, (08.04.2021). (Document No.

501) It has all the potential to sabotage the efforts of the Indian Government to
maximise overall better health returns from a synergistic health system of
medicine which wisely accommodates allopathic and traditional medicine in the
best interest of mankind, ignoring the financial tyranny of the profit oriented chemical
drug manufacturing multinationals. Earlier on 31.07.2020 prescient words from Dr.
Andraž Teršek, Professor of Constitutional Law, Slovenia: “After the 2020
Coronavirus pandemic (first wave?!) the European public is already alerted about the
vaccine against this virus. And undecided on the subject: some people can hardly wait
for the vaccine, others are already very afraid of it. And last but not least, the daily
politics has already made clear its intention to classify people (legally, by Acts or
Statues) into different “risk groups,” according to their previous and chronic illnesses.
On the one hand, with the intention of adjusting to the (higher) level of insurance
premiums that people will have to pay according to their “risk for the health of others.”
And on the other hand, with the intention that the State will legally allow itself control
over the fundamental human and constitutional right to privacy and over the
fundamental human and constitutional right to freedom of movement;xi again –
according to the determination of such “risk. It has already become clear that the
fundamental rights already acquired, even the s. c. “Strasbourg minimal standards,”
xii
will have to be fought for again.xiii ECtHR decision in a case of Vavřička and Others
v. The Czech Republic will play a big part. Hopefully not too big to handle for the
ECtHR; in the sense of “politically” avoiding a determined and concrete “legal
decision.” ECtHR is expected to give its decision before the end of 2020: just as the
question of a general vaccination obligation against Covid-19 will arise. Hard times
and human rights challenges lie ahead.” [Compulsory Vaccination Controversy,
ECtHR and Fundamental Human Rights, Teršek, 31.07.2020 Document No. 457]
xi
At this point, I would like to reiterate that the doctrine of positive obligations of the state may be
under “political pressure” in particular. In terms of a possible reduction of the s. c. “reasonable and
legitimate legal expectations” towards the state. In the sense what the state “must”, not only “should”
do to ensure that the level of protection of fundamental rights and freedoms already achieved, meaning
the quality and effectiveness of their legal protection, is not reduced. My professional and public work
so far has been defined primarily by an active commitment to this goal: that this level should not be
lowered, but at most strengthened and raised.
xii
This concept was already explained above. At this point, I would like to reiterate that the doctrine of
positive obligations of the state may be under “political pressure” in particular. In terms of a possible
reduction of the s. c. “reasonable and legitimate legal expectations” towards the state. In the sense what
the state “must”, not only “should” do to ensure that the level of protection of fundamental rights and
freedoms already achieved, meaning the quality and effectiveness of their legal protection, is not
reduced. My professional and public work so far has been defined primarily by an active commitment to
this goal: that this level should not be lowered, but at most strengthened and raised. For detailed and
comprehensive insight into the doctrine of positive obligations of the state see Alastair Mowbray: The

Development of Positive Obligations Under the European Convention on Human Rights by the European
Court of Human Rights. Oxford: Cambridge University Press, 2014.
xiii
Exactly today, when I am concluding this article (July 29, 2020), the Slovenian media published two
important news: first, that a new European legal policy is being adopted regarding the question of WHO
will be allowed to enter EU Member States (from which non-EU countries) and second, in Slovenia, the
law will soon prescribe mandatory tracking of people who tested positive for COVID-19 via a special
application on a mobile phone.
7. The brief principled dissent of Judge Paul Lemmens centred on Article 2 of ECHR
Protocol No.1, Right to Education, hence in this Article 8 Issue, he “would have
preferred to have had all these issues properly and separately examined.”
8. The dissent of Judge Krzysztof Wojtyczek conservatively noted in Vavřička at paras
14-16 [Article 8 Issue, which is the scant scientific evidence in long term safety and
efficacy of vaccines in general] (Document No. 501) that
“14……….I also note that no evidence was presented to the Court which would
show that those States which have introduced the obligation to vaccinate perform
better in terms of public health than the States which have not introduced such an
obligation. In this second group, no decline in the rate of vaccination below the
recommended targets has been established before the Court. The fact that in many
States the objectives of health policy can apparently be achieved without
introducing an obligation to vaccinate is a very powerful argument that less
restrictive means are indeed available and that the impugned interference is not
necessary in a democratic society. The fact that the majority explicitly dismisses the
“less restrictive alternative” test without further explanations for this rejection
gives the impression that the applicants’ point under this test would have been taken
had it been applied.
15. The majority relies upon a number of specific but questionable arguments. In
paragraph 272 of the judgment the majority states: “With regard to the aims
pursued by the vaccination duty, as argued by the Government and as recognised
by the domestic courts, the objective of the relevant legislation is to protect against
diseases which may pose a serious risk to health. This refers both to those who
receive the vaccinations in question as well as those who cannot be vaccinated and
are thus in a state of vulnerability, relying on the attainment of a high level of
vaccination within society at large for protection against the contagious diseases
in question.” In paragraph 306 they further argue: “The Court considers that it
cannot be regarded as disproportionate for a State to require those for whom
vaccination represents a remote risk to health to accept this universally practised

protective measure, as a matter of legal duty and in the name of social solidarity,
for the sake of the small number of vulnerable children who are unable to benefit
from vaccination.” The problem is that this argument is valid for some diseases
only. It does not work for a disease like tetanus, which is not contagious (WHO,
Tetanus,
https://www.who.int/immunization/monitoring_surveillance/burden/vpd/surveillan
ce_type/passive/tetanus/en/)
and is problematic for pertussis because of the specificity of vaccine protection
(Pertussis vaccines: WHO position paper – August 2015, Weekly epidemiological
record, No. 35, 2015, 90, 433–460
https://www.who.int/wer/2015/wer9035.pdf?ua=1).
In paragraph 288 the majority argues: “Those to whom such treatment cannot be
administered are indirectly protected against contagious diseases as long as the
requisite level of vaccination coverage is maintained in their community, i.e. their
protection comes from herd immunity. Thus, where the view is taken that a policy
of voluntary vaccination is not sufficient to achieve and maintain herd immunity, or
herd immunity is not relevant due to the nature of the disease (e.g. tetanus),
domestic authorities may reasonably introduce a compulsory vaccination policy in
order to achieve an appropriate level of protection against serious diseases.” I do
not see any logical link between the first and the second sentence: this is a non
sequitur. Moreover, the fact that “herd immunity is not relevant due to the nature
of the disease (e.g. tetanus)” does not suffice to justify the power of the domestic
authorities to “introduce a compulsory vaccination policy in order to achieve an
appropriate level of protection against serious diseases”. In paragraph 308 the
following argument is raised: “Lastly, the applicants argued that the system was
incoherent, in that while small children were required to be vaccinated, this did not
apply to those employed in preschools. The Court notes, however, the Government’s
reply that the general vaccination duty, which consists of initial vaccinations as
well as booster vaccinations, applies to everyone residing in the Czech Republic
permanently or on a long-term basis (see paragraphs 11 and 77 above), so that the
staff members concerned should normally have received all the prescribed
vaccinations at the relevant time, as required by law.” The problem is that the
obligation to vaccinate in respect of certain diseases was introduced after some

older staff members had become adults, so they would have not received all the
currently prescribed vaccinations at the relevant time. For instance, the vaccine
against rubella became available only in the late 1960s, while the vaccines against
hepatitis B and Haemophilus influenzae type b infections became available only in
the 1980s. Moreover, any staff members who spent their childhood abroad have not
necessarily received all the vaccinations currently prescribed in the Czech
Republic. In paragraphs 279 and 306 the majority refers to “social solidarity”
(“solidarité sociale”). It is not clear what this concept (bringing to mind the work
of Émile Durkheim) means here. The New Oxford Dictionary of English (Oxford
1998, p. 1772), provides the following definition of solidarity tout court: unity or
agreement of feeling or action, especially among individuals with a common
interest; mutual support within a group. The Dictionnaire Larousse 2019 (Paris
2018, p. 1081) gives the following meanings of the word “solidarité” in French: 1)
dépendance mutuelle entre des personnes liées par des intérêts communs, esprit de
corps ; 2) sentiment qui pousse les hommes à s’accorder une aide mutuelle (the
meanings in legal language have been omitted here; see also E. Littré, Dictionnaire
de la langue française, Paris, Hachette 1874, t. 4, p. 1968). Although the French
word solidarité may also have a different meaning (le fait de faire contribuer
certains membres d’une collectivité nationale à l’assistance (financière, matérielle)
d’autres personnes (Le Petit Robert, Paris, Le Robert 2013, p. 2390)), the very idea
of solidarity, as initially understood in ordinary language (stemming from legal
language), presupposes spontaneous self-organisation, not sacrifices imposed by
State power. The two underlying concepts of social organisation are very different,
the second approach (based upon legal obligations) compensating for shortcomings
in the first.
E. The quality of the decision-making process at the national level
16. In assessing the proportionality of measures restricting Convention rights the
Court takes sometimes into account the quality of the domestic decision-making
process (see Animal Defenders, cited above, §§ 113-116; see also Budayeva and
Others v. Russia, nos. 15339/02 and 4 others, § 136, ECHR 2008 (extracts); Brincat
and Others v. Malta, nos. 60908/11 and 4 others, § 101, 24 July 2014; Parrillo,
cited above, § 170; Garib v. the Netherlands [GC], no. 43494/09, § 138, 6
November 2017; and Lekić v. Slovenia [GC], no. 36480/07, §§ 109, 117-118, 11

December 2018). The applicants point to numerous deficiencies in the decision-

making process at the domestic level. They restate and endorse very precise factual
allegations made in the Czech press. They allege, in particular, conflicts of interests
among persons involved in the decision-making process and the fact that documents
on which the risk evaluation of the different vaccines were based have not been
made public. The majority replies with this argument in paragraph 297 of the
judgment: “As for the integrity of the policy-making process, the Court notes that
in reply to the applicants’ claim about conflicts of interest the Government have
explained the procedure followed by the NIC, in accordance with relevant
European and international standards (see paragraph 200 above).” With all due
respect, the system of declarations described in paragraph 200, which is apparently
devoid of sanctions for making false declarations, is clearly insufficient. The
majority further argues in the same paragraph: “In the light of the elements before
it, the Court considers that the applicants have not sufficiently substantiated their
allegations that the domestic system is tainted by conflicts of interest, or their
suggestion that the position on vaccination adopted by the relevant Czech expert
bodies, or by the WHO, is compromised by financial support from pharmaceutical
corporations.” This is precisely where the problem lies: many citizens no longer
trust public institutions. It is not sufficient that decision-making processes are fair:
they must be perceived to be fair, and there should therefore be far-reaching legal
arrangements to protect the integrity of the process and build public confidence.
The pro-choice attitude in the field of vaccination reflects a broader problem of
mistrust among citizens vis-à-vis the democratic institutions. I further note that no
national document containing a precise assessment of the various vaccines’
efficiency and the attendant risks has been presented to the Court, as though no
such assessment had ever been made in the respondent State or had ever been the
subject of public debate. The fundamental issues enumerated above (see point 6 of
this votum separatum) appear to have been left unaddressed in publicly available
documents related to the decision-making process at national level. The persons
affected by the obligation to vaccinate are entitled to know not only the precise risk
for each and every disease, but also how this risk was calculated and assessed by
those who took the decision to introduce the obligation to vaccinate. Their
legitimate queries in this respect remain without a satisfactory answer. ”

9. It is to be noted that while U.S. Courts have noted the customary international law
aspect of The Nuremberg Code, 1947 (in United States v. Karl Brandt et al, NMT I,
19.07.1947, the ECHR having noted the Nuremberg Military Tribunal’s contribution
(the NMT was composed of judges from Russia, U.K., U.S., France etc) to customary
international law in Feldek v. Slovakia, ECHR no. 29032 of 95 pp.87-116,
12.07.2001 (Document No. 171) & Maktouf and Damjanović v. Bosnia and
Herzegovina, ECHR [GC], nos. 2312 of 08 pp.3-45, 18.07.2013 (Document No.
310), has in no case of forced medical treatment or vaccination factored in the
customary international law prohibition of The Nuremberg Code, 1947 (in United
States v. Karl Brandt et al, 19.07.1947) into ECHR judgements. This may be the reason
why conflicting judgements have been passed assuming as a given not open to
challenge (per incuriam?) the government’s assertion of public interest of vaccination,
so as to allow states (an impermissible?) exemption from the customary international
law of bodily integrity and right to choose medical experimental treatment for self and
children, which was cast in stone by the NMT, thus, (inappropriately?) permitting E.U.
Member States to flout the Nuremberg Code, 1947, which is well settled Customary
International Law, and in the background of today’s ill structured experiments
(including even direct and focussed assaults being proposed by some rogue doctors/
scientists in some countries on the Human DNA) cannot be tolerated in a just and
humane World. This could be the reason for the strong dissent of Judge Paul Lemmens
& Judge Krzysztof Wojtyczek in Vavřička v. the Czech Republic, ECHR No.
47621/13, (08.04.2021). (Document No. 501)
10. Kindly read contents of accompanying 32 GB USB Flash Drive carefully and take
notice of the documents and convey acceptance and receipt.[Only For Respondents]
11. In this carefully considered opinion, having gone through the legal, scientific and
medical tomes in very great detail, it appears plainly unwise to cause the prima facie
deliberate and forced ingestion of irritants and toxins, sans informed consent, into
pregnant mothers, new-borns, infants, children, teens, adults and the elderly. Even
though well-intentioned, this action by the highly revered medical profession, all in the
name of immunisation/ better health is, at present, in truth, nothing but a dangerous
“EXPERIMENT.” See also para 24 at pp.40-85.
12. That late Mr. Justice Anton Scalia, in an erudite 2011 judgement, [on an issue which
was narrowly focussed on Federal Law based denial of vaccine claims liability under

inadmissible State Laws, and not on the broader human rights issue of informed consent
for dangerous/ unsafe and hence experimental vaccine forcing by the States/ Federal
Governments] in acerbic trademark “Opportunistic Textualism Style” [visible even in
the earlier claim against US Armed Forces involuntary experimental medications in
United States v. James B. Stanley, 483 US 669 (1987)] [Document No. 133] rejected
the strongest objections of the Minority, and most emphatically held for the Majority
that vaccination/ immunisation is a necessary evil, not ordinarily amenable to civil
damages claims against a manufacturer, being “UNAVOIDABLY UNSAFE.” [Russell
Bruesewitz et al v. Wyeth LLC et al, 562 U.S. 223 (2011), US SC Case No. 09-152,
22.02.2011 – Document No. 279] at pp.4-5 & pp.7-14: pp.4-5 “……..A claimant may
also recover for unlisted side effects, and for listed side effects that occur at times other
than those specified in the Table, but for those the claimant must prove causation.
Unlike in tort suits, claimants under the Act are not required to show that the
administered vaccine was defectively manufactured, labeled, or designed. Successful
claimants receive compensation for medical, rehabilitation, counseling, special
education, and vocational training expenses; diminished earning capacity; pain and
suffering; and $250,000 for vaccine-related deaths. Attorney’s fees are provided, not
only for successful cases, but even for unsuccessful claims that are not frivolous. These
awards are paid out of a fund created by an excise tax on each vaccine dose. The quid
pro quo for this, designed to stabilize the vaccine market, was the provision of
significant tort liability protections for vaccine manufacturers. The Act requires
claimants to seek relief through the compensation program before filing suit for more
than $1,000. Manufacturers are generally immunized from liability for failure to warn
if they have complied with all regulatory requirements (including but not limited to
warning requirements) and have given the warning either to the claimant or the
claimant’s physician. They are immunized from liability for punitive damages absent
failure to comply with regulatory requirements, “fraud,” “intentional and wrongful
withholding of information,” or other “criminal or illegal activity.” And most relevant
to the present case, the Act expressly eliminates liability for a vaccine’s unavoidable,
adverse side effects:….” pp.7-14 “…We set forth again the statutory text at issue: “No
vaccine manufacturer shall be liable in a civil action for damages arising from a
vaccine-related injury or death associated with the administration of a vaccine after
October 1, 1988, if the injury or death resulted from side effects that were unavoidable

even though the vaccine was properly prepared and was accompanied by proper
directions and warnings.” The “even though” clause clarifies the word that precedes
it. It delineates the preventative measures that a vaccine manufacturer must have taken
for a side-effect to be considered “unavoidable” under the statute. Provided that there
was proper manufacture and warning, any remaining side effects, including those
resulting from design defects, are deemed to have been unavoidable. State-law design-
defect claims are therefore preempted. If a manufacturer could be held liable for failure
to use a different design, the word “unavoidable” would do no work. A side effect of a
vaccine could always have been avoidable by use of a differently designed vaccine not
containing the harmful element. The language of the provision thus suggests that the
design of the vaccine is a given, not subject to question in the tort action. What the
statute establishes as a complete defense must be unavoidability (given safe
manufacture and warning) with respect to the particular design. Which plainly implies
that the design itself is not open to question. A further textual indication leads to the
same conclusion. Products-liability law establishes a classic and well known
triumvirate of grounds for liability: defective manufacture, inadequate directions or
warnings, and defective design. If all three were intended to be preserved, it would be
strange to mention specifically only two, and leave the third to implication. It would
have been much easier (and much more natural) to provide that manufacturers would
be liable for “defective manufacture, defective directions or warning, and defective
design.” It seems that the statute fails to mention design-defect liability “by deliberate
choice, not inadvertence.” Barnhart v. Peabody Coal Co., 537 U. S. 149, 168 (2003).
Ex pressio unius, exclusio alterius. The dissent’s principal textual argument is
mistaken. We agree with its premise that “‘side effects that were unavoidable’ must
refer to side effects caused by a vaccine’s design.” We do not comprehend, however,
the second step of its reasoning, which is that the use of the conditional term “if” in the
introductory phrase “if the injury or death resulted from side effects that were
unavoidable” “plainly implies that some side effects stemming from a vaccine’s design
are ‘unavoidable,’ while others are avoidable.” That is not so. The “if” clause makes
total sense whether the design to which “unavoidable” refers is (as the dissent believes)
any feasible design (making the side effects of the design used for the vaccine at issue
avoidable), or (as we believe) the particular design used for the vaccine at issue
(making its side effects unavoidable). Under the latter view, the condition established

by the “if” clause is that the vaccine have been properly labeled and manufactured;
and under the former, that it have been properly designed, labeled, and manufactured.
Neither view renders the “if” clause a nullity. Which of the two variants must be
preferred is addressed by our textual analysis, and is in no way determined by the “if”
clause. Petitioners’ and the dissent’s textual argument also rests upon the proposition
that the word “unavoidable” in §300aa–22(b)(1) is a term of art that incorporates
comment k to Restatement (Second) of Torts §402A (1963–1964). The Restatement
generally holds a manufacturer strictly liable for harm to person or property caused by
“any product in a defective condition unreasonably dangerous to the user.” Comment
k exempts from this strict-liability rule “unavoidably unsafe products.” An unavoidably
unsafe product is defined by a hodge-podge of criteria and a few examples, such as the
Pasteur rabies vaccine and experimental pharmaceuticals. Despite this lack of clarity,
petitioners seize upon one phrase in the comment k analysis, and assert that by 1986 a
majority of courts had made this a sine qua non requirement for an “unavoidably
unsafe product”: a case-specific showing that the product was “quite incapable of
being made safer for [its] intended . . . use.” We have no need to consider the finer
points of comment k. Whatever consistent judicial gloss that comment may have been
given in 1986, there is no reason to believe that §300aa–22(b)(1) was invoking it. The
comment creates a special category of “unavoidably unsafe products,” while the statute
refers to “side effects that were unavoidable.” That the latter uses the adjective
“unavoidable” and the former the adverb “unavoidably” does not establish that
Congress had comment k in mind. “Unavoidable” is hardly a rarely used word. Even
the cases petitioners cite as putting a definitive gloss on comment k use the precise
phrase “unavoidably unsafe product”; none attaches special significance to the term
“unavoidable” standing alone. The textual problems with petitioners’ interpretation do
not end there. The phrase “even though” in the clause “even though the vaccine was
properly prepared and [labeled]” is meant to signal the unexpected: unavoidable side
effects persist despite best manufacturing and labeling practices. But petitioners’
reading eliminates any opposition between the “even though” clause—called a
concessive subordinate clause by grammarians—and the word “unavoidable.” Their
reading makes pre-emption turn equally on unavoidability, proper preparation, and
proper labeling. Thus, the dissent twice refers to the requirements of proper
preparation and proper labeling as “two additional prerequisites” for preemption

independent of unavoidability. The primary textual justification for the dissent’s

position depends on that independence. But linking independent ideas is the job of a
coordinating junction like “and,” not a subordinating junction like “even though.”
Petitioners and the dissent contend that the interpretation we propose would render
part of §300aa–22(b)(1) superfluous: Congress could have more tersely and more
clearly preempted design-defect claims by barring liability “if . . . the vaccine was
properly prepared and was accompanied by proper directions and warnings.” The
intervening passage (“the injury or death resulted from side effects that were
unavoidable even though”) is unnecessary. True enough. But the rule against giving a
portion of text an interpretation which renders it superfluous does not prescribe that a
passage which could have been more terse does not mean what it says. The rule applies
only if verbosity and prolixity can be eliminated by giving the offending passage, or the
remainder of the text, a competing interpretation. That is not the case here. To be sure,
petitioners’ and the dissent’s interpretation gives independent meaning to the
intervening passage (the supposed meaning of comment k); but it does so only at the
expense of rendering the remainder of the provision superfluous. Since a vaccine is not
“quite incapable of being made safer for [its] intended use” if manufacturing defects
could have been eliminated or better warnings provided, the entire “even though”
clause is a useless appendage. It would suffice to say “if the injury or death resulted
from side effects that were unavoidable”—full stop. The structure of the NCVIA and of
vaccine regulation in general reinforces what the text of §300aa–22(b)(1) suggests. A
vaccine’s license spells out the manufacturing method that must be followed and the
directions and warnings that must accompany the product. Manufacturers ordinarily
must obtain the Food and Drug Administration’s (FDA) approval before modifying
either. Deviations from the license thus provide objective evidence of manufacturing
defects or inadequate warnings. Further objective evidence comes from the FDA’s
regulations—more than 90 of them—that pervasively regulate the manufacturing
process, down to the requirements for plumbing and ventilation systems at each
manufacturing facility. Material noncompliance with any one of them, or with any other
FDA regulation, could cost the manufacturer its regulatory-compliance defense.
Design defects, in contrast, do not merit a single mention in the NCVIA or the FDA’s
regulations. Indeed, the FDA has never even spelled out in regulations the criteria it
uses to decide whether a vaccine is safe and effective for its intended use. And the

decision is surely not an easy one. Drug manufacturers often could trade a little less
efficacy for a little more safety, but the safest design is not always the best one. Striking
the right balance between safety and efficacy is especially difficult with respect to
vaccines, which affect public as well as individual health. Yet the Act, which in every
other respect micromanages manufacturers, is silent on how to evaluate competing
designs. Are manufacturers liable only for failing to employ an alternative design that
the FDA has approved for distribution (an approval it takes years to obtain)? Or does
it suffice that a vaccine design has been approved in other countries? Or could there
be liability for failure to use a design that exists only in a lab? Neither the Act nor the
FDA regulations provide an answer, leaving the universe of alternative designs to be
limited only by an expert’s imagination. Jurors, of course, often decide similar
questions with little guidance, and we do not suggest that the absence of guidance alone
suggests preemption. But the lack of guidance for design defects combined with the
extensive guidance for the two grounds of liability specifically mentioned in the Act
strongly suggests that design defects were not mentioned because they are not a basis
for liability. The mandates contained in the Act lead to the same conclusion. Design-
defect torts, broadly speaking, have two beneficial effects: (1) prompting the
development of improved designs, and (2) providing compensation for inflicted injuries.
The NCVIA provides other means for achieving both effects. We have already
discussed the Act’s generous compensation scheme……”
13. That ethics based decision making demands that, whereas it is for the doctor to
advise the course of treatment, it is for the patient to finally decide the treatment
especially in a scenario where the State has abdicated on the all important issue of
torts liability for design defects, which can be proven before a court of law, but
even so the claims are barred by law in violation of Customary International Law.
14. That it is clearly “UNSAFE” to continue to proceed business as usual with this
“EXPERIMENT” with the present uncritical approach, sans unbiased appraisal by
independent, widely-read informed members of the public, including lawyers,
prosecutors and judges who have carried out a wider legal and historical study
supervening narrow medical, genetic, immunological and scientific fields of
specialization with analytical historical bent of mind. The approach of the United States
to fix a maximum value of $250,000 for vaccine-related deaths, that too payable from
tax-payers money, is reprehensible, since no amount of money can ever compensate the

grief of the parents who lose a child to forced vaccinations; much worse, perhaps, is the
fate of the parents, who for the rest of their living years, after a forced vaccination,
provide decades long care for a child who is alive (in truth undead) but oblivious to the
goings on around her.
15. That given the present lack of state of the art knowledge, in the scientific field of
Immunology, about possibly permanent irrecoverable ill effects upon the HUMAN
GENE/ DNA during the ensuing 50 to 100 years, which may likely be caused by
ongoing politically and media backed experimental vaccinations in ever spiralling
varieties with originals competing with fakes in a mad rush to obtain the vaccines, the
deliberated forcing of ingestion, inhalation & injection of diverse irritants, mRNAs,
adjuvants and sundry toxins like thimerosal, aluminum, mercury and diverse heavy
metals, all of it without a fully tested and well accepted immunological mechanism of
human genetic modification caused by vaccinations, has all the potential to distort the
HUMAN GENE/ DNA itself, in years to come. eg at VAERS Non-Domestic ID 427519
dt. 18.07.2011 (at p.70 below) “remarkable mercury toxic effect, 21,40 (ref. value 5-9,
test titer anti-corps, deletion of multiple DNA” & ID 607598 19.08.2015 (at pp.77-78
below) “Genetic investigations in 2014 showed an X-linked mutation in the cyclin-
dependent-kinase-like-5-gene that had not been identified before” See also VAERS
Non-Domestic ID 318247 dt. 07.07.2008 (at pp.53-56 below) “”
16. Over-vaccination causes reduction of irreplaceable innate genetic natural immunity of
mothers which historically immunised the new born via its mother’s milk for 2-3 years
after birth. A child who takes 5-7 years to build up her immunity to nature’s risks now
misses out on the shelter of the initial 2-3 years of mother’s immunity, forcing neonates
to be vaccinated at birth, an inherently flawed medical experiment. That there is
collateral damage by mass vaccinations, especially during a pandemic, as noted in
Document No. 495 “seropositivity suppresses innate immunity because Ag-specific
Abs outcompete NABs for binding to CoV and prevent training of innate immune
system.” [Concern COVID-19 Mass Vaccination, Geert Vanden Bossche, 03.03.2021]
[Document No. 495]
17. The multinational pharmaceutical companies, (who have an invidious presence in the
corridors of power, the WHO, and other institutions), and their chosen mouthpieces,
should not be emboldened to muffle the voices of concern, even going to the extent of
making ad hominem attacks, raised by some members of medical community itself or

vaccine industry hacks, the conservative media and the suffering (uniformed) public, in
this mad rush to sell and make blood money from medicines and vaccines. That the
financial risks to these companies, of death and loss claims from vaccines, has been
removed by fiat, hence there is no longer any restraint on the multinational
pharmaceutical companies forcing them to demonstrate with independent government/
institutionally overseen scientific long term vaccinated / unvaccinated cohort studies,
in courts of law that their vaccines are safe and effective. Most of rural India even today
abhors vaccination due to unproven safety and efficacy risks. Insurance companies are
unwilling to underwrite vaccine damage claims.
18. That a sure-fire indicator of an ethical conundrum is the waiver to the strict medical
code on advertisement provided by none other than the WHO to vaccine majors and
States Parties. This makes the ethically impermissible action legally unchallengeable
because of a global waiver by WHO and all States Parties and makes less than truthful
advertisement of vaccines legally permissible. [Principle 1 Nuremberg Code/ Kodex
1947, Permissible Medical Experiments] [Document Nos. 102 & 103] That in order to
camouflage the 1975-77 uproar caused by APVDC over widespread DPT Vaccine
Damage, [The Vaccine Damage Campaign, New Scientist, Vol. 70, No. 1001 (1976)
pp. 404-406 Document No. 125] the vaccine majors, with a gap of 30 years after the
Nuremberg Code, 1947, adopted a successful 1976-1977 strategy to quietly push for
change of the name of Reiter Syndrome (to ReA), named after Hans Conrad Julius
Reiter (February 26, 1881 – November 25, 1969) the Nazi physician imprisoned for
war crimes/ medical experiments (typhus vaccine trials on prisoners) at the
concentration camp at Buchenwald, but after release allowed to practise till his death in
1969. Many of his colleagues were hanged to death for crimes against humanity.
[Document Nos. 319 & 317 at p.1116] See also para 25 at p.85 below, para 33 at p.93
below & para 35 at pp.99-111 below. And so it was hoped that the general public would
forget the 1948 forced vaccinations and succumb to the 1975 (and now 2021)
vaccinations which are for all practical purposes mandatory, because the Hobson
Choice of No Air Travel, No Mall, No Cinema, No DG Club (Delhi), No Mumbai local
trains etc which violates Articles 14, 19 & 21 [besides Customary International Law
which treats as Crimes Against Humanity, the forcing of “Unavoidably Unsafe”
vaccinations] is being ignored by certain Courts of Record in India, the ECHR
(completely) and the US Supreme Court (partially). For inherent risk of harm and deficit

of safety protocols and the lack of proof of effectiveness of vaccines reference may be
had to Document No. 317 at p.149, pp.386-387, p.389, p.393, p.697, p.772, p.1112,
p.1271 & p.1280 & Document No. 319 at p.14, p.40, p.45, pp.275-276, p.279, p.290
& pp.1124-1125. Document No. 279 2011.02.22 Russell Bruesewitz et al v. Wyeth
LLC et al USSC Case No. 09-152 at pp.1-8 is extracted: “For the last 66 years, vaccines
have been subject to the same federal premarket approval process as prescription
drugs,……… public became much less alarmed at the threat of those diseases, and
much more concerned with the risk of injury from the vaccines themselves…….
Whereas between 1978 and 1981 only nine product-liability suits were filed against
DTP manufacturers, by the mid-1980’s the suits numbered more than 200 each year….
potential tort liability exceeded its annual sales by a factor of 200….. Despite the large
number of suits, there were many complaints that obtaining compensation for
legitimate vaccine-inflicted injuries was too costly and difficult….. A claimant may also
recover for unlisted side effects, and for listed side effects that occur at times other than
those specified in the Table, but for those the claimant must prove causation…. not
required to show that the administered vaccine was defectively manufactured, labeled,
or designed…... $250,000 for vaccine-related deaths …… awards are paid out of a fund
created by an excise tax on each vaccine dose….. significant tort liability protections
for vaccine manufacturers….. warning requirements) and have given the warning
either to the claimant or the claimant’s physician….. Act expressly eliminates liability
for a vaccine’s unavoidable, adverse side effects…. injury or death resulted from side
effects that were unavoidable… DTP vaccine manufactured by Lederle Laboratories.
It first received federal approval in 1948….. Provided that there was proper
manufacture and warning, any remaining side effects, including those resulting from
design defects, are deemed to have been unavoidable….. What the statute establishes
as a complete defense must be unavoidability (given safe manufacture and warning)
with respect to the particular design. Which plainly implies that the design itself is not
open to question35… It seems that the statute fails to mention design-defect liability “by
deliberate choice, not inadvertence.” Barnhart v. Peabody Coal Co., 537 U. S. 149,
168 (2003). Expressio unius, exclusio alterius.”
35
The dissent advocates for another possibility: “[A] side effect is ‘unavoidable’ . . . where there is no
feasible alternative design that would eliminate the side effect of the vaccine without compromising its
cost and utility.” Post, at 15 (opinion of SOTOMAYOR, J.). The dissent makes no effort to ground that
position in the text of §300aa–22(b)(1)

19. This disturbing scenario shall place the future of mankind at risk, if left only in the
hands of a few narrow specialists, whose only care is and indeed should be only for
their immediate task at hand. That this lack of oversight is real and not illusionary, given
that the oversight bodies so far constituted are of medical specialists alone. Hence what
is actually happening today is effectively without any proper oversight of the
Legislatures, the Executives and the Judiciary.
20. Let it not be forgotten that it is to the People of the World including India whose
interests these institutions are ultimately answerable to under the Constitution of India,
the other Constitutions of the World, the International Bill of Rights and Customary
International Law.
21. That a blog article from Modena, Italy dated 21.09.2018 [Document No. 404]
“Laboratory Raided after Baffling Vaccine Discovery” reports Electron Microscope
identified trace unlisted particles in vaccines [presence of heavy metals in brains of
children has been verified from Document No. 558 - 2021.06.29 Non Domestic
VAERS DATA, US CDC 187MB: See pp.69-70 VAERS ID 422383 & pp.79-84
VAERS ID 613257 01.10.2015 below] “Typhim Vi” [Lead, Ferrochrome, Silicon,
Titanium], “Tetabulin” [Silicon, Magnesium, Iron, Titanium, Aluminum, Zinc],
“Vivotif, Berna” [Iron, Aluminum, Zirconium, Hydrogen Fluoride, Strontium,
Bismuth, Chloride], “Inflexal V” [Copper, Tin, Lead, Zinc, Iron, Silicon, Aluminum,
Titanium], “Mencevax ACWY” [Iron, Chromium, Nickel, Zirconium, Aluminum,
Silicon], “Infanrix” [Titanium, Silicon], “Infanrix Hexa” [Barium, Iron, Copper,
Silicon, Magnesium, Titanium, Gold, Tin, Chromium, Zinc, Stainless steel, Nickel],
“Typherix” [Titanium, Stainless steel, aluminum, Silicon, Chromium, Barium],
“Priorix” [Stainless steel. Calcium, Iron, Copper, Silicon, Aluminum, Magnesium,
Lead, Titanium, Nickel], “Varilrix” [Iron, Zinc, Silicon, Aluminum, Titanium,
Magnesium, Zirconin, Bismuth], “Fluarix” [Aluminum, Copper, Iron, Bismuth,
Silicon, Zinc, Magnesium, Barium, Bromine, Chromium, Nickel], “Cervarix”
[Silicon, Iron, Magnesium, Calcium, Zinc, Copper, Barium, Bismuth, Chromium,
Nickel], “Dif-Tet-All” [Iron, Barium, Silicon, Aluminum, Zinc, Copper, Chromium],
“Menjugate Kit” [Silicon, Titanium, Iron, Zinc, Antimony, Stainless steel,
Zirconium], “Focctria” [Iron, Chromium, Nickel, Copper, Silicon, Aluminum,
Titanium, Zinc], “Agrippal” [Iron, Barium, Zinc, Chromium, Silicon, Lead, Bismuth,
Aluminum, Cerium, Titanium, Nickel], “Fluad” [Calcium, Silicon, Aluminum, Iron,

Titanium, Barium, Magnesium], “Menvco” [Calcium, Silicon, Aluminum, Iron,

Chromium, Nickel, Barium], “Prevnar 13” [Iron, Chromium, Stainless steel, Calcium,
Silicon, Sulfur, Nickel, Titanium, Manganese, Barium, Magnesium], “Meningitec”
[Chromium, Silicon, Iron, Nickel, Stainless steel, Calcium, Titanium, Lead,
Zirconium], “Vaxigrip” [Iron, Chromium, Nickel, Silicon, Aluminum, Zinc, Silver,
Titanium], “Stamaril Pasteur” [Calcium, Silicon, Aluminum, Iron, Chromium],
“Gardasil” [Copper, Iron, Lead, Bismuth, Calcium, Silicon, Magnesium, Barium,
Sulfur, Titanium], “Repevax” [Bismuth, Iron, Silicon, Magnesium, Barium, Calcium,
Titanium, Bromine, Gold, Copper, Silver, Chromium, Nickel, Manganese], “MMR
VaxPro” [Silicon, Iron, Chromium, Nickel, Calcium, Aluminum, Vanadium, Barium,
Platinum, Silver]. These are the similar metals found in a vaccinated child who expired
on 08.10.2013 [VAERS Non-Domestic ID 613257 dt. 01.10.2015 at pp.79-83 below –
p.83 [Heavy metals positive in thymus and brain, kidneys and liver (cobalt, nickel,
aluminum)] - pp.79-82 “intoxicated by metals…… Hosp. report 7/8-OCT2013 due to
cardio-respiratory arrest, from which he eventually died ……..possible relationship
between clinical features and vaccination….. progressive encephalopathy…."cellular
analysis" on 23FEB12 showed:…. metal intoxication and red blood cells with irregular
shape….” and another vaccinated child who suffered 100% disability – VAERS Non-
Domestic ID 422383 dt. 06.05.2011 (at pp.69-70 below) “On 18 May 2009,
myneralogram was performed and showed the following: Copper: 84.83 μg/g
Creatinine (normal range: 1.45-60); Manganese: 12.54 μg/g Creatinine (normal
range: less than 4.5); Molybdenum: 223.82 μg/g Creatinine (normal range: 9.7-100);
Selenium: 137.69 μg/g Creatinine (normal range: 12-90); Calcium: 370.59 μg/g
Creatinine (normal range: 55-245); Magnesium: 332.45 μg/g Creatinine (normal
range: 12-150); Antimony: 6.32 μg/g Creatinine (Less than 0.59); Beryllium: 1.79 μg/g
Creatinine (less than 1.2); Bismuth: 0.25 Creatinine g/L (normal range: less than 0.15);
Mercury: 5.04 Creatinine g/L (normal range: less than 1.0); Nickel : 44.11 Creatinine
g/L (normal range: less than 3.0); Palladium: 5.49 Creatinine g/L (normal range: less
than 1.4); Silver: 1.56 Creatinine g/L (normal range: less than 1.4); Lead: 41.85
Creatinine g/L (normal range: less than 5.0); Titanium: 84.26 Creatinine g/L (normal
range not provided). On 3 July 2009, urinary porphyrins profile was performed and
suggested a noticeable mercury toxic effect on bodily physiology. On 28 July 2009, lab
tests were performed and showed the following: Antimony: 99 (normal range: less than

2.0); Lead: 24 (normal range: less than 5.0); Mercury: 5.5 (normal range: less than
5.5). Analysis were performed in a foreign country and showed that the subject
presented intoxication by mercury. GBMH micrfotrace minerals analysis were
performed in a foreign country and showed that the subject presented an exaggerate
expelling of mercury and lead. Lab tests from foreign countries showed that the subject
presented mercury intoxication. The subject was diagnosed with intoxication by
mercury, bad immunological system and encephalopathy”
22. That the U.S. Supreme Court in Bruesewitz, 22.02.2011 [Russell Bruesewitz et al v.
Wyeth LLC et al, 562 U.S. 223 US SC Case No. 09-152] (Document No. 279) held
vaccines to be “UNAVOIDABLY UNSAFE.” You only have to make a call on your
mobile phone and while waiting for an answer, or tune into any radio or TV channel
and there is this bombardment of an innocent small child’s voice telling you how safe
it is to take the COVID-19 vaccination and imploring you to save others by taking the
vaccination yourself. The child most innocently assures you that the vaccine is not only
100% safe but is effective in eradicating COVID-19. Not true – See Non Domestic
VAERS DATA, US CDC 187MB, 29.06.2021. (Document No. 558- Soft copy only)
23. That the respected authors, Lucija Tomljenovic and Christopher A. Shaw in Vaccines
and Autoimmunity, Wiley-Blackwell, 2015, ISBN 9781118663431 (Document No.
338) in Chapter 4 Answers to Common Misconceptions Regarding the Toxicity of
Aluminum Adjuvants in Vaccines state at p.45:
“That the safety issue of Al in vaccines has indeed been overlooked by the regulators
(for more than 90 years while these compounds have been in use) is illustrated by the
following statement from the World Health Organization (WHO) Special Committee on
the Safety of Vaccines (WHO, 2005): “The Committee considered the safety of
adjuvants used in vaccines. This hitherto neglected subject is becoming increasingly
important given modern advances in vaccine development and manufacture.”
Dietary versus vaccine-derived Al: is there a difference?
Although Al is clearly neurotoxic, a common assertion is that humans obtain much more
Al from diet than from vaccines, and that, therefore, the adjuvant form of Al does not
represent a toxicological risk (Offit and Jew, 2003). However, this notion contradicts
basic toxicological principles. For instance, it should be obvious that the route of
exposure which bypasses the protective barriers of the gastrointestinal tract (GIT)
and/or the skin will likely require a much lower dose to produce a toxic outcome. In the

case of Al, only ∼0.25% of dietary Al is absorbed into systemic circulation (Yokel et
al., 2008), and it is rapidly filtered by the kidneys in those with healthy kidney function.
In contrast, Al hydroxide (the most common adjuvant form) injected intramuscularly
may be absorbed at nearly 100% efficiency over time (Yokel and McNamara, 2001)
and follows a completely different route in the body (i.e. accumulation in other organs,
including the spleen and the brain) (Khan et al., 2013). What is also not widely known
is that current regular human dietary consumption of Al is far from innocuous (Joshi,
1990; Rogers and Simon, 1999; Walton, 2012b). Although average estimates of total
daily intakes vary between 2 and 25mg Al/day (14–175 mg/week), individual intake in
urban societies can easily exceed 100 mg/day (700 mg/week), due to a widespread
increase in consumption of processed convenience foods, which are typically high in
Al-containing additives (Tomljenovic, 2011). In response to increased dietary intake of
Al, in 2006 the Food and Agriculture Organization (FAO) WHO Expert Committee
amended its provisional tolerable weekly intake (PTWI) for Al from 7 mg/kg/bw (490
mg/week, for an average 70 kg human) to 1mg/kg/bw (70 mg/week) (FAO/WHO, 2006).
The Committee concluded that, “aluminum compounds have the potential to affect the
reproductive system and developing nervous system at doses lower than those used in
establishing the previous PTWI and therefore [we] revised the PTWI” (FAO/WHO,
2006). The take-home message is that a large proportion of people are unwittingly
consuming significantly more Al than is considered safe by the expert food authorities
(for more details, refer to Tomljenovic (2011)).”
24. That to verify “Elements of Crime” involved in this ICL Matter it is vital to analyse in
tabular form 0.65% of 1,02,483 data points downloaded at 4:55 PM IST on 29.06.2021
from the US CDC VAERS Non-Domestic Data (187 Mb) (Document No. 558) from
07.02.1990 to 17.06.2021 from:
https://vaers.hhs.gov/data/datasets.html
A SAMPLE OF 662 DATA POINTS TAKEN FROM “EXTRACTS FROM US CDC VAERS
DATA, 29.06.2021” (Document No. 615)
107643 13.02.1998: (M0.8) pt recv vax & devel suspected encephalopathy w/convuls;dx of
pseudo lennox synd made;the reporter indicated that this event resulted in permanent disability;
114488 29.09.1998: (F1.3) pt recv vax 9SEP98 & 6hr post vax pt parents found pt collapsed &
unresponsive;pt adm to ICU & was ventilated for 3 days;12SEP98 pt died;pt COD sudden infant
synd; autopsy-hypoxic encephalopathy following out of hosp cardiac arrest;
114919 13.10.1998: (F12) pt recv vax 29MAY98 & 24JUN pt devel cardiac failure, hepatic
failure (cytolysis & hepatic encephalopathy) causing death five days later on 29JUN98;vax
induced fulminant hepatitis or aspirin induced reye's synd or metabolic disease;
162771 29.11.2000: (M33) On 7/12/00, a dose of Engerix-B [In every 1mL THIMEROSAL,
mercury assay, 1 μg; 2-PHENOXYETHANOL 5000 μg; ALUMINUM HYDROXIDE aluminum

by assay 500 μg - GSK] was given. On 8/20/00, this male subject was dx'd with encephalopathy
and optic neuritis. As of 11/20/00, at the time of the report to the authorities, the outcome was
unknown. The reporting physician considered the events to possibly related to Engerix-B Adult.
This report was received from the Spanish regulatory authorities and no further information will
be available. MRI-demyelination
162985 04.12.2000: (F43) In April, May and June 1998, the pt was vaccinated with Engerix-B
[In every 1mL THIMEROSAL, mercury assay, 1 μg; 2-PHENOXYETHANOL 5000 μg;
ALUMINUM HYDROXIDE aluminum by assay 500 μg - GSK] at a dose of 20μg and approx. 2
months later, in the middle of 8/98, the pt suddenly developed urinary incontinence, lower limbs
sensitive disorder (paresthesia and pain) and walking difficulty. Physical exam retrieved a muscle
weakness. No precise dx was made. An unspecified corticotherapy and a monthly injection of
tetracosactrin (Bynacthene) were initiated without efficiency. In 8/00, the pt was hospitalized.
Antibodies were then negative. The most recent information received on 11/22/00, reports the
outcome of the pt as not yet recovered. The reporter's causality assessment is: not specified.
Follow-up information describes the occurrence of demyelinating encephalopathy. A treatment
with amitriptyline for lower limbs pain and paresthesia were started. In 3/99, prednisolone
(Solupred) was added. In 10/99, uro-dynamic check-up showed neurogenic bladder. In 1/00,
prednisolone was stopped. The APSSAPS reported the case with the dx of multiple sclerosis and
the physician reporter's dx was demyelination encephalopathy. Causality assessment by the
AFSSAPS as dubious for Engerix-B. Anti-SSB, anti-SL and antinuclear antibodies were positive;
Anti-SSM antibodies were negative. Cerebral MRI showed areas of demyelinization
compatible with a multiple sclerosis and hypersignals at cerebral pedungulus level and the
EMG revealed peripheral disorder (moderate signs of axonal polyneuropathy of lower limbs) ;
Salivary biopsy-was grade IV, DX of Goujerot-Sjogren's Syndrome with neurological
localization was evoked;;
ON 12/00 medullar MRI-nml; Anti-HBs antibodies were positive at 53 IU/L, in the absence of a
new hepatitis B vaccination or of a supposed contact with the virus.
165526 02.02.2001: (M52) At an unspecified date in 1995 or 1996, the pt developed severe
asthenia, myalgia and fasiculations. It is currently unknown if this symptom started prior or after
the first, second, third or booster injection of Engerix. Then swallowing difficulties occurred and
a gastric catheter was set up. The pt also developed phonation and respiratory disorders. Three
diagnosis were suspected, amyotrophic lateral sclerosis, Kennedy disease or bulbo-spinal
atrophy. On 6 19/98 approximately 1 1/2 year after the Engerix-B [In every 0.5mL
THIMEROSAL, mercury assay, 0.5 μg; 2-PHENOXYETHANOL 2500 μg; ALUMINUM
HYDROXIDE aluminum by assay 250 μg - GSK] vax, the pt died.;;
The most recent information received on 1/26/01 reports the outcome of the pt as died due to
unknown cause. Follow up states that the final diagnosis was probable Kennedy syndrome with
suspected cerebral vasculitis. According to the hospital report, the first events occurred in 1997.
CT scan showed small cerebrovascular attacks. In April 1998, brain MRI showed many T2
hypersignals. Encephalopathy of a vascular etiology was suspected. According to the reporter,
the pt was suffering from bulbo-spinal atrophy. Hypothesis of amyotrophic lateral sclerosis and
Kennedy's syndrome were suggested. The most recent info received on 06/18/02. Reporter's
causality assessment: probably unrelated to drug intake. CT scan showed small strokes and brain
MRI was normal; brain MRI showed many T2 hypersignlas (04/98); CT scan-cerebrovascular
attacks.
165811 13.02.2001: (M2) This report describes the occurence of a Guillain Barre syndrome in
a 19 month old boy receiving Engerix-B [In every 0.5mL THIMEROSAL, mercury assay, 0.5 μg;
2-PHENOXYETHANOL 2500 μg; ALUMINUM HYDROXIDE aluminum by assay 250 μg -
GSK]. A judicial inquiry has been opened for this case. On 02/05/00, a dose of Engerix was
given. On 02/07/00, this boy developed suddenly, in a subfebrile context, a grippal syndrome
with impossibility to walk, swallowing disorders and difficulties in breathing. The same day, he
was hospitalized. On admission he was conscious, apyretic, bradypneic but without any given
sign of respiratory distress and presented no cyanosis. Hemodynamic status was normal. A
diagnosis of Guillain Barre Syndrome was made. A neurosurgeon involved in the legal procedure

made a diagnosis of post vaccination encephalopathy. Subsequently, he was intubated and put
under artificial ventilation. He was treated with Immunoglobulin for 5 days. Since no clinical
improvement occurred and due to the emergence of neurovegetative symptoms, a second course
of Immunoglobulin for 48 hours was administered. Currently, a slight neurological improvement
had occurred with the disappearance of the neurovegitative signs and the reapparition of muscular
tone at the level of both upper limbs. During his hospitalization, he developed also a nosocomial
pneumopathy which his currently treated with Ceflazidime and Amikacine. The evolution is
favorable. A tracheostomy was evoked, but the child's parents were reluctant to this. As of
02/01/01, at the time of this report, the events were ongoing. The reporting physician did not
assess a causal relationship. Hemodynamic status was normal on admission; neurological exam
showed a flaccid quadriplegia with areflexia without signs of pyramidal irritation as well as a
convergent strabismus; clinical exam was normal. Blood test were WBC-13,800; Serology
Cytomegalovirus-positive;;
Platelets-682,000; Liver and Kidney function tests-nml; Hydro-electrolytic work-up-nml; HIV I
and II-neg; Hep C-neg; Hep B-pending; CSF-<3 X 2, Albumin on 2/7/00-.22 g/l and on 2/17/00
3.38 g/l; Glucose 1.07; Hemoglobin-11/3 g/dl.
168618 12.04.2001: (M1.8) On 12/4/96, the pt received Infanrix [In every 0.5 mL ALUMINUM
HYDROXIDE aluminum by assay 625 μg; Residual Formaldehyde ≤100 μg and Polysorbate 80
≤100 μg - GSK] and Polio Sabin-S. Approx. 1 week, post vax, the pt developed restlessness,
slightly increased temperature alternating with apathy and sleepiness. On 12/19/96, fever of 39C
occurred followed by a severe convulsion with unconsciousness on 12/20/96. The pt had to be
shaken to recover consciousness his salivation being excessive. the vaccinee consulted a
physician who diagnosed purulent tonsillitis. Due to worsening of his general condition and to
the partial unconsciousness, he was admitted to the hospital. According to follow-up info from
06/01/2001, the hospital physician reported that two hours after hospitalization the vaccinee
again experienced a convulsion. It was noticeable that in both events on 12/20/1996 the mother
was looking after the older brother. The mother denied a further examination by an
electroencephalcorem. The vaccinee was discharged from hospital on 12/31/1996 by the mother's
request. The hospital physician did not specify the causality. The initial reporter mentioned that
in the beginning of 1/97, the pt experienced, within 24 hours, 9 episodes of convulsion. Initially,
he was dx'd with suspected epilepsy grand mal by the hospital physicians. Later they doubted it.
After these severe attacks the vaccine developed motor retardation and speech disorder and a
mental handicap. This case became a legal one, because the pt's parents claimed damages by their
lawyer. The lawyer's medical consultant suspected an encephalopathy induced by polio
vaccination. Information received on 4/5/01, did not report the outcome of the vaccines. The
reporter did not specify the causality. Further information has been requested. On 06/01/2001 the
information did not report the outcome of the event. The reporter and the hospital physician did
not specify the causality. No further info will be available. The initial reporter mentioned that in
the beginning of Jan. 1997 the vaccinee experienced within 24 hrs nine episodes of convulsion.
Initially the vaccinee was diagnosed with suspected epilepsy grand mal by the hospital physician.
Later they doubted it. After these severe attacks the vaccinee developed motor retardation, speech
disorder and a mental handicap. Information received on 06/01/2001 did not report the outcome
of the event. The reporter and the hospital physician did not specify the causality. No further info
will be available. polio sarin-12/04/1996 recurrent infections of the upper respiratory tract.
173936 07.08.2001: (F80) In 3/01, the pt was vaccinated with a 1st Engerix-B [In every 1mL
THIMEROSAL, mercury assay, 1 μg; 2-PHENOXYETHANOL 5000 μg; ALUMINUM
HYDROXIDE aluminum by assay 500 μg - GSK]. In 6/01, the pt developed fulminant B
Hepatitis, leading to or prolonging hospitalization and requiring a transfer in the resuscitation
unit. In 7/01, the pt died. Death was due to the event. The most recent information was received
on 7/31/01. The reporter's causality assessment was not specified. In July 2001, the pt
experienced vomiting, nausea, major cytolysis, petechiae, confusion and cutaneous icterus. The
pt's conditions aggravated. Diagnosis of fulminant B hepatitis was made. Biological examination
showed coagulation disorder wit prothrombin time increased. At a date as yet unknown, the pt
was transferred in the resuscitation unit. On 07/23/2001 the pt experienced shock. Diagnosis of

major hepatic failure and encephalopathy were made. On 07/24/2001, the pt died due to fulminant
B hepatitis. It was noticed that two dialysis pt were carrying hep b virus. Hepatitis B core
antibody, surface antigen-positive; polymerage chain reaction-positive;; Arteritis, diabetes
mellitus, essential hypertension, hemodialysis, renal failure, anemia, cholecystectomy
176378 17.10.2001: (M0.25) An approximately 3.5 month old male child born at the 38th week
of pregnancy by a dystoic delivery (cesarean section because of fetus-pelvis disproportion and
long labor) weighing 2.920 kg (Apgar 10/10) who on 12/06/96 was vaccinated with a 1st dose of
hepatitis b vaccine recombinant. Concomitant therapy on 12/06/96 included a 1st dose of
poliovirus vaccine (Polioral) and a 1st dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus
toxoid *Acelluvax DTP). There were no other concomitant medications. It was noted that the
child developed normally until the age of three months. Around the middle of December 1996,
the child's parents noticed the occurrence of myoclonic episodes without any apparent triggering
event. It was reported that these episodes became more and more frequent, and the child's
pediatrician advised an EEG be performed. On 02/19/97 (when the child was 5 months old)
and EEG revealed an 'alteration of the brain's electrical activity.' On 02/22/97 the child was
vaccinated with a 2nd dose of hepatitis b vaccine recombinant. Concomitant therapy on 02/22/97
included a 2nd dose of poliovirus (Polioral) and 2nd dose of diphtheria toxoid (+) pertussis
vaccine (+) tetanus toxoid (Acelluvax DTP). It was reported that three days after these
vaccinations the child's condition deteriorated, and that he was admitted to the hospital from
02/25/97 to 03/01/97 with the diagnosis of "benign myoclonic epilepsy." During
hospitalization, the child suffered from several massive myoclonic episodes daily. It was reported
that because of the persistency of these critical episodes, the child was treated with nitrazepam
(Mogadon) and then with magnesio dipropilacetato (Depamag) and clobazam (Frisium) without
any substancial clinical improvement. On 03/24/97, the child was admitted to the hospital again
where he underwent a brain MRI (results not reported), a conjunctival biopsy (normal) and a
psychometric evaluation which showed developmental delay with a developmental age of about
3-4 months (chronological age of the child being 7 months). It was reported that the child's
seizures were increasing in both frequency and intensity. In November during an episode of high
fever (39C), the child suffered from another critical seizure, which lasted for 3 minutes and was
stopped by the administration of diazepam (Valium). On 11/16/97, the patient was again
hospitalized and diagnosed with meningism-tonsillitis in subject with myoclonic epilepsy. From
this point on, the child's parents refer to several episodes characterized by a scream, clonic
movements of the upper limbs, hypotonia, and the eye being fixed and open. It was reported that
the 3rd episode occurred after the administration of MMR. The child was admitted to a rehab
for 03/98 through 04/98. On 11/20/98, the child was vaccinated with a 4th dose of poliovirus
vaccine (Imovax Polio) without reaction. In 03/99, the child sought neuropsychiatric consultation
care of a hospital were the specialists concluded that "the general elcetro-clinic picture of the
patient suggests a cerebral damage whose cause cannot be identified." During the last two
years, the child's parents refer to frequent febrile episodes, the etiology which remains unclear in
spite of the fact that numerous exams were performed. It was reported that the child's mother was
allergic to metals, and that the child's father had type II diabetes. It was noted by a business
partner that the patient experienced encephalopathy (date and details were not provided).
Epilepsy, developmental delay, encephalopathy, delay in psychomotor development, and
meningism-tonsillitis were considered by a business partner to be disabling. Follow up info
received indicated that despite several attempts, it was not possible to retrieve further info about
the case. No further info is available. Case closed.; EEG on 2/19/97-"alteration of the brain's
electrical activity";;
Routine blood work on 2/25/97-all wnl; EEG on 2/25/97-results not reported; ophthalmological
exam on 2/25/97-nml; Head CT on 2/25/97-nml; Conjunctival biopsy on 3/24/97-nml; MRI of
brain on 3/24/97-results not reported; Psychiatric evaluation on 3/24/97-Developmental delay
with developmental age of about 3-4 months; Labs-nml; EEG on 4/14/97-Massive myoclonic
episode; Neurological exam-Massive myoclonic episodes and neurological deficits;;
EEG in 9/97-Improvement in EEG pattern; 11/97 body temperature 39C; Prematurity

178961 13.12.2001: (M1.3) Information has been received from a health professional concerning
a 16 month old male who in 11/01 was vaccinated in the left arm with a 1st dose of MMRII.
[COMMENT: serious side effects of NEOMYCIN (see ingredients of MMR II, Merck Sharp &
Dohme), such as: hearing problems, ringing in your ears, or a feeling of fullness in the ears;
spinning sensation, nausea, feeling like you might pass out; loss of balance or coordination,
trouble walking; numbness or tingly feeling under your skin; muscle twitching, seizure
(convulsions); urinating less than usual or not at all; drowsiness, confusion, mood changes,
increased thirst, loss of appetite, nausea and vomiting; swelling, weight gain, feeling short of
breath; weak or shallow breathing; or severe stomach cramps, diarrhea that is watery or
bloody.] Five days, post vax, the child experienced a fever and breathing disorder. Then, within
the following night, his respiratory disorder was aggravated and in the morning he presented with
cyanosis, respiratory distress and neurological trouble (shifty eyes). He was hospitalized,
received oxygen and was ventilated. A few days later, he died. The dx was acute respiratory
distress syndrome probably of viral origin. The exact cause of death was not specified. It was
noted that he had received previous immunizations without any problem. No autopsy was
performed. No further information is available. Follow-up info from the hospital medical record
indicated that the boy was the third child of a three children family in good general state of health
and was born at 36.5 weeks of amenorrhea. He experienced varicella in July 2001. He received
his MMR on 10/15/2001. The infant did not present with any pathology and had an excellent
psychomotor development. The first symptoms appeared on 10/20/2001 with febrile syndrome
and respiratory troubles associated with a laryngitis treated with homeopathy. On 10/21/2001,
two episodes of post food vomiting occurred and the child was cyanotic and dyspneic when he
woke up. The prarents described their child as absent and with an altered behavior. There was no
notion of head injury or drug poisoning. He received prednisone and epinephrine and was
transferred to an intensive care unit. Upon admission, hemodynamic was correct, saturometry
(83%) at ambient temperature. He received oxygen by nasal route and saturation reached 92-
93%, fever was at 40 deg. C, tachycardia at 180/min. There was also dyspnea., absence of ocular
following intermittent strabismus, obnibulation and peripheral hypertonia. The ENT examination
was normal. Thorax radiography revealed a bilateral fleecy pneumopathy. Arterial garometry
showed hypoxemia reacting to oxygen without any hypercapnia. The first diagnosis was the
following: infectious pneumopathy associated with an infectious or hypoxic encephalopathy.
During hospitalization, pulmonary lesions aggravated with stubborn hypoxemia and signs of
typical and severe acute respiratory distress syndrome which necessitated intubation, ventilation
controlled with enalgesic sedation and curarisation. Pneumothorax right then left were drained
by pleurocath. A diffuse, generalized ventilated received antibiotics and received dobutamine
after placement of a central venous route and azots monoxide. The child was transferred to
another intensive care unit on the fifth day of care for severe SDRA (azote monoxide dependent)
and a therapy with oscillator and respiratory assistance were introduced. On 10/27/2001 the
child died. In conclusion, the child experienced an acute respiratory distress syndrome, probably
secondary to an infectious pulmonary pathology, from probable viral origin. It was not possible
to distinguish a hypoxic encephalopathy secondary to the SDRA and a viral infectious
encephalitis. Serum and CSF were still available. No further info is available.;;
Radiology-revealed b/l fleecy pneumopathy; ophthalmologica exam-did not follow light (papilla
with pale coloration); arterial blood gas measurement-hypoxamia reacting to oxygen w/0
hypercapnia; total heartbeat count-tachycardia; CSF glucose-glycorrachia; cerebrospinal fluid
total protein test-proteinorrhachia; cerebrospinal fluid culture-sterile; Varicella;
180555 28.01.2002: (F1) On an unspecified date in 1992, the child received a dose of Engerix-B
[In every 0.5mL THIMEROSAL, mercury assay, 0.5 μg; 2-PHENOXYETHANOL 2500 μg;
ALUMINUM HYDROXIDE aluminum by assay 250 μg - GSK]: some time later, she started to
suffer from unspecified symptoms and during 1994, she died with a dx of encephalopathy of
unknown origin, which was confirmed by autopsy and a copy of the autopsy report is not
available. The father reports that the event had been reported to local Regulatory Authority at the
time of onset and that causality assessment was not specified.;

184745 17.05.2002: (F0.7) A regulatory authority reported that an 8 month old female received
Hib-Titer mixed with Anatoxal Diteper (diphtheria and tetanus toxoids and pertussis), Polio
Sabin Oral (poliovirus vaccine live oral) and Meningitec vaccine on 9/19/00. On 9/29/00 until
3/13/01, the child experienced encephalopathy that resulted in death. Necrosia and
biochemical tests showed hyperglicinemia, so the authorities assessment was that there have been
amino acid metabolism disorders. The death has not been related to any of the vaccines that the
child received. Follow-up info received on 05/17/02. The reporting product is Meningitec.
Correspondence and info concerning aMeningitec lot number was also received.;;
Lab test abnormal NOS-biochemical test showed hyperglicinemia;
205374 25.06.2003: (F1) Information has been received from two health professionals
concerning a 12 month old female with mental retardation severity unspecified who in
approximately July 1977, was vaccinated with measles virus vaccine live (+) mumps virus
vaccine live. In July 1977, on the 13th day post vaccination, the patient developed fever with
convulsions. The spinal fluid protein was 83mg%. The patient experienced sequela with mild
ataxia syndrome in questionable encephalopathy. Upon internal review, convulsions and
encephalopathy were considered to be an other important medical event (OMIC). No further
information is available.;;
Body temp: fever; CSF 83mg%;;
Mental retardation severity unspecified;;
213049 26.11.2003: (F34) This case was reported by the regulatory authority and described the
occurrence of Hashimoto's thyroiditis in a 39 year old female vaccinated with Havrix and Engerix
B [In every 0.5mL THIMEROSAL, mercury assay, 0.5 μg; 2-PHENOXYETHANOL 2500 μg;
ALUMINUM HYDROXIDE aluminum by assay 250 μg - GSK] for hep A and B prophylaxis.
Concurrent medical conditions included amenorrhea and lipid metabolism disorders (no more
information). Historic and concurrent vaccines included TAB (typhoid, paratyphoid A, B
vaccine), four injections of Hevac B in 1985-86, one injection of GenHevac B in 1991 and one
injection of tetanus+poliomyelitis in 1992. On 9/19/94, 10/21/94 and 9/22/95, the subject
received three doses of Havrix. On 3/4/96, the subject received a booster injection of Engerix B
vaccine. In March 2001, around five years after the last injection of Engerix B and Havrix, the
subject reported Hashimoto's thyroiditis (occurred after amenorrhea), asthenia, polyalgia
inefficiently treated with antalgics, paresthesia, intense and constant pain with decreased activity
and walking difficulty. The subject was treated with Levothyrox. Biological test showed positive
anti-nuclear and anti-thyroid peroxydase antibodies. In April 2001, the subject was hospitalized.
Biological test showed positive anti-thyroglobulin antibodies. In May 2001, EMG and CPK level
were normal. Lyme's disease serology was negative. In June 2001, MRI showed a small
hypersignal. Between March 2001 and November 2001, she reported memory and concentration
difficulties, panic disorders and cephalea. In November 2001, she developed an encephalopathy
linked to her Hashimoto's thyroiditis, leading to cognitive disorders. In December 2001, a
treatment with Plaquenil was initiated. In March 2002, the subject was hospitalized. Lumbar
puncture showed a slight proteinorrachia. In April 2002, the subject complained of
breathlessness. She was treated with corticosteroid at 80mg, which improved her
symptomatology. From 5/29/02 to July 2002, doses of corticoids were gradually reduced. In July
2002, asthenia and cephalea increased. From September 2002 to February 2003, she was treated
fro metrorrhagia (non suspected adverse event) with Exacyl, Methergin and Luteran. In
November 2002, the subject was treated with Plaquenil at 200mg twice per day. In January 2003,
the subject was hospitalized, corticoid treatmeent was discontinued. Amitriptyline hydrochloride
was increased. On 1/27/03, left deltoid biopsy showed lesions of macrophagic myofascitis. From
August 20 April 2003, the subject's cephalalgias improved. In February 2003, the subject
presented with fatigability. In April 2003, the subject complained of dizziness feeling. In 2003,
the subject reported arthralgia, weakness, sleeping disorders and myalgia. At the time of
reporting, the outcome of the subject was unknown. The agency considered the macrophagic
myofascitis as unlikely related to Engerix B, Havrix, GenHevac B, Hevac B and TP vaccine. The
other events were not assessed.;;

Antinuclear antibody 1/320 Mar 2001, 1/160 Apr 2001; CPK normal May 2001; EMG normal
May 2001; TSH 3.84 Mar 2001; thyroglobulin antibody positive Apr 2001. In March 2001: anti-
thyroid peroxydase antibody: positive. Antinuclear antibody: 1/320. In April 2001: anti-thyroid
peroxydase antibody: positive. Anti-thyroglobulin antibody: positive. Antinuclear antiobdy:
1/160. In May 2001: Lyme's disease serology: negative. Electromyogram: normal. Coloscopy-
gastroscopy: normal. In June 2001: cerebral MRI, a little hypersignal in T2. In March 2002:
lumbar puncture slight proteinorrachia, no anti-TPO antibodies in the cerebrospinal fluid. On
1/27/03: left deltoid muscular biopsy: accumulation of pigmented, PAS positive macrophages in
the fascia, evoking a macrophagic myofascitis. In summer 2003: Electroencephgalogram:
abnormal, In October 2003: Sleeping investigations: sleeping impairment. Restless leg
syndrome (especially nocturnal was evoked. Information from Annual Follow-up report states
(As date 23 Feb 05). No furthur information obtainable.;;
Amenorrhea, lipid metabolism disorder, multiparity, overweight.;;
Family's medical history included her father with vascular disorders and her mother with tobacco
obstructive bronchopneumopathy.;;
226569 14.09.2004: (F0.1) A physician reported via a foreign regulatory authority the occurrence
of suspected encephalopathy in a female child who was vaccinated with diphtheria-tetanus-
pertussis(a)-poliomyelitis/haemophilus influenzae B vaccine for prophylaxis. Concurrent
medical conditions were rhinitis, conjunctivitis, mild abstipation, teething discomfort, febrile
infection with beginning pneumonia. Concurrent medications since 4/5/04 were homeopathic
drugs, unspecified. The child was very happy, friendly, kind, devoted, restful and well-balanced.
On 4/19/04 at 11:00 AM, the subject received the first dose of diphtheria-tetanus-pertussis(a)-
poliomyelitis/haemophilus influenzae B vaccine (lot number 16190/20B224), IM into the right
thigh. The subject developed recurrently screaming with high frequency, started the same day at
7 PM in the evening, and showed unusual restless (subject threw her head to and fro, moved like
a humming top, pulled her hair, no usual eye contact). The child was screaming approximately
every half an hour at night. On 4/20, the subject again developed long periods of screaming, was
aggressive and unhappy. On 4/21, the subject developed suspected brachialgia (right side). On
an unknown date the subject developed discomfort in the right hand. She used her left hand; was
clumsy with right her hand although she was right-hander. Furthermore, the subject developed
increased weeping, especially when lying down (child was sleeping in sitting position). On 5/8
and 5/9/04, the subject urinary excretion was increased. The reporting physician suspected
cerebral irritation in the meaning of an inflammation or cerebral edema. He reported suspected
encephalopathy with differential diagnosis cephalgia and suspected brachialgia with differential
diagnosis paraesthesia. The child was not presented to physician while symptoms were persistent.
Suspected encephalopathy resolved on 5/10/04, suspected brachialgia (right side) resolved on
5/8/04, screaming was persisting for almost three weeks. The other events were resolved on an
unknown date.;;
Homeopathic medication;;
Conjunctivitis; Dental Discomfort; Febrile Infection; Obstipation; Pneumonia; Rhinitis;;
244790 03.10.2005: (M28) Initial report received on Sept 22 2005 through the health authorities
(reference number 116210347). It is reported that a 28 year old male was administered the first
dose of a yellow fever vaccine (batch number nor reported) by intramuscular route on June 01
2005, the first doe of a tetanus toxoid (mfr and batch number not reported) by intramuscular route
on Jul 14 2005, the first dose of polysaccharide salmonella typhi antigen (mfr and batch number
not reported) by intramuscular route on June 14 2005, a first dose of anti hepatitis A and B
vaccine (Twinrix, batch number not reported) by intramuscular route on June 14 2005, and a
second dose of anti hepatitis A and B vaccine (Twinrix, batch number not reported) by
intramuscular route on Jul 14 2005. On Jul 15 2005, he developed myelitis and encephalopathy.
The were both considered as serious and life threatening. A MNR was performed (see lab
comments). Multifocal affectation of white periventricular substance highly suggestive of
multiple sclerosis. Presence of lesions at under tentorial level and multifocal affectation of spinal,
cervical and dorsal cord. The patient was recovered with sequelae on Jul 25 2005. No further
information is available. Case is closed;;

A MNR was performed (see lab comments): Multifocal affectation of white periventricular
substance of both cerebral hemispheres with multiple confluent lesions and no mass effect
highly suggestive of multiple sclerosis. Presence of lesions, in addition, at undertentorial level
into right brain stem and medium cerebellous pedunculus. Multifocal affectation of spinal,
cervical and dorsal cord, with centromedullary predominance spreading out to almost the whole
of them.;;
245714 20.10.2005: (UNK) Information was received from a law firm as background
information for a case in litigation. The law firm created a fact sheet which was a review of
information from a variety of sources. The fact sheet indicated that an unk number of pt's were
vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus
vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (manf unk) or a dose
of measles virus vaccine live (unspecified) (+) rubella virus vaccine live (unspecified) (manf
unk). Following vaccination the following adverse events were reported with the figures in
parentheses the number of reported cases: autism (287), Crohn's disease and other serious chronic
stomach problems (136), epilepsy (132), other forms of brain damage (including meningitis,
cerebral palsy, encephalopathy, encephalitis) (77), hearing and vision problems (81), arthritis and
arthralgia (including crippling juvenile rheumatoid arthritis) (50), behavioral and learning
problems in older children (110), myalgic encephalomyelitis and chronic fatigue (41), diabetes
(15), Guillain Barre syndrome (9), idiopathic thrombocytopenic purpura and other purpuras (6),
Subacute sclerosing panencephalitis (3), Wegener's granulamatosis (2), leukemia (1), and
multiple sclerosis (1). There were 18 reported deaths. The cause of death was unk. It was noted
that some of these children had more than one adverse reaction. upon internal review autism,
epilepsy, other forms of brain damage (including meningitis, encephalopathy, encephalitis, etc),
myalgic encephalomyelitis, Guillain Barre syndrome, Sub Acute sclerosing panencephalitis,
leukemia and multiple sclerosis were considered to be other important medical events (OMIC).
Crippling juvenile rheumatoid arthritis was considered to be disabling. No further information is
available.;;
[COMMENT: Wistar-38 (WI-38) The WI-38 cell line was developed in July 1962 at Wistar
Institute, Pennsylvania, from lung tissue taken from a therapeutically aborted fetus of about 3
months gestational age by Karolinska Institute in Sweden without the knowledge of Mrs. X]
249278 14.12.2005: (M1.43) This case was reported by the authorities and described the
occurrence of motor retardation in a 4 month old male subject who was vaccinated with
Diphtheria and tetanus toxoid and acellular pertussis vaccine (Infanrix) [In every 0.5 mL
ALUMINUM HYDROXIDE aluminum by assay 625 μg; Residual Formaldehyde ≤100 μg and
Polysorbate 80 ≤100 μg - GSK],hepatitis b vaccine (Engerix B) [In every 0.5mL THIMEROSAL,
mercury assay, 0.5 μg; 2-PHENOXYETHANOL 2500 μg; ALUMINUM HYDROXIDE aluminum
by assay 250 μg - GSK]., poliomyelitis vaccine unspecified for prophylaxis. On April 23 1999,
May 12 1998 and March 17 1998 the subject received 3rd dose, 2nd dose and 1st dose of Infanrix,
On May 12 1998 and March 17 1998 the subject received 2nd dose and 1st dose of Engerix B.
On April 23 1999, May 12 1998 and March 17 1998 the subject receive 3rd, 2nd, and 1st dose of
Poliomyelitis vaccine. The subjects psychic, neural and motor development was normal up to the
second administration of vaccines. On May 12 1998. In the time interval between the first and
second doses of vaccines, the subject developed fever, vomiting, diarrhea, episodes of
convulsions with spasms causing abnormal flexion of the head and upper limbs, generalised
muscle hypotonia and loss of consciousness, which worsened after the second administration of
vaccinations. The subject was hospitalised more than once and finally, in 2000, the following
diagnosis, severe epileptogenic encephalopathy, psychic neural and motor retardation was
made. In Aug 2003, the causal relationship between the vaccinations and the subjects illness
was stated by a Medical commission (the parents had applied for the reimbursement of their
sons damages, due to mandatory poliomyelitis, diphtheria tetanus pertussis and Hepatitis B
vaccination, according to the law. The regulatory authority reported that the events were
disabling and possibly related to vaccination with Infanrix, Engerix B and Poliomyelitis vaccine.
Further information has been requested.;;

254836 01.05.2006: (F51) Initial case was reported on 4/25/06. It was reported that a 51 year old
female pt was vaccinated with typhoid fever vaccine (Typhim VI, N in series and hepatitis A
vaccine. 15 days after vaccination, she developed polyneuritis. The symptoms were characterized
by severe pain when lying, and loss of strength in the muscle of the torso (latissimus dorsi). The
pt is treated with high dose prednisone, the outcome is unknown. Concomitant medication and
relevant medical history was not reported. More information on the outcome is expected.
Polyneuritis can be caused by several factors such as malnutrition, alcohol, infection or metabolic
diseases. In this case, the pt appears to have developed polyneuritis post/vax of both Typhim
Vi and Havrix. Since the event is temporarily associated with administration of both vaccines,
it is difficult to determine the causality due to one vaccine. It should be noted that as per product
monograph for Havrix, encephalopathy, neuropathy, myelitis, paresthesia and Guillair-Barre
syndrome have been reported following administration of Havrix. (OMIC);;
258145 08.06.2006: (F0.61) This case was reported by the regulatory authority and described the
occurrence of multi focal ischemic encephalopathy in a 7 month old female subject who was
vaccinated with hepatitis B vaccine Engerix B Pediatric [In every 0.5mL THIMEROSAL, mercury
assay, 0.5 μg; 2-PHENOXYETHANOL 2500 μg; ALUMINUM HYDROXIDE aluminum by assay
250 μg - GSK], for prophylaxis. Concurrent medication included co trimoxazole (Bactrim). On
3/27/1996, the subject received a 1st dose of Engerix B pediatric (10 μg, intramuscular, batch
number ENG1726B9). On 3/31/1996, 4 days after vaccination, the subject developed diarrhea,
vomiting and fever. Diagnosis of gastroenteritis was made. The subject was treated with co
trimoxazole Bactrim. On 4/3/1996, general status aggravated. The subject developed dehydration
and ocular revulsion. The subject was hospitalized. At the admission, she presented with shock
state and severe dehydration with sodium at 176 mmol/l. Then, she had generalized convulsions
and hyperthermia with body temperature at 42 celsius degrees. The subject was transferred to a
specialized unit. Scan showed disseminated ischemic lesions, especially at fontal lobes level of
grey nucleus and caudate nucleus (bilateral). Then MRI brain confirmed multiple ischemic
lesions and electroencephalogram showed severe diffuse suffering. Diagnosis of multiple
cerebral ischemia accident ant then ischemic encephalopathy was made. At an unspecified date,
digestive symptoms and shock improved. At the time of reporting May 2006, the events were
resolved with the following serious sequelae, bedridden encephalopathy and epilepsy. The
regulatory authority reported that the events were life threatening and dubiously related to
vaccination with Engerix B pediatric. They also considered the encephalopathy as possibly
linked to the viral gastroenteritis. No more information will be available. This case is closed.;;
Body temperature 4/3/1996 42 deg C, Electroencephalogram 4/1996 abnormal, MRI brain
abnormal, Scan 4/3/1996 abnormal, Sodium 176 mmol/L. Scan showed disseminated ischemic
lesions, especially at fontal lobes level of grey nucleus and caudate nucleus (bilateral). Then MRI
brain confirmed multiple ischemic lesions and electroencephalogram showed severe diffuse
suffering.;; Co-Trimoxazole
261819 18.08.2006: (M0.41) This case was reported in a literature article and described the
occurrence of acute metabolic acidosis in a 5 month old male subject who was vaccinated with
combined diphtheria, tetanus, pertussis (A or W not known) vaccine for prophylaxis. Concurrent
medical conditions Leigh's disease (not identified at the time of the vaccination). The child's
condition had been relatively normal before vaccination. On an unspecified date the subject
received unspecified dose of Diphtheria, tetanus, pertussis (A or W not known) (unknown).
Seven hours after vaccination with Diphtheria, tetanus, pertussis (A or W not known), the
subject experienced fever, convulsions and coma with respiratory difficulties. Routine and
biochemical examinations of the of the cerebrospinal fluid were normal. Metabolic acidosis lactic
acidemia and pyruvic acidemia were documented. He was diagnosed with an acute
encephalopathy and treated with intravenous fluids, manitol and antibiotics. The laboratory
examination results showed the following: marked elevations in urine lactic acid, pyruvic acid,
fumaric acid, and blood lactic acid. Blood amino acids and acylcarnitine profiles were normal.
Brain magnetic resonance imaging disclosed bilateral basal ganglia damage and atrophy of the
brainstem. These parameters also characterize subacute necrotizing cerebrospinal disease. He
manifested a slight improvement 3 to 7 days after treatment and the fever subsided to normal

temperatures and he gained consciousness gradually. However, feeding was difficult and he
suffered low intelligence quotient score and generalized palsies. He experienced also hypertonic
musculature of the extremities and trunk. Physiotherapy and nutrition treatments were
ineffective. His condition improved with administration of thiamine, L-carnitine, coenzyme Q10
and vitamin E. At the age of about 1 to 1 and a half year, the child died of respiratory failure,
Post mortem findings were symmetric foci, cystic cavitations with neuronal loss, and vascular
proliferation as the typical findings described in Leigh's syndrome. The author considered that
although the vaccine was not the primary cause of the acute metabolic crisis, the severe acute
episode occurred coincidentally.;; The laboratory examination results showed the following:
marked elevations in urine lactic acid, pyruvic acid, fumaric acid, and blood lactic acid. Blood
amino acids and acylcarnitine profiles were normal. Brain magnetic resonance imaging disclosed
bilateral basal ganglia damage and atrophy of the brainstem. These parameters also characterize
subacute necrotizing cerebrospinal disease. ;; Hypoglycemia, Leigh's disease, metabolic acidosis
261820 18.08.2006: (F0.58) This case was reported in a literature article and described the
occurrence of acute metabolic acidosis in a 7 month old male subject who was vaccinated with
hepatitis B (manufacturer unspecified) vaccine for prophylaxis. Concurrent medical conditions
Leigh's disease (not identified at the time of the vaccination). The child's condition had been
relatively normal before vaccination. On an unspecified date the subject received unspecified
dose of hepatitis B vaccine. Eight hours after vaccination with hepatitis B vaccine subject
experienced fever, convulsions and coma with respiratory difficulties. Routine and
biochemical examinations of the cerebrospinal fluid were normal. Metabolic acidosis, lactic
acidemia and pyruvic acidemia were documented. She was diagnosed with an acute
encephalopathy and treated with intravenous fluids, manitol and antibiotics. The laboratory
examination results showed the following: marked elevations in urine lactic acid, pyruvic acid,
fumaric acid, and blood lactic acid. Blood amino acids and acyclcarnitine profiles were normal.
Brain magnetic resonance imaging disclosed bilateral basal ganglia damage and atrophy of the
brainstem. These parameters characterize also subacute necrotizing cerebrospinal disease. She
manifested a slight improvement 3 to 7 days after treatment and the fever subsided to normal
temperatures and she gained consciousness gradually. However, feeding was difficult and she
suffered low intelligence quotient score and generalized palsies. She experienced also hypertonic
musculature of the extremities and trunk. Physiotherapy and nutrition treatments were
ineffective. Here condition improved with the administration of thiamine, L-carnitine, coenzyme
Q10 and vitamin E. At the age of about 1 to 1 and a half year, the child died of respiratory
failure. Post mortem findings were symmetric foci, cystic cavitations with neuronal loss, and
vascular proliferation as the typical findings described in Leigh's syndrome. The author
considered that although the vaccine was not the primary cause of the acute metabolic crisis, the
severe acute episode occurred coincidentally.
269926 01.02.2007: (F0.18) A 02 month old female patient, with no medical history reported,
experienced toxic encephalopathy, diarrhea and severe dehydration the same day after
receiving her 1st intramuscular dose of ActHib, batch number Z0602-1, in the left deltoid,
concomitantly with her 1st dose of OPV (other MFR) on 13 December 2006. On 13 December
2006, the patient experienced diarrhea, vomiting and sopor leading to the visit of the local
sanitary unit. The pediatrician was absent therefore the patient was hospitalized the same day.
The patient's parents told the physicians that before 2 day i.e. 13 December 2006, the patient had
cold and then threw up. Initially those episodes were occasional, however the patient's condition
got worse and she had frequent episodes of vomiting, she could not eat something, she had bowel
movements from 3-4 times/day to more than 10 times/day. She also presented with watery stools,
oliguria with yellow discoloration of urine, crying hoarse. 1.5 hour later, the patient became
soporose and twitch, with poor response and eyes turnover. The situation got worse and the
patient was transferred to an other hospital on 16 December 2006. The subjects temperature was
36.4C, R=60, P=130, BP=70/33 mmHg. The physical exam showed narcosis, shortness of breath,
breath by mouth, looking cyanotic, pale lips, marbling skin, cold peripheral limbs and trunk, poor
skin elasticity, depressed anterior fontanelle, hollow eyes, no tears when crying, staring eyes,
pupils 2.5mm, poor light reflex, nasal ala flapping obviously, rough sound of breath with coarse

rales, regular rhythm, no murmurs, abdominal distention without absent bowel sound,
hypomyotonia, pathological reflex not found. Lab test revealed WBC=22.3x 10^9/l with
N=45.4%, L=38.4%. Blood chemical indicators were abnormal revealing heart damage, liver
damage and renal damage. The patient received fasting and Oxygen inhalation, monitoring of
vital signs and polyparamaters, CEFUROXIME, NS (sodium chloride) to expand blood volume
and Sodium bicarbonate to correct acid/base balance. The baby died on 20 December 2006.
The diagnosis needed to be confirmed. According to the local doctor, the event might be related
to the vaccine.;; The subject's temperature was 97.6 degrees F, R= 60, P=130, BP=70/33 mmHg,
the physical exam showed narcosis, shortness of breath, breath by mouth, looking cyanotic, pale
lips, marbling skin, cold peripheral limbs and trunk, poor skin elasticity, depressed anterior
fontanelle, hollow eyes, no tears when crying, staring eyes, pupils 2.5 mm, poor light reflex,
"nasal ala" flapping obviously, rough sound breath with course rales, regular rhythm, no
murmurs, abdominal distention "without absent bowel sound", hypomyotonia, pathological
reflex not found. Lab tests revealed WBC= 22.3 x 10^9/L with N= 45.4%, L= 38.4%. Blood
chemical indicators were abnormal revealing heart damage, liver damage and renal damage.;;
272544 19.02.2007: (F58) This case was initially reported on 06-Feb-2007. This case concerns
a 58 year old female patient. The patient was taking concomitant levothyroxine for
hypothyroidism, omeprazole for dysphagia, and amitriptyline and citalopram for unknown
indications. The patient received typhoid vaccine, Typhim Vi, batch number Z0515-3, on 16-
Oct-2006. On 18-Oct-2006, two days post vaccination, the patient was admitted to hospital and
acute disseminated encephalopathy was confirmed on MRI scan. At the time of reporting the
patient had not yet recovered. Both the regulatory authority and reporter considered the event to
be serious.;; Acute Disseminated encephalopathy was confirmed on MRI scan.;;
AMITRIPTYLINE PO 50.0 mg, CITALOPRAM PO, LEVOTHYROXINE PO ,
OMEPRAZOLE PO,;;
272717 20.02.2007: (F2) Information has been received from a physician concerning a 35 month
old female who on 02-FEB-2007 was vaccinated with Pneumovax at 8:00 pm. There was no
concomitant medication. On 02-FEB-2007 20 seconds after vaccine application the patient
experienced anaphylactic shock and was hospitalized. At 9:30 pm aprox the patient was
placed on a pediatric intensive care unit with respiratory assistance, Resuscitation technique and
treatment were performed and on 02-FEB-2007 the patient died at 5:00am. The cause of death
was anaphylactic shock which generated peritoneal compartment syndrome, renal failure, multi
organ failure. The reporter felt the anaphylactic shock was related to therapy with Pneumovax
vaccine. Anaphylactic shock was considered to be other important medical event. Additional
information is not expected. The following is a translation of an e-mail from the primary report.
On Friday 2nd of February 2007, at 08:00pm Pneumovax 23 was administered to a female child
in an injectable (a place where injections are applied). Theoretically the vaccine was administered
in the buttock (intramuscular? Physician guess so). Her mother was holding her so the male nurse
can apply the vaccine. Her mother comments "20 seconds after the vaccine was applied, she
looked at me and her small eyed went back and faint". By car she was taken to a clinic. During
the way to the clinic, her bladder sphincter relaxed and she could feel her heart beating.
According to ER when she arrived she was on cardiac arrest. When trying to give respiratory
assistance, the anesthesiologist referred liquid in the larynx. Rescue maneuvers were done. She
was administered HC03, adrenaline, atropine and nasogastric probe was set. First she recovered
the cardiac rhythm and then the breathing, which was irregular and weak. She was then
transferred to the hospital's intensive care unit with mechanical respiratory assistance, dopa and
antibiotics. Analysis performed blood, brain computer tomography (edema), thorax X ray. She
had convulsions and oligoanuria with abdominal distention (free liquid was drained from the
peritoneal cavity), compartmental syndrome. She entered in multi organ failure and died on
February 5, 2007 at 5:00am. The physician diagnosed anaphylactic shock which was the cause
of death.;; chest x-ray 03?Feb07 Comment: Bronchoaspiration, electroencephalopathy 03?Feb07
Comment: plain, computed axial tomography 03?Feb07 Comment: Norma – Brain
272805 21.02.2007: (M1.05) This case was reported by a regulatory authority and described the
occurrence of severe acute demyelinating encephalomyelitis (ADEM) in a 12 month old male

subject who was vaccinated with Infanrix IPV Hib for prophylaxis. The subjects medical history
included severe respiratory tract infection with reduced general condition about four weeks prior
to the events in mid December 2006. These medical conditions were completely resolved after
several days. On 15 January 2007 the subject received the first dose of Infanrix Ipv Hib (0.5 ml
intramuscular, unknown thigh). Less than one day post vaccination with Infanrix Ipv Hib, on 15
January 2007, the subject experienced increased body temperature up to 38.5 deg C.
Approximately one day post vaccination with Infanrix Ipv Hib, on 16 January 2007, the subject
experienced increasing tiredness and personality change with restlessness and sleeplessness. The
subject was treated with Paracetamol on 18 January 2007. Approximately three days post
vaccination with Infanrix Ipv Hib, on 18 January 2007, the subject experienced repeatedly
episodes of fixed gaze, decreased responsiveness (not taking up contact with parents), increased
touch sensitivity and reduced fluid intake. The subject was eating normal and experienced neither
fever nor vomiting. On 18 January 2007 the subject was hospitalised for 10 days, In hospital,
severe acute demyelination encephalomyelitis was diagnosed. The event was considered to be
life threatening. Examination on admission showed reduced general condition with 10.3 kg (45
percentile), 78 cm (78 percentile), head circumference 48 cm, blood pressure 90/47 mmHg, body
temperature 36.2 deg C. Neurological examination showed somnolent agitated stated of
consciousness with repeated opening up of the eyes without searching for visual contact,
intermittent increase of touch sensitivity, specific defensive reaction, generalised ataxia, no signs
of meningism, fontanel normal. Otorhinolaryngologic examination showed left tympanic
membrane reddened, right side covered with earwax, tonsillar ring normal, palpable small
submandidular lymph node both sides. Heart and lungs were normal. Abdomen was soft, slightly
blcated, lively bowel sound, no resistances. Testicles both side descended. The skin showed
neurodermatitis with lichenification in face and on back of the hands and generalised dry skin.
All laboratory blood examinations on admission, including C reactive protein, were normal. After
admission to hospital, encephalopathy due to vaccination with considered at first due to timely
relationship. No signs of acute inflammatory disorder were observed. Due to slow improvement,
nuclear magnetic resonance was performed on 20 January 2007, which showed diffuse signal
enhancements in marrow, cortex and in basal core regions, as well as mild external cerebral
atrophy. Laboratory examinations of metabolism showed distinctly increased ammonia, but were
otherwise normal. Therefore disorder of urea cycle metabolism was considered and high calorie
infusion therapy with protein restriction was started. Blood ammonia normalized. But NMR
results did not support suspected diffuse cerebral damage due to increased ammonia. There fore
the hospital physicians suspected ADEM. Cerebrospinal fluid examination showed mild
pleocytosis with about 50-3 cells, but was otherwise normal. These results were consistent with
suspect ADEM. After exclusion of disorder of urea cycle metabolism with hyperammonemia as
far as possible the subject received high dose corticosteroid therapy with methylprednisolone.
Previous normalized ammonia level stayed normal during high dose corticosteroid therapy.
Serology for Mycoplasma was negative. Serology for other infective agents had not been
performed. During hospitalisation the subject developed mild gastroenteritis with subfebrile body
temperature and hypertension arterial (systolic blood pressure up to 130 mmHg, diastolic blood
pressure up to 80 mmHg). These events were considered to be caused by central regulatory
disturbance and during ongoing course of hospitalisation due to treatment with high dose
corticosteroid. Cerebral symptoms improved on high dose corticosteroid therapy. On 24 January
2007 the subject was discharged from hospital with residual mild neurological symptoms.
Overall diagnosis of the event was severe acute demyelination encephalomyelitis with good
prognosis (good tendency of regression). The hospital physicians considered that due to timely
relation ADEM was most probably related to respiratory infection, which had been experienced
several weeks ago. The hospital physicians considered further that, in principle, a causal
relationship of ADEM to vaccination with Infanrix Ipv Hib might be possible, but that due to
timely relation the relationship ADEM to vaccination with Infanrix Ipv Hib was unlikely. At the
time of reporting the overall outcome of the events was unspecified. The vaccination course with
Infanrix Ipv Hib was discontinued. No further information will be available.;; Alanine
aminotransferase 18Jan2007 normal, Alanine aminotransferase 20Jan2007 normal, Alanine
aminotransferase 22Jan2007 24U/L 37, amino acid level 20Jan2007 normal, Ammonia

20Jan2007 193 Umol/l, Ammonia 22Jan2007 42 umol/l, Ammonia 24Jan2007 26 umol/l,

Ammonia 27Jan2007 15 umol/l, Aspartate aminotransferase 18Jan2007 normal, Aspartate
aminotransferase 20Jan2007 normal, Aspartate aminotransferase 22Jan2007 21 U/L 37, bilirubin
total 22Jan2007 0.27 mg/dl, Blood count 18Jan2007 normal, blood count 20Jan2007 normal,
blood creatinine 18Jan2007 normal, blood creatinine 20Jan2007 normal, Blood electrolytes
18Jan2007 normal, blood electrolytes 20Jan2007 normal, blood gases 18Jan2007 normal, Blood
glucose 18Jan2007 normal, blood glucose 20Jan2007 normal, blood glucose 27Jan2007
108mg/dl, blood pressure 18Jan2007 90.47mmHg, Body temperature 15Jan2007 up to 38.5 deg
C, body temperature 18Jan2007 36.2 deg C, C reactive protein 18Jan2007 0.3mg/dl, C reactive
protein 20JAN2007 0.12 mg/dl, CSF cell count 21JAN2007 55/3, CSF culture 21Jan2007
negative, cerebrospinal fluid glucose 21Jan2007 46mg/dl, cerebrospinal fluid protein 21Jan2007
31mg/dl, diastolic blood pressure 2007 up to 80 mmHg, Head circumference 18Jan2007 48cm,
lactate 20Jan2007 1.5 mmol/l, lactate dehydrogenase 20Jan2007 normal, mycoplasma antibody
25Jan2007 negative, systolic blood pressure 2007 up to 130 mmHg, thyroid stimulating hormone
22Jan2007 1.97 uU/ml, Xanthochromia 21Jan2007 negative. Metabolic screening, performed on
20 January 2007, amino acids in urine normal, free carnitine normal, acylcarnitine normal,
homocysteine normal, fatty acids with overlength chains normal. Cranial Ultrasonography,
performed on 19 January 2007 normal, abdominal Ultrasonography, performed on 19 January
2007 splenomegaly, suspected obstipation, otherwise normal. Ocular Ultrasonography,
performed on 19 January 2007 exclusion of papillodema, no thickening of optic nerves.
Electroencephalogram EEG, preformed on 19 January 2007 normal, exclusion of encephalitis.
Cranial nuclear magnetic resonance performed on 20 January 2007 signs of external atrophy
especially in the area of the mesial temporal lobes and the sylvian fissure, enlargement of the
external subarachoid space. No signs of intracracranial or intercranial hemorrhage, as far as
determinable by NMR. No signs of fresh areas of possible infarction. Signal enhancements,
which are relatively symmetrically distributed, supratentorial and also in the core regions.
Distinctly confluent signal enhancements, especially in the are of the thalami, without signs of
diffusion disorder or disorder of blood brain barrier. Additionally, high parietal occipital, in parts
confluent signal enhancements mainly of white matter. In parts with gyral involvement and
involvement of the gray matter. Furthermore, relatively symmetrically distributed signal
enhancements in brain stem, especially dorsal of bridge of Varolius. In conclusion, the results
are consistent with acute demyelination encephalomyelitis ADEM, with relatively atypical
symmetric distribution of the involved areas and lack of B Blood brain barrier disorder.;;
Ammonia increased, dry skin all over body, lichenification, neurodermatitis;; General condition
reduced, respiratory tract infection.
274949 27.03.2007: (M0.75) It was reported in a published article, title as stated above that an
9-month-old "relatively normal" male with no family history. The patient was vaccinated
with a dose of Attenuvax (manufacturer unknown) at the age of 9 months. Twelve hours
following vaccination the patient developed a fever, convulsions, and coma with respiratory
difficulty (mild to severe). At the time she was suspected to be suffering from acute metabolic
disturbance. Routine and biochemical examinations of the cerebrospinal fluid were normal;
metabolic acidosis and hypoglycemia were documented. She was diagnosed with acute
encephalopathy and treated with intravenous fluids, mannitol, and antibiotics. He manifested a
slight improvement 3 to 7 days after treatment. His fever subsided to normal temperature and he
gained consciousness gradually. However, feeding was difficult, and he suffered low intelligence
quotient score and generalized palsies. He experienced hypertonic musculature of the extremities
and trunk. Physiotherapy and nutrition treatments were ineffective. Laboratory examinations
revealed marked elevations in urine lactic acid, pyruvic acid, fumaric acid, and blood lactic acid.
Blood amino acids and acylearnitine profiles were normal. Brain magnetic resonance imaging
disclosed bilateral basal ganglia damage and atrophy of the brainstem. These parameters
also characterize subacute necrotizing cerebrospinal disease (Leigh disease). The patient
improved with thiamine, L-carnitine, coenzyme Q10, and vitamin E, but she died from
respiratory failure at approximately age 1 to 1 1/2 years. Postmortem examination
demonstrated symmetrical foci, cystic cavitations with neuronal loss, and vascular proliferation

as the typical findings described in Leigh syndrome. If the physician had diagnosed the etiologic
disorder (Leigh syndrome) and if the physician had treated the patient before vaccinations, the
acute cerebral damage may have been prevented. No further information is available. A copy
of the published article is attached as further documentation of the patient's experience.;;
magnetic resonance imaging Brain = disclosed bilateral basal ganglia damage and atrophy of
brainstem, urine L-lactate test Marked elevation, Pyruvic acid = marked elevation, Fumaric acid
= marked elevation, serum L-lactate test Marked elevation
303518 24.01.2008; (F2) This case was reported by a healthcare professional and described the
occurrence of possible encephalopathy in a 2-year-old female subject who was vaccinated with
Infanrix (GlaxoSmithKline) [In every 0.5 mL ALUMINUM HYDROXIDE aluminum by assay
625 μg; Residual Formaldehyde ≤100 μg and Polysorbate 80 ≤100 μg - GSK], Hepatitis B
vaccine, Polio vaccine, Measles mumps rubella vaccine, for prophylaxis. The subject did not
have a medical history and she was on no treatment when she was immunised. On 11 January
2008 the subject received primary course of Infanrix (intramuscular, right deltoid), primary
course of Hepatitis B vaccine (intramuscular, left deltoid), primary course of Polio vaccine (oral),
primary course of Measles mumps rubella vaccine (intramuscular, left thigh). On 12 January
2008, 1 day after vaccination with Hepatitis B vaccine, Infanrix, measles mumps rubella
vaccine and Polio vaccine, the subject experienced fever more than 40 deg C, extreme
headache and possible encephalopathy. The subject was hospitalised on 16 January 2008. At
the time of reporting the outcome of the events was unspecified. The healthcare professional
considered the events were possibly related to vaccination with Infanrix, Hepatitis B vaccine,
Polio vaccine and Measles mumps rubella vaccine. ;;
Body temperature 12Jan2008 40deg C ;;
306627 07.03.2008; (F) Information has been received regarding a case in litigation from a
consumer concerning herself who in August 2006, was vaccinated with a dose of Varivax
(Oka/Merck). The patient indicated that the vaccine was part of the health check that was
required for staff members to screen for chickenpox and she was recommended to have the
vaccine as she had no immunity. In 2007, 16 months later, the patient stated that following the
vaccine she developed peculiar symptoms and was eventually told that she had a resultant
encephalopathy. The patient reported that she then began to suffer which can only be described
as complex partial and simple partial seizures. In all that time, she had two weeks where she felt
respite from the effects of this terrible affliction. The patient indicated that every other
day/week/month she battled the seizures and various other debilitating symptoms, and the effect
of the drugs given to her to try to suppress her brain as the only provided solution by a number
of neurological consultants. According to the patient, on that morning in August 2006, she started
the day as any other: a confident, funny, vibrant, happy, motivated, hard working, logical, driven,
diligent person and professional. Because of the vaccine, she was unable to recognize any of
those qualities in herself. The patient stated that however as of late it had worsened again not
only in that she had seizures daily, but that she also had a resultant bigeminy related to the
seizures which left her feeling worse. The patient indicated that it was for this reason that she
had to finally resign from her job. She stated that she could not function at all with the symptoms
and the unpredictability of her prognosis did not allow for any fixed short or long term plans
related to work. The patient indicated that she was not depressed, nor had she assumed a sick
role at any point in the disaster. She also stated that she was forced to seek sound competent
medical advice in another country. The patient stated that she cannot control her consciousness
or her conscious brain. She cannot control any aspect of her life. The events were considered to
be disabling and an other important medical event by the reporter. Additional information has
been requested.
318247 07.07.2008: DMD (M1.6) It has been reported in a published article as stated above that
an 18-month-old male developed hypotonia, delayed milestones, and spinal muscular atrophy
after being vaccination with RECOMBIVAX HB, MMR II, [COMMENT: serious side effects
of NEOMYCIN (see ingredients of MMR II, Merck Sharp & Dohme), such as: hearing
problems, ringing in your ears, or a feeling of fullness in the ears; spinning sensation, nausea,
feeling like you might pass out; loss of balance or coordination, trouble walking; numbness or

tingly feeling under your skin; muscle twitching, seizure (convulsions); urinating less than usual
or not at all; drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and
vomiting; swelling, weight gain, feeling short of breath; weak or shallow breathing; or severe
stomach cramps, diarrhea that is watery or bloody.]diphtheria toxoid (+) pertussis acellular
vaccine (unspecified) (+) tetanus toxoid, and MENACTRA. Macrophagic myofasciitis is a novel,
"inflammatory myopathy" described after a variety of vaccinations, almost exclusively in adults.
We examined the relevance of histological findings of this myopathy to the clinical presentation
in pediatric patients. Muscle biopsies from 8 children (7 months to 6 years old) with histological
features of macrophagic myofasciitis were reviewed and correlated with the clinical
manifestations. Patient's underwent quadriceps muscle biopsy for suspected mitochondrial
disease (4 patients), spinal muscular atrophy (2 patients), myoglobinuria (1 patient), and
hypotonia with motor delay (1 patient). All biopsies showed identical granulomas composed of
periodic acid-Schiff-positive and CD68-positive macrophages. Characteristic aluminum
hydroxide crystals were identified by electron microscopy in 2 cases. The biopsy established
diagnoses other than macrophagic myofasciitis in 5 patients: spinal muscular atrophy (2),
Duchenne muscular dystrophy (1), phospho-glycerate kinase deficiency (1), and cytochrome
c oxidase deficiency (1). Three children with manifestations and/or a family history of
mitochondrial disease had otherwise morphologically normal muscle. All children had routine
vaccinations between 2 months and 1 year before the biopsy with up to 11 intramuscular
injections, including the biopsy sites. There was no correlation between histological findings of
macrophagic myofascitis in biopsies and the clinical symptoms. We believe that macrophagic
myofasciitis represents a localized histological hallmark of previous immunization with the
aluminum hydroxide adjuvants contained in vaccines, rather than a primary or distinct
inflammatory muscle disease. Macrophagic myofasciitis was initially reported in adult patients
with myalgia, arthralgia, weakness, and fever; and histologically documented collections of
periodic acid-Schiff-positive macrophages accompanied by lympho-plasmocytic infiltrates in
muscle biopsies. Electron microscopy of these macrophages demonstrated a characteristic
intracytoplasmic inclusion identified by mass spectrometry as aluminum hydroxide, an adjuvant
used in vaccines. Because the patients were vaccinated 3 to 96 months before biopsy, the
development of the muscle lesions and the clinical symptoms were attributed to prolonged
tissue retention and an abnormal immunological response to aluminum hydroxide. The
largest published series of patients originated after an anti-hepatitis B vaccination campaign.
Subsequently several cases of this disease were reported from other countries. Despite universal
vaccination programs, myofasciitis has been rarely observed in children. Histological changes of
myofasciitis were considered as significant in some of the pediatric cases or regarded as an
incidental morphologic finding in other series of patients. We report the clinical and pathological
findings in 8 children with biopsy-proven macrophagic myofasciitis, overlapping with a variety
of neuromuscular disorders. All patients with characteristic pathological changes in muscle
biopsy were retrospectively studied. After obtaining informed consent, these patients had
undergone open quadriceps femoris biopsy under local anesthesia to evaluate suspected
neuromuscular disorders. The biopsy specimens were snap frozen in isopentane cooled with
liquid nitrogen at -70C. Enzyme histochemistry (ATPase (at 9.4, 4.6, and 4.31), reduced
nicotinamide adenine dinucleotide (NADH), succinic dehydrogenase, acid and alkaline
phosphatase, and nonspecific esterase) and routine staining (hemtoxylin-eosin (H & E) modified
Gomori trichrome, and periodic acid-Schiff reaction) were performed using established
techniques. Immunohistochemistry for the following antigens was carried out: CD68, CD20,
CD3, CD8, S-100 protein, trypsin-antitrypsin, antichymotrypsin, factor XIILA, MIB-I, and
CDIA, using a Ventana immunostainer and supplied antibody kits and/or Novocastra primary
antibodies in the recommended dilutions. In cases 3 and 5 (WAES #0807USA00005 and
#0807USA00007), with severe myopathic changes, supplementary immunohistochemistry was
performed for the following components: dystrophin (centra, carboxyl, and amino domains); a-,
b-, x-, and 8-sarcoglycan; b-dystroglycan; mcrosin; and spectrin; each with positive and negative
controls. Small tissue pieces were fixed in 1.6% glutaraldehyde for electron microscopy, and
additional samples were snap frozed for biochemical studies (subsequently carried out only in
case 7, WAES #0807USA0009). In case 8, (WAES #0807USA00010), only paraffin-embedded

material was available, limiting examination to inflammatory cell typing. All the biopsies
displayed characteristic focal collections of periodic acid-Schiff-positive and oil red O-positive
epitlhelioid macrophages, slightly basophilic cytoplasm reactive for CD68, trypsin-antitrypsin,
antichymotrypsin, acid phosphatase, and nonspecific esterase. In 3 biopsies (cases 2, 7, (WAES
#0807USA00004, #0807USA00009) and 9 these changes were accompanied by rare B-cell and
T-cell infiltrations, representing less than 10% of the inflammatory cell population. Biopsies
from cases 1 and 3 (WAES #0806USA07636 and WAES #0807USA00005) also displayed few,
small nodular collections of CD-45-positive cells composed of a mixture of CD3-, CD8-, CD20-
, and CD68-immunoreactive cells. In case 8 (WAES#0807USA00010), macrophagic infiltrate
was limited to the perimysium and fascia. Myonecrosis in conjunction with granulomas was
present in 2 cases (# 4 WAES #0807USA00006 and #5 WAES#0807USA00007). Occasional
regeneration fibers were observed in all biopsies. In 1 case, macrophage infiltrations were
accompanied by intense fibrosis (case 8 WAES #0807USA00010). In addition to collections of
macrophages, the biopsies in case 1 (8076USA07636) and case 3 (WAES #0807USA00005)
showed groups of highly atrophic rounded fibers, fiber type grouping, and markedly enlarged
type I fibers, consistent with spinal muscular atrophy, subsequently confirmed by genetic testing.
Cases 2 (WAES #0807USA00004), 4 (WAES #0807USA00006), and 6 (0807USA00008), with
the clinical diagnosis of mito chondrial diseases, showed only minimal variability in size and
shape of individual muscle fibers, without red ragged fibers or apparent abnormalities in NADH
dehydrogenase or succinic dehydrogenase. Cytochrome oxidase was normal in cases 2 (WAES
#0807USA00004) and 4 (WAES #0807USA00006), and absent in most fibers in case 6 (WAES
#0807USA00008). Case 5 (WAES #0807USA00007) showed generalized rounding, size
variability scattered enlarged dystrophic an necrotic fibers, and focal fat ingrowth; it was entirely
negative for the carboxyl domain of dystrophin. Case 7 (WAES#0807USA00009) showed
minimal variability in the size and shape of muscle fibers and marked type 1 preponderance
(more than 95% of fiber population). Biochemical testing revealed reduction of phosphoglycerate
kinase to 19% of control values. The biopsy in case 8 (WAES #0807USA00010) was available
in paraffin-embedded tissue and except for marked accumulation of macrophages and occasional
regenerating fibers, showed no abnormalities. Electron microscopy showed macrophages with
intracytoplasmic, osimophilic spicular inclusions of aluminum hydroxide in 2 cases (6
WAES#0807USA00004 and 7 WAES #0807USA00009). Plastic-embedded tissue from 4 cases
(1 WAES #0806USA07636, case 2 WAES (# 0807USA00004), case 3 WAES
(#0807USA00005), case 5 (WAES #0807USA00007) did not contain macrophages, and tissue
was not available in 2 consultation cases (case 4 WAES #0807USA00006) and case 8 (WAES
#0807USA00010). Adults with macrophagic myofasciitis usually report myalgia, arthralgia, and
other symptoms reminiscent of chronic fatigue syndrome. The original description of
macrophagic myofasciitis as a new entity, as well as the majority of subsequently reported
patients originated in a foreign country. Because the patient were previously immunized against
hepatitis B (84-86%), hepatitis A (19%) and tetanus (58%) 3-96 months before the biopsy,
difficulty in clearing aluminum from the injection site and an abnormal immune response to
prolonged tissue retention of aluminum hydroxide were considered to be the etiology of the
disease. The role of immunity was further stressed by report of cases associated with a multiple
sclerosis-like syndrome, rheumatoid arthritis, systemic lupus erythematosus, and inclusion body
myositis. Presence of circulating autoantibodies, the frequent association with DRB1 human
lymphocyte antigen genotype, and a consistent response to corticosteroids also suggested an
immune-mediated syndrome. However, the increased frequency of immunological disorders
among patients with myofasciitis can also be explained by selection bias, because many
individuals with autoimmune disease and myalgia undergo muscle biopsy. Moreover, despite
systemic myalgia, the granulomas are always limited to the injection sites and their presence may
represent coincidental focal reaction to aluminum derivatives, unrelated to the underlying
systemic or neuromuscular disease. Examples of such fortuitous associations of myofasciitis and
other conditions such as centronuclear myopathy, ocular myopathy, and facic-scapulo-humeral
dystrophy have been described previously. The selection of the deltoid muscle for vaccination as
well as biopsy site may explain the almost exclusive occurrence of this disease in the foreign
population. On the other hand, the virtual absence of this entity in adults from other countries

could be related to strict adherence to selection of the biopsy site remote from any previous
injections. To the best of our knowledge, no case of myofasciitis has been reported when a muscle
other than the site of vaccination was selected for biopsy in an adult. By analogy, the quadriceps
femoris is the site of choice for immunization as well as biopsy in all the reported pediatric cases
with this condition. Also, all our vaccinated by multiple, bilateral injections to "thigh muscles,"
from 2 months to 1 year before the biopsy of the vastus lateralis muscle. Despite world-wide
childhood immunization programs, only few pediatric cases of macrophagic myofasciitis have
been published. Another journal reported 7 children with this diagnosis out of 490 muscle
biopsies from several centers. Another journal described pathological changes consistent with
macrophagic myofasciitis in 2 of 220 pediatric muscle biopsies over an 8-year period. These
figures are similar to 8 cases in approximately 800 predominantly pediatric biopsies over a 5-
year period in our institution. One of the conceivable explanations for the rarity of in routine
pediatric biopsies is the small size of macrophage collections-usually below 1 mm in diameter in
our samples. Almost consistently, pediatric patients show poor or no correlation between the
clinical presentations and biopsy findings. Among the reported cases of childhood myofasciitis,
only 1 had clinical signs of muscle disease and improved after corticosteroid treatment, most
likely due to coincidence of myofasciitis and vasculitis. In other reports, myofasciitis was
associated with motor delay and hypotonia that was difficult to explain by muscle biopsy
findings. In 1 of these patients, it was considered a cause of motor retardation, whereas the other
reported children with this entity had unrelated medical problems. Among other foreign children
with myofasciitis 4 exhibited central nervous system disorders and none had muscle disease or
responded to corticosteroids. In a recently reported series of 7 pediatric patients from another
country, all had nonrelated neurological disease, most often mitochondrial cytopathies. Five of
our patients suffered from a clearly defined neuromuscular disorder (Duchenne muscular
dystrophy, cytochrome c oxidase deficiency, phospho-glycerate deficiency, and spinal muscular
atrophy (in 2 children). The remaining 3 children with morphologically normal muscle, had a
family history and/or clinical manifestations of serious neurological disease with lactic acidosis,
consistent with mitochondrial cytopathies. Recently, another journal described macrophagic
myofasciitis in 6 foreign children and suggested that parental consanguinity may play a role in
genetic susceptibility for this disease. Five of our patients were products of consanguineous
unions. Although unlikely, increased risk of developing an unusual vaccination site reaction due
to consanguinity remains an open question, especially in this population with frequent
intermarriages. Because of small sizes of specimens and sampling error inherent to electron
microscopy, characteristic aluminum hydroxide deposits were found only in 2 of our cases.
However, the light microscopic and immunohistochemical features were diagnostic of
macrophagic myofasciitis. These morphological changes were indistinguishable from
postvaccination granulomas in immunized patients and experimental animals. They differed from
adverse tissue reaction to intramuscular drug injections or undesirable postimmunization site
reactions that display acute inflammation with necrosis, microabscesses, eosinophils, and foreign
body granulomas. Although myonecrosis has not been seen in adults with myofasciitis, it was
obvious in 2 of our biopsies, most likely due to a greater sensitivity of the intrinsically diseased
and immature muscle of children as compared to essentially healthy adults. Muscle necrosis was
also observed in 2 of 7 pediatric patients in the study. However, because regenerating muscle
fibers have been reported in this condition, including all our cases, the presence or absence of
necrosis in the tissue could be a consequence of the time interval between immunization and
biopsy. Fiber necrosis in the biopsy of patient with Duchenne muscular dystrophy obviously
represented 1 of the morphological manifestations of the disease process. Significant doubts have
been raised about the relevance of characteristic aluminum containing lesions in muscle to
clinical manifestations of macrophagic myofasciitis. Magnetic resonance spectroscopy showed
no abnormalities in muscle energy metabolism in patients with this disease. Furthermore,
experimental injections of vaccines with aluminum hydroxide adjuvants produce persistent
lesions identical to that seen in macrophagic myofasciitis in animals that remain asymptomatic.
The incidental nature of these granulomas was also documented in a single human autopsy case.
The clinical presentations in our patients cannot be explained by the granulomas in the muscle.
Each of the reported children suffered from specific neurological disease proven by either biopsy

or supplementary clinical and biochemical studies. We conclude, therefore, that in the so-called
childhood macrophagic myofasciitis, the intramuscular aluminum-containing granulomas
represent a localized reactive process at the vaccine injection site, rather than an expression of a
specific systemic inflammatory disease. Therefore, detection of these lesions in muscle biopsy
does not preclude another coexistent muscle disease. We believe that the emergence of
macrophagic myofasciitis as an entity is a consequence of inappropriate selection of the
previously immunized muscle group for diagnostic biopsy in subjects with concomitant
neuromuscular or systemic disease. Upon internal review, developmental delay was determined
to be an other important medical event. This is one of several reports from the same source. The
other patients' experiences can be found in WAES #0806USA07636 and #0807USA00004 to
WAES #0807USA00010. A copy of the literature article is attached as further documentation of
the patient's experience.::
muscular biopsy, Type grouping, large round fibers, Spinal muscular atrophy ;;
Prophylaxis
320432 25.07.2008: DMD (F2) Initial report received on 19 June 2008 from a literature article
search. Macrophagic myofasciitis is a novel described after a variety of vaccinations, almost
exclusively in adults. We examined the relevance of histological findings of this myopathy to
the clinical presentation in pediatric patients. Muscle biopsies from 8 children (7 months to 6
years old) with histological features of macrophagic myofasciitis were reviewed and correlated
with the clinical manifestations. Patients underwent quadriceps muscle biopsy for suspected
mitochondrial disease (4 patients), spinal muscular atrophy (2 patients), myoglobinuria (1
patient), and hypotonia with motor delay (1 patient). All biopsies showed identical granulomas
composed of periodic acid-Schiff-positive and CD68-positive macrophages. Characteristic
aluminum hydroxide crystals were identified by electron microscopy in 2 cases. The biopsy
established diagnoses other than macrophagic myofasciitis in 5 patients: spinal muscular atrophy
(2), Duchenne muscular dystrophy (1), phospho-glycerate kinase deficiency (1), and
cytochrome c oxidase deficiency (1). Three children with manifestations and/or a family history
of mitochondrial disease had otherwise morphologically normal muscle. All children had routine
vaccinations between 2 months and 1 year before the biopsy, with up to 11 intramuscular
injections, including the biopsy sites. There was no correlation between histological findings of
macrophagic myofasciitis in biopsies and the clinical symptoms. We believe that macrophagic
myofasciitis represents a localized histological hallmark of previous immunization with the
aluminum hydroxide adjuvants contained in vaccines, rather than aprimary or distinct
inflammatory muscle disease. Follow-up information received on 10 July 2008 from one of
the authors of the article. It was reported that all children were foreign and immunized in a
foreign country. The author did not have any details of samples - these were routine
immunizations as required and approved by the local authorities. All children had unrelated
diseases, such as mitochondrial myopathies, spinal muscular atrophy, Duchenne muscular
dystrophy, and enzyme deficiencies. The author expected, that by now, all children but one
were dead due to causes unrelated to immunization. This case is for the fourth patient in the
literature article: An 18 month old male patient, with a neuromuscular disorder, received DPT
(manufacturer and lot # not reported), MMR (manufacturer and lot # not reported), HEPATITIS
B (manufacturer and lot # not reported) and H. INFLUENZA (manufacturer and lot # not
reported) on an unspecified date and developed biopsy-proven macrophagic myofasciitis. The
patient's history included spasticity, lactic acidosis from age 9 months, and a family history of
lactic acidosis. The muscle biopsy was obtained at 27 months of age and additional muscle
biopsy findings included focal necrosis around granuloma, normal muscle. Corrective version
created on 23 July 2008. The outcome was unknown as death was not confirmed. For this
literature article, 8 individual cases were created as follows: Case 2008-02053 for patient 1, Case
2008-02311 for patient 2, Case 2008-02312 for patient 3, Case 2008-02313 for patient 4, Case
2008-02314 for patient 5, Case 2008-02315 for patient 6, Case 2008-02317 for patient 7 and
Case 2008-02318 for patient 8. Relevant Test/Laboratory Data: Biopsy-proven macrophagic
myofasciitis at 27 months of age. Additional muscle biopsy findings included focal necrosis
around granuloma, normal muscle. ;;

Biopsy-proven macrophagic myofasciitis at 27 months of age. Additional muscle biopsy

findings included focal necrosis around granuloma, normal muscle.;;
For all 8 patient: Routine vaccinations between 2 months and 1 year before he biopsy, with up to
11 intramuscular injections, including biopsy sites. For patient 4: The patient's history included
spasticity, lactic acidosis from age 9 months, and a family history of lactic acidosis.
325528 16.09.2008: (M0.2) This case was reported by a physician in the frame of a study and
described the occurrence of severe respiratory distress in a 6-month-old male subject who was
vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included
developmental motor delay and congenital anomaly which was Ohtahara Syndrome (early-
infantile epileptic encephalopathy). Concurrent medications included Valporoic acid. On 18
March 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On
15 July 2008, 4 months after vaccination with ROTARIX, the subject experienced tonic-clonic
seizures (6 per day). He was admitted at hospital on 18 July 2008 with diagnosis of status
epilepticus. The acute treatment was diazepam but it was not resolved. He was admitted at ICU
to barbiturate coma with thiopental and mechanical ventilation. In ICU, the subject presented
pneumonia in right base with rale in both lungs with poor evolution and persistent status
epilepticus. On 19 August 2008, the patient showed severe bronchospasm and severe
respiratory distress with irreversible cardiorespiratory failure and died. The subject was
hospitalised and the physician considered the events were life-threatening. Laboratory tests
performed on 19 July 2008 and showed the following results: Blood pH: 7.37; Blood pCO2 38.5
mmHg; Blood pO2: 103.8 mmHg; Blood HCO3: 22 mEq/L; Base Excess: -3.3; Sodium: 122.5
mEq/L; Potassium: 4.07 mEq/L, Ionised Calcium: 1.03 mEq/L. Laboratory tests were performed
on 23 July 2008 and showed the following results: Hemoglobin: 11.2 g/dL; Hematocrit: 33%;
Leukocytes: 5370/mm3; Neutrophils: 4050/mm3; Lymphocytes: 760/mm3; Blood glucose: 73
mg/dL; Urea: 2 mg/dL; Creatinine: 0.4 mg/dL; Protein Total: 5.4 g/dL; Albumin: 3.5 g/dL; ALT:
17U/L; AST: 35 U/L; Alkaline phosphatase: 91 U/L; Calcium: 9.7 mEq/L; Sodium: 152 mEq/L;
Sodium: 152 mEq/L; Potassium: 5.1 mEq/L; Magnesium: 2.2 mEq/L; PT: 16.5 sec; PTT: 38.4
sec; Fibrinogen: 231 mg/ml. Laboratory tests were performed on 1 August 2008 and showed the
following results: Blood pH: 7.24; Blood pCO2: 73 mmHg; Blood pO2: 59 mmHg; Blood HCO3:
26 mEq/L; Oxygen saturation: 85%. The subject was treated with mechanical ventilation,
RANITIDINE, phenytoin, diazepam, cefotaxime, THIOPENTAL, omeprazole, albumin,
albumin (Albumin 20%), nalbuphine, methylprednisolone, vitamin K, FUROSEMIDE,
midazolam, ambroxol, normal immunoglobulin (Immune globulin), CEFTAZIDINIE,
vancomycin, metoclopramide and nifedipine. The physician considered the events were
unrelated to vaccination with ROTARIX. The subject died on 19 August 2008. Primary cause of
death was severe respiratory distress and the secondary cause of death was severe bronchospasm,
pneumonia in right base, barbiturate coma and status epilepticus. An autopsy was not performed.
No further information expected, the case has been closed.;;
Alanine aminotransferase, 23Jul2008, 17U/L; Albumin, 23Jul2008, 3.5g/dl; Alkaline
phosphatase, 23Jul2008, 91U/L; Arterial blood pH, 01Aug2008, 7.24; Aspartate
aminotransferase, 23Jul2008, 35U/L; Base excess, 19Jul2008, -3.3; Blood bicarbonate,
19Jul2008, 22mEq/L; Blood bicarbonate, 01Aug2008, 26mEq/L; Blood carbon dioxide,
19Jul2008, 38.5mmHg; Blood carbon dioxide, 01Aug2008, 73mmHg; Blood glucose,
23Jul2008, 73mg/dl; Calcium, 23Jul2008, 9.7mEq/L; Creatinine, 23Jul2008, 0.4mg/dl;
Fibrinogen, 23Jul2008, 231mg/ml; Hematocrit, 23Jul2008, 33%; Hemoglobin, 23Jul2008,
11.2g/dl; Ionized calcium, 19Jul2008, 1.03mEq/L; Leukocyte count NOS, 23Jul2008,
5370/mm3; Lymphocytes, 23Jul2008, 760/mm3; Magnesium, 23Jul2008, 2.2mEq/L; Neutrophil
count, 23Jul2008, 4050/mm3; Oxygen saturation, 01Aug2008, 85%; Oxygen tension, 19Jul2008,
103.8mmHg; Oxygen tension, 01Aug2008, 59mmHg; Partial prothrombin time, 23Jul2008,
38.4sec; Platelet count, 23Jul2008, 167000/mm3; Potassium, 19Jul2008, 4.07mEq/L; Potassium,
23Jul2008, 5.1mEq/L; Protein total, 23Jul2008, 5.4g/dl; Prothrombin time, 23Jul2008, 16.5sec;
Sodium, 19Jul2008, 122.5mEq/L; Sodium, 23Jul2008, 152mEq/L; Urea, 23Jul2008, 2mg/dl;;
Valproic acid;;
Developmental motor delay, early-infantile epileptic encephalo

338633 29.01.2009: (F19) This case was reported by the regulatory authority (number
LY20081033 and AG 0812167) and described the occurrence of multiple sclerosis in a 19-year-
old female subject who was vaccinated with ENGERIX B [In every 0.5mL THIMEROSAL,
mercury assay, 0.5 μg; 2-PHENOXYETHANOL 2500 μg; ALUMINUM HYDROXIDE aluminum
by assay 250 μg - GSK] adult (GlaxoSmithKline). Medical conditions and concurrent
medications were unspecified. On an unspecified date, the subject received a first dose of
hepatitis B vaccine (manufacture, injection site and batch unknown). On 25 June 2008, the
subject received a second dose of ENGERIX B adult (20 μg, subcutaneous, batch 429B4). On 30
June 2008, 5 days after vaccination with ENGERIX B adult, the subject experienced,
demyelinating disease of central nervous system event, associated with left hemiparesis
associated with paroxysmal contractures, important rotational vertigo and vomiting during 3
days. From 06 to 13 August 2008, the subject was hospitalised for etiologic research about
demyelinating event. She was treated with cortisone bolus at 1g daily during 3 days. In August
2008, visual evoked potentials were normal. On 06 August 2008, cerebral MRI showed
inflammatory pathology with T2 and FLAIR hypersignals. Some signals were T1 hyposignals
which evoked black holes but without contrast enhanced with gadolinium. Cerebrospinal fluid
analysis revealed inflammatory profile with 11 lymphocytic elements, cerebrospinal fluid
proteins without hypoglycorrhachia and with inflammatory immunoglobulin G index at 1.54,
immuno fixing showing oligoclonal profile. Post vaccinal anti-Hepatitis B virus serology was
negative. According to the reporter, possible post vaccinal acute disseminated encephalopathy
(immunoglobulin G index was very high) was ruled out due to this result. A medullar MRI
showed plaques on C2, C3 and C4, and dorsal plaque on D12 level. In October 2008, on
unspecified date, the subject experienced left retro-ocular pain and decreased left visual acuity.
On 24 October 2008, 7 to 10 days after retro-ocular pain occurrence, visual evoked potentials
evidenced optic retrobulbar neuritis: the subject was hospitalised for left optic neuritis retrobulbar
flare up. This event confirmed multiple sclerosis diagnosis. The subject received cortisone bolus
at 1g daily during 3 days. A long term treatment was evoked for the future. At the time of
reporting, multiple sclerosis was unresolved, and outcome of the other events was unknown. The
regulatory authority considered multiple sclerosis as unlikely related to vaccination with
ENGERIX B adult, according to the method of imputability.;;
Cerebrospinal fluid abnormal, 06Aug2008, see lab text; Nuclear magnetic resonance ima, 2008,
see lab text; Nuclear magnetic resonance ima, 06Aug2008, see lab text; Virus serology test
negative, 06Aug2008, see lab text; Visual evoked potentials, 24Oct2008, see lab text; Visual
evoked potentials norma, Aug2008, normal; On 06 August 2008, Cerebral MRI showed
inflammatory pathology with several T2 and FLAIR hypersignals. Some signals were T1
hyposignals which evoked black holes but without contrast enhanced with gadolinium.
Cerebrospinal fluid analysis: revealed inflammatory profile with 11 lymphocytic elements,
cerebrospinal fluid proteins without hypoglycorrhachia and with inflammatory immunoglobulin
G index at 1.54, immuno fixing showed oligoclonal profile. Post vaccinal anti-Hepatitis B virus
serology was negative. Medullar MRI: plaques on C2, C3 and C4, and dorsal plaque in D12
level. On 24 October 2008: visual evoked potentials evidenced optic retrobulbar neuritis.;;
The subject had no relevant medical conditions.
338862 03.02.2009: (M0.5) Information regarding PREVENAR [In every 0.5mL ALUMINUM
PHOSPHATE 125μg] was received from a healthcare professional via a regulatory authority
regarding a 5-month-old male patient who experienced encephalopathy, psychomotor retardation
and convulsions. The patient received the second dose on 30-Mar-2007. Additional suspect
medication included INFANRIX HEXA [In every 0.5mL ALUMINUM PHOSPHATE 320μg,
ALUMINUM HYDROXIDE 500μg]. The patient experienced encephalopathy, psychomotor
and convulsions on 01-Apr-2007. The events involved inpatient hospitalization. The patient
was treated for convulsions with SABRIL, DEPAKIN and KEPPRA. It is reported that the
patient is presently 27 months old and does not crawl, walk, does not respond to stimuli
and shows convulsions many times during the day. No additional information was available
at the time of this report.;;
Concomitant medications were not reported.;;

Past therapies included PREVENAR and INFANRIX HEXA on 16-Jan-2007.

363082 27.10.2009: (M1.08) Case reversioned to change PREVENAR [In every 0.5mL
ALUMINUM PHOSPHATE 125μg] to a suspect vaccine. Follow-up information received on 15-
Oct-2009 updated the events to include GUILLAIN-BARRE Syndrome, gastroenteritis, viral
infection and lab results. Information regarding MENINGITEC was received from a healthcare
professional regarding a 14-month-old male patient who experienced cough, respiratory failure,
no stools for days, hypertension, pronounced anemia, otitis media, cried painfully, encephalitis,
cardiac failure, intravenous tube sepsis, thrombocytopenia, GUILLAIN-BARRE Syndrome,
gastroenteritis and viral infection. Additional suspect medication included PREVENAR. Two
days after receiving his first MENINGITEC vaccination, the patient developed a high fever
of 39 deg. C. and cough. An ENT specialist diagnosed otitis media and treated the patient with
SUMAMED. The cough diminished. The fever and the otitis resolved. On 06-Mar-2009 the
child's parents noticed a disoriented look. His behavior was normal but he cried painfully several
times at night. The patient developed paresis in his arms and dropped his head; bending his neck
was painful and he became generally flaccid. After admission to a clinic with clinical signs of
encephalitis on 07-Mar-2009, the child was hospitalized; this event was considered to be life
threatening. An electroencephalogram performed showed signs supporting the encephalitis; an
electroneurography revealed polyneuropathy. The patient experienced no stools for days
(constipation). He later required three courses of plasmapheresis. During the third pheresis he
experienced circulatory insufficiency and was diagnosed with cardiac failure of unknown origin.
Acute respiratory failure was also reported. On multiple occasions the patient developed
hypertension which was treated with Captopril. Red blood cell transfusion was administered for
pronounced anemia. On 21-Mar-2009 high fever, increased inflammatory laboratory parameters,
and thrombocytopenia suggested catheter sepsis. Moreover, the patient was also considered to
be experiencing GUILLAIN BARRE Syndrome and a viral infection of unknown origin. His
status improved after removal of the intravenous tube, antibiotic and antimycotic treatment; his
inflammation parameters decreased and thrombocyte numbers increased. The child was
discharged on 14-Apr-2009 and was considered to be "improving". It was mentioned that the
patient received the additional following therapy medications during the course of the reported
events: NIZORAL, SOLU-MEDROL, Mannisol (Mannitol), NUBAIN, CATAFLAM,
DUPHALAC, Controloc," "Cefalekol", "Herpesin", "Lisin", "Aminoven infant", Infusamin
(amino acids nos), Furosemid (Furosemide), Protamin (protamine hydrochloride), potassium
chloride, Immunoglobulin, Meronen (meropenem), DIFLUCAN, GUTTALAX and
ALGOPYRIN. Upon follow-up it was noted that the child was hospitalized with on 02-Jul-2009
for gastroenteritis and a viral infection. Stools cultures performed were negative; the patient was
discharged on 06-Jul-2009. As of 09-Oct-2009, the child reportedly had received
electrostimulation and continues with medical gymnastic therapy. The patient can now walk with
assistance and is regaining his gait. See relevant test results below.;;
Antibody test, 00-Mar-2009, CSF/blood sampling failed to reveal Herpes-IgM, -IgA1, A2; EBV
IgM and CMV-IgM; IgG antibodies against these viruses detected; uncertain positivity for tick
antibodies; negative for mumps, enterovirus and LCM (Lymphatic choriomeningitis. Body
temperature, 00-Mar-2009, 39 deg. C.; Culture, Mar-2009, catheter flora; under cultivation;
Culture stool, 02-Jul-2009, salmonella, shigella, E. coli, yersinia entercolitica and campylobacter
could not be cultured; clostridium difficile A/B toxin was negative; Electroencephalogram, 00-
Mar-2009, repeats showed improvements; 08-Mar-2009, signs supporting encephalitis/ brain
disorder; Electroneurography, ENG: showed marked bilateral decrease in conducting velocity
and amplitudes of the motor fibers in n. medianus and n. ulnaris. Conducting velocities and
amplitudes of th fibers in the sensorial nerves of the upper extremities are normal, potentials in
similar fibers of the lower extremities of the lower extremities are absent. Severe demyelinisation
neuropathy revealed primarily suggesting GUILLAIN-BARRE syndrome; BANNWARTH
syndrome cannot be excluded; Laboratory test, 00-UNK-2009, no alterations found supporting
GUILLAIN-BARRE or encephalopathy; no tick-borne infection found; 00-Mar-2009, revealed
no bacteria or fungi; 00-Mar-2009, inflammation parameters decreased; 21-Mar-2009, revealed
"increased laboratory parameters"; Lumbar puncture, 08-Mar-2009 CSF: revealed no

pathological signs, herpes simplex negative; elevated protein; Nuclear magnetic resonance
imaging, 06-Mar-2009, no pathological signs or morphological alterations; 08-Mar-2009, normal
status of brain (parenchyma and ventricules) and spinal column; no signs of meningitis; Platelet
count, 00-Mar-2009, performed in emergency department : 84 (control value: 150 - 400); 00-
Mar-2009, thrombocyte number increased; 21-Mar-2009, thrombocytopenia; Polymerase chain
reaction, 00-Mar-2009, negative for virus herpes simplex (type 1 and 2); Protein total, 00-Mar-
2009, CSF: 229 mg/L, (150-450); Stool analysis, 00-Mar-2009, ESBL positivity, Klebsiella and
Rotavirus found; White blood cell count, 00-Mar-2009, CSF: 9;;
The patient's concurrent illness includes epidermal necrosis (acute, disseminated:reported as
Aden syndrome)
383762 29.03.2010: (F0.05) This case was reported by a regulatory authority (# PT-
INFARMED-L201003-947) and described the occurrence of nephritic syndrome in a 2-week-old
female subject who was vaccinated with ENGERIX B (GlaxoSmithKline) [In every 0.5mL
THIMEROSAL, mercury assay, 0.5 μg; 2-PHENOXYETHANOL 2500 μg; ALUMINUM
HYDROXIDE aluminum by assay 250 μg - GSK]. The subject's medical history included birth
asphyxia and toxic encephalopathy. No previous history of adverse reaction to other drugs.
Concurrent medications included Phenobarbitone, Ascorbic acid and VIGANTOL. On 3
February 2010, the subject received 1st dose of ENGERIX B (intramuscular, administration site
unknown). On 6 February 2010, 3 days after vaccination with ENGERIX B, the subject
experienced nephritic syndrome, oliguria, hematuria, ponderal increased, hypertension arterial,
complement factor c3 decreased, complement factor c4 decreased, proteinuria, generalized
edema and urticarial rash. The regulatory authority reported that the events were clinically
significant (or requiring intervention). The subject was treated with corticosteroid. At the time of
reporting, the events were improved. The regulatory authority reported that the events were
probably related to vaccination with ENGERIX B. No further information is expected, the
regulatory Authority has provided GSK with all the available information for the time being, if
they ever get any further information they will send it to GSK.;;
PHENOBARBITONE; ASCORBIC ACID; VIGANTOL (Colecalciferol + Vitamin D);;
Birth asphyxia; toxic encephalopathy
389914 03.06.2010: (M5) Case received from the Health Authorities on 25 May 2010 under a
non-reported reference number. A 5-year-old male patient with no outpatient or medical
history, no allergies, had received his intramuscular injection of IMOVAX POLIO vaccine
batch number B5952 on 15 December 2009 and his intramuscular injection of DPT vaccine
from another manufacturer batch number 73-H (numbers in series and anatomical site of
vaccinations not reported). 30 minutes after the vaccination the patient's temperature was normal
and the patient was sent back home. On 16 December 2009 at 6am the patient's temperature was
of 37.5 degrees C. On 16 December 2009, i.e. one day after vaccination, the patient
experienced "tonic/clonic"seizures defined as "sporadic convulsions" by the patient's
mother, fever, drowsiness and lethargy. The seizures were associated with apnea and cyanosis.
The patient was hospitalized. He received corrective treatment with IM RELANIUM. The patient
also suffered from post-hypoxic encephalopathy and post-vaccination total necrosis of brain
on unspecified dates. On 19 February 2010 the patient was sent to the neurological department.
The patient died on 25 February 2010 at 10 am. List of documents held by sender: Health
Authorities cover letter.;;
The patient had no outpatient or medical history, no allergies.
398756 17.09.2010: (F0.8) This case was considered medically important. Information regarding
PREVENAR was received from a healthcare professional regarding a 9-month-old female patient
who experienced encephalopathy diagnosed as Krabbe's disease. The patient received a dose in
2008. The patient experienced encephalopathy at the age of nine months, estimated date Mar-
2009, diagnosed as Krabbe's disease. The reporting physician did not consider that this could
be related to vaccination but when she proposed to vaccinate the patient's brother with
PREVENAR, the mother refused because the neurologist who took care of the patient at the
time of disease occurrence would have said that her daughter's disease could have been revealed

by vaccination with PREVENAR. The reporting physician wondered if this could be true but
declined to provide further information. The patient had not recovered. No additional information
was available at the time of this report.;;
Relevant medical history was not provided.
407744 10.11.2010:(F1.1) Information has been received from a published literature article
concerning a 13 month old generalized healthy girl who was developing normally and whose
past history was remarkable solely for prenatal sonographic detection of dolichocephaly and left
ectopic kidney during routine evaluation. She was admitted to the paediatric department of
another hospital after she developed a fever of up to 40 C degrees, 1 day after she had received
the MMRV vaccination. Her temperature did not normalize until 6 days later, at which point
she had generalized seizures for the first time. She appeared to be lethargic and encephalopathic.
The results of a computed tomography (CT) of the brain were normal. Cerebrospinal fluid (CSF)
obtained through a lumbar puncture showed 1 cell/mm3, protein of 15 mg% and glucose of 58
mg%. Serology tests for herpesvirus, enteroviruses, West Nile virus, varicella zoster virus,
cytomegalovirus, measles, rubella, and mumps, and regular cultures were negative. Diagnoses of
bacterial or viral meningitis/encephalitis or acute disseminated encephalomyelitis (ADEM) were
considered and were treated accordingly. She was started on phenobarbital for her seizures. A
metabolic survey including blood gases, blood and CSF lactate, blood ammonia, carnitine, acyl
carnitine, and biotinidase, as well as plasma and CSF amino acids were all normal. Her seizures
continued with increasing frequency. An electroencephalogram (EEG) showed slow background
compatible with encephalopathy. After phenobarbital and then hydantoin failed to control the
seizures, valproic acid with the addition of topiramate was initiated. Seventeen days after
admission, the seizures were still not controlled, but had rather increased in number. They had
switched to brief tonic seizures, with the upper extremities stretching forwards. A repeat lumbar
puncture showed 14 cells/mm3, glucose of 76 mg% and protein of 156 mg%. She then received
a course of intravenous immunoglobulin which led to no improvement, where upon she was
transferred to our service. At the time, physical and neurological examination was positive for
marked ataxia and repeated falling when she attempted to walk. She also had repeated multiple
Salaam attacks with myoclonic head flexion and arm stretching. Her EEG was compatible with
modified hypsarrhythmia. She was started on adrenocorticotrophic hormone (ACTH) protocol
(6) and the seizures promptly ceased; she became alert, her ataxia resolved, her mental status
improved, and she recovered completely within 1 week. The case was characterized by high fever
and severe encephalitis in very close temporal relationship to MMR II [COMMENT: serious
side effects of NEOMYCIN (see ingredients of MMR II, Merck Sharp & Dohme), such as:
hearing problems, ringing in your ears, or a feeling of fullness in the ears; spinning sensation,
nausea, feeling like you might pass out; loss of balance or coordination, trouble walking;
numbness or tingly feeling under your skin; muscle twitching, seizure (convulsions); urinating
less than usual or not at all; drowsiness, confusion, mood changes, increased thirst, loss of
appetite, nausea and vomiting; swelling, weight gain, feeling short of breath; weak or shallow
breathing; or severe stomach cramps, diarrhea that is watery or bloody.]. The child developed
modified hypsarrhythmia and recovered promptly with the initiation of ACTH protocol. No
culpable agent was identified in the child, and so the proximity in time between the
administration of vaccine to symptoms onset makes it reasonable to identify the vaccine as
the cause. No further information is available .;;
Head computed axial tomography, normal;;
Ectopic kidney
412004 07.12.2010: (F0.17) Initial report received on 06 Jul 2010: This patient was enrolled in
a study. The patient received the first dose of study vaccine on 10 Feb 2010, and the second dose
on 14 Apr 2010 and the third dose on 09 Jun 2010. The patient also received the concomitant
vaccines rotavirus vaccine on 10 Feb 2010 and 14 Apr 2010, DTaP-IPV-Hib on 10 Feb 2010, 14
Apr 2010 and 09 Jun 2010 and pneumococcal conjugate vaccine on 10 Feb 2010and 09 Jun 2010.
On an unspecified date in May 2010, the patient experienced unclear head trauma with right
frontal area bruising and swelling. There was no conscious change, seizure, vomiting at that time.

On an unspecified date in Jun 2010, the patient fell down from a chair and was admitted to
hospital on 24 Jun 2010. On 25 Jun 2010 the patient experienced frequent seizure attacks.
Anisocoria was noted. Brain computerised tomogram (CT) showed right subdural haemorrhage
with midline shifting to left side. On 25 Jun 2010, removal of hematoma with hemovac for
drainage was performed. Post-operation course was smooth. On 29 Jun 2010 the patient was
discharged from hospital. The investigator did not suspect a relationship between the right
subdural haemorrhage and the study vaccine. In the absence of the investigator's causality
assessment, Novartis has assessed the fall and head injury as suspected for reporting purposes.
Follow-up received on 15 Jul 2010: The investigator stated that the cause of unclear head trauma
may have been 1) Just due to an accident (favoured). 2) The patient was reported to have had
common cold for 3 days and took many drugs, before head trauma. The investigator reported
'maybe the patient had viral encephalitis or sedation by drugs and they induced patient's unclear
consciousness and fall'. 3) Child abuse. The onset date of the unclear head trauma was 24 Jun
2010. The seriousness criteria for the unclear head trauma was hospitalisation and persistence of
significant disability or incapacity. A brain CT on 28 Jun 2010 showed left SDH with collateral
function, small amount of SDH and no hydrocephalus or midline shift. The patient's frequent
seizure attacks were due to head trauma. At the time of reporting, the patient's condition was:
coma scale E 1-2, Ve Me-5, pupil 3+/3+, decreased muscle power left upper limb 1, left lower
limb 2, right upper limb 5, right lower limb 4. The patient was receiving feeding through a
neogastric (NG) tube and was using a mechanical ventilator. The patient's condition was reported
as recovered with sequelae. The investigator did not suspect a relationship between the events
and the study vaccine. Follow-up received on 27 Jul 2010: The onset date of the subdural
haemorrhage was 24 Jun 2010. Data reconciliation received on 28 Jul 2010 (prior to circulation
of previous follow-up): Patient number corrected. Follow-up received on 26 Nov 2010: A brain
magnetic resonance image (MRI) showed subdural haemorrhage 5mm thickness at right temporal
occipital and along occipital 'falx', subdural empyema (SDE) about 11mm in thickness at left
fronto-temporal, suggesting hypoxic-ischemic encephalopathy (HIE) along the medial surfaces
of right occipital lobe. An Electroencephalography (EEG) finding was indicative of diffuse
subdural haemorrhage over the left frontal-parietal-temporal region and right occipital regions
(5mm - 18mm), and left limb weakness (little improvement). It was noted that the patient 'could
not sit still'. The patient experienced 4-6 episodes of vomiting. Under the impression of
progression of chronic SDH with depressed skull over right parietal region, the patient was
hospitalised on 12 Oct 2010 for further evaluation and surgical intervention. The operation
procedure included a 'burr hole' of chronic SDH with subdural-peritoneal shunt insertion, left
side, depressed skull subdural-peritoneal cranioplasty, right side on 13 Oct 2010. The patient was
discharged on 20 Oct 2010 with Phenobarbital. At the time of reporting, the patient's condition
was still persisting. In the absence of an investigator causality assessment, Novartis has processed
the events 'hypoxic-ischaemic encephalopathy' and 'subdural empyema' as suspected for
reporting purposes. The case will be reassessed on receipt of follow-up information.;;
Coma scale, E 1-2, Ve Me -5, Pupil 3+/3+, Decreased muscle power: left upper limb 1, left lower
limb 2, right upper limb 5, right lower limb 4; Nuclear magnetic resonance imaging, Abnormal,
subdural haemorrhage 5mm thickness at right temporal occipital and along occipital 'falx',
subdural empyema (SDE) about 11mm in thickness at left fronto-temporal, suggesting hypoxic-
ischemic encephalopathy (HIE) along the medial surfaces of right occipital lobe. Another MRI
showed subdural over the left frontal-parietal-temporal region and right occipital regions (5mm
- 18mm), and left limb weakness (little improvement); 06/25/2010, Scan brain, Abnormal, Right
subdural hemorrhage with midline shifting to left side; 06/28/2010, Scan brain, Abnormal, left
SDH with midline shifting to the side; 06/28/2010, Scan brain, Abnormal, Progression of
ischaemic change over the whole hemisphere, with collateral function. Small amount of SDH,
no hydrocephalus or midline shift; Electroencephalogram, Abnormal, indicative of diffuse
cerebral function which was 'probably' more severe in the right hemisphere.;;
No other medications
412841 15.12.2010: (F68) This case was reported in a literature article and described the
occurrence of paraneoplastic encephalomyelitis in a 68-year-old female subject who was

vaccinated with influenza virus vaccine (Influenza vaccine, manufacturer unspecified).

Concurrent medical conditions included acetaminophen and penicillin allergy. She has been
raising domestic birds for the previous 4-5 months. She denied having travelled anywhere during
the 6 months before she was admitted. At unspecified time the subject was vaccinated with
unspecified dose of influenza vaccine. She was admitted because of the onset of an acute
headache with nausea and vomiting, an unsteady gait, and psychomotor retardation 2 days
after she had been given a routine influenza vaccination. She had previously been vaccinated
for influenza. She then gradually developed hypokinetic mutism, stool and urinary incontinence,
and prolonged daytime somnolence; 2 weeks after the vaccination, she was totally bedridden.
She had no perivaccination fever. Eighteen days after the vaccination, the patient was transferred
to other hospital, where she presented with psychomotor retardation and abulia; she answered
only to her name and followed only simple one-step orders during mental testing. Relevant test
results included neurological examination showing meningism, along with Brudzinski's sign and
papilledema. Her arms and legs were rigid, and her legs were hyperreflexic. Cerebrospinal fluid
tests revealed increased intracranial pressure, elevated levels of protein (158 mg/dl),
immunoglobulin G (IgG; 11.1 mg/dl), immunoglobulin A (IgA; 1.77 mg/dl), and albumin (87.2
mg/dl) with pleocytosis. A brain magnetic resonance imaging showed ventriculomegaly and
leptomeningeal enhancement in both temporo-parietooccipital areas and the ventral brainstem,
without cortical ribbon sign or demyelinating white matter change. An electroencephalogram
showed intermittent background slowing from alpha waves (8 Hz) to delta waves (1-2 Hz) on
both sides of the fronto-temporo-central areas. A somatosensory evoked potential analysis
showed normal central and peripheral responses with bilateral median nerve stimulation but no
cortical response with bilateral tibial nerve stimulation. A nerve conduction velocity exam
showed no evidence of peripheral neuropathy. She therefore was diagnosed with
encephalomyelitis. An etiological survey showed no evidence of infection, heavy metal or
substance intoxication, or metabolic or endocrine disorders. A tumor marker survey revealed
elevated carcinoembryonic antigen (119.21 ng/ml). Chest computed tomography showed one
infiltrated mass over the left upper lung; a computerized tomography guided biopsy confirmed
that it was lung adenocarcinoma. Because paraneoplastic neurology syndrome with
encephalomyelitis was suspected, an indirect immunofluorescent assay to intensively screen the
patient's CSF was used and serum for paraneoplastic antibodies: antineuronal nuclear antibody
(ANNA-1, ANNA-2, ANNA-3), anti-Purkinje cell antibody (PCA-1, PCA2, PCA-Tr),
amphiphysin, CV2, Ma family antibodies, antiglial nuclear antibody (AGNA), antineuronal
glutamic acid decarboxylase (anti-GAD) antibody, antiglutamate receptor (GluR1) antibody, and
neuromyelitis optica (NMO) antibody. The assay was negative for all these antibodies.
Comparing the chest X-ray from day 3 with that from day 16 after the onset of her neurological
deficits, a markedly increased infiltrating lung mass associated with the patient's clinical
deterioration was found. The patient was treated with dexamethasone (2.5 mg/8hours) and
gefitinib (250 mg/once daily) on day 30 after the onset of the symptoms. She was also given
mannitol for 4 weeks for her persistently increasing intracranial pressure. Her alertness and
orientation improved, but she continued to be hypokinetic and hypotalkative after the above
treatment. The target therapy for lung adenocarcinoma was shifted to erlotinib (150 mg/once
daily) after 3 months of gefitinib therapy. The subject's cognition and communication gradually
improved; she was able to speak in short phrases 4 months after the onset of the symptoms and,
with assistance, to eat, dress herself, and use the toilet without incontinence. A 6-month follow
up CSF study showed normal open pressure and an IgG level with mildly elevated total protein
and albumin. Three months after the target therapy for lung adenocarcinoma, her tumor was in
remission. The subject was currently in physical therapy to improve her ability to walk. The
author considered that the development of an acute onset and rapidly progressive
encephalomyelitis in the subject showed a close chronological correlation with her influenza
vaccination, which suggested that the immunization had triggered or mounted the
encephalopathy. On the basis of the evidence of elevated IgG and IgA in the subject's CSF, the
postvaccinal adaptive immune responses targeted cancer antigens that were shared with
structures in the nervous system, therapy causing paraneoplastic encephalomyelitis, probably
through an underlying B cell-mediated immune pathway. The fact that this patient had not had

such a post vaccinal response before, suggested an altered adaptive immunity in the presence of
lung adenocarcinoma. The author concluded that paraneoplastic encephalomielitis may occur in
a patient with lung adenocarcinoma after an influenza vaccination.;;
Albumin, 87.2mg/dl; CSF protein, 158mg/dl; CSF test, see text; Carcinoembryonic antigen,
119.21ng/ml; Computerized tomogram thorax, see text; Electroencephalogram, see text; IgA,
1.77mg/dl; IgG, 11.1mg/dl; Indirect immunofluorescence, negative; Lung biopsy, see text;
Nuclear magnetic resonance ima, see text;;
drug allergy; Penicilline allergy
414808 18.01.2011: (F0.4) Report received from the Health Authorities on 13 January 2011,
through the local affiliates under the local reference number SK20110003. A 5-month-old
female patient, with unknown medical history, was diagnosed with acute myocarditis and
encephalopathy after receiving a dose of IMOVAX POLIO (lot number D0239) and a dose of
DTAP vaccine from unknown manufacturer (lot number not reported) on 04 January 2011 by
IM route, in the antero-lateral aspect of the upper thigh. On 04 January 2011, after vaccination,
she developed severe fever. On 05 January 2011, she was admitted to hospital and the diagnosis
was acute myocarditis and encephalopathy. She died on 12 January 2011. An autopsy is
planned.;;
Unknown relevant medical history, unknown concomitant drug(s)
416163 03.02.2011: (M70) Initial report received from the Foreign Health Authority (reference
number: PB20110013) on 21 Jan 2011: This poly medicated patient had a medical history of left
knee prosthesis insertion, aortic ectasia with 2 prosthesis placement, endarterectomy, benign
prostatic hyperplasia, endobrachyoesophagus and transient ischaemic attack in 2006. The patient
received one injection of AGRIPPAL (Influenza virus vaccine, batch number: unknown) in Dec
2010. In the morning of 21 Dec 2010, the patient experienced clinical presentation of agitation
associated to fall and difficulties to pick him up. He also experienced urine leak without vomiting
or abnormal movement in a context of mild dry cough for 48 hours. On admission to emergency,
the patient was found to have arterial blood pressure at 128/77 mmHg, pulse at 100 bpm, O2
saturation at 91 then 93% from breathing ambient air (AA), fever with body temperature at 39
degree C, regular heart sounds, symmetric and clear vesicular murmur. There was no dyspnoea.
The patient presented with temporo-spatial disorientation but was well-conscious, walking
disorder and acute behavior disorder. Electrolyte blood test and complete blood cell count were
normal, with no metabolic disorder. Cerebral scanner (without injection) revealed multiple
ischemic lesions looking old and did not show haemorrhage or mass syndrome. The patient
could have taken antipsychotic prescribed for his wife. The patient was quietly disoriented at
times with few paraphasia, with no negligence, apraxia nor marked sensitive-motor deficiency.
The patient presented clinical presentation of acute febrile encephalopathy. The patient was
hospitalized and received IV Zovirax pending supplementary results. Electrolyte blood tests
showed normal values. The patient was quiet. On 22 Dec 2010, neurological exam was normal
and PCR HSV1/2 and V2V were negative. On 23 Dec 2010, the patient's body temperature was
at 38 degree C and then he was apyretic at 37.2 degree C. Cardiopulmonary auscultation was
normal. Abdomen was flexible. Neurological exam was strictly normal. Urine culture did not
show any germ. The patient was finally diagnosed with febrile confusion without etiology. The
patient recovered from the events cough, confusion, fever, agitation, fall, walking disorder, urine
leak and acute behaviour disorder. The health authority provided a possible causal relationship
for the events cough, mental confusion and fever with the vaccine.;;
KARDEGIC; LEXOMIL; ESOMEPRAZOLE; ESCITALOPRAM; ISOPTINE; APROVEL;
PERMIXON;;
Benign prostatic hyperplasia; Barrett's oesophagus;;
Aortic dilatation; Endarterectomy; 2006,Transient ischaemic attack; Knee arthroplasty
416303 07.02.2011: (M0.1) This case was reported by a regulatory authority (LT-SMCA-1296)
and described the occurrence of sepsis in a 1-month-old male subject who was vaccinated with
ENGERIX B (GlaxoSmithKline) [In every 0.5mL THIMEROSAL, mercury assay, 0.5 μg; 2-
PHENOXYETHANOL 2500 μg; ALUMINUM HYDROXIDE aluminum by assay 250 μg - GSK]..
The subject was born 40 weeks of gestation in chronic hypoxia and aspiration of green amniotic

fluid. Rating scale was 7-8 according to Apgar scores. Immediately after birth, intubation was
performed (because of suspected meconium aspiration). The subject was monitored during the
adaptation period for possible infection, but blood tests for inflammatory changes were negative.
The subject left the hospital on 3rd March 2001, his condition was good. Previous vaccination
included bacillus calmette-guerin vaccine (non-gsk) (manufacturer unspecified; route and
injection site unknown) and hepatitis B vaccine recombinant (GlaxoSmithKline; route and
injection site unknown) both given on 2 March 2001. Concurrent medications included
Phytomenadione also given on 2 March 2001. Concurrent medical conditions included amino
acid metabolism disorder (diagnosed in 2006), anemia (in September 2006, HB 107/g/l),
cardiomyopathy (since 2003, Q-T longus) and hypothyroidism (diagnosed when he was 1 year
old). At the time of the event, the subject's sister had a purulent tonsillitis, the grandmother had
a herpes labialis and a patient of the hospital where the subject was hospitalised had eyes infection
(purulent). On 4 April 2001 the subject received 2nd dose of ENGERIX B (intramuscular,
injection site unknown, batch number not provided). Three days after the vaccination, the subject
was examined by a doctor; there was no reaction to the vaccine. On 8 April 2001, 4 days after
vaccination with ENGERIX B, the subject went to the Children's intensive care unit because of
cyanosis of face, impaired breathing. On arrival the he was lethargic, sluggish response to the
environmental, and assessment in accordance with the Glasgow scale was 10 points. The subject's
condition was assessed as severe. Neuroinfection (possible encephalitis) was suspected. The
subject was hospitalised and the regulatory authority reported that the events were disabling. On
8 April 2001, 4 days after vaccination with ENGERIX B, the subject also developed somnolence,
apnea, coma, sepsis and tracheobronchitis. The subject was consulted by child neurologist on 8
April 2001: antibodies against herpes virus, cytomegalovirus and toxoplasmosis test were
negative. In blood culture grew streptococcus pneumoneae. Blood tests showed following results:
white blood cells 19.9 x 10^9 / l, C-reactive protein 81.80 mg / l, haemoglobin 83 g / l. Lumbar
puncture was performed but showed no abnormalities. Other tests were performed: heart rate 170
bpm, blood pressure 78/52 mmHg, respiratory rate 36 times per minute and chest X-ray which
showed interstitial edema symptoms. The subject was treated with antibiotics and anti-viral
medication (Antiviral) (positive dynamics of blood tests). On 9 April 2001, 5 days after
vaccination with ENGERIX Bn the subject developed tonic-clonic seizures which were
recurrent, and he was still somnolent and sluggish. On 9 April 2001, a computerized tomography
was performed: symmetrical areas of the lower density in both sides of the frontal and parietal.
There were no specific changes in electroencephalogram. Ultrasonography showed murmur
gradus I-II. The subject's condition in Pediatric intensive care unit improved, but repeated
episodes of apnea and tonic-clonic seizureswere were observed, metabolic encephalopathy, and
epilepsy debut were suspected. Diagnosis was "Sepsis septicemia. Coma. Insuff. Dust ask III ?.
Trachiobronchitis ac. Thrombophlebitis v. femoralis Aseptic ac. Symptomatic Epilepsy". The
subject was treated with Phenobarbital (10 mg 2 times a day). His condition improved (no
seizures), so he was send home. It was recommended to monitor the neurological status and to
consult the cardiologist again (because of systolic murmur). It was recommended to consult the
Human Genetics center (because of suspect toxic metabolic encephalopathy. There was no attack
till 17 Jul 2001. The neurologist confirmed the psychomotor retardation (neurodevelopment
disorder). At the end of July 2001 after a severe attack he was hospitalized. Diagnosis was
"Observatio epilepsiam aquo ad. VCC: defectos atrialis seventh". Since then, the attacks keep
recurrent: at the beginning they were apnea type, later - clonic, sometimes focal, generalized
tonic-clonic. For life-threatening seizures (Status Epilepticus), the subject was often hospitalized.
The treatment was: DEPAKINE, diazepam and clonazepam. But despite intensive treatment
respiratory failure and cardiac arrest, leading to epileptic seizure episodes were recurrent. In
November 2002, LAMICTAL was started, but seizures persisted. Child development was a
substantial lag. At the time of reporting, coma, sepsis and tracheobronchitis were resolved, apnea,
clonic-tonic convulsions, epilepsy, neurodevelopmental disorder were unresolved and the
outcome of the other events were unspecified. The regulatory authority reported that somnolence,
cyanosis, apnea, clonic-tonic convulsions, coma, epilepsy, sepsis and tracheobronchitis were
unlikely to be related to vaccination with ENGERIX B.;;

Blood culture, 08Apr2001, Strepto. pneumon; Blood pressure,. 08Apr2001, 78/52mmHg; C-

reactive protein, Apr2001, 86.10mg/l; C-reactive protein, 08Apr2001, 81.80mg/l; Chest X-ray,
08Apr2001, see text units; Computerized tomography, 09Apr2001, see textunits;
Cytomegalovirus antibody, 09Apr2001, Negativeunits; Electroencephalogram, 08Apr2001, No
changeunits; Glasgow coma scale, 08Apr2001, 10score; Heart rate, 08Apr2001, 170bpm;
Hemoglobin, 08Apr2001, 83g/l; Herpes simplex antibody, 09Apr2001, Negativeunits;
Leukocyte count NOS, 08Apr2001, 19.9x10^9/l; Lumbar puncture, 08Apr2001, Normalunits;
Respiratory rate, 08Apr2001, 36per minute; Toxoplasma serology, 09Apr2001, Negativeunits;
Ultrasound scan, 09Apr2001, See textunits; White blood cells, 08Apr2001, 19.9x10^9/l;;
Phytomenadione;;
Amino acid; Metabolism disorder; Anemia; Cardiomyopathy; Hypothyroidism;;
Amniotic Fluid Aspiration; Apgar score low; Neonatal hypoxia
416385 08.02.2011: (F0.38) This case was reported by a regulatory authority (DE-PEI-
PEI2010038744) and described the occurrence of hemorrhagic shock and encephalopathy
syndrome (HSES) in a 4-month-old female subject who was vaccinated with DTP vaccine
(manufacturer unspecified), Polio vaccine and Hib vaccine. The subject's mother had epilepsy.
In 34 weeks of gestation the mother fell down the stairs, which resulted in hemorrhage
(complication of pregnancy) and the need for section (premature baby 33 to 36 weeks). Newborn
period was probably without complications. On 13 October 1994 the subject received first dose
of DTP vaccine. On 6 December 1994 the subject received 2nd dose of DTP vaccine (unknown
route and application site), unspecified dose of Polio vaccine (oral). On the same day the subject
experienced fever and serous rhinitis. On 07 December 1994 the subject developed recurrent
vomiting and thin stools. In the morning of 09 December 1994 the subject had convulsive
symptoms and was hospitalised. This was followed by a long-lasting tonic-clonic seizure, which
ceased after treatment with DIAZEPAM and CLONAZEPAM. The subject was treated
intensively, including stabilisation of circulation. The subject developed consumptive
coagulopathy needing therapy. Artificial respiration and prophylaxis for brain edema was
necessary until 14 December 1994. In further course inflammatory signs improved under
treatment with antibiotics. There was a changing neurological status. Due to unspecific
prodromal symptoms followed by fulminant hemorrhage, hyperventilation, cardio respiratory
insufficiency and encephalopathy without pathologic germ detection, the subject was diagnosed
with hemorrhagic shock and encephalopathy syndrome (HSES), possibly a human spongiform
encephalopathy. In summary, the subject had developed gastroenteritis two days after
vaccination, followed by hemorrhagic shock, encephalopathy syndrome with circulatory shock
and consumptive coagulopathy. After acute phase the subject developed distinct neurological
defects. Further course was serious with spastic quadriparesis, epilepsy, global developmental
delay and brain damage. Additionally the subject had severe scoliosis, requiring surgery. The
events were disabling and causing permanent damage. The PEI also reported about unspecified
Hib vaccine. It was unclear, if this was a combination vaccine for DTP-Hib or if these were
separate vaccines. Follow-up information has been requested. ;;
Complication of pregnancy; maternal epilepsy; premature baby 33 to 36 weeks
417189 18.02.2011: (F72) This case was reported in a literature article and described the
occurrence of tetany in a 72-year-old female subject who was vaccinated with TEDIVAX
(GlaxoSmithKline) and TETANUS immunoglobulin. The subject's medical history included
cataract surgery on both sides. Concurrent medical conditions included small hiatal hernia,
hypercholesterolemia, hypertension arterial and oesophagitis grade B. No use of nicotine or
alcohol. Concurrent medications included Bisoprolol, Teveten, Lipanthyl, Nexiam, Sipralexa,
Human Tetanus immunoglobulin and Lorazepam. She had neither taken neuroleptics nor
prokinetics. On an unspecified date, the subject received an unspecified dose of TEDIVAX (route
unknown, unknown deltoid) due to a fall with her bike. It was purely an accidental fall without
dizziness or loss of consciousness, where she scraped her left elbow on the tarmac. 1 week after
vaccination with TEDIVAX, the subject experienced painful, contorted fingers I-IV of the left
hand, trismus and dysphagia. Therefore, she could barely eat and drink. She also showed
hypertonia of both chewing and mouth floor muscles with a small, symmetrical mouth opening

and limited tongue expulsion. The plantar reflexes were in flexion and tendon reflexes were
symmetric, but rather sharp. Examination of the ocular motor system and the other cranial nerves
were normal. The scrape was cleaned and disinfected after collection of exudate for culture. After
several days, the following new symptoms appeared: Arterial hypertension, tachycardia, urinary
retention and pearls of sweat on the left side of the forehead and left cheek. In addition, the patient
was extremely disoriented and confused, objectively confirmed by a 'mini-mental state
evaluation' with a score of 14/30. Whereas the spasticity and trismus under continuous
physiotherapy and occupational therapy progressively improved, her mental state went rather
fluctuating. One month after her admission, she was so confused and dysphasic that auto-
anamnesia and executing assignments at the clinical neurological examination were impossible.
She then scored 2/30 on the mini-mental state evaluation. The subject was hospitalised. The
thoracic and abdominal clinical examinations showed no particularities. The patient had no fever
(36.4 deg.C). She was normocard (pulse = 73 bpm) and hypertensive (184/79 mmHg). On the
left elbow a bruise could be seen. Further there were no infection signs on the limbs. The clinical
neurological examination revealed the following abnormalities: A contorted hand and forearm
left, except the little finger, and where the extension of the wrist was more rigid than the flexion.
The finger-nose test was also slightly disturbed left by the muscle spasms of the left hand. The
results of blood tests on admission were as follows C-reactive protein: 2.08 mg/l; lactate
dehydrogenase: 504 U/l; creatine kinase: 161 U/l; normal renal function, liver function and
ionogram; no leukocytosis. The [Due to memory limitations, the remainder of this text could
not be compared.] sis. The electrocardiogram showed a regular sinus rhythm and nonspecific
repolarisation dysfunction. Radiography of the left hand, wrist and forearm did not give
arguments for a fracture or a dislocation. The chest radiograph showed a normal aspect of heart
and lungs. The electroencephalogram at recording had a normal curve. Despite the recent booster
of a tetanus vaccination and the administration of HTIG the clinical picture was very suggestive
of the diagnosis of tetanus. An Electroencephalogram was done again and also a blood test and
a lumbar puncture to exclude encephalitis. The electroencephalogram showed a diffuse delayed
and epileptic disturbed curve, characterized by triphasic waves with no clear peak wave
complexes, matching an encephalopathy image. The lumbar puncture showed no signs of
inflammation 2 leukocytes/mm ^3 and a normal lactate. However, there was a slight increase in
protein concentration of 51 mg/dl and a slightly elevated IgG index of 0.73. The culture of lumbar
fluid remained sterile. Because the previous CT scan of the brains showed no obvious intracranial
abnormalities, a magnetic resonance imaging of the brain was performed 5 weeks after
admission. This one showed no evidence of encephalitis either, but extensive white matter
lesions, presumably of vascular origin ("small vessel disease") in both cerebral hemispheres and
in the brain trunk. Because of a suspicion of epileptic suffering based on the disturbed
electroencephalogram curve, valproate (Depakine) 2 x 500 mg/d was started, first through syrup,
later in tabs. The encephalopathy improved gradually. Her mental progress correlated with higher
scores on the mini-mental state evaluation and the normalization of the electroencephalogram
curve. The control electroencephalogram showed 1 and 3 weeks after starting valproate
respectively the disappearance of the epileptic activity and the normalization of the basic rhythm.
During her further hospitalization, patient received logopedia therapy for the mild dysphagia and
dysphasia. Eventually the patient spent 2 months on the internal medicine department. The
subject was treated with Penicillin G and Flagyl to prevent further production and distribution of
the tetanus toxin. Human tetanus immunoglobulin was injected to neutralize the unbound toxin
outside the central nervous system. Valium was introduced to minimize the effect of the toxin in
the central nervous system, namely the trismus and muscle spasms. Magnesium sulphate was
also administered with a second dose of tetanus toxoid. After 2 days of this treatment, a
neurological assessment showed a decline in the clinical status. The subject showed a dystonia
of the left arm with a flexion contracture of the left hand and a locked jaw. A treatment with
Catapressan was started for one month to check the autonomous signs. Depakine was started
because of suspicion of epilepsy. At her hospital discharge she had fully recovered from the
trismus and tetany, she showed normal cardiovascular parameters and she scored 21/30 on the
mini-mental state evaluation. Her continued confusion and increased risk of falling made a return
home impossible. Therefore she was transferred to a rehabilitation service for either placement

in a nursing and rest home, or living independently with home care, according to her further
evolution. At the time of reporting, the outcome of the other events was unspecified.;;
Blood culture, negative units; Blood pressure, 184/79mmHg; Body temperature, 36.4deg.C; C-
reactive protein, 2.08mg/l; CSF IgG increased, 0.73 Units; CSF lactate, normal units; CSF white
blood cell count, 2/mm^3; Cerebrospinal fluid protein, 51mg/dl; Chest X-ray, see text units;
Computerized tomogram, see text units; Creatine kinase, 161U/l; Electrocardiogram, see text
units; Electroencephalogram, normal units; Lactate dehydrogenase, 504U/l; Liver function test,
normal units; Lumbar puncture, see text units; Neurological examination, see text units; Nuclear
magnetic resonance ima, see text units; Pulse rate, 73bpm; Renal function test, normal units; X-
ray, see text units;;
Bisoprolol; Eprosartan mesylate; Fenofibrate; Esomeprazole; Escitalopram Oxalate;
Lorazepam;;
Falling off from bike; Hiatal hernia; Hypercholesterolemia; Hypertension arterial; Oesophageal
symptoms (Reflux Oesoph);;
Cataract surgery
420533 08.04.2011: (M0.96) This is a spontaneous report received from the Regulatory
Authority, Regulatory Authority report number 137473. A hospital physician (contactable
through Regulatory Authority only) referred that an 11-month-old male patient (weight reported
as 5.6kg at time of events) received the 3rd dose of PREVENAR 13, AMORPHOUS
ALUMINUM HYDROXYPHOSPHATE SULFATE aluminum by assay 125μg; POLYSORBATE
80 100μg MSD] intramuscular on 25Mar2011 at 10:00 and the 3rd dose of INFANRIX HEXA
[In every 0.5mL ALUMINUM PHOSPHATE 320μg, ALUMINUM HYDROXIDE
500μg]intramuscular on 25Mar2011 at 10:00, both as vaccination. No relevant past drug
history has been provided. The patient had a relevant history of Hypoxic-ischaemic
encephalopathy (Perinatal (III grade)), Convulsion, Dysphagia, Respiratory distress and
Gastrointestinal tube insertion (Due to hypoxic-ischaemic encephalopathy). Concomitant
medications included PROTOVIT and TACHIPIRINA. On 26Mar2011 the patient experienced
fever (body temperature (38-38.5 Centigrade). On 27Mar2011 the patient also experienced
hypotonia and sweating attack. The outcome of fever, hypotonia and sweating attack was
reported as not recovered. The patient died on 28Mar2011 at 07:00. The cause of death was
not reported.;;
Body temperature (26Mar2011): 38-38.5 degrees centigrade;;
PROTOVIT; TACHIPIRINA;;
Perinatal (III grade); convulsions; hypoxic-ischaemic encephalopathy; dysphagia; respiratory
distress; Nasogastric tube insertion due to hypoxic-ischaemic encephalopathy
422383 06.05.2011: (M0.38) [HEAVY METALS 1] This case was reported by a lawyer and
described the occurrence of pervasive developmental disorder in a 2-year-old male subject who
was vaccinated with INFANRIX-POLIO-HIB (GlaxoSmithKline), (new strain) [“PRODUCT
DE-REGISTERED IN SWEDEN ON 08.09.2020; MUST NOT BE MIXED WITH OTHER
MEDICINAL PRODUCTS” WARNING ISRAEL (GSK) APRIL 2018; In every 0.5mL
AMORPHOUS ALUMINUM HYDROXYPHOSPHATE SULFATE aluminum by assay 500μg;
POLYSORBATE 80 50μg] PRIORIX, (non-GSK) HBVAXPRO, (non-GSK) PENTAVAC,
(non-GSK) C MENINGOCOCCAL, (non-GSK) PREVENAR, (non-GSK) MENJUGATE
and (non-GSK) VARIVAX. On 19 August 2005, the subject received unspecified dose of
HBVAXPRO (unknown route of administration). On 15 September 2005, the subject received
unspecified dose of HEP B (Non-GSK) (unknown route of administration). On 19 October 2005,
the subject received unspecified dose of PENTAVAC (unknown route of administration) and
unspecified dose of C MENINGOCOCCAL (unknown route of administration). On 11
November 2005, the subject received unspecified dose of PREVENAR (unknown route of
administration). On 15 December 2005, the subject received unspecified dose of INFANRIX-
POLIO-HIB (unknown route of administration) and unspecified dose of MENJUGATE
(unknown route of administration). On 25 January 2006, the subject received unspecified dose
of PREVENAR (unknown route of administration). On 22 February 2006, the subject received
unspecified dose of INFANRIX-POLIO-HIB (unknown route of administration). On 8

September 2006, the subject received unspecified dose of PREVENAR (unknown route of
administration). On 8 November 2006, the subject received unspecified dose of VARIVAX
(unknown route of administration) and unspecified dose of PRIORIX (unknown route of
administration). On 5 February 2007, the subject received unspecified dose of MENJUGATE
(unknown route of administration) and unspecified dose of PENTAVAC (unknown route of
administration). On an unspecified date (at the age of two), within months of vaccination with
INFANRIX-POLIO-HIB, PRIORIX, C MENINGOCOCCAL vaccine, HEP B (Non-GSK),
MENJUGATE, PENTAVAC, PREVENAR and VARIVAX, the subject didn't talk and he was
hospitalized several times admitted in the ER due to every cold he presented finalized in a
bronchitis or pneumonia (his immune system was very depressed). He was diagnosed of
pervasive developmental disorder. On 18 May 2009, myneralogram was performed and
showed the following: Copper: 84.83 μg/g Creatinine (normal range: 1.45-60); Manganese: 12.54
μg/g Creatinine (normal range: less than 4.5); Molybdenum: 223.82 μg/g Creatinine (normal
range: 9.7-100); Selenium: 137.69 μg/g Creatinine (normal range: 12-90); Calcium: 370.59 μg/g
Creatinine (normal range: 55-245); Magnesium: 332.45 μg/g Creatinine (normal range: 12-150);
Antimony: 6.32 μg/g Creatinine (Less than 0.59); Beryllium: 1.79 μg/g Creatinine (less than
1.2); Bismuth: 0.25 Creatinine g/L (normal range: less than 0.15); Mercury: 5.04 Creatinine g/L
(normal range: less than 1.0); Nickel : 44.11 Creatinine g/L (normal range: less than 3.0);
Palladium: 5.49 Creatinine g/L (normal range: less than 1.4); Silver: 1.56 Creatinine g/L (normal
range: less than 1.4); Lead: 41.85 Creatinine g/L (normal range: less than 5.0); Titanium: 84.26
Creatinine g/L (normal range not provided). On 3 July 2009, urinary porphyrins profile was
performed and suggested a noticeable mercury toxic effect on bodily physiology. On 28 July
2009, lab tests were performed and showed the following: Antimony: 99 (normal range: less than
2.0); Lead: 24 (normal range: less than 5.0); Mercury: 5.5 (normal range: less than 5.5). Analysis
were performed in a foreign country and showed that the subject presented intoxication by
mercury. GBMH micrfotrace minerals analysis were performed in a foreign country and showed
that the subject presented an exaggerate expelling of mercury and lead. Lab tests from foreign
countries showed that the subject presented mercury intoxication. The subject was diagnosed
with intoxication by mercury, bad immunological system and encephalopathy. According to the
mother the subject improved a lot due to supplements, biological diet and treatment in a
hyperbaric chamber and private teachers.;;
Hair copper, 18May2009, 84.83IU; Hair mercury, 18May2009, 5.04IU; Hair mercury,
28Jul2009, 5.5IU; Porphyrins urine, 03Jul2009, See text NA;;
Antibiotics;;
Immunodepression;;
Surgery; Urinary reflux
427518 18.07.2011: (F6) born healthy, now 100% disability, psychomotor retardation,
hypofisa corpus callosum, encephalopathy, she couldn't walk any more, she tends to fall down
when she stays on her legs, epilepsy resistent on remedies, Sy West psychomotor anxiety, doesn't
eat solid food, hyperactive, before the event had ataxic walking, attention distracted,
disinterested, echolalia, doctors denied any connection between previous DTPr vaccination
(on 06/17/2002) and health deterioration, then, after second DTPr dose ( on 04/01/2008) she
has been immunuzed again!
IgG 3,43, IgA 0,28, IgM 0,76 Bordatella pertussis (+) although vaccinated on 06/17/2002 and
hospitalized on 10/23/2002, for us unexplained data;;
BCG 02/21/2002, DTPr polio 06/17/2002, 04/02/2008, 05/16/2008;;
hyperactive, epilepsy resistent on remedies, psycho motor anxiety, echolalia, hypocalzaemia,
427519 18.07.2011: (M0.54) born healthy, now 100% disability, three days after the
immunization temperature 41 grade Celsius, went in neurological status of coma, was in coma
for month and half, then awakened, stopped to walk forever- use wheel chair now, diagnosis
global developmental delay, post pertussis encephalopathy;;
remarkable mercury toxic effect, 21,40 (ref. value 5-9, test titer anti-corps, deletion of
multiple DNA;;
BCG 02/01/2002, DTPr polio 06/14/2002, 07/16/2002, 08/ 18/2002,;;

427520 18.07.2011: (F0.13) born healthy, now 100% disability, post vaccination
encephalopathy, myoclonic epilepsy resistent of remedies, 4 hours after the immunization had
epileptic convulsion, her body was trembling, she lost her consciousness, she had irregular and
uncontrolled movements of legs and arms, she turned her eyes on right direction, and had muscle
spasm of right side, it lasted half of hour, 2 months later diagnosis epilepsy, she stopped to eat,
4 years she didn't walk, twice she was paralysed, center for termo regulation deosn't function
well, hyperactivity, became too delicate (day light disturb her, requires delicate balance between
being hungry and being satiated, requires delicate temperature balance between cold and hot, has
very delicate nails,;;
allergy tests (milk without glucose), deletion of nucleotide hetero zygotes,;;
BCG 07/24/2003, DTPr polio 09/10/2003
442637 15.11.2011: (M44) This case was reported in a literature article and described the
occurrence of encephalitis brain stem in a 44-year-old male subject who was vaccinated with
Influenza vaccine (unspecified, manufacturer unspecified). Concurrent medical conditions
included pituitary macroadenoma. Concurrent medications included Bromocriptine with normal
prolactin levels. Otherwise the subject's medical history was unremarkable. On an unspecified
date, the subject received 1st dose of Influenza vaccine (unspecified) (route and injection site
unknown). 9 days after vaccination with Influenza vaccine (unspecified), the subject experienced
mild weakness of the left arm and leg which progressed to difficulty walking in the following 4
days. The subject was hospitalised. At an unspecified time after vaccination with Influenza
vaccine (unspecified), on admission, the subject was conscious, alert and oriented with intact
language skills. He had a proportional left hemiparesis (2/5 on medical research council scale)
and urinary incontinence. His sensation was intact and there were no brainstem findings (such as
facial muscle weakness, nystagmus, oculomotor paresis or conjugate gaze palsy), pathological
reflexes, cerebellar symptoms or fever. Relevant tests were performed: Magnetic Resonance
Imaging (MRI) examination showed a massive hyperintense lesion in the brainstem reaching
from pons to midbrain and caudal diencephalon on T2- and fluid attenuated inversion recovery
(FLAIR)-weighted scans. The central part of the lesion enhanced contrast in a circular pattern.
T1-weighted sections without contrast enhancement did not show any lesions. Absence of any
cranial nerve/oculomotor findings suggested that most of the T2 lesion consisted of edema with
no functional effect on brainstem structures. Notably, gradient axial images showed multiple foci
of hypointensities not only in the brainstem but also in widespread locations in both cerebral
hemispheres, including thalami and basal ganglia. On careful examination, small punctate
hyperintensities could also be observed on T2-weighted sections at some but not all of the
corresponding locations. The spinal MRI examination did not yield any lesions. Visual evoked
potential (VEP) and somatosensory evoked potential (SEP) studies were both normal. Complete
blood count and routine serum biochemistry tests (including serum B12, folate levels and thyroid
function tests) were normal. Particularly, the numbers of leukocytes and leukocyte subsets were
normal suggesting that the immune status of the patient was intact. Sedimentation rate and serum
C-reactive protein levels were also normal. Cerebrospinal fluid (CSF) examination was normal
with no oligoclonal bands and no atypical cells. The serological screening for vasculitis,
autoimmune diseases (anti-nuclear antibody, anti-DNA, rheumatoid factor, extractable nuclear
antigen screen, anti-neutrophil cytoplasmic antibodies, anti-cardiolipin antibodies, lupus
anticoagulant, antithyroid antibodies), paraneoplastic disorders (antibodies to Hu, Yo, Ri, Ma,
CV2, amphiphysin, voltage-gated potassium channels), syphilis, herpes simplex virus (HSV),
cytomegalovirus, Epstein-Barr virus and human immunodeficiency virus yielded negative
results. The subject was treated with high dose of methylprednisolone (1000mg iv for 10 days
plus oral tapering) since magnetic resonance spectroscopy (MRS) findings of the MRI lesion
were consistent with an active demyelinating disorder (with no evident axonal damage). The
subject showed a remarkable response to the treatment. In 1 week, left hemiparesis significantly
ameliorated and urinary incontinence ceased. One month later, the subject had only mild left
hemiparesis (4/5), the brainstem lesion had considerable got smaller, the contrast enhancement
had vanished and the punctate hypointense lesions on gradient images had been reduced in size
and number but were still persisting. On the 6 months follow-up, neurological examination was

completely normal and the brainstem lesion had disappeared, however, punctate lesions were
still present. At the time of reporting, urinary incontinence was resolved and the other events
were improved. The author considered the events were possibly related to vaccination with
Influenza vaccine (unspecified). Summary of the literature article: Vaccination against various
viral agents including influenza has been frequently reported to trigger an encephalopathy. Most
patients with post-vaccination encephalopathy present with lesions distributed all over the central
nervous system (CNS) including or not including the brainstem. While isolated brainstem
involvement is an extremely rare complication for any type of vaccination, there are a few
documented post-vaccination encephalitis cases presenting with the involvement of the
brainstem as well as other CNS structures. The article reports a case presenting with an isolated
brainstem lesion and multiple punctate lesions in both hemispheres possibly induced by influenza
vaccination. The subject showed a remarkable response to high dose steroid treatment. Detailed
diagnostic studies failed to yield any results supporting inflammatory/demyelinating diseases,
suggesting that influenza vaccination might have been associated with the clinical findings. This
case implies that vaccination might be related with a wide range of clinical syndromes,
including brainstem encephalitis.;;
Blood count, Normal; C-reactive protein normal, Normal; CSF test normal, Normal;
Cerebrospinal fluid oligoclona, Normal; Cytomegalovirus serology, Negative; Epstein-Barr virus
serology ne, Negative; Folate, Normal; HIV negative, Negative; Herpes simplex serology,
Negative; Nuclear magnetic resonance ima, Brainstem lesion; Nuclear magnetic resonance ima,
No lesion; Serology normal, Normal; Somatosensory evoked potential, Normal; Syphilis test
negative, Negative; Thyroid function test, Normal; Visual evoked potentials, Normal; Vitamin
B12, Normal; White blood cells, Normal;;
Bromocriptine;;
Pituitary macroadenoma
457993 25.06.2012: (F17) Case received from the Health Authorities on 15-JUN-2012 under the
reference number T020101212 and medically confirmed. A 17-year-old female patient had
received the three doses of GARDASIL (batch numbers not reported) in December 2008,
January 2009 and April 2009. The route of vaccine administration reported as transdermal is to
be clarified with HA. She had a medical history of obsessive-compulsive disorder,
trichotillomania, major depressive disorder, and had undergone tonsillectomy in June 2010. It
was reported that she was having a long-term treatment with SEROPRAM 10 mg per os. She
was hospitalized since 06-AUG-2010 due to major depressive disorder and catatonia. During
hospitalization, on an unspecified date between 06-AUG-2010 and 12-AUG-2010, she was given
TEMESTA per os, 2 injections of TERCIAN 50 mg via intravenous route and one injection of
RISPERDAL via intravenous route. On 13-AUG-2010 she was hospitalized with clinical features
of hyperthermia at 38.7 C associated with mutism and generalized hypertonia with
neurovegetative dysautonomia. Biological work-up on 13-AUG-2010 showed inflammatory
syndrome with CRP at 100 mg/l and rhabdomyolysis with CPK at 2400 IU/l. On 16-AUG-2010
SEG and brain MRI were normal. The following non drug-induced aetiologies were ruled out:
EEG did not enable to evidence any evident epileptic activity. Brain CT scan showed no cerebral
thrombophlebitis but right maxillary sinusitis was present. Lumbar puncture showed CSF white
cell count at 20/mm3, CSF glucose at 1.78 g/l and CSF protein at 0.27 g/l. Infectious work-up
were negative for Cytomegalovirus, HIV, varicella, Lyme disease, Leptospirosis and syphilis.
Autoimmune workup was negative. Further to lumbar puncture results a treatment with
ZOVIRAX and RIVOTRIL was started and the patient was transferred to neurology department
where she was given Dantrolene on 14-AUG-2010, ZOVIRAX was maintained. On 15-AUG-
2010 at 4.00 am the patient experienced acute respiratory distress on right lung atelectasis. She
was intubated, ventilated, sedated and treatments with ROCEPHIN and TAVANIC were
initiated. These treatments failed. Dantrolene was also stopped then started again on 16-AUG-
2010. On 26-AUG-2010 the patient was still intubated and sedated as the attempts of extubation
failed. Neurovegatative dysautonomia was still present. On 29-AUG-2010 tracheal aspiration
showed p.aeruginosa therefore the patient was put on TIENAM and AMIKLIN. On 02-SEP-2010
she experienced epilepticus status which regressed on PENTHOTAL, as well as GARDENAL

and KEPPRA. Her hemodynamic status was stable. According to the physicians the only
differential diagnosis was malignant catalonia, which was very rare. On 09-SEP-2010, the patient
experienced clonism after each lifting of sedation despite treatment with TEMESTA,
GARDENAL and KEPPRA. Autoimmune limbic encephalitis was treated with TEGELINE. On
21-SEP-2010, she experienced a convulsion treated by PRODILANTIN and PENTHOTAL. It
was followed by ketogenic diet causing hepatic cytolysis, acute renal insufficiency, cardiac
insufficiency and hypertriglyceridemia. On 04-OCT-2010, corticotherapy was initiated. On 08-
OCT-2010, ketogenic diet was poorly tolerated, causing hepatocellular insufficiency, acute renal
insufficiency, hyperkalemia and gastrointestinal obstruction. Continued hemofiltration enabled
to improve prothrombin level and hepatic function. On 17-OCT-2010, the patient experienced a
septic shock. On 19-OCT-2010, she was found to have multi-organ failure. The patient died on
20-OCT-2010. The patient's parents sent a letter to the Health Authorities questioning a causal
relationship between vaccination with GARDASIL and their daughter's death linked with
meningoencephalitis. The general practitioner was contacted. The patient had received the 3
doses of GARDASIL in December 2008, January 2009 and April 2009. On 18-APR-2009, the
patient presented with malaise preceded by lipothymic sensations and nausea. Emergency
medical assistance service was called and the patient received an injection of magnesium. There
was no recurrence. The patient had no history of convulsion. EEG performed on 12-MAY-2009
was unremarkable. Citalopram 0.5 dosage form per day was introduced at the end of Feb. On 11-
OCT-2010, the conclusion of hospital report (intensive care) was provided: Malignant epilepticus
status. Encephalitis limbic autoimmune suggested. Early failure of ketogenic diet. Significant
immune suppression induced by barbiturates and corticotherapy. Septic shock with pulmonary
and digestive starting point. Acute respiratory distress. Multi-organ failure. Brain autopsy was
suggested and accepted by the parents. Autopsy report on 22-OCT-2010: absence of spongiform
encephalopathy. Quite diffuse astrocytic gliosis of the focal signal of the meningitis were noted.
Elements suggesting meningoencephalitis. Lesions showed subacute inflammatory
pathology mainly meningeal associated to tissue context. Time to onset of the event made it
difficult to attribute a causal relationship to GARDASIL. On 08-JUN-2012, a discussion with the
neurologist who had followed the patient was reported: Autoimmune encephalitis was the
central problem, the other manifestations being complications. The neurologist affirmed that
the symptomatology linked to the autoimmune encephalitis started before 06-AUG-2010,
and this already for the symptomatologies at the end of July 2010 and beginning of August. It
seemed at least possible that the symptoms which sneakily appeared over the previous months
(and according to the parents starting on beginning of 2009) could be related to the autoimmune
encephalitis. Upon medical review, the company judged relevant to code the adverse events
respiratory distress, septic shock, renal insufficiency, cardiac insufficiency, hepatic cytolysis,
right lung atelectasis, pseudomonas aeruginosa infection, status epilepticus, gastrointestinal
obstruction, malaise, nausea and lipothymic sensations which were mentioned by the CA in the
narrative but not coded. The Health Authorities assessed the causal relationship between the
reported reactions and RISPERDAL and TERICAN as possible" (C2 S2 12) according to
the foreign method of assessment. The Health Authorities assessed the causal relationship
between the reported reactions and SEROPRAM and vaccination with GARDASIL as doubtful
(C1 S1 11) according to the foreign method of assessment. Other business partner numbers
include E2012-03912. No further information is available.;;
electroencephalography, 12May09, normal; brain radionuclear scan, ??Aug10, no cerebral
thrombophlebitis, sinusitis; electroencephalography, 16Aug10, normal, no epileptic activity;
magnetic resonance imaging, 16Aug10, normal; diagnostic laboratory test, 29Aug10, Aspiration
tracheal P.aeroginosa; autopsy, 22Oct10, Result for brain autopsy: astrocytal gliosis; autopsy,
22Oct10, Result for brain: subacute inflammatory lesions; diagnostic laboratory test,
Leptospirosis negative; diagnostic laboratory test, Syphilis test negative; diagnostic laboratory
test, autoantibody test negative.; body temp, 13Aug10, 38.7 C; serum C-reactive protein,
13Aug10, 100 mg/l; serum creatine kinase, 13Aug10, 2400 IU/l; CSF glucose, ??Aug10, 1.78
g/l; CSF white cell count, ??Aug10, 20 /mm3, normal; cerebrospinal fluid total protein test,
??Aug10, 0.27 g/l; serum potassium, 08Oct10, hyperkaliemia; serum triglyceride, End Sep-Beg
Oct-2010: hypertriglyceridemia; serum varicella zoster virus antibody, virus test negative;

Cytomegalovirus culture, negative; serum HIV-1 p24 antibody test, negative; serum antiadrenal
antibody test, workup negative; serum Borrelia burgdorferi antibody test, negative;;
TEMESTA;;
Obsessive-compulsive disorder; Trichotillomania; Major depression;;
Tonsillectomy
458835 09.07.2012: (F0.3) Initial report was received from the scientific literature in the foreign
country on 27 June 2012. The following is verbatim from the report: A 47-year-old female was
referred because of seizure recurrence. She was born at term following a normal pregnancy and
delivery with no relevant family history. Her initial development had not caused any concerns.
At 3 months, she had smallpox vaccination [1965]. The next day, though afebrile, she became
stuporous, very difficult to feed and showed no response or spontaneous movement. This lasted
several days. No diagnosis was established on evaluation by her local paediatrician. She
gradually recovered, but subsequent development was severely delayed. Intellectual disability
was diagnosed by her local paediatrician. She received formal compensation as her condition
was felt to be a consequence of vaccination. She never acquired language, but could
communicate to some extent non-verbally. At five, she started to experience seizures with brief
head drop. At the age of ten, she experienced several generalized tonic-clonic seizures. She was
started on phenobarbital and switched to phenytoin with a period of remission of 5 years. At
fifteen, she developed complex partial seizures. In her late thirties, she moved to a residential
care home. At the age of 42, after a further period of apparent remission of 4 years; her medication
was stopped. Carers reported changes in her behaviour; she looked far 'more serious', and laughed
less frequently. One year before her admission and 4 years after having stopped her medication,
her complex partial seizures recurred and she had an episode of nonconvulsive status epilepticus.
She was started on valproate with a slight decrease of her seizure frequency. During her
admission, she had frequent head drop episodes. A prolonged EEG (Fig. 1) showed frequent
episodes of bilateral slow (1e2 Hz) sharp and slow waves lasting up to several seconds,
occasionally with concomitant head drop episodes. Brain MRI could not be performed because
of lack of cooperation. Given her history of vaccine encephalopathy, SCNIA sequencing was
requested, but did not disclose any mutation, duplication or deletion. Genome-wide array
comparative genomic hybrization (CGH) showed a 15q11.2-q13.1 deletion. Methylation-
specific polymerization chain reaction showed loss of the maternal allele. She also underwent
quantitative facial analysis (dense surface modelling and signature graph analyses, as detailed in
the Supplementary Material), confirming that her subtle facial dysmorphism was typical of
Angelman syndrome." The patient's outcome was not reported. Documents held by sender:
None.;;
Genome-wide array comparative genomic hybridization (OGH) showed a 15q11.2-q13.1
deletion. Quantitative facial analysis confirmed the patient's subtle facial dysmorphism was
typical of Angelman Syndrome.;;
The patient was born at term following a normal pregnancy and delivery with no relevant family
history. Her initial development had not caused any concerns.
493400 05.06.2013: (F0.25) Case was received from a consumer via the Health Authority in a
foreign country on 29-May-2013 under the reference number FI-FIMEA-20130515. Case not
medically confirmed. A 2-month-old female patient, with a medical history of hernia
operation, which ended the her crying, had received the first dose of ROTATEQ (batch number
0396Z, lot number 667460/0396Z, Exp. Date: 31-JAN-2012) via oral route on 02-Feb-2011.
After vaccination, the patient became stiffer little by little and had stiff hips. The patient was
weepy and her sleeping rhythm became mixed up. On 04-Mar-2011, the patient received the
second dose of ROTATEQ (batch no. 0396Z, lot number 667460/0396Z, Exp. Date: 31-JAN-
2012) and also the first dose of INFANRIX POLIO HIB (GSK, batch no. A20CA635E,
intramuscular, left thigh) and SYNFLORIX (GSK, batch no. ASPNA030AC, intramuscular,
right thigh). A few days after these vaccinations, the patient started to regress. All the relatives
noticed the something was not the way it should be, the parents did not regard the symptoms as
abnormal because she was found healthy before. The only abnormality with the baby found
until 04-Mar-2011 was stiff hips at the age of 2 months which was considered normal by

the doctor.[??????] The patient did not learn to turn on her stomach, the parents showed
wondering why she won't learn it. The symptoms started slowly. First the eyes rolled
momentarily upwards, no eye contact could be made with the baby. The baby also could not hold
her head up and was more limp, even though she could hold her head up already at the age of 1
month while being lifted up from lying down position. On 13-Apr-2011 a doctor noticed squint
in the right eye. She did not smile much, did not turn to her stomach and did not try to grasp toys
with her hands. Epilepsy symptoms emerged, e.g. absence. She received D3 of ROTATEQ
(0618Z, oral) and D2 of INFANRIX POLIO HIB (batch no. A20CA575B, intramuscular, right
thigh) and SYNFLORIX (batch no. ASPNA030AC, intramuscular, left thigh) on 01-Jun-2011.
On 10-Jun-2011, a child neurologist stated the baby to be neurologically clearly abnormal.
A momentary eye contact was made, but she did not follow with the eyes, it was more like a
wondering glance and at times mild outward squint in both eyes. When lifted up holding under
arms, it felt like she was flowing through the ars, corresponding there was stiffness in the lower
limbs. The results of a video-EEG examination on 10-Jun-2011 were abnormal. After the
examination, KEPPRA 100 mg/ml oral solution (levetiracetam, 45 mg, twice a day) was started.
The baby received D3 of INFANRIX POLIO HIB (batch no. A20CA646B, intramuscular, right
thigh) and SYNFLORIX (batch no. ASPNA05, intramuscular, left thigh) on 07-Dec-2011. After
approximately two weeks, a back and forth nystagmus started. There was also some twitching of
the head. KEPPRA dose was increased, but did not remove the nystagmus. At that time, the
KEPPRA dose was 0.9 ml in the morning and 1 ml in the evening. KEPPRA was planned to be
discontinued in May-2013, as no fits had been observed. Final diagnosis included
encephalopathy, epilepsy, dystonia and neurodevelopmental disorder. At the time of
reporting, the patient had not recovered. ;;
06/10/2011, Electroencephalogram, Abnormal;;
No other medications;;
Hernia repair; Crying
[Same patient VAERS ID 493345]
498134 31.07.2013: (M0.4) This is a spontaneous report received from a contactable physician
through the contactable foreign Health Authority. Regulatory Authority report number DE-PEI-
PEI2013005128. A 5-month-old male patient that received, at the age of 5 months, the third dose
of PREVENAR 13 (lot no. F32598) at 0.5 ml single dose intramuscularly at his left thigh and the
third dose of INFANRIX HEXA (lot no. A21CB363A) at 0.5ml single dose intramuscularly at
his right thigh, both on 16Oct2012. He had received previous doses of PREVENAR 13 and
INFANRIX HEXA on 02Aug2012 and on 18Sep2012 that had been well tolerated. Medical
history included meconium aspiration, NG-infection (GBS), Group B streptococcus neonatal
sepsis. Concomitant medications were not reported. On 17Nov2012, the patient developed
Watanabe-Syndrome / benign focal epilepsy, lasting for unknown period of time. The
patient was hospitalized from 17Nov2012 to 23Nov2012 (as well as on 05Dec2012) and
condition was not life threatening. In the hospital examinations were performed, that excluded
the following diagnosis: sepsis, meningitis, and brain malformation. The patient underwent lab
tests and procedures which included: Cerebrospinal fluid protein, result: 23 mg/dl, activated
partial thromboplastin time prolonged: 39 seconds on 05Dec2012, blood calcium: 2.75 mmol/l
on 27Nov2012, blood cholesterol esterase increased: 12155 iu/l on 05Dec2012, CSF protein: 23
mg/dl on 17Nov2012, eosinophil count: 7% on 17Nov2012, eosinophil count: 9% on
27Nov2012, eosinophil count: 6.3% on 05Dec2012, lymphocyte count: 74% on 17Nov2012,
lymphocyte count: 77% on 27Nov2012, lymphocyte morphology abnormal: 8% on 17Nov2012,
lymphocyte morphology abnormal: 5% on 27Nov2012, mean cell haemoglobin concentration:
34.2 g/dl on 27Nov2012, mean cell haemoglobin concentration: 34.2 g/dl on 20Dec2012, platelet
count: 377000000 /mm3 on 17Nov2012, 371000000 on 05Dec2012, 476000000 on 20Dec2012,
EEG results (19Nov2013): normal (no units provided), PCR results (unknown date; unit: HSV1,
HSV2): negative, Blood analysis (27Nov2012): A Neutropenia of 322/ul was observed. Outcome
of the event was unknown at the time of reporting. Anamnesis: Birth: Spontaneous birth after
41+1 gestational week (weight at birth 3200 grams, height 52cm, head circumference 37 cm),
mother B streptococcus positive, fever, mother was treated with penicillin. In the morning of

17Nov2012 the child lost body tension, showed eye deviation to the left, clenched the teeth
and was not responsive. The episode lasted 3 minutes, afterwards the child was responsive
again but still weak. The child slept for approximately one hour. 15 minutes after waking up
another event with atony and missing responsiveness occurred. Due to that the child was
admitted to hospital. The child had no temperature during the progress. In the emergency room
two similar episodes with decreased of saturation and cyanosis of lips were observed. A
temperature of 38 C was reported. The blood sugar was stated as normalized. Family anamnesis:
The grandfather also showed attacks at the age of 6 months for a few weeks, even though the
great-grandfather at birth. It was not clear how the attacks looked. Neurological examination:
Always inconspicuous neurological state with equal-sided motor functions. Clinical findings: 6-
month-old child (weight 7kgs, height 70cm, RR 99/72mmHg, pulse 120/min, temperature 36.2
C). No indication for heart disease was found. cMRT (05Dec2012): age-appropriate
inconspicuous MRT of skull. Assessment, therapy and progression: Due to loss of tone and
worsening of general condition, a cerebrospinal fluid puncture was performed at day of admission
to exclude a HSV-encephalopathy. Therapy with acyclovir was started and stopped on
20Nov2012 due to negative HSV-PCR. A benign form of infant epilepsy was assumed. Due to
normal development and EEG and family history a Watanabe syndrome was assumed. The EEG
was assessed as inconspicuous, the MRT did not show any conspicuities. Blood analysis no
indices for neutropenia were found. Antiepileptic medicinal treatment was performed due to the
event. The neutropenia as of 27Nov2012 was assessed as reactive due to a viral infection. The
antiepileptic therapy was assessed as good and prognosis was assessed as excellent. On
20Nov2012 a therapy with sultiam was started. Medication at discharge of hospital: Sultiam until
25Nov2012: 12.5mg, twice daily; from 26Nov2012: 25mg in the morning, 12.5mg in the
evening. This case is being treated according to the foreign IfSG (Protection against Infection
Act). [GERMANY, 2001, Section 2 Definitions (11). vaccine injury - are the health-related and
economic consequences of a health impairment due to vaccination the degree of which exceeds
that of a normal post-vaccinal reaction; a vaccine injury is also present if agents capable of
replication were used for vaccination and persons other than the person vaccinated were
injured,… Section 6 Notifiable diseases (1) The following shall be notified on a named-patient
basis 1… 2…. 3. the suspicion of a health impairment the degree of which exceeds that of a
normal postvaccinal reaction,… Section 8 Persons obliged to notify (1) The following persons
shall be obliged to notify: 1… 2… 3… 4… 5. in the case of section 6 paragraph 1 nos. 1, 2 and 5
and paragraph 3 members of any paramedical profession the exercise or use of professional title
of which requires a state regulated training or recognition,… Section 9 Notification on a named-
patient basis (1) Notification on a named-patient basis by one of the persons mentioned in section
8 paragraph 1 nos. 1, 4 to 8 must contain the following information: 1. surname, forename of the
patient 2. Sex 3. day, month and year of birth 4. address of the main residence and, if not
identical: address of the current abode 5. activity in facilities within the meaning of section 36
paragraph 1 or 2; activity within the meaning of section 42 paragraph 1 in case of acute gastro-
enteritis, acute viral hepatitis, abdominal typhus/paratyphoid fever and cholera 6. cared for in
a community facility pursuant to section 33 7. diagnosis or suspected diagnosis 8. date of clinical
presentation or date of diagnosis, if applicable date of death 9. likely source of infection 10.
country in which the infection was presumably acquired; for tuberculosis country of birth and
nationality 11. name, address and telephone number of the laboratory charged with diagnosing
the pathogen 12. referral to a hospital or admission to a hospital or other institution providing
in-patient care and discharge from the institution, if known to the person obliged to notify 13.
any blood, organ or tissue donation within the preceding six months 14. name, address and
telephone number of the notifier 15. for a notification pursuant to section 6 paragraph 1 no. 3
the information specified in section 22 paragraph 2. For the persons mentioned in section 8
paragraph 1 nos. 4 to 8, the obligation to notify is limited to the information available to them. ]
Follow-up (22Jul2013): New information received from Regulatory Authority includes: event
recoded from "Seizure cerebral" to "Watanabe-Syndrome / benign focal epilepsy", lab data,
outcome of event, hospitalization dates, anamnesis, medical history, family anamnesis,

neurological examination, clinical findings, medication at discharge at hospital. No follow-up

attempts needed, follow-up automatically provided by PEI. ;;
05-DEC-2012, Activated partial thromboplastin time prolonged, 39 seconds; 27-NOV-2012,
Blood calcium, 2.75 mmol/l; 05-DEC-2012, Blood cholesterol esterase increased, 12155 IU/l;
17-NOV-2012, Body temperature, 38 Centigrade; 17-NOV-2012, CSF protein, 23 mg/dl; 17-
NOV-2012, Eosinophil count, 7%; 27-NOV-2012, Eosinophil count, 9%; 05-DEC-2012,
Eosinophil count, 6.3%; 17-NOV-2012, Lymphocyte count, 74%; 27-NOV-2012, Lymphocyte
count, 77%; 17-NOV-2012, Lymphocyte morphology abnormal, 8%; 27-NOV-2012,
Lymphocyte morphology abnormal, 5%; 27-NOV-2012, Mean cell haemoglobin concentration,
34.2 g/dl; 20-DEC-2012, Mean cell haemoglobin concentration, 34.2 g/dl; 27-NOV-2012,
Neutrophil count, 322 ul; 17-NOV-2012, Platelet count, 377000000 /mm3; 05-DEC-2012,
Platelet count, 371000000 /mm3; 20-DEC-2012, Platelet count, 476000000 /mm3; EEG
(19Nov2013): normal; PCR (unknown date): unit HSV1, HSV2, negative;;
02-AUG-2012, Dose 1, INFANRIX HEXA, No adverse event; 02-AUG-2012, Dose 1,
PREVENAR-13, No adverse event; 18-SEP-2012, Dose 2, INFANRIX HEXA, No adverse
event; 18-SEP-2012, Dose 2, PREVENAR-13, No adverse event; Group B streptococcus
neonatal sepsis; Meconium aspiration; Neisseria gonorrhoeae infection
499757 19.08.2013: (UNK) Case received from the Health Authorities on 07 August 2013 under
the reference number PL-URPL-N988/2013. A patient (age and gender not reported), with no
reported medical history and concomitant therapy, had received an intramuscular dose of
IMOVAX POLIO (batch number G7200, expired date November 2013) in the right arm, an
intramuscular dose of ACTHIB (batch number H1505-2, expired date September 2014) in the
right thigh and an intramuscular dose of DTP vaccine (other manufacturer, batch number
20911003A, expired date November 2014) in the left arm on 01 August 2013 at 11:30. On 02
August 2013 at 08:40, the patient experienced fever 38-38.4 degrees C, difficulty to walk,
apathy, drowsiness and encephalopathy. The same day, the patient was brought to the doctor
and was referred to hospital. The patient was hospitalized. The patient's outcome was unknown.
Reporter's comments: "in the past postvaccinal adverse events did not occur." Sender's
comments: "fever is expected reaction for all administered vaccines. Encephalopathy is expected
for DTP only however known for the others. In the database from 2010, 216 cases of
encephalopathy after DTP, 4 after IMOVAX POLIO and 49 after ACTHIB are reported.
The temporal relationship indicated the causal relationship and the simultaneous
administration of the vaccines make not possible indicate only one vaccine suspected to
cause the reaction. The reporting doctor classified the reaction as "serious"." The HA coded
fever, somnolence, apathy, movement disorder and encephalopathy.
506841 09.10.2013: (UNK0) This infant report was received on 30-Sep-2013. Ref 598. This case
is linked to the maternal report E2013-03550. This case is medically confirmed. A neonate
received a dose of MMRVAXPRO (batch number H008125, lot number 1609AA),
transplacentally on 19-Apr-2013. [Institute of Medicine 1991. Adverse Effects of Pertussis and
Rubella Vaccines. Washington, DC: The National Academies Press.
https://doi.org/10.17226/1815, ISBN 978-0-309-04499-8 pp.144-145 - anaphylaxis in an infant
presumably could be mediated by IgG antibody received transplacentally from the mother] The
patient's mother, aged of 29 years old, was pregnant at the time of vaccination. MMRVAXPRO
was given by mistake instead of whooping cough vaccine. The patient's mother's LMP was
04-Oct-2012 and her EDD was 12-Jul-2013. She did not have an abnormal antenatal test and
did not experience any adverse effect post vaccination. She had previously received the first dose
of MMR vaccine (manufacturer and batch number not reported) on 07-Jan-1990. She had
no previous pregnancies. She had a BMI of 42. The patient was delivered at 39+4 weeks
gestation. The patient was born with neurological complications of neonatal seizures,
hypoxic ischaemic encephalopathy and left arm weakness. At the time of reporting the
patient had not recovered.;;
Immunisation;;

NOTE: Pertussis & Whooping Cough are interchangeable terms; ISBN 978-0-309-04499-8 p.9
Note 1 (Document No. 140)
607598 19.08.2015: (F0.25) This case was reported in a literature article and described
the occurrence of generalized tonic-clonic seizure in a 3-month-old female patient who
received DTPa vaccine. Co-suspect products included Polio (oral or inactivated
unknown) vaccine. Concurrent medical conditions included encephalopathy NOS and X-
linked chromosomal disorder. On an unknown date, the patient received DTPa
vaccine at an unknown dose and Polio vaccine at an unknown dose. On an unknown
date, 14 days after receiving DTPa vaccine and Polio vaccine the patient
experienced generalized tonic-clonic seizure (serious criteria GSK medically
significant), encephalopathy NOS (serious criteria GSK medically significant),
infantile spasms (serious criteria GSK medically significant), myoclonic seizure
NOS (serious criteria GSK medically significant), focal seizures (serious criteria
GSK medically significant), upward deviation of eyes (serious criteria GSK
medically significant), staring, decreased eye contact, decreased muscle tone,
weakness, head deformity, eye movement disorder, central nervous system
disorder, cognitive impairment, developmental delay, serotyped repetitive
movements and salivation. The patient was treated with carbamazepine, valproic acid,
topiramate, phenobarbital, lamotrigine, tetracosactide, clonazepam, levetiracetam,
vigabatrin, zonisamise and ethosuximide. On an unknown date, the outcome of the
generalized tonic-clonic seizure, infantile spasms, myoclonic seizures NOS, focal
seizures, upward deviation of eyes, staring, decreased eye contact, decreased muscle
tone, weakness, head deformity, eye movement disorder, central nervous system
disorder, cognitive impairment, developmental delay, stereotyped repetitive movements
and salivation were not recovered/not resolved and the outcome of the encephalopathy
NOS was unknown. It was unknown if the reporter considered the generalized tonic-
clonic seizure, encephalopathy NOS, infantile spasms, myoclonic seizure NOS, focal
seizures, upward deviation of eyes, staring, decreased eye contact, decreased muscle
tone, weakness, head deformity, eye movement disorder, central nervous system
disorder, cognitive impairment, developmental delay, stereotyped repetitive movements
and salivation to be related to DTPa vaccine and Polio vaccine. Additional information
received: This case was reported in a literature article and it described the occurrence of
convulsions in a female patient approximately 3 months and 2 weeks old who had
received an unspecified absorbed diphtheria-tetanus-pertussis vaccine and unspecified
poliovirus vaccine (manufacturers unknown). The patient had been born of the third
pregnancy of a nullipara woman. She had had a birth weight of 3040 gr and a length of
50 cm. Concurrent medical conditions included cycling-dependent-kinase-like-5-gene-
associated early infantile epileptic encephalopathy that was diagnosed after the
event onset. No further information on the patient's medical history, concurrent medical
conditions or concomitant medication was provided. On an unspecified date, when she
was 3 months old, she received an unspecified absorbed diphtheria-tetanus-pertussis
vaccine and an unspecified poliovirus vaccine (dosages, administration routes and sites
unknown; batch numbers not provided). On an unspecified date, approximately 2 weeks
after vaccination, the patient started having paroxystical episodes lasting for a few
seconds (staring and loss of muscular tone) as well as repeated infantile spasms. Upon
neurological examination, she was found to have an unspecified head deformation,
diffuse muscular hypotonia, symmetrical reflexes, positive Babinski reflex and
involuntary eye movements as well as being unable to hold her head up. She was
also found to have hypsarhythmia. Her diagnoses at this time included symptomatic
generalized epilepsy, perinatal central nervous system damage and developmental delay.

The patient was reviewed in a clinic in 2012 where she was noted to have focal
myoclonic and tonic seizures, with upwards eye movements and 5 to 20 infantile spasms
per day. She was diagnosed with early infantile epileptic encephalopathy, type 2 in
2014 after undergoing genetic testing. At the time of reporting the authors commented
that the patient had reduced cognitive development, stereotypical movements, diffuse
muscular hypotonia, hypersalivation and symmetrical reflexes. In addition to this, she
could not speak or walk, displayed no eye contact and did not respond to examination
although she could sit. The patient underwent a video-electroencephalograph at the onset
of the symptoms that showed hypsarhythmia and 3 seizures. Genetic investigations in
2014 showed an X-linked mutation in the cyclin-dependent-kinase-like-5-gene that
had not been identified before. Initial antiepileptic treatment included carbamazepine
30 mg/kg/day, valproic acid 50-300 mg/kg/day, topiramate 6-7 mg/kg/day, phenobarbital
7 mg/kg/day, lamotrigine 2 mg/kg/day and SYNACTHEN Depot No. 10 in different
combinations but the seizures persisted. At the time of the review she was on
clonazepam, levetiracetam, vigabatrin, valproic acid, Zonisamide and aethosuximidi in
different combinations. At the time of reporting her treatment included valproic acid 600
mg/kg/day and ethosuximid 8 ml/day. The outcome of the events was no recovery at the
time of reporting as the authors commented that she was still presenting generalized
tonic-clonic seizures with head turning movements to the right lasting for 1 min 1 to 2
times a day with breaks of 2 to 5 days. The authors did not comment on any possible
causal relationship between the events and the vaccines. The authors did not include
a conclusion.;;
The patient underwent a video-electroencephalograph at the onset of the symptoms that
showed hypsarhythmia and 3 seizures. Genetic investigations in 2014 showed an X-
linked mutation in the cyclin-dependent-kinase-like-5-gene that had not been
identified before; Babinski reflex test, positive; 2014, Cytogenetic analysis, CDKL 5
mutation absent; Electroencephalogram, Hypsarhythmia and 3 seizures absent;
Neurological examination, head deformity, muscular hypotonia absent; Reflex test
normal, symmetrical reflexes absent;;;
Encephalopathy; X-linked chromosomal disorder;;
613257 01.10.2015: (M0.58) [HEAVY METALS 2] This case is linked with case E2015-
10587 (same reporter, similar adverse events). Case of vaccination error (1st dose
ROTATEQ administered (adm) after 32 weeks (wks) of age when according to SmPC
1st dose of ROTATEQ should not be adm. later 32 wks of age) and possible overdose (a
dose of DTPa-IPV-Hib-HB and a dose of Hep B vaccine probably adm. on same date)
received from a legal claim through company lawyer 22SEP15. Case medically
confirmed (several medical reports received). The following vaccines were adm. (routes
not reported): 1st dose ENGERIX, manufactured GSK, batch number (#)
XHBVSP70AK at birth. 2nd dose of ENGERIX, batch # A21LA779B on 16MAR11,
3rd dose HBVAXPRO, batch# NP28771 on 13JUL11. INFANRIX, GSK, 1st dose
(batch# A20CA605A) on 16MAR11, 2nd dose (batch# A20CA562B) on 16MAY11.
INFANRIX HEXA, batch# A21CA800A on 13JUL11. ROTATEQ: 1st dose (batch#
0480Z) on 30MAR11, 2nd dose (batch# 1265Z) on 08JUN11, 3rd dose (batch #0211Z)
on 05AUG11. NEISVAC C, Baxter: 1st dose (batch# VN914233) on 16MAR11 and 2nd
dose (batch# VN914233) on 16MAY11. PREVENAR 13, manufactured Wyeth: 1st dose
(batch #E88580) on 30MAR11, 2nd dose (batch# F01211) on 08JUN11 and 3rd dose
(batch# illegible) on 05AUG11. There were discrepancies between vaccines adm.
between different documents provided: According to claimants there was 1st dose of
ROTATEQ adm 30MAR11, this dose does not appear in Regional Health Authorities

vaccination card. According to claimant on 16MAR11, patient (pt) received NEISVAC

C and INFANRIX HEXA, according to regional authorities he was vaccinated that day
with a INFANRIX IPV + Bib a ENGERIX B and a NEISVAC C. According to claimant,
pt was vaccinated 16MAY11 with NEISVAC C and INFANRIX HEXA when according
to regional authorities vaccination card he received that a meningococcal C vaccine and
DTPa-Hib-IPV vaccine (GSK vaccine). According to claimant he received 3rd dose of
HBVAXPRO on 13JUL11 concomitantly with dose of DTPa-Hib-IPV vaccine when
according to Regional Health Authorities he received a dose of INFANRIX HEXA so it
is not clear whether the pt received a dose of HBVAXPRO or not. In the documentation
provided there were one report from Health Authorities, one from the claimant and
several medical reports. Agency Report: Male, son of non-consanguineous parents, born
after a normal pregnancy at 41 plus 3 (41 plus 6 according to medical reports) week
through vaginal delivery (weight (wt) 3.490 gr., head circumference 34/34.5 em) with
prolonged expulsive but good general state (Apgar 9/10), cephalohematoma (at 48 hours
according to lawyers report), reanimation maneuvers not required. Early jaundice treated
with natural phototherapy. 05JAN11, routinely medical checkup within usual healthy
checkup program didn't reflect any alteration in pt. 29MAR11 report, written he
presented with postural plagiocephaly and torticollis with neck right lateralization,
physiotherapist visit prescribed. Normal neuro exploration. 30MAR11, physiotherapist
started treating him and noticed he presented a hypotonia picture so decided to derive
him for evaluation (report issues 31MAY11 and stated reason for visit was to evaluate
muscle tone after derivation from physiotherapist). Several physicians (phys.) did not
observe the picture referred by physiotherapist and in one report it was reflected
torticollis evidenced when he was 2 months old being treated by physiotherapist, was
diagnosis (dx) hypotonia so he was derived to the neuropediatrician when he was 5
months (mths) old who referred normal evaluation. In the physiotherapist's report it was
reflected neuropediatrician that assessed him did not find any significant alteration,
denying presence of hypotonia. In report of neuropediatrician it as stated that
physiotherapist insisted on existence of hypotonic picture, with poor cephalic
equilibration, evaluated by 2 pediatricians and one neuropediatrician when he was 5 mths
old and none study was indicated and decided expecting attitude. 31MAY11, hospital
(hosp) report informed of no anomalies in exploration and only control and follow-up by
pediatrician was recommended (to stop therapy was recommended according to lawyer's
report). Next visit at same hosp. 04AUG15 due to intermittent awakenings during night
reported they were considered to be related to teething and was discharged with analgesic
treatment (tx) (apirteal according to lawyer's report, dose and dates not reported). In this
report, neurologic exploration normal. First report of phys. other than physiotherapist
reported any grade of hypotonia was dated 31AUG11, diagnosing him of mild axial
hypotonia, incomplete sitting with retarded motor skills for age. Clinical judgment was
mild idiopathic motor development delay (within the normal limits for age). From that
moment on, reports started to refer alterations in pt's exploration. First one 12SEP11,
stated that diagnosis (dx) was hypotonia of unknown origin, psychomotor development
delay to evaluate. Reports 27SEP11 and 23NOV11 reflected that he was also assessed
by other phys. Two reports from 13SEP11 and 06OCT11 reflected neither diagnostic
impression nor recommended therapeutic attitude, presumably because incomplete
reports had been sent to Agency. Both reports only compile anamnesis and exploration
data and in one of them diagnostic tests data. After global evaluation and complementary
studies (among them, evoked potentials that revealed a slightly delayed P100 wave in a
bilateral and symmetric way in the visual stimulation with glasses, electroencephalogram
with slowed background activity for his age and generalized intedctal epileptiform

activity with sleep and superficial sleep) initial tx with DEPAKINE indicated, which
damaged his general state and later KEPPRA with same result, so eventually all
antiepileptic tx was withdrawn. Dx performed after that moment unmistakably evidence
clinical features (hypotonia with unstable cephalic hold, no sitting position, no
intentional manipulation or very scarce, globally retarded maturation, scarce interaction
with environment, retarded motor maturation, deficient prelanguage for his age, usual
awakenings and from 9 mth old on, sporadic myoclonias) in this reports: hosp. 23NOV11
(psychomotor development delay, hypotonia under study and sleepy, not included in
HA's report), medical center report from 30JAN12 (idiopathic congenital
encephalopathy, severe global psychomotor development delay, myoclonias) (report
from a phys. 14MAR12 (early postnatal progressive encephalopathy, myoclonias of
cortical-subcortical origin). After 12MAR12, highlighted info was report from a
foundation on 11DEC12 his parents brought him in order to check if he was intoxicated
by metals. That foundation diagnosed him of multiple chemical sensitivity. Very poorly
structured info, probably related to a visit to an environmental medicine center (only one
of reports was dated and signed, on 29-NOV-2012), where different determinations were
performed (cellular analysis, salvia testing) and different recommendations performed
(walnut tree dye, liquid chlorophyll, wild oregano oil, curcuma, fennel and betaine
among others). Hosp. report 7/8-OCT2013 due to cardio-respiratory arrest, from
which he eventually died. Health Authorities assessed possible relationship between
clinical features and vaccination. First of all, they tried to establish temporal
sequence between pt's vaccination and clinical features he presented with. In light of
documents that were submitted they concluded that no neurologic alterations were
present at the time of birth and that it was physiotherapist who detected first signals of
alarm once the clinical picture stated to develop. So, start of clinical picture, clinical
picture of progressive character, must had happened between moment he was derived
from pediatry to physiotherapy (29MAR11) and moment that physiotherapist requested
evaluation of the picture of hypotonia she had observed (31MAY11). It was not possible
to determine exact moment of debut of symptomatology. In HAs report it was highlighted
that there were discrepancies btwn vaccination card provided by Reg. PV center and
vaccinations mentioned in legal claim regarding pentavalent or hexavalent
vaccines, but according to HAs report they weren't SPMSD vaccines. Conclusion of HA
were he developed a picture of progressive encephalopathy; it was impossible to
precise exact moment symptoms appeared and thus it was not possible to determine
latency period between one or another vaccine adm. and debut of clinical picture;
since available scientific information had reported cases of encephalopathy/encephalitis
associated to adm. of at least 2 vaccines he was adm; and before difficulty to reconcile
previous points, they considered impossible whether to absolutely accept or refute a
possible causality relationship between the vaccination and appearance of clinical
feature. Claimant's Report: Pt history: Mother suffered from lymphoblastic leukemia
when she was 20 years old. Eutocic delivery after well controlled term gestation.
Neonatal torticollis. Controlled pregnancy without complication. Epidural during
delivery. 30MAR11, visited physiotherapist for first time for rehabilitation when 3 mths
old, derived from his pediatrician due to dx of congenital torticollis. Infant also presented
with series of alert signals such as: pulgar stay and no control capacity of trunk nor
cephalic. Besides, he did not respond properly to any neurological test showing a blocked
maturing development. 31MAY11, neuropediatrician found the infant noonal and
stopped the therapy. 12SEP11, he did not adopt sitting position gross psychomotor: poor
cephalic hold/control and occipital flattening, 4-limb hypotonia and sterotyped
movements. The dx was hypotonia without clinical cause and motor development delay

to evaluate. The recommendations were: visit physiotherapist, neuropediatrician and

ophthalmologist. 13SEP11, he visited a neuropediatrician due to hypotonia he suffered
since he was 3 mths old. At the time of that reporting, he showed unstable cephalic hold.
Globally retarded maturation. It was reported that for at least 2 mths he presented with
episodes of non-grouped abrupt whole body startle response, approx. 20-30/day, only
during vigil. Absent reflexes and convergent strabismus also reported in medical reports.
06OCT11, a neuropediatrician diagnosed him with global maturation retardation,
cerebral-motor disorder, symptomatic microcephaly and possible myoclonias. It was
reported that he had improved and with less shakes than before, he suffered from
plagiocephaly and cerebral MRI showed scarce volume for his age, not presenting
structural anomalies. 23NOV11, a pediatrician reported hypermetropia. He requested
clinical analysis and blood analysis for valproic acid. 30JAN12 and NOV2011 medical
Center reported that a generalized myoclonia with generalized P.O. discharge was
registered. In the exploration severe axial hypotonia was remarked. Wt and head
circumference stagnation observed. Cranial TAC was advised in order to rule out
presence of calcifications. Results from gene CDKL5 and MECP2 studies were pending.
Certain genes remained to be checked for mutations. In NOV-2011 treatment with
DEPAKINE was started. In NOV2011 medical Center diagnosed microcephaly and axial
hypotonia. JAN2012: DEPAKINE was withdrawn due to intolerance. A "cellular
analysis" on 23FEB12 showed: probable antiphospholipid syndrome "thrombus", metal
intoxication and red blood cells with irregular shape among other (see lab comments).
14MAR12: neuropediatrician suggested copper metabolism study, blood ammonia
study, among others. It was found that blood ammonia and glutamic oxaloacetic
transaminase (GOT) levels were discreetly elevated. It was highlighted that he had
feeding issues, with a very low wt curve, confirming microcephaly and cerebral atrophy
suggested in the neural image. It was also mentioned pyramidalism, visual sensory
impairment and feeding difficulties (in MR). Report on 12SEP12, reported a cellular
analysis that indicated that metal intoxication persisted apparently due to whooping
cough vaccine. 21SEP12, etiologic assessment performed by to physicians reported that
taking into account Karch-Lasagna algorithms relationship between vaccination and
encephalitis was considered probable (related to third dose of INFANRIX HEXA),
meaning that adverse effect produced after vaccination could be due to the vaccine.
An alternative explanation would be less possible. 11DEC12 his parents visit a
foundation to see if his child was intoxicated with the metals contained in the
vaccines. He was taken to a non-conventional therapist that achieved a clear
improval with tx. After 1 month the evoked potentials were repeated and they were
normal. Brain activity also improved. After 2 or 3 months of tx a progressive improval
was observed at that time and also the motor movility was improving. He had always
stayed at home, he had not attended kindergarten. He eated 50% ecological food and
drank filtered water. Test QESSI performed and diagnosed of Multiple Chemical
Sensibility. 15JUN12, Pharmacovigilance service concluded to keep the case as not
evaluated for the application of causality KarhLasagna algorithym of the
Pharmacovigilance Service, which could be later reviewed as long as new clinical data,
explorations, course and diagnostic were provided for any period from his birth until that
moment. 28AUG12 Agency granted 80% disability: multiple disability,
encephalopathy of unknown origin, maturing retardation. 08OCT13 he died. Death
report reported of a 2 year-old male brought to ER by his parents in cardio-respiratory
arrest. They reported that he was at home pale, cyanotic and not reacting, and he was like
that for 5-10 minutes. In minutes before arrest he had a yogurt. No previous convulsions
to the episode. No fever or other associated symptoms. Diagnosis at discharge, main:

cardio-respiratory arrest, chronic encephalopathy of unknown origin. Partial report of a

physician on 25MAR14 stated that the vaccine INFANRIX HEXA, administered on
13JUL11 as per calendar, as the cause of post vaccination encephalopathy. Regional HA
report confirmed 80% of disability. Pediatrician Medical report (patient died): admitted
07OCT13. Pt hx was psychomotor development delay, hypotonia, no sitting position, no
bipedalism, absence of spontaneous language, myoclonias of morning predominance,
bad oral tolerance, wt and ht stagnation, not known medical allergies, bad tolerance to
some NSAIDs. Current illness was cardio-respiratory arrest, his parents noticed at home
that he was pale, cyanotic, and not reacting, for over 5-10 minutes. His physical
exploration showed that his initial constant were blood pressure of 60/30, 70/40 mmHg,
when he arrived to pediatric intensive care unit (PICU) it was 100/50 mmHg. He showed
asystolia, 30 beats/min (extreme bradycardia for minutes), 100, 120 beats/min (previous
to his transfer to PICU. When he arrived it was 140 beats/min. O2 saturation 100% post-
intubation (fraction of inspired oxygen 100%), bad general state, badly perfunded,
cyanosis and generalized paleness, absence of spontaneous breathing movements,
asystole, generalized hypoventilation, tympanitic abd. to palpation, mydriatic pupils with
little reaction (under atropine effects). Advanced cardiopulmonary resuscitation during
20 minutes. An intraosseous line was inserted. He evolved requiring 5 doses of
adrenaline, bicarbonate and volumetric expansion. After 20 min. of cardiopulmonary
resuscitation pulse present with spontaneous beats, being moved to PICU. Hemodynamic
after arrest: Normal and stable BP during first hrs with no vasoactive support required.
Oscillating Heart rate with bradycardia episodes of even 53 beats/min, lactic at adm: 15
mmol/1, creatinine kinase: 166 U/L, troponin I 0.01, 0.02, 0.04 mcg/1, bad perfusion and
coloration since his adm. Resp connected to mechanical ventilation with low aggressive
parameters since adm. Normal cardiopulmonary auscultation. Synchronized intermittent
mandatory ventilation plus pressure support with normal respiratory pattern with
spontaneous breathing since first hour of adm. and he was changed to CPAP plus PS.
Limitation of therapeutic efforts was agreed with parents, keeping CPAP until
maintained apnea with subsequent asystole, dying at 19:45 (08-OCT-2013). Diuresis
since adm. He showed hypopotassaemia of 2.1 mEq/1 and hypocalcemia of 4.7 mg/dl
starting being corrected until death. Hyperglycaemia around 300 mg/dl requiring insulin
therapy and continuous perfusion. Bad neurological state since adm, with absence of
reactivity, axial predominant atrophy with limb hypertonia, marked clonus, initial
mydriasis due to atropine moving to fixed bilateral miosis with fixed ocular upward
deviation. No corneal reflex or eye-head. Sporadic myoclonias similar to those
previously presented. Initial apnea test negative, but after that he had two apneas that
ended in asystolia, limitation of therapeutic efforts and started agonic breathing.
Alternating Bispectral Index around 50 with suppression ration from 0 to 20. Once
limitation of therapeutic efforts and agonic breathing started sedation-analgesia was
initiated. Txs received: adrenaline, bircarbonate, physiological saline, atropine,
midalozam, fentanyl, calcic gluconate, actrapid insulin, sodium chloride, potassium
chloride, glucose serum 5%. Discharge diagnoses: cardio-respiratory arrest, chronic
encephalopathy of unk origin. Relevant Test/Laboratory Data: 09NOV11. EEG:
generalized interictal epileptiform activity with sleep and superficial sleep. Outgrowth
discharges with generalized peaks of short length. Brain MRI: scarce volume for his age,
not presenting structural anomalies, good differentiation between white and grey matter.
27SEP11. Vigil EEG was normal. As his parents reported, he suffered a shake with
intermittent light stimulus which was not recorded in EEG. 19SEP11: normal lactic,
normal beta-OH butyrate, negative TORCH serology. On 27APR12 and 17MAY12 a
report showed pathogens: Ascaris Lumbricoide and Larvae (in brain), Strongiloides (in

brain), Fasciola Hepatica, Oxiurio (Entewb. Veoniculae), bacteria: Clostrydium Tetani,

Treponema Pallidum, Streptomyce Griseus, Virus HIV p24 and Rev. Tran. (in thymus),
VIH (1 and 2) in thymus, cytomegalovirus, Hep C; fungi: Candida albicans in blood.
Heavy metals positive in thymus and brain, kidneys and liver (cobalt, nickel,
aluminum), colorant negative, toxics negative, solvents negative, benzene in thymus,
immune system: lack of rodanase enzyme, cytochrome C and gluthatione in saliva,
ferritin enzyme present in white blood cells in brain, lack of betaglycan in white blood
cells, intoxication by vaccines, hereditary grade 3 intoxication, low, presence of toxic
immunosuppressors (heavy metals and azoic colorants). Those analysis showed
normal CBC, normal biochemical analysis except for increased AST-GOT, low
creatinine, toxicology (all normal), aminoacids in urine showed elevated taurine, genetic
studies showed no mutation of Rett-Foxg1 syndrome gene, increased level of lactate
dehydrogenase, low partial 02 blood pressure, very high ammonia ion in plasma, serum
aminoacids: very high histidine (684 micwmol/1), very low glycine, They included
cranial MRI, electroencephalogram-sleep deprivation with abnormal conclusions,
evoked cortical visual potentials also with abnormal results. All available medical
records will be provided upon request. Additional information has been requested.;;
EEG (09NOV2011): generalized interictal epileptiform activity with sleep and
superficial sleep. Outgrowth discharges with generalized peaks of short length. Brain
MRI (06-OCT2011): scarce volume for his age, not presenting structural anomalies,
good differentiation between white and grey matter. On 27-APR-2012 and 17-MAY-
2012 a report showed pathogens: Ascaris Lumbricoide and Larvae (in brain),
Strongiloides (in brain), Fasciola Hepatica, Oxiurio (Entewb. Veoniculae), bacteria:
Clostrydium Tetani, Treponema Pallidum, Strepotomyce Griseus, Virus HIV p24 and
Rev. Tran. (in thymus), VIH (1 and 2) in thymus, cytomegalovirus, hepatitis C; fungi:
Candida albicans in blood. Heavy metals positive in thymus and brain, kidneys and
liver (cobalt, nickel, aluminum), colorant negative, toxics negative, solvents negative,
benzene in thymus, immune system: lack of rodanase enzyme, cytochrome C and
gluthatione in saliva, ferritin enzyme present in white blood cells in brain, lack of
betaglycan in white blood cells, intoxication by vaccines, hereditary grade 3 intoxication,
low, presence of toxic immunosuppressors (heavy metals and azoic colorants). Those
analysis showed noonal complete blood count, normal biochemical analysis except for
increased AST-GOT, low creatinine, toxicology (all normal), aminoacids in urine
showed elevated taurine, genetic studies showed no mutation of Rett-Foxg1 syndrome
gene, increased level of lactate dehydrogenase, low partial 02 blood pressure, very high
anunonia ion in plasma, serum aminoacids: very high histidine (684 micwmol/1), very
low glycine, they included cranial MRI, electroencephalogram-sleep deprivation with
abnormal conclusions, evoked cortical visual potentials also with abnormal results.
09/19/2011, Blood ketone body, normal; 09/19/2011, Blood lactate dehydrogenase,
increased, normal; 09/27/2011, Electroencephalogram, normal; 09/19/2011, Serology
test, negative;;
Medical observation, no known allergies; Immunisation;;
Medical observation, eutocic delivery after well controlled term gestation. Controlled
pregnancy without complication. Epidural during delivery. Dilatation during 13/14 hours
(dystocic), prolonged vaginal expulsive (2/3h). Oxytocic, epidural analgesia, normal
delivery no requiring resuscitative measures. Apgar of 9/10, breastfed without problems
and no sleep alterations; Son of non-consanguineous parents, 1st pregnancy and 1st son,
born after a normal pregnancy at 41 plus 6 week through vaginal delivery (weight 3.490
gr., cranial perimeter 34/34.5 em) with prolonged expulsive but good general state,
cephalohematoma, early jaundice (bilirubin 16.5) at the third day of age that was treated

with natural phototherapy; On 05-JAN-2011 a routinely medical checkup with the usual
healthy checkup program did not reflect any alteration in the patient. On 29-MAR-2011
the patient presented with postural plagiocephaly and torticollis with neck right
lateralization, noonal neurological exploration. Mouth asymmetry when crying since
birth; On 30-MAR-2011: diagnosis of congenital torticollis; Breastfeeding until he was
16 months old; Healthy alive father 38 years old, healthy alive mother 33 years old;
Mother suffered from lymphoblastic leukemia when she was 20 years old. His mother
history was blood group O/RH+ and appendectomy; Mother head circumference: 54.5
and father: 60 em; No neurological relative's relevant medical history; Maternal
grandparents alive with good health stay. Paternal grandfather 81 years-old with
hypercholesterolemia and depression. Paternal grandmother 67 years-old with aneurysm
cerebral with leg paralysis as sequelae; 10/26/2010, ENGERIX-B, first dose of hepatitis
B vaccine at birth (ENGERIX, by GSK, number: XHBVSP70AK); INFANRIX;
NEISVAC-C; INFANRIX HEXA; PREVENAR
613883 12.10.2015: (F12) [Same as 610702 28.09.2015, 613855 09.10.2015] This case
was reported by a consumer via regulatory authority and described the occurrence of
postural orthostatic tachycardia syndrome in a 12-year-old female patient who received
HPV 16 + 18 vaccine. Co-suspect products included HPV 16 + 18 vaccine. In 2010, the
patient received the 1st dose of HPV 16 + 18 vaccine (unknown). In 2010, immediately
after receiving HPV 16 + 18 vaccine, the patient experienced fatigue extreme (serious
criteria other), ice pick headache (serious criteria other) dizziness (serious criteria other),
nausea (serious criteria other) and pain in limb (serious criteria other). In 2010, the patient
received the 2nd dose of HPV 16 + 18 vaccine (unknown). On an unknown date the
patient experienced postural orthostatic tachycardia syndrome (serious criteria other),
encephalopathy (serious criteria GSK medically significant and other) and chronic
fatigue syndrome (serious criteria other). On an unknown date, the outcome of the
postural orthostatic tachycardia syndrome, encephalopathy, chronic fatigue syndrome,
fatigue extreme, ice pick headache, dizziness, nausea and pain in limb were unknown.
It was unknown if the reporter considered the postural orthostatic tachycardia
syndrome, encephalopathy, chronic fatigue syndrome, fatigue extreme, ice pick
headache, dizziness, nausea and pain in limb to be related to HPV 16 + 18 vaccine.
RA verbatim: 05-OCT-2015. Serious case identified in an article in the lay press on 21-
Sep-2015. Case not medically confirmed as it was reported by a consumer. A female
patient received HPV vaccine (mfr unknown, lot not reported), injection site and route
not reported when she was 12 year-old in 2010. The patient began suffering from
headaches, dizziness, nausea, aching limbs and feeling tired immediately after having
the first injection of HPV vaccine at school. her health problems spiraled after the
second dose and by Christmas she had extreme fatigue and piercing headaches so severe
her parents feared she had a brain tumour. The patient was initially diagnosed with
Myalgic Encephalopathy and Chronic Fatigue Syndrome, and then with Postural
Tachycardia Syndrome (PoTS). To be noted that the reported was patient's relative.
The outcome of AEs was not reported. The case was considered serious due to other
significant medical events.;;
Unknown;;
25. If an alien from Planet X were to land in the midst of the Earth Vaccine Dispute her fair
comment may well be:

“Never in history has so much blood money been earned from experimental scientific
medical procedure (the 200 year old practice of vaccinations), unproven in its life-long
or even long-term efficacy in verifiable placebo controlled double blind long term
medical trials, legally declared on 22.02.2011 to be ‘unavoidably unsafe’; suspected to
be at least a contributory cause in maiming or killing millions of neonates, girls and
boys, men and women across the World, yet vaccine majors earn blood money from
vaccine sales fooling gullible Governments to use ordinary taxpayers money for
vaccine injury claims; adding insult to injury WHO waives ethical ban to advertise
experimental vaccines in the medical space; net result is vaccine majors, less than
truthfully, advertise vaccines as safe and effective without any legal liability to
demonstrate in courts of law rule mandated safety/ efficacy records basis scientific
double blind, placebo controlled trials/ studies over 10-20 years at the very least, which
have been vociferously demanded from as far back as 1948, for which see [Document
No. 125 - The Vaccine Damage Campaign, New Scientist, Vol. 70, No. 1001 (1976)
pp. 404-406, at p.405], and US CDC #20-02002-FOIA dt. 29.07.2020 [Document No.
520 p.23 ICAN Part XII – “This letter is in response to your Centers for Disease
Control and Prevention and Agency for Toxic Substances and Disease Registry
(CDC/ATSDR) Freedom of Information Act (FOIA) request of July 13, 2020, for: "All
documents in the CDC’s possession which compare the health outcomes between
children that have received vaccines and children that have never received any
vaccines.” A search of our records failed to reveal any documents pertaining to your
request. The CDC has not conducted a study of health outcomes in vaccinated vs
unvaccinated populations."] which is conclusive of the fact that no vaccinated versus
unvaccinated children safety/ efficacy records exist from 01.07.1946 (date of
establishment of the health agency) onwards. Further, there are no CDC safety/ efficacy
records for 1995 varicella vaccine. [New York,. South District, Case 1:19-cv-10235,
Informed Consent Action Network v. United States Food and Drug Administration,
04.11.2019 & 30.04.2021 :: “Section 355(l) of Title 21, entitled “Public disclosure of
safety and effectiveness data and action package,” provides that: Safety and
effectiveness data and information which has been submitted in an application under
subsection (b) for a drug and which has not previously been disclosed to the public
shall be made available to the public, upon request, unless extraordinary circumstances
are shown” Document No. 510 pp.304-311 ICAN Part II - At p.310; “Pursuant to

the FDA's representations that (a) the FDA has completed processing (and re-
processing, as applicable) all records identified in the parties' letters to the Court,
dated January 28, 2020 (Dkt. No. 8) and dated February 8, 2021 (Dkt. No. 19), and
that (b) the FDA engaged in an adequate search, the above-captioned action is
voluntarily dismissed, with prejudice pursuant to Federal Rule of Civil Procedure
41(a)(l)(A)(ii)” Document No. 520 pp.319-321 ICAN Part XII - At p.320]
26. That the suspect long term efficacy and low safety thresholds of experimental medical
procedures including vaccinations has been a matter of recurrent challenge by right
thinking doctors and citizens for over 200 years, in lawful and constitutionally
guaranteed civil protest, street meetings, printed material, published books, court
cases, public petitions and social media platforms [Be it clear to all persons and
authorities that any attempt of any authority, even if it be a Court of Record, to stifle
the voices of free speech and reason, without a proper hearing would not only violate
the Constitution of India but the legislatively protected human rights of citizens to
refuse to accept upon their person the crime of non-consensual medical experiments
which are “CRIMES AGAINST HUMANITY” [Refer para 41at pp.115-118 below] per
well settled Customary International Law], for at least 170 years since 1850s, for which
a quick reference may be had to Document Nos. 3, 6, 25, 70, 79, 83-85, 90-91, 98, 100,
102-104, 106, 108, 118, 120-121, 125 [The Vaccine Damage Campaign, New Scientist,
Vol. 70, No. 1001 (1976) pp. 404-406)], 127, 129, 131-133, 136, 140, 147, 154, 160B,
165, 169, 172, 181, 185, 193, 195, 199-200, 202-203, 207-208, 210, 214-216, 219, 221-
222, 225, 227, 229, 232, 234-238, 241-242, 247, 252-254, 256-258, 259B, 261-267,
269-272, 279-284, 288, 293-299, 301-302, 305-308, 311-316, 318, 321-327, 329-334,
338-340, 342-350, 352-355, 357, 360-361, 363-364, 366-372, 375-377, 379-385, 387,
389-390, 392, 396-398, 402-406, 408-409, 411, 414-420, 422, 424-429, 432-434, 436,
438-440, 442, 445-446, 450-455, 457-458, 460, 462-468, 470-480, 482-501, 503, 505-
533, 535-536, 538-546, 548-551, 553-565, 566 ECLJ Letter 21.07.2021 to the WMA
on the 2021 Revision-of its Code “The “Nuremberg Code”, which encapsulates
medical ethics, is heavily inspired by this historical oath. It was at that time that
conscientious objection was recognized as a duty imposed on people who have received
the order to collaborate in the making of severe crimes violating natural law. It has
been acknowledged that the conscience of the doctors directing them to “do no harm”
was above national laws. A principle was set, that when faced with a profoundly unjust

order which “outraged the conscience of mankind”, following the expression of the
Universal Declaration of Human Rights, the subordinate must refuse to obey, it is their
duty as a member of humanity.” 567-570, 572-573, 575-576, 578-582, 584-589, 591-
593, 597-598, 601 “Upon perusing the same it does not reveal any step taken by
Meghalaya Police in order to specifically identify and book those persons ... using
various social media platforms with regard to the efficacy of the vaccines .... They can
be easily apprehended by the Meghalaya Police (provided it has the will to do so), since
all of them are invariably using various social media platforms, thereby leaving an
electronic trail. We would request the learned Advocate General to take serious note of
this matter and apprise the Court specifically on the next date the steps taken by the
Meghalaya Police in this regard.”[Refer para 41 at pp.115-118 below], 604-606, 608
& 611 “"I'm here today because I want to support the constitutional right of every
Greek citizen to say 'yes' or 'no' to vaccination. I personally am vaccinated, but I believe
it is my colleagues' right to not get vaccinated if they don't want to," said Evangelia
Karatzouli, a nurse at a public hospital.”. That Document Nos. 474-475, 478, 486-487
& 508-520 are testament to the fact that a robust determined and principled stand has
been taken by ICAN of the U.S. before the OHCHR and the OTP ICC, to point out
for rectification the serious defects in the United States Vaccine System. ICAN has
taken up this grave issue not only with the OHCHR and the OTP ICC, it has also
approached the U.S. CDC & U.S. Courts for relief to the suffering public from grave
defects in the United States Vaccine System. That, nevertheless, this petitioner is all
praise for the U.S. CDC for exhibiting a level of transparency not available anywhere
else in the World. That this Notice could never have been prepared in such an effective
manner without the assistance petitioner received from the U.S. CDC’s website. Hence
it is bounden duty as a global citizen to place this appreciation to the U.S. CDC
(estd. 1946), and its 15,000 staff on record for all times to come. That the Rest of the
World has totally failed its citizens by not educating them on the low levels of safety
and suspect long term efficacy of vaccines (against inbuilt whole life immunity), thus
precluding any scope for “Informed Consent” which, inter alia, constitutes in itself,
CRIMES AGAINST HUMANITY without any manner of doubt. That the Infection
Protection Act - IfSG Act, 2001 of Germany [Document No. 169] is globally the most
robust act to ensure accurate recording of injuries and deaths due to disease while the
Law no. 2002-303 of 4 March 2002 on patients rights and on the quality of the health

system of France [Document No. 181] read with Article 1386-1 of the Civil Code, is
globally the most robust act to ensure restitution for injuries and deaths caused by
negligence of the medical system. Hence French citizens have a better prospect of
restitution for vaccine injury and death as noted in Case of Vo v. France, ECHR
Application no. 53924 of 2000, 08.07.2004 [Document No. 208] and Case C-621-15
N.W. and Ors v Sanofi Pasteur MSD SNC, Judgement CJEU 2nd Chamber [2017] ECR
I 21.06.2017 [Document Nos. 375, 376 & 385]. However even in France Article 1386-
9 of the Civil Code places initial burden of proof on claimants “The plaintiff is required
to prove the damage, the defect and the causal relationship between defect and
damage.” Even as Germany has otherwise strict reporting of injuries and deaths due to
disease, the reporting of vaccine injuries has been made, most mysteriously, subject to
availability of information. The relevant provisions are extracted: “Section 2
Definitions (11). vaccine injury - are the health-related and economic consequences of
a health impairment due to vaccination the degree of which exceeds that of a normal
post-vaccinal reaction; a vaccine injury is also present if agents capable of replication
were used for vaccination and persons other than the person vaccinated were injured,…
Section 6 Notifiable diseases (1) The following shall be notified on a named-patient
basis 1… 2…. 3. the suspicion of a health impairment the degree of which exceeds that
of a normal post vaccinal reaction,… Section 8 Persons obliged to notify (1) The
following persons shall be obliged to notify: 1… 2… 3… 4… 5. in the case of section 6
paragraph 1 nos. 1, 2 and 5 and paragraph 3 members of any paramedical profession
the exercise or use of professional title of which requires a state regulated training or
recognition,… Section 9 Notification on a named-patient basis (1) Notification on a
named-patient basis by one of the persons mentioned in section 8 paragraph 1 nos. 1,
4 to 8 must contain the following information: 1. surname, forename of the patient 2.
Sex 3. day, month and year of birth 4. address of the main residence and, if not identical:
address of the current abode 5. activity in facilities within the meaning of section 36
paragraph 1 or 2; activity within the meaning of section 42 paragraph 1 in case of
acute gastro-enteritis, acute viral hepatitis, abdominal typhus/paratyphoid fever and
cholera 6. cared for in a community facility pursuant to section 33 7. diagnosis or
suspected diagnosis 8. date of clinical presentation or date of diagnosis, if applicable
date of death 9. likely source of infection 10. country in which the infection was
presumably acquired; for tuberculosis country of birth and nationality 11. name,

address and telephone number of the laboratory charged with diagnosing the pathogen
12. referral to a hospital or admission to a hospital or other institution providing in-
patient care and discharge from the institution, if known to the person obliged to notify
13. any blood, organ or tissue donation within the preceding six months 14. name,
address and telephone number of the notifier 15. for a notification pursuant to section
6 paragraph 1 no. 3 the information specified in section 22 paragraph 2. For the
persons mentioned in section 8 paragraph 1 nos. 4 to 8, the obligation to notify is
limited to the information available to them.”
27. “A correlate of protection, defined as a specific immune marker that is associated with
protection against infection or disease, is important for vaccine development,
evaluating individual susceptibility to disease, and evaluating population immunity.”
[Bolotin et al, JID 2020 Vol. 221 pp.1576-1583, at p.1576] However, in “Is There a
Correlate of Protection for Measles Vaccine,” JID 2020 Vol. 221 pp.1571-1572, that
doyen of vaccinations, Stanley A. Plotkin, in his editorial, points towards the present
poor state of vaccination knowledge due to oversimplified approach of the vaccine
industry, and fully supports the finding of the authors of this latest research on the
“scant data” which invalidates the hitherto assumed “correlates of protection”
approach because of huge knowledge gaps in “the multiplicity of antibody and cellular
immune functions and the many ways in which those functions interact”. [Bolotin et al,
JID 2020 Vol. 221 pp.1576-1583, at p.1576 “Conclusions. Our findings underscore the
scant data upon which the commonly used 120 mIU/mL measles threshold of protection
is based, suggesting that further work is required to characterize the measles immunity
threshold.” Document Nos. 433 & 434]
28. Stanley A. Plotkin (S.A.P.), having fairly disclosed at JID 2020 Vol. 221 p.1572
“Potential conflicts of interest. S.A.P. reports personal fees from Merck,
GlaxoSmithKline, and Sanofi outside of the submitted work. The author has submitted
the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the
editors consider relevant to the content of the manuscript have been disclosed.“
conclusively holds at JID 2020 Vol. 221 p.1571“To define a correlate of protection by
a vaccine is not easy, as I have learned over the years. In 2001, I first wrote about the
subject, attempting to simplify it with certain definitions and criteria. Subsequently I
realized that nothing is simple, as has been noted from times immemorial. The reasons
for this lack of simplicity are manifold, including lack of standardization of critical

immunologic tests, the multiplicity of antibody and cellular immune functions and the
many ways in which those functions interact. In addition, challenge dose and number
of challenges also figure into estimations of correlates.”
29. That the current method of declaring effectiveness of a vaccine based on seropositivity
or on levels of titres have been shown to be based on guesstimates, and no concrete data
has emerged since 1925 to scientifically establish these methods of declaring
effectiveness of a vaccine, as anything but guesstimates. (Document No. 338 p.45, 242
& 304)
30. That the US HHS released “Electronic Support for Public Health VAERS Final Report,
10.11.2011” (Document No. 284) showing 1 Adverse Event for every 38 vaccinations.
(2.6%) This is nowhere near the 1 in 1000 that are routinely advertised by vaccine
majors. Studies have found that only 1% of adverse events are reported (goes up to 5-
10% in the U.S.). This is not surprising given that in US Non Domestic VAERS Data
at ID 493400 05.06.2013 (F0.25) at pp.74-75 above “ROTATEQ (batch number 0396Z,
lot number 667460/0396Z, Exp. Date: 31-JAN-2012) via oral route on 02-Feb-2011.
After vaccination, the patient became stiffer little by little and had stiff hips……… which
was considered normal by the doctor…..” That hence this was initially not reported
in February 2011 till 05 June 2013. “On 10-Jun-2011, a child neurologist stated the
baby to be neurologically clearly abnormal …. Final diagnosis included
encephalopathy, epilepsy, dystonia and neurodevelopmental disorder. At the time of
reporting, the patient had not recovered” That in advanced countries like U.S.A. only
about 10% of adverse events are “on record” reported whereas in less advanced
countries the reportage plummets to as low as 1%. Therefore this case being finally
reported after delay of more than 2 years on 05.06.2013 is not atypical of the malaise
of resistance of the prevalent system of vaccination to neglect to take on record every
single adverse event. (Document Nos. 558 & 615) Also important are Document Nos.
294-295, 342, 468, 480, 485, 488-489, 495, 508, 521-523 & 528. Taking this malaise
as a benchmark the true position may be stated as somewhere between 1 adverse event
for every 3.8 to 1 adverse event for every 38 vaccinations, which is only to be expected
after the US Supreme Court held vaccinations to be “Unavoidably Unsafe.” [Russell
Bruesewitz et al v. Wyeth LLC et al, 562 U.S. 223 (2011), US SC Case No. 09-152,
22.02.2011- Document No. 279]
31. Suppressio Veri, Suggestio Falsi

32. That PERMISSIBLE MEDlCAL EXPERIMENTS Principles 1-10 at pp.181-182 in

“The Medical Case”, "Trials of War Criminals before the Nüremberg Military
Tribunals under Control Council Law No. 10", Vol. 2, pp. 181-182 are interalia
(Document Nos. 102 & 103):
“PERMISSIBLE MEDICAL EXPERIMENTS
The great weight of the evidence before us is to the effect that certain types of medical
experiments on human beings when kept within reasonably well-defined bounds,
conform to the ethics of the medical profession generally. The protagonists of the
practice of human experimentation justify their views on the basis that such experiments
yield results for the good of society that are unprocurable by other methods or means
of study. All agree, however, that certain basic principles must be observed in order to
satisfy moral, ethical and legal concepts:
1. The voluntary consent of the human subject is absolutely essential. This means that
the person involved should have legal capacity to give consent; should be so situated
as to be able to exercise free power of choice, without the intervention of any element
of force, fraud, deceit, -duress, over-reaching, or other ulterior form of constraint or
coercion; and should have sufficient knowledge and comprehension of the elements of
the subject matter involved as to enable him to make an understanding and enlightened
decision. This latter element requires that before the acceptance of an affirmative
decision by the experimental subject there should be made known to him the nature,
duration, and purpose of the experiment; the method and means by which it is to be
conducted; all inconveniences and hazards reasonably to be expected; and the effects
upon his health or person which may possibly come from his participation in the
experiment.
The duty and responsibility for ascertaining the quality of the consent rests upon each
individual who initiates, directs or engages in the experiment. It is a personal duty and
responsibility which may not be delegated to another with impunity.
2. The experiment should be such as to yield fruitful results for the good of society,
unprocurable by other methods or means of study, and not random and unnecessary in
nature.
3. The experiment should be so designed and based on the results of animal
experimentation and a knowledge of the natural history of the disease or other problem
under study that the anticipated results will justify the performance of the experiment.

4. The experiment should be so conducted as to avoid all unnecessary physical and

mental suffering and injury.
5. No experiment should be conducted where there is an a priori reason to believe that
death or disabling injury will occur; except, perhaps, in those experiments where the
experimental physicians also serve as subjects.
6. The degree of risk to be taken should never exceed that determined by the
humanitarian importance of the problem to be
solved by the experiment.
7. Proper preparations should be made and adequate facilities provided to protect the
experimental subject against even remote possibilities of injury, disability, or death.
8. The experiment should be conducted only by scientifically qualified persons. The
highest degree of skill and care should be required through all stages of the experiment
of those who conduct or engage in the experiment.
9. During the course of the experiment the human subject should be at liberty to bring
the experiment to an end if he has reached the physical or mental state where
continuation of the experiment seems to him to be impossible.
10. During the course of the experiment the scientist in charge must be prepared to
terminate the experiment at any stage, if he has probably cause to believe, in the
exercise of the good faith, superior skill and careful judgment required of him that a
continuation of the experiment is likely to result in injury, disability, or death to the
experimental subject.”
33. That in “The Medical Case” the Nüremberg Military Tribunal I passed judgement in
The United States of America vs. Karl Brandt et al. on 19.07.1947, and subsequently
sentenced Karl Brandt and six others to death by hanging on 20.08.1947. The sentences
were confirmed on 22.11.1947 by the Military Governor. Motion for leave to challenge
the seven death sentences in Misc. No. 286, Karl Brandt, v. The United States of
America was denied by the US Supreme Court along with Misc. Nos. 287-289 on
16.02.1948. The execution of death sentences imposed on Karl Brandt, Rudolf Erandt,
Karl Gebhardt, Joacliim Mrugowsky, Viktor Brack, Wolfram Sievers, and Waldemar
Hoven were ordered on 14.05.1948 by the Military Governor. Executions were carried
out at Landsberg prison on 02.06.1948.
34. That in Case No. 86-393 United States v. James B. Stanley, 483 US 669 (1987)
[Document No. 133] the US Supreme Court rejected Stanley’s compensation claim on

25.06.1987 [Reportedly basis a strong dissent of Justices Brennan, Marshall, Stevens

& O’Connor, An Act of Congress was passed “For the relief of James B. Stanley”, i.e.
Private Law 108-8, 103d Congress pp.5066-5067, assented by The President on
25.10.1994, Stanley was awarded $400,577 by an arbitral tribunal Document No. 147]
placing the armed forces and the offending official defendants alleged to have
committed crimes against humanity beyond the reach of the constitutional claim of a
veteran soldier. The dissenting judges stated inter alia:
Brennan J., “In experiments designed to test the effects of lysergic acid diethylamide
(LSD), the Government of the United States treated thousands of its citizens as though
they were laboratory animals, dosing them with this dangerous drug without their
consent. One of the victims, James B. Stanley, seeks compensation from the Government
officials who injured him. The Court holds that the Constitution provides him with no
remedy, solely because his injuries were inflicted while he performed his duties in the
Nation's Armed Forces. If our Constitution required this result, the Court's decision,
though legally necessary, would expose a tragic flaw in that document. But in reality,
the Court disregards the commands of our Constitution, and bows instead to the
purported requirements of a different master, military discipline, declining to provide
Stanley with a remedy because it finds "special factors counselling hesitation." Bivens
v. Six Unknown Fed. Narcotics Agents, 403 U. S. 388, 396 (1971). This is abdication,
not hesitation. I dissent.
I. Before addressing the legal questions presented, it is important to place the
Government's conduct in historical context. The medical trials at Nuremberg in 1947
deeply impressed upon the world that experimentation with unknowing human subjects
is morally and legally unacceptable. The United States Military Tribunal established
the Nuremberg Code as a standard against which to judge German scientists who
experimented with human subjects. Its first principle was: "1. The voluntary consent of
the human subject is absolutely essential. "The duty and responsibility for ascertaining
the quality of the consent rests upon each individual who initiates, directs or engages
in the experiment. It is a personal duty and responsibility which may not be delegated
to another with impunity." United States v. Brandt (The Medical Case), 2 Trials of War
Criminals Before the Nuremberg Military Tribunals Under Control Council Law No.
10, pp. 181-182 (1949) (emphasis added). The United States military developed the
Code, which applies to all citizens -soldiers as well as civilians. In the 1950's, in

defiance of this principle, military intelligence agencies and the Central Intelligence
Agency (CIA) began surreptitiously testing chemical and biological materials,
including LSD. These programs, which were "designed to determine the potential
effects of chemical or biological agents when used operationally against individuals
unaware that they had received a drug," included drug testing on "unwitting, non-
volunteer" Americans. S. Rep. No. 94-755, Book I, p. 385 (1976) (S. Rep.).3 James B.
Stanley, a master sergeant in the Army, alleges that he was one of 1,000 soldiers
covertly administered LSD by Army Intelligence between 1955 and 1958. See id., at
392.4 The Army recognized the moral and legal implications of its conduct. In a 1959
Staff Study, the United States Army Intelligence Corps (USAINTC) discussed its covert
administration of LSD to soldiers: "'It was always a tenet of Army Intelligence that the
basic American principle of dignity and welfare of the individual will not be violated. .
. . In intelligence, the stakes involved and the interests of national security may permit
a more tolerant interpretation of moral-ethical values, but not legal limits, through
necessity .... Any claim against the US Government for alleged injury due to EA 1729
[LSD] must be legally shown to have been due to the material. Proper security and
appropriate operational techniques can protect the fact of employment of EA 1729."'
Id., at 416-417 (quoting USAINTC Staff Study, Material Testing Program EA 1729, p.
26 (Oct. 15, 1959)). That is, legal liability could be avoided by covering up the LSD
experiments. When the experiments were uncovered, the Senate agreed with the Army's
conclusion that its experiments were of questionable legality, and issued a strong
condemnation: "[I]n the Army's tests, as with those of the CIA, individual rights were
... subordinated to national security considerations; informed consent and follow-up
examinations of subjects were neglected in efforts to maintain the secrecy of the tests.
Finally, the command and control problems which were apparent in the CIA's
programs are paralleled by a lack of clear authorization and supervision in the Army's
programs." S. Rep., at 411.1 Having invoked national security to conceal its actions,
the Government now argues that the preservation of military discipline requires that
Government officials remain free to violate the constitutional rights of soldiers without
fear of money damages. What this case and others like it demonstrate, however, is that
Government officials (military or civilian) must not be left with such freedom. See, e.
g., Jaffee v. United States, 663 F. 2d 1226 (CA3 1981) (en banc) (exposure of soldiers
to nuclear radiation during atomic weapons testing); Schnurman v. United States, 490

F. Supp. 429 (ED Va. 1980) (exposure of unknowing soldier to mustard gas); Thornwell
v. United States, 471 F. Supp. 344 (DC 1979) (soldiers used to test the effects of LSD
without their knowledge);cf. Barrett v. United States, No. 76 Civ. 381 (SDNY, May 5,
1987) (death of mental hospital patient used as the unconsenting subject of an Army
experiment to test mescaline derivative).
II. Serious violations of the constitutional rights of soldiers must be exposed and
punished. Of course, experimentation with unconsenting soldiers, like any
constitutional violation, may be enjoined if and when discovered. An injunction,
however, comes too late for those already injured; for these victims, "it is damages or
nothing." Bivens, 403 U. S., at 410 (Harlan, J., concurring). The solution for Stanley
and other soldiers, as for any citizen, lies in a Bivens action-an action for damages
brought directly under the Constitution for the violation of constitutional rights by
federal officials. But the Court today holds that no Bivens remedy is available for
service-connected injuries, because "special factors counse[l] hesitation." Id., at 396.
The practical result of this decision is absolute immunity from liability for money
damages for all federal officials who intentionally violate the constitutional rights of
those serving in the military. First, I will demonstrate that the Court has reached this
result only by ignoring governing precedent. The Court confers absolute immunity from
money damages on federal officials (military and civilian alike) without consideration
of longstanding case law establishing the general rule that such officials are liable for
damages caused by their intentional violations of well-established constitutional rights.
If applied here, that rule would require a different result. Then I will show that the
Court denies Stanley's Bivens action solely on the basis of an unwarranted extension of
the narrow exception to this rule created in Chappell v. Wallace, 462 U. S. 296 (1983).
The Court's reading of Chappell tears it from its analytical moorings, ignores the
considerations decisive in our immunity cases, and leads to an unjust and illogical
result.
A. The Court acknowledges that Stanley may bring a Bivens action for damages under
the Constitution unless there are "special factors counselling hesitation in the absence
of affirmative action by Congress." Bivens, supra, at 396. Ascertaining the propriety of
a damages award is the purpose of both the Bivens "special factors" analysis and the
inquiry into whether these federal officials are entitled to absolute immunity from
money damages.' As a practical matter, the immunity inquiry and the "special factors"

inquiry are the same; the policy considerations that inform them are identical, and a
court can examine these considerations only once. In Davis v. Passman, 442 U. S. 228
(1979), the Court explicitly acknowledged that the immunity question and the "special
factors" question are intertwined. The Court recognized that
"a suit against a Congressman for putatively unconstitutional actions taken in the
course of his official conduct does raise special concerns counseling hesitation" under
Bivens, but held that "these concerns are coextensive with the protections afforded by
the Speech or Debate Clause," id., at 246, which "shields federal legislators with
absolute immunity," id., at 236, n. 11.1 Absent immunity, the Court said, legislators
ought to be liable in damages, as are ordinary persons. See id., at 246. The same
analysis applies to federal officials making decisions in military matters. Absent
immunity, they are liable for damages, as are all
citizens………..…..B……….….C……..……III…..……..A……….….B The second
"special factor" in Chappell-congressional activity "provid[ing] for the review and
remedy of complaints and grievances such as those presented by" the injured soldier-
is not present here. Chappell, 462 U. S., at 302.9 The Veterans' Benefits Act is irrelevant
where, as here, the injuries alleged stem (in large part) from pain and suffering in forms
not covered by the Act. The UCMJ assists only when the soldier is on active duty and
the tortfeasor is another military member. Here, in contrast to the situation in Chappell,
no intramilitary system "provides for the ... remedy" of Stanley's complaint. 462 U. S.,
at 302. See also Bush v. Lucas, 462 U. S. 367, 386, 388, 378, n. 14 (1983) (special
factors counseling hesitation found because claims were "fully cognizable" within an
"elaborate remedial system, providing "comprehensive," "meaningful," and
"constitutionally adequate" remedies)………… In Chappell the Court found that both
the imperatives of military discipline and the congressional creation of constitutionally
adequate remedies for the alleged violations constituted "special factors counselling
hesitation," and refused to infer a Bivens action. In this case, the invocation of "military
discipline" is hollow, and congressional activity non-existent; a Bivens action must
lie."[ Stevens J. concurring in Part III]
IV. The soldier's case is instructive: Subject to most unilateral discipline, forced to risk
mutiliation and death, conscripted without, perhaps against, his will-he is still
conscripted with his capacities to act, to hold his own or fail in situations, to meet real
challenges for real stakes. Though a mere 'number' to the High Command, he is not a

token and not a thing. (Imagine what he would say if it turned out that the war was a
game staged to sample observations on his endurance, courage, or cowardice.)" H.
Jonas, Philosophical Reflections on Experimenting with Human Subjects, in
Experimentation with Human Subjects 3 (P. Freund ed. 1969). The subject of
experimentation who has not volunteered is treated as an object, a sample. James
Stanley will receive no compensation for this indignity. A test providing absolute
immunity for intentional constitutional torts only when such immunity was essential to
maintenance of military discipline would "take into account the special importance of
defending our Nation without completely abandoning the freedoms that make it worth
defending." Goldman v. Weinberger, 475 U. S. 503, 530-531 (1986) (O'CONNOR, J.,
dissenting). But absent a showing that military discipline is concretely (not abstractly)
implicated by Stanley's action, its talismanic invocation does not counsel hesitation in
the face of an intentional constitutional tort, such as the Government's experimentation
on an unknowing human subject. Soldiers ought not be asked to defend a Constitution
indifferent to their essential human dignity. I dissent.” Marshall J., “Joins with Justice
Brennan”
Stevens J. “Joins in Part III with Justice Brennan” &
O’Connor J., “I agree with both the Court and JUSTICE BRENNAN that James
Stanley's cause of action under the Federal Tort Claims Act (FTCA), 28 U. S. C. § 2671
et seq., should not have been reinstated by the Court of Appeals. I therefore join Part I
of the Court's opinion. I further agree with the Court that under Chappell v. Wallace,
462 U. S. 296 (1983), there is generally no remedy available under Bivens v. Six
Unknown Fed. Narcotics Agents, 403 U. S. 388 (1971), for injuries that arise out of the
course of activity incident to military service. Ante, at 683-684. In Chappell v. Wallace,
supra, this Court unanimously held that enlisted military personnel may not maintain
a suit to recover damages from a superior officer for alleged constitutional violations.
The "special factors" that we found relevant to the propriety of a Bivens action by
enlisted personnel against their military superiors "also formed the basis" of this
Court's decision in Feres v. United States, 340 U. S. 135 (1950), that the FTCA does
not extend to injuries arising out of military service. Chappell, supra, at 298. In my
view, therefore, Chappell and Feres must be read together; both cases unmistakably
stand for the proposition that the special circumstances of the military mandate that
civilian courts avoid entertaining a suit involving harm caused as a result of military

service. Thus, no amount of negligence, recklessness, or perhaps even deliberate

indifference on the part of the military would justify the entertainment of a Bivens action
involving actions incident to military service. Nonetheless, the Chappell exception to
the availability of a Bivens action applies only to "injuries that 'arise out of or are in
the course of activity incident to service.'" Ante, at 684 (quoting Feres v. United States,
supra, at 146). In my view, conduct of the type alleged in this case is so far beyond the
bounds of human decency that as a matter of law it simply cannot be considered a part
of the military mission. The bar created by Chappell-a judicial exception to an implied
remedy for the violation of constitutional rights-surely cannot insulate defendants from
liability for deliberate and calculated exposure of otherwise healthy military personnel
to medical experimentation without their consent, outside of any combat, combat
training, or military exigency, and for no other reason than to gather information on
the effect of lysergic acid diethylamide on human beings. No judicially crafted rule
should insulate from liability the involuntary and unknowing human experimentation
alleged to have occurred in this case. Indeed, as JUSTICE BRENNAN observes, the
United States military played an instrumental role in the criminal prosecution of Nazi
officials who experimented with human subjects during the Second World War, ante, at
687, and the standards that the Nuremberg Military Tribunals developed to judge the
behavior of the defendants stated that the "voluntary consent of the human subject is
absolutely essential ... to satisfy moral, ethical and legal concepts." United States v.
Brandt (The Medical Case), 2 Trials of War Criminals Before the Nuremberg Military
Tribunals Under Control Council Law No. 10, p. 181 (1949). If this principle is violated
the very least that society can do is to see that the victims are compensated, as best they
can be, by the perpetrators. I am prepared to say that our Constitution's promise of due
process of law guarantees this much. Accordingly, I would permit James Stanley's
Bivens action to go forward, and I therefore dissent.”
35. That in Rabi Abdullahi v. Pfizer Inc., 562 F. 3d 163 US Court of Appeals 2nd Circuit
Case No. 05-4863-cv, (30.01.2009) it was held (Pfizer’s subsequent appeal was refused
hearing in the US Supreme Court, hence judgement is final):
“A. The Prohibition of Nonconsensual Medical Experimentation on Humans
Appellants’ ATS claims are premised on the existence of a norm of customary
international law prohibiting medical experimentation on non-consenting human
subjects. To determine whether this prohibition constitutes a universally accepted norm

of customary international law, we examine the current state of international law by

consulting the sources identified by Article 38 of the Statute of the International Court
of Justice (“ICJ Statute”), to which the United States and all members of the United
Nations are parties. Flores, 414 F.3d at 250; see, e.g., United States v. Yousef, 327 F.3d
56, 100-01 (2d Cir. 2003). Article 38 identifies the authorities that provide “competent
proof of the content of customary international law.”Flores, 414 F.3d at 251. These
sources consist of:
(a) international conventions, whether general or particular, establishing rules
expressly recognized by the contesting states;
(b) international custom, as evidence of a general practice accepted as law;
(c) the general principles of law recognized by civilized nations;
(d) . . . judicial decisions and the teachings of the most highly qualified publicists of the
various nations, as subsidiary means for the determination of rules of law.
Statute of the International Court of Justice, art. 38(1), June 26, 1945, 59 Stat. 1055,
1060, T.S. No. 993 [hereinafter ICJ Statute].
The appellants ground their claims in four sources of international law that
categorically forbid medical experimentation on non-consenting human subjects: (1)
the Nuremberg Code, which states as its first principle that “[t]he voluntary consent of
the human subject is absolutely essential”; (2) the World Medical Association’s
Declaration of Helsinki, which sets forth ethical principles to guide physicians world-
wide and provides that human subjects should be volunteers and grant their informed
consent to participate in research; (3) the guidelines authored by the Council for
International Organizations of Medical Services (“CIOMS”), which require “the
voluntary informed consent of [a] prospective subject”; and (4) Article 7 of the
International Covenant on Civil and Political Rights (“ICCPR”), which provides that
“no one shall be subjected without his free consent to medical or scientific
experimentation.”………………………………………………………………………………
In sum, it was inappropriate for the district court to forego a more extensive
examination of whether treaties, international agreements, or State practice have
ripened the prohibition of non consensual medical experimentation on human subjects
into a customary international law norm that is sufficiently (i) universal and obligatory,
(ii) specific and definable, and (iii) of mutual concern, to permit courts to infer a cause

of action under the ATS. See Sosa, 542 U.S. at 732-35. We now proceed with such an
examination.
i. Universality
The appellants must allege the violation of a norm of customary international law to
which States universally subscribe. See Sosa, 542 U.S. at 732; Vietnam Ass’n for
Victims of Agent Orange, 517 F.3d at 117. The prohibition on non consensual medical
experimentation on human beings meets this standard because, among other reasons,
it is specific, focused and accepted by nations around the world without significant
exception. The evolution of the prohibition into a norm of customary international law
began with the war crimes trials at Nuremberg. The United States, the Soviet Union,
the United Kingdom and France “acting in the interest of all the United Nations,”
established the International Military Tribunal (“IMT”) through entry into the London
Agreement of August 8, 1945. M. Cheriff Bassiouni et al., An Appraisal of Human
Experimentation in International Law and Practice: The Need for International
Regulation of Human Experimentation, 72 J. Crim. L. & Criminology 1597, 1640 &
n.220 (1981) (internal quotation marks omitted). Annexed to the London Agreement
was the London Charter, which served as the IMT’s Constitution. See Agreement for
the Prosecution and Punishment of the Major War Criminals of the European Axis
Powers, with annexed Charter of the International Military Tribunal art. 2, Aug. 8,
1945, 59 Stat. 1544, 82 U.N.T.S. 279. According to the Charter, the IMT had the “power
to try and punish persons who, acting in the interests of the European Axis countries,
whether as individuals or as members of organisations, committed,” among other
offenses, war crimes and crimes against humanity. Id. at art. The IMT tried 22 “major”
Nazi war criminals leaving “lower-level” war criminals, including “[l]eading
physicians . . . and leading German industrialists,” to be tried in subsequent trials by
U.S. military tribunals acting “under the aegis of the IMT.” United States Holocaust
Memorial Museum, War Crimes Trials, Holocaust Encylopedia (2008),
http://www.ushmm.org/wlc/article.php?lang=en&ModuleId=10005140.
The law that authorized the creation of the U.S. military tribunals, Control Council Law
No. 10, was enacted in 1945 by the Allied Control Council, see id., an authority through
which the London Agreement signatories exerted joint-control over Germany, see
Encyclopedia Britannica, Germany, Encyclopedia Britannica Online (2009),
http://search.eb.com/eb/article-58214.

Control Council Law No. 10 stated that its purpose was to “give effect to the terms of .
. . the London Agreement .. . and the [London] Charter,” and “to establish a uniform
legal basis in Germany for the prosecution of war criminals.” Allied Control Council
No. 10, preamble, (Dec. 20, 1945), http://avalon.law.yale.edu/imt/imt10.asp. Law No.
10 expressly incorporated the London Agreement, identifying it as an “integral part[]
of this Law.” Id. at art. I. Law No. 10 also authorized military tribunals of the occupying
powers to prosecute individuals for the same crimes over which the IMT had
jurisdiction, including war crimes and crimes against humanity, see id. at arts. II-III,
and made military tribunal prosecutions subject to the IMT’s right of first refusal, see
id. at art. III. Consequently, the U.S. military tribunals effectively operated as
extensions of the IMT, see Telford Taylor, Final Report to the Secretary of the Army on
the Nuremberg War Crimes Trials Under Control Council Law No. 10 7, 107 (1949)
[hereinafter Report on Nuremberg War Crimes Trials], available at
http://www.loc.gov/rr/frd/Military_Law/pdf/NT_final-report.pdf
(explaining that “the trials under Law No. 10 were to be a means of carrying out such
‘declarations of criminality’ . . . as the International Military Tribunal might make”
and that “[t]he first [IMT] trial and the 12 following [military tribunal] trials . . . form
a single sequence based on common principles”), and Control Council Law No. 10
served to implement the commitments undertaken in the London Agreement, see id. at
7 (noting that “the two documents supplemented each other” and “[m]ajor criminals
not tried under the one could be tried under the other”). In August 1947, Military
Tribunal 1, staffed by American judges and prosecutors and conducted under American
procedural rules, see George J. Annas, The Nuremberg Code in U.S. Courts: Ethics
versus Expediency in The Nazi Doctors and the Nuremberg Code 201, 201 (George J.
Annas & Michael A. Grodin eds., 1992), promulgated the Nuremberg Code as part of
the tribunal’s final judgment against fifteen doctors who were found guilty of war
crimes and crimes against humanity for conducting medical experiments without the
subjects’ consent, Brandt, 2 Nuremberg Trials, at 181-82. Among the non consensual
experiments that the tribunal cited as a basis for their convictions were the testing of
drugs for immunization against malaria, epidemic jaundice, typhus, smallpox and
cholera. Id. at 175-178. Seven of the convicted doctors were sentenced to death and the
remaining eight were sentenced to varying terms of imprisonment. Id. at 298-300. The
tribunal emphasized that [i]n every single instance appearing in the record, subjects

were used who did not consent to the experiments; indeed, as to some of the
experiments, it is not even contended by the defendants that the subjects occupied the
status of volunteers. Id. at 183. The judgment concluded that “[m]anifestly human
experiments under such conditions are contrary to the principles of the law of nations
as they result from usages established among civilized peoples, from the laws of
humanity, and from the dictates of public conscience.” Id. (emphasis added and
internal quotation marks omitted). The Code created as part of the tribunal’s judgment
therefore emphasized as its first principle that “[t]he voluntary consent of the human
subject is absolutely essential.” Id. at 181. The American tribunal’s conclusion that
action that contravened the Code’s first principle constituted a crime against humanity
is a lucid indication of the international legal significance of the prohibition on
nonconsensual medical experimentation. As Justices of the Supreme Court have
recognized, “[t]he medical trials at Nuremberg in 1947 deeply impressed upon the
world that experimentation with unknowing human subjects is morally and legally
unacceptable.” United States v. Stanley, 483 U.S. 669, 687 (1987) (Brennan, J.,
concurring in part and dissenting in part) (emphasis added); see also id. at 709-10
(O’Connor, J., concurring in part and dissenting in part). Moreover, both the legal
principles articulated in the trials’ authorizing documents and their application in
judgments at Nuremberg occupy a position of special importance in the development of
bedrock norms of international law. United States courts examining the Nuremberg
judgments have recognized that “[t]he universal and fundamental rights of human
beings identified by Nuremberg—rights against genocide, enslavement, and other
inhumane acts .. .—are the direct ancestors of the universal and fundamental norms
recognized as jus cogens,”from which no derogation is permitted, irrespective of the
consent or practice of a given State. Siderman de Blake v. Republic of Arg., 965 F.2d
699, 715 (9th Cir. 1992) (cited in Sampson v. F.R.G., 250 F.3d 1145, 1150 (7th Cir.
2001)). As Telford Taylor, who served as an assistant to Justice Robert Jackson during
his time as Chief Prosecutor for the IMT and then became Chief Counsel for War
Crimes on the Nuremberg trials held under the authority of Control Council Law No.
10, explained, “Nuremberg was based on enduring [legal] principles and not on
temporary political expedients, and this fundamental point is apparent from the
reaffirmation of the Nuremberg principles in Control Council Law No. 10, and their
application and refinement in the 12 judgments rendered under that law during the 3-

year period, 1947 to 1949.” Taylor, Report on Nuremberg War Crimes Trials, at 107
(emphasis added). Consistent with this view, the Code’s first principle has endured:
“[S]ignificant world opinion has not come to the defense of the nature or manner in
which the experiments were conducted in the Nazi concentration camps.” Bassiouni et
al., supra, at 1641. Rather, since Nuremberg, states throughout the world have shown
through international accords and domestic law-making that they consider the
prohibition on nonconsensual medical experimentation identified at Nuremberg as a
norm of customary international law. In 1955, the draft International Covenants on
Human Rights was revised to add a second sentence to its prohibition of torture and
cruel, inhuman or degrading treatment or punishment. The addition provided that “[i]n
particular, no one shall be subjected without his free consent to medical or scientific
experimentation involving risk, where such is not required by his state of physical or
mental health.” Annotations on the text of the draft International Covenants on Human
Rights, at 31, U.N. GAOR, 10th Sess., Annexes, agenda item 28 (II), U.N. Doc. A/2929
(July 1, 1955). The clause was later revised to offer the simpler and sweeping
prohibition that “no one shall be subjected without his free consent to medical or
scientific experimentation.” ICCPR, supra, at art. 7. This prohibition became part of
Article 7 of the ICCPR, which entered into force in 1976, and is legally binding on the
more than 160 States-Parties that have ratified the convention without reservation to
the provision.10 By its terms this prohibition is not limited to state actors; rather, it
guarantees individuals the right to be free from non consensual medical
experimentation by any entity–state actors, private actors, or state and private actors
behaving in concert. Its status as a norm that states conceive as legally binding–and
therefore part of customary international law–is confirmed by Article 2 of the accord,
which requires that “[e]ach State Party . . . undertake[] to respect and to ensure to all
individuals within its territory and subject to its jurisdiction the rights recognized in the
present Covenant.” ICCPR art. 2(1). The international community’s recognition in the
ICCPR of its obligation to protect humans, regardless of the source of the action, is
powerful evidence of the prohibition’s place in customary international law. It is clear
that, as the court mentioned in Sosa, the Universal Declaration of Human Rights and
the ICCPR themselves could not establish the relevant, applicable rule of international
law in that case. Sosa, 542 U.S. at 754. Nonetheless, the ICCPR, when viewed as a
reaffirmation of the norm as articulated in the Nuremberg Code, is potent authority for

the universal acceptance of the prohibition on non consensual medical

experimentation. As we discuss below, see infra pp. 28-30, the fact that the prohibition
on medical experimentation on humans without consent has been consciously
embedded by Congress in our law and reaffirmed on numerous occasions by the FDA
demonstrates that the United States government views the norm as the source of a
binding legal obligation even though the United States has not ratified the ICCPR in
full. In 1964, the World Medical Association adopted the Declaration of Helsinki, which
enunciated standards for obtaining informed consent from human subjects. It provided
that in clinical research combined with professional care, “[i]f at all possible,
consistent with patient psychology, the doctor should obtain the patient’s freely given
consent after the patient has been given a full explanation,” and that non-therapeutic
clinical research on a person “cannot be undertaken without his free consent, after he
has been fully informed.” World Med. Ass’n, Declaration of Helsinki: Code of Ethics
of the World Medical Association, art. III(3a), G.A. Res. (1964),
http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1816102&blobtype=pdf.
The Declaration has since been amended five times. The informed consent provision
now provides that “subjects must be volunteers and informed participants in the
research project.” Declaration of Helsinki, supra, at art. 20. The Declaration also
requires that “[i]n any research on human beings, each potential subject must be
adequately informed of the aims, methods, . . . anticipated benefits and potential risks
of the study, and the discomfort it may entail” and that researchers “obtain the
subject’s freely-given informed consent, preferably in writing.” Id. at art. 22. Although
the Declaration itself is non-binding, since the 1960s, it has spurred States to regulate
human experimentation, often by incorporating its informed consent requirement into
domestic laws or regulations. See Delon Human & Sev S. Fluss, The World Medical
Association’s Declaration of Helsinki: Historical and Contemporary Perspectives, 8-
11 (July 24,2001) (fifth draft),
http://www.wma.net/e/ethicsunit/pdf/draft_historical_contemporary_perspectives.pdf
(describing legal and regulatory developments in Australia, Belgium, Brazil, China,
Israel, Japan, New Zealand, Norway, Switzerland, and the United States following the
Declaration of Helsinki). Currently, the laws and regulations of at least eighty-four
countries, including the United States, require the informed consent of human subjects
in medical research. That this conduct has been the subject of domestic legislation is

not, of course, in and of itself proof of a norm. See Flores, 414 F.3d 249. However, the
incorporation of this norm into the laws of this country and this host of others is a
powerful indication of the international acceptance of this norm as a binding legal
obligation, where, as here, states have shown that the norm is of mutual concern by
including it in a variety of international accords. The history of the norm in United
States law demonstrates that it has been firmly embedded for more than 45 years and–
except for our dissenting colleague–its validity has never been seriously questioned by
any court. Congress mandated patient-subject consent in drug research in 1962.
Bassiouni et al., supra, at 1624 (citing 21 U.S.C. § 355(i) (1976)). In response, the FDA
promulgated its first regulations requiring the informed consent of human subjects.
Tellingly, the sources on which our government relied in outlawing non-consensual
human medical experimentation were the Nuremberg Code and the Declaration of
Helsinki, which suggests the government conceived of these sources’ articulation of the
norm as a binding legal obligation. Bassiouni et al., supra, at 1625-26 (citing 21 C.F.R.
§ 310.102(h) (1980)). Today, FDA regulations require informed consent to U.S.
investigators’ research, whether conducted domestically or in a foreign country, to
support applications for the approval of new drugs. See 21 C.F.R. §§ 50.20, 50.23-.25,
50.27, 312.20, 312.120 (2008); 45 C.F.R. §§ 46.111, 46.116-.117 (2008). The
importance that the United States government attributes to this norm is demonstrated
by its willingness to use domestic law to coerce compliance with the norm throughout
the world. United States law requires that, as a predicate to FDA approval of any new
drug, both American and foreign sponsors of drug research involving clinical trials,
whether conducted here or abroad, procure informed consent from human subjects. 21
C.F.R. §§ 312.20, 312.120 (2008); see also Dep’t of Health & Human Servs., Office of
Inspector Gen., The Globalization of Clinical Trials 5 (2001),
http://www.oig.hhs.gov/oei/reports/oei-01-00-00190.pdf.
Sponsors conducting research under an Investigational New Drug Application
(“IND”) are obligated to adhere to FDA regulations, which require informed consent.
21 C.F.R. § 312.20 (2008); The Globalization of Clinical Trials, supra, at 5. Prior to
April 2008, sponsors conducting research under non-IND guidelines were obligated to
adhere to the ethical principles of the 1989 version of the Declaration of Helsinki or
the host country’s regulations, whichever offered greater protection to the human
subject. 21 C.F.R. § 312.120 (2007); The Globalization of Clinical Trials, supra, at 5.

The April 2008 revisions to the non-IND guidelines reaffirmed the informed consent
requirement. Human Subject Protection: Foreign Clinical Studies Not Conducted
Under an Investigational New Drug Application, 73 Fed. Reg. 22,800, 22,801, 22,803,
22,804, 22,816 (Apr. 28, 2008) (codified at 21 C.F.R. pt. 312). Foreign clinical studies
not conducted under an IND must now comply with the Good Clinical Practice
guidelines (“GCP”) promulgated by the International Conference on Harmonisation
of Technical Requirements for Registration of Pharmaceuticals for Human Use, 62
Fed. Reg. 25,692 (May 9, 1997), which require informed consent to medical
experimentation. 21 C.F.R. § 312.120 (2008). Additional international law sources
support the norm’s status as customary international law. The European Union
embraced the norm prohibiting non consensual medical experimentation through a
2001 Directive passed by the European Parliament and the Council of the European
Union. The Directive accepted the informed consent principles of the 1996 version of
the Declaration of Helsinki. Council Directive 2001/20/EC, preamble (2), 2001 O.J. (L
121) 37 (EC) [hereinafter 2001 Clinical Trial Directive]. It also required member
States to adopt rules protecting individuals incapable of giving informed consent and
permitting clinical trials only where “the trial subject or, when the person is not able
to give informed consent, his legal representative has given his written consent after
being informed of the nature, significance, implications and risks of the clinical trial.”
Id. at art. (1), (2)(d). The Directive further required all member States to implement by
2004 domestic laws, regulations, and administrative provisions to comply with its
informed consent requirements. Id. at art. 22(1). Since 1997, thirty-four member States
of the Council of Europe have also signed the Convention on Human Rights and
Biomedicine, a binding convention and a source of customary international law.
Convention for the Protection of Human Rights and Dignity of the Human Being with
regard to the Application of Biology and Medicine: Convention on Human Rights and
Biomedicine, art. 5, 15-16, opened for signature Apr. 4, 1997, E.T.S. No. 164,
http://conventions.coe.int/Treaty/en/Treaties/html/164.htm
[hereinafter Convention on Human Rights and Biomedicine]; Convention on Human
Rights and Biomedicine, Chart of Signatures and Ratifications as of Aug. 8, 2008,
http://conventions.coe.int/Treaty/Commun/ChercheSig.asp?NT=164&CM=8&DF=8/8/2008&CL=ENG.
It provides that an “intervention in the health field may only be carried out after the
person concerned has given free and informed consent to it” and that the informed
consent of human subjects is required for their involvement in medical research.

Convention on Human Rights and Biomedicine, supra, at art. 5.14 In 2005, the General
Conference of the United Nations Educational, Scientific and Cultural Organization
(UNESCO) adopted the Universal Declaration on Bioethics and Human Rights, which
requires “the prior, free, express and informed consent of the person concerned” for
research-oriented treatments. Universal Declaration on Bioethics and Human Rights,
UNESCO Gen. Conf. Res., at art. 6, 33rd Sess., 33 C/Resolution 36, (Oct. 19, 2005).
This history illustrates that from its origins with the trial of the Nazi doctors at
Nuremberg through its evolution in international conventions, agreements,
declarations, and domestic laws and regulations, the norm prohibiting non consensual
medical experimentation on human subjects has become firmly embedded and has
secured universal acceptance in the community of nations. Unlike our dissenting
colleague’s customary international law analysis, which essentially rests on the
mistaken assumption that ratified international treaties are the only valid sources of
customary international law for ATS purposes, see Dissent at 19-20, we reach this
conclusion as a result of our review of the multiplicity of sources–including
international conventions, whether general or particular, and international custom as
identified through international agreements, declarations and a consistent pattern of
action by national law-making authorities–that our precedent requires us to examine
for the purpose of determining the existence of a norm of customary international law.
Our dissenting colleague’s reasoning fails to engage the incompatibility of non
consensual human testing with key sources of customary international law identified in
Article 38 of the ICJ’s statute, most importantly international custom, as evidence of a
general practice accepted as law, as well as the general principles of law recognized
by civilized nations. See supra p. 15.
ii. Specificity
Sosa requires that we recognize causes of action only to enforce those customary
international law norms that are no “less definite [in] content . . . than the historical
paradigms familiar when [the ATS] was enacted.” Sosa, 542 U.S. at 732. The norm
prohibiting non consensual medical experimentation on human subjects meets this
requirement. In United States v. Smith, 18 U.S. (5 Wheat) 153, 159-61 (1820), Justice
Story found that “whatever may be the diversity of definitions, . . . all writers concur,
in holding, that robbery or forcible depredations upon the sea . . . is piracy.” Id. at 161.
We have little trouble concluding that a norm forbidding non consensual human

medical experimentation is every bit as concrete—indeed even more so—than the norm
prohibiting piracy that Story describes, or interference with the right of safe conducts
and the rights of ambassadors, which together are the paradigmatic norms identified
in Sosa. Id. at 724. The Nuremberg Code, Article 7 of the ICCPR, the Declaration of
Helsinki, the Convention on Human Rights and Biomedicine, the Universal Declaration
on Bioethics and Human Rights, the 2001 Clinical Trial Directive, and the domestic
laws of at least eighty-four States all uniformly and unmistakably prohibit medical
experiments on human beings without their consent, thereby providing concrete content
for the norm. The appellants allege that Pfizer knowingly and purposefully conducted
such experiments on a large scale. Whatever uncertainty may exist at the margin is
irrelevant here because appellants allege a complete failure on the part of Pfizer and
the Nigerian government to inform appellants of the existence of the Trovan
experiments. These allegations, if true, implicate Pfizer and the Nigerian government
in conduct that is at the core of any reasonable iteration of the prohibition against
involuntary medical experimentation. While the prohibition in question applies to the
testing of drugs without the consent of human subjects on the scale Pfizer allegedly
conducted, we do not suggest that it would extend to instances of routine or isolated
failures by medical professionals to obtain informed consent, such as those arising from
simple negligence. The allegations in the complaints involve anything but a doctor’s
routine or erroneous failure to obtain such consent from his patient.
iii. Mutual Concern
Customary international law proscribes only transgressions that are of “mutual”
concern to States—“those involving States’ actions performed . . . towards or with
regard to the other.” Flores, 414 F.3d at 249 (differentiating matters of “mutual”
concern from those of “several” concern, in which “States are separately and
independently interested”). Conduct that States have prohibited through domestic
legislation is also actionable under the ATS as a violation of customary international
law when nations of the world have demonstrated “by means of express international
accords” that the wrong is of mutual concern. Filartiga, 630 F.2d at 888. An important,
but not exclusive, component of this test is a showing that the conduct in question is
“capable of impairing international peace and security.” Flores, 414 F.3d at 249.
Appellants have made both of these showings. As we have seen, States throughout the
world have entered into two express and binding international agreements prohibiting

non consensual medical experimentation: the ICCPR and the Convention on Human
Rights and Biomedicine. The entry of over 160 States into these agreements and the
European Union’s passage of the 2001 Clinical Trial Directive demonstrates that
States have not only acted independently to outlaw large-scale, non consensual drug
testing on humans, but they have also acted in concert to do so. In other words, acting
out of a sense of mutual concern, “the nations [of the world] have made it their
business, both through international accords and unilateral action,” to demonstrate
their intention to eliminate conduct of the type alleged in the complaints. Filartiga, 630
F.2d at 889. The administration of drug trials without informed consent on the scale
alleged in the complaints poses a real threat to international peace and security. Over
the last two decades, pharmaceutical companies in industrialized countries have looked
to poorer, developing countries as sites for the medical research essential to the
development of new drugs. See James V. Lavery, Putting International Research Ethics
Guidelines to Work for the Benefit of Developing Countries, 4 Yale J. Health Pol’y L.
& Ethics 319, 320-21 (2004); The Globalization of Clinical Trials, supra, at 8.16
Pharmaceutical companies recognize the potential benefits of drug trials to poor
nations and have sought to promote access to medicines and health care in underserved
populations through philanthropy and partnership with governments and NGOs. See,
e.g., PhRMA, Press Releases: Worldwide Pharmaceutical Industry Launches Global
Health Progress Initiative to Expand Efforts to Improve Health in Developing
Countries (April 16, 2008),
http://www.phrma.org/news_room/press_releases/global_health_progress_initiative_
launched_to_improve_health_in_developing_countries/
(describing initiative by worldwide pharmaceutical industry to “further access to
medicines; build capacity of health workers in developing nations; advocate for global
action to address health challenges; and continue R&D to develop new tools to fight
diseases that plague the developing world”); PhRMA, Profile2008: Pharmaceutical
Industry 42 (2008), http://www.phrma.org/files/2008%20Profile.pdf
(describing contributions by American pharmaceutical companies to the promotion of
global access to medicines and health care). This trend offers the possibility of
enormous health benefits for the world community. Life-saving drugs can potentially
be developed more quickly and cheaply, and developing countries may be given access
to cutting edge medicines and treatments to assist under resourced and understaffed

public health systems, which grapple with life-threatening diseases afflicting their
populations. The success of these efforts promises to play a major role in reducing the
cross-border spread of contagious diseases, which is a significant threat to
international peace and stability. The administration of drug trials without informed
consent on the scale alleged in the complaints directly threatens these efforts because
such conduct fosters distrust and resistance to international drug trials, cutting edge
medical innovation, and critical international public health initiatives in which
pharmaceutical companies play a key role. This case itself supplies an exceptionally
good illustration of why this is so. The Associated Press reported that the Trovan trials
in Kano apparently engendered such distrust in the local population that it was a factor
contributing to an eleven month-long, local boycott of a polio vaccination campaign in
2004, which impeded international and national efforts to vaccinate the population
against a polio outbreak with catastrophic results.18 According to the World Health
Organization, polio originating in Nigeria triggered a major international outbreak of
the disease between 2003 and 2006, causing it to spread across west, central, and the
Horn of Africa and the Middle East, and to re-infect twenty previously polio-free
countries. The administration of drug trials without informed consent poses threats to
national security by impairing our relations with other countries. Seven of the world’s
twelve largest pharmaceutical manufacturers – a group that includes Pfizer – are
American companies. Global 500, Fortune, July 21, 2008,
http://money.cnn.com/magazines/fortune/global500/2008/industries/21/index.html.
Consequently, American companies are likely to be sponsors of medical experiments
on human subjects abroad. As this case illustrates, the failure to secure consent for
human experimentation has the potential to generate substantial anti-American animus
and hostility. Unsurprisingly, as noted above, see supra p. 30, our government actively
attempts to prevent this practice in foreign countries. For example, federal law requires
that data generated from testing on human subjects abroad that is used to seek
regulatory approval for a given drug must, at minimum, be the result of testing
conducted consistent with the requirements of informed consent. Consequently, the US
government denies access to the US market for any new drug unless the drug’s research
data is generated in a manner consistent with the customary international law norm
prohibiting drug trials on human subjects without informed consent. For these reasons,
we hold that the appellants have pled facts sufficient to state a cause of action under

the ATS for a violation of the norm of customary international law prohibiting medical
experimentation on human subjects without their knowledge or consent. In such an
instance, ATS jurisdiction exists over plaintiffs’ claims. The district court determined
that the norm existed, but concluded that because no single source recognizing the norm
was legally binding on the United States and created a private cause of action, it could
not infer such a right under the ATS. Presumably, on this basis, it simultaneously held
that there was no subject matter jurisdiction over plaintiffs’ claims. Under Sosa, this
approach was not correct. Sosa makes clear that the critical inquiry is whether the
variety of sources that we are required to consult establishes a customary international
law norm that is sufficiently specific, universally accepted, and obligatory for courts to
recognize a cause of action to enforce the norm. Nothing in Sosa suggests that this
inquiry can be halted if some of the sources of international law giving rise to the norm
are found not to be binding or not to explicitly authorize a cause of action. We believe
that the issues raised by this appeal regarding customary international law are framed
by our analysis and by that of our dissenting colleague. He contends that our analysis
is created from “whole cloth.” Dissent at 1. We believe that his approach to customary
international law is unselfconsciously reactionary and static. The approach does not
accommodate itself to the normative world that, by their commitments and conduct over
the past fifty years, states–including our own– have shown they believe to exist.”
36. That in Kalpana Mehta and Ors v. Union of India and Ors, MANU-SC-0519-2018,
(2018) 7 SCC 1 (09.05.2018) the Constitution Bench of the Hon’ble Supreme Court of
India noticed attempt of GSK & MSD (US vaccine majors) to conduct an experiment
in the garb of free vaccination drive [a type of conduct strongly deprecated in Rabi
Abdullahi v. Pfizer Inc., 562 F. 3d 163 US Court of Appeals 2nd Circuit Case No. 05-
4863-cv, basis customary international law/ The Medical Case, United States v. Karl
Brandt et al, 19.07.1947]: “The initial debate and deliberation before the two-Judge
Bench that was hearing the instant Writ Petitions had focussed around the justifiability
of the action taken by the Drugs Controller General of India and the Indian Council of
Medical Research (ICMR) pertaining to the approval of a vaccine, namely, Human
Papilloma Virus (HPV) manufactured by the Respondent No. 7, M/s. GlaxoSmithKline
Asia Pvt. Ltd., and the Respondent No. 8, MSD Pharmaceuticals Private Limited, for
preventing cervical cancer in women and the experimentation of the vaccine was done
as an immunisation by the Governments of Gujarat and Andhra Pradesh (before

bifurcation, the State of Andhra Pradesh, eventually the State of Andhra Pradesh and
the State of Telangana) with the charity provided by the Respondent No. 6, namely,
PATH International. Apart from the aforesaid issue, the grievance with regard to the
untimely death of certain persons and the grant of compensation on the foundation that
there had been experiment of the drugs on young girls who had not reached the age of
majority without the consent of their parents/guardians was also highlighted. Be it
stated, it was also projected that women, though being fully informed, had become
victims of the said vaccination. In essence, the submissions were advanced pertaining
to the hazards of the vaccination and obtaining of consent without making the persons
aware of the possible after effects and the consequences of the administration of such
vaccine.” That this matter is now pending for a final decision (Likely date of listing in
WP(C) 588 of 2012, 17.09.2021).
37. That in Union of India & ors., v. Agricas LLP & ors., MANU/SC/0614/2020
(26.08.2020) (Document No. 459) at MANU p.12 paras 26-27, p.13 para 29, pp.15-16
para 34, p.18 para 38 it was held (Sanjiv Khanna J.) "26. ….States as signatories to the
international treaty…..obligation to act in conformity….bear responsibility for
breaches, be it as a consequence of legislative enactment, executive action or even
judicial decisions…....In international law, municipal laws cannot prevail upon the
treaties as internal actions must comply with the international obligation. They may
constitute breach of the treaty. 27. Thus, breach of a stipulation in international law
cannot be justified by the State by referring to its domestic legal position. This rule of
international law is unexceptionable and prosaic, as the contra view would permit the
international obligations to be evaded by the simple method of domestic legislation,
executive action or judicial decision. Contracting States are under an obligation to act
in conformity with the rules of international law and bear responsibility for breaches
whether committed by the legislature, executive or even judiciary. In a way, therefore,
international treaties are constraint on sovereign activity, albeit voluntarily agreed."
and at p.13 para 29 "29. Various theories have been put forward to explain applicability
of international customary and treaty law in domestic law..... " and at pp.15-16 para 34
"34. ..Article 73 of the Constitution delineates the extent of executive power of the Union
which extends to all matters with respect to which the Parliament has the power to
make laws and it extends to the exercise of such rights, authority and jurisdiction as
are exercisable by the Central Government by virtue of any treaty or agreement.... For

the purpose of the present case, Article 253 of the Constitution is important as it states
that notwithstanding anything in the foregoing provisions of this Chapter, the
Parliament has the power to make laws for the whole or any part of the territory of
India for implementing any treaty, agreement or convention with any other country or
countries or decisions made at any international conference, association or body...."
and at p.18 para 38 "38. Even earlier in Gramophone Company of India Ltd. v.
Birendra Bahadur Pandey and Others, (1984) 2 SCC 534, this Court had held as
under: “5. There can be no question that nations must march with the international
community and the Municipal law must respect rules of International law even as
nations respect international opinion..."
38. Kindly take formal notice for “RESTITUTION” concerning “ulterior” “coercion”
with “elements of force, fraud, deceit, duress, over-reaching” in “unavoidably unsafe”
“medical or scientific experimentation” tantamount to egregious crimes against
humanity by continuing to persevere in omission of international rule of law mandated
"voluntary consent" provision in India's National Vaccine Policy, April 2011
compounded by the continuing deliberate pre-meditated violation of the International
Covenant on Civil and Political Rights, ICCPR, Article 7(a)(ii) & Principle 1 of the ten
point Nuremberg Code/ Kodex 1947, Permissible Medical Experiments ["The Medical
Case" 20.08.1947/ 16.02.1948 "trials of war criminals before the Nüremberg Military
Tribunals", Vol. 2, pp. 181-182. Washington, D.C.: U.S. Government Printing Office,
1949 in violation of Article 21 of the Constitution of India read with Articles 51, 73 and
253 thereof and customary international law, as acceded to by India and duly noted in
Memorial of the Republic of India dated 13.09.2017, India v. Pakistan (Jadhav Case)
(Document No. 378) at the International Court of Justice. [Only For Respondents]
39. As regards RESTITUTION” in Customary International Law it is most illuminative
to quote the Memorial of the Republic of India dated 13.09.2017, India v. Pakistan
(Jadhav Case) (Document No. 378) paras 192-196 at pp.82-83: “XII. RESTITUTION
192) The protection of human rights is now generally recognised to be a fundamental
aim of modern international law, and as a result, international human rights law has
inevitably reduced the content of the reserved domain of State sovereignty. “…No state
can credibly claim that its treatment of those within its territory or jurisdiction is
exclusively an internal matter”107. As a precursor to human rights law, the law on
diplomatic protection has played an important role in setting some benchmarks for the

protection of individuals. From the international minimum standard to the ICCPR and
beyond, international law has increasingly accommodated within its rubric, principles
and standards that seek to further the cause of protection of human rights. 193) The
Commentary on Remedies in International Human Rights Law notes that, “The
atrocities perpetrated during the Second World War brought about a fundamental
change in the law. Today, concern for the promotion and protection of human rights is
woven throughout the United Nations Charter, beginning with the preamble, which
“reaffirm[s] faith in fundamental human rights, in the dignity and worth of the human
person, in the equal rights of men and women and of nations large and small…”.108
194) The principles of State Responsibility are now well entrenched. Attempts at
codification of principles that would apply for fixing State Responsibility and
fashioning remedies have been attempted by different institutions since the early 20th
Century and on 31 May 2001, the International Law Commission (ILC) adopted the
Articles on the Responsibility of States for Internationally Wrongful Acts (ARSIWA).
195) Although, the articles have not attained the status of a Convention, they are “…an
active and useful part of the process of international law. They are considered by courts
and commentators to be in whole or in large part an accurate codification of the
customary international law state responsibility …”.109 196) In the Bosnian Genocide
case, this Court noted that “The rules for attributing alleged internationally wrongful
conduct to a State do not vary with the nature of the wrongful act in question in the
absence of a clearly expressed lex specialis. Genocide will be considered as
attributable to a State if and to the extent that the physical acts constitutive of genocide
that have been committed by organs or persons other than the state’s own agents were
carried out, wholly or in part, on the instructions or directions of the State, or under its
effective control. This is the state of customary international law, as reflected in the ILC
Articles on State Responsibility”.110
107
Remedies in International Human Rights Law, Third Edition, Dinah Shelton, page 1
108
Ibid., page 7.
109
State Responsibility, The General Part, First Edition, James Crawford, page 43.
110
Application of the Convention on the Prevention and Punishment of the Crime of Genocide (Bosnia
and Herzegovina v. Serbia and Montenegro), ICJ Rep. 2007 p.43, p. 209. ”
40. That the respondents may note that whether “coercion” has “elements of force, fraud,
deceit, duress, over-reaching” is one aspect only of this notice. There are also
Vaccination Acts of States and sundry acts including of the Union of India, that have

provision for compulsory vaccination in violation of customary international law which

would be taken up for challenge for violation of Article 51/ being incompatible with
Customary International Law. Kindly note that in every such instance both the States
and the Union “bear responsibility for breaches, be it as a consequence of legislative
enactment, executive action or even judicial decisions.” (Document Nos. 109, 113,
115, 119 & 122-123)] [Union of India & ors., v. Agricas LLP & ors.,
MANU/SC/0614/2020 (26.08.2020) (Document No. 459) at MANU para 26, p.11]
41. That in regard to para 26 at pp.86-89 above and Document No. 601 it is most
respectfully submitted that the width and sweep of human rights being what it is, the
possibility of human rights violation by “the government or even the Courts of law”
cannot be ruled out, as noted in Ram Deo Chauhan v. Bani Kanta Das 2010 (14) SCC
209 at SCC pp.222-226 in paras 42-59 [Document No. 274A]: “42. Therefore, it is
imperative that while interpreting the powers and jurisdiction of NHRC, the Court
construes section 2(d) of the 1993 Act along with its long title and also the Statement
of Objects and Reasons of the said Act. The relevant portion of the statement of objects
and reasons are excerpted below: "2. However, there has been growing concern in the
country and abroad about issues relating to human rights. Having regard to this,
changing social realities and the emerging trends in the nature of crime and violence,
Government has been reviewing the existing laws, procedures, and system of
administration of justice; with a view to bringing about greater accountability and
transparency in them, and devising efficient and effective methods of dealing with the
situation." 43. In his Tagore Law Lecture (The Dialectics and Dynamics of Human
Rights in India), Justice V.R. Krishna Iyer describes the width and sweep of human
rights in his matchless words and which are worth quoting: "Human rights are writ on
a large canvas, as large as the sky. The law makers, lawyers and particularly, the
judges, must make the printed text vibrant with human values, not be scared of
consequences on the status quo order. The militant challenges of today need a
mobilization of revolutionary consciousness sans which civilized systems cease to exist.
Remember, we are all active navigators, not idle passengers, on spaceship earth as it
ascends to celestial levels of the glorious human future." We share the same view. 44.
What was said by Alexander Hamilton, the great constitutional expert and political
philosopher, way back in 1775, is poignant still today for having a clear perception of
what human rights are. The words of Hamilton still resonate with a strange relevance

and immediacy, and are quoted below: "The sacred rights of mankind are not to be
rummaged for, among old parchments, or musty records. They are written, as with a
sun beam in the whole volume of human nature, by the hand of divinity itself; and can
never be erased or obscured by mortal power." 45.....One must accept that human rights
are not like edicts inscribed on a rock. They are made and unmade on the crucible of
experience and through irreversible process of human struggle for freedom. They admit
of a certain degree of fluidity. Categories of human rights, being of infinite variety, are
never really closed. ...........take care of situations not covered by sub- sections (a) to (i)
of Section 12 of the 1993 Act. 46. The jurisdiction of NHRC thus stands enlarged by
section 12(j) of the 1993 Act, to take necessary action for the protection of human rights.
Such action would include inquiring into cases where a party has been denied the
protection of any law to which he is entitled, whether by a private party, a public
institution, the government or even the Courts of law. ......if a person is entitled to
benefit under a particular law, and benefits under that law have been denied to him, it
will amount to a violation of his human rights. 47. Human rights are the basic, inherent,
immutable and inalienable rights to which a person is entitled simply by virtue of his
being born a human. They are such rights which are to be made available as a matter
of right. Constitution and Legislations of civilized country recognise them since they
are so quintessentially part of every human being. That is why every democratic country
committed to rule of Law put into force mechanisms for their enforcement and
protection. 48. Human rights are universal in nature. The Universal Declaration of
Human Rights (hereinafter referred to as UDHR) adopted by the General Assembly of
the United Nations on 10th December 1948 recognizes and requires the observance of
certain universal rights, articulated therein, to be human rights, and these are
acknowledged and accepted as equal and inalienable and necessary for the inherent
dignity and development of an individual. Consequently, though the term `human rights'
itself has not been defined in UDHR, the nature and content of human rights can be
understood from the rights enunciated therein. 49. Possibly considering the wide sweep
of such basic rights, the definition of `human rights' in the 1993 Act has been designedly
kept very broad to encompass within it all the rights relating to life, liberty, equality
and dignity of the individual guaranteed by the Constitution or embodied in the
International Covenants and enforceable by Courts in India. Thus, if a person has been
guaranteed certain rights either under the Constitution or under an International

Covenant or under a law, and he is denied access to such a right, then it amounts to a
clear violation of his human right and NHRC has the jurisdiction to intervene for
protecting it. 50..........The assumption in the judgment under review that there can be
no violation of a person's human right by a judgment of this Court is possibly not
correct. 51.......The instances of this Court's judgment violating the human rights of the
citizens may be extremely rare but it cannot be said that such a situation can never
happen. 52. We can remind ourselves of the majority decision of the Constitution Bench
of this court in Additional District Magistrate Jabalpur v. Shivakant Shukla reported in
(1976) 2 SCC 521. The majority opinion was that in view of the Presidential order dated
27-6-1975 under Article 359(1) of the Constitution, no person has the locus standi to
move any writ petition under Article 226 before a High Court for Habeas Corpus or
any other writ to enforce any right to personal liberty of a person detained under the
then law of preventive detention{ Maintenance of Internal Security Act of 1971}, on the
ground that the order is illegal or malafide or not in compliance with the Act.(See paras
78 and 136 of the report) 53. The lone dissenting voice of Justice Khanna interpreted
the legal position differently by inter alia holding: (SCC p.777, para 593) "593. (8)
Article 226 under which the High Courts can issue writs of Habeas Corpus is an
integral part of the Constitution. No power has been conferred upon any authority in
the Constitution for suspending the power of the High Court to issue writs in the nature
of habeas corpus during the period of emergency. Such a result cannot be brought
about by putting some particular construction on the Presidential order in question."
54. There is no doubt that the majority judgment of this court in the ADM Jabalpur case
(supra) violated the fundamental rights of a large number of people in this
country.........In fact the dissent of Justice Khanna became the law of the land when, by
virtue of the Forty Fourth Constitutional Amendment, Articles 20 and 21 were excluded
from the purview of suspension during emergency. 55.......NHRC cannot function as a
parallel seat of justice to rectify or correct or comment upon orders passed by
........courts of competent jurisdiction........well-established gamut of the corrective
machinery of appeal, revision, review, curative petition and so on. 56...... NHRC made
its recommendations on 21-5-2001 only after the judgment in first review (No. 1105 of
2000) was passed on 10-5-2001 by this Court. 57. About NHRC, this Court in Paramjit
Kaur v. State of Punjab and Ors.(1999) 2 SCC 131 held: (SCC p.127, para 10-11) "10.
The Commission headed by a former Chief Justice of India is a unique expert body in

itself. The Fundamental Rights, contained in Part III of the Constitution of India,
represent the basic human rights possessed by every human being in this world
inhabited by people of different continents, countries, castes, colours and religions. The
country, the colour and the religion may have divided them into different groups but as
human beings, they are all one and possess the same rights. 11........The Commission,
therefore, is truly an expert body to which a reference has been made by this Court in
the instant case." 58...... Therefore, NHRC, a statutory body, in a given situation, may
have to act under the order or direction given by this Court in exercise of its
constitutional power of judicial review. 59..... in the facts of this case, NHRC has not
committed any illegality by taking into consideration the article written by Professor
Ved Kumari and then making a mere recommendation to the Governor, for considering
the petitioner's plea for commutation. We are of the opinion that in doing so, NHRC
acted within its jurisdiction.” (Document No. 274A)
HEALTH EFFECTS OF INCREASE IN CONCENTRATION OF CO2
42. “Carbon dioxide is an asphyxiant and an irritant gas. It acts as a simple asphyxiant by
displacing the oxygen in the respiratory system.” (Document No. 537 at p.62).
“Further evidence that increased concentrations of carbon dioxide are detrimental to
human health is provided by a large number of studies in the field of epidemiology.”
(Document No. 226 at p.2). “Many studies in animals and in humans have shown that
the immune system, like most other organs of the body, is a potential target of toxicity,
and that damage to this system can be associated with a wide range of adverse and
sometimes life threatening events. Immunotoxicology can be very broadly defined as
the study of adverse effects on the immune system resulting from drug treatments, or
from exposure to household, occupational, and environmental chemicals and, in some
instances, biological materials. Collectively, these agents are frequently referred to as
xenobiotics.” (Document No. 324 at p.4). “18. That the linkage between pandemics
like COVID-19 and increasing global warming caused by sudden sustained rise in
CO2-e levels in 2019-2020 is best explained in a 2011 article from Archives of Clinical
Microbiology 2011 Vol. 2 No. 2:4, 14.03.2011” (Document No. 469 at p.37). “..most
of the perceptible impacts of climate change are linked indirectly to the underlying
emissions, with atmospheric warming playing a prominent role along the chain of
causality. But not all impacts are brokered by warming. In fact, oceanographers have
long stressed that even if technologies are developed and deployed that prevent Earth's

surface temperature from increasing despite rapidly growing CO2 emissions (e.g.,
geoengineering proposals such as solar radiation management), CO2 itself has a direct
and extremely dangerous impact on marine ecosystems. Carbon dioxide entering the
surface ocean undergoes a chemical reaction to raise the acidity (lower the pH) of
seawater and ultimately prevent corals and other photosynthetic organisms-the base of
the marine food web-from efficiently building their skeleta (National Research Council
2010). Here we argue that the human species has an analogous danger lurking in the
shadows of global warming-a significant risk to our wellbeing and survival caused
directly by the CO2 itself. ” (Document No. 449 at p.1).
43. Kindly keep the Date Wise Documents (and Full Documents**) for the future record.
Document No. 1 would be ANNEXURE P-1 and Document No. 616 would be
ANNEXURE P-616.
44. That the respondents must take steps to enforce Customary International Law.
Pandemics, which after all, are rooted in unacceptable fossil fuel CO2 (a xenobiotic)
producing driven activity which causes CO2 levels in less developed countries like
India, disproportionate to their CO2 activity, seem to have become an excuse to commit
Crimes Against Humanity, in violation of strict proscription against experimental
treatments/ inoculations/ vaccinations whether prophylactic, therapeutic or preventive.
That in the event of failure to enforce Customary International Law, provisions of Basic
Principles and Guidelines on the Right to a Remedy and Reparation for Victims of
Gross Violations of International Human Rights Law and Serious Violations of
International Humanitarian Law (UN General Assembly Resolution 60/147,
16.12.2005 Document No. 216C) are attracted to this case. That the respondents would
be required under Customary International Law to take all restorative, reparative and
ameliorative measures explained in Res 60/147 Articles 18-22: “18. In accordance
with domestic law and international law, and taking account of individual
circumstances, victims of gross violations of international human rights law and
serious violations of international humanitarian law should, as appropriate and
proportional to the gravity of the violation and the circumstances of each case, be
provided with full and effective reparation, as laid out in principles 19 to 23, which
include the following forms: restitution, compensation, rehabilitation, satisfaction and
guarantees of non-repetition.” xxx “19. Restitution should, whenever possible, restore
the victim to the original situation before the gross violations of international human

rights law or serious violations of international humanitarian law occurred. Restitution

includes, as appropriate: restoration of liberty, enjoyment of human rights, identity,
family life and citizenship, return to one’s place of residence, restoration of employment
and return of property.” xxx “20. Compensation should be provided for any
economically assessable damage, as appropriate and proportional to the gravity of the
violation and the circumstances of each case, resulting from gross violations of
international human rights law and serious violations of international humanitarian
law, such as: (a) Physical or mental harm; (b) Lost opportunities, including
employment, education and social benefits; (c) Material damages and loss of earnings,
including loss of earning potential; (d) Moral damage; (e) Costs required for legal or
expert assistance, medicine and medical services, and psychological and social
services.” xxx “21. Rehabilitation should include medical and psychological care as
well as legal and social services.” xxx “22. Satisfaction should include, where
applicable, any or all of the following: (a) Effective measures aimed at the cessation of
continuing violations; (b) Verification of the facts and full and public disclosure of the
truth to the extent that such disclosure does not cause further harm or threaten the
safety and interests of the victim, the victim’s relatives, witnesses, or persons who have
intervened to assist the victim or prevent the occurrence of further violations; (c) The
search for the whereabouts of the disappeared, for the identities of the children
abducted, and for the bodies of those killed, and assistance in the recovery,
identification and reburial of the bodies in accordance with the expressed or presumed
wish of the victims, or the cultural practices of the families and communities; (d) An
official declaration or a judicial decision restoring the dignity, the reputation and the
rights of the victim and of persons closely connected with the victim; (e) Public apology,
including acknowledgement of the facts and acceptance of responsibility; (f) Judicial
and administrative sanctions against persons liable for the violations; (g)
Commemorations and tributes to the victims; (h) Inclusion of an accurate account of
the violations that occurred in international human rights law and international
humanitarian law training and in educational material at all levels.” xxx “23.
Guarantees of non-repetition should include, where applicable, any or all of the
following measures, which will also contribute to prevention: (a) Ensuring effective
civilian control of military and security forces; (b) Ensuring that all civilian and
military proceedings abide by international standards of due process, fairness and

impartiality; (c) Strengthening the independence of the judiciary; (d) Protecting

persons in the legal, medical and healthcare professions, the media and other related
professions, and human rights defenders; (e) Providing, on a priority and continued
basis, human rights and international humanitarian law education to all sectors of
society and training for law enforcement officials as well as military and security
forces; (f) Promoting the observance of codes of conduct and ethical norms, in
particular international standards, by public servants, including law enforcement,
correctional, media, medical, psychological, social service and military personnel, as
well as by economic enterprises; (g) Promoting mechanisms for preventing and
monitoring social conflicts and their resolution; (h) Reviewing and reforming laws
contributing to or allowing gross violations of international human rights law and
serious violations of international humanitarian law.”
LOCUS FOR PUBLIC INTEREST LITIGATION
45. That it may be noted that locus for this proposed Public Interest Litigation arises from
m Document No.160A:
“A/RES/53/144 8 March 1999 Declaration on the Right and Responsibility of
Individuals, Groups and Organs of Society to Promote and Protect Universally
Recognized Human Rights and Fundamental Freedoms:
‘Article 1 Everyone has the right, individually and in association with others, to
promote and to strive for the protection and realization of human rights and
fundamental freedoms at the national and international levels.
Article 5 For the purpose of promoting and protecting human rights and fundamental
freedoms, everyone has the right, individually and in association with others, at the
national and international levels:(a) To meet or assemble peacefully;(b) To form, join
and participate in non-governmental organizations, associations or groups; (c) To
communicate with non-governmental or intergovernmental organizations.
Article 9 1. In the exercise of human rights and fundamental freedoms, including the
promotion and protection of human rights as referred to in the present Declaration,
everyone has the right, individually and in association with others, to benefit from an
effective remedy and to be protected in the event of the violation of those rights. 2. To
this end, everyone whose rights or freedoms are allegedly violated has the right, either
in person or through legally authorized representation, to complain to and have that
complaint promptly reviewed in a public hearing before an independent, impartial and

competent judicial or other authority established by law and to obtain from such an
authority a decision, in accordance with law, providing redress, including any
compensation due, where there has been a violation of that person’s rights or freedoms,
as well as enforcement of the eventual decision and award, all without undue delay. 3.
To the same end, everyone has the right, individually and in association with others,
inter alia: (a) To complain about the policies and actions of individual officials and
governmental bodies with regard to violations of human rights and fundamental
freedoms, by petition or other appropriate means, to competent domestic judicial,
administrative or legislative authorities or any other competent authority provided for
by the legal system of the State, which should render their decision on the complaint
without undue delay;(b) To attend public hearings, proceedings and trials so as to form
an opinion on their compliance with national law and applicable international
obligations and commitments; (c) To offer and provide professionally qualified legal
assistance or other relevant advice and assistance in defending human rights and
fundamental freedoms. 4. To the same end, and in accordance with applicable
international instruments and procedures, everyone has the right, individually and in
association with others, to unhindered access to and communication with international
bodies with general or special competence to receive and consider communications on
matters of human rights and fundamental freedoms. 5. The State shall conduct a prompt
and impartial investigation or ensure that an inquiry takes place whenever there is
reasonable ground to believe that a violation of human rights and fundamental
freedoms has occurred in any territory under its jurisdiction.
Article 10 No one shall participate, by act or by failure to act where required, in
violating human rights and fundamental freedoms and no one shall be subjected to
punishment or adverse action of any kind for refusing to do so.
Article 16 Individuals, non-governmental organizations and relevant institutions have
an important role to play in contributing to making the public more aware of questions
relating to all human rights and fundamental freedoms through activities such as
education, training and research in these areas to strengthen further, inter alia,
understanding, tolerance, peace and friendly relations among nations and among all
racial and religious groups, bearing in mind the various backgrounds of the societies
and communities in which they carry out their activities.

1097
124
UNIWORLD: ITED WE LIVE, DlVIOED WE DIE
Article 19 . othing in rhe pre. ·ent Declaration shall be interpreted as imp/ ingfor an
indi idual, group or organ of societv or any State the right to engage in any acti ity or
to perform any act aimed at the destruction of the right · and freedoms referred lo in
the present Declaration. ' .,
46. The partie may kmdly notice the earli r notice 28.06.2021 Document o. 557 which
would be A. XURE P-557 Do .um nt . 558 .. 2021 .06.29 on Dom tic AERS
DATA 187MB , which would be EXURE P-558 and thi noti being
Document o. 616 which would be A EX RE P-616 in the prop ed Public Int r t
Litigation under Cu t mary International Law in tenns of the tatutory provi ion of
Section 80 Ci ii Procedure Code 1908.
Place: Gurugram~ India
Dated: I 1.09.2021
Sarvadaman Singh Ob roi
1102 Tower l, niworld Garden I ector 47 Gurugram-122018, Mob. o.
9818768349 Email: maniob rot gmail.com
ENCLOSURES:
Table of Date Wi e Documents ( 1-616) anne d at pp.130-146
32 GB USB Flash Drive (**Full Document at Document o. 614 8GB)
------- -------PROOF OF RECEIPT .124-1..9

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TABLE OF DATE WISE DOCUMENTS

S.No. Document Detail Pages
1 1784.01.01 A treatise on cancers, Fearon 95pp. 95
2 1818.01.01 Lecture on Atresia Vaginae 14
3 1821.01.01 Observations on the Use and Abuse of Mercurial Medicines, James 228
Hamilton
4 1823.01.01 History of The Yellow Fever , City of Natchez, Henry Tooley 24
5 1832.01.01 A Treatise on the Diseases produced by onanism, Tissot 116
6 1832.01.01 Homeopathic Repertory, Boennighausen 1582pp. 1582
7 1832.01.01 The diseases of infants and children, Ruddock Edward Harris 248
8 1833.04.18 A Concise View of Homoeopathic Medicine, C. Hering English 29
translation Matlack, Philadelphia, U.S. 1833
9 1834.01.01 A Letter Addressed to the Medical Practitioners of Great Britain, 40
Rev. Thomas Everest
10 1834.09.30 A Popular View of Homoeopathy, Rev. Thomas Everest 96
11 1835.05.27 The Necessity and Usefulness of Homeopathy, German with English 72
manuscript C. Hering, Allentown, U.S. 1835
12 1838.01.01 Homoeopathic Practice of Medicine, Jacob Jeanes 399
13 1842.01.01 Homoeopathy - Two Book Reviews 19
14 1842.01.01 Observations on the Epidemic Yellow Fever of Natchez, Monette 163
15 1843.01.01 The British Journal of Homœopathy, Drysdale 519
16 1844.01.01 Sequel to Homoeopathy Unmasked, Wood 100
17 1845.01.01 The general nature and treatment of tumours, Macilwain 231
18 1846.01.01 A Manual of Homoeopathic Cookery 186
19 1846.01.01 Homoeopathy, Allopathy and Young Physic, Forbes 63
20 1846.01.01 Materia Medica Pura, Hahneman Vol. I Eng Translation Hempel, 242
1846
21 1846.01.31 Review of Homoeopathy, Allopathy and Young Physic, Lawson 37
22 1846.04.01 Letter to John Forbes article 01.01.1846, Henderson 66
23 1847.01.01 Homoeopathy via Young Physic., Russell 20
24 1848.01.01 Allopathy, Hahnemannism and Rational Homoeopathy, Becker 29
25 1850.08.02 House of Commons, LJM, Vol. 2, No. 21 (Sep., 1850), Vaccine 7
Refusal pp. 916-921
26 1851.01.01 James Silk Buckingham on Homoeopathy 7
27 1852.01.01 Homoeopathy in 1851, Russell 448
28 1852.01.01 Homoeopathy Speech, Irregular Practice, Simpson 64
29 1852.01.01 Homoeopathy Unveiled, Brodribb 45
30 1852.01.01 The Sides of the Body and Drug Affinities, Boenninghausen 32
31 1852.05.01 Homoeopathy and the Homoeopaths, Bushnan 232
32 1853.01.01 A treatise on Apoplexy, John C. Peters 178
33 1853.01.01 Homoeopathy Its Reason 28
34 1854.01.01 A Defence of Homoeopathy, R. De Charms 135
35 1854.01.01 Diseases of Children, Teste 351
36 1854.01.01 Homoeopathy Explained and Illustrated, Battye 46
37 1854.01.01 New Orleans Report, Epidemic Yellow Fever of 1853 602
38 1854.01.01 Tableau of the Yellow Fever of 1853, Bennet Dowler 67
39 1854.01.01 The History of the Epidemic Fever at New Orleans in 1853, Fenner 93
40 1855.01.01 The British and Foreign Homœopathic Medical Directory, Atkins 141
41 1856.01.01 History of the Epidemic of Yellow Fever in Charleston in 1854, Cain 39
42 1856.08.19 The People v. Peter W. Roff, Supreme Court, King's County, N.Y. 17
43 1859.01.01 A Complete Treatise on Headaches, Peters 625
44 1859.01.01 Charleston Report, Epidemic Yellow Fever of 1858 72
45 1859.01.01 Homoeopathic Domestic Physician, Pulte 638
46 1860.01.01 Homoeopathy Contrasted with Allopathy, Stehman 18
47 1861.06.01 Homoeopathy A Letter by Sir Benjamin Brodie 7
48 1861.09.01 Remarks on Sir Benjamin Brodie's Letter on Homoeopathy, Drysdale 20
49 1862.01.01 Homoeopathy in Manchester Contrasted With Its Alleged Principles, 94
Roberts

50 1863.01.01 Allopathy and Homoeopathy Contrasted, Sweeney 20

51 1863.01.01 Clinical Lectures on Diptheria, Ludlam 131
52 1864.01.01 Journal of the British Homoeopathic Society, Quin 572
53 1865.07.01 Brodie's Biography, Pollock 10
54 1866.06.08 The True and The False Sciences, Homoeopathy, F. Gilas 41
55 1869.01.01 Veterinary Pharmacopoeia Including the Outlines of Materia Medica 317
and Therapeutics, Richard V Tuson
56 1870.01.01 Modern Medicine and Homoeopathy, Drysdale 16
57 1871.01.01 The Philosophy of Homoepathy, Morgan 79
58 1872.01.01 Allopathy and Homoeopathy, Hiller 39
59 1874.01.01 Essays on Medicine, Sharp 831
61 1874.01.01 The Influence of Homoeopathy on General Medicine, Dudgeon 38
62 1874.01.01 The Yellow Fever Epidemic of 1873, Jerome Cochran 121
65 1878.01.01 The Germ Theories, Drysdale 78
66 1878.08.31 Homoeopathy A Letter, Hilbers 25
67 1879.01.01 Homoeopathy Vindicated, Berridge 48
68 1880.01.01 A Memorial of Constantine Hering, Raue 373
69 1880.01.01 On the Study of the Materia Medica, Pope 29
70 1880.07.09 Vaccination Act, 1880 7
71 1884.01.01 A Hand-Book of Skin Diseases, Kippax 309
72 1886.01.01 The Botanic Pharmacopoeia 104
73 1889.01.01 Chronic Diseases, Hahneman, English translation Hempel 317
74 1892.01.01 The Homeopathic therapeutics of hemorrhoids, Jefferson Guernsey 150
75 1893.01.01 Curability of Tumours, JC Burnett 349
76 1883.01.01 Hering's Domestic Physician 480
77 1894.01.01 Non-surgical treatment of diseases of the Glands and Bones, Clarke 188
78 1894.01.01 Sharp's Tracts on Homoeopathy 238
79 1894.02.23 Allinson v. General Council of Medical Education and Registration, 17
[1894] 2 QB 750
80 1895.01.01 A Hand-Book on the Diseases of Children, Fisher 931
81 1896.01.01 A Compend of the Principles of Homoeopathy, Boericke 174
82 1896.01.01 A Homeopathic Text Book of Surgery, Fisher EXTRACTS 140
83 1897.01.15 The Queen v. The Guardians of the Lewisham Union, [1897] 1 QB 4
498
84 1897.02.04 Epidemic Diseases Act, 1897 2
85 1899.01.01 The Fallacy of Vaccination, Alexander Wilder 22
86 1900.01.01 Dictionary of Practical Materia Medica, Vol 1, John Henry Clarke 969
87 1901.01.01 Practical Homeopathic Therapeutics, Willis Alonzo Dewey 384
88 1902.01.01 Dictionary of Practical Materia Medica, Vol 2, John Henry Clarke 882
89 1905.01.01 Materia Medica and Clinical Therapeutics, Fred J. Petersen 373
90 1905.02.20 Henning Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 29
(1905)
91 1907.01.01 Vaccinosis and its Cure by Thuja, JC Burnett 157
92 1915.01.01 Keynotes Of The Homoeopathic Materia Medica, Adolph von Lippe 69
93 1918.11.30 The Story of Brockton's Fight Against Influenza 36
94A 1919.01.01 Treatment of Influenza, Stearns 60
94B 1919.01.01 American Materia Medica, Therapeutics and Pharmacognosy, 470
Ellingwood
95 1920.01.01 Woman and the new race, Margaret Sanger 331
96 1921.01.01 Psychology of Color, Grumbine 60
97 1922.01.01 Cambridge History of Ancient India Extracts 41
98 1923.02.23 Declaration de Geneve, 23.02.1923, Rights of the Child 2
99 1927.01.01 Pocket Manual of Homoeopathic Materia Medica, William Boericke 595
100 1942.10.31 Homoeopathy and the nosodes Hom Herald 1942 October Vol V No 8
8

101 1945.06.26 Charter of the United Nations, its Origin, its Court and Need to 92
Protect Dependent Peoples
102 1947.07.19 The Medical Case NMT I 98
103 1947.08.20 The Medical Case, NMT; United States v. Karl Brandt and others, 44
US SC 16.02.1948 Extracts
104 1948.09.15 World Medical Association Declaration of Geneva, The Physician’s 2
Pledge
105 1948.12.09 Convention on the Prevention and Punishment of the Crime of 4
Genocide
106 1948.12.10 International Bill of Human Rights 1948 9
107 1949.01.08 Constituent Assembly Debates Volume VII 4 Nov 1948 to 8 Jan 1373
1949
108 1950.07.29 Principles of International Law Recognized in the Charter of the 6
Nüremberg Tribunal with Commentary
109 1953.11.09 Punjab Vaccination Act, 1953 extended to petitioner in Haryana 17
110 1954.06.06 Indian Materia Medica. Vol.1 by Nadkarni K.M. Extracts 304
111 1956.10.27 The Delhi Homoepathic Act, 1956 27
112 1957.06.26 Indigenous and Tribal Populations Convention, C107 12
113 1957.12.28 Delhi Municipal Corporation Act 1957 Compulsory Vaccination 186
114 1959.03.31 The Constitution (Andaman and Nicobar Islands) Scheduled Tribes 1
Order, 1959
115 1960.06.28 The Orissa Vaccination Act, 1960 15
116 1963.02.17 ICRC Centenary and 40 Years of Child Rights, 17.02.1963 13
117 1964.01.01 The magic of the minimum dose, Dr Dorothy Shepherd 222
118 1964.06.15 World Medical Association Declaration of Helsinki, Principles for 4
Medical Research
119 1964.10.01 The Maharashtra Vaccination Act, 1964 16
120 1966.12.16 UN GA Resolution 2200 (XXI) 16.12.1966 A ICESCR, ICCPR 12
121 1968.11.26 Convention on the Non-Applicability of Statutory Limitations to War 3
Crimes and Crimes Against Humanity
122 1969.06.23 The Himachal Pradesh Vaccination Act, 1968 9
123 1973.09.19 The West Bengal Vaccination Act, 1973 9
124 1973.12.18 The Homoeopathy Central Council Act, 1973 12
125 1976.05.20 The Vaccine Damage Campaign, New Scientist, Vol. 70, No. 1001 5
(1976) pp. 404-406 .
126 1977.01.01 Women in Medicine, Chaff 1132
127 1978.02.27 Pfizer Inc et al v. Government of India et al, MANU-USSC-0132- 15
1978
128 1979.01.01 Women’s Studies International Quarterly Volume 2, Issue 1, 1979 3
pp.128-129 3pp.
129 1980.02.28 Policy Statement, Research on Human Subjects, 1980 Hon’ble 11
Justice H.R. Khanna
130 1982.01.01 The Complete Book of Homeopathy, Weiner 314
131 1983.04.30 Rubella Vaccine-Induced Arthritis Infection and Immunity, Apr. 7
1983, Vol. 40, No. 1 pp.22-28
132 1986.01.10 Summary For Approval of Merck Sharp & Dohme MSD 321
RECOMBIVAX HB Extract
133 1987.06.25 United States v. James B. Stanley Case No.86-393 483 US 669 42
(1987)
134 1988.01.01 Homeopathy Medicine for the 21st Century, Dana Ullman 304
135 1989.01.01 A controlled evaluation of a homoeopathic preparation Br. J. Clin. 7
Pharmac. (1989), 27, pp.329-335
136 1989.11.20 Convention on the Rights of the Child 15
137 1990.01.01 Homoeopathy As Art and Science, Elizabeth W Hubbard 354
138 1991.01.01 Schaums Outline of Genetics, William D. Stansfield 459
139 1991.01.01 The Book of Infinite Wisdom, Stephen Thomas Chang 216
140 1991.07.01 Adverse Effects of Pertussis and Rubella Vaccines, Institute of 382
Medicine 1991, Washington, DC, The National Academies Press,

141 1992.01.01 Synoptic Materia Medica I Frans Vermuelen 528

142 1993.01.01 Homeopathy for Common Ailments, Robin Hayfield 97
143 1993.01.01 The New Concise Guide to Homoeopathy, Garion-Hutchings . 143
144 1994.01.01 Homeopathy, More Than a Cure, Jiri Cehovsky 107
145 1994.01.01 The Infinitesimal Dose The Scientific Roots of Homoeopathy, Colin 142
B. Lessell
146 1994.07.01 The Genius of Homoeopathic Remedies, S.M. Guanavante 270
147 1994.10.25 An Act For the relief of James B. Stanley Private Law 108-8 103d 2
Congress pp.5066-5067
148 1995.01.01 Golden Fountain The Complete Guide to Urine Therapy 134
149 1995.01.01 The Patient’s Guide to Homeopathic Medicine, Ullman 129
150 1996.01.01 A Coloured Atlas of the Chinese Materia Medica (1995 edition) Min 524
of Public Health PRC
151 1996.01.09 National Human Rights Commission v. State of Arunachal Pradesh 8
(1996) 1 SCC 742, MANU-SC-1047-1996
152 1996.05.01 Property Owners' Association v. State of Maharashtra, (1996) 4 SCC 4
49, 3J Art31C
153 1997.06.23 TN Pazhakudi Makkal Sangam v. Govt of TN, 1997 [Vol XLI] MLJ 52
(Crl) 655
154 1998.01.01 Clinical Experience With Some Rare Nosodes S. K. Ghosh 97
155 1998.01.01 Fundamental Research in Ultra High Dilution and Homoeopathy , 266
Schulte
156 1998.01.01 Homoeopathy, A Critical Appraisal, Edzard Ernst, Eckhart G. Hahn 253
157 1998.01.01 Homeopathy in the light of modern science, A.C. Dutta 158
158 1998.07.17 The Rome Statute of the International Criminal Court, 1998 90
159 1998.09.30 Understanding Pleomorphism and Isopathic Homeopathy, Erika 20
Craig
160A 1999.03.08 Right and Responsibility of Individuals.. Protect Universally 7
Recognized Human Rights and Fundamental Freedoms
160B 1999.08.31 Should Childhood Immunisation Be Compulsory Jour of Medical 5
Ethics, Vol. 25, No. 4 Aug., 1999, pp. 330-334
161 2000.06.30 Dioscorides de Materia Medica 960
162 2000.07.01 Fifty Years of the Supreme Court , Ch. 13 The Directions of 27
Environmental Justice ISBN 9780195662559
163 2000.07.01 Fifty Years of the Supreme Court , Ch. 18 International Law ISBN 30
9780195662559
164 2000.07.10 Secret Note Ministry of Mines in Samatha Tribal Land Rights Case 110
11.07.1997
165 2000.09.06 Ethical guidelines for biomedical research on human subject, 2000 77
166 2000.09.12 Property Owners' Association v. State of Maharashtra, (2000) 6 1
SCALE 571, 3J Art31C
167 2000.10.18 SC Ignores Samatha in Narmada Bachao Andolan v. Union of India 109
and others
168 2001.01.01 A Homoeopathic Approach to Cancer, Ramakrishnan and Coulter, 279
2001
169 2001.01.01 Act on the Prevention and Control of Infectious Diseases in Humans 77
(Infection Protection Act - IfSG) Germany
455, 5J Art31C
171 2001.07.12 Feldek v. Slovakia, ECHR no.29032 of 95 pp.87-116 35
172 2001.11.06 EC European Parliament Council, Community Code Medicinal 62
Products for Human use, 2001
173 2001.11.23 SC ORDER IA 502 of 1999 in WP 202 of 1995 17
174 2002.01.01 Handbook of Medicinal Herbs, Duke 893
175 2002.01.01 Homeopathy, Beyond Flat Earth Medicine, Dooley 94
176 2002.01.01 South American Medicinal Plants, Roth 498
177 2002.01.01 The Emerging Science of Homeopathy Complexity, Biodynamics 423
and Nanopharmacology

178 2002.01.30 The Shekhar Singh Report in IA 502 of 1999 in WP 202 of 1995 26
522, 7J Art 31C
181 2002.03.05 LOI n° 2002-303 du 4 mars 2002 relative...é du système de santé 60
60pp. (on patients rights and on the quality of the health system, France)
183 2002.05.07 SC ORDER IA 502 of 1999 in WP 202 of 1995 9pp. 9
184 2002.05.09 SC ORDER IA 502 of 1999 in WP 202 of 1995 7pp. 7
185 2002.06.02 An overview of the immune system, The Lancet 13
186 2002.06.03 Central Empowered Committee Notification 3
190 2003.01.01 From Nuremberg to The Hague The Future of International Criminal 208
Justice
191 2003.01.01 Homeopathy - Annotated Research Guide to Internet References, 148
Parker
192 2003.01.01 International Criminal Law by Antonio Cassese 534
193 2003.02.25 ALUMINUM incorporation into the brain of suckling rats through 1
maternal milk, Fifth Keele Meeting
194 2003.02.28 Final Report Andaman and Nicobar Islands Tourism Plan 20
195 2003.05.31 Mercury in Medicine, Taking Unnecessary Risks, United States 81
Congress Report May 2003
196 2003.07.01 Himmler's Crusade Race, Hale 2003 463
197 2003.07.21 The Jarawa Tribe of Andaman Islands, S.A. Awaradi Dissent Report 63
pp.1-262
198 2003.07.21 The Jarawa Tribe of Andaman Islands, S.A. Awaradi pp.263-331, 113
372-415
199 2003.08.13 A shot in the dark, The Guardian 17
200 2003.09.11 Consensus conference Paris Hepatitis B vaccination guidelines 11
201 2003.11.03 Report of CEC in SC ORDER IA 502 of 1999 in WP 202 of 1995 4
202 2003.12.31 Do Vaccines Contain Harmful Preservatives, Residuals Pediatrics 8
2003 vol. 112 pp.1394-1401
203 2004.01.01 The Pediatric Autoimmune Neuropsychiatric Disorders, Pediatrics 4
2004 Vol. 113 pp.883-886
204 2004.01.01 The Practice of Traditional Western Herbalism, Wood 256
205 2004.01.28 State of Kerala v. Chandramohanan, (2004) 3 SCC 429 6
206 2004.01.30 The Development of Positive Obligations Under the ECHR, Alistair 256
R. Mowbray
207 2004.07.01 And the Walls Came Tumbling Down 480
208 2004.07.08 Case of Vo v. France, ECHR Application no. 53924 of 2000 60
209 2004.10.01 Non Implementation SC ORDER IA 502 of 1999 in WP 202 of 1995 12
210 2004.11.09 Vaccination Public Hearing, Paris Hepatitis B sclerosis 9
211 2004.12.21 Policy on Jarawa Tribe of Andaman Islands 4
212A 2005.01.28 SC ORDER IA 502 of 1999 in WP 202 of 1995 5
212B 2005.02.18 SC ORDER IA 502 of 1999 in WP 202 of 1995 4
213 2005.03.15 Narmada Bachao Andolan v. Union of India and others Narmada 19
Bachao Andolan v. Union of India and others (2005) 4 SCC 32
214 2005.05.16 Australian Homoeopathic Association, A Statement on 9
Homoeoprophylaxis
215A 2005.07.28 GSK ENGERIX B Product Monograph Ethyl Mercury Thimerosal 20
ALUMINUM
215B 2005.08.10 Aventis Pasteur VAXIGRIP Product Monograph Ethyl Mercury 33
Thimerosal
216A 2005.10.21 SC ORDER IA 502 of 1999 in WP 202 of 1995 6
216B 2005.12.09 SC ORDER IA 502 of 1999 in WP 202 of 1995 13
216C 9

2005.12.16 Basic Principles and Guidelines on the Right to a Remedy and

Reparation
217 2006.01.01 Ayurvedic Medicine The Principles of Traditional Practice, Pole 379
218 2006.01.01 Encyclopedia of Homeopathy, Lockie 337
219 2006.01.01 Multiple sclerosis and hepatitis B vaccination Medical Hypotheses 3
Vol 66(1), 2006, pp.84-86
220 2006.01.01 National Formulary of Unani Medicine Part 1 336
221 2006.02.01 Developmental Regression & Mitochondrial Dysfunction, Jour. 3
Child Neurology Feb 2006 Vol 21 No. 2 pp.170-172
222 2006.04.04 Nosodes in Homeopathy, ECHAMP 4
223 2006.05.01 Sex and Sexuality, McAnulty & Burnette 987
224 2006.05.10 Who Are Indigenous Peoples? 2
225 2006.05.30 Overview patients rights European Union 51
226 2006.06.25 Health effects of increase in concentration of carbon dioxide, DS 3
Robertson
227 2006.07.01 Fact Sheet Homeopathic Immunisation 2
228 2006.07.31 Clinical Observations of Children’s Remedies 3rd ed., Farokh J. 655
Master
229 2006.10.31 ICMR ethical guidelines for biomedical research for human 120
participants 2006
230 2006.11.30 VRAN Vaccination Facts You need to know 2
231 2007.01.01 Beyond the Veil of Delusions Understanding Relationships Through 326
Homeopathy, Fuller
232 2007.01.01 Positive obligations under the ECHR , Jean-François Akandji-Kombe 72
233 2007.01.01 Principles and practice of homeopathy the therapeutic and healing 455
process, David Owen
234 2007.03.05 Vaccinations and Their Side Effects Thomas Quak 17
235 2007.03.22 Sample of Ingredients in Vaccines 7
236 2007.07.09 The Use of Nosodes in Homeopathy Summary Sheet, ECHAMP 1
237 2007.08.25 Recurrent anaphylaxis The Lancet 2007 Vol. 370 p.652 1
238 2007.09.28 Role of HLA-G, HLA-E and KIR2DL4 in Pregnancy, Int J Hum 15
Genet, 2007 vol. 7(3) pp.219-233
239 2007.10.03 Dynamized Preparations in Cell Culture, ACRC, Thrissur eCAM 7
2009 Vol 6 (2) pp.257–263
240 2007.11.28 Case of the Saramaka People v. Suriname, Inter-Am. Ct. H.R. (Ser. 63
C) Report No. 172
242 2007.12.31 The Campaign Against Patrick Holford, Quack Ben Goldacre, 13
Patrick Holford & Gillian McKeith
243 2007.09.13 Res 61 of 295. United Nations Declaration on the Rights of 17
Indigenous Peoples
244A 2007.09.15 Indian Medicinal Plants An Illustrated Dictionary, Khare 826
244B 2008.01.01 Practical Materia Medica of the Medieval Eastern Mediterranean 664
245 2008.01.01 Selected healing herbs of Himalaya a pictorial herbaria guide, 146
G.V.R. Joseph
246 2008.01.01 The fate of the Jarawas Some Lessons Across Space and Time 20
247 2008.01.01 The Placement, Quack Ben Goldacre, Patrick Holford & Gillian 46
McKeith
248 2008.01.01 The Practical Handbook of Homeopathy, Griffith 395
249 2008.01.01 The UN Declaration 2008 and the Protection of Indigenous Rights in 40
Brazil, Max Planck UNYB pp.247-286
250 2008.01.05 Yellow Fever Remedy hpathy 2
251 2008.02.03 Psidium Guajava, A Review of its traditional uses, Nadkarni Volume 27
I p.1020- Reducing sugars
252 2008.03.08 Vaccines Led to Autism, AP 1
253 2008.03.12 The Prevention of Epidemic Diseases by Homoeopathy 34
254 2008.03.12 Vaccination Myths 20
255 2008.03.31 Extracts India's Foreign Relations 2008 Part I, MEA 8

256 2008.04.07 CNN Helps Autism Debacle Blow Up in Government 10

257 2008.06.03 Natural Immunity - Why You Should Not Vaccinate Pat McKay 181
258 2008.06.30 Homoeopathy and the treatment of autism Pt II Similia Jun 2008 vol. 14
20 no. 1 pp.11-23, 30
259A 2008.07.01 Carbon Dioxide Absorption in the Near Infrared 19
259B 2009.01.01 International Compilation of Human Research Protections, US HHS 85
260 2009.01.01The History of American Homeopathy, Haller 210
261 2009.01.25 Against Compulsory Vaccination, Why HPV Vaccines Are 189
Dangerous To The Lives Of Girls 2012 ed
262 2009.01.30 Rabi Abdullahi v. Pfizer Inc., US Court of Appeals 2nd Circuit Case 89
No. 05-4863-cv, 562 F. 3d 163
263 2009.02.10 The Case Against Hepatitis B Vaccination, 2012 ed 54
264 2009.05.05 The Scientific Status of Homeopathy Briefing Paper May 2009, 10
ECHAMP
265 2009.05.07 Vaccine Refusal, Mandatory Immunization, and the Risks NEJM 8
2009 Vol 360 (19) pp.1981-1988
266 2009.06.08 A case of idiopathic nephrotic syndrome J High Dilution Res 2009 7
Vol 8 (26) pp.26-32
267 2009.10.20 WHO, UNICEF, World Bank. State of the world’s vaccines 3rd ed 208
2009
268 2010.01.01 Cytotoxic effects of homeopathic remedies on breast cancer Intl Jour 9
of Oncology 2010 Vol 36 pp.395-403
269 2010.02.03 CERVARIX GSK 62
270 2010.02.05 Against Compulsory Vaccination, A Long Train of Abuses and 193
Usurpations 2012 ed
271 2010.02.06 MMR Vaccine and autism, BMJ, Vol. 340, No. 7741 pp.271-272 2
272 2010.04.27 WHO Lecture 9 Part 3 Manual for assessment of national regulatory 130
authority for vaccines 2010
273 2010.10.17 Bracho et al Cuban Leptospirosis epidemic control study 11
Homeopathy 2010 Vol. 99, pp.156-166
274A 2010.11.19 Ram Deo Chauhan v. Bani Kanta Das 2010 14 SCC 209 2J 21
274B 2010.12.03 State of UP v. Hirendra Pal Singh,(2011) 5 SCC 305, 3J Art31C 7
275 2011.01.01 American Herbal Pharmacopoeia, botanical medicines, Upton 791
276 2011.01.01 Homoeopathy in Childhood disease, Carrel Beau 76
277 2011.01.01 Pathways of Homoeopathic Medicine, homoeopathy, naturopathy 112
and conventional medicine, Blessing
278 2011.01.01 Psorinum Therapy, ECAM, Vol. 2011, Article ID 724743, 7
279 2011.02.22 Russell Bruesewitz et al v. Wyeth LLC et al, 562 U.S. 223 US SC 57
Case No. 09-152 “Unavoidably Unsafe”
280 2011.04.30 National Vaccine Policy, MoHFW April 2011 23
281 2011.05.19 TYPHERIXä GSK AUSTRALIA 3
282 2011.05.27 MENINGITEC-PI PFIZER AUSTRALIA 9
283 2011.07.01 Informed consent in vaccination in India Medicolegal aspects Human 5
Vaccines vol. 7 issue 7 July 2011 pp.723-727
284 2011.11.10 Electronic Support for Public Health VAERS Final Report [1 in 38 7
Adverse Events]
285 2011.11.25 1st Indian Forest Congress, 2011, Antidiabetic Drugs from Plants, 28
Leads from Ayurveda
286 2011.11.25 1st Indian Forest Congress, 2011, Volume 1 175
287 2011.12.23 Jagjit Singh Aurora and Ors. v. Union of India, 2012 GLH (1) 362 27
288 2012.01.01 All The Missing Souls, David Scheffer 629
289 2012.01.01 Female Sexual Inversion, c. 1870-1920, Chiara Beccalossi 319
290 2012.01.01 Homeopathy and Ayurveda, Connelly 67
291 2012.01.01 Homeopathy for Farm and Garden, Vaikunthanath Das Kaviraj 373
292 2012.01.25 Homoeopathic management in Gynecological disorders, Sarkar 35
293 2012.02.17 Vaccine Illusion How Vaccination Compromises our Natural 117
Immunity

294 2012.03.20 Adverse Effects of Vaccines Evidence and Causality by Committee 449
to Review Institute of Medicine Part I
295 2012.03.20 Adverse Effects of Vaccines Evidence and Causality by Committee 446
to Review Institute of Medicine Part II
296 2012.04.30 Abdullahi v. Pfizer Second Circuit Finds a Nonconsensual Medical 15
Claim Actionable under ATS
297 2012.07.01 Medical Ethics Today The BMAs Handbook of Ethics and Law, 3rd 332
ed, BMA Part I
ed, BMA Part II
ed, BMA Part III
300 2012.09.04 Evolution and Philosophy behind the Indian Constitution, Sridhar 180
301 2012.10.26 TETABULIN SD Baxter U.K., Irish Med. Board License 8
302 2012.11.10 UNICEF WHO Immunization Summary 2011 226
303 2013.01.01 Inspiring Homeopathy, Treatment of Universal Layers, Tinus Smits 57
EXTRACTS
304 2013.01.01 New World Veterinary Repertory, Pitcairn Extracts 201
305 2013.02.15 Global Vaccine Action Plan WHO 152
306 2013.02.26 Global Vaccine Action Plan 2011-2020 6 Strategic Objectives pp.34- 19
71
307A 2013.03.08 Homoeopathy in Advanced malignant pathologies, Alok Pareek 62
307B 2013.03.09 Annual Report AYUSH MoHFW English, 2012 108
308 2013.07.01 National Vaccine Policy, ethical equity issues IJME Vol X No 3 Jul- 8
Sep 2013 pp.183-190
309 2013.07.03 Kamlesh C. Shah v. State of Maharashtra, (2013) 7 SCC 510 3J 10
Art31C
310 2013.07.18 Maktouf and Damjanović v. Bosnia and Herzegovina, ECHR [GC], 50
nos. 2312 of 08 pp.3-45
311 2013.07.27 Dissolving illusions disease, vaccines and the forgotten history, 321
Suzanne Humphries Extracts
312 2013.08.30 Alleged Irregularities in the Conduct of Studies using HPV Vaccine, 54
72nd Parliamentary Report
313 2013.08.31 Office Report in WP Civil 558 of 2012 Kalpana Mehta and Ors. v. 2
Union of India and Ors.,
315 2013.11.13 UK Medical Research Council and multicentre clinical trials, JRSM 12
2013, Vol. 106 (12) pp. 498–509
316 2014.01.01 Bullous pemphigoid in infants characteristics, vaccination, Orphanet 12
Journal of Rare Diseases (2014) 9:185
317 2014.01.01 Encyclopedia of Medical Immunology Autoimmune Diseases 1327
318 2014.01.01 INFLEXAL V Version 1 Johnson & Johnson EUROPE 2013-14 8
319 2014.01.01 The Autoimmune Diseases 5th ed 1213
320 2014.04.01 UN GA Res 68 167 Amnesty International Reply dated 01.04.2014 7
to OHCHR letter dated 26.02.2014
321 2014.02.12 3 SC ORDERS Aravalli Appeal Gair Mumkin Pahar with HC Order 48
and lower court fraud
322 2014.04.30 A brief history of vaccines & vaccination in India Indian J Med Res. 21
2014 Apr Vol 139(4) pp.491–511
323 2014.05.21 Mandatory Vaccinations, Precedent and Current Laws, US 14
Congressional Research Service
324 2014.07.01 Immune System Cytokine Release Encyclopedia of Toxicology 3rd 23
ed Vol. 2 Wexler Extracts

327 2014.08.28 Whistleblower Claims CDC Covered Up Data Showing Vaccine- 3

Autism Link , TIME
328 2014.10.02 Reducing healthcare costs with homeopathy, October 2014, 9
ECHAMP
329 2014.10.20 WHO SAGE WG Strategies addressing vaccine hesitancy, 2014 253
330 2014.10.23 Varilrix_cmi_au_007_approved GSK AUSTRALIA 4
332 2014.11.10 UNICEF WHO Immunization Summary 2013 221
333 2014.12.12 Weekly epidemiological record 2014, Yr 89, No.50 pp.561-576, 16
WHO
334 2014.12.22 Action Taken by Government on Observations, 72nd Report, HPV 75
PATH, 81st Parliamentary Report
335 2015.01.01 Homeopathy for Pregnancy, Birth, and Your Baby's First Year, 749
Miranda Castro
336 2015.01.01 Medicine in Early Modern Tibet, Gyatso 539
337 2015.01.01 The Parent's Guide to Homeopathy, Keneipp 393
338 2015.01.01 Vaccines and Autoimmunity, ISBN 9781118663431 394
340 2015.01.13 Hon'ble Supreme Court of India ORDER in WP Civil Kalpana Mehta 5
and Ors. v. Union of India and Ors.,
341 2015.01.15 Pleuropulmonary Blastoma A Report on 350 Cases Cancer Jan 2015 10
pp.276-285
342 2015.02.01 The 21 curious questions we're never allowed to ask about vaccines 14
344 2015.05.20 Center For One Baxter Products and Services Directory 22
345 2015.05.20 Gavi HPV Programs Application to Implementation, Hanson, 12
Vaccines 2015, Vol 3(2) pp.408-419
346 2015.06.15 IMA to move court against homoeo association - The Hindu 2
348 2015.09.09 WHO Mission Vision Immunization Vaccines 2015-2030 43
349 2015.09.18 The 1959 meeting in Vienna on controlled clinical trials, JRSM 4
2015, Vol. 108 (9) pp. 372–375
350 2015.10.14 Jacob Puliyel v. Union of India and Ors, MANU-DE-3058-2015, 223 3
(2015) DLT 674
351 2015.10.16 Supreme Court Advocates on Record Assoc. v. Union of India 5J 391
Art31C
352 2015.11.09 WHO Immunization in Practice 2015 288
356 2016.01.01 Ayurvedic pharmacopoeial plant drugs expanded therapeutics, 643
Khare
357 2016.01.01 Bullous pemphigoid in infant post vaccination IJIP 2016, Vol. 29(2) 5
pp.295–299
358 2016.01.01 Homeopathy, The Undiluted Facts Including a Comprehensive A-Z 153
Lexicon, Edzard Ernst
359 2016.01.01 Natural Health and Healing, Yoga, Meditation, Nature Cure, 106
Acupressure & Homeopathy
361 2016.02.25 WHO Global Routine Immunization Strategies and Practices 2016 78

362 2016.03.16 GSR-313-E dated16.03.2016 Amdt to Drugs and Cosmetics Rules 3

1945
363 2016.05.11 Military Rehabilitation and Compensation Commission v. May 13
MANU-AUSH-0020-2016 [2016]HCA 19
364 2016.06.01 7 things about vaccines and autism that the Movie VAXXED won't 6
tell you
365 2016.10.28 History of Development of Homoeopathy in India pp.76-83 8
366 2017.01.01 Resolving Mass Claims in France, Biard Amaro 62
367 2017.01.17 Intl Ethical Guidelines for Health-related Research Involving 119
Humans CIOMS Geneva 2016
368 2017.01.23 New Quality-Control Investigations on Vaccines, Micro- and 13
Nanocontamination
369 2017.01.24 Vaccine safety E course Manual, WHO 207
370 2017.02.13 Suit opens in Tokyo court over cervical cancer vaccine side effects, 4
The Japan Times 13.02.2017
371 2017.03.30 Varilrix_pi_009_01_approved GSK AUSTRALIA 14
372 2017.04.05 Kalpana Mehta and Ors. v. Union of India and Ors., MANU-SC- 16
0421-2017, (2017) 7 SCC 295
373 2017.05.31 Prevalence of Homeopathy Use , Homeopathy 2017 Vol. 106, pp.69- 10
78
374 2017.06.06 Plotkin’s Vaccines 7th ed 2018 2331
375 2017.06.21 Case C-621-15 N.W. and Ors v Sanofi Pasteur MSD SNC, 11
Judgement CJEU 2nd Chamber [2017] ECR I
376 2017.06.21 Case C-621-15 N.W. and Ors v Sanofi Pasteur MSD SNC, Opinion 16
of Advocate General 07.03.2017
377 2017.07.11 Interview, WHO’s revised norms are allowing the use of unsafe 4
vaccines
378 2017.09.13 Memorial of the Republic of India, 13.09.2017 India v. Pakistan 94
(Jadhav Case) ICJ
379 2017.10.05 Global Immunizations & UNICEF's Role, Vaccine Industry 24
Consultation 2017 Session 1 Update
380 2017.10.31 National Ethical Guidelines for BioMedical Research Involving 42
Children
381 2017.11.22 Constitutional Court of Italy Extract Judgement Veneto Region v. 14
Italy Compulsory Vaccination
382 2017.11.23 The Constitutional Court of Italy has Voted for Mandatory Vaccines, 1
Sofia News Agency
383 2017.12.31 Case C-621-15 N.W. and Ors v Sanofi Pasteur MSD SNC, An 15
example of judicial distortion
384 2017.12.31 Full Harmonization, Consumer Protection and Products Liability, C- 22
621-15 ERPL 2018 Vol 26(1) pp.119–140
385 2018.01.01 Liability for Vaccine Injury in US, EU and the Developing World, 48
Emory Law Journal Vol. 67(3) pp.415-462
386 2018.01.01 Quality Control in Preliminary Examination vol 1 and II 2018 236
Extracts
387 2018.01.01 When Ideology Trumps Science, Why We Question the Experts on 195
Everything
388 2018.01.16 Homoeopathic Thyroidinum 3x Int J Complement Alt Med. 2018 4
vol. 11(1) pp.1‒4.
389 2018.01.18 ICMR National Ethical Guidelines for Biomedical Research on 187
Human Subjects, 2017
390 2018.01.25 The influence of political ideology & trust on willingness to 13
vaccinate, Baumgaertner PLOSONE
391 2018.01.29 India Protection of Judges Case 136
392 2018.02.01 The Psychological Roots of Anti-Vaccination Attitudes, Health 9
Psychology 2018, Vol. 37(4) pp.307–315
393 2018.02.07 The Goa Foundation v. Sesa Sterlite Ltd, (2018) 4 SCC 218 2J 48
Art31C

394 2018.03.21 City of Oakland v. BP PLC, Climate Tutorial, Dist. Court California 189
(N) C17-06011 WHA
395 2018.03.27 10-Years-of-the-UK-Climate-Change-Act_Fankhauser-et-al 43
396 2018.05.02 Measles rubella vaccination drive kicks off in Punjab, Times of India 2
02.05.2018
397 2018.05.09 Kalpana Mehta and Ors v. Union of India and Ors, MANU-SC-0519- 139
2018, (2018) 7 SCC 1
398 2018.05.16 Why Relying on Parliamentary Panel Reports is Important in 8
Litigation, The Wire
399 2018.05.18 Homoeopathy Central Council (Amendment) Ordinance, 2018 4
400 2018.05.18 Ordinance Summary- Homoeopathy Central Council, 2018 1
401 2018.05.18 The Homoeopathy Central Council (Amendment) Ordinance, 2018 2
402 2018.07.07 India WHO and UNICEF estimates of immunization coverage 2017 18
revision
403 2018.07.13 Aparna Gupta v. State of NCT of Delhi and Ors, MANU-DE-2559- 10
2018, 253 (2018) DLT 210
404 2018.09.21 Laboratory Raided after Baffling Vaccine Discovery 21.09.2018 48
405 2018.09.21 An ethical appraisal of the choice of vaccines IJME vol IV No. 1 Jan- 2
Mar 2019 pp.28-29
406 2018.10.22 The organization and delivery of vaccination services in the 169
European Union
407 2018.11.13 World Energy Outlok, CNPC,2018 58
408 2018.12.20 Package Insert GSK ENGERIX-B 16
409 2018.12.22 Package Insert MSD RECOMBIVAX HB 10
410 2019.01.01 A Homoeopathic Approach to Cancer. Vols. I & II, Farokh Master 971
411 2019.01.01 Duration of Pediatric Clinical Trials FDA, Zimmerman JAMA 8
Pediatrics Jan 2019 Vol 173(1) pp.60-67
412 2019.01.01 Healing Knowledge in the Early Modern Atlantic World, Crawford 385
413 2019.01.01 Homeopathy Reconsidered What Really Helps Patients, Natalie 133
Grams
414 2019.01.01 How the Immune System Works 169
415 2019.01.01 Vernacular Medicine in Colonial India Family, Market and 445
Homoeopathy, Shinjini Das
416 2019.01.15 Hon'ble High Court of Delhi Order 15.01.2019 in W.P. Civil 343 of 4
2019 Master Hridaan Kumar Minor v. UOI
417 2019.01.18 I. A. Dy. No. 84763 of 2019 in W.P. Civil 343 of 2019 Master 12
Hridaan Kumar Minor v. UOI 18.01.2019
421 2019.02.05 Government of India Allocation of Business Rules,. 1961 181
422 2019.02.19 The Vaccingate of Italy, Down To Earth with COVID-19 articles 71
423 2019.03.13 Early Day Motions, House of Commons, UK-WIDE CLIMATE 158
EMERGENCY,EDM #2177
424 2019.03.19 New Drugs and Clinical Trials Rules GSR-227-E 119
425 2019.04.04 Italy’s governing parties struggle to find path forward on vaccines, 7
POLITICO
426 2019.05.14 Why the Government Pays Billions to People Who Claim Injury by 15
Vaccines The Atlantic 14.05.2019
427 2019.07.15 OA 710 of 2017 Shailesh Singh v. Sheela Hospital et al 15
428 2019.08.08 The National Medical Commission Act, 2019 30 of 2019 28
429 2019.08.14 Priorix GSK CANADA 23
430 2019.09.16 State of Odisha v. Anup Kumar Senapati, (2019) 19 SCC 626 3J 26
Art31C
431 2019.09.19 Union of India v. Tarsem Singh, (2019) 9 SCC 304 2J Art31C 36

432 2019.10.24 ICMR Policy on Research Publications 2019 21

433 2019.11.01 Is There a Correlate of Protection for Measles Vaccine, Stanley A. 2
Plotkin, JID 2020 Vol. 221 pp.1571-1572
434 2019.11.01 What is the Evidence to Support a Correlate of Protection for 8
Measles, JID 2020 Vol. 221 pp.1576-1583
435 2019.11.11 Report of the Commissioner of Police, Gurugram in Climate Change 135
Offence
436 2019.12.09 The legality of mandatory vaccination IJME vol V No. 1 pp.57-61 5
437 2020.01.01 Autonomic Nervous System and Homeopathy, Personalized 108
Nutrition, Girase
438 2020.01.01 Basic Immunology Functions and Disorders of the Immune System 328
439 2020.01.01 Coronavirus - COVID 2019 A Survival Manual, Myths to Facts, 54pp.
Homeopathy and Allopathy, Weing Li
440 2020.01.01 Deadliest Enemy_ Our War Against Killer Germs 180
441 2020.01.01 Evidence-Based Ayurveda Defining A New Scientific Path, Khare 325
442 2020.02.06 Vaccines truth, lies and controversy Peter C Gotzsche 223
443 2020.02.07 Homeopathy India Brazil Memorandum Of Understanding 4
444 2020.02.25 Final India Climate Change Notice 36
445 2020.02.28 Vaccine Excipient Summary-Excipients In U.S. Vaccines by 4
Vaccine-February 2020
446 2020.03.11 Forget coronavirus, homoeopathy can’t cure anything. It’s a placebo, 15
at best
447 2020.03.20 Report of the SC Committee on Tree Valuation 18.02.2020 and 47
25.02.2020 with Orders
448 2020.04.14 Plague of Corruption - Restoring Faith in the Promise of Science, 333
Judy Mikovits
449 2020.04.20 Fossil fuel combustion is driving indoor CO2 toward levels harmful 8
to human cognition
450 2020.04.23 COVID-19 A harbinger for climate action 5
451 2020.04.30 ICMR SOP Template EC COVID19 2
452 2020.05.06 Partly false claim Vaccines contain to..., yeast and other substances 6
Reuters
453 2020.05.29 Ministry of AYUSH, Govt. of India Homeopathy Guidelines for 12
COVID-19
454 2020.06.17 Causality assessment of adverse events following immunization 35
Bellavite P. F1000 Research 2020 vol 9 (170)
455 2020.06.17 Causality assessment of an adverse event following immunization 86
WHO Manual Revised 2019
456 2020.07.01 Trees in Trouble 271
457 2020.07.31 Compulsory Vaccination Controversy, ECtHR and Fundamental 5
Human Rights, Teršek
458 2020.08.20 Moderna COVID-19 mRNA-1273-P301-Protocol 135
459 2020.08.26 Union of India and Ors v. Agricas LLP and Ors MANU-SC-0614- 41
2020
460 2020.09.06 Ethics Committees Guidance COVID19 06.09.2020 17
461 2020.09.07 ECHR Case No. 39371 of 2020 Duarte Agostinho and others v. 7
Portugal and 32 others
462 2020.09.17 Astra Zeneca COVID-19 Phase III Study 111
463 2020.09.20 The National Commission for Indian System of Medicine Act, 2020 29
14 of 2020
464 2020.09.20 The National Commission for Homoeopathy Act, 2020 15 of 2020 26
465 2020.09.29 WP Civil 7313 of 2020 Prashant Reddy T v. DGCI ORDER High 2
Court of Delhi 29.09.2020
466 2020.09.30 Lachesis in COVID-19 Homoeopathic Links 2020 Vol. 33(3) 2
pp.233–234
467 2020.09.30 Question for written answer to the European Commission Rule 138 E 1
468 2020.10.28 Ingredients in Vaccines and The fiasco of the 1976 ‘swine flu affair’ 30
BBC Future

469 2020.10.31 Carbon Offences by Multinational Companies 178

470 2020.11.25 Immunological and virological aspects of SARS COV-2 vaccine 18
platforms, HAS
471 2020.11.30 United States CDC VAERS Data Use Guide 30.11.2020 17
472 2020.12.13 WHO Emergency Use Listing Procedure 13.12.2020 63
473 2020.12.14 Johnson & Johnson COVID-19 ensemble-1-study-protocol 184
474 2020.12.17 ICAN Tamar Massoyan Artinian v. Monica Bharel Commissioner 240
MDPH, PIaintiffs MOL & Affidavits
MDPH Complaint 18.12.2020
477 2020.12.22 Supreme Court of Norway Case HR-2020-2472-P Nature and Youth 50
Norway v. The State, Judgement 22.12.2020
MDPH Signed joint
479 2020.12.24 A Parallel approach to tackle Coronavirus 4
480 2020.12.28 Attacking ourselves, top doctors reveal vaccines turn our immune 6
system against us Nexus Newsfeed
481 2021.01.01 Grays Atlas of Anatomy 3rd ed 2021 1362
482 2021.01.01 International Compilation of Human Research Protections, US HHS 198
483 2021.01.06 INFANRIX QUINTA GSK 12
484 2021.01.13 The European Medicines Agency’s EU conditional authorisation for 3
COVID-19 vaccines
485 2021.01.15 A Letter to Dr. Eric S. Lander, the President’s Science Advisor, The 5
White House
486 2021.01.15 2020.12.18 ICAN Tamar Massoyan Artinian v. Monica Bharel 10
Affidavit of Elizabethb Scurria Morgan
487 2021.01.15 2020.12.18 ICAN Tamar Massoyan Artinian v. Monica Bharel 1
Commissioner MDPH Notice to School Nurses.
488 2021.01.18 I don’t think anybody really knows, Vanessa Bowden et al 15
489 2021.02.05 US NVAC Feb 2021 Meeting Summary 22
491 2021.02.22 Hon'ble High Court of Delhi Order W.P. C. 5315 of 2020 Master 4
Arnesh Shaw v. UOI (Duchenne Muscular Dystrophy)
492 2021.02.25 Serious Adverse Events Noitification on SUGAM 1
493 2021.02.27 Fact check COVID-19 vaccines do not co...dients listed in these posts 5
Reuters 5pp.
494 2021.03.03 ATAGI immunisation provider guide to obtaining informed consent 11
for COVID-19 vaccine
495 2021.03.03 Concern COVID-19 Mass Vaccination Geert Vanden Bossche 21
496 2021.03.03 COVID-19 Saudi Arabia makes vaccination mandatory for Hajj 2
pilgrims
497 2021.03.12 MMRVAXPRO - Summary of Product Characteristics 8
499 2021.03.30 Maddalena Cirignotta Testimony Before US HHS House Committee 6
30.03.2020
500 2021.04.01 US NVAC Meeting Notice 16-17 June 2021 1
501 2021.04.08 Vavřička v. the Czech Republic, ECHR 99
502 2021.04.16 COMI 230 of 2021 JMFC Gurugram, with Order, Climate & Health 110
Emergency
503 2021.04.23 Covid Care Center, Gujarat HC Auditorium 6
504 2021.04.23 Prosecution response in re CIL, KSC-BC-2020-06 49
505 2021.04.25 Implementation Framework Annx MoHFW DO no Z.28015-85- 5
2021-DM Cell dt 25.04.2021

506 2021.04.29 Ministry of Home Affairs ORDER No. 40-3-2020-DM-I(A) dated 7

29.04.2021
507 2021.04.30 In Re Distribution of Essential Supplies and Services, MANU-SC- 35
0366-2021, AIR 2021 SC 2356
508 2021.04.30 The Israeli People Committee Interim Conclusion Report April 2021 29
509 2021.05.03 ICAN Documentation in United States Vaccine System Defects 377
From 02.10.2017 to 03.05.2021 Parts I to XII - PART I 02.10.2017 to
22.02.2018
From 02.10.2017 to 03.05.2021 Parts I to XII - PART II 15.03.2018 to
09.04.2020
From 02.10.2017 to 03.05.2021 Parts I to XII - PART III Anthony Fauci Emails
25.01.2020 to 19.02.2020
From 02.10.2017 to 03.05.2021 Parts I to XII - PART IV Anthony Fauci Emails
14.02.2020 to 27.02.2020
From 02.10.2017 to 03.05.2021 Parts I to XII - PART V Anthony Fauci Emails
24.02.2020 to 13.03.2020
From 02.10.2017 to 03.05.2021 Parts I to XII - PART VI Anthony Fauci Emails
24.02.2020 to 23.03.2020
From 02.10.2017 to 03.05.2021 Parts I to XII - PART VII Anthony Fauci Emails
03.03.2020 to 07.04.2020
From 02.10.2017 to 03.05.2021 Parts I to XII - PART VIII Anthony Fauci
Emails 21.03.2020 to 26.04.2020
From 02.10.2017 to 03.05.2021 Parts I to XII - PART IX Anthony Fauci Emails
20.04.2020 to 05.05.2020
From 02.10.2017 to 03.05.2021 Parts I to XII - PART X Anthony Fauci Emails
08.04.2020 to 05.05.2020
From 02.10.2017 to 03.05.2021 Parts I to XII - PART XI 29.04.2020 to
17.07.2020
From 02.10.2017 to 03.05.2021 Parts I to XII - PART XII 20.07.2020 to
03.05.2021
521 2021.05.05 VAERS data released today showed 118,902... EU..330,000 Adverse 13
Events, The Defender
522 2021.05.17 Israeli People’s Committee Releases Report ... COVID Injections , 5
Covid Call To Humanity
523 2021.05.20 FRIGHTENING! – 16th update on Adverse Reactions...UK 9
Government, MHRA Rights and Freedoms
525 2021.05.22 Vaccines truth, lies, and controversy, The New Dark Age 4
526 2021.05.25 Baba Ramdev fires 25 questions at IMA, asks 'is there any allopathic 5
medicine to turn cruel person kind
527 2021.05.25 Check on Saudi Arabia’s vaccination req... TH Travel CEO, 2
Malaysia, Malay Mail
528 2021.05.25 The 25 Questions to IMA in Hindi with English translation 2
529 2021.05.27 Ministry of Home Affairs ORDER No. 40-3-2020-DM-I(A) dated 1
27.05.2021
530 2021.05.31 In Re Distribution of Essential Supplies and Services, MANU-SC- 22
0365-2021

532 2021.06.04 Advisory, Travel and Visa Restrictions related to COVID-19, MHA 14
533 2021.06.07 Details of Haj 2021 to be announced soon, Saudi minister - India 2
Today World News
534 2021.06.07 MNCs CARBON CRIME COMI 230 OF 2021 SUBMISSION 60
07.06.2021 WITH ORDER
535 2021.06.11 Clinical research in resource-limited settings CIOMS Geneva 2021 140
536 2021.06.11 FAO 153 of 2021 Dr. J.A. Jayalal v. Rohit Jha ORDER 11.06.2021 1
537 2021.06.12 Complaint CrPC 166A CO2 Poisoning 75
538 2021.06.13 Saudi allows 60,000 vaccinated resident..., bars foreigners again, 4
ABS-CBN News
541 2021.06.20 Delhi Disaster Management Authority ORDER No. F.2-07-2020-pt 5
file-III-442 dated 20.06.2021
542 2021.06.21 PIL 6 of 2021 RG HC of Meghalaya v. State of Meghalaya Order 2
21.06.2021
543 2021.06.22 Djibouti makes COVID-19 vaccination compulsory, aa.com.tr 1
544 2021.06.22 High Court of Gujarat Order dated 22.06.2021 in SCA 8309 of 2021 1
titled Yogendra Kumar v. IAF
23.06.2021
546 2021.06.24 Djibouti Press Release 24.06.2021 COVID-19 Let us all vaccinate 1
ourselves
547 2021.06.24 Jaishankar aims at citizen-friendly passport services - Asian News 4
from UK
548 2021.06.24 MHRA UK Coronavirus vaccine summary of Yellow Card reporting 20
UPTO 16.06.2021
549 2021.06.24 Saudi Arabia Travel Guidelines and Requirements due to COVID-19 4
550 2021.06.25 MEA says overseas vaccine supply will d...d on availability - Asian 3
News from UK
551 2021.06.25 Merkel defends patent protection for Covid vax _ English.Lokmat 3
552 2021.06.26 Important Orders & Documents Setting up ICL Courts in India from 120
2011 to 2021 OTP ICC letters at pp.92-97
553 2021.06.26 Delhi Disaster Management Authority ORDER No. F.2-07-2020-pt 6
file-III-445 dated 26.06.2021
554 2021.06.26 Notice Delhi Gymkhana Club 26.06.2021 1
555 2021.06.27 EU excludes Covishield from ‘Green Pass’ list - Asian News from 4
UK
556 2021.06.28 Delhi Gymkhana Club Notice for Club Opening 4
557 2021.06.28 Notice Section 80 CPC and Crimes against Humanity Ulterior Form 7
of Constraint to Vaccinate
558 2021.06.29 Non Domestic VAERS DATA, US CDC 187MB 187MB
559 2021.06.29 Explainer, What are patent waivers for ...Coronavirus pandemic 13
News, Al Jazeera
560 2021.06.30 Access to Justice in International Systems, Salles and Cruz 6
561 2021.06.30 No EU ban on Covishield, but request must for approval - Asian 5
News from UK
30.06.2021
563 2021.07.01 Accept Indian vaccines or face mandator... India tells EU - London 5
Daily Digital
564 2021.07.01 Cytochrome P450 Articles and Editorials Jan 2020 to Jun 2021 in 49
Psychiatric Times Journal
565 2021.07.01 Cytochrome P450 Scientific Journal Articles and Book Extracts 258
From Jan 2004 to Jun 2021
566 2021.07.01 ECLJ-Letter-to-the-WMA-on-the-2021-Revision-of-its-Code 10

568 2021.07.01 Nine countries in Europe accepting Covi...Report India News, The 4
Indian Express
569 2021.07.02 Behind Mumbai fake vaccine scam a medi...centre _ India News,The 5
Indian Express
570 2021.07.04 Italy's governing parties struggle to find path forward in vaccines 7
571 2021.07.06 Environment and the European Convention on Human Rights, ECHR 33
Press Release
572 2021.07.12 The Vaccination Vexation A Constitutional Law Perspective 5
574 2021.07.14 Madras Bar Association v. Union of India MANU-SC-0429-2021 74
575 2021.07.14 NCRPB No. Y-13-34-2021-Office of Dy. Director-UD 9
576 2021.07.15 Vaccine Policy Conundrum, Academia 4
577A 2021.07.16 Down to Earth 16-30 June 2021 60
577B 2021.07.17 Wipro, TCS, Infosys, other IT firms aims to call back employees 2
578 2021.07.19 CS OS 320 of 2021 RDA AIIMS Rishikesh v. Ram Kishan Yadav 2
ORDER 19.07.2021
579 2021.07.20 Case Status PIL 6 of 2021 RG HC of Meghalaya v. State of 2
Meghalaya
580 2021.07.20 Case Status SCA 8309 of 2021 Gujarat HC 3
581 2021.07.20 Gmail - IN RE DB I MATTER 22.07.2021 PIL 6 OF 2021 RG HC 1
OF MEGHALAYA V. STATE OF MEGHALAYA
582 2021.07.21 Global distribution and coincidence of pollution, climate impacts, 18
and health risk, Marcantonio R, PLOS ONE
583 2021.07.22 MoEF&CC letter No. 5-2/2020-ROHQ dt. 22.07.2021. to RO North 8
MoEF&CC, Chandigarh copied to PCCF Haryana and Punjab on tree cuttingin
compliance of Cabinet Secretariat U.O. No. 1/1/2021-Min III (vol. 1I) dated
07.07.2021
22.07.2021
585 2021.07.25 What went wrong in Bharat Biotech's Covaxin deal with Brazil, HT 2
Delhi
586 2021.07.26 CS OS 320 of 2021 RDA AIIMS Rishikesh v. Ram Kishan Yadav 1
ORDER 26.07.2021
587 2021.07.27 FAO 153 of 2021 Dr. J.A. Jayalal v. Rohit Jha JUDGEMENT 9
27.07.2021
588 2021.07.28 CDC says fully vaccinated people spread the Delta variant Business 15
Insider India
589 2021.07.28 HC rejects IMA president’s plea against court order - The Hindu 3
590 2021.07.29 Part of Blinken's civil society meet, Tibet House Director Dorji 10
expresses concern about CCP
591 2021.07.30 Delhi High Court issues notice to Swami Ramdev over his remarks 3
on allopathy
592 2021.07.30 Himachal Pradesh landslide viral video from Sirmaur has Twitter 10
shocked
593 2021.07.31 The European Unions response to the pandemic, Fernanda Neutel 5
594 2021.08.01 The Law and Science of Climate Change Attribution, Michael 8
Burger, 51 ELR 10646, 8-2021
595 2021.08.01 Turkey is under the shock of unprecedented forest fires - Terrifying, 2
The Statesman
596 2021.08.02 Focus on maritime security, peacekeeping, terror as India enters 4
UNSC presidency
598 2021.08.08 Covishield, Covaxin Mix Shows Positive Results, News18 4
599 2021.08.08 Time running out to stop 'catastrophe', warns Alok Sharma, WION 2

600A 2021.08.09 IPCC AR 6 WG I Full Report EXTRACTS 193

600B 2021.08.09 IPCC AR 6 UN Secretary-General's Code Red For Humanity 2
09.08.2021
602 2021.08.11 Glaciers Melting, Experts explain why Himachal is Seeing Increasing 4
Landslides
603 2021.08.11 Record-breaking drought in Chile makes climate change very easy to 2
see
604 2021.08.12 Case Status, WP Civil 558 of 2012 Kalpana Mehta and Ors. v. Union 3
of India and Ors.,
605 2021.08.13 Delta Plus variant claims third life in man who was fully vaccinated 2
606 2021.06.13 Mixing Covid vaccines is very wrong, Serum Institute chief Cyrus 2
Poonawalla
607 2021.08.19 India may not commit to mid-century 'net zero' but TOI New Delhi 3
608 2021.08.19 India stresses on ·flexibility· in climate goals for developing world 6
HT New Delhi
609 2021.08.22 Palm-oil plan for Andamans skirt legal hurdles, Asian News 3
610 2021.08.26 Covid-19 Updates - Wipro 4
611 2021.08.26 Greek health workers protest against introduction of mandatory 2
COVID jabs
612 2021.08.28 TCS has a vaccination plan to gets its employees back to office, 3
Quartz India
613 2021.09.06 The Israel Vaccine Crisis Should Be A Warning To The World , 3
Canada Man's Sandbox
614 2021.09.11 Full Documents on 32 GB flash drive – 28GB
615 2021.09.11 EXTRACTS from US CDC Non Domestic VAERS DATA,
29.06.2021
616 2021.09.11 Second Notice Section 80 CPC and Crimes against Humanity 146
Ulterior Form of Constraint to Vaccinate (POD*)

1/11/22, 4:00 PM Boys more at risk from Pfizer jab side-effect than Covid, suggests study I Coronavirus I The Guardian
ANNEXURE P-48 1120
Coronavims
o This article is more than 3 months old
Boys more at risl< from Pfizer jab side-effect

than Covid, suggests study
US researchers say teenagers are more likely to get vaccine-related
myocarditis than end up in hospital with Covid
Coronavims - latest updates
See all our coronavirus coverage
Ian Sample Science editor

-@iansample
Fri 10 Sep 202118.00 BST
Healthy boys may be more likely to be admitted to hospital with a

rare side-effect of the Pfizer/BioNTech Covid vaccine that causes
inflammation of the heart than with Covid itself, US researchers
claim.
Their analysis of medical data suggests that boys aged 12 to 15, with
no underlying medical conditions, are four to six times more likely
to be diagnosed with vaccine-related myocarditis than ending up in
hospital with Covid over a four-month period.
https://www.theguardian.com/world/2021/sep/10/boys-more-at-risk-from-pfizer-jab-side-effect-than-covid-suggests-study 1/4
1121
Most children who experienced the rare side-effect had symptoms
within days of the second shot of Pfizer/BioNTech vaccine, though a
similar side-effect is seen with the Modernajab. About 86% of the
boys affected required some hospital care, the authors said.
Saul Faust, professor of paediatric immunology and infectious

diseases at the University of Southampton, who was not involved in
the work, said the findings appeared to justify the cautious approach
taken on teenage vaccines by the UK's Joint Committee on Vaccines
and Immunisation.
The JCVI did not recommend vaccinating healthy 12 to 15-year-olds,

but referred the matter to the UK's chief medical officers who are
expected to make a final decision next week. Children aged 12 to 15
who are particularly vulnerable to Covid, or who live with an at-risk
person, are eligible for the shots.
In the latest study, which has yet to be peer reviewed, Dr Tracy H0eg
at the University of California and colleagues analysed adverse
reactions to Covid vaccines in US children aged 12 to 17 during the
first six months of 2021. They estimate the rate of myocarditis after
two shots of Pfizer/BioNTech vaccine to be 162.2 cases per million
for healthy boys aged 12 to 15 and 94 cases per million for healthy
boys aged 16 to 17. The equivalent rates for girls were 13.4 and 13
cases per million, respectively. At current US infection rates, the risk
of a healthy adolescent being taken to hospital with Covid in the
next 120 days is about 44 per million, they said.
How reliable the data is and whether similar numbers could be seen
in the UK if healthy 12 to 15-year-olds are vaccinated are unclear:
vaccine reactions are recorded differently in the US and shots are
given at longer time intervals in the UK. According to the UK
medicines regulator, the rate of myocarditis after Covid vaccination
is only six per million shots of Pfizer/BioNTech.
So far, UK children have not been admitted to hospital for Covid in

large numbers and may not be at great risk of long Covid. While the
recent Clock study found that up to 14% of children who caught
Covid may still have symptoms 15 weeks later, levels of fatigue
1122
appear similar to those in children who have not caught the virus.
This suggests that children may be spared some of the most
debilitating problems seen in adult long Covid.
The overwhelming majority of myocarditis

appears after the second dose of vaccine, so offering single shots
could protect children while reducing their risk of the side effect
even further.
"While myocarditis after vaccination is exceptionally rare, we may

be able to change the first or second doses or combine vaccines
differently to avoid the risk at all, once we understand the
physiology better;' said Prof Faust. "On balance, there is no urgency
to immunise children from a medical perspective, although if
schools are unable to maintain education for the vast majority at all
times, the overall balance could shift. If my two teenage children are
offered the vaccine by the NHS my GP wife and I will have no
hesitation in allowing them to receive the vaccine:'
Prof Adam Finn, a member of JCVI at the University of Bristol, said:

"I stand by the JCVI advice, which is not to go ahead at this time
with vaccinating healthy 12 to 15-year-olds on health outcome risk-
benefit grounds given the current uncertainty - as there is a small
but plausible risk that rare harms could turn out to outweigh modest
benefits:'
The MHRA said it has been closely monitoring all available data on
the potential risk of myocarditis and pericarditis following Covid-19
vaccination. "We have concluded that the Covid-19 vaccines made
by Pfizer/BioNTech and Moderna may be linked with a small
increase in the risk of these very rare conditions. The cases tended
to be mild and the vast majority recovered with simple treatment
and rest;' they added.
The spokesperson said the latest study had been considered by the
government's independent advisory body, the Covid-19 vaccines
benefit risk expert working group, which found that the
interpretation of the findings was limited by the fact that the study
did not take into account differences in treatment practices when
1123
comparing hospitalisation rates between Covid-19 infections and
myocarditis and pericarditis presenting post-vaccination, and there
was no assessment of severity and duration of illness after
admission.
"Safety monitoring strategies are in place for individuals under 18

years, including monitoring myocarditis and pericarditis occurring
post-vaccination and the long term outcomes with these events. The
MHRA continues to keep the safety of Covid-19 vaccines under close
and continual review;' the spokesperson added.
• This article was amended on 12 September 2021 to add feedback

from the MHRA
1124
ANNEXURE P-49
MANU/OT/0099/2021
IN THE SPECIAL COURT FOR PROTECTION OF CHILDREN FROM SEXUAL
OFFENCES ACT, 2012 AT FORT, GREATER BOMBAY
Order Below Exhibit No. 56 in POCSO Special Case No. 263 of 2015 (CNR No.
MHCC02-007977-2015)
Appellants: Pankaj Arjunbhai Koli
Vs.
Respondent: The State of Maharashtra
Sanjashree J. Gharat, J.
Counsels:
For Appellant/Petitioner/Plaintiff: Nilesh Oza, Ld. Adv., Nizam and Mishra, Advs.
For Respondents/Defendant: Kalpana Hire, Ld. SPP
ORDER
Sanjashree J. Gharat, J.
1 . This is an application filed by the Accused to investigate and launch prosecution
against the person responsible for forced vaccination of Accused against his Will.
2 . It is submitted that by Order dated 18.08.2021 this Court pronounced the
judgment and convicted the Accused. On same day, the Accused was taken into
judicial custody. However, before taking to the jail he was taken to the Hospital and
despite his strong refusal/oppose, he is forcefully given the Corona Vaccine by the
concerned Police officials and Doctors. Therefore, necessary action be initiated
against the concern Doctors and Police officials.
3. The Ld. Advocate for Accused placed reliance on following citations:-
i. Common Cause Vs. Union of India reported in
MANU/SC/0232/2018 : (2018) 5 SCC 1
ii. Aruna Ramachandra Shanbaug V. Union of India
reported in MANU/SC/0218/2011 : (2011)4 SCC 454.
iii. K.S. Puttuwamy Vs. Union of India reported in
(2017)70 SCC 7.
iv. Montgomerry Vs. Lanarshire Health Board reported in
MANU/UKSC/0010/2015 : (2015) UK SC 11.
v. Webster Vs. Burton Hospitals NHS Foundation Trust
reported in MANU/UKWA/0059/2017 : (2017) EWCA
Civ 62.
vi. Airedale N.H.S. Trust Vs. Bland reported in
Manu/UKHL/0005/1993 : (1993)1 All ER 821
vii. Meghalaya Vs. State of Meghalaya.
viii. Dinthar Incident Aizawl Vs. State of Mizoram reported
in .
ix. Osbert Khaling Vs. State of Manipur reported in .

1125
ix. Osbert Khaling Vs. State of Manipur reported in .

x. Madan Mili Vs. UOI reported in .
xi. A. Varghese Vs. Union of India reported in .
xii. Master Haridaan Kumar (Minor through Petitioners
Anubhav Kumar and Mr. Abhinav Mukherji) Vs. Union
o f India reported in W.P.(C) 343/2019 & CM Nos.
1604-1605/2019.
xiii. Baby Veda Kalaan & Others Vs. Director of Education &
Others W.P.(C) 350/2019 & CM Nos. 1642-1644/2019.
4 . The Reply is filed by J.J. Marg Police Station. It is submitted that while the
Accused was taken to the Arthur Road Jail, the Jail Authority directed to get RTPCR
Test and vaccination done before admitting the Accused to the Hospital. Therefore, he
was taken for vaccination. It is further submitted that at that time the Accused not
opposed in any manner for vaccination.
5. The Reply is also filed by the Jail Authorities. It is submitted that the Accused was
brought to the Arthur Road Jail on 18.08.2021. However, at that time the Report of
RTPCR was not available. Moreover, the oral instructions were given to verify the
status of vaccination of Accused.
6 . It is further submitted that in view of the directions given by the Hon'ble High
Court in sue motto P.I.L. No. 1/2021 it is mandatory to get the Accused vaccinated
who are more than 45 years. Accordingly, the directions were issued by Maharashtra
State. Moreover, in the Meeting dated 07.05.2021 and 11.05.2021 the High Power
Committee given directions for getting the RTPCR Test and getting the vaccination of
Accused. It is submitted that the vaccination is important looking into the social
health of the prisoners. However, nobody was vaccinated against their wish.
7. Heard Ld. Advocate appearing on behalf of Accused and Ld. SPP. for State.
8 . The present Application is filed by the Accused alleging that he was forcefully
vaccinated when he was remanded to the judicial custody. It is submitted on behalf
of the Ld. Advocate for the Accused that he is against the vaccination and therefore,
he also preferred Writ Petition/appropriate proceeding before the Hon'ble High Court
and same is pending.
9. Per contra, it is the contention of prosecution that vaccination is necessary while
admitting the Accused in judicial custody.
10. Heard Ld. SPP. for State and Ld. Advocate for the Accused.
11. In the present matter on 18.08.2021, I hold Accused guilty and judgment was
suspended for hearing Accused on the point of sentence awarded to the Accused.
1 2 . On that day the Ld. Adv. requested time to argue on the point of sentence
awarded to the Accused. The said prayer came to be allowed. Thereafter, the matter
was adjourned to 21.08.2021. On that day the Accused was not produced from Jail.
Even on that day the Ld. Advocate for Accused prayed time and submitted that he has
to take instructions from Accused. Therefore, the adjournment was granted.
13. Thereafter, the matter was fixed on 24.08.2021. On that day the Accused was
produced from J.C. The Ld. Advocate for Accused instead of arguing on the point of
sentence filed two applications, one is for taking action for forceful vaccination and

1126
secondly for providing copy of Judgment.

1 4 . The Ld. Advocate for Accused argued the application. From the line of his
argument it appears that the Ld. Advocate Oza is against the 'vaccination itself'. He
submitted that he filed Writ Petition before the Hon'ble High Court against the
decision of vaccination making compulsory. He further submitted that the vaccination
is not giving protection from corona. It is to be noted that the Advocate representing
party has to plead the grievance of his party. Therefore, there should be grievance of
party and not of Advocate. Whenever there is right there is remedy. The provisions
are available for safeguarding the right of parties.
1 5 . As stated earlier Ld. Advocate for Accused filed an application for forceful
vaccination on 24.08.2021. The said application is having 33 pages. Therefore, in
order to verify contents of Application I have made inquiry with the Accused in open
Court. At that time the Accused submitted that after he was taken in Jail Custody on
18.08.2021 he had no occasions to interact with Advocate till application is filed. He
further submitted that from 18.08.2021 till 24.08.2021 his advocate neither met him
in jail nor contacted in any manner. So also, during said period his relatives/family
members also not met him in jail.
1 6 . He claims that on 24.08.2021 after 18.08.2021 for the first time he met his
relatives/family members in Court. At that time he disclosed to his relatives/family
members about vaccination given to him. He claims that his family members might
have shared the said information to his Advocate. Therefore, question arises at whose
instructions the present application is drafted which is running 33 pages and
produced on very same day.
17. I have made enquiry with the Accused about his grievance of vaccination. He
stated that he watched some video and therefore, he was not intending to take
vaccination. Therefore, I have made enquiry with Accused whether he brought the
said fact to the notice of the police staff who took him for vaccination, or to the staff
who gave vaccination that he do not wanted to take vaccination, to which, he replied
in negative. Thereafter, I made inquiry whether he brought the said fact to the notice
of jail staff, after he was taken to jail, then he replied in negative. Therefore, it
appears that the Accused not objected while RTPCR Test and vaccination is done.
Therefore, the contention made in the application that accused was forcibly
vaccinated is devoid of any merit. In fact it appears that he is not aware about
contents of present application.
18. Secondly, as per Reply filed by the Superintendent of Jail in view of direction
given in the suo moto PIL No. 1/21 by Hon'ble Chief Justice and in view of guidelines
of High Power Committee it is mandatory to give vaccination for Accused above 45
years. Moreover, as per the policy decision of government and looking into the
possibility of getting infected the fellow prisoners it is necessary to give vaccination.
So also, the vaccination is made compulsory for travelling in local train, plane for
working in any establishment by the Government.
1 9 . So far as grievance of Ld. Advocate Oza for Accused is concerned, same is
pending before the Hon'ble High Court. Therefore, this Court can't give opinion on the
issue of making vaccination mandatory/compulsory.
20. Moreover, the Accused not made any grievance that he was hand cuffed while
taking to the jail. The reasonable force is required even for the safety of Accused in
transmitting him to jail.

1127
21. Considering the reasons stated hereinabove there is no grievance of Accused as

alleged in the application. Therefore, the citation relied by the Accused are not
discussed.
22. As stated earlier, the accused claims that he had not made aware anybody that
he is not intending to take vaccination. Therefore, it can't be said that there was
forceful vaccination. Moreover, it is mandatory to admit the Accused in prison after
vaccination. (Accused above 45 years). It appears that the Ld. Advocate already
pursuing the decision of making vaccination mandatory. Considering the reason
mentioned hereinabove I do not find any merit in the present application. The
Accused is at liberty to approach the proper authority for relaxation of condition of
making vaccination compulsory. This Court is not having any jurisdiction to deal with
the said subject. Therefore, I proceed to pass following order:-
ORDER
The Application filed vide Exh. 56 stands rejected.

1/5/22, 9:50 AM Global Covid Summit
1128
ANNEXURE P-50
Physicians Declaration II - Updated

Global Covid Summit
International Alliance of Physicians and Medical Scientists
GlobalCovidSummit.org
October 29, 2021
VIEW ORIGINAL DECLARATION
WE, THE PHYSICIANS OF THE WORLD, united and loyal to the Hippocratic
Oath, recognizing the imminent threat to humanity brought forth by current
Covid-19 policies, are compelled to declare the following:
WHEREAS, after 20 months of research, millions of patients treated, hundreds

of clinical trials performed and scientific data shared, we have demonstrated and
documented our success and understanding in combating COVID-19;
WHEREAS, in considering the risks vs. benefits of major policy decisions,

thousands of physicians and medical scientists worldwide have reached consensus
on three foundational principles;
NOW THEREFORE, IT IS:
RESOLVED, THAT HEALTHY CHILDREN SHALL NOT BE SUBJECT TO

FORCED VACCINATION (view sun12orting evidence)
• Negligible clinical risks from SARS-CoV-2 infection exist for healthy children
under eighteen.
• Long term safetY. of the current COVID vaccines in children cannot be determined
prior to instituting such policies. Without high-powered, reproducible, long term
safety data, risks to the long-term health status of children remain too high to
support use in healthy children.
• Children risk severe, adverse events from receiving the vaccine. Permanent
physical damage to the brain, heart, immune and reproductive system associated
with SARS-CoV-2 spike protein-based genetic vaccines has been demonstrated in
children.
• Healthy, unvaccinated children are critical to achieving herd immunity. Natural
immunity is proven to tolerate infection, benefiting community protection while
there is insufficient data to assess whether Covid vaccines assist herd immunity.
RESOLVED, THAT NATURALLY IMMUNE PERSONS RECOVERED FROM

SARS-CoV-2 SHALL NOT BE SUBJECT TO ANY RESTRICTIONS OR VACCINE
MANDATES (view su1212orting evidence)
• Natural immunitY. is the most protective, and longest-lasting solution against the
development of COVID-19 disease and its more serious outcomes.
https://doctorsandscientistsdeclaration.org 1/12
1129
• Naturally immune P-ersons are at the lowest risk of transmission, thus should not
be subject to travel, professional, medical or social restrictions.
• Natural immunity_P-rovides the best source of herd immunity, a condition
necessary for eradicating the Covid virus.
RESOLVED, THAT ALL HEALTH AGENCIES AND INSTITUTIONS SHALL

CEASE INTERFERING WITH PHYSICIANS TREATING INDIVIDUAL PATIENTS
(view SUJ!J!Orting evidence)
• Early intervention with numerous, available agents has P-roven to be safe and
effective, and has saved hundreds of thousands of lives.
• No medicine already_given regulatO[Y_g_P-P-roval shall be restricted from "off-label"
use, particularly during this global humanitarian crisis caused by a rapidly
mutating virus, which requires quick to adopt treatment strategies.
• Health agencies shall be P-rohibited from interfering with P-hysicians prescribing
evidence-based treatments they deem necessary, and insurance companies must
cease blocking payments for life-saving medicine prescribed by doctors.
RECOMMENDED LEGISIATIVE OR EXECUTIVE ACTION:
We believe that violating any of these three principles unnecessarily and directly
risks death to our citizens. We hereby recommend the leaders of states, provinces
and nations legislate or take executive action to prohibit the three practices
described above.
IN WITNESS WHEREOF, the undersigned has signed this Declaration.
Sign the Declaration II

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Sign
Co-Signers
Physicians and Medical Scientists
Dr. Ira Bernstein, co-founder, Canadian Covid Care Alliance; lecturer, Dept. of
Family and Community Medicine, University of Toronto
Dr. Paul E. Alexander, clinical epidemiologist, former WHO-PARO and US

HHS consultant/ senior Covid Pandemic advisor
1131
Dr. Pierre Kory, critical care and pulmonary medicine specialist, former Chief of
Critical Care Service and Medical Director of Trauma and Life Support Center at
University of Wisconsin
Dr. Hector Carvallo, former professor of Internal Medicine, Universidad de

Buenos Aires, former Director Ezeiza Hospital, Buenos Aires, Argentina
Dr. Mobeen Syed, physician, computer scientist, CEO of DrBeen Corp (US),
clinical consultant (Pakistan)
Dr. Paul E. Marik, professor of medicine and Chief of Pulmonary and Critical
Care Medicine, Eastern Virginia Medical School
Dr. Flavio Cadegiani, endocrinologist & visiting professor, faculty of Floriano

(FAESF); ad hoc consultant, Brazilian Health Regulatory Agency (Anvisa);
1132
consultant for National Commission for Incorporation of New Technologies,
Devices and Drugs, Brazil
Dr. Marc G. Wathelet, molecular biologist, innate immunology and coronavirus

expert, consultant, Belgium
Dr. Tess Lawrie, Director, The Evidence-Based Medicine Consultancy Ltd;

founder, British Ivermectin Recommendation Development; CEO of non-profit
Ebmcsquared CiC
Dr. Eivind H. Vinjevoll, senior consultant of anesthesiology and intensive care

medicine, chief medical advisor of emergency medicine, Volda, Norway
Dr. Heather Gessling, family medicine doctor in Columbia, Missouri
1133
Dr. Mark McDonald, double board-certified child and adolescent psychiatrist,

Los Angeles, California
Dr. Olufemi Emmanuel Babalola, professor of ophthalmology, IP HOD

Surgery, Bingham University, Jos/Karu, Nigeria
Dr. Richard Urso, scientist, sole inventor of an FDA-approved wound healing

drug, former Chief of Orbital Oncology at MD Anderson Cancer Center
Dr. John Littell, family physician, with practices in Kissimmee and Ocala,
Florida
1134
Dr. Ryan Cole, board-certified pathologist, CEO of Cole Diagnostics, Boise,

Idaho
Dr. Brian Tyson, family medicine doctor, Urgent Care Covid Clinic, Imperial
Valley, California
Prof. Andrea G. Stramezzi, Italy
Dr. Zsuszanna Rago, specialist in coronavirus, primary care; IVERCOV project

leader, University of Debrecen, Hungary
1135
Dr. Robert W. Malone, gene therapy, bio-defense, vaccines and immunology;

discoverer of in-vitro and in-vivo RNA transfection and architect of mRNA vaccine
platform
Dr. Jean-Jacques Rajter, critical care, pulmonary medicine, sleep medicine
Dr. Wong Ang Peng, Malaysian Alliance for Effective Covid Control (MAECC)
Dr. Peter McCullough, clinical cardiologist, preventive cardiology and

advanced lipidology, former vice chief of internal medicine at Baylor University
Medical Center
1136
Dr. Jose Iglesias, associate professor, Hackensack Meridian School of Medicine

at Seton Hall
Dr. GeertVanden Bossche, virology, vaccine R&D, former Sr Ebola Program

Manager, Global Alliance for Vaccines & Immunization (GAVI), former Head of
Vaccine Development Office, German Center for Infection Research
Dr. Li-Meng Yan, independent virologist, former researcher, Hong Kong

University
Dr. Yoav Yehezkelli, lecturer, Tel Aviv University; former director of research
and primary care medicine, Meuhedet Health Services; co-founder of Israeli
epidemic management team
Dr. Catherine L. Lawson, research professor, Institute for Quantitative

Biomedicine, Rutgers University, Piscataway, New Jersey
Dr. Barton Lane, emeritus professor of diagnostic radiology, Stanford

University Medical Center, Palo Alto, California
Dr. Domingo Luis Caceres Ortiz, family medicine specialist, president of the
Medical Foundation of the College of Surgeons of Puerto Rico
Dr. Grace Lu-Yao, professor and vice-chair, Department of Medical Oncology,

Thomas Jefferson University, Philadelphia, Pennsylvania
1137
Dr. Claudio Saliba de Avelar, medical coordinator, Espa«;o Mulher, Pardini
Institute, Belo Horizonte, Brazil
Dr. Claudia Chaufan, professor, Health Policy and Global Health, York
University, Toronto
Dr. Gregory Dembo, director of Transplant Anesthesia, University of

Washington Medical Center, Seattle, Washington
Dr. Paul Carter, orthopedic surgeon, Los Angeles County-USC Medical Center,
California
Dr. Panayiotis A. Ellinas, family medicine, former US Army Lt Colonel and

Army Surgeon General Subject Matter Expert in preventive medicine
Dr. Mark Dunphy, nuclear medicine physician, Memorial Sloan Kettering

Cancer Center, New York, New York
Dr. Brian J. Koos, maternal and fetal medicine, UCLA Medical Center, Los
Angeles, California
Dr. Vladimir Algarin, general practitioner, Carolina, Puerto Rico
Dr. Sandra Bezares, internal medicine specialist, Caguas, Puerto Rico
Dr. Alberto Pupi, professor of clinical pathophysiology, University of Florence

Medical College, Italy
Dr. Thomas A. Johnson, internal medicine, Ascension Medical Group,

Brookfield, Wisconsin
Dr. Orest Stecyk, family medicine, UH Cleveland Medical Center, Cleveland,

Ohio
Dr. Peter Parry, associate professor, child & adolescent psychiatry, The
University of Queensland, Brisbane, Australia
Dr. Giovanni Frajese, endocrinology and cancer research; associate professor,

Applied Medical Technical Sciences, University of Rome "Foro Italico", Rome,
Italy
Dr. Eric Wargotz, Clinical Professor of Pathology & Laboratory Medicine, the
George Washington University School of Medicine, Washington, DC
Dr. Phillip Sirota, Veterans Affairs Health Care System, Phoenix, Arizona
Dr. Donald W. Miller, retired Professor Emeritus of Surgery, former Chief of

Division of Cardiothoracic Surgery, University of Washington School of Medicine,
Seattle, Washington
Dr. Xiaoxu Lin, former microbiologist, Walter Reed Army Institute of Research,
Viral Diseases Branch, former in-theater infectious diseases surveillance lab head,
US Army
https://doctorsandscientistsdeclaration .org 10/12

1138
Dr. R. Duane Cook, thoracic and cardiovascular surgeon, University of Florida
Health
Dr. Sylvia Monserrate Nunez Fidalgo, general practitioner, San Juan, Puerto
Rico
Dr. Ming Chu Wang, Department of Anesthesia, National Taiwan University

Hospital, Taipei, Taiwan
Dr. Ondrej Halgas, biomedical researcher, University of Toronto, Canada
Dr. Mark Kreimer, board certified emergency medicine physician, Brooklyn,

NewYork
Dr. Ram Duriseti, clinical associate professor, Stanford University Division of

Emergency Medicine, Palo Alto, California
Dr. Kraig Lage, diagnostic radiology, University Of Missouri HealthCare,

Columbia, Missouri
Dr. Annie L. Emmick, board certified pediatric specialist, Northwestern

Medicine, Illinois
Dr. Mario Beauregard, neuroscientist, Department of Psychology, University of

Arizona
Dr. Brent Stewart, Emeritus Professor, Diagnostic Physics, University of

Washington School of Medicine, Seattle, Washington
Dr. Andrei N. Tchernitchin, director of Laboratory of Experimental

Endocrinology and Environmental Pathology ICBM, Faculty of Medicine,
University of Chile
Dr Simon J Thornley, public health physician, lecturer and researcher in

epidemiology and biostatistics, University of Auckland, New Zealand
Dr. Spiro P. Pantazatos, Assistant Professor of Clinical Neurobiology

(Psychiatry) at Columbia University, research scientist at New York State
Psychiatric Institute
Dr. Marialuisa Partisani, deputy head, general medicine, HIV infection care
center, Hopitaux Universitaires de Strasbourg, France
Professor Fernando N obre, Medical School University of Lisbon; founder and

President of AMI (International Medical Assistance Foundation); recipient of the
Legion d'Honneur
Dr. Allesandro Santin, professor of obstetrics, gynecology, and reproductive

sciences, Yale School of Medicine; Disease Aligned Research team leader, Yale
Cancer Center
Dr. James Geiger, surgical critical care and pediatric surgery, University of
Michigan Health System; Director of Pediatric Trauma and Associate Director for
https://doctorsandscientistsdeclaration .org 11/12

1139
Surgical Services, Pediatric Intensive Care Unit at St. Vincent Medical Center
Dr. Marie Kuffner, former professor of clinical anesthesiology and former chief
of staff, UCLA Medical Center; past president of the California Medical Association
And thousands more physicians, medical scientists and researchers from around
the globe.
Global Covid Summit
1/5/22, 9:48 AM Supporting Evidence - Global Covid Summit
1140
Supporting Evidence
Early COVID Treatment Works
1. A ComP-arative Study on lvermectin-Do~_cycline and Hydroxychloroguine-

Azithromycin TheraP-y on COVID-19 Patients, Abu Taiub Mohammed Mohiuddin
Chowdhury, Mohammad Shahbaz, Md Rezaul Karim, Jahirul Islam, Guo Dan,
Shuixiang He
2. Early initiation of P-rOP-hylactic anticoagulation for P-revention of coronavirus
disease 2019 mortality in P-atients admitted to hosP-ital in the United States:
cohort study, Matthew S Freiberg, et al
3. lvermectin in combination with doxy_cycline for treating COVID-19 symP-toms: a
randomized trial, Reaz, Mahmud, Rahman, Mujibur, lftikher, Alam, Ahmed, Kazi
Gias Uddin, Kabir, A. K. M. Humayon, S. K. Jakaria Been, Mohammad Aftab,
Mohammad Monirul, Anindita Das, Mohammad Mahfuzul, Mohammad Abdullah,
Mohammad Zaid
4. The Role of Steroids in the Management of COVID-19 Infection
Zayar Lin, Wai Hnin Phyu, Zin Hnin Phyu, and Tin Zar Mon
5. Antithrombotic TheraP-Y to Ameliorate ComP-lications of COVID-19, Brett L
Houston et al
6. COVID-19 outP-atients: early risk-stratified treatment with zinc P-lus low-dose
bydroxychloroguine and azithromycin: a retrosP-ective case series study, Roland
Derwand, Martin Scholz, Vladimir Zelenko
7. lvermectin Treatment May lmP-rove the Prognosis of Patients With COVID-19,
Saiful Islam Kha, Sakirul Islam Khan, Chitto Ranjan Debnath, Progga Nanda Nath,
Mamun Al Mahtab, Hiroaki Nabeka, Seiji Matsuda, Sheikh Mohammad Fazle
Akbar
8. lvermectin and the odds of hosP-italization due to COVID-19: evidence from a
guasi-exP-erimental analysis based on a P-Ublic intervention in Mexico City, Jose
Merino, Victor Hugo Borja, Oliva Lopez, Jose Alfredo Ochoa, Eduardo Clark, Lila
Petersen, Saul Caballero
9. Evaluation of lvermectin as a Potential Treatment for Mild to Moderate COVID-
19: A Double-Blind Randomized Placebo Controlled Trial in Eastern India,
Ravikirti, Roy, R., Pattadar, C., Raj, R., Agarwal, N., Biswas, B., Manjhi, P. K., Rai, D.
K., Shyama, Kumar, A., & Sarfaraz, A.
10. Hydroxychloroguine for P-rOP-hylaxis and treatment of COVID-19 in health-care
workers, Simova T., Vekov J., Krasnaliev V., Kornovski P., Bozhinov
11. Effica~ of a Low Dose of Melatonin ••• in HosP-italized Patients with COVID-19
ell , GholamHossein Alishiri
12. The ten reasons why corticosteroid theraP-y reduces mortality in severe COVID-19
ell Yaseen M. Arabi, George P. Chrousos & G. Umberto Meduri
13. Early short course corticosteroids in hosP-italized P-atients with COVID-19 ell
(Multi-center quasi-experimental study), Mayur S. Ramesh et al.
14. Doxy_cycline and Hydroxychloroguine as Treatment for High-Risk COVID-19
Patients: ExP-erience from Case Series of 54 Patients in Long-Term Care Facilities ,
Ahmad I. et al.
15. Fluvoxamine vs Placebo and Clinical Deterioration in OutP-atients With
.SymP-tomatic COVID-19. A Randomized Clinical Trial, Lenze E. et al.
16. Possible TheraP-eutic Effects of Adjuvant Quercetin SUP-P-lementation Against
Early-Stage COVID-19 Infection: A ProsP-ective, Randomized, Controlled, and
https://doctorsandscientistsdeclaration.org/home/supporting-evidence/#recovered 1/6
1141
OP-en-Label Study, Di Pierro F. et al.
17. Antivirals With Adjunctive Corticosteroids Prevent Clinical Progression of Early
Coronavirus 2019 Pneumonia: A RetrosP-ective Cohort Study, Ooi ST et al.
18. Zinc sulfate in combination with a zinc ionoP-hore may imP-rove outcomes in
hosP-italized COVID-19 P-atients, Carlucci P. et al.
19. SARS-CoV-2 P-OSitivity rates associated with circulating 25-hydroxyvitamin D
levels 9 , Kaufman H. et al.
20. Hydroxychloroguine and Azithromycin Treatment of HosP-italized Patients
Infected with SARS-CoV-2 in Senegal from March to October 2020, Taieb F. et al.
21. Doxy_cycline and Hydroxychloroguine as Treatment for High-Risk COVID-19
Patients: ExP-erience from Case Series of 54 Patients in Long-Term Care Facilities,
Ahmad I. et al.
22. Hydroxychloroguine in Early Treatment of High-Risk COVID-19 OutP-atients:
Efficacy and Safety Evidence, Risch, Harvey.
23. Metaanalyses and Aggregated lvermectin Studies - 1
24. Metaanalyses and Aggregated Hydroxychloroguin Studies - 1
25. Metaanalyses and Aggregated lvermectin Studies - 2
Vaccinating Children Means Unnecessary Risks

1. Deaths by Age U.S.: 0-18, Centers for Disease Control (CDC).
2. Why is COVID-19 less severe in children? A review of the P-rOP-OSed mechanisms
underlying the age-related difference in severity of SARS-CoV-2 infections, Petra
Zimmermann, Nigel Curtis
3. SARS-CoV-2 mRNA Vaccination-Associated Myocarditis in Children Ages 12-17: A
Stratified National Database Analysis, Tracy Beth H0eg, Allison Krug, Josh
Stevenson, John Mandrola
4. Characteristics and Outcomes of Children With Coronavirus Disease 2019
.(COVID-19) Infection Admitted to US and Canadian Pediatric Intensive Care Units,
Lara S. Shekerdemian, MD, MHA; Nabihah R. Mahmood, MD; Katie K. Wolfe, MD;
et al.
5. State-Level Data on COVID-19 child mortality, American Academy of Pediatrics
6. Deaths in Children and Young PeoP-le in England following SARS-CoV-2 infection
during the first P-andemic year: a national study using linked mandatory child
death reP-orting data, C. Smith, D. Odd, R Harwood, J. Ward, M. Linney, M. Clark, D.
Hargreaves, SN Ladhani, E. Draper, PJ Davis, SE Kenny, E. Whittaker, K. Luyt, RM
Viner, LK Fraser
7. Risk factors for intensive care admission and death amongst children and young
P-eOP-le admitted to hosP-ital with COVID-19 and PIMS-TS in England during the
first P-andemic year, JL Ward, R. Harwood, C. Smith, S. Kenny, M. Clark, PJ Davis,
ES Draper, D. Hargreaves, S. Ladhani, M. Linney, K. Luyt, S. Turner, E. Whittaker,
LK Fraser, RM Viner
8. Shedding of Infectious SARS-CoV-2 DesP-ite Vaccination, Kasen K. Riemersma,
Brittany E. Grogan, Amanda Kita-Yarbro, Peter J. Halfmann, Hannah E. Segaloff,
Anna Kocharian, Kelsey R. Florek, Ryan Westergaard, Allen Bateman, Gunnar E.
Jeppson, Yoshihiro Kawaoka, David H. O'Connor, Thomas C. Friedrich, Katarina M.
Grande
9. UK Government Recommendations on Vaccinating Children - Ages 12-15
10. ComP-arison of children and young_P-eOP-le admitted with SARS-CoV-2 across the
UK in the first and second P-andemic waves: P-r0SP-ective multicentre
observational cohort study, Semple et al.
1/5/22, 9 :48 AM Supporting Evidence - Global Covid Summit
1142
11. Distinct antibody resP-onses to SARS-CoV-2 in children and adults across the
COVID-19 clinical SP-ectrum, Stuart P. Weisberg, Thomas J. Connors, Donna L.
Farber
12. OP-en Schools, Covid-19, and Child and Teacher Morbidity in Sweden, Jonas F.
Ludvigsson, Lars Engerstrom, Charlotta Nordenhall, Emma Larsson
13. Transient Cardiac Injury in Adolescents Receiving the BNT162b2 mRNA Vaccine,
Ori Snapiri, Chen Rosenberg Danziger, Nina Shirman, Avichai Weissbach,
Alexander Lowenthal, ltay Ayalon, Dganit Adam, Havatzelet Yarden-Bilavsky,
Efraim Bilavsky
14. Myocarditis following COVID-19 mRNA vaccination, Saif Abu Mouch, Ariel
Roguin, Elias Hellou, Amorina lshai, Uri Shoshan, Lamis Mahamid, Marwan Zoabi,
Marina Aisman, Nimrod Goldschmid, Noa Berar Yanay
15. Myocarditis following COVID-19 vaccination, Albert, E., Aurigemma, G., Saucedo,
J., Gerson, D.S.
16. Acute Myocardial Infarction and Myocarditis following COVID-19 Vaccination,
Aye, Y. N., Mai, A. S., Zhang, A., Lim, 0. Z. H., Lin, N., Ng, C. H., ... Chew, N. W. S.
17. Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting, Barda,
N., Dagan, N., Ben-Shlomo, Y., Kepten, E., Waxman, J., Ohana, R., ... Balker, R. D.
18. COVID19 Vaccine for Adolescents. Concern about Myocarditis and Pericarditis,
Calcaterra, G., Mehta, J. L., de Gregorio, C., Butera, G., Neroni, P., Fanos, V.,
Bassareo, P.
19. Multisystem inflammatory~yndrome in a male adolescent after his second Pfizer-
BioNTech COVID-19 vaccine, Chai, Q., Nygaard, U., Schmidt, R. C., Zaremba, T.,
Moller, A. M., & Thorvig, C. M.
20. Occurrence of acute infarct-like myocarditis following COVID-19 vaccination: just
an accidental co-incidence or rather vaccination-associated autoimmune
myocarditis?, Chamling, B., Vehof, V., Drakos, S., Weil, M., Stalling, P., Vahlhaus,
C., ... Yi lmaz, A.
21. Myocarditis and Pericarditis Following mRNA COVID-19 Vaccination: What Do We
Know So Far?, Das, B. B., Moskowitz, W. B., Taylor, M. B., Palmer, A.
22. BiOP-SY.:P-roven lymP-hog:tic myocarditis following first mRNA COVID-19
vaccination in a 40-year-old male: case reP-ort, Ehrlich, P., Klingel, K., Ohlmann-
Knafo, S., Huttinger, S., Sood, N., Pickuth, D., & Kindermann, M.
2 3. Myocarditis should be considered in those with a troP-onin rise and unobstructed
coronary arteries following Pfizer-BioNTech COVID-19 vaccination, loannou, A.
24. Myocarditis Following COVID-19 Vaccination, Isaak, A., Feisst, A., & Luetkens, J.
A.
25. Myocarditis following COVID-19 vaccination, Kaul, R., Sreenivasan, J., Goel, A.,
Malik, A., Bandyopadhyay, D., Jin, C., ... Panza, J. A.
26. Patients With Acute Myocarditis Following mRNA COVID-19 Vaccination, Kim, H.
W., Jenista, E. R., Wendell, D. C., Azevedo, C. F., Campbell, M. J., Darty, S. N., . . .
Kim, R. J.
27. Cardiac Imaging of Acute Myocarditis Following COVID-19 mRNA Vaccination,
Kim, I. C., Kim, H., Lee, H.J., Kim, J. Y., & Kim, J. Y.
28. Why are we vaccinating children against COVID-19?, Kostoff, R. N., Calina, D.,
Kanduc, D., Briggs, M. B., Vlachoyiannopoulos, P., Svistunov, A. A., & Tsatsakis, A.
29. Thrombog:toP-enia following Pfizer and Moderna SARS-CoV-2 vaccination, Lee, E.
J., Cines, D. B., Gernsheimer, T., Kessler, C., Michel, M., Tarantino, M. D., . . . Bussel,
J. B.
30. Myocarditis following COVID-19 vaccination - A case series, Levin, D., Shimon,
G., Fadlon-Derai, M., Gershovitz, L., Shovali, A., Sebbag, A., ... Gordon, B.
1143
31. Vaccine advisory committee must be more transP-arent about decisions, Mahase,
E.
32. COVID vaccines cut the risk of transmitting Delta - but not for Long, Mallapaty, S.
33. Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel, Mevorach,
D., Anis, E., Cedar, N., Bromberg, M., Haas, E. J., Nadir, E., .. . Alroy-Preis, S.
34. COVID-19 Vaccine-Induced Thrombosis and ThromboMOP-enia: First Confirmed
Case from India, Mishra, K., Barki, 5., Pattanayak, 5., Shyam, M., Sreen, A., Kumar,
S., & Kotwa l, J.
35. Cardiovascular magnetic resonance findings in young adult P-atients with acute
myocarditis following mRNA COVID-19 vaccination: a case series, Patel, Y. R.,
Louis, D. W., Atalay, M., Agarwal, 5., & Shah, N. R.
36. A ReP-ort on Myocarditis Adverse Events in the U.S. Vaccine Adverse Events
ReP-orting_.System (YAERS) in Association with COVID-19 Injectable Biological
Products, Rose, J., & McCullough, P.A.
37. Transient Cardiac Injury in Adolescents Receiving the BNT162b2 mRNA COVID-19
Vaccine, Snapiri, 0., Rosenberg Danziger, C., Shirman, N., Weissbach, A.,
Lowenthal, A., Ayalon, I., ... Bilavsky, E.
38. Myocarditis after Covid-19 Vaccination in a Large Health Care Organization,
Witberg, G., Barda, N., Hoss, 5., Richter, I., Wiessman, M., Aviv, Y., ... Kornowski,
R.
(OVID-Recovered Immunity is Durable

1. One-year sustained cellular and humoral immunities of COVID-19 convalescents,
Jie Zhang, Hao Lin, Beiwei Ye, Min Zhao, Jianbo Zhan, et al.
2. ComP-aring SARS-CoV-2 natural immuni:ty to vaccine-induced immunity_;
reinfections versus breakthrough infections, Sivan Gazit, Roei Shlezinger, Ga lit
Perez, Roni Lotan, Asaf Peretz, Amir Ben-Tov, Dani Cohen, Khitam Muhsen,
Gabriel Chadick, Tal Patalon.
3. Shedding of Infectious SARS-CoV-2 DesP-ite Vaccination, Kasen K. Riemersma,
Brittany E. Grogan, Amanda Kita-Yarbro, Gunnar E. Jeppson, David H. O'Connor,
Thomas C. Friedrich, Katarina M. Grande
4. Necessi:ty of COVID-19 vaccination in P-reviously infected individuals, Nabin K.
Shrestha, Patrick C. Burke, Amy S. Nowacki, Paul Terpeluk, Steven M. Gordon
5. Large-scale study of antibody titer decay following BNT162b2 mRNA vaccine or
SARS-CoV-2 infection, Ariel Israel, Yotam Shenhar, llan Green, Eugene Merzon,
Avivit Golan-Cohen, Alejandro A Schaffer, Eytan Ruppin, Shlomo Vinker, Eli
Magen.
6. Discrete Immune ResP-onse Signature to SARS-CoV-2 mRNA Vaccination Versus
Infection, Ellie lvanova, Joseph Devlin, et al.
7. SARS-CoV-2 infection induces Long-Lived bone marrow P-Lasma cells in humans,
Jackson S. Turner, Wooseob Kim, Elizaveta Kalaidina, Charles W. Goss, Adriana M.
Rauseo, Aaron J. Schmitz, Lena Hansen, Alem Haile, Michael K. Klebert, Iskra
Pusic, Jane A. O'Halloran, Rachel M. Presti, Ali H. Ellebedy.
8. Longitudinal analysis shows durable and broad immune memory after SARS-CoV-
2 infection with P-ersisting antibody resP-onses and memory B and T cells, Kristen
W. Cohen, Susanne L. Linderman, Zoe Moodie, Julie Czartoski, Lilin Lai, Grace
Mantus, Carson Norwood, Lindsay E. Nyhoff, Venkata Viswanadh Edara, et al.
9. Incidence of Severe Acute ResP-iratory....Syndrome Coronavirus-2 infection among
P-reviously infected or vaccinated emP-Loyees, N Kojima, A Roshani, M Brobeck, A
Baca,JD Klausner
1144
10. Single cell P-rofiling of T and B cell reP-ertoires following SARS-CoV-2 mRNA
vaccine, Suhas Sureshchandra, Sloan A. Lewis, Brianna Doratt, Allen Jankeel,
lzabela lbraim, llhem Messaoudi
11. Immunological memorY. to SARS-CoV-2 assessed for UP- to 8 months after
infection, Jennifer M. Dan, Jose Mateus, Yu Kato, Kathryn M. Hastie, et al.
12. mRNA vaccine-induced T cells resP-ond identically to SARS-CoV-2 variants of
concern but differ in Longevity and homing.P-rOP-erties deP-ending on P-rior
infection status, Jason Neidleman, Xiaoyu Luo, Matthew McGregor, Guorui Xie,
Victoria Murray, Warner C. Greene, Sulggi A. Lee, Nadia R. Roan.
13. Persistence of neutralizing antibodies a year after SARS-CoV-2 infection, Anu
Haveri, Nina Ekstrom, Anna Solastie, Camilla Virta, Pamela Osterlund, Elina
lsosaari, Hanna Nohynek, Arto A. Palmu, Merit Melin.
14. Quantifying the risk of SARS-CoV-2 reinfection over time, Eamon O Murchu,
Paula Byrne, Paul G. Carty, et al.
15. SARS-CoV-2 antibody.:P-OSitivity_P-rotects against reinfection for at Least seven
months with 95% effica~. Laith J. Abu-Raddad, Hiam Chemaitelly, Peter Coyle,
Joel A. Malek.
16. Natural immunity~gainst COVID-19 significantly reduces the risk of reinfection:
findings from a cohort of sero-survey_P-articiP-ants, Bijaya Kumar Mishra,
Debdutta Bhattacharya, Jaya Singh Kshatri, Sanghamitra Pati
17. Protection of P-revious SARS-CoV-2 infection is similar to that of BNT162b2
vaccine P-rotection: A three-month nationwide exP-erience from Israel, Vair
Goldberg, Micha Mandel, Yonatan Woodbridge, Ronen Fluss, llya Novikov, Rami
Yaari, Arnona Ziv, Laurence Freedman, Amit Huppert, et al.
18. Immune MemorY. in Mild COVID-19 Patients and UnexP-osed Donors Reveals
Persistent T Cell ResP-onses After SARS-CoV-2 Infection, Asgar Ansari, Rakesh
Arya, Shilpa Sachan, Someshwar Nath Jha, Anurag Kalia, Anupam Lall, Alessandro
Sette, et al.
19. Live virus neutralisation testing in convalescent P-atients and subjects vaccinated
~gainst 19A, 20B, 201/501 Y.V1 and 20H/501 Y.V2 isolates of SARS-CoV-2,
Claudia Gonzalez, Carla Saade, Antonin Bal, Martine Valette, et al.
20. SARS-CoV-2-sP-ecific T cell memorY. is sustained in COVID-19 convalescent
P-atients for 10 months with successful develoP-ment of stem cell-Like memorY. T
cells, Jae Hyung Jung, Min-Seok Rha, Moa Sa, Hee Kyoung Choi, Ji Hoon Jeon, et
al, Nature Communications.
21. Antibody Evolution after SARS-CoV-2 mRNA Vaccination, Alice Cho, Frauke
Muecksch, Dennis Schaefer-Babajew, Zijun Wang, et al.
22. Differential effects of the second SARS-CoV-2 mRNA vaccine dose on T cell
immunity in na"ive and COVID-19 recovered individuals, Carmen Camara, Daniel
Lozano-Ojalvo, Eduardo Lopez-Granados. et al.
23. Anti-sP-ike antibody resP-onse to natural SARS-CoV-2 infection in the general
P-OP-ulation, Jia Wei, Philippa C. Matthews, Nicole Stoesser, et al.
24. SARS-CoV-2 Natural Antibody ResP-onse Persists for at Least 12 Months in a
Nationwide Study From the Faroe Islands. Maria Skaalum Petersen, Cecilie Bo
Hansen, Marnar Frfheim Kristiansen, et al.
25. SecondarY. household transmission of SARS-CoV-2 among children and
adolescents: clinical and eP-idemiological asP-ects, Afonso, E. T., Marques, S. M.,
Costa, L. D. C., Fortes, P. M., Peixoto, F., Bichuetti-Silva, D. C., .. . Guimaraes, R. A.
26. The role of children and adolescents in the transmission of SARS-CoV-2 virus
within family clusters: A Largg_P-OP-Ulation study from Oman, Alqayoudhi, A., Al
Manji, A., Al Khalili, 5., Al Maani, A., Alkindi, H., Alyaquobi, F., ... Al-Abri, S.
1145
27. A school outbreak of P-andemic (H1N1) 2009 infection: assessment of secondary
household transmission and the P-rotective role of oseltamivir, Leung, Y. H., Li, M.
P., & Chuang, 5. K.
28. Household transmission of SARS-CoV-2: a systematic review and meta-analysis
of secondary attack rate, Madewell, Z. J., Yang, Y., Longini, I. M., Jr., Halloran, M.
E., & Dean, N. E.
29. Can children of the SP-utni kV vaccine reciP-ients become symP-tomatic?,
Mehraeen, E., 5eyedAlinaghi, 5., & Karimi, A.
Global Covid Summit
Z-16025/05/2012 Imm p/f 1146
Government of India ANNEXURE P-51
Immunization Division
Nirman Bhawan, New Delhi
Date: 05th November 2021
Causality assessment results of 22 reported Serious Adverse Events Following

Immunization (AEFI) cases following COVID-19 vaccination approved by National AEFI
Committee on 18th October 2021.
The Immunization Division, MOHFW has taken several steps to strengthen the national
AEFI surveillance system for COVID-19 vaccinations. Considering the importance and critical
nature of the task, steps were taken to include medical specialists, cardiologists, neurologists,
pulmonary medicine specialists, obstetrician-gynecologist as members of the causality
assessment sub-committee at the national level. A Special Group has been framed to conduct
causality assessment of AEFIs following COVID-19 vaccination. The results of causality
assessment done by this Special Group is discussed in the national AEFI committee meeting
for final approval.
The results of the causality assessment for 22 cases completed on 18th October 2021 after
thorough review, deliberation and approval by the National AEFI Committee is given in the
annexure (anonymized line list of the causality assessment done by the National AEFI
Committee).
09 out of 22 cases for which Causality assessment has been done were found to have
consistent causal association to vaccination. Of these 09 cases, 05 cases were vaccine
product related reaction and 04 cases were immunization anxiety related reaction. 12 cases
have inconsistent causal association to vaccination (coincidental - not linked to vaccination),
including 05 death cases. There was 01 case (death) in indeterminate category.
Vaccine product related reactions are expected reactions that can be attributed to
vaccination based on current scientific evidence. Examples of such reactions are allergic
reactions and anaphylaxis, etc.
Indeterminate reactions are reactions which have occurred soon after vaccination but
there is no definitive evidence in current literature or clinical trial data that this event could
have been caused due to the vaccine. Further observations, analysis and studies are required.
Unclassifiable events are events which have been investigated but there is not enough
evidence for assigning a diagnosis due to missing crucial information. When this relevant
information becomes available, the case may be reconsidered for causality assessment.
Coincidental events are events that are reported following immunization but for which a
clear cause other than vaccination is found on investigation.
Overall, the benefits of vaccination are overwhelmingly greater than the small risk of
harm. However, as a measure of utmost precaution, all emerging signals of harm are being
constantly tracked and reviewed periodically.
1147
CAUSALITY CLASSIFICATION OF 22 AEFI CASES APPROVED BY THE NATIONAL AEFI COMMITTEE
ON 18 OCT 2021- (NEW DELHI)
D - UNCLASSIFIABLE
DATE OF
DATE OF
S. AGE (IN REASON FOR CLASSIFICATION* BY APPROVAL BY
NATIONAL ID YEAR SEX VACCINATION VACCINE DIAGNOSIS
NO. YEARS) REPORTING/ OUTCOME NATIONAL AEFI COMMITTEE NATIONAL AEFI
(DD/MM/YYYY)
COMMITTEE
HOSPITALIZED AND
1 IND(CO-AEFI)KABMP21002 2021 42 FEMALE 18-01-2021 COVISHIELD ANXIETY REACTION A4 18-10-2021
RECOVERED
HOSPITALIZED AND
2 IND(CO-AEFI)KACDG21001 2021 50 FEMALE 18-01-2021 COVISHIELD ANXIETY REACTION A4 18-10-2021
RECOVERED
HOSPITALIZED AND
3 IND(CO-AEFI)KEKZK21001 2021 44 FEMALE 21-01-2021 COVISHIELD FEVER, HEADACHE AND VOMITING A1 18-10-2021
RECOVERED
HOSPITALIZED AND
4 IND(CO-AEFI)MPMDS21001 2021 26 MALE 16-01-2021 COVISHIELD ANXIETY REACTION A4 18-10-2021
RECOVERED
HOSPITALIZED AND
5 IND(CO-AEFI)ORBGH21003 2021 28 FEMALE 16-01-2021 COVISHIELD PNEUMONIA (COVID POSITIVE) C 18-10-2021
RECOVERED
HOSPITALIZED AND
6 IND(CO-AEFI)TSRJS21002 2021 36 FEMALE 18-01-2021 COVISHIELD NON CARDIAC CHEST PAIN C 18-10-2021
RECOVERED
7 IND(CO-AEFI)MPBHP21001 2021 45 MALE DEATH 17-02-2021 COVISHIELD COVID 19 DISEASE C 18-10-2021
HOSPITALIZED AND CVA (MULTIPLE INFARCTS) IN KNOWN CASE OF TAKAYASU

8 IND(CO-AEFI)ORGJM21001 2021 30 FEMALE 19-02-2021 COVISHIELD C 18-10-2021
RECOVERED ARTERITIS
HOSPITALIZED AND
9 IND(CO-AEFI)ORSUN21004 2021 25 MALE 18-01-2021 COVISHIELD ALLERGIC RASH A1 18-10-2021
RECOVERED
HOSPITALIZED AND CVA (ACUTE ISCHEMIC INFARCT- LEFT BASAL GANGLIA)

10 IND(CO-AEFI)WBDMD21007 2021 45 FEMALE 02-03-2021 COVISHIELD C 18-10-2021
RECOVERED WITH HYPERTENSION
11 IND(CO-AEFI)WBMBD21004 2021 21 FEMALE SEVERE AND RECOVERED 25-01-2021 COVISHIELD ANAPHYLAXIS A1 18-10-2021
ACUTE CORONARY SYNDROME WITH UNDERLYING

12 IND(CO-AEFI)WBSPG21001 2021 76 MALE DEATH 09-03-2021 COVISHIELD C 18-10-2021
DIABETES MELLITUS, HYPERTENSION AND COPD
Page 1 of 2
1148
ON 18 OCT 2021- (NEW DELHI)
D - UNCLASSIFIABLE
DATE OF
DATE OF
S. AGE (IN REASON FOR CLASSIFICATION* BY APPROVAL BY
NATIONAL ID YEAR SEX VACCINATION VACCINE DIAGNOSIS
NO. YEARS) REPORTING/ OUTCOME NATIONAL AEFI COMMITTEE NATIONAL AEFI
(DD/MM/YYYY)
COMMITTEE
13 IND(CO-AEFI)UPMZP21001 2021 46 MALE DEATH 15-03-2021 COVISHIELD HEMORRHAGIC CVA WITH HYPERTENSION C 18-10-2021
HOSPITALIZED AND
14 IND(CO-AEFI)KARMN21001 2021 36 FEMALE 20-01-2021 COVISHIELD ACUTE GASTRITIS C 18-10-2021
RECOVERED
LOBAR PNEUMONIA WITH EMPHYSEMA WITH
PULMONARY ALVEOLAR PROTEINACEOUS WITH
15 IND(CO-AEFI)WBBDN21005 2021 78 MALE DEATH 23-03-2021 COVISHIELD C 18-10-2021
INTERSTITIAL LUNG DISEASE WITH PROLIFERATIVE
GLOMERULONEPHRITIS
HOSPITALIZED AND
16 IND(CO-AEFI)HAKNL21003 2021 45 FEMALE 29-01-2021 COVISHIELD ANAPHYLAXIS A1 18-10-2021
RECOVERED
HOSPITALIZED AND
17 IND(CO-AEFI)WBDJL21010 2021 73 FEMALE 18-03-2021 COVISHIELD POST STROKE EPILEPSY C 18-10-2021
RECOVERED
HOSPITALIZED AND
18 IND(CO-AEFI)KACBP21003 2021 27 FEMALE 19-02-2021 COVISHIELD EPILEPSY C 18-10-2021
RECOVERED
SUDDEN CARDIAC DEATH WITH DIABETES MELLITUS AND

19 IND(CO-AEFI)GUGNR21003 2021 48 FEMALE DEATH 25-03-2021 COVISHIELD C 18-10-2021
CORONARY ARTERY DISEASE
HOSPITALIZED AND
20 IND(CO-AEFI)GOGOS21018 2021 20 FEMALE 27-06-2021 COVISHIELD ANAPHYLAXIS A1 18-10-2021
RECOVERED
HOSPITALIZED AND
21 IND(CO-AEFI)GUGNR21006 2021 21 FEMALE 27-07-2021 COVISHIELD VASOVAGAL REACTION A4 18-10-2021
RECOVERED
22 IND(CO-AEFI)TNCBE21001 2021 20 FEMALE DEATH 08-06-2021 COVISHIELD MULTISYSTEM INFLAMMATORY SYNDROME OF CHILDREN B1 18-10-2021
*Covid vaccine is a new vaccine. The causality may change as more information become available.
Verified by Dr Anil Gurtoo and Dr Anju Seth on 25th October 2021
Page 2 of 2
Z-16025/05/2012 Imm p/f 1149
Government of India ANNEXURE P-52
Immunization Division
Nirman Bhawan, New Delhi
Date: 07th December 2021
Causality assessment results of 178 reported Serious Adverse Events Following

Immunization (AEFI) cases following COVID-19 vaccination approved by National AEFI
Committee on 22nd November 2021.
The Immunization Division, MoHFW has taken several steps to strengthen the national
AEFI surveillance system for COVID-19 vaccinations. Considering the importance and critical
nature of the task, steps were taken to include medical specialists, cardiologists, neurologists,
pulmonary medicine specialists, obstetrician-gynecologist as members of the causality
assessment sub-committee at the national level. A Special Group has been framed to conduct
causality assessment of AEFIs following COVID-19 vaccination. The results of causality
assessment done by this Special Group is discussed in the national AEFI committee meeting
for final approval.
The results of the causality assessment for 178 cases completed on 22nd November 2021
after thorough review, deliberation and approval by the National AEFI Committee is given in
the annexure (anonymized line list of the causality assessment done by the National AEFI
Committee).
67 out of 178 cases for which Causality assessment has been done were found to have
consistent causal association to vaccination. Of these 67 cases, 52 cases were vaccine
product related reaction including 04 deaths and 15 cases were immunization anxiety related
reaction. 77 cases have inconsistent causal association to vaccination (coincidental - not
linked to vaccination), including 33 death cases. 30 cases were in indeterminate category
including 03 death cases. There were 04 cases in unclassifiable category, including 03 death
cases.
Vaccine product related reactions are expected reactions that can be attributed to
vaccination based on current scientific evidence. Examples of such reactions are allergic
reactions and anaphylaxis, etc.
Indeterminate reactions are reactions which have occurred soon after vaccination but
there is no definitive evidence in current literature or clinical trial data that this event could
have been caused due to the vaccine. Further observations, analysis and studies are required.
Unclassifiable events are events which have been investigated but there is not enough
evidence for assigning a diagnosis due to missing crucial information. When this relevant
information becomes available, the case may be reconsidered for causality assessment.
Coincidental events are events that are reported following immunization but for which a
clear cause other than vaccination is found on investigation.
Overall, the benefits of vaccination are overwhelmingly greater than the small risk of
harm. However, as a measure of utmost precaution, all emerging signals of harm are being
constantly tracked and reviewed periodically.
1150
ON 22 NOV 2021- (NEW DELHI)
D - UNCLASSIFIABLE
DATE OF DATE OF APPROVAL

S. AGE (IN CLASSIFICATION* BY
NATIONAL ID YEAR SEX REASON FOR REPORTING/ OUTCOME VACCINATION VACCINE DIAGNOSIS BY NATIONAL AEFI
NO. YEARS) NATIONAL AEFI COMMITTEE
(DD/MM/YYYY) COMMITTEE
1 IND(CO-AEFI)CGMMD21002 2021 44 FEMALE HOSPITALIZED & RECOVERED 30-01-2021 COVISHIELD ACUTE TRANSVERSE MYELITIS B1 22-Nov-21
2 IND(CO-AEFI)HAJND21001 2021 35 FEMALE SEVERE & RECOVERED 23-01-2021 COVISHIELD FACIAL PALSY B1 22-Nov-21
3 IND(CO-AEFI)KASHI21002 2021 35 FEMALE HOSPITALIZED & RECOVERED 25-01-2021 COVISHIELD GUILLAIN BARRE SYNDROME B1 22-Nov-21
SEIZURE (KNOWN PATIENT OF SEIZURES AND WAS ON
4 IND(CO-AEFI)KAGBG21001 2021 23 FEMALE HOSPITALIZED & RECOVERED 05-02-2021 COVISHIELD C 22-Nov-21
TAPERING DOSE OF PHENYTOIN)
5 IND(CO-AEFI)MPSVP21001 2021 23 FEMALE HOSPITALIZED & RECOVERED 27-01-2021 COVISHIELD ANAPHYLAXIS A1 22-Nov-21
6 IND(CO-AEFI)MHBMC21009 2021 42 FEMALE HOSPITALIZED & RECOVERED 25-01-2021 COVISHIELD COVID INFECTION C 22-Nov-21
7 IND(CO-AEFI)PDPNY21001 2021 47 FEMALE HOSPITALIZED & RECOVERED 09-02-2021 COVISHIELD ANXIETY REACTION A4 22-Nov-21
8 IND(CO-AEFI)PBSAN21007 2021 33 MALE HOSPITALIZED & RECOVERED 16-01-2021 COVISHIELD FEVER A1 22-Nov-21
9 IND(CO-AEFI)SIEST21003 2021 29 FEMALE HOSPITALIZED & RECOVERED 19-01-2021 COVISHIELD ANAPHYLAXIS A1 22-Nov-21
10 IND(CO-AEFI)UAHRD21001 2021 32 FEMALE HOSPITALIZED & RECOVERED 16-01-2021 COVISHIELD ANAPHYLAXIS A1 22-Nov-21
11 IND(CO-AEFI)WBRMH21002 2021 37 MALE SEVERE & RECOVERED 22-01-2021 COVISHIELD FEVER A1 22-Nov-21
12 IND(CO-AEFI)WBHGL21001 2021 48 FEMALE HOSPITALIZED & RECOVERED 17-02-2021 COVISHIELD ANAPHYLAXIS A1 22-Nov-21
ACUTE ISCHAEMIC THROMBOEMBOLIC INFARCT IN A
13 IND(CO-AEFI)TSMBR21001 2021 36 FEMALE HOSPITALIZED & RECOVERED 16-02-2021 COVISHIELD KNOWN CASE OF DIABETES MELLITUS AND RHEUMATIC C 22-Nov-21
HEART DISEASE
THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME LIKE
14 IND(CO-AEFI)KEKNU21001 2021 24 FEMALE DEATH 03-02-2021 COVISHIELD B2 22-Nov-21
ILLNESS WITH COVID 19 INFECTION
15 IND(CO-AEFI)WBCAL21017 2021 43 MALE HOSPITALIZED & RECOVERED 13-02-2021 COVISHIELD VASOVAGAL SYNCOPE A4 22-Nov-21
ISCHAEMIC HEART DISEASE WITH PREVIOUS HISTORY OF
16 IND(CO-AEFI)MHBMC21016 2021 55 MALE HOSPITALIZED & RECOVERED 19-02-2021 COVISHIELD C 22-Nov-21
SIMILAR EPISODE
17 IND(CO-AEFI)MHBMC21018 2021 58 MALE HOSPITALIZED & RECOVERED 28-01-2021 COVISHIELD FACIAL PALSY B1 22-Nov-21
18 IND(CO-AEFI)MHBMC21019 2021 27 FEMALE HOSPITALIZED & RECOVERED 20-02-2021 COVISHIELD ALLERGIC RASH WITH FEVER A1 22-Nov-21
19 IND(CO-AEFI)ORGJM21002 2021 56 FEMALE HOSPITALIZED & RECOVERED 25-02-2021 COVISHIELD ANAPHYLAXIS A1 22-Nov-21
20 IND(CO-AEFI)KEWYD21002 2021 39 FEMALE SEVERE & RECOVERED 29-01-2021 COVISHIELD FACIAL PALSY B1 22-Nov-21
21 IND(CO-AEFI)ORSUN21003 2021 24 FEMALE HOSPITALIZED & RECOVERED 18-01-2021 COVISHIELD FEVER, BODYACHE, VOMITTING, FATIGUE AND VERTIGO A1 22-Nov-21
22 IND(CO-AEFI)UPBRP21001 2021 71 MALE HOSPITALIZED & RECOVERED 04-03-2021 COVISHIELD ANXIETY REACTION A4 22-Nov-21
23 IND(CO-AEFI)MHBMC21022 2021 51 MALE SEVERE & RECOVERED 22-02-2021 COVISHIELD LEFT 3RD NERVE PALSY (PUPIL SPARING) INCOMPLETE C 22-Nov-21
24 IND(CO-AEFI)MHBMC21001 2021 39 FEMALE HOSPITALIZED & RECOVERED 22-01-2021 COVISHIELD FEVER WITH GENERALISED WEAKNESS A1 22-Nov-21
25 IND(CO-AEFI)ORNUP21002 2021 26 FEMALE HOSPITALIZED & RECOVERED 23-01-2021 COVISHIELD FEVER WITH HEADACHE A1 22-Nov-21
26 IND(CO-AEFI)ORKRD21002 2021 52 FEMALE HOSPITALIZED & RECOVERED 21-01-2021 COVISHIELD ANXIETY REACTION A4 22-Nov-21
27 IND(CO-AEFI)GURJT21003 2021 25 FEMALE HOSPITALIZED & RECOVERED 28-01-2021 COVISHIELD SEIZURE D 22-Nov-21
28 IND(CO-AEFI)TRTRW21005 2021 46 FEMALE HOSPITALIZED & RECOVERED 04-02-2021 COVISHIELD FEVER A1 22-Nov-21
29 IND(CO-AEFI)MHBMC21002 2021 47 FEMALE HOSPITALIZED & RECOVERED 25-01-2021 COVISHIELD FEVER, MALAISE & VOMITTING A1 22-Nov-21
30 IND(CO-AEFI)GUBVN21001 2021 35 FEMALE SEVERE & RECOVERED 19-01-2021 COVISHIELD FEVER A1 22-Nov-21
31 IND(CO-AEFI)HPHMR21001 2021 56 FEMALE DEATH 29-01-2021 COVISHIELD GUILLAIN BARRE SYNDROME B2 22-Nov-21
32 IND(CO-AEFI)UPSHP21001 2021 28 MALE HOSPITALIZED & RECOVERED 04-02-2021 COVISHIELD ANAPHYLAXIS A1 22-Nov-21
33 IND(CO-AEFI)APPKM21001 2021 24 FEMALE HOSPITALIZED & RECOVERED 23-01-2021 COVISHIELD SEPSIS WITH PYELONEPHRITIS WITH ACUTE KIDNEY INJURY C 22-Nov-21
34 IND(CO-AEFI)TRTRW21006 2021 25 MALE HOSPITALIZED & RECOVERED 11-02-2021 COVISHIELD ENCEPHALOMALACIA WITH GLIOSIS C 22-Nov-21
35 IND(CO-AEFI)TSMDK21001 2021 42 FEMALE HOSPITALIZED & RECOVERED 19-01-2021 COVISHIELD SEIZURE DISORDER C 22-Nov-21
36 IND(CO-AEFI)WBCAL21007 2021 51 FEMALE HOSPITALIZED & RECOVERED 16-01-2021 COVISHIELD ACUTE FEBRILE ILLNESS A1 22-Nov-21
37 IND(CO-AEFI)WBCAL21010 2021 40 MALE SEVERE & RECOVERED 19-01-2021 COVISHIELD FEVER WITH ARTHRALGIA A1 22-Nov-21
38 IND(CO-AEFI)KAUDU21002 2021 52 MALE HOSPITALIZED & RECOVERED 09-02-2021 COVISHIELD VIRAL PNEUMONIA C 22-Nov-21
39 IND(CO-AEFI)WBCAL21011 2021 49 MALE SEVERE & RECOVERED 29-01-2021 COVISHIELD FACIAL PALSY B1 22-Nov-21
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40 IND(CO-AEFI)HAPKL21001 2021 46 FEMALE SEVERE & RECOVERED 25-01-2021 COVISHIELD BILATERAL CENTRAL RETINAL VEIN OCCLUSION B1 22-Nov-21
UNCONTROLLED DIABETES WITH ANTERIOR UVEITIS AND
41 IND(CO-AEFI)HAPKL21002 2021 37 MALE SEVERE & RECOVERED 05-02-2021 COVISHIELD C 22-Nov-21
RETINOPATHY
42 IND(CO-AEFI)KADHA21002 2021 40 FEMALE HOSPITALIZED & RECOVERED 10-02-2021 COVISHIELD BILATERAL PNEUMONIA WITH DIABETES MELLITUS C 22-Nov-21
DIABETIC KETOACIDOSIS WITH HYPOTHYROIDISM WITH
43 IND(CO-AEFI)KAMYS21003 2021 41 MALE HOSPITALIZED & RECOVERED 12-02-2021 COVISHIELD C 22-Nov-21
FOCAL SEIZURE
44 IND(CO-AEFI)WBMBD21003 2021 40 FEMALE SEVERE & RECOVERED 25-01-2021 COVISHIELD ANXIETY REACTION A4 22-Nov-21
45 IND(CO-AEFI)DLWES21007 2021 27 MALE HOSPITALIZED & RECOVERED 23-02-2021 COVISHIELD BRONCHIAL ASTHMA WITH ACUTE EXACERBATION C 22-Nov-21
46 IND(CO-AEFI)UPBRL21004 2021 31 FEMALE SEVERE & RECOVERED 29-01-2021 COVISHIELD ANXIETY REACTION A4 22-Nov-21
47 IND(CO-AEFI)CGBTR21001 2021 23 FEMALE HOSPITALIZED & RECOVERED 04-02-2021 COVISHIELD ALLERGIC REACTION A1 22-Nov-21
48 IND(CO-AEFI)KEKZK21003 2021 62 FEMALE HOSPITALIZED & RECOVERED 02-02-2021 COVISHIELD GUILLAIN BARRE SYNDROME B1 22-Nov-21
ACUTE CORONARY SYNDROME IN A KNOWN CASE OF
49 IND(CO-AEFI)HAFBD21001 2021 77 FEMALE DEATH 06-03-2021 COVISHIELD C 22-Nov-21
DIABETES MELLITUS
50 IND(CO-AEFI)MHBMC21027 2021 87 MALE HOSPITALIZED & RECOVERED 11-02-2021 COVISHIELD COVID-19 DISEASE C 22-Nov-21
51 IND(CO-AEFI)MHBMC21026 2021 77 MALE HOSPITALIZED & RECOVERED 04-03-2021 COVISHIELD CEREBROVASCULAR ACCIDENT WITH DIABETES MELLITUS C 22-Nov-21
ACUTE GASTROENTERITIS WITH HYP0GLYCAEMIA, WITH
52 IND(CO-AEFI)TNVPM21001 2021 76 FEMALE DEATH 06-03-2021 COVISHIELD DYSELECTROLAEMIA, WITH METABOLIC ENCEPHALOPATHY C 22-Nov-21
WITH ATRIAL FIBRILATION
ACUTE CORONARY SYNDROME WITH DIABETES MELLITUS,
53 IND(CO-AEFI)BICPW21003 2021 74 FEMALE DEATH 08-03-2021 COVISHIELD C 22-Nov-21
HYPERTENSION AND ASTHMA
54 IND(CO-AEFI)WBMBD21008 2021 63 MALE HOSPITALIZED & RECOVERED 10-03-2021 COVISHIELD HEMOPTYSIS C 22-Nov-21
55 IND(CO-AEFI)BIAGB21001 2021 45 FEMALE DEATH 08-03-2021 COVISHIELD SUDDEN UNEXPLAINED DEATH D 22-Nov-21
56 IND(CO-AEFI)SIEST21001 2021 36 FEMALE HOSPITALIZED & RECOVERED 20-01-2021 COVISHIELD ACUTE FEBRILE ILLNESS WITH HEADACHE AND MYALGIA A1 22-Nov-21
57 IND(CO-AEFI)WBDJL21007 2021 22 MALE SEVERE & RECOVERED 29-01-2021 COVISHIELD CHILLS WITH NAUSEA A1 22-Nov-21
MULTIPLE MYELOMA, SEPSIS, ACUTE ON CHRONIC KIDNEY
58 IND(CO-AEFI)APPKM21003 2021 39 FEMALE DEATH 21-01-2021 COVISHIELD C 22-Nov-21
DISEASE
59 IND(CO-AEFI)WBSPG21010 2021 77 MALE DEATH 09-03-2021 COVISHIELD UNEXPLAINED DEATH D 22-Nov-21
60 IND(CO-AEFI)APEGV21002 2021 87 MALE DEATH 15-03-2021 COVISHIELD SUDDEN CARDIAC DEATH WITH DIABETES MELLITUS C 22-Nov-21
61 IND(CO-AEFI)GUGIR21001 2021 40 FEMALE HOSPITALIZED & RECOVERED 25-02-2021 COVISHIELD SEIZURE DISORDER C 22-Nov-21
62 IND(CO-AEFI)HPMND21002 2021 69 MALE HOSPITALIZED & RECOVERED 09-03-2021 COVISHIELD MODERATE COVID 19 DISEASE C 22-Nov-21
63 IND(CO-AEFI)JHRNC21005 2021 35 MALE HOSPITALIZED & RECOVERED 10-03-2021 COVISHIELD ACUTE INFERO POSTERIOR WALL MYOCARDIAL INFARCTION B1 22-Nov-21
HYPERTENSION WITH COPD WITH ACUTE EXACERBATION
64 IND(CO-AEFI)SISTH21001 2021 64 FEMALE DEATH 03-03-2021 COVISHIELD WITH LOWER RESPIRATORY TRACT INFECTION WITH C 22-Nov-21
RESPIRATORY FAILURE
65 IND(CO-AEFI)GOGOS21002 2021 39 FEMALE SEVERE & RECOVERED 02-02-2021 COVISHIELD FEVER WITH LOCAL SITE PAIN A1 22-Nov-21
CORONARY ARTERY DISEASE WITH ANTERIOR WALL
66 IND(CO-AEFI)APPKM21004 2021 78 MALE DEATH 08-03-2021 COVISHIELD MYOCARDIAL INFARCTION WITH TYPE 2 DIABETES C 22-Nov-21
MILLETUS WITH HYPERTENSION WITH CARDIOGENIC SHOCK
67 IND(CO-AEFI)APVSM21001 2021 39 FEMALE DEATH 05-03-2021 COVISHIELD GULLIAN BARRE SYNDROME WITH PNEUMONIA B1 22-Nov-21
68 IND(CO-AEFI)KEPLK21003 2021 40 FEMALE HOSPITALIZED & RECOVERED 04-03-2021 COVISHIELD ACUTE DISSEMINATED ENCEPHALOMYELITIS B1 22-Nov-21
69 IND(CO-AEFI)CGMGL21001 2021 51 FEMALE HOSPITALIZED & RECOVERED 08-03-2021 COVISHIELD ANXIETY REACTION A4 22-Nov-21
ACUTE ANTERIOR WALL MYOCARDIAL INFARCTION WITH
70 IND(CO-AEFI)WBNDG21001 2021 71 FEMALE DEATH 19-03-2021 COVISHIELD C 22-Nov-21
TYPE II DIABETES MELLITUS
71 IND(CO-AEFI)GOGON21003 2021 35 MALE HOSPITALIZED & RECOVERED 15-02-2021 COVISHIELD MILD COVID DISEASE C 22-Nov-21
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ACUTE INFERIOR WALL MYOCARDIAL INFARCTION WITH

72 IND(CO-AEFI)KEPTM21003 2021 81 FEMALE HOSPITALIZED & RECOVERED 20-03-2021 COVISHIELD C 22-Nov-21
UNDERLYING DIABETES, HYPERTENSION & DYSLIPIDEMIA.
73 IND(CO-AEFI)HAHSR21004 2021 68 FEMALE DEATH 22-03-2021 COVISHIELD ANAPHYLAXIS A1 22-Nov-21
74 IND(CO-AEFI)HAKTL21001 2021 61 FEMALE HOSPITALIZED & RECOVERED 18-03-2021 COVISHIELD ACCELERATED HYPERTENSION C 22-Nov-21
ACUTE CORONARY SYNDROME WITH UNDRLYING
75 IND(CO-AEFI)WBSPG21002 2021 66 MALE DEATH 19-03-2021 COVISHIELD C 22-Nov-21
DIABETES, HYPERTENSION AND CHRONIC SMOKING
COVID 19 DISEASE WITH ACUTE RESPIRATORY DISTRESS
76 IND(CO-AEFI)UPBDH21001 2021 73 MALE DEATH 17-03-2021 COVISHIELD SYNDROME WITH UNDERLYING DIABETES MELLITUS AND C 22-Nov-21
HYPERTENSION
77 IND(CO-AEFI)UPBBK21001 2021 55 MALE HOSPITALIZED & RECOVERED 17-03-2021 COVISHIELD FEVER AND BODY ACHE A1 22-Nov-21
78 IND(CO-AEFI)MPBPL21001 2021 35 FEMALE SEVERE & RECOVERED 16-01-2021 COVISHIELD ACUTE FEBRILE ILLNESS A1 22-Nov-21
79 IND(CO-AEFI)MPBTL21001 2021 32 MALE HOSPITALIZED & RECOVERED 11-02-2021 COVISHIELD GUILLAIN BARRE SYNDROME B1 22-Nov-21
ACUTE MYOCARDIAL INFARCTION IN A KNOWN CASE OF
80 IND(CO-AEFI)KABEL21008 2021 76 MALE DEATH 26-03-2021 COVISHIELD C 22-Nov-21
DIABETES MELLITUS AND HYPERTENSION.
ACUTE CORONARY SYNDROME LEADING TO MYOCARDIAL
81 IND(CO-AEFI)DLNDL21004 2021 61 MALE DEATH 25-03-2021 COVISHIELD C 22-Nov-21
INFARCTION AND PULMONARY EDEMA
82 IND(CO-AEFI)GOGOS21005 2021 63 MALE HOSPITALIZED & RECOVERED 24-03-2021 COVISHIELD ALLERGIC REACTION A1 22-Nov-21
83 IND(CO-AEFI)GOGOS21006 2021 62 MALE HOSPITALIZED & RECOVERED 09-03-2021 COVISHIELD COVID 19 DISEASE C 22-Nov-21
CORONARY ARTERY DISEASE WITH ACUTE CORONARY
84 IND(CO-AEFI)KEAPZ21017 2021 63 MALE HOSPITALIZED & RECOVERED 27-03-2021 COVISHIELD C 22-Nov-21
SYNDROME (NSTEMI)
ACUTE MYOCARDIAL INFARCTION with underlying COPD
85 IND(CO-AEFI)RJSKR21001 2021 66 MALE DEATH 26-03-2021 COVISHIELD C 22-Nov-21
and chronic smoking
86 IND(CO-AEFI)MPBRW21003 2021 59 FEMALE DEATH 03-02-2021 COVISHIELD SEVERE COVID 19 DISEASE C 22-Nov-21
87 IND(CO-AEFI)UPHTR21001 2021 50 FEMALE HOSPITALIZED & RECOVERED 28-01-2021 COVISHIELD ANXIETY REACTION A4 22-Nov-21
88 IND(CO-AEFI)WBCAL21026 2021 74 MALE HOSPITALIZED & RECOVERED 30-03-2021 COVISHIELD FEVER, JOINT PAIN, VOMITTING AND SYNCOPE A1 22-Nov-21
ACUTE MYOCARDIAL INFARCTION WITH PREVIOUS HISTORY
89 IND(CO-AEFI)WBMBD21012 2021 63 MALE DEATH 31-03-2021 COVISHIELD C 22-Nov-21
OF CORONARY ARTERY DISEASE AND CHRONIC SMOKER
SEVERE COVID 19 PNEUMONIA WITH RESPIRATORY

90 IND(CO-AEFI)KEAPZ21007 2021 68 MALE DEATH 12-03-2021 COVISHIELD FAILURE WITH UNDERLYING DIABETES, HYPERTENSION AND C 22-Nov-21
CORONARY ARTERY DISEASE WITH RENAL FAILURE
91 IND(CO-AEFI)MPBRW21004 2021 67 MALE DEATH 01-04-2021 COVISHIELD SEVERE COVID DISEASE C 22-Nov-21
SUDDEN CARDIAC DEATH WITH POST MORTEM
92 IND(CO-AEFI)ORNRP21002 2021 66 MALE DEATH 01-04-2021 COVISHIELD C 22-Nov-21
CONFIRMED ATHEROVASCULAR DISEASE
93 IND(CO-AEFI)KEAPZ21008 2021 56 MALE DEATH 06-03-2021 COVISHIELD ACUTE MYOCARDIAL INFARCTION with underlying Diabetes C 22-Nov-21
94 IND(CO-AEFI)TNCNI21006 2021 33 MALE HOSPITALIZED & RECOVERED 03-03-2021 COVISHIELD ANAPHYLAXIS A1 22-Nov-21
95 IND(CO-AEFI)KABMP21017 2021 66 MALE HOSPITALIZED & RECOVERED 06-03-2021 COVISHIELD GUILLAIN BARRE SYNDROME B1 22-Nov-21
96 IND(CO-AEFI)WBMBD21015 2021 45 FEMALE HOSPITALIZED & RECOVERED 23-03-2021 COVISHIELD ALLERGIC REACTION A1 22-Nov-21
97 IND(CO-AEFI)MPMDL21003 2021 73 FEMALE HOSPITALIZED & RECOVERED 22-03-2021 COVISHIELD COVID 19 DISEASE WITH UNDERLYING HYPERTENSION C 22-Nov-21
98 IND(CO-AEFI)MHBMC21041 2021 68 FEMALE SEVERE & RECOVERED 26-03-2021 COVISHIELD ANXIETY REACTION A4 22-Nov-21
99 IND(CO-AEFI)WBDMD21008 2021 34 MALE SEVERE & RECOVERED 05-03-2021 COVISHIELD MILD COVID 19 INFECTION C 22-Nov-21
100 IND(CO-AEFI)CGRGH21002 2021 65 FEMALE HOSPITALIZED & RECOVERED 17-03-2021 COVISHIELD HYPERTENSION C 22-Nov-21
101 IND(CO-AEFI)TNCNI21009 2021 59 FEMALE HOSPITALIZED & RECOVERED 19-01-2021 COVISHIELD ANXIETY REACTION A4 22-Nov-21
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102 IND(CO-AEFI)WBBDN21011 2021 58 FEMALE HOSPITALIZED & RECOVERED 03-04-2021 COVISHIELD FEVER, NAUSEA, VOMITING A1 22-Nov-21
COVID 19 PNEUMONIA WITH HYPERTENSION AND TYPE 2
103 IND(CO-AEFI)GOGON21008 2021 56 MALE HOSPITALIZED & RECOVERED 24-03-2021 COVISHIELD C 22-Nov-21
DIABETES MELLITUS
NSTEMI WITH BILATERAL ATYPICAL PNEUMONITIS WITH
104 IND(CO-AEFI)RJUDP21003 2021 61 MALE HOSPITALIZED & RECOVERED 03-04-2021 COVISHIELD HYPERTENSION, DIABETES MELLITUS AND LEFT C 22-Nov-21
VENTRICULAR HYPERTROPHY
105 IND(CO-AEFI)UPMRD21006 2021 49 MALE HOSPITALIZED & RECOVERED 05-04-2021 COVISHIELD ANXIETY REACTION A4 22-Nov-21
TYPE 2 DIABETES MELLITUS WITH ALZHEIMER WITH
106 IND(CO-AEFI)GOGOS21008 2021 87 FEMALE HOSPITALIZED & RECOVERED 04-03-2021 COVISHIELD HYPERTENSIVE EMERGENCY WITH LEFT VENTRICULAR C 22-Nov-21
FAILURE
107 IND(CO-AEFI)UPBJN21004 2021 67 MALE DEATH 01-04-2021 COVAXIN UNEXPLAINED DEATH D 22-Nov-21
108 IND(CO-AEFI)KEKNU21007 2021 24 FEMALE HOSPITALIZED & RECOVERED 25-02-2021 COVISHIELD MILD COVID 19 DISEASE C 22-Nov-21
109 IND(CO-AEFI)GOGON21009 2021 55 MALE HOSPITALIZED & RECOVERED 18-03-2021 COVISHIELD MODERATE COVID 19 DISEASE WITH HYPERTENSION C 22-Nov-21
MILD COVID 19 DISEASE IN A KNOWN CASE OF DIABETES
110 IND(CO-AEFI)GOGON21010 2021 46 MALE HOSPITALIZED & RECOVERED 20-03-2021 COVISHIELD C 22-Nov-21
MELLITUS
111 IND(CO-AEFI)KAMYS21007 2021 51 MALE HOSPITALIZED & RECOVERED 26-03-2021 COVISHIELD ANAPHYLAXIS A1 22-Nov-21
112 IND(CO-AEFI)WBUDJ21006 2021 55 MALE DEATH 06-03-2021 COVISHIELD COVID 19 DISEASE, PNEUMONIA AND ARDS C 22-Nov-21
ACUTE MYOCARDIAL INFARCTION WITH POST MORTEM
113 IND(CO-AEFI)HPMND21005 2021 61 MALE DEATH 12-04-2021 COVISHIELD C 22-Nov-21
CONFIRMED ATHEROVASCULAR DISEASE
COVID 19 DISEASE WITH HYPERTENSION AND
114 IND(CO-AEFI)WBBDN21013 2021 60 FEMALE DEATH 26-03-2021 COVISHIELD C 22-Nov-21
HYPOTHYROIDISM
115 IND(CO-AEFI)WBBDN21012 2021 50 FEMALE HOSPITALIZED & RECOVERED 03-04-2021 COVISHIELD FEVER AND GASTRITIS A1 22-Nov-21
116 IND(CO-AEFI)UPMAI21001 2021 37 FEMALE SEVERE & RECOVERED 05-02-2021 COVISHIELD ANXIETY REACTION A4 22-Nov-21
117 IND(CO-AEFI)KEIDK21003 2021 60 FEMALE HOSPITALIZED & RECOVERED 05-04-2021 COVISHIELD ANXIETY REACTION A4 22-Nov-21
118 IND(CO-AEFI)MPCDW21001 2021 63 MALE DEATH 17-03-2021 COVISHIELD BILATERAL PNEUMONIA WITH RESPIRATORY FAILURE C 22-Nov-21
COVID 19 DISEASE WITH UNDERLYING DIABETES MELLITUS,
119 IND(CO-AEFI)GOGON21014 2021 79 MALE HOSPITALIZED & RECOVERED 31-03-2021 COVISHIELD HYPERTENSION, ISCHEMIC HEART DISEASE, CHRONIC C 22-Nov-21
KIDNEY DISEASE
120 IND(CO-AEFI)KABEL21010 2021 62 FEMALE DEATH 01-04-2021 COVISHIELD COVID 19 PNEUMONIA WITH SEPSIS WITH RENAL FAILURE C 22-Nov-21
121 IND(CO-AEFI)PBPTL21007 2021 64 MALE SEVERE & RECOVERED 11-04-2021 COVISHIELD ALLERGIC REACTION A1 22-Nov-21
122 IND(CO-AEFI)MPSNI21005 2021 68 FEMALE DEATH 22-03-2021 COVISHIELD SEVERE COVID 19 PNEUMONIA C 22-Nov-21
123 IND(CO-AEFI)GOGOS21011 2021 62 MALE HOSPITALIZED & RECOVERED 26-03-2021 COVISHIELD MILD COVID-19 PNEUMONIA C 22-Nov-21
124 IND(CO-AEFI)PDYNM21001 2021 82 MALE DEATH 08-03-2021 COVISHIELD SEVERE ACUTE RESPIRATORY ILLNESS C 22-Nov-21
125 IND(CO-AEFI)GOGOS21010 2021 58 FEMALE HOSPITALIZED & RECOVERED 26-03-2021 COVISHIELD MILD COVID 19 DISEASE C 22-Nov-21
ACUTE INFERIOR AND POSTERIOR WALL MYOCARDIAL
126 IND(CO-AEFI)GOGON21015 2021 55 MALE HOSPITALIZED & RECOVERED 11-04-2021 COVISHIELD B1 22-Nov-21
INFARCTION
127 IND(CO-AEFI)KEKZK21004 2021 44 FEMALE HOSPITALIZED & RECOVERED 18-02-2021 COVISHIELD GUILLAIN BARRE SYNDROME B1 22-Nov-21
128 IND(CO-AEFI)WBASN21005 2021 37 MALE HOSPITALIZED & RECOVERED 22-02-2021 COVISHIELD ANXIETY REACTION A4 22-Nov-21
129 IND(CO-AEFI)KEAPZ21020 2021 54 FEMALE HOSPITALIZED & RECOVERED 08-03-2021 COVISHIELD GUILLAIN BARRE SYNDROME B1 22-Nov-21
130 IND(CO-AEFI)PBPTL21002 2021 53 FEMALE SEVERE & RECOVERED 24-02-2021 COVISHIELD ALLERGIC REACTION A1 22-Nov-21
131 IND(CO-AEFI)PBPTL21003 2021 43 MALE SEVERE & RECOVERED 26-02-2021 COVISHIELD FACIAL PALSY B2 22-Nov-21
132 IND(CO-AEFI)JKKUA21001 2021 21 MALE DEATH 21-04-2021 COVISHIELD ANAPHYLACTIC SHOCK A1 22-Nov-21
133 IND(CO-AEFI)WBCAL21028 2021 28 FEMALE SEVERE & RECOVERED 19-04-2021 COVISHIELD ALLERGIC REACTION A1 22-Nov-21
134 IND(CO-AEFI)CGRNG21005 2021 46 FEMALE HOSPITALIZED & RECOVERED 03-04-2021 COVISHIELD ACUTE FEBRILE ILLNESS A1 22-Nov-21
135 IND(CO-AEFI)UPBAD21002 2021 55 MALE DEATH 05-04-2021 COVISHIELD HEPATITIS C WITH CHRONIC KIDNEY DISEASE C 22-Nov-21
136 IND(CO-AEFI)WBDJL21013 2021 64 FEMALE HOSPITALIZED & RECOVERED 06-04-2021 COVISHIELD CHOLECYSTITIS WITH HYPERTENSION C 22-Nov-21
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137 IND(CO-AEFI)TRTRW21012 2021 57 FEMALE HOSPITALIZED & RECOVERED 30-03-2021 COVISHIELD SEIZURE DISORDER C 22-Nov-21
138 IND(CO-AEFI)RJJPR21004 2021 48 MALE HOSPITALIZED & RECOVERED 01-04-2021 COVISHIELD ACUTE FEBRILE ILLNESS A1 22-Nov-21
139 IND(CO-AEFI)KETHR21019 2021 70 FEMALE HOSPITALIZED & RECOVERED 15-04-2021 COVISHIELD GUILLAIN BARRE SYNDROME B1 22-Nov-21
140 IND(CO-AEFI)GOGON21027 2021 78 FEMALE DEATH 13-03-2021 COVISHIELD COVID-19 DISEASE C 22-Nov-21
141 IND(CO-AEFI)WBMNP21005 2021 24 FEMALE HOSPITALIZED & RECOVERED 27-01-2021 COVISHIELD ALLERGIC REACTION A1 22-Nov-21
142 IND(CO-AEFI)WBAPD21005 2021 42 MALE SEVERE & RECOVERED 22-02-2021 COVISHIELD ALLERGIC RASH A1 22-Nov-21
SEIZURE DISORDER IN POST-OPERATIVE MENINGIOMA
143 IND(CO-AEFI)KEPLK21013 2021 42 FEMALE HOSPITALIZED & RECOVERED 21-05-2021 COVISHIELD C 22-Nov-21
WITH REOCCURRENCE
144 IND(CO-AEFI)DLSDR21002 2021 28 MALE HOSPITALIZED & RECOVERED 05-05-2021 COVISHIELD ACUTE IDIOPATHIC THROMBOCYTOPENIC PURPURA B1 22-Nov-21
COVID-19 DISEASE (PNEUMONIA, ACUTE RESPIRATORY
145 IND(CO-AEFI)TNCNI21016 2021 50 FEMALE DEATH 07-04-2021 COVISHIELD DISTRESS SYNDROME, SEPSIS, ACUTE KIDNEY INJURY AND C 22-Nov-21
TYPE 1 RESPIRATORY FAILURE)
ANTERIOR WALL MYOCARDIAL INFARCTION WITH
146 IND(CO-AEFI)GOGON21033 2021 65 FEMALE HOSPITALIZED & RECOVERED 28-05-2021 COVISHIELD C 22-Nov-21
HYPERTENSION
147 IND(CO-AEFI)TSRGY21005 2021 49 MALE HOSPITALIZED & RECOVERED 12-04-2021 COVISHIELD IDIOPATHIC THROMBOCYTOPENIC PURPURA B1 22-Nov-21
148 IND(CO-AEFI)TSHYD21022 2021 18 FEMALE DEATH 29-05-2021 COVISHIELD THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME A1 22-Nov-21
149 IND(CO-AEFI)ORRYG21005 2021 19 FEMALE HOSPITALIZED & RECOVERED 08-06-2021 COVISHIELD ALLERGIC REACTION, VOMITTING AND PAIN IN ABDOMEN A1 22-Nov-21
150 IND(CO-AEFI)HAPNP21008 2021 20 MALE HOSPITALIZED & RECOVERED 21-06-2021 COVISHIELD ALLERGIC REACTION A1 22-Nov-21
151 IND(CO-AEFI)GUSBK21001 2021 25 MALE HOSPITALIZED & RECOVERED 24-06-2021 COVISHIELD GUILLAIN BARRE SYNDROME B1 22-Nov-21
152 IND(CO-AEFI)MEEKH21004 2021 19 FEMALE HOSPITALIZED & RECOVERED 14-06-2021 COVISHIELD FOCAL SEIZURE B1 22-Nov-21
153 IND(CO-AEFI)KEPLK21017 2021 53 FEMALE HOSPITALIZED & RECOVERED 29-06-2021 COVISHIELD ANXIETY REACTION A4 22-Nov-21
154 IND(CO-AEFI)RJJPR21015 2021 43 FEMALE HOSPITALIZED & RECOVERED 02-07-2021 COVISHIELD ANAPHYLAXIS A1 22-Nov-21
155 IND(CO-AEFI)MHBMC21099 2021 51 FEMALE DEATH 03-04-2021 COVISHIELD SEVERE COVID PNEUMONIA C 22-Nov-21
156 IND(CO-AEFI)UPPSN21002 2021 58 FEMALE HOSPITALIZED & RECOVERED 08-07-2021 COVISHIELD SEIZURE IN A KNOWN CASE OF CVA AND HYPERTENSION C 22-Nov-21
157 IND(CO-AEFI)WBCAL21032 2021 37 FEMALE HOSPITALIZED & RECOVERED 26-06-2021 COVISHIELD ACUTE FEBRILE ILLNESS WITH VOMITING A1 22-Nov-21
158 IND(CO-AEFI)UPRBL21002 2021 77 MALE DEATH 17-03-2021 COVISHIELD COVID 19 PNEUMONIA C 22-Nov-21
159 IND(CO-AEFI)UPGZA21001 2021 85 MALE DEATH 09-04-2021 COVISHIELD SEVERE COVID 19 PNEUMONIA C 22-Nov-21
160 IND(CO-AEFI)GUJMD21003 2021 22 MALE HOSPITALIZED & RECOVERED 14-04-2021 COVISHIELD ANAPHYLAXIS A1 22-Nov-21
LEFT FOCAL SEIZURES (RIGHT FRONTAL MENINGIOMA) IN A
161 IND(CO-AEFI)KETHR21032 2021 58 FEMALE HOSPITALIZED & RECOVERED 06-07-2021 COVAXIN KNOWN CASE OF CARCINOMA THYROID AND C 22-Nov-21
HYPOTHYROIDISM
162 IND(CO-AEFI)KETRM21027 2021 21 FEMALE HOSPITALIZED & RECOVERED 03-07-2021 COVISHIELD THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME A1 22-Nov-21
163 IND(CO-AEFI)MHTHN21019 2021 36 FEMALE HOSPITALIZED & RECOVERED 19-03-2021 COVISHIELD ACUTE DISSEMINATED ENCEPHALOMYELITIS B1 22-Nov-21
164 IND(CO-AEFI)MHBMC21059 2021 22 MALE HOSPITALIZED & RECOVERED 29-06-2021 COVISHIELD SEIZURE B1 22-Nov-21
EXFOLIATIVE DERMATITIS WITH SEPSIS WITH URINARY
165 IND(CO-AEFI)WBNPG21008 2021 62 FEMALE HOSPITALIZED & RECOVERED 22-05-2021 COVISHIELD TRACT INFECTION WITH DIABETES MELLITUS WITH B2 22-Nov-21
HYPERTENSION WITH HYPOTHYROIDISM
166 IND(CO-AEFI)WBCAL21033 2021 25 FEMALE HOSPITALIZED & RECOVERED 22-07-2021 COVISHIELD ALLERGIC REACTION A1 22-Nov-21
167 IND(CO-AEFI)HAJJR21003 2021 31 FEMALE HOSPITALIZED & RECOVERED 25-01-2021 COVISHIELD ALLERGIC REACTION A1 22-Nov-21
168 IND(CO-AEFI)KETHR21035 2021 23 FEMALE HOSPITALIZED & RECOVERED 15-07-2021 COVISHIELD SEIZURE DISORDER? ECLAMPSIA C 22-Nov-21
169 IND(CO-AEFI)UPGBN21004 2021 47 MALE DEATH 15-04-2021 COVISHIELD COVID 19 DISEASE C 22-Nov-21
Page 5 of 6
1155
D - UNCLASSIFIABLE

NON-ST-ELEVATION MYOCARDIAL INFARCTION with AGE-

170 IND(CO-AEFI)KETRM21031 2021 56 MALE HOSPITALIZED & RECOVERED 01-08-2021 COVISHIELD 56 YEARS and RISK FACTORS OF SMOKING, ALCOHOL C 22-Nov-21
CONSUMPTION WITH FAMILY HISTORY.
171 IND(CO-AEFI)KEWYD21019 2021 37 MALE HOSPITALIZED & RECOVERED 19-07-2021 COVISHIELD ACUTE ANTERIOR WALL MYOCARDIAL INFARCTION B1 22-Nov-21
172 IND(CO-AEFI)MHBMC21066 2021 19 FEMALE HOSPITALIZED & RECOVERED 30-07-2021 COVISHIELD ACUTE FEBRILE ILLNESS A1 22-Nov-21
173 IND(CO-AEFI)WBDJL21034 2021 32 MALE SEVERE & RECOVERED 09-08-2021 COVISHIELD ANAPHYLAXIS A1 22-Nov-21
174 IND(CO-AEFI)PDPNY21006 2021 20 MALE HOSPITALIZED & RECOVERED 17-06-2021 COVISHIELD GUILLAIN BARRE SYNDROME B1 22-Nov-21
175 IND(CO-AEFI)KEPTM21011 2021 51 FEMALE HOSPITALIZED & RECOVERED 14-08-2021 COVISHIELD ALLERGIC BRONCHITIS C 22-Nov-21
176 IND(CO-AEFI)DLNWE21006 2021 24 FEMALE HOSPITALIZED & RECOVERED 06-08-2021 COVISHIELD ALLERGIC REACTION A1 22-Nov-21
177 IND(CO-AEFI)MPSDL21001 2021 51 MALE SEVERE & RECOVERED 01-04-2021 COVISHIELD FOCAL SEIZURE B1 22-Nov-21
178 IND(CO-AEFI)KEAPZ21040 2021 28 FEMALE DEATH 07-06-2021 COVISHIELD THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME A1 22-Nov-21
*Covid vaccine is a new vaccine. The causality may change as more information become available.
Verified by Dr Anil Gurtoo and Dr Anju Seth on 01 Dec 2021
Page 6 of 6
ANNEXURE P-53
1156
New Guideline in view of initial signs of surge in Covid-
19/Omicron cases
taxguru.in/corporate-law/new-guideline-view-initial-signs-surge-covid-19-omicron-cases.html
No. 40-3/2020-DM-I(A)
Government of India
Ministry of Home Affairs
North Block, New Delhi-110001
Dated 27th December, 2021
ORDER
Whereas, an Order of even number dated 28th September 2021, was issued to ensure
compliance with the containment measures for COVID-19, as conveyed vide Ministry of
Health & Family Welfare (MoHFW) DO letter No. Z.28015/85/2021-DM Cell, dated 21′
September, 2021, which was further extended for a period upto 31.12.2021 vide Order of
even number, dated 30.11.2021;
And whereas, in view of the initial signs of surge in cases of COVID-19 as well as
increased detection of the Variant of Concern (VoC), ‘Omicron’, in different parts of the
country, MoHFW vide D.O. letter No. Z.28015/318/21-EMR, dated 21St December, 2021,
has issued an advisory to all the States and Union Territories (UTs), prescribing a
normative framework for taking evidence based containment measures at district/ local
level;
Whereas, in exercise of the powers conferred under section 6(2)(i) of the Disaster
Management Act, 2005 (DM Act), the National Disaster Management Authority (NDMA)
has directed the undersigned to issue an Order, for containment of COVID19 in the
country;
1/6
1157
Now, therefore, in exercise of the powers, conferred under Section 10(2)(1) of the DM
Act, the undersigned, hereby directs the State/ UT Governments and State/ UT
Authorities to consider implementation of the normative framework, as conveyed vide
aforesaid MoHFW advisory, dated 21′ December, 2021, as per Annexure-I, until
31.01.2022. States/ UTs will take necessary measures, under the relevant provisions of
the DM Act. It is further directed that:
(i) The National Directives for COVID-19 Management, as specified in Annexure II, shall
continue to be strictly followed throughout the country.
(ii) All the District Magistrates shall strictly enforce the above measures. For the
enforcement of social distancing, State/ UT Governments may, as far as possible, use the
provisions of Section 144 of the Criminal Procedure Code (CrPC) of 1973.
(iii) Any person violating these measures will be liable to be proceeded against as per the
provisions of Sections 51 to 60 of the DM Act, besides legal action under Section 188 of
the IPC, and other legal provisions, as applicable.
Union Home Secretary
and, Chairperson, National Executive Committee (NEC)
To:
1. The Secretaries of Ministries/ Departments of Government of India
2. The Chief Secretaries/Administrators of States/Union Territories
(As per list attached)
Copy to:
i. All Members of the National. Executive Committee
ii. Member Secretary, National Disaster Management Authority
Annexure-I
D.O.No.Z. 28015/318/21-EMR
21 December, 2021
This is regarding the measures that need to be taken in view of initial signs of surge in
cases of Covid-19 as well as increased detection of the Variant of Concern (VoC),
‘Omicron’ in different parts of the country.
2. In this context kindly recall this Ministry’s earlier guidance shared with States/UTs on
multiple occasions regarding the recommended strategies for containment and
restrictions, keeping the District as a
2/6
3. At the district level there should be constant review of emerging data regarding the1158
population affected by COVID-19, geographical spread, hospital infrastructure and its
utilization, manpower, notifying Containment Zones, enforcement of perimeter of
containment zones etc. This evidence should be the basis for effective decision making at
the district level Such a strategy ensures that infection is contained at the local level itself
before it spreads to other parts of the state.
4. The main elements of the framework to be used by States and UTs to facilitate decision
making at the District Level are as follows:
i) Test positivity of 10% or more in the last one week
OR
ii) Bed occupancy of 40% or more on oxygen supported or ICU beds
In case any one of these parameters are met in any District, district level containment
measures and restrictions may be put in place forthwith. Equally important, the
restrictions must be strictly enforced.
5. Based on current scientific evidence, the VOC Omicron is at least 3 times more
transmissible than the Delta Besides, the Delta VOC is still present in different parts of the
country. Hence, even greater foresight, data analysis, dynamic decision making and strict
& prompt containment action is required at the local and district level. The decision
making at the State/UT and district level must be very prompt and focussed.
6. The template above provides a normative However, based on the local situation and
population characteristics such as density etc., and keeping in mind the higher
transmissibility of Omicron, States/UTs can take containment measures and restrictions
even before these thresholds are reached.
7. Some of the strategic areas of intervention focusing on containment, test, track,

surveillance, clinical management, vaccination and Covid Appropriate Behaviour to be
taken up are as follows:
A -Containment: imposition of night curfew, strict regulation of large gatherings,

curtailing numbers in marriages and funerals, restricting numbers in offices, industries,
public transport etc. In case of all new clusters of Covid positive cases, prompt notification
of “Containment Zones”, “Buffer Zones” should be done, strict perimeter control of
Containment Zone as per extant guidelines must be ensured. All cluster samples must be
sent to INSACOG Labs for Genome Sequencing without delay.
B. Testing and surveillance: testing as per ICMR and MoHFVV guidelines, door to door
case search, testing of all SARI/ILI and vulnerable/co-morbid people, ensuring right
proportion of RTPCR tests in total tests being conducted daily, contact tracing of all Covid
positive persons & their timely testing, utilizing the access to “AIR SUVIDHA” Portal by
State Surveillance Officers (SSOs) & District Surveillance Officers (DSOs) to monitor the
international passengers who have arrived in their States & Districts etc.
3/6
C. Clinical Management: increase bed capacity, other logistics like ambulances, 1159
mechanism for seamless shifting of patients, availability and operational readiness of
oxygen equipments, buffer stock of drugs to be ensured by prompt utilization of
Emergency Covid Response Package (ECRP-II) funds released by Central Government
& other available resources etc. The existing National Clinical Management Protocol
remains unchanged for Omicron.
Ensure stringent enforcement of home isolation as per extant guidelines. This would
include among others: customized kit for persons undergoing home isolation, their regular
monitoring through call centers as well as home visits etc. This will be a very critical
activity in the days to come specially to ensure that persons under home isolation do not
spread the virus to others in view of its higher transmissibility.
D. Vaccination: ensure 100% coverage of left out first and second dose eligible
beneficiaries in an accelerated manner. Special focus to be given to those districts where
the first & second dose coverage is less than the national average. The door-to-door
vaccination campaign need to be strengthened.
E. Community engagement and Covid Appropriate Behaviour: Ensure advance

engagement and information so that there is no misinformation or panic, transparent
communication on hospital and testing infrastructure availability, regular press briefings
etc. Participation of community backed by strict enforcement is necessary for ensuring
Covid Appropriate Behaviour.
8. Kindly activate the War rooms/EOCs and keep analyzing all trends and surges, no
matter how small and keep taking proactive action at the district/local level.
Regular reviews with field officers and proactive action in this regard will definitely control
the spread of infection and flatten the curve.
Yours sincerely
(Rajesh Bhushan)
Chief Secretary/Administrator of all States / UTs
Annexure-II
NATIONAL DIRECTIVES FOR COVID-19 MANAGEMENT
1. Face covering: Wearing of face cover is compulsory in public places; in workplaces;

and during transport.
2. Social distancing: Individuals must maintain a minimum distance of 6 feet (2 gaz ki

doori) in public places.
Shops will ensure physical distancing among customers.
4/6
1160
3. Spitting in public places will be punishable with fine, as may be prescribed by the
State/ UT local authority in accordance with its laws, rules or regulations.
Additional directives for Work Places
4. Work from home (Will): As far as possible the practice of WfH should be followed.
5. Staggering of work/ business hours will be followed in offices, work places, shops,
markets and industrial & commercial establishments.
6. Screening & hygiene: Provision for thermal scanning, hand wash or sanitizer will be
made at all entry points and of hand wash or sanitizer at exit points and common areas.
7. Frequent sanitization of entire workplace, common facilities and all points which
come into human contact e.g. door handles etc., will be ensured, including between
shifts.
8. Social distancing: All persons in charge of work places will ensure adequate distance
between workers and other staff.
****
Instruction to States to Implement New Guideline in view of initial signs of surge in

Covid-19/Omicron cases
Home Secretary
Government of India
North Block
New Delhi
27th December, 2021
D.O. No. 40-3/2020-DM-I (A)
Dear Chief Secretary,
Kindly refer to the Ministry of Home Affairs (MHA) Order of even number issued today, for
ensuring implementation of the measures that need to be taken, in view of initial signs of
surge in cases of COVID-19, as well as increased detection of the Variant of Concern
(VoC), ‘Omicron’, in different parts of the country, as conveyed vide Ministry of Health and
Family Welfare (MoHFW) D.O. letter dated 21st December, 2021.
2. The country has witnessed an overall decline in active cases. However, the new
variant, Omicron (designated as a VoC by the WHO on 26th November 2021), is reported
to be at least 3 times more transmissible than the Delta VoC, and is posing a new
challenge for the COVID containment measures. In the countries with Omicron-driven
surge, the growth trajectory of cases has been very steep. In our country, 578 Omicron
cases have already been reported in 19 States/UTs.
5/6
1161 in
3. Globally, Omicron cases have already been reported in 116 countries. Further, surge
cases is also being reported across various countries, especially in the USA, the UK,
Europe (France, Italy, Spain), Russia, South Africa, Vietnam, Australia, etc.
4. In this background, in the MoHFW advisory dated 21.12.2021, a normative framework

has been provided. With distinct presence of the Delta variant and detection of Omicron
cases in many States, there is need for greater foresight, data analysis, dynamic decision
making, and strict and prompt containment actions at the local and district levels, based
on the assessment of the situation.
5. On 23rd December, 2021, the Hon’ble Prime Minister has reviewed the status of
COVID-19, Omicron VoC and preparedness of health systems across the country. After
review, he has directed that we should be `Satark’ and `Saavdhan’. As per his directions,
it is important to maintain a high level of vigil and alertness at all levels. State
Governments should ensure that the health systems in the States are strengthened to
meet any challenge posed by the new variant. Further, the State Governments/UT
Administrations should ensure that oxygen supply equipment are installed and are fully
functional and the buffer stock of essential drugs should also be maintained.
7. I would also like to emphasise that there should be continued focus on the five-fold
strategy, i.e., Test-Track-Treat-Vaccination and adherence to COVID Appropriate
Behaviour, to avoid the possibility of surge in COVID-19 cases, especially keeping in view
the new VoC. The State enforcement machinery should strictly enforce the norms of
COVID Appropriate Behaviour, i.e., wearing of face masks and maintaining safe social
distancing in all public areas/gatherings.
8. As mentioned in my earlier DO letter, dated 30th November, 2021, with a view to

discourage any misinformation in respect of the new VoC, which creates anxiety among
the public, all States and UTs should proactively and regularly hold media briefings at the
highest level to disseminate the right information to them. States/UTs should also educate
them about various preventive measures undertaken by them and also advise them to
strictly follow COVID Appropriate Behaviour.
9. I would, therefore, urge you to issue necessary directions to the districts and all other
local authorities concerned, to take necessary measures for prompt and effective
management of COVID-19, strict compliance with various advisories issued by the
MoHFW on the new VoC and strict enforcement of COVID Appropriate Behaviour.
With regards,
Yours sincerely,
(Ajay Bhalla)
Chief Secretaries of all States
6/6
1/12/22, 7:16 AM Omicron was in Canadian wastewater in November before it was found in South Africa, World News I wionews.com
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m Researchers at Dalhousie University show that Omicron was in Nova Scotia wastewater in November. Photograph:( Twitter )
W FOLLOWUS
STORY HIGHLIGHTS
The first case of Omicron in Nova Scotia was confirmed on Dec. 13, just a few weeks after it was reported in South Africa on
Nov. 24.
Omicron was found in Nova Scotia wastewater weeks before it was discovered by the province
- and even before the novel COVID-19 strain was reported by South Africa, according to new
research from Dalhousie University in Canada.
Explaining the situation, Professor Graham Gagnon, director of the Dalhousie University Centre
for Water Resource Studies, said that "Our team detected Omicron, retrospectively, in Nova
Scotia wastewater in mid-November and will be able to orovide further information in the
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In late November, the first Omicron case was reported in South Africa.
Also read I After Xi'an, China locks down another city after detecting Omicron cases
(https://www.wionews.com/world/after-xian-china-locks-down-another-city-after-detecting-
omicron-cases-443820)
On December 13, the first cases in Nova Scotia were confirmed, and they were related to a
COVID-19 epidemic at St. Francis Xavier University in Antigonish.
According to the university, the virus survives longer in the gastrointestinal tract than in the
respiratory tract, which means genetic material can be identified in human waste despite the
fact that COVID-19 is a respiratory sickness.
Since December 2020, the Dalhousie team has been monitoring wastewater for COVID-19
indicators at the Halifax region's four main wastewater treatment plants: Halifax, Dartmouth,
Mill Cove, and Eastern Passage, as well as the Dalhousie campus's five student dormitories.
Explainer: China's 'zero covid' strategy; what it is, how it functions and does it work?
(https://www.wionews.com/world/explainer-chinas-zero-covid-strategy-what-it-is-how-it-
functions-and-does-it-work-442865)
"For us, it's been a successful project," said Gagnon. "It's a tool that can be used to help make
decisions."
Other sections of Canada are undergoing similar tests.
Since Omicron was discovered in the province in December, the levels of the COVID-19 virus
reported in wastewater have surged by nearly 88 percent in Saskatchewan.
According to Gagnon, a similar surge occurred in Nova Scotia, but he declined to be more
precise until the data was double-checked.
(With inputs from agencies)
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V
ANNEXURE P-55
IN THE COURT OF SH. SAURABH SHARMA

CIVIL JUDGE (JUNIOR DIVISiON), GURUGRAM
APPLICATION NO. of 2021

IN
CML SUIT NO. 79/2021
. (Suit u/ s-32 & 36 o.f Specific Relief Act 1963)
IN THE ·MATTER OF:

The· Secretary,
Ministry of Health and Family Welfare,
Government of India, ·
Nirman Bhawan, New Delhi-110011.
IN
·Sarvadaman Sin~h Oberoi
... Plaintiff
VERSUS,
Deputy C0mmissioner-Cum-Collector
& Chairperson, Gurugram District
Disaster Management Authority & Ors:
... Defendants(s)
APPLICATION ON BEHALF OF RESPONDEN,T N0.6,

UNDER ORDER VII RULE 11 R/W SEC-151 OF THE CIVIL
PROCEDURE CODE 1908 AND ALSO R/W SECTION-71 OF
. THE DISASTER MANAGEMENT ACT,2005.
THE APPLICANT ABOVE NAMED MOST RESPECTFULLY·

SHOWETH: -
1165
1. That the present application is being moved for and on
behalf of the defendant no.6 to reject the suit of the
plaintiff, as same has not been filed with a valid or a
reasonable cause of action, and is riot good in the eyes of
law.
2. That the· Applicant/Respondent No.6 submits that the
subject matter of the present suit does not fall within the
since the relief. under the said Act is -limited to ·. Civil

- . . .. .
Rights,.·anenforcement of fundamental right~ca.nrtot be·
invoked under the provisions of the· said. Act.
3. That, moreover the jurisdiction of the Civil Court is
expressly barred by Section-71 of the Disaster
Management Act, 2005, v,hich states as -
"No court (except the Supreme Court and aHon 'ble High
Court) shall have jurisdiction to entertain any suit. or
proceeding in respect of anything done, action taken,
orders made, direction, instruction or guidelines issued
by the Central Government, National Authority, State

1166
Government, State Authority or District Authority in
pursuance of any power conferred by, or in relation to
·its functions, by this Act."
4. That the filing of the present petition . by the
petitioner /plaintiff causes huge loss to the
applicant/respondent as it delays execution of the said
award. Applicant on t~e grounds of equity deserves
compensation for causing intentional delayedin payment
of the Awru:ded amount and consequential recovery of the
a.IIl.OUrits which has been incurred by the applicate to

·. .
represent .this fallacious and vexatiou~ case filed by the

.
petitioner (Mathura Authority).
5. That the balance of convenience lies is in favour of· the
defendant no.6 and the rule of law and judicial procedure
suggests that case must be ·heard by the co.urt of
competent jurisdiction hence present suit may be
rejected.
Prayer
1167
In the light of the above fact and circumstances presented
before this Court, it is most humbly prayed, that this
Court may be pleased to reject the suit of the plaintiff.

1168
ANNEXURE P-56
IN THE COURT OF SH. SAURABH SHARMA CIVIL JUDGE (JUNIOR

DIVISION) , GURUGRAM
IN THE MATTER OF:

Sarvadaman Singh Oberoi ... Applicant/ Petitioner-in-person
Versus
Deputy Commissioner-cum-Collector & Chairperson, Gurugram District Disaster
Management Authority & others
... Defendants
NDOH: 11.01.2022
Connected to APP 35/2021 NDOH: 24.01.2022
REJOINDER TO APPLICATION DATED 10.01.2022 ON BEHALF OF

RESPONDENT NO. 6, UNDER ORDER VII RULE 11 R/W SEC-151 OF THE
CIVIL PROCEDURE CODE 1908 AND ALSO R/W SECTION 71 OF THE
DISASTER MANAGEMENT ACT, 2005 IN SUIT FOR PERMANENT
INJUNCTION UNDER SECTIONS 32 & 36 OF THE SPECIFIC RELIEF ACT, 1963
READ WITH CUSTOMARY INTERNATIONAL LAW (WITH APPLICATION
FOR TEMPORARY INJUNCTION)
1. That for the reasons as explained in paragraphs 2 and 3 below it is denied that the
present application has not been filed with a valid or a reasonable cause of action,
and is riot good in the eyes oflaw. The application has grave and valid cause under
customary international law, Articles 300-A, 14, 19 & 21 as held by a 9 judges
bench in Justice K.S. Puttaswamy (Retd) and another v. Union of India and
others, (2017) 10 SCC 1 at SCC p.138 para 6 (& SCC p.8 para R).
2. That the application under the Specific Relief Act, 1963 read with Customary
International Law (CIL hereinafter) for right to property (which includes rights to
property of "special value or interest to the plaintifj'', in a matter of the greatest
complexity, enticement/ forcible persuasion to experimental treatment (EUL
Vaccine) in breach of informed voluntary consent by resort to overarching
restrictions on free movement of persons hesitant to subject their person/ body
(protected under right to privacy - Justice K. S. Puttaswamy (Retd.) v. Union of
India, (2017) 10 SCC 1 - 9 JUDGES BENCH- ANNEXURE A-18) to invasion
by emergency use license (EUL hereinafter) vaccines (experimental i.e. not fully
proven yet to be effective and inherently decignedly unsafe as per US Supreme
1169
2
Court - ANNEXURE A-5) some of which are mRNA based hence potentially
DNA altering vaccines (petitioner's DNA is protected under right to privacy),
hence falls within Section 4 of the Specific Relief Act, 1963, "4. Specific relief to
be granted only for enforcing individual civil rights and not for enforcing penal
laws.-Specific relief can be granted only for the purpose of enforcing individual
civil rights and notfor the mere purpose ofenforcing a penal law. " That individual
civil rights encompass all statutory reliefs such as in Section 10 of the Specific
Relief Act, 1963, constitutional rights such as Article 300-A of the Constitution of
India & fundamental rights such as Articles 14, 19 & 21 of the Constitution oflndia.
That Section 10 of the Specific Relief Act, 1963, "JO. Cases in which specific
performance of contract enforceable. -Except as otherwise provided in this
Chapter, the specific performance of any contract may, in the discretion of the
court, be enforced-(a) when there exists no standard for ascertaining the actual
damage caused by the non-performance of the act agreed to be done; or, (b) when
the act agreed to be done in such that compensation in money for its non-
performance would not afford adequate relief
Explanation. -Unless and until the contrary is proved, the court shall presume-
(i) that the breach of a contract to transfer immovable property cannot be
adequately relieved by compensation in money; and
(ii) that the breach of a contract to transfer movable property can be so relieved
except in the following cases:-
(a) where the property is not an ordinary article ofcommerce, or is ofspecial value
or interest to the plaintiff. or consists of goods which are not easily obtainable in
the market;
(b) where the property is held by the defendant as the agent or trustee of the
plaintiff. "
3. (a) DISASTER MANAGEMENT ACT, 2005 - STATEMENT OF OBJECTS AND

REASONS
"The Government have decided to enact a law on disaster management to provide
for requisite institutional mechanisms for drawing up and monitoring the
implementation of the disaster management plans, ensuring measures by various
wings ofGovernment for prevention and mitigating effects ofdisasters and for
undertaking a holistic, coordinated and prompt response to any disaster situation.
1170
3
2. The Disaster Management Bill, 2005 provides for setting up of a National
Disaster Management Authority under the Chairmanship of the Prime Minister,
State Disaster Management Authorities under the Chairmanship ofthe Chief
Ministers and District Disaster Management Authorities under the Chairmanship
of District Magistrates. The Bill also provides for concerned Ministries or
Departments to draw up department-wise plans in accordance with the national
disaster management plan. It provides for constitution of a National Disaster
Response Force and setting up the National Institute of Disaster ~Management.
The Bill provides for the constitution of the-National Fund for Disaster Response
and the National ·Fund for Disaster Mitigation and similar Funds at the State and
District levels. The Bill provides for specific role for Local Bodies in disaster
management including Panchayati Raj Institutions as well as Urban Local Bodies
like Municipalities.
3. The proposed enactment will facilitate effective steps for the mitigation of
disasters, prepare for and coordinate effective response to disasters, as also
matters connected therewith or incidental thereto .
4. The Bill seeks to achieve the above objects .
(b) Complex jurisdictional facts [and negative facts being that State, in its oral
arguments has claimed a contract between the State and its citizen under Article
5 JA Fundamental Duties to submit his privacy/ body (property protected by
Article 300A) to DNA damage / protein spike adjuvant damage in COVISHIELD/
COVAXIN respectively] arise and hence matter is not amenable to writ i.e. Article
32/226 in the High Court;(See para 5 below) furthermore not amenable to Section
30 of Act 10 of 1994 till the 28 year hiatus in Section 31 is rectified; exclusion of
criminal law of India vide List ill Item 1 (Art. 246); bars constitutional remedy
. concerning human rights offence; attracts mischief of Articles 2.3 & 14.1 ICCPR,
1966. Only this civil remedy of specific relief of injunction is immediately available
in this emergent fact and law situation. In this background this court would hesitate
to readily accept statutory exclusion of jurisdiction because "It is settled law that
the exclusion ofthe jurisdiction of the Civil Courts is not to be readily inferred, but
that such exclusion must either be explicitly expressed or clearly implied. It is also
well settled that even ifjurisdiction is so excluded, the Civil Courts have jurisdiction
to examine into cases where the provisions ofthe Act have not,been complied with,
1171
or the statutory tribunal has not acted in conformity with the fundamental principles
ofjudicial procedure. " [Secretary of State v. Mask & Co., [1940] 132 [P.C.]]
This principle oflaw was upheld in Rand Mahan ta v. Nirmalendu Sana, 2021 (3)
RCR (Civil) 815, MANU-SC-0519-2021. That it is pertinent to note that in
Guidelines issued for" Management of Biological Disasters" by the National
Disaster Management Authority in July 2008 under Sections 6 & 10 of the Disaster
Management Act, 2005 [ISBN: 978-81-906483-6-3] at Chapter 4, Para 4.2.5 viii)
Immunisation/vaccination programmes; at page 43 the Policy of ND MA is "India
has a sizeable capability, built over the years, for implementation of its universal
immunisation programme for six vaccine preventable diseases. It is capable ofmass
vaccination campaigns in disaster settings. Mass vaccination campaigns and
proplrylaxis programmes could be useful when indicated in diseases like tetanus,
measles, typhoid, cholera, viral hepatitis, etc. Appropriate influenza vaccination,
depending on the causative strain, may be considered when the situation demands
it. Such campaigns may be required in pandemic influenza and BT attacks using
smallpox virus or for any other emerging bacterial or viral etiologies. MoH&FW
will lay down a clear vaccination policy. have a stockpile of vaccines, identify and
train the vaccinators and have cold chain management. Capacity will be developed
in the pharmaceutical sector for creating a viable high-tech infrastructure for
vaccine research and production. Immunisation programmes under continuous
monitoring and reporting mechanisms will be an effective preventive strategy. "
(c) That in an RTI Reply No. Z.60011/2020-CVAC dated 09.03.2021 to Sh. Anurag
Sinha, Qtr No. 10, P.O. Swang Bokaro, Jharkand, Gomia, 829128, Jharkand the
MoH&FW has clarified that no adverse consequences shall arise to unvaccinated
persons and the vaccine is purely voluntary, a "clear vaccination policy" in accord
with para 4.2.5 viii) of the Guidelines issued for" Management of Biological
Disasters" by the National Disaster Management Authority in July 2008 under
Sections 6 & 10 of the Disaster Management Act, 2005 [ISBN: 978-81-906483-6-
3]. Thus national policy is clearly laid down by Central Government whose
direction binds State Governments under Sections 6 & 10 of the Disaster
Management Act, 2005. The copy of the reply follows:
1172
s
~flTT;r .mm ::r.s.60011 :0512020-mattrm

:ITT«,~ •
~ :1-!CW.,
~ITTm
~CR mu-. 2021
_.,,,.
To.
I .
~h. Anurag Sinha.
6tr no. 10 po swang bokaro
Jharkhand , gomia , 829128
Jharkhand
'f'l~r 3TT1< Ji'G-;fi .,m.tt .3-ff$- ,r.:r:i,wm'tli~.f3iTT'$' 21 1006Jo. 3'7"<-tl",~ . ~ - 200s

~ tia.t ,q- ~~ :,.,t.~e,i'I ., m kfl,; 3,TI.tr 3lf$".(RTI)
cfi1 ~ 27 02.2021 q;'\ l<1'=C, tGTT
I.mm I ~ ili ,;nr.;r

! if-l'f
l - - - - - - - - - -- -- --
f<l;m :;ft m<mi" ~JT . .-11ll~q-,c--ll ,

-~ ~ "B' ~ ofil" - ~ ·
I
, iv ;' mt ~ ias ips "f"dlt't<i m ~

., ~ ~ ;~ ~ t I
1 <h1 mrcf.t· ~ cf.! ~ ~ ~ rl'T ~ "'~ tii rTT
i ;;rr.rftq,lfm<R"~<fm<!i'tt-~~6
v i~ c'i<f~ .;tf ~ 'TT" ~·r. ~ - fa~afa~_<11N<1 , I

~ cf>irif~r;;;, q,.f] , fu:;rc;rt ~~I?.. mJ.1 ~ ~ i
I
fc.ttr<f<TT~~~ ;
i
Vi q-<)T ~ ~ ~ qi: ~ t ~ffi ~ ~ 6 I
~ ~ ;;JT Wl,"(f ~- f.'wll" 3ftr ffic!iffi fii~171 i';T?.1 I
I *- l
1173
2. mt 3TT'1' 3r<TT ~ ~ ;,ffe t. ~ ~.i;n, ~ vil<IT, 3'TT1fmr, cm. m. tJ". m.). q;.;i .
435 m.-wi . .=-~<! 3fn' cifum ~ r .i-~. :},"Qr! :ITTrvl', ~ ~ *~ 3'm't ~ l!1fG::r
i 3o ft;:r, ~ ~ ~ ~ 'fjzj t I cl'! ~.ff ~ it ~ ~ f I
~
~ l f- J;t-
(m-cr fuc:)
.wn ~ }ln" ~~.m. 31ffi!' ,ff<W
c.T'n;C!( 7.: ot !-<3cU'1.'-! 0,
"
~ ~ t ~~: ~V' \
,. },~77[ L~~~3l~ ~.~" ~
(.!W/600~1 ·c,-=oi'll! i:l l!llisc!""<J.{3-ITT'~/21 t00630, ~
qfta-r{
27.02.2021
~ ~ JITT .tr.~
"'~~ Hi
- IF, .F..
2. }!<TT~ (~.). BIT.~ qq:,-~
4. That in view of the facts and law arising as at paras 2 & 3 above, the contention of
the respondent that "the filing of the present petition by the petitioner I plaintiff
causes huge loss to the applicant I respondent" is misconceived and hence the
respondents' further contention that "Applicant on the grounds of equity deserves
compensation for causing intentional delayed in payment of the Awarded amount
and consequential recovery of the amounts which has been incurred by the
applicate to represent this fallacious and vexatious case filed by the petitioner" is
misconceived and hence the respondents needs must furnish apology for hurt caused
from 01.01.2022 till date by the issue of Paras II (COVID-19 Vaccination ofeligible
persons (more than 15 Years) is mandatory.) & VII (The violators of COVID-19
appropriate behavior including wearing of masks, social distancing and persons
(adults) who have not received any COVID-19 vaccination dose or due for 2nd
COVID-19 vaccination dose. shall be imposed a fine of R.s. 500/- by issuing a
Challan. Institutional violators shall be imposed a fine ofRs. 5 000/- similarly. Non-
payment offine and major violations will attract proceedings under the provisions
of Section 51 to 60 of the Disaster Management Act. 2005, besides legal action
under Section 188 of the IPC, and other legal pro \visions as applicable.) I II &VIII
in the Notifications dated 01.01.2022 of GDDMA/ HSDMA respectively.
5. That the balance of convenience lies in favour of· the petitioner and the rule of law
and judicial procedure suggests that case must be heard by this court of original
1174
customary international law jurisdiction which alone is competent to hear present

suit due complex jurisdictional facts requiring admission/ denial of documents at
preliminary stage in light of the rulings (1) Mcons Infrastructure Ltd v. Cherian
Varkey Construction Co. Pvt. Ltd., (2010) 8 SCC 48 (2) Shamsher Singh
Verma v. State of Haryana, (2016) 15 SCC 485 and as also elucidated in DD
Basu's Commentary on the Constitution of India, 9th Edition, ISBN: 978-8 1-3 125-
263-5. The relevant extract from Basu's 9th Edition Volume 10 pp.10630-10631 is
as follows:
- ----
Dr --
Durga-Das
- -Basu.
- - Com1m•mm:i-
- - - - - :0- -,-C d1· · 9tli Editi c•n • \"ol•ume I 0. ::oIf:
-;::.- -:-.--:--:-.~ ,-J-
11 111e nn<tliut1on o 11 " ·
!SB'\ : 97S-S 1-3125- 263 -5

Printed hy: Saurabh Printers ht. Lld .. 6"A-68, Ecotec l1 Extn.- I• Ka<-11°" · Gr··a•er
J _, '
'\;oid:i
· ·•
10630 Art. 226 Parr \II-Th!! Srm es- Clwprer \ 1- T/ie High Courrs in 1he Srmes
Exceptions to the Rule of Exh austion in India

. 1. Our Su preme Cou11 has. accordingly. uch:no\\·ledged a number of e:-;ceptional
circumstances under which relief under Art. 226 ma,· be 2ranted notwi1hst::rndin2 the
fact that the petitioner has not exhausted his statuiory (emedies. These e:-;ception~
make ou r ,nit juri sdicti on fo r more effecti,·e and\\ ider than in Englund and rnuh:e ii
comparable to th:it in the L'.S..4 . ,\·here liberal exi:ep\[Qfl S to the exhau stion of qatut C1~
ry remedies postponing judicial re,·ie,\· are admitted· ·' ' (thou~h the decisions are not.
in all respects. uniform.· ~ ·
2. Vvl1at the. e exceptional circumqance s are. cannot be exhau tiYelv enumerated::;-~
be~·a~~<;_~ the_ m~tter is pre-e~1inently o~e for the di scretion of the C~urt i,suing the
\\·nt. which 1s to be exercised accord mg to the fact-. of each case. It 1s the Im,·. that a
claimant will not be required to uYail some other procedure if that other procedure is
··Jess satisfactory'· or ..otherwise in appropriate .. In each case the que. tion is ,,·hether
the court should exercise its discretion . it \\ ould be both foo li sh and impossible to seek
to anticipare·· all the factors that may properly influence the court's discretion_:_;-· NeY-
erthe less. the following may be menti oned amon!!st i · · ,. ere the . u v
grant relief v hou 0 t ton· reme 1es haw not been exhausted-
(i l V-._. here ~here ,~;q~ a complete lac~ of j uri. dictiorv~·ith the officer or authori -
ty or tnbunal.. to take the acuon impugned.-· e.g .. where the proceed-
, . . . . ... ~S il
in2 ~ ha\"e oeen taken under a b,\- \\'h1ch 1s 11 /1m r1res-· or upon an erro-
neou:- interpret.;ition of the . tatut c:, 9r \\·here the imposition is \\'ithout au -
thorit,· of 1.rn·- ·' or ufrm 1·ire., :··•·' - The same principle appl ie, in cases
wher~ ,1ction i~ taken on the basis of a rule tdele!!ated de le!!i . bti,e l \\·hich
is 1/irrn 1·ire.1 tht' p:1rent ..\L·t _:~' -' ur without a.1~ m:.11erials- to support the
c\1nc!u~ion tha t the ,.;_ta.tutory c0nd i1ion~ precedent fo r the a<s,;u1np1ion of ju-
risdi ' tic1:1 did :.::-; i,1:·--·' " hut 11<11 whert' the determin,niun of the ·urisdictional
fact it~d f in \·ohe,, ::i e.a orate Jn( u1 r~· 0 11 ta ·111g c,·idence an
c alllh)l he m e n a fh :I \ : .. ·
., .T.c 1. , . _c, ;,il A'.1;, ;;1 9r, ,s 1 .' SC R - I · < i1 (1 il' i,; ()i ,co11111 Cu. ,·. I . T.'O .. :\I R
' .
1
i /.· · ~ 1, : ~: rt , .• .\·t d 1 · 11: F ( r, -.. \\'ur en ..-\I R !963 SC ~f-.. •,.f~ ;..; ,
(:, 1• · ·. • '" ; __' _l'l~.' 1.-~ SCR :"..!(1: I,,; , _ , _ L... ~-
1175
g
PRAYER
It is most respectfully prayed that in view of submissions above the application of
respondents under Order 7 Rule 11 deserves dismissal.
Gurugram
11.01.2022
[ 2,,-CI I . k 2,,1.__-,
Lt Col 01eteran) Sarvadaman Singh Oberoi
Mob: 9818768349, Email: manioberoi@gmail.com ·
ANNEXURE P-57 1176
HISTORY OF HOMOEOPATHY IN INDIA 1839-2013

The system of homoeopathy was brought into India by missionaries and travellers during
the life time of Dr Hahnemann (10.04.1755-02.07.1843). But, the earliest evidence of
official patronage received to system was through a Romanian, Dr. John Martin
Honigberger. Dr. Honigberger arrived at Lahore in 1829-30, and later in 1839 was invited
to treat Maharaja Ranjit Singh of Punjab.
In Nov. 1851, a Native Homoeopathic Hospital and free dispensary was started at Calcutta
under the patronage of the honorable Sir John Hunter Little, Dy. Governor of Bengal and
President of the council of India. Dr. Tonnere, a French allopathic doctor by education but a
converted homoeopathic doctor, was appointed as In-charge of that hospital.
In 1867 Banaras Homoeopathic Hospital was established with Shri Loke Nath Moitra, as
Physician In-charge. In August 1869 a homoeopathic charitable dispensary was started at
Allahabad with Shri Priya Nath Bose as the Physician In-charge of the dispensary. In 1870,
the Maharaja of Jaipur sent for Dr. Salazar of Calcutta for the treatment of his cataract.
In April 1937, Md. Ghias–ud-idin, M.L.A. moved a resolution in the Legislative Assembly
of Bengal for its recognition. The resolution was passed and forwarded to the State
Governments for its implementation and Bengal became the first province in India to
constitute a Homoeopathic State Faculty in 1943.
In 1937 the Central Legislative Assembly resolved, “That this Assembly recommends to the
Governor General in Council that he may be pleased to introduce Homoeopathic treatment
in government hospitals and give homoeopathic colleges in India the same status and
recognition as in the case of allopathic colleges”.
This was followed by constitution of the Homoeopathic Enquiry Committee. In 1949, this
Enquiry Committee submitted its report recommending that Central Homoeopathic Council
be constituted. In 1952, a Homoeopathic Adhoc Committee (later re-christened as
‘Homoeopathic Advisory Committee' in 1954) was constituted, which was to advise the
Government on all matters related to Homoeopathy, namely homoeopathic education,
homoeopathic research, regulation of practice, pharmacopoeia, rural medical aid, drug
1177
manufacture, family planning, financial aid to homoeopathic colleges, dispensaries,

hospitals and cooperation with International Homoeopathic Medical League.
After independence and formation of National Government, on 17th February, 1948 Shri
Satish Chandra Samanta, M.P. (West Bengal) moved a resolution in the Central Legislative
Assembly (Constituent Assembly) which runs as follows: “This Assembly is of opinion that
homoeopathic system of treatment be recognized by the Indian Union and that a General
Council and a State Faculty of Homoeopathic Medicine be established at once”.
This resolution was discussed for three hours and unanimously adopted as an official
resolution on 17th February 1948 under first Health Minister of India Rajkumari Amrit Kaur.
This was followed by constitution of the Homoeopathic Enquiry Committee in 1948 by the
Central Government. In 1949, this Enquiry Committee submitted its report recommending
that Central Homoeopathic Council be constituted.
In 1952, Rajkumari Amrit Kaur, the then Union Health Minister appointed a Homoeopathic
Ad-hoc Committee , which was to advise the Government on all matters related to
Homoeopathy, namely homoeopathic education, homoeopathic research, regulation of
practice, pharmacopoeia, rural medical aid, drug manufacture, family planning, financial aid
to homoeopathic colleges, dispensaries, hospitals and cooperation with International
Homoeopathic Medical League.
In 1954 Government re-christened it as Homoeopathic Advisory Committee. In 1956, this

Advisory Committee was taken over by the Minister of Health and Secretary in the Ministry
of Health became its first Chairman. Govt. of India appointed Dr. K. G. Saxena as first
Honorary Homoeopathic Advisor in 1962. This Advisory Committee also recommended
the constitution of a Central Council of Homoeopathy. A special panel of Planning
Commission of Indian Systems of Medicine and Homoeopathy endorsed this
recommendation in 1952, 1956 and 1966. The Central Council of Health comprising of the
State Health Ministers recommended in 1965 that the Central Council of Indian Systems of
Medicine may be set up as early as possible to lay down and regulate the standards of
education, examination and practice in Ayurveda, Unani and Homoeopathy.
1178
The Central Council of Health, therefore, constituted a Sub-Committee in October, 1967

with Pandit Shiv Sharma the Chairman to look into the details of the proposed legislation.
Accordingly, the Bill for Indian Medicine and Homoeopathy Central Council was introduced
in the Rajya Sabha on 17-12-1968. A joint Committee of Parliament considered the Bill.
The exponents of Homoeopathy and also the experts of the three systems of Indian Medicine,
viz., Ayurveda, Unani and Siddha represented before the committee that the basic concepts
of Indian Medicine were different from the fundamentals of Homoeopathy and, therefore, a
separate Council of Homoeopathy was needed. For the proper growth and development of
all the four systems, the Committee recommended two separate independent Central
Councils, one for all the three systems of Indian Medicine and the other for Homoeopathy.
The Committee amended the Bill suitably so as to make provisions for a composite Central
Council for the three Indian Systems deleting references to Homoeopathy. The Committee
also recommended for preparation of a separate Bill for Homoeopathy and drafted a Bill on
similar lines for introduction in Parliament. On the basis of these, The Homoeopathic
Central Council Bill was drafted and was introduced in the Rajya Sabha on 3rd April, 1972.
Subsequently the bill was passed by the Lok Sabha and on 19th December, 1973, the
President of India gave his consent to the bill. Thus Homeopathy Central Council Act, 1973
came into existence in 1973
Homoeopathy is currently used in over 80 countries. It has legal recognition as an individual

system of medicine in 42 countries and is recognized as a part of complementary and
alternative medicine in 28 countries.[1] WHO considers Homeopathy as one of the most
commonly used forms of Traditional & Complementary Medicine (T&CM).[2] Legal Status
of Traditional Medicine and Complementary/Alternative Medicine, A Worldwide Review,
WHO 2001
[1] 2001 Legal Status of Traditional Medicine and Complementary/Alternative Medicine: A

worldwide review. Geneva: World Health organization, 2001
[2] WHO; Safety issues in the preparation of homeopathic medicines, 2009
[3] AYUSH Annual Report, 2012-2013 (Extracts)

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IN THE COURT OF CIVIL JUDGE (SENIOR DIVISION) , GURUGRAM

CIVIL SUIT NO. 192 OF 2022

IN THE MATTER OF:

SUIT FOR PERMANENT INJUNCTION UNDER THE SPECIFIC RELIEF ACT,

IN THE COURT OF CIVIL JUDGE (SENIOR DIVISION) , GURUGRAM

CIVIL SUIT NO. 192 OF 2022

IN THE MATTER OF:

ANNEXURE P 12: P-12 2017.01.31 Allocation of Business Rules of

ANNEXURE P 34: P-34 2021.02.22 Hon'ble High Court of Delhi

IANNEXURE P 55: P-55 2022.01.11 Union of India Application 1164-

IN THE COURT OF CIVIL JUDGE (SENIOR DIVISION), GURUGRAM

CIVIL SUIT NO. OF 2022

11'1' THE MATTER OF:

1. Union of India through Secretary, Ministry of Ayush, Government of India, Ayush

IN THE COURT OF CIVIL JUDGE (SENIOR DIVISION) , GURUGRAM

CIVIL SUIT NO. OF 2022

IN THE MATTER OF:

Mob: 9818768349, Email: manioberoi@gmail.com

IN THE COURT OF CIVIL JUDGE (SENIOR DIVISION) , GURUGRAM

CIVIL SUIT NO. 192 OF 2022

IN THE MATTER OF:

SUIT FOR PERMANENT INJUNCTION UNDER THE SPECIFIC RELIEF ACT,

Most respectfully submitted

4. That documents in ANNEXURES P 1 to P 57 are submitted herewith for admission

IN THE COURT OF CIVIL JUDGE (SENIOR DIVISION), GURUGRAM

CIVIL SUIT NO. OF 2022

IN THE MATTER OF:

1102/Tower 1 Uniworld Garden I, Sector 4 7 Gurugram, Haryana~ do hereby solemnly affirm

and declare as under:-

affidavit on his own behalf.

., . .. . Oath c.-;1n, r;•: :::1nn&t

IN THE COURT OF CIVIL JUDGE (SENIOR DIVISION) , GURUGRAM

CIVIL SUIT NO. 192 OF 2022

IN THE MATTER OF:

EXEMPTION UNDER SECTION 80(2) CPC IN SUIT FOR PERMANENT

Most respectfully submitted

4. That documents in ANNEXURES P 1 to P 57 are submitted herewith for admission

and feelings of loss of dignity as we no longer live in a monarchical or sovereign

IN THE COURT OF CIVIL JUDGE (SENIOR DIVISION) , GURUGRAM

CIVIL SUIT NO. OF 2022

IN THE MATTER OF:

1102/Tower 1 Uniworld Garden I, Sector 4 7 Gurugram, Haryana, do hereby solemnly affirm

and declare as under:-

on his own behalf.

',JfJRU ... - submissions are based upon information believed to be true.

132 [P. C.] SECRET.ARY OF STATE v. MASK & Co. [1940

the jurisdiction of Civil Court was barred to enter-

2022-01-11 (Page 1 of 7) MANU/PR/0022/1940 SARVADAMAN OBEROI

A. W.R.] SECRETARY OF STAT& v. MASK & Co. [P. C.] 133

2022-01-11 (Page 2 of 7) MANU/PR/0022/1940 SARVADAMAN OBEROI

134 [P. C.J SECRETARY OF STATE v. MASH & Co. [1~)40

2022-01-11 (Page 3 of 7) MANU/PR/0022/1940 SARVADAMAN OBEROI

A, W.R.] SECRETARY OF ST.A.TE v. MASK & Co. [P, C.] 13S

2022-01-11 (Page 4 of 7) MANU/PR/0022/1940 SARVADAMAN OBEROI

136 [P. C.J SECRETARY OF STATE v. MASK & Co. [1940

2022-01-11 (Page 5 of 7) MANU/PR/0022/1940 SARVADAMAN OBEROI

A. W.R.] SECRETARY OF STATE v. MASK & Co. [P. c.] 137

held, as regards the present case, that 4 A I R 1937 Mad 536.

2022-01-11 (Page 6 of 7) MANU/PR/0022/1940 SARVADAMAN OBEROI

138 [P. C.] SULEMA.N HAJI v. ABDULLA HAJI [1940

2022-01-11 (Page 7 of 7) MANU/PR/0022/1940 SARVADAMAN OBEROI

572 SUPREME COURT OABES (1979) 1 sec

(1979) 1 Supreme Court Cases 572