The document discusses the history and development of pharmaceutical legislation in India. It notes that legislation was first introduced under British rule to regulate the import of medicines. In 1931, the Chopra Committee was formed to recommend a comprehensive drug law, which led to the Drugs and Cosmetics Act of 1940. The committee also recommended establishing drug laboratories and a pharmacopoeia. Later committees like the Bhore Committee further strengthened standards for pharmacists. The Hathi Committee covered aspects like licensing and price control. Overall the document provides an overview of key events and committees that shaped pharmaceutical regulation in India.

1. Presented By
Ashish R. Chaudhari
Asst. Professor
P R Patil Institute of Pharmacy Talegaon SP
Wardha
P R Patil Institute of Pharmacy Talegaon SP Wardha

2. Purpose of Pharmaceutical legislation
To ensure that the patients receive drugs of
required quality, tested and evaluated for safety and
efficacy for their intended result.

3. Origin of Pharmaceutical Legislation in India
⦁ Earlier, the allopathic system of medicine was brought by Britisher’s to
our country and allopathic medicines were mainly imported
⦁ To have some control on the import, the British Rulers introduced
⦁ The Indian Merchandise Marks Act 1889
⦁ The Sea Customs Act 1898
⦁ Indian Tariff Act 1894
⦁ The Opium Act 1878
⦁ Poison Act 1919
⦁ They were not comprehensive enough to control the chaotic and
deplorable conditions in the drugs trade and industry.

4. Year Name of Founder Name of shop/
Industry
Year of
commenceme nt
of manufacturing
1811 Mr. Bathgate (East
India Company)
Chemist Shop in
Calcutta
1910
(Tinctures, Spirits)
1821 Mr. Smith Stainstreet
and Co.
Apothecary Shop 1918
1901 Acharya Praffula
Chandra Ray
(Calcutta)
Bengal Chemicals and
Pharmaceutical Works
1903 Prof. T.K Gajjar Factory at Parel
Alembic Chemical works, Baroda

5.  Units were not sufficient to fulfil the requirements of Indian
Public.
 Drugs were imported form UK, Germany and France.
 During first world war cheaper drugs were imported into
India, which increased the demand for indigenous drugs.
 Unhealthy competition grew up and Indian market was
flooded with inferior quality drugs.
Reasons for formation of Chopra Committee

6.  Public pressurized government to introduce effective legislation
to control import, manufacture, distribution and sale of drugs.
 There was no legal and effective control on pharmacy
profession.
 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.
Reasons for formation of Chopra Committee

7. Drug Enquire Committee
 On representation from the Indian people, the Viceroy
appointed a committtee On 11th August,1930, under the
chairmanship of Col. R.N. Chopra.
 So, this committee also called its viceroy
committee/R.N.Chopra committee/Drug Enquiry
committee.
 The report was published in 1931.
 The committee aspects were

8. a. To enquire into the extent to which drugs and chemicals of
impure quality or defective strength, particularly those
recognized by the British Pharmacopoeia are imported, in the
public interest, of controlling such importation, manufacture
and sale and to make recommendations.
b. Recommendations to overcome the above.
c. The enquire into the necessity of legislation to restrict the
profession of pharmacy to duly qualified persons and to make
recommendations.
Aspects of Drugs Enquire Committee

9. Recommendations of Drugs Enquire Committee
1) Formation of Central Pharmacy Council and State
Pharmacy Council
2) Creation of Drug Control Machinery
3) Establishment of well equipped Central Drug
Laboratory, and State Drug Laboratory. (CDL)
4) Compilation of an Indian pharmacopoeia
Total 90 Recommendations

10.  Enactment of IMPORT OF DRUGS BILL 1937.
 Drug Act 1940
(DRUGS AND COSMETIC ACT 1940 and Rules 1945.)
 PHARMACY ACT 1948
 DRUGS AND MAGIC REMEDIES (Objectionable Advertisement)
ACT, 1954 and Rules 1955.
 MEDICINAL & TOILET PREPARATIONS (Excise Duties) Act,
1955 and Rules, 1956.
 Publications of first edition of INDIAN PHARMACOPOEIA in 1955
based on British pharmacopoeia 1948
Outcomes of Drug Inquire Committee

11.  Health Survey and Development
or BHORE committee
 MUDALIAR committee
 HATHI committee
Committees In Relation to Pharmaceutical Legislation

12. ⦁ October 1943---Health Survey and Development Committee
⦁ Chairman----Sir Joseph Bhore - by Govt of India
COMMITTEE RECOMMENDATIONS:
 Establishment of an All India Pharmaceutical Council and provincial
Pharmaceutical Council
 Strengthening of profession standards of pharmacists
 Maintaining disciplinary control
 Starting of revised courses of study
 Setting up of Central Drug Laboratory
 Rigid enforcement of the Drug and Cosmetics Act, 1940
Health Survey and Development or BHORE committee

13. ⦁ In 1959, Healthy Survey and Planning Committee
appointed
⦁ Chairman-
DR.A. LAKSHMANSWAMY MUDALIAR
 Recommended the inclusion of indigenous systems of
medicine under the purview of the Drugs Act.
MUDALIAR COMMITTEE

14. HATHI COMMITTEE (1974)
• Important milestone in pharmaceutical legislation
history is Hathi Committee
• Chairman- JAISUKH LAL HATHI
• This committee covered all the aspects of
 Licensing,
 price control ,
 imports,
 Role of foreign sector and quality control.

15.  A Text book of Pharmaceutical Jurisprudence by Dr.
B. S. Kuchekar
 A text book of Forensic Pharmacy – B. M. Mithal
 A text book of Pharmaceutical Jurisprudence &Ethics—Dr. S. P.
Agarwal & Dr. Rajesh Khanna
 A test book of pharmaceutical Jurisprudence –K. Sampath
 A test book of Forensic Pharmacy –N.K. Jain
References