Pharmaceutical legislation

Pharmaceutical Legislations – A brief review, Introduction, Study of drugs enquiry committee, Health survey and development committee, Hathi committee and Mudaliar committee

1. Pharmaceutical
legislation
Submitted By –
VirendraVaishnav
B.Pharmacy5
th
Sem
Apollo College of Pharmacy , Durg
Guided By-Mr.ChandraDwivedi
Assistant Professor

2. What is legislation ?
Law intends for regulation and control of various
aspects of life.
These aspects might be social ,economical and
political.
Pharmaceutical legislation is mix legislation ,which
overlappingly covers both social and economic
aspects.

3. What is the purpose of pharmaceutical
legislation?
To ensure that the patients receive drugs
of required quality , tested and evaluated
for safety and efficacy for their intended
result

4. The allopathic system of medicine was brought by
British to our country and were mainly imported.
To have some control , The britishruler introduced
The Indian merchandise marks act 1889
The sea customs act 1898
Indian tariff act 1878
Origin of pharmaceutical legislation
in India

5. To ensure that the patients receive drugs or required
quality and evaluated for safety as well as efficacy for
their intended use…
Pharmaceutical legislation is associated with the
health of the society
drug bill was introduced in 1940 in legislative
assembly and drug bill was passed, which came to
force in 1947.
Objective

6. The main objective of this act was to regulate the
import , manufacture ,distribution and sale of drugs
and cosmetics in India.
The pharmacy act 1948 was passed with the main
objective to regulate the profession of pharmacy in
India.

7. DRUG ENQUIRY COMMITTEE
Appointed by Indian govt. in 11Aug 1939
Committee chairman was Lt. col R.N.chopra. So
also called as the chopra committee.
The committee was asked to make enquiries
and then to make recommendation for smooth
control of manufacture , import ,distribution of
drug in public interest.

8. Recommendations of DCE
Formation of central pharmacy council and state
pharmacy council which would look after the education
and training of professionals.
Creation of drug control machinery (departments ) at the
centers and branches in all states .

9. Establishment of well equipped central drug
laboratory (CDL) with competent staff and experts for
an efficient and speedy working .
Appointment of an advisory board to advise the govt.
in making rules to carry out the objects of the act.
Setting up of courses for training in pharmacy .

10. Registration of every patent and proprietary medicines
of undisclosed formula manufactured in India or
imported from outside the country .
Compilation of an Indian pharmacopeia .
The drug industry in India should be developed.

11. BHORE Committee
BHATIA Committee
MUDALIAR Committee
HATHI Committee

12. MUDALIAR COMMITTEE
In 1959 health survey and planning committee appointed
Chairman Dr. A.lakshman swamymudaliar
Recommended the inclusion of indeginoussystem of medicine
under the preview of then drugs act.
This committee found the conditions in PHCs to be
unsatisfactory and suggested that the PHC already established
should be strengthened before new ones are opened.
Each PHC not serve more than 40k population.

13. HATHI COMMITTEE
THE report of the Hathi committee is an important landmark
in the development of Indian pharmaceutical industry.
Committee formed in 1975 under the chairmanship JAI
SUKH LAL HATHI
This committee covered all aspects of licensing , price
control ,imports ,foreign sector, quality control .

14. Based on the committee report the govt. announced
Drug (price control) policy ,1979.
Key objectives of the policy were :
To ensure adequate availability of drugs
To provide drugs at affordable prices
To achieve self sufficiency in production and self reliance
in drug technology.

15. Thank You