The document summarizes the key events and legislation related to pharmaceutical regulation in India. It discusses the origins of pharmacy in India in the early 1900s and the reasons for establishing the Chopra Committee in 1931 to recommend comprehensive drug legislation. The Chopra Committee's recommendations led to the passage of the Drugs Act in 1940. Subsequent legislation included the Pharmacy Act of 1948, Drugs and Magic Remedies Act of 1954, and Narcotic Drugs and Psychotropic Substances Act of 1985. The Hathi Committee was formed in 1975 to analyze the drug industry and recommend measures to improve quality, reduce prices, and ensure drug availability. The Mashelkar Committee was appointed in 2003 to examine drug regulatory issues and suggest improvements

1. PHARMACEUTICAL
LEGISLATION

2. LEGISLATION
 Law intends for regulation and control of
various aspects of life.
 These aspects might be social, economical
and political.
 Pharmaceutical legislation is a mixed
legislation, which overlappingly covers both
social and economic aspects.

3. WHAT IS THE PURPOSE/OBJECTIVE OF
PHARMACEUTICAL LEGISLATION?
 TO ENSURE THAT THE PATIENT RECEIVE
DRUGS OF REQUIRED QUALITY, TESTED
AND EVALUATED FOR SAFETY AND
EFFICACY FOR THEIR INTENDED RESULT.

4. ORIGIN OF PHARMACY
 In 1811 first chemist shop opened by Mr. Bathgate, who
came to India with East India company in Calcutta.
 In 1910 they have started manufacture of tincture and
spirits
 In 1821 another firm, Smith Stan street and co. started
apothecary shop and started manufacturing in 1918.
 In 1901 Bengal Chemical and Pharmaceutical works, a
small factory was started in Calcutta by Acharya P.C.
Ray
 In 1903 Prof. T. K. Gajjar opened small factory at Parel
for the development of Pharmaceutical units and
Alembic chemical works Ltd. at Baroda

5. REASONS FOR FORMATION OF CHOPRA COMMITTEE
1. Units were not sufficient to fulfill the requirements of
Indian Public.
2. Drugs were imported form UK, Germany and France.
3. During first world war cheaper drugs were imported
into India, which increased the demand for indigenous
drugs.
4. Unhealthy competition grew up and Indian market
was flooded with inferior quality drugs.
5. There was no legal and effective control on pharmacy
profession.
6. Hence to have a comprehensive legislation, the Indian
government appointed a ‘ Drug Enquiry Committee’
under the chairmanship of Col. R.N. Chopra in 1931.
this was formally known as Chopra Committee

6. DRUG ENQUIRY COMMITTEE/ CHOPRA COMMITTEE

7. • IMPLEMENTATIONS:-
•The outbreak of the second world war in 1939 delayed the
introduction of legislation on the lines suggested by the
Chopra Committee which the Indian government
contemplated and considered as urgent.
• However, the Drugs Act was passed in 1940 partly
implementing the Chopra recommendations.
 Finally an Import of Drug Bill was introduced in 1937.
 This bill dealt with only import of drugs and
manufacturing and sale of drugs was not included.
Drug bill was introduced in 1940 in legislative assembly,
and Drug Bill 1940 was passed, which came to force
in 1947. since then drug act was amended many times
and at present it covers the provisions related to Drugs,
Cosmetics, Ayurvedic, including Unani and Homeopathic
medicines.
•

8. The present Drug and Cosmetic Act is an improved version of
the Drug Act, 1940. the main objective of this act was to
regulate the import, manufacture, distribution and sale of
drugs and cosmetics in India.
The Central Government made several rules entitled the
Drug and Cosmetic Rules 1945. These act and rules were
amended from time to time
 The Pharmacy act 1948 was passed with the main objective
to regulate the profession of Pharmacy in India.
 In 1954 the Drug and Magic Remedies Act was passed
with the main aim to control certain types of advertisements
related to drug and to prohibit certain types of
advertisements related to magic remedies.
 Medicinal and Toilet Preparations (Excise duty) Act,
1955 was passed providing for the levy and collection of
duties of excise on medicinal and toilet preparations
containing alcohol, opium Indian hemp or other narcotic
drugs

9.  The Drugs and Magic Remedies (Objectionable
Advertisement) Act, 1954
 The Narcotic Drugs and Psychotropic
Substances Act, 1985- The main objective of
this act was to consolidate and amend the laws
relating to narcotic drugs and Psychotropic
substance.
 The Drugs (Prices Control) Order 1995 (under
the Essential Commodities Act)

10. OTHER ACTS INCLUDED WERE:-
Prevention of food Adulteration act, 1954 and rules.
The Industries (Development and Regulations) Act,
1951.
The Industrial Employment (Standing order) Act 1946
and
 rules.
Industrial Dispute Act, 1947.
Factory Act, 1948.
The Indian Patent and Design Act 1970.
The Trade and Merchandise Mark, 1958.
The Epidemic Disease Act, 1897.
Shops and Establishment acts of respective states.

11.  In the context of large-scale expansion of the
drugs and pharmaceuticals industry, with a view
to ensuring the regulated and rapid growth of
drug manufacture and further with a view to
ensure that all essential drugs are made available
to the consumers at reasonable prices,
Government constituted a Committee in February,
1974 under the Chairmanship of Shri Jaisukhlal
Hathi, Member of Parliament and there were
officials and non-officials members, to enquire into
various facts of the drugs industry in India.
INDUSTRY
(HATHI COMMITTEE)
1975

12.  To promote growth of Drug Industry specially small sector
 To improve technological development
 To take effective quality control measures on drugs
 To reduce the price of medicines as well as to
rationalized the price structure.
 To provide essential drugs throughout the country
 Creating an environment conducive to channelizing new
investment into the pharmaceutical industry,
 Introducing new technologies and new drugs, and
strengthening the indigenous capability for production of
drugs.
THE COMMITTEE ON DRUGS AND PHARMACEUTICAL
INDUSTRY
(HATHI COMMITTEE)
1975

13.  Ministry of Pertoleum and Chemicals Govt. Of India Shri.
Jaisukhlal Hathi Chairman.
 In 1975, the Hathi Committee which was appointed by the
Government of India to analyse the Indian drug industry,
It recommends that;
 A restricted list of essential drugs and measures
be implemented to ensure their production.
 A gradual shift be made from brand names to
generic names
The price control measures be effected with the aim
of making life-saving drugs and essential drugs
affordable
 The public sector play a leading role in drug
production and certain drugs be reserved to
encourage the growth of Indian drug companies.

14. Committee also felt necessary in the context of large scale
expansion of drug and pharmaceutical industry envisaged
during Fifth Five Year Plan Period.
The term of reference were as under ;
1. To enquiry into the progress made by the industry and
the status achieved by it .
2. To examine the present arrangement for the flow of new
technology into the industry
3. To recommend the other arrangement to ensure
equitable distribution of basic drugs and raw material
especially to small sector.
4. To recommend measures effective quality control of
drugs and for rendering assistance to small scale units in
this regard.

15. MASHELKAR COMMITTEE-
OBJECTIVE/PURPOSE
 The Central Government constituted an Expert Committee under the
chairmanship of Dr. Raghunath Anant Mashelkar(Ramesh Mashelkar),
Director General of the Council of Scientific and Industrial Research
in January 2003 to undertake a comprehensive examination of drug
regulatory issues, including the problem of spurious drugs and to
suggest measures to improve the drug administration in the
country.
He was the President of Indian National Science
Academy (2004-2006),
President of Institution of Chemical Engineers (2007)
President of Global Research Alliance (2007-2018).
He was also first Chairperson of Academy of
Scientific and Innovative Research (AcSIR).
He is a Fellow of the Royal Society
Fellow of the Royal Academy of
Engineering (FREng) Foreign associate of US National
Academy of Engineering and the US National
Academy of Sciences

16.  The Committee, recommended setting up of a Central
Drugs Authority reporting directly to the Ministry of
Health and Family Welfare and a system of centralized
licensing.
 The Central Government considered the
recommendations of the Committee and proposed to
make amendments in the Act, in order to facilitate
setting up of a Central Drugs Authority and introduction
of Centralized licensing for manufacture of drugs

17. RECOMMENDATIONS OF MASHELKAR COMMITTEE
Drug Regulation at
central level
ƒ1.Transform the Central Drugs Standard Control Organization into
a well-equipped, independent and professionally managed body,
with the status of CDA, under the Ministry of Health and Family
Welfare Drug Regulation at central level ƒ
2.Establish 10 main divisions within the CDA manned by
adequately trained manpower.
3.Provide for funds for new structure and sourcing of external
expertise and provide for technical manpower .
4.ƒAllow CDA to grant manufacturing licenses to address issue of
non-uniformity of enforcement
Drug Regulation at state
level ƒ
1.Strengthen state drug control organizations with additional
manpower, infrastructure, technical capabilities and adequate
budget .
ƒ2.Set up intelligence cum legal cell under the supervision of
trained senior nodal officers, and enforce condition of licence for
sale of drugs
Medical Devices and
Diagnostics
1.Separately define medical devices and frame guidelines for their
regulation ƒ
2.Set up Medical Devices Division in the CDA.
3.CDA should set up regulatory mechanism for quality assurance
and post-marketing surveillance of imported and locally made
medical devices

18. RECOMMENDATIONS CONTINUED…..
Clinical Research 1.Share responsibility for safety of Indian subjects in clinical
research by all stakeholders (investigators, sponsors, ethics
committee and regulators) ƒ
2.Institutionalize Good Clinical Practices to achieve credibility for
data generated in India ƒ
3.Require regulatory agency to develop adequate capacity to
undertake routine inspections of clinical trial sites ƒ
4.Consider expedited approvals for Phase II and III clinical trials on
the basis of approvals accorded by International Conference on
Harmonization signatory countries Clinical Research ƒ
5.A single window clearance mechanism for approval of
applications related to drug research ƒ
6.Rationalize policies related to animal experiments

19. RECOMMENDATIONS CONTINUED…..
Spurious and Substandard
Drugs
1.Create effective interaction among stakeholders
(regulators, consumers, industry, medical profession)
2.Enhance penalties making offences cognisable and
non-bailable ƒ
2.Identify designated courts for speedy trials of spurious
drug cases
3.Discourage proliferation of drug distribution outlets.
4. Industry should create counterfeit drug strategies and
surveillance systems ƒ
5.Review system to tackle issue of non-uniformity in
action taken on sub-standard drugs in different states ƒ
6.Strengthen states with technical know-how and
manpower to monitor quality of drugs manufactured and
sold ƒ
7.Improve testing laboratories by making Good
Laboratory Practices norms a statutory requirement,
accreditation with National Accreditation Board for
Testing and Calibration Laboratories mandatory, etc