History of drug legislation In India

1. Pharmaceutical legislation

2. • Jurisprudence is the study of fundamental
legal principles.
• Ethics is the science of human conduct.
INTRODUCTION

3. Functions and purpose of law
• To establish justice, stability and peaceful
changes in a society.

4. Forensic Pharmacy
• ‘Forensic’ is derived from latin word ‘forencis’
meaning forum ,which signifies a public place,
market place or a place of assembly for
judicial and other business.
• Forensic pharmacy is the application of
pharmaceutical knowledge to legal problems.

5. History of Drug Legislation in India

6. Before 1940
• Establishment of Bengal Chemical and
Pharmaceutical Works at Calcutta (1901) by
Acharya P. C. Ray
• A small factory at Parel (Bombay, now Mumbai)
by Prof T. K. Gajjar (1903)
• Alembic chemical works at Baroda (now
Vadodara) (1907) by Prof. T. K. Gajjar and
Rajmitra B. D. Amin
• In 1908-09 the import and export of drugs
amounted to Rs 73 lakhs and Rs 15.5 lakhs.

7. Problems
• No control on drugs
• Anything completely devoid of therapeutic
agent can be made, sold or imported
• In absence of any restrictions on quality of
drugs imported, many adulterated and
spurious drugs came in Indian markets
• As a result of such frauds, the British
Government was forced to initiate action for
drug legislation.

8. • Sir Haroon Zaffer moved a resolution on March 9, 1927
in the council of states recommending to the Governer
General "to take immediate steps to control the craze
of medicinal drugs by legislation for standardization of
preparation and sale of such drugs."
• In every civilized country the sale of foods and drugs is
control by law, but in India there were no such
restrictions.
• To avoid this Lt. Col. H. A. J Gidney in the legislative
council demanded for the control of adulterated
drugs.

9. • On september 4, 1928 he moved for leave to
adjourned the house for the consideration of the
"Gigantic Quinine fraud".
• The local press and even the pharmaceutical
journal of England supported the agitation.
• In response to such agitations, Drugs enquiry
committee constituted under the chairman ship
of Col. R. N. Chopra as Chairman , Shri C.
Govindan nair as secretary and Dr. B. Mukharjee
as assistant secretary.
• This Drug Enquiry Committee was later known by
the name ‘Chopra Committee’.

10. The main objectives of Drugs Enquiry
Committee
• To enquire & check the quality of drugs, that
are being imported, manufactured and sold.
• To suggest remedial measures in preventing
adulteration.
• To restrict the profession of pharmacy to
qualified persons.
• The committee submitted its report in 1931.

11. Recommendations of Drugs Enquiry
Committee
• Central legislation i.e. separate Drugs Act and
Pharmacy Act
• Setting up of testing laboratories in all states to
control quality of drugs
• Appointment of advisory board
• Setting up of courses for training in pharmacy and
min qualification for registration as pharmacist
• Drug industry in India should be developed
• To compile an Indian Pharmacopoeia
• Cinchona department should cultivate cinchona

12. Continued..
• Registration of every patent and proprietary
medicine
• The crude single drugs as well as compounded
medicines should brought under control

13. • Until 1937 British rulers do not act on this report .
• In 1937 import of drugs bill was introduced with limited
reference to import and later it was withdrawn due to
public criticism.
• Finally in the year 1940 The Drugs Bill was introduced in the
Parliament, based on the recommendation of D. E. C (Drug
enquiry committee) and after in-depth deliberation The
Drugs Act, 1940 was enacted which was latter amended to
the Drugs and Cosmetics Act, 1940.
 Purpose of Drugs Act:
 To regulate: Import, manufacture, distribution and sale of
drugs.
• Later on, Drugs Enquiry Committee & Health Survey and
Development Committee lead foundation for The
Pharmacy Act, 1948.
AFTER 1940

14. IMPORTANT MILESTONES IN DRUG
LEGISLATION OF INDIA
• 1878 - Opium act enacted
• 1919 -- The poison Act enacted.
• 1940 - Drugs Bill introduced in Parliament and Drugs act
later amended to Drugs & Cosmetic Act
• 1946 - Indian Pharmaceutical Codex (I.P.C) published.
• 1947 - The Indian Nursing Council Act enacted.
• 1948 -- The Pharmacy Act, 1948 & The Dentists Act, 1948
enacted.
• 1954 -- The first B. Pharmacy Course approved by
Pharmacy Council of India at Birla College, Pilani.
• 1955 -- First Indian Pharmacopoeia published.
• 1956 -- Essential Commodities Act enacted.

15. CONTINUED…
• 1960 -- Prevention of Cruelty to Animals Act passed
• 1962 -- Beginning of National Pharmacy week
celebrations in third week of November every year.
• 1963 -- The Indian Hospitals Pharmacists association
(IHPA) was launched at Pilani, Rajasthan.
• 1970 -- First DPCO (Drugs Price Control Ordrer)
• 1985 -- The Narcotic Drugs & Psychotropic Substances
Act enacted.
• 1986 -- Consumer Protection Act enacted.

16. IP editions
https://www.ipc.gov.in/
Indian Pharmacopoeia

18. THANK YOU