Pharmaceutical legislation in India is the first chapter of Pharmaceutical jurisprudence subject of second year diploma in pharmacy.

1. Anti-Protozoal Drugs
SECOND YEAR DIPLOMA IN PHARMACY
Genesis Institute of Pharmacy, Radhanagari
Pharmaceutical Jurisprudence
(Subject Code: 0814)
Presentation on
Pharmaceutical Legislation in India
Presented by
Miss. Shweta N. Kalebere
Lecturer, Genesis Institute of Pharmacy

2. Pharmaceutical Jurisprudence
JURIS + PRUDENTIA
Law intends to regulate and control various aspects of social life.
• Social
• Economical
• Political
Pharmaceutical Legislation is such a mixed legislation, which covers
both social and economic aspects of society.
LAW KNOWLEDGE

3. Purpose of Pharmaceutical Legislation In India:
To ensure that the patients receive drugs of required
quality, tested and evaluated for safety and efficacy for
their intended result.

4. Origin and Nature of Pharmaceutical Legislation in India
LAW CREATED BY PARLIAMENT
Year Name of Founder Name of shop/Industry Year of commencement
of manufacturing
1811 Mr. Bathgate(East India Company) Chemist shop in Calcutta 1910
1821 Mr. Smith Stainstreet and co. Apothecary shop 1918
1901 Acharya Prafula Chandra Ray(
Calcutta)
Bengal Chemicals and
Pharmaceutical Works
-
1903 Prof. T. K. Gajjar Factory at parel
Alembic chemical Works,
Baroda
-
HISTORY OF PHARMACEUTICAL UNITS

5. Year Act Name
1878
Opium Act
1919
Poisons Act
1930
Dangerous Drug Act

6. DRUG ENQUIRY COMMITTEE
(D.E.C.)
1931
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.
Chairman : Lt. Col. R. N. Chopra

7. Reasons For Formation of Chopra Committee
1)Units were not Sufficient to fulfill the
Requirements of Indian Public.
2)Drugs were imported from UK,
Germany and France.

8. 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.

9. 5) Public pressurized Govt. to introduce
effective legislation to control import,
manufacture, distribution and sale of
drugs.
6) There was no legal and effective
control on pharmacy profession.

10. Recommendations
1. The formation of Central Pharmacy Council and the
provincial (state) Pharmacy Councils which would
look after the education and training of professionals.
These councils would maintain the register
containing the names and addresses of the Registered
Pharmacists.

11. 2)The D.E.C. suggested the creation of
drug control machinery (Departments)
at the Centre with branches in all the
states.

12. 3)The establishment of a well-equipped
Central Drug Laboratory (CDL) with
competent Staff and experts for an efficient
and speedy working of Drug Control
Department.
4) Setting of the test laboratories in all
states to control the quality of the
production of drugs &
pharmaceuticals.

13. 4) Appointment of an advisory board to advice the Govt. in
making rules.
5) The drug industry in India should be developed.
6) Setting of courses for training in pharmacy.
7) Priscribing minimum qualification for registration as
pharmacists

14. Scope and Objectives of Pharmaceutical Legislation
Scope
It is related with legal system which regulate the conduct of pharmacy business &
practice of profession of pharmacy.
A thorough understanding of all laws pertaining to pharmacy is essential & all
legal aspects must be satisfied by those who wish to practice the pharmacy
business.
It helps the pharmacist to understand their legal & ethical responsibilities & their
by avoid the danger of unnecessary legal proceedings.
1.
2.
3.

15. The patient should get the drugs of good quality which are tested &
evaluated for safety purpose.
It also covers the legal aspect relating to manufacture of drugs in
pharmaceutical industries, their storage, sale, distribution.
The pharmaceutical Legislation safeguards the health of the people by
making right medication by controlling pharmacy business & Profession.
4.
5.
6.

16. 1) To promote health care by regulating the manufacture of good quality drugs.
2) To make these drugs available to the public at reasonable prices & through
qualified person.
3) To safeguard the people from misleading & false advertisements relating to
drugs & remedies.
4) To regulate the profession of Pharmacy.
5) To Promote the Indigenous research technology.
Objectives

17. 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.

18. 1. The present Drug and Cosmetic Act is an improved
version of the Drug Act, 1940.
The main objective of this act was to regulate -
• Import
• Manufacture
• Distribution
• Sale
of drugs and cosmetics in India.
2)The Central Government made several rules
entitled the Drug and Cosmetic Rules 1945. These
act and rules were amended from time to time.

19. 3. The Pharmacy act 1948 was passed with the main
objective to regulate the profession of Pharmacy in
India.
4. 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.

20. 5. Medical 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.
6) Central Government Implemented
Drug Price Control Order 1987.

21. 7. In 1985 Narcotic and Psychotropic
Substance Act, was passed. The
main objective of this act was to
consolidate and amend the laws
relating to narcotic drugs and
Psychotropic substance.

22. Other Acts Included Were-
1. Prevention of Food Adulteration Act, 1954 and Rules
2. The industries (Development and Regulations) Act, 1951
3. The Industrial Employment (Standing Order) Act,1946 and rules
4. Industrial Dispute Act,1947
5. Factory Act, 1948
6. The Indian patent and Design Act 1970
7. The Trade and Merchandise Mark Act, 1958
8. The Epidemic Diseases Act,1897
9. Shops and Establishments Acts of respective states

23. Thank You