SYLLABUS

613. INDIAN PHARMACEUTICAL REGULATION AND GUIDELINES

Teaching Hours-4 H/W Credit : 3

1. Drugs and Cosmetic Act 1940 and Rules 1945, Present policies for import
and export of drugs and pharmaceuticals.
2. DCGI guidelines for manufacturing and registration of pharmaceuticals.
3. State FDA guidelines for manufacturing and registration of
pharmaceuticals.
4. Narcotic Drugs and Psychotropic substances Act 1985 and Rules
5. Drugs( Price Control) Order 1995
6. Drugs and Magic remedies (Objectionable Advertisements) Act 1954
7. Prevention of cruelty to animals Act 1960 with special reference to IAEC.
8. Introduction and applications of : ISO standards, ORANGE BOOK, Six
sigma
and White papers in pharmaceutical practices.
9. Introduction to all International pharmaceutical regulatory authorities
like: IIG,IPEC, CTFA and COLIPA. WHO , USFDA, MHRA, EMEA, TGA,
ANVISA, OECD, ICH etc.
Reference:
1. The Drugs And Cosmetics Act, 1940 & Rules-1945 Law Publication
2. Drugs And Cosmetics Act 1940 & Rules 1945, Malik Vijay, Eastern Book
Company
3. The Drugs ( Prices Control) Order, 1987 : Along with New Drugs Policy,
1994 And Drugs (Prices Control) Order 1995, Law Publication
4. A Text Book Of Forensic Pharmacy, By- Jain N.K., Vallabh Prakashan
5.NDPS ACT 1985 & The Prevention Of Illicit Traffic In Narcotic Drugs And
Psychotropic Substances Act, 1988”, Law Publication
6. Guide lines of IIG,IPEC, CTFA and COLIPA. WHO , USFDA, MHRA, EMEA,
TGA, ANVISA, OECD, ICH,ISO etc.
7. Drugs and Magic remedies (Objectionable Advertisements) Act 1954-
Law Publication
8. Prevention of cruelty to animals Act 1960 with special reference to
IAEC- Law Publication
 D & C Act
An Act to regulate the import, manufacture, distribution and sale of drugs
and cosmetics.
How it regulate, it regulate by –
1) Licensing procedures by Authorities -DCG(I),Dy.DC,State
LA,Custom.Collector. For-
a) Import
b) Manufacture
c) Distribution
d) Sale
e) Export- of Different drugs & Cosmetics.
2) Inspection procedures by Authorities.-DI,SDI,AC,DC,JC
3) Sampling & testing procedures by Authorities.- DI,SDI, AC,DL,CDL
4) Amendment in Drugs & Cosmetics Act & Rules by DCC,DTAB & CG.
 Authorities Under D & C Act
1) DCG, India, Delhi-LA for granting of License/Approval
of-(LA under Sec-21)

a) New drugs approvals-Allopathic &Homoeopathic

& Clearance of Fixed dose combinations.
b) LVP, Vaccines, Sera, r-DNA recombinant products
c) Blood Bank & its products
d) Medical devices
e) BA/BE study centers approvals
f) Clinical Trails centers approvals
g) Import, Export approval Procedures
h) WHO GMP certificate issuance
i) Regarding amendment in D & C Act & Rules-
Framing Policy on Drugs & Cosmetics
j) Ban of Drugs in India
k) Amendment in IP-Member of IP Commission
l) Establish the drug standards and regulations, and
administer the drug and cosmetics Act and Rules.
m) Co-ordinate with the drugs controller of states
and union territories.
n) Check and control the quality of drugs and
cosmetics.
2) Dy.DC-Zonal officers-N,S,E,W,C ZONES
( DDC, ADC, Inspectors)
a) Inspecting Authorities
b) Renewal of Licenses
c) Export clearance of drug & cosmetics at ports
3) ADC & Drugs Inspectors- Inspecting Authorities
4) Central Drug Laboratories-Appealate
laboratory, keeping & supplying Reference
standards, analytical method development
5) DCC & DTAB –For Drugs & ASU Drugs
 Director Of AYUSH, New Delhi
• Guideline Regarding AYUSH system of
Medicines.
• Amendment in D & C Act & Rules Regarding
AYSUH system of Medicines.
• New AYSUH Medicine product approval.
• Inspection of Public Testing laboratory for
testing of AYSU medicines.
• Preparation of Ayur.Pharmacopoea.
Drug Technical Advisory Board( For
Drugs and Ayurvedic Drugs)
To advise the Central Government and the
State Governments on technical matters
arising out of the administration of this Act
and to carry out the other functions assigned
to it by this Act.
Drugs Consultative Committee(For
Drugs and Ayurvedic Drugs)
To advise the Central Government, the State
Governments and the Drugs Technical
Advisory Board on any other matter tending
to secure uniformity throughout [India] in the
administration of this Act.
 State Licensing Authorities.
a) Commissioner –For Allopathic Drugs-Dr. H.G.Koshia.
b) Joint Commissioner(Drug)-For Homoeopathic
drugs & Cosmetics
c) Joint Commissioner(Ayurved)-A,S,U drugs
d) Dy. Commissioners(6)-Inspecting Authority at HQ
d) Assistant Commissioner-(District)-For Sale of
drugs(Retail & wholesale license)
e) Senior Drugs Inspectors- -Inspecting Authority
f) Drugs Inspectors-Inspecting Authority
g) JC(T) Baroda- Analysis of drugs,Ayu.drugs &
Cosmetics & issue of Test Reports, Inspection of
Public Testing Laboratory. Analysis of Food & issue of
Test Reports
(Labo. At Baroda, Rajkot, Bhuj)
 Power of Commissioner

1) Approval of plan of Premises for Drugs.

2) Grant & Renewal of License for Manufacturing of Drugs.
3) Grant of additional product permission of drugs.
4) Issuance of different certificates as mentioned in next slide.
5) Preparing License of Blood Bank, LVP, Vaccines, Sera, Medical Devices in triplicate for approving of CLAA
& sending for approval.
6) Grant & Renewal of Test License.
7) Grant & Renewal of License for Public testing Laboratory.

Power of Joint Commissioner(drugs)

1) Approval of plan of Premises for Cosmetics & Homoeopathic drugs.

2) Grant & Renewal of License for Manufacturing of Cosmetics & Homoeopathic drugs.
3) Grant of additional product permission of Cosmetics & Homoeopathic drugs.
4) Issuance of different certificates as mentioned in next slide.

Power of Joint Commissioner(Ayurved)

1) Approval of plan of Premises for Ayurvedic, Sidhdha, Unani drugs.

2) Grant & Renewal of License for Manufacturing of Ayurvedic, Sidhdha, Unani drugs.
3) Grant of additional product permission of Ayurvedic, Sidhdha, Unani drugs.
4) Grant & Renewal of License for Public testing Laboratory for ASU drugs.
5) Issuance of different certificates as mentioned in next slide in respect of ASU drugs.
 Fees and Certificates issued by FDCA
1. Rs. 50/- for certificate for no conviction.
2. Rs. 50/- for certificate for performance.
3. Rs. 50/- for certificate for capacity.
4. Rs. 50/- for certificate for registration-cum-
membership.
5. Rs. 50/- for certificate for regarding intermediate.
6. Rs. 50/- for certificate for Free Sale.
7. Rs. 50/- for certificate regarding market product.
8. Rs. 50/- for certificate whether particular item is drug
or otherwise.
9. Rs. 50/- for certificate regarding consumption.
10.Rs. 50/- for certificate validity of licence.
11. Rs. 1000/- for WHO, GMP original certificate and Rs.
50/- additional copy.
12. Rs. 500/- for original state GMP certificate and Rs.
50/- for additional copy.
13. Rs. 50/- for original other certificate and Rs. 10/- for
additional copy.
14.Fees for the approval of the plan.
a) Rs. 250/- for allopathic plan.
b) Rs. 50/- for ayurvedic and homeopathic plan.
c) Rs. 100/- for cosmetics plan.
15. Fees for change of plan:
a) Rs. 100/- for allopathic plan.
b) Rs. 20/- for ayurvedic and homeopathic plan.
c) Rs. 50/- for cosmetics plan.
 Central Drugs Laboratory
(i)To analyze or test such samples of drugs as may
be sent to it under sub-section (2) of Section 11,
or under sub-section (4) of Section 25 of the Act;
(ii) To carry out such other duties as may be
entrusted to it by the Central Government or,
with the permission of the Central Government,
by a State Government after consultation with
the Drugs Technical Advisory Board.
 List Of Central Drugs Laboratories
(1)Central Drugs Laboratory, Kolkotta-For Drugs-
(Main laboratory.)
(2)Central Research Institute, Kasauli-
For Vaccine,Sera,Toxoid for human use.
(3) For Oral Polio Vaccine-
(a)Pasteur Institute of India, Coonoor.
(b) Enterovirus Research Centre (Indian Council
of Medical Research), Haffkin Institute
Compound, Parel, Bombay-400012.]
(c) The National Institute of Biologicals, NOIDA.]
(4)Indian Veterinary Research Institute,
Izatnagar or Mukteshwar-
-For veterinary Vaccine,Sera,Toxoids
(5) Central Drug Testing Laboratory, Chennai-
For condoms
(6) Serologist and Chemical Examiner to the
Government of India, Calcutta- For VDRL
Antigen.
(7) Central Drug Testing Laboratory, Thane-
-For Intra-Utrine Devices and falope Rings
8) For human blood and human blood products
(a) National Institutes of Communicable
Disease, Department of Microbiology, Delhi.
(b) National Institute of Virology, Pune
(c) Centre of Advanced Research in Virology,
Christian Medical College, Vellore.]
(9) Homoeopathy Pharmacopoeia Laboratory,
Ghaziabad-For Homoeopathic drugs
(10) National Institute of Biologicals, NOIDA-
- For Blood Grouping reagent and diagnostic kits
for Human Immunodeficiency Virus, Hepatitis B
Surface Antigen and Hepatitis C Virus
 Definitions
“Ayurvedic, Siddha or Unani drug”
It includes all medicines intended for internal or
external use for or in the diagnosis, treatment,
mitigation or prevention of [disease or disorder in
human beings or animals, and manufactured]
exclusively in accordance with the formulae
described in, the authoritative books of
Ayurvedic, Siddha and Unani (Tibb) systems of
medicine], specified in the First Schedule
First Schedule
Books of Ayurveda
1. Arogya Kalpadruma
2. Arka Prakasha
3. Arya Bhishak
4. Ashtanga Hridaya
5. Ashtanga Samgraha
6. Ayurveda Kalpadruma
7. Ayurveda Prakasha
8. Ayurveda Samgraha
9. Bhaishajya Ratnavali
10. Brihat Bhaishajya Ratnakara
11. Bhava Prakasha
12. Brihat Nighantu Ratnakara
13. Charaka Samihita
14. Chakra Datta
15. Gada Nigraha
16. Kupi Pakva Rasayana
17. Nighantu Ratnakara
18. Rasa Chandanshu
19. Rasa Raja Sundara
20. Rasaratna Samuchaya
21.[Rasatantra Sara Va Siddha Prayoga Sangraha—Part 1]
22. Rasa Tarangini
23. Rasa Yoga Sagara
24. Rasa Yoga Ratnakara
25. Rasa Yoga Samgraha
26. Rasendra Sara Samgraha
27. Rasa Pradipika
28. Sahasrayoga
29. Sarvaroga Chikitsa Ratnam
30. Sarvayoga Chikitsa Ratnam
31. Sharangadhara Samhita
32. Siddha Bhaishajya Manimala
33. Sidha Yoga Samgraha
34. Sushruta Samhita
35. Vaidya Chintamani
36. Vaidyaka Shabda Sindu
37. Vaidyaka Chikitsa Sara
38. Vidya Jiwan
39. Vasava Rajeeyam
40. Yoga Ratnakara
41. Yoga Tarangini
42. Yoga Chintamani
43. Kashyapasamhita
44. Bhelasamhita
45. Vishwanathachikitsa
46. Vrindachikitsa
47. Ayurvedachintamani
48. Abhinavachintamani
49. Ayurveda-Ratnakara
50. Yogaratnasangraha
51. Rasamrita
52. Dravyagunanighantu
53. Rasamanijari
54. Banagasena
[54A Ayurvedic Formulary of India (Part-I)
54B Ayurveda Sara Samgraha]
54C Ayurvedic Pharmacopoeia of India
Books of Siddha
55 Siddha Vaidya Thirattu
56 Therayar Maha Karisal
57 Brahma Muni Karukkadai (300)
58 Bhogar (700)
59 Pulippani (500)
60 Agasthiyar Paripuranam (400)
61 Therayar Yamagam
62 Agasthiyar Chenduram (300)
63 Agasthiyar (1500)
64 Athmarakshamrutham
65 Agasthiyar Pin (80)
66 Agasshiyar Rathna Chrukkam
67 Therayar Karisal (300)
68 Veeramamuni Nasa Kandam
69 Agasthiyar (600)
70 Agasthiyar Kanma Soothiram
71 18 Siddar’s Chillarai Kovai
72 Yog Vatha Kaviyam
73 Therayar Tharu
74 Agasthiyar Vaidya Kaviyam (1500)
75 Bala Vagadam
76 Chimittu Rathna (Rathna) Churukkam
77 Nagamuni (200)
78 Agasthiyar Chillarai Kovai
79 Chikicha Rathna Deepam
80 Agasthiyar Nayana Vidhi
81 Yugi Karisal (151)
82 Agasthiyar Vallathi (600)
83 Therayar Thaila Varkam
1[84 Siddha Formulary of India (Part I)]
Books of UNANI TIBB SYSTEM
Serial No. Name of book
1 Karabadin Qadri
2 Karabadin Kabir
3 Karabadin Azam
4 Ilaj-ul-Amraz
5 Al Karabadin
6 Biaz Kabir Vol. II
7 Karabadin Jadid
8 Kithalf-ul-Taklis
9 Sanat-ul-Taklis
10 Mifta-ul-Khazain
11 Madan-ul-Aksir
12 Makhzan-ul-murabhat
[13 National Formulary of Unani Medicine (Part I)]
 Definition of Cosmetics
“Cosmetic” means any article intended to be
rubbed, poured, sprinkled or sprayed on, or
introduced into, or otherwise applicated to,
the human body or any part thereof for
cleansing, beautifying, promoting
attractiveness, or altering the appearance and
includes any article intended for use as a
component of cosmetic.
• Kanku used for tilak in forehead is a Cosmetic
but it is used in puja is not cosmetic because it
is not applied on the body of human being.
• Similarly perfume sprayed on the body of
human being is a cosmetics but it is sprayed
on the handkerchief is not a cosmetic.
• Similarly in case of Turmeric like Kanku.
 Homoeopathic medicines
Homoeopathic medicines include any drug which is
recorded in Homoeopathic proving 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 combination of
ingredients of such Homoeopathic medicines but
does not include a medicine which is administered by
Parenteral route.
 ‘New Homoeopathic Medicine’
(i) a Homoeopathic medicine which is not specified in the
Homoeopathic Pharmacopoeia of India or United States of
America or of the United Kingdom or the German
Homoeopathic Pharmacopoeia; or
(ii) which is not recognized in authoritative Homoeopathic
literature as efficacious under the conditions
recommended; or
(iii) a combination of Homoeopathic medicines containing
one or more medicines which are not specified in any of
the Pharmacopoeias referred to in clause (i) as
Homoeopathic medicines and also not recognized in
authoritative Homoeopathic literature as efficacious
under the conditions recommended.]
“Drug” includes—
(i) all medicines for internal or external use of human beings or
animals and all substances intended to be used for or in the
diagnosis, treatment, mitigation or prevention of any disease or
disorder in human beings or animals, including preparations
applied on human body for the purpose of repelling insects like
mosquitoes;( Odomos Cream, but not tortoise coil )

(ii) such substances (other than food) intended to affect the structure
or any function of human body or intended to be used for the
destruction of (vermin) or insects which cause disease in human
beings or animals, as may be specified from time to time by the
Central Government by notification in the Official Gazette;]
Ex. Black Phenyl etc.
(iii) all substances intended for use as components
of a drug including empty gelatin capsules; and

(iv) such devices intended for internal or external

use in the diagnosis, treatment, mitigation or
prevention of disease or disorder in human
beings or animals, as may be specified from time
to time by the Central Government by
notification in the Official Gazette, after
consultation with the Board ;]-Medical Devices.
 Retail sale
means a sale [whether to a hospital, or
dispensary, or a medical, educational or
research institute or to any other person] other
than a sale by way of wholesale dealing;
sale by way of wholesale dealing
means sale to a person for the purpose of selling
again and includes sale to a hospital, dispensary,
medical, educational or research institution.
“Government Analyst” means—
(i) in relation to Ayurvedic, Siddha or Unani drug,
a Government Analyst appointed by Central
Government or a State Government under
section 33F; and

(ii) in relation to any other drug or cosmetic , a

Government Analyst appointed by the Central
Government or a State Government under
section 20;]
“Inspector” means—
(i) in relation to Ayurvedic, Siddha or Unani drug,
an Inspector appointed by the Central
Government or a State Government under
section 33G; and

(ii) in relation to any other drug or cosmetic, an

Inspector appointed by the Central Government
or a State Government under section 21;]
“Manufacture” in relation to any drug [or cosmetic] includes
any process or part of a process for making, altering,
ornamenting, finishing, packing, labeling, breaking up or
otherwise treating or adopting any drug [or cosmetic] with a
view to its [sale or distribution] but does not include the
compounding or dispensing [of any drug, or the packing of
any drug or cosmetic,] in the ordinary course of retail
business; and “to manufacture” shall be construed
accordingly;]
Import means with its grammatical variations and cognate
expressions means to bring into [India];
Export means with its grammatical variations and cognate
expressions means to send out of [India];
 patent or proprietary medicine
“ It means, --
(i) in relation to Ayurvedic, Siddha or Unani Tibb systems of medicine all
formulations containing only such ingredients mentioned in the formulae
described in the authoritative books of Ayurveda, Siddha or Unani Tibb
systems of medicine specified in the First Schedule, but does not include a
medicine which is administered by parenteral route and also a formulation
included in the authoritative books as specified in clause (a);

(ii) in relation to any other systems of medicine, a drug which is a remedy or

prescription presented in a form ready for internal or external
administration of human beings or animals and which is not included in
the edition of Indian Pharmacopoeia for the time being or any other
Pharmacopoeia authorized in this behalf by Central Government after
consultation with the Drugs Technical Advisory Board constituted under
section 5;]]
 Misbranded drugs.
(a) if it is so colored, coated, powdered or polished that
damage is concealed or if it is made to appear of
better or greater therapeutic value than it really is; or

(b) if it is not labeled in the prescribed manner; or

(c) if its label or container or anything accompanying the

drug bears any statement,design or device which
makes any false claim for the drug or which is false or
misleading in any particular; ]
 Adulterated drugs
(a) if it consists, in whole or in part, of any filthy, putrid or decomposed
substance; or
(b) if it has been prepared, packed or stored under insanitary conditions
whereby it may have been contaminated with filth or whereby it may
have been rendered injurious to health; or
(c) if its container is composed in whole or in part, of any poisonous or
deleterious substance which may render the contents injurious to health;
or
(d) if it bears or contains, for purposes of colouring only, a colour other than
one which is prescribed; or
(e) if it contains any harmful or toxic substance which may render it injurious
to health; or
(f) if any substance has been mixed therewith so as to reduce its quality or
strength.
 Spurious drugs.
(a) if it is imported under a name which belongs to another drug; or

(b) if it is an imitation of , or a substitute for, another drug or resembles

another drug in a manner likely to deceive or bears upon it or upon its
label or container the name of another drug unless it is plainly and
conspicuously marked so as to reveal its true character and its lack of
identity with such other drug ; or

(c) if the label or the container bears the name of an individual or company
purporting to be the manufacturer of the drug, which individual or
company is fictitious or does not exist; or

(d) if it has been substituted wholly or in part by another drug or substance;

or

(e) if it purports to be the product of a manufacturer of whom it is not truly a

product .
“Central Licence Approving Authority”
means the Drugs Controller, India, appointed
by the Central Government.
Loan licence
means a licence which a licensing authority
may issue to an applicant who does not have
his own arrangements for manufacture but
who intends to avail himself of the
manufacturing facilities owned by a licensee
in Form 25.
 Definition of
Misbranded Ayur. Drugs/Cosmetics.
Adulterated Ayur. Drugs/Cosmetics
Spurious drugs Ayur. Drugs/Cosmetics.
are almost similar to definition of drug
Please referred D & C Act.
‘Repacking’
means the process of breaking up any drug
from a bulk container into small package and
the labeling of each such package with a view
to its sale and distribution, but does not
include the compounding or dispensing or
the packing of any drug in the ordinary
course of the retail business.
“Large Volume Parenterals”
shall mean the sterile solutions intended for
parenteral administration with a volume of
100 ml. or more (and shall include anti-
coagulant solutions) in one container of the
finished dosage from intended for single
use.]
 Definition of new drug
(a) A drug, as defined in the Act including bulk drug
substance which has not been used in the country to any
significant extent under the conditions prescribed,
recommended or suggested in the labeling thereof and
has not been recognized as effective and safe by the
licensing authority mentioned under Rule 21 for the
proposed claims. Provided that the limited use, if any, has
been with the permission of the licensing authority.]

(b) A new drug already approved by the Licensing Authority

mentioned in Rule 21 for certain claims, which is now
proposed to be marketed with modified or new claims,
namely, indications, dosage, dosage form (including
sustained release dosage form) and route of
administration.
(c) A fixed dose combination of two or more drugs, individually approved
earlier for certain claims, which are now proposed to be combined for the
first time in a fixed ratio, or if the ratio of ingredients in an already
marketed combination is proposed to be changed, with certain claims, viz.
indications, dosage, dosage form (including sustained release dosage form)
and route of administration. (See items (b) and (c) of Appendix VI to
Schedule Y.)

Explanation.- For the purpose of this rule. –

(i) all vaccines shall be new drugs unless certified otherwise by the Licensing
Authority under Rule 21;

(ii) a new drug shall continue to be considered as new drug for a period of
four years from the date of its first approval or its inclusion in the Indian
Pharmacopoeia, whichever is earlier.]
(1) “Central Licence Approving Authority” means
the Drugs Controller, India, appointed by the
Central Government.
(2) Sec-21“licensing authority”
means the authority appointed by the Central
Government to perform the duties of the
licensing authority under these Rules and
includes any person to whom the powers of a
licensing authority may be delegated under Rule
22;
 Medical device
• A medical device is an instrument, apparatus, implant, in vitro
reagent, or other similar or related article, which is intended for
use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, or intended to
affect the structure or any function of the body and which does
not achieve any of its primary intended purposes through
chemical action within or on the body.

• Whereas medicinal products (also called pharmaceuticals) achieve

their principal action by pharmacological, metabolic or
immunological means, medical devices act by other means like
physical, mechanical, thermal.

• Medical devices include a wide range of products varying in

complexity and application. Examples include tongue depressors,
medical thermometers, and blood sugar meters.
 Medical Devices-in USA
• Medical machine, contrivance, implant, in vitro reagent, or other
similar or related article, including a component part, or accessory
that is:

• recognized in the official National Formulary, or the United States

Pharmacopoeia, or any supplement to them,

• intended for use in the diagnosis of disease or other conditions, or

in the cure, mitigation, treatment or prevention of disease, in man
or other animals, or

• intended to affect the structure or any function of the body of

man or other animals, and which does not achieve any of its
primary intended purposes through chemical action within or on
the body of man or other animals and which is not dependent
upon being metabolized for the achievement of any of its primary
intended purposes.
 Medical devices-in Canada
• The term medical devices, as defined in the
Food and Drugs Act, covers a wide range of
health or medical instruments used in the
treatment, mitigation, diagnosis or
prevention of a disease or abnormal physical
condition. Health Canada reviews medical
devices to assess their safety, effectiveness
and quality before being authorized for sale
in Canada[citation needed].
 Medical devices- in EU
“Any instrument, apparatus, appliance, software, material or other
article, whether used alone or in combination, including the software
intended by its manufacturer to be used specifically for diagnostic and/or
therapeutic purposes and necessary for its proper application, intended
by the manufacturer to be used for human beings. Devices are to be used
for the purpose of: Diagnosis, prevention, monitoring, treatment or
alleviation of disease.

Diagnosis, monitoring, treatment, alleviation of or compensation for an

injury or handicap.

Investigation, replacement or modification of the anatomy or of a

physiological process Control of conception

This includes devices that do not achieve its principal intended action in
or on the human body by pharmacological, immunological or metabolic
means, but which may be assisted in its function by such means."