FACULTY OF LAW

JAMIA MILLIA ISLAMIA

SUBJECT: HEALTH LAW

TOPIC : LEGAL REGULATION OF AYURVEDIC MEDICINE

Submitted to- Submitted by-

Dr. Subhradipta Sarkar Abhinav Pandey
Faculty of Law Semester-VIII
Jamia Millia Islamia(Self-Financed)
Roll no. 04

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 ACKNOWLEDGEMENT

I am deeply indebted toDr Subhradipta Sarkar., Faculty of Law, Jamia Millia Islamia, New
Delhi for his initial and continuous encouragement and guidance, without which this work
would have been very difficult for me. If I have failed to come up to his expectation, both on
facts and interpretation, I alone am responsible.

I would be failing in my obligations if I do not convey my thanks to all the authors of the books
and articles from which I have quoted and made references.

I am very thankful to everyone who have had given me their direct and indirect support to
complete my work and give support to outcome from and difficulty while completing my work.

I wish to thank my parents and my brother for their moral support and constant inspiration. I am
also thankful to those who have not being mentioned by name but nevertheless having been of
invaluable help in their inscrutable ways. Lastly, I would like to thank the Almighty God,
without who’s blessing no one can accomplish anything.

-ABHINAV PANDEY

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 TABLE OF CONTENTS

S.no Topic Page

no.

1. Introduction 4

2. Legal Regulations In India 5

3. Drugs and Cosmetics Act, 1940 6

4. Drugs and Cosmetics Rule, 1945 8

5. Drugs & Magic Remedies (Objectionable Advertisements Act,

9
1954 an d Rules

6. Indian Medicine Central Council (Minimum Standards Of

Education In Indian Medicine) Regulations, 1986.
10

7. Problems In Present system 12

8. Problems In Present system and judicial response 13

9. Conclusion 15

10. Bibliography 16

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 INTRODUCTION

Ayurveda not merely being a system of medicine, but a way of life” - Charak Samhita

Its objective is to accomplish physical, mental, social and spiritual well-being by adopting
preventive and primitive’s approaches as well as treating disease with a holistic approach1.

WHO recognised traditional, complimentary, alternative medicine for both developing and
developed countries under the slogan “Health For All”. Later on WHO organised TM(
Traditional Medicine) Programme for globally addressing the issue of Cultivation of Herbs,
manufacturing and other basic regulation for the TM medicines.

As per definition, “Traditional medicine is the knowledge, skills and practices of holistic
healthcare, recognized and accepted for its role in the maintenance of health and the treatment
of diseases. It is based on indigenous theories, beliefs and experiences that are passed on from
generation to generation”2 . WHO categorised Ayurveda as TM for India and it is getting
popularity because it focuses more on changing lifestyle of people and focuses on inner
strength and self healing of human body. Worldwide popularity of educational publications in
Ayurveda is a further accreditation of the established order of wellbeing centres in popular and
its therapeutics value as a system of medicine especially.

In India, Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy
(AYUSH) in the Ministry of Health and Family Welfare has been officially accorded with the
responsibility of undertaking all activities related to production, development, quality
assurance and standardization of these medicines and to disseminate the guidelines for
production of raw material used in Ayurvedic Siddha and Unani medicines3.

Apart from AAYUSH, many individuals and organizations such as Banaras Hindu University,
Gujarat Ayurveda University, National Institute of Ayurveda and, Institute of Ayurveda and
Integrative Medicine are promoting Ayurveda on scientific lines which may prove to be a boon
for its global acceptance.4

1
Acharya JT. 25. Vol. 30. New Delhi: Rashtriya Sanskrita Sansthan; 2002. Caraka Samhita by Agnivesh, Sutra Sthana.
2
Choi SH. WHO Strategy and Activities in Traditional Medicine. Chin Med. 2009.
3
http://www.plimism.nic.in/ (April. 10. 2020, 3:32pm)
4
http://www.bhu,ac,in , www.ayurveduniversity.com , www.nia.nic.in .(April.10.2020, 5:20pm)
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 Legal Regulations In India

First concern as to quality and substandard of medicines was raised in first Quarter of 1900’s,
who brought this issue in front of Council of States in 1927. Government Appointed a “Drug
Enquiry Committee” under chairmanship of Lt. Col. RN Chopra in 1930, which recommended
formation of a Central legislation for setting up of suitable standard. On 10 April 1940 act was
passed under the name of Drugs Act.

Need For Drug Regulations

 To prescribe and enforce standards for manufacturing, distribution, sale, marketing and
information of drugs.
 To ensure availability of quality drugs to the people.
 To promote public protection from hazards/harmful effects of drugs.

Types of Legal Provisions

 Enabling provisions
 Prohibitive provisions
 Penal provisions
 Empowering provisions for authorities/specific actions
 Exemption provisions

At present, Following acts and rules are managing and controlling manufacture, export and
research of drugs and cosmetics in India –

 Drugs and Cosmetics act, 1940.

 Drugs and Cosmetics Rule, 1945.
 Pharmacy Act, 1948. - An Act to regulate the profession of pharmacy. WHEREAS it is
expedient to make better provision for the regulation of the profession and practice of
pharmacy and for that purpose to constitute Pharmacy Councils;5
 Drugs and Magic Remedies Act, 1954.

5
https://indiacode.nic.in/bitstream/123456789/1364/1/194808.pdf April.12.2020, 8:00pm.
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  Medicinal And Toilet Preparations Act, 1955. - An Act to provide for the levy and
collection of duties of excise on medicinal and toilet preparations containing alcohol,
[narcotic drug or narcotic].6
 Narcotics Drugs and Psychotropic Substances Act, 1985. - An Act to consolidate and
amend the law relating to narcotic drugs, to make stringent provisions for the control
and regulation of operations relating to narcotic drugs and psychotropic substances [,
to provide for the forfeiture of property derived from, or used in, illicit traffic in
narcotic drugs and psychotropic substances, to implement the provisions of the
International Conventions on Narcotic Drugs and Psychotropic Substances]7 and for
matters connected therewith.

Drugs And Cosmetics Act, 1940.

This act was originally known as the Drug Act and was passed in 1940. The original act was
prepared in accordance to the recommendations of the Chopra Committee formed in 1930. The
related Drugs Rules was passed in 1945. Since 1940, the act has undergone several
amendments and is now known as the Drugs and Cosmetics Act, 1940.

Objectives of Act

 To regulate the import, manufacture, distribution and sale of drugs & cosmetics through
licensing.
 Manufacture, distribution and sale of drugs and cosmetics by qualified persons only.
 To prevent substandard in drugs, presumably for maintaining high standards of medical
treatment.
 To regulate the manufacture and sale of Ayurvedic, Siddha and Unani drugs.
 To establish Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committees
(DCC) for Allopathic and allied drugs and cosmetics.

There are 98 books in Schedule –I of The Drugs And Cosmetics Act, 1940 in which there are 54
Books on Ayurveda only. Also there are books 54 A,B,C which are added through amendment and

6
Subs. by Act 19 of 1961, s. 2, for sub-section (4) (w.e.f. 1-6- 1961).
7
Ins. by Act 2 of 1989, s. 2 (w.e.f. 29-5-1989).
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 are on Ayurvedic Formulary of India(AFI) , Ayurveda Sara Sanghara and Ayurveda Pharmacopoiea
of India (API) and any other amendment will automatically included in schedule – I.

Sec 3(a) of the Act defines-

“[Ayurvedic, Siddha or Unani] drug” includes all medicines intended for internal or external
use for or in the diagnosis, treatment, mitigation or prevention of 3 [disease or disorder in
human beings or animals, and manufactured] exclusively in accordance with the formulae
described in, the authoritative books of 3 [Ayurvedic, Siddha and Unani Tibb system of
medicine], specified in the First Schedule8;”

Sec 3(h)(i) of the Act defines-

“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 Ayurvedic, 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).9”

Chapter IVA from Section 33B to 33O and First Schedule pertain to ASU drugs10.

Few Important sections deals with the Ayurveda -

Sec - 33-C. Ayurvedic and Unani Drugs Technical Advisory Board.

Sec- 33-D. The Ayurvedic, Siddha and Unani Drugs Consultative Committee.

Sec- 33-E. Misbranded drugs.

Sec- 33-EE. Adulterated drugs.

Sec - 33-EEA. Spurious drugs.

Sec- 33-EEB. Regulation of manufacturer for sale of Ayurvedic, Siddha and Unani drugs.

8
Drugs and Cosmetic Act,1940.
9
Id.
10
Drugs And Cosmetics Act, 1940.
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 Sec- 33-EEC. Prohibition of manufacture and sale of certain Ahyurvedic, Siddha and Unani
drugs.

Sec- 33-EED. Power of Central Government to prohibit manufacture, etc., of Ayurvedic,

Siddha or Unani drugs in public interest.

Sec- 33-I. Penalty for manufacture, sale, etc., of Ayurvedic, Siddha or Unani drug in
contravention of this Chapter.

Sec - 33-J. Penalty for subsequent offences.

Sec- 33-N. Power of Central Government to make rules.

Schedule – II of the Act - STANDARDS TO BE COMPLIED WITH BY IMPORTED DRUGS

AND BY DRUGS MANUFACTURED FOR SALE, STOCKED OR EXHIBITED FOR SALE
OR DISTRIBUTED11.

Drugs And Cosmetics Rule,1945

Drugs and Cosmetic Rules, 1945 (D&C Rules) regulate the import, manufacture, distribution,
sale, packaging and labelling of drugs, including ASU Drugs, and cosmetics.

This legislation has been amended several time to keep in pace with the modern time and
developing medicines.

Act contains Form- 1 to 50 which are further divided in parts and schedules.

Act is divided in Part – XIX and also divided in Schedule A to Y and which is also divided in
sub issues. Thus it is very extensive set of rules which cover almost all the health industry
aspects.

Thus here are few provisions which are necessary for Ayurvedic Medicines12-

 Part XVI Rule 151 – 160 – Manufacture for sale of Ayurvedic(including Siddha) or
Unani Drugs.

11
Id At. 5.
12
http://vbch.dnh.nic.in/pdf/Rules%20and%20regulations%20of%20Drug%20and%20Cosmetics%20act.pdf April.10.2020, 5:40.
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  Part XVI –A Rule 160A- 160 J – Approval of institutions for carrying out tests on
ASU Drugs And Raw material used in their Manufacture.
 Part XVII Rule 161 – Labelling, Packaging and Limit of Alcohol in ASU Drugs.
 Part XVII Rule 161B – Shelf Life or date of Expiry of ASU Medicines.
 Part XVIII Rule 162- 167 – Government analysts and Inspectors for ASU Drugs
 Part XIX Rule 168 – 170 – Standards of ASU Drugs.
 Schedule – A – Different types of Forms particularly 24D,24E,25D,25E,26D,26E,26E-
I , 47,48,49.
 Schedule B-1 Fees for the test or Analysis by Pharmacopoeial Laboratory for Indian
Medicine or the Govt. Analyst.
 Schedule- E- I – List Of Poisonous Substances under ASU systems of Medicine.
 Schedule FF – Standard For Opthalmic Preperations.
 Schedule T- Good Manufacturing Practices For ASU Medicines.
 Schedule Y – Requirements And Guidelines for permission to import and/or
manufacture of New Drugs for sale or to undertake clinical trials.
 Schedule Z (PROPOSED yet not implemented) – Requirement and guidelines for
permission to manufacture of ASU Drugs for sale or to undertake clinical trials.

 Ayurvedic Formulary of India - Part-I - 444 Formulations 351 Single Drugs.

 Ayurvedic Formulary of India - Part-II - 191 Formulations 271 Single Drugs.

Plant species generally Regarded as Safe (GRAS) – 599 Plant species to be used after special
purification and in a very small dose – 28.

Drugs & Magic Remedies (Objectionable Advertisements Act, 1954 an d Rules

The regulation of advertisements for drugs, arguably including ASU Drugs, is governed by the
Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (DMROA Act) and
the Drugs and Magic Remedies (Objectionable Advertisements) Rules, 1955 (DMROA
Rules). ASCI is a body that also looks at this aspect though dependant on self-regulation by
industry players.

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 The Advertising Standards Council of India (ASCI), a self-regulatory organisation for the
advertising industry, to monitor misleading advertisements being published in print and TV
media.13

Purpose Of The Act

 Prohibition of advertisement of certain drugs for treatment of certain diseases and

disorders.
 Prohibition of misleading advertisements relating to drugs.
 Prohibition of advertisement of magic remedies for treatment of certain diseases and
disorders.
 Prohibition of import into, and export from, India of certain advertisements.

Central Government notified amendment of the Drugs & Cosmetics Rules, 1945 on
24th December, 2018 to insert Rule 170 specifically for controlling inappropriate
advertisements of Ayurvedic, Siddha and Unani medicines. Considering the emerging
situation of misleading advertisements, Ministry of AYUSH signed MoU with Advertising
Standards Council of India (ASCI) for two years to undertake monitoring of AYUSH-related
advertisements in the print and television media and bring the cases of contravention of legal
provisions to the notice of the State Regulatory Authorities for necessary action. Similarly,
Department of Consumers Affairs has set up an online system called GAMA (Grievances
Against Misleading Advertisements) portal for registering public complaints of misleading
advertisements of various commodities including AYUSH medicines and allied products. As
a result of monitoring by ASCI, 732 cases of misleading advertisements of AYUSH were
reported in 2017-18 and 497 cases in 2018-19. Out of which 456 cases of violation of Drugs
& Magic Remedies Act, 1954 in 2017-18 and 203 cases in 2018-19 have been escalated to the
State Regulators for taking necessary action in accordance with legal provisions14.

Indian Medicine Central Council (Minimum Standards Of Education In Indian

Medicine) Regulations, 1986. Schedule-I of the act was amended with objective to produce
graduates of profound scholarship having deep basis of Ayurveda with scientific knowledge
in accordance with Ayurvedic fundamentals with extensive practical training who would be

13
http://164.100.47.194/loksabha/questions/QResult15.aspx?qref=57551&lsno=16 April .10.2020.
14
https://pib.gov.in/PressReleasePage.aspx?PRID=1576159 April.11.2020, 3:40.
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 able and efficient teachers, research workers and Kaya Chikitsaks (Physicians) and
Shalayachikitsaks (Surgeons) fully competent to serve in the medical and health services of
the country15.

The Amendment Provides for –

 ADMISSION QUALIFICATION- 12th standard with 50% aggregate in Physics,

Chemistry and Biology.
 MINIMUM AGE FOR ADMISSION-

a) 15 years as on 1st October in the year of admission for first year of Pre-
Ayurvedic Course.
b) 16 years as on 1st October in the year of admission for Second Year of Pre
Ayurvedic Course.
c) 17 years as on 1st October in the year of admission for Main Ayurvedic
Course.

 DURATION OF COURSE.
 DEGREE TO BE AWARDED- Ayurvedacharya (Bachelor of Ayurvedic Medicine
and Surgery).

Amendment provides extensive set of Information and regulations for the colleges and
internship programmes necessary for the proper implementation of the Act.

Problems In Present system-

Manufacture and Practice of Ayurveda both require license from the authorities, although
point of license and rules as to provide as vary from state to state.

Reason behind such varied laws is developing situation of country. About 70% of the Indian
population lives in rural regions and has availability of very basic health care and some have
scarcity of even basic medical care. There is a scarcity of medical doctors in these regions as
they are now not inclined to work in locations in which the infrastructure is poor, and
medicines and healthcare device aren't available. This unmet want has stuck the attention of

http://ayush.gov.in/sites/default/files/IMCC%20%28Minimum%20Standards%20of%20Education%20in%20Indian%20Medicin
15

e%29%20%28Amendment%29%20Regulations%2C%201989_0.pdf April.11.2020, 7:10pm.

11 | P a g e
 politicians and policy-makers. The government has responded to this trouble through
amending legal guidelines, implementing new policies.

New Policies brought new challenges in face of medical system. The following polices –

i. The new Medical Termination of Pregnancy (Amendment) Draft bill; which says that
‘medical termination of pregnancy can be performed by Ayurveda and Homoeopathy
practitioners’16;
ii. The National Rural Health Mission (integrating practitioners of AYUSH [Ayurveda,
Yoga, Naturopathy, Unani, Siddha and Homoeopathy] into the mainstream);
iii. some states allowing practitioners of AYUSH to prescribe allopathic medicines
iv. employing AYUSH doctors in allopathic nursing homes/hospitals initiation of new
medical courses such as the 3-year rural medical assistants programme to address the
shortage of medical practitioners in rural areas; and
v. increased litigations involving cross system 17practice all over India.

Issues with Regulatory Provisions and Judicial Response

Allopathy is regulated by the Indian Medical Council Act, 1956; AYUSH by the Indian
Medicine Central Council Act, 1970. Under the Indian Medicine Central Council Act, 1970,
there is the ‘Central Register of Indian Medicine’ and ‘State Register of Indian medicine’,
which regulate the registration of practitioners of Indian medicine. Similarly, under the Indian
Medical Council Act, 1956, there is the, ‘Indian Medical Register’ and ‘State Medical
Register’, which regulate the registration of practitioners of medicine. These separate
legislations and separate registers with different names (i.e. Register of Indian Medicine
versus Indian Medical Register) indicate that the law-makers wanted the systems to be
independent of each other. Another issue is due to referring ‘vaids’ and ‘hakims’ as ‘doctors’
even though the Indian Medicine Central Council Act, 1970, does not contain the word
‘doctor’ at all and refers to such practitioners only as vaids and hakims.18

16
https://www.prsindia.org/uploads/media/draft/Draft%20Medical%20Termination%20of%20Pregnancy%20Amendment%20Bill
%202014.pdf .
17
Cross-system prescription’ is defined as a doctor of one system of medical practice prescribing medicines of another system, in
which she/he has not been formally trained or studied.
18
Indian Medical Council Act,1970.
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 In case of - Dr Mukhtiar Chand & Ors. v. State of Punjab was pronounced on 8-1-1998 by a
two judge bench comprising of judges K. T. Thomas and Syed Shah Mohammed Quadri.

‘The definition of “Indian medicine” and “modern advance” have been clarified. The
practitioners can make use of the modern advances in various sciences such as a radiology
report, (X-ray), complete blood picture, lipids report, ECG, etc., for purpose of practice in
their own system of medicine’.Further the Court held that ‘a harmonious reading of Section
15 of the Indian Medical Council Act, 1956 and Section 17 of Indian Medicine Central
Council Act, 1970 leads to the conclusion that there is no scope for a person enrolled on the
State or Central Registers of Indian Medicine to practice modern scientific medicine in any of
its branches unless that person is also enrolled on a State Medical Register within the meaning
of the 1956 Act’19

In simple terms , the right to prescribe drugs of a system of medicine would be synonymous
with the right to practice that system of medicine. Although in Section 15 (2)of the 1956 Act
occupied the field vide Central Act 24 of 1964, the benefit of the said rule is available to
those states where the privilege of such rights to practice any system of medicine is conferred
by the state law under which practitioners of Indian medicine are registered in the state, which
is for the time being in force. In broad sense, if any state Act recognized the qualification of
an integrated course as sufficient qualification for registration in the State Medical Register of
that state, the prohibition of Section 15(2)(b) will not be applicable. Hence, some state
governments have authorized ayurvedic and homoeopathic doctors to prescribe allopathic
drugs where there is a shortage of allopathic doctors.

Chandigarh Nursing Home vs Sukhdeep Kaur

20
- an Ayurvedic doctor could not
diagnose Stevens–Johnson syndrome, the life-threatening side-effect of an allopathic
medicine, which he himself had prescribed. Unfortunately, he continued to treat the child for
measles. The consumer forum took note of the inadequate knowledge and lack of skills of the
ayurvedic doctor. In this landmark case, the forum said that the state government may
authorize an AYUSH doctor to prescribe medicines for allopathy, but that does not authorize
the doctor to prescribe wrong medicines and to diagnose the disease wrongly. Hence, the
doctor was found negligent and was asked to pay compensation.

19
(1998) 7 SCC 579.
20
First Appeal No.591 of 2010.

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 Bhanwar Kanwar v. Gupta case an ayurvedic doctor had advertised in a newspaper, offering
patients with seizures treatment with ayurvedic medicines and also claimed total cure. A
family sought ayurvedic treatment of their 4-year-old child. In spite of giving the prescribed
medicine, the child continued to have seizures and his condition started to worsen. The family
consulted the practitioner many times over the next 3 years but the seizures did not stop. Later
the family came to know that the ayurvedic doctor was prescribing allopathic medications in
the name of ayurvedic ones.In a landmark judgment, the Supreme Court upheld that the
ayurvedic doctor was entitled to practise allopathy in the state of Uttar Pradesh (UP), as per
letter No.726/ 712200315 dated 24th February, 2003 of the Secretary, Medical Education
Department, Government of UP. However, to curb a false representation and to restore faith
of the people in the ayurvedic system, the Court opined that the ayurvedic doctor was guilty
of unfair trade practice and adopted unfair methods and deceptive practice by making false
statements orally as well as in writing that he was prescribing only ayurvedic medicines.
Thus, the victim was entitled for compensation for the injury suffered.21

Indian Medical Association v/s V.P. Shantha & Ors 22.”, India’s Apex Court declared that
medical services provided to a patient by a doctor (excluding when the medical
practitioner has been treating the patient free of cost), by way of medical consultation,
medical diagnosis and treatment of the same, either medicinal or surgical, come under the
scope of the Consumer Protection Act and doctors can be prosecuted for insufficiency/
negligence in the medical service.

Dr. Laxman Balkrishna Joshi v/s Dr. Trimbak Bapu Godbole and Anr. had laid down that,
when a patient consults a doctor, the doctor has certain duties, namely (i) duty of care in
deciding whether to undertake the case; (ii) duty of care in deciding what treatment to give;
and (iii) duty of care in the administration of that treatment. A breach of any of these duties
gives a cause of action for negligence.23

From all aforementioned cases we can see that there is need to regulate license and practice of
medicine and also to strike balance between economic and health system. Government should
not be allowed to skip everything only on the ground of low economic condition of the
country.

21
[2013 4 SCC 252].
22
1995 SCC (6) 651.
23
1969) 1 SCR 206.
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 CONCLUSION

The Drug and Cosmetic Act and Rules (DCA&R) contain regulatory provisions for and
Ayurvedic, Siddha, Unani (ASU) drugs. Understandably, the nature of allopathic pills and
ASU drugs are exceptionally different from each different. However, many troubles related to
safety, satisfactory and efficacy continue to be commonplace to any drug - be it contemporary
or ASU. The National Policy 2002 of Indian Systems of Medicine sincerely states the want
for massive evidence for Ayurveda patent and proprietary (P&P) products, but this advice
nevertheless awaits implementation. Currently P&P ASU capsules can be placed in the
market without any scientific or scientific statistics as proof. Increasing quantity of news and
guides are thinking safety of ASU pills. Current scientometrics suggests boom in case reports
showing damaging activities with ASU merchandise. The producers need to be more
accountable and proactive to make sure safety, excellent and efficacy of ASU capsules
especially while people have extra expectancies from Ayurveda products. Ayurveda has huge
capability for herbal product drug discovery of new the phytoactives as novel chemical
scaffolds. Admittedly, scientifically robust direction of discovery and improvement of
evidence based ASU pills is not an clean venture. Discovery of artemisinin from traditional
Chinese medicine required over 30 years of rigorous medical work. India desires to follow the
strong path of discoveries like reserpine, which require excessive level of dedication from
socially responsible scientific and business network. The Government rules, oversight and
surveillance is required to make sure that gullible patients aren't exploited. What is being
sporadically done below the pretext of herbal drug development is certainly no longer in line
with the simple principles, ethos and practice of Indian traditions. The AYUSH network has
responsibility to hold legacy and make sure that its credibility isn't compromised for
reasonably-priced publicity or quick term economic gains. In a long term such inept efforts
can erode credibility and likely to bring disrepute to Indian traditions and expertise history.
The age old knowledge systems like Ayurveda, Siddha and Unani are deeply rooted in Indian
culture. All these system of medication also require proper check and balance and not only
this there is also need of Health legislations amendment to ensure equality and less friction
between centre and state laws. Thus it will be rightful to conclude that India although revived
its traditional medical system but it needs to amend, regulate and develop it.

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 BIBLIOGRAPHY

Cites referred

https://tibmedcouncil.org/wp-content/uploads/2018/04/PS-1-dr-katoch.pdf

https://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/6_India_Ayu
rvedic.pdf?ua=1

https://www.mondaq.com/india/food-and-drugs-law/775662/you-shall-not-pass-a-look-at-the-
recent-ban-on-advertising-of-ayurvedic-drugs

http://ayush.gov.in/

Articles

 Bhushan Patwardhan, Ayurvedic drugs in case: Claims, evidence, regulations and

ethics, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5052386/
 Ashutosh Chauhan, Deepak Kumar Semwal, Satyendra Prasad Mishra, 2 and Ruchi
Badoni Semwa, Ayurvedic research and methodology: Present status and future
strategies, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5041382/
 Dr Galib Ruknuddin, Assistant Professor, Recent Amendment in D&C Act with special
reference to Ayurvedic Drug Industry,
https://www.researchgate.net/publication/26494224

Acts Referred

 Drugs and Cosmetics Act, 1940.

 Drugs and Cosmetics Rules, 1945.
 Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules
 Food Standards & Safety Act
 Pharmacy Act, 1948.
 Medicinal And Toilet Preparations Act, 1955.
 Narcotics Drugs and Psychotropic Substances Act, 1985.
 Indian Medicine Central Council (Minimum Standards Of Education In Indian
Medicine) Regulations, 1986.

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