This document summarizes the history of pharmaceutical legislation in India. It discusses several important committees that shaped pharmacy laws in India, including the Chopra Committee (1930-31), Bhore Committee (1943-46), Hathi Committee (1974), and Mudaliar Committee (1959). The key recommendations of these committees included establishing a central pharmacy council, developing pharmacy education standards, enacting drug laws, and improving availability of medicines across India. The first Indian Pharmacopoeia was published in 1955. Overall, the document traces the origin and development of pharmacy legislation from the late 19th century to the post-independence period.

1. • Lins Mary Joy, Associate Professor,
• Department Of Pharmacognosy
• Nirmala College of Pharmacy, Muvattupuzha

2. PHARMACEUTICAL
LEGISLATIONS
• Part -I
• A brief review, Introduction.
• Part - II
• Study of Drugs Enquiry Committee.
• Health Survey and Development Committee,
• Hathi Committee and
• Mudaliar Committee

3. Outcomes
You should be able to:
 Understand various laws related to pharmacy and their by understand the
legal procedures that to be followed and not be followed while carrying
out any pharmacy jobs.
 understand the origin of modern medicine in India;
 explain the genesis and development of pharmacy legislation;
 compare the status pharmacy in India with other countries before the
appointment of the Chopra committee;
 mention the important recommendations of various Committee;
 genesis of the Drugs Act 1940.

4. PHARMACEUTICAL
LEGISLATION
Define
• Involves law which has
been enacted by
governing bodies relating
to pharmacy or
pharmacists.
• Includes drug, medicines
any substances related to
health of society.
Importance
• Usage of low quality
medicines result in
ineffective therapy,
exacerbation of disease,
resistance to medicines
and even death.

5. • To ensure that the patients receive drugs of required quality
• (ie. tested and evaluated for safety and efficacy ) at reasonable
prices through qualified persons.
• To promote health care by regulating the manufacture, supply and
distribution of quality drugs.
• To safeguard the people from false or misleading advertisements
relating to drugs or magic remedies.
• To promote indigenous research technology.
• To regulate pharmacy profession.
What are the objectives of
Pharmaceutical legislation ?.

6. Write a note on origin of
pharmaceutical legislation in India.
• Legislations existing in India during the 19th and early 20th centuries
• The Opium Act 1878 - Regulates the cultivation ,manufacture, possession,
transport, export, import and sale of opium.
• Indian Merchandise Act 1889 - Concerned with the misbranding of goods.
• The Indian Tariff Act 1894 and The Sea Customs Act 1898 - For the levy of
customs duty on goods imported to India or exported from India.
• The Poisons Act 1919 -Regulate the import, possession and sale of poisons.
• The Cantonment Act 1924 For adulteration of drug or medicine .
• The Dangerous Drugs Act 1930 - To control cultivation, manufacturing,
possession, import, export, transport and sale of drugs like Coca, Hemp &
Opium.

7. State enactments
• . Bengal Food Adulteration Act 1919,
• the Bengal Excise Act 1909,
• the Madras Prevention of Adulteration Act 1919, The
Bombay Prevention of Adulteration Act 1925, the United
Provinces (now Uttar Pradesh) Prevention of
Adulteration Act 1912 and
• the Bihar and Orissa Prevention of Adulteration Act
1919.
• Failed to touch the regulatory aspects of drugs and
pharmaceuticals.

8. History of Pharmaceutical units
• 1811: Mr. Bathgate (East India Company) -Chemist Shop
in Calcutta.
• 1821: Mr. Smith Stainstreet and Co. -Apothecary Shop.
• 1901 Acharya Praffula Chandra Ray (Calcutta) Bengal
Chemicals and Pharmaceutical Works.
• 1907 Prof. T.K Gajjar Factory at Parel Alembic Chemical
works, Baroda
• 1942 CSIR Council for Scientific and industrial Research

9. 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.
• Eq: Quinine Fraud (Quinine: Antimalarial Drug)

10. 5. Public pressurized government to introduce effective legislation
to control import, manufacture, distribution and sale of drugs.
• 6. There was no legal and effective control on pharmacy
profession.
• 7. Hence to have a comprehensive legislation, the Indian
government appointed a ‘ Drug Enquiry Committee’ under the
chairmanship of Col. R.N. Chopra in 1930 and published its
report in 1931.
• This was formally known as Chopra Committee.

11. • What were the recommendations of Drug Enquiry Committee?
• 1.A central law to control drugs & Pharmacy profession in India.
• 2. Formation of Central Pharmacy Council (PCI) and State Pharmacy
Council.
• 3. Creation of Drug Control Machinery. (DCM) . Regulation of every
medicine manufactured in India and imported from the country.
• 4. Establishment of well equipped Central Drug Laboratory, and State Drug
Laboratory. (CDL).
• 5. Development of Advisory board to advice the government in making laws.
• 6. Compilation of Indian Pharmacopoeia.
• 7. Development of drug Industry in India.
• 8. Setting up of courses for training of pharmacists & prescribing minimum
qualification for registration of pharmacists.

12. Implementations:-
• In 1932- Prof. Mahadev Lal Schroff started Pharmacy education in
Banaras Hindhu University .
• 1935-United Province Pharmaceutical Association.(IPA)
• 1937 - Import of Drug Bill was introduced . (Import of drugs
only)
• 1939 – Indian Journal of Pharmacy was started by ML Schroff.
• Due to Second World War in 1939, there was delay in introduction
of the legislation.
• Government was reluctant to implement the recommendations of
DEC, and the public was pressurizing the government.

13. • 1940 - Drug bill was introduced and passed in legislative assembly,
which came to force in 1947 as Drugs Act.
• The present Drug and Cosmetic Act is an improved version of the
Drug Act, 1940 and it covers the provisions related to Drugs,
Cosmetics, Ayurvedic, including Unani and Homeopathic
medicines. . The main objective of this act was to regulate the
import, manufacture, distribution and sale of drugs and cosmetics
in India.
• 1941 - First DTAB(Drugs Technical Advisory Board ) under this
act was constituted and CDL(Central Drugs Laboratory) was
established in Calcutta.
• 1945 - The Central Government made several rules entitled the
Drug and Cosmetic Rules. These act and rules were amended from
time to time.

14. • 1946-Indian Pharmacopoeial list was published.
• 1948 - The Pharmacy act (To regulate the profession of
Pharmacy in India.)
• 1949 - Pharmacy Council of India was developed(PCI).
• 1954 - Drug and Magic Remedies Act (To control certain
types of advertisements related to drug and to prohibit
certain types of advertisements related to magic remedies.)
• 1955 - Medicinal and Toilet Preparations Act (For the levy
and collection of duties of excise on medicinal and toilet
preparations containing alcohol, opium Indian hemp or other
narcotic drugs.)
• 1955 – First edition of IP published.

15. • 1985 - Narcotic and Psychotropic Substance Act( To consolidate
and amend the laws relating to Narcotic drugs and Psychotropic
substance.)
• 1987 - Central government implemented Drug Price Control
order

16. • Other acts included were:-
• The Epidemic Disease Act, 1897.
• The Industrial Employment (Standing order) Act 1946 and rules.
• Industrial Dispute Act, 1947.
• Factory Act, 1948.
• The Industries (Development and Regulations) Act, 1951.
• Prevention of food Adulteration act, 1954 and rules.
• 1958 - The Trade and Merchandise Mark.
• 1960 - Prevention of cruelty to animals act.
• 1970 - The Indian Patent and Design Act .
• 1971 - Medical Termination of Pregnancy Act
•
• Shops and Establishment acts of respective states.

17. HEALTH SURVEY AND
DEVELOPMENT COMMITTEE/
BHORE COMMITTEE.
• In 1943 Government of India appointed this committee
under the chairmanship of Sir Joseph Bhore .
Functions
• To make a survey of existing position in respect to health
care organization.
• To make recommendations for future developments.

18. RECOMMENDATIONS
 Establishment of All India Pharmaceutical Council & Provincial
Pharmaceutical Council .
 Enactment of legislation designed to
 Protest the public from incompetence.
 Raise the professional standards of pharmacists. & Safeguard the interest of
qualified pharmacists.
 Revised courses of study - Licentiate Pharmacist, Graduate Pharmacists and
Pharmaceutical Technologists.
 Measures for registration of Pharmacists & maintaining disciplinary control
over practice & profession of Pharmacy.
 Frame a small committee to examine the requirements of country in drugs and
medical requisites.
 Setting of CDL.
 Enforcement of Drugs Act 1940 throughout the country.

19. • Implementation
• Name of small committee
• Submission of report.

20. Hathi committee
• Chairman : Jaysukhlal Hathi.1974
• Constitution
• Report submitted -
• Function
• To take a comprehensive look into drug industry & enquire into various
facets of drugs .
• Recommendations
• Encouraged the development of indigenous industry vis-à-vis the foreign
dominated multinational companies.
• Abundant availability of essential life saving medicines of relevant
standards at controlled price .

21. Mudaliar committee
• Health Survey and Planning Committee in 1959 is
appointed to measure the progress achieved after
implementing the suggestions of Bohre committee
• Chairman: Dr. A Lakshmanswamy Mudaliar.
• Submission of report : 1962

22. RECOMMENDATIONS
• Integration of medical & health services as recommended
by Bhore committee.
• Establish an All India Health Service .
• Establish a regional administrative level between state and
district level.
• Strengthen existing primary health centers & district
hospitals.
• A primary health center should cater a maximum of
40000 people.
• It is necessary to bring drugs prepared according to
indigenous system of medicine also within the purview
of the Drug Act.

24. • 1. The first edition of India Pharmacopoeia was published in the year :
a. 1940
b. 1950
c. 1955
d. 1985
Ans : 1955

25. Frequently asked questions.
• What is the objective of Pharmaceutical Legislation in India?
• Write a note on origin/ history of Pharmaceutical
Legislation in India.
• Why there was a strong demand for pharmacy legislation in
India in the early part of the 20th century?
• What were the recommendations of Drug Enquiry
Committee?
• What is significance of Chopra Committee in the history of
pharmaceutical legislation in India?
• Write a brief review on Hathi committee.

26. • 1. Give an account of pharmaceutical legislations in India.
2. Describe the recommendations made by Chopra
committee.
3. Write contributions of Joseph Bhore committee to
pharmacy profession.
4. Write final recommendations of Drug Enquiry Committee.
5. Discuss pre-independence pharmaceutical legislation of
India.
6. Give the recommendations of ‘Hathi Committee’.
7. Give future trends in pharmaceutical legislation
8. Give two recommendations made by Bhatia Committee.
9. List four key functions of CDSCO.
10. Give two recommendations made by Drug Enquiry
Committee.
11. Give significance of Drug Enquiry committee.
12. Justify repealing of the ‘dangerous drugs act’ into
Narcotics and Psychotropic substances act’.
13. What is CDSCO. State importance of CDSCO.
14. State Indian drug Policy.

27. REFERENCES
• Forensic Pharmacy-N.K.Jain
• Forensic Pharmacy-Mithal
• Pharmaceutical Jurisprudence Dr. Shalini Sharma