in that presentation information regarding how to start pharmaceutical acts in all over India & also provides history of pharmaceutical legislation in India

1. PHARMACEUTICAL
LEGISLATION IN INDIA
Ravikumar R Patil
Assistant Professor
LNBC Institute of Pharmacy,
Raigaon, Satara, MS

2. Intro
The purpose of pharmaceutical legislation
is to ensure that the patients receive
drugs of required quantity, tested &
evaluation for safety as well as efficacy
for their intended use.
It means the pharmaceutical legislation is
associated with the health of the society.
2Ravikumar R Patil

3. History
 At 1811 first chemist shop opened by
Mr. Bathgate & then started manufacturing
firm of tinctures & spirit in 1910.
 Another apothecary shop opened in 1821 &
firm 1918 by Smith Stanistreet & Co.
 In 1901 Acharya Prafulla Chandra Roy
started small factory Bengal Chemical &
Pharmaceutical work.
 In 1903 Prof. T. K. Gajjar started small
factory at parel & after under his led started
other pharmaceutical unit in Baroda named
by Alembic Chemicals Works Ltd.
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4.  In that days, all those units not sufficient
to fulfill the requirements of Indian public.
So, that’s why medicines was imported
from abroad mainly U.K ,France,
Germany.
 After first world war the spurious &
adulterate drugs imported from abroad.
That’s result affect on human beings.
 Finally, 9th March 1927, The British Govt.
work on drug legislation & passed the
resolution.
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5. Recommendations of D.E.C
The committee submitted their report in 1931 with
90 recommendations. The main
recommendations are as follows:
- Formation of Central & State Pharmacy
Councils which would look after the education &
training of professionals.
- Creation of Drug Control Department at the
centre with the branches in all the states.
- Establishment of a well-equipped CDL with
competent staff & experts for an efficient &
speedy working of Drug Control Department &
also suggest small laboratories would work
under the guidance of CDL.
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6.  Due to second world war British rulers did
not act on this report until 1937.
 After, pressurised from Indian public, the
British rulers introduced Import of Drug Bill in
1937 with limited reference, later withdrawn
this bill due to public criticism.
 Finally, in 1940 The Drugs Act introduced in
the parliament, based on recommendations
of D.E.C.
 In 1940, The Drug Act was enacted which
was latter ammended to the Drugs & 6Ravikumar R Patil

7. Health Survey & Development
Committee
 In 1945 the committee constituted under the
chairmanship of Justice Bhore.
 This committee work on or re-emphasized: -
- The need for the qualified & trained
pharmacists & registration of pharmacists.
- Formation of councils to govern the
profession at centre & in provinces (states)
- Strengthening of the provisions of Drug Act
- More drug control laboratories for
strengthening of infrastructure for drug7Ravikumar R Patil

8. By their recommendations of D.E.C &
Health Survey & Development committee
helped to provides foundation of
Pharmacy Act 1948 & on that basis the
pharmacy council of India was constituted
in 1949 prescribed with minimum
qualification for registration as pharmacist
& described the process for registration.
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9. Hathi Committee
 Under the leadership of Jaisukh Lal
Hathi committee constituted & he submit
their report in 1975.
 They recommends all the aspects
related to :
- Licensing for manufacturing of medicines
for achieving self sufficiency in
medicines.
- Price control of essential medicines.
- Import of medicines & their quality
control. 9Ravikumar R Patil

10. Mudaliar Committee
(Health Survey & Planning Committee)
 Committee constituted in 1959 under the
chairmanship of Dr. A Lakshmanswamy
Mudaliar.
 They submit their report in 1962.
 They focus on PHC (Primary Health Care) &
provides following recommendations:
- Strengthening of the district hospital with
specialist services to serve as central base10Ravikumar R Patil

11. - Regional organisation in each state
between the headquarters organisation &
the district in charge of a Regional
Deputy or Assistant Directors each to
supervise two or three district medical &
health officers.
- To improve the quality of health care
provided by the primary health centers.
- Each primary health centers not to serve
more than 40,000 populations.
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