Legislation for pharmacy practice in India, their origin and nature, scope and objectives, drug enquiry committee and different types of committees

1. Prepared by: DIPALI TRIVEDI
Designation: Assistant Professor

2. PHARMACEUTICAL
LEGISLATION IN INDIA

3. Pharmaceutical Jurisprudence:
 It is a study of laws and fundamental principles, related to pharmacy
profession.
 It covers laws, rules, regulations on medicines, drugs, pharmaceuticals,
cosmetics and pharmacy profession.
 It controls and regulate the pharmacy profession and various functions
including sale, manufacture, import, export, distribution, pricing etc. of drugs and
cosmetics.
Pharmaceutical Legislations:
 The law intends for regulation and control of various aspects of life of both
human being and animals.
 These aspects might be social, economical and political.
 Pharmaceutical legislation is a mixed legislation, which covers both social and
economic aspects.

4.  To control over practice and profession of pharmacy.
 To control and regulate manufacture, import, distribution and sale of drugs,
pharmaceuticals and cosmetics.
 To make available at reasonable prices various drugs of standard quality.
 To safeguard public health and protect them from misleading advertisements of
drugs and magic remedies.
 To regulate use of alcohol in medicinal and toilet preparations .
 To control and regulate various operations related to narcotic drugs,
psychotropic substances and dangerous drugs in order to control the misuse of
addiction forming drugs like cocaine, morphine, heroin, ganja etc.
 To control and regulate import, possession and sale of poisons.

5.  Earlier, the allopathic system of medicine was brought by Britishers to
our country and allopathic medicines were mainly imported:
 To have some control on the import, the British Rulers introduced:
 The Indian Merchandise Marks Act 1889
 The Sea Customs Act 1898
 Indian Tariff Act 1894
 The Opium Act 1878
 Poison Act 1919
 They were not comprehensive enough to control the chaotic and
deplorable conditions in the drugs trade and industry.

6.  In the year 1931, a Drugs Enquiry Committee (DEC) was
appointed in the interest of public health.
 Under the Chairmanship of Late Col. R. N. Chopra.
The committee was asked to study and recommend proper ways
to control:
a. Entry of qualified persons to pharmacy profession.
b. Import, manufacture, distribution and sale of drugs and
pharmaceuticals.

7.  Creation of “Drugs Control Department” at the centre with
branches in all states.
 Establishment of well equipped “Central Drug Laboratory” with
competent staff and experts.
 Creation of “Central Pharmacy Council and State Pharmacy
Council” to educate and train properly young persons desirous to
enter the pharmacy profession.
 To provide “Central legislations” in order to control drugs and the
pharmacy profession.
 Constitution of “Advisory Board” to advice Government on
technical matters.
 Organized development of “Drugs Industry” in India.
 Compilation of “Pharmacopoeia of India”, etc..

8. A. Health Survey and
Development committee
B. MUDALIAR committee
C.HATHI committee

9.  October 1943---Health Survey and Development
 Committee – by Govt of India
 Chairman----Sir Joseph Bhore.
COMMITTEE RECOMMENDATIONS:
Establishment of an All India Pharmaceutical Council and
provincial Pharmaceutical Council
 Strengthening of profession standards of pharmacists
 Maintaining disciplinary control
 Starting of revised courses of study
 Setting up of Central Drug Laboratory
 Rigid enforcement of the Drug and Cosmetics Act, 1940

10.  Year 1959--- Mudaliar Committee
 Committee – by Govt of India
 Chairman----Dr. A Lakshamanaswamy
Mudaliar, Vice Chancellor of Madras University.
 Health Survey and Planning Committee
 Recommended the inclusion of indigenous
systems of medicine under the purview of the
Drugs Act.

11. Important milestone in pharmaceutical legislation history is
Hathi Committee
 Year 1974-- Mudaliar Committee
 Committee – by Govt of India
 Chairman---- Mr. Jaisukhlal Hathi
 After conducting various meetings the committee
submitted its report in the year 1975.
 This committee covered all the aspects of
Licensing, price control, imports, role of foreign
sector quality control.

12. THANK YOU