This course exposes the student to several important legislations re- lated to the profession of pharmacy in India. The Drugs and Cosmetics Act, along with its amendments are the core of this course. Other acts, which are covered, include the Pharmacy Act, dangerous drugs, medicinal and toilet preparation Act etc. Besides this the new drug policy, professional ethics, OPCODE , patent and design Act will be discussed.

1. POWERD BY -AKANSHA SINGH

2. PHARMACEUTICAL
LEGISLATION ARE :-
(1)Law intends for regulation & control of various
aspect of life.
(2) These aspect might be social economic & political.
(3) Pharmaceutical legislation is a mixed legislation ,
which overlapping covers both social & economics
aspects.

3. ORIGIN :-
 1811 1st chemist shop opened by Mr. Bhatgate
who comes to India company in calcutta.
 1910 they have started manufactured to tincture &
spirits.
 1821 another firm ,smith stanistreet & co. started
apothecary shop & started manufacture in 1918.
 1903 Bengal Chemical and Pharmaceutical works,
a small factory was started in calcutta by Acharya
P.C Ray.

4. - The 1st world war the need was improved.
- Demand of indigenous drug was also
improved.
- Competition becomes unhealthy and
Indian marked flooded with inferior ,
substandard and even harmful drugs.

5.  1. Pharmacist in relation to his job.
 2. Pharmacist in relation to his trade.
 3. Pharmacist in relation to medical profession.
 4. Pharmacist in relation to his profession.
SCOPE AND OBJECTIVES :-
PCI framed the following ethics for Indian
Pharmacists, which may be categorised
under the following headings:

6. LIST OF AMENDING ACTS
AND ADAPTATION ORDERS :-
 1. The Adaptation of Laws Order, 1950.
 2. The Adaptation of Laws (No.3) Order, 1956.
 3. The Pharmacy (Amendment) Act, 1959 (24 of 1959).
 4. The Pharmacy (Amendment) Act, 1976 (70 of 1976).
 5. The Pharmacy (Amendment) Act, 1982 (22 of 1982).
 6. The Delegated Legislation Provisions (Amendment) Act,
1985 (4 of 1986). Pharmacy Act

7. MISCELLANEOUS ACT:-
There are also some other enactments , which are
directly or indirectly related manufacture ,
distribution & sale of Drugs & Pharmaceutical in
India. These are :-
 Prevention of food Adulteration Act , 1946.
 The Industries Act , 1951 (Development & Regulation).
 Industrial Dispute Act ,1947.
 Factory Act , 1948.
 The Indian Patent & Design Act , 1970.
 The Trade & Mechanism Mark Act , 1958.
 The Epidemic Diseases Act , 1897.

8. OBJECTIVE :-
 To ensure that the patients receive drugs of required
quality , tested and evaluation for safety as well as
efficacy for their intended use.
To control import manufacture , distribution & sale of
Drugs & Cosmetic.
 Pharmaceutical legislation is associated with the
health of society.
The act & Rules were amended from time of time.
Central Govt. has made many rules for the same &
presented it as Drug & Cosmetic Rules 1945.

9. DRUG EQUIRY COMMITTEE
Appointed by India Govt. in 1931.
Committee chairman was Lt. Col. R. N. Chopra.
Also called as DEC or Chopra committee.
In the recommendation , the Drug Enquired
Committee Suggested the creation of drug control
machinery at the centre with branches in all the states.

10. BASIC QUESTION RELATED
TO CHAPTER :-
 Q . WRITE SHORT NOTES IN SCOPS &
OBJECTIVE OF PHARMACEUTICAL
LEGISLATION IN INDIA AND ORIGIN ??
 Q . WRITE MISCELLANEOUS ACT ??

11. Q1. When and how the allopathic system of
medicine was brought to India?
ANS :- The allopathic system of medicine which is also
known as modern medicine, was brought to India by the
British traders and the rulers during the colonial period. It
was during the later part of the 19th century that the
allopathic system of medicine became popular in India.

12. Q2. What is “English medicine”?
ANS :- English medicine is the name commonly used by
the Indians to denote the allopathic or modern system of
medicine. During the period British rulers, most of the
allopathic medicines were imported from England. Till
then the indigenous systems of medicine like ayurveda,
siddha and unani popular in India. In order to distinguish
the western medicines (modern medicine) from the Indian
medicines the people started to call the modern medicine
as English medicine. Later this name became very popular
in India.

13. Q3. In what way the Indian drug regulation system was
different from other countries like England during the British
rule ,perticullarly in the early part of 20th century ?
ANS :- In other countries there were specific legislations to control
the manufacture, import, sales and use of medicines. In United
Kingdom, they made two enactments namely the Therapeutic
Substance Act of 1925 and the Food and Drugs (Adulteration) Act of
1928 with the objective of fully safeguarding the interests of the
British people through the control of almost all activities related to
medicines and pharmaceuticals. However in India there was no
legislation to control the activities related to medicines. This has
resulted in dumping spurious and substandard medicines in large
quantities in India and the quacks were permitted to treat the
patients.

14. Q4What is significance of Chopra Committee
in the history of Pharmaceutical Legislation in
India ?
ANS :- The Drug Enquiry Committee under the
Chairmanship of Col. R.N. Chopra was constituted by the
Government of India in August 1930 to study the issues
related to drugs and the profession of pharmacy and other
related matters. During those days the Indian market was
flooded with spurious and substandard medicines and
there was no legislation to monitor and control the
situation.

15. The Committee submitted its Report in 1931 after having a
thorough analysis and study of the prevailing situation in the
country. Since the Committee was headed by Col. R.N. Chopra,
that Report is known as Chopra Committee Report. The findings
and recommendations of the Committee were responsible for the
genesis of pharmaceutical legislation in India. Acts like the Drugs
Act 1940 (which later became the Drugs and Cosmetics Act) and
the Pharmacy Act 1948 were enacted because of the
recommendations of the Chopra Committee. The Chopra
Committee Report has played an important role in the evolvement
of pharmaceutical legislation in India.