About the pharmaceutical legislation and different committees formed with different regulations which are necessary to run pharma industry

1. Pharmaceutical
legislation
Submitted by:-
Yugal kishor vishwakarma
(5th sem)
Guided by :-
Mr. Chandra Dwivedi
(Asst. Prof. Apollo college
of pharmacy)

2. :-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

3. 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.

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

5. Objective
 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.

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 11
aug1930 .
 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. Types of committees
BHORE Committee
BHATIA Committee
MUDALIAR Committee
HATHI Committee

12. MUDALIAR COMMITTEE
 In 1959 health survey and planning
committee appointed
 Chairman Dr. A.lakshman swamy mudaliar
 Recommended the inclusion of indeginous
system of medicine under the preview of
then drugs act.

13.  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.

14. 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 .

15.  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.