Pharmaceutical legislation in india

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 INDORE MAHAVIDHYALAYA

2. PHARMACEUTICAL LEGISLATION IN INDIA

3. Definitions 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. Scope and objectives 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. Origin and nature 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. Drug enquiry committee 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: Entry of qualified persons to pharmacy profession. Import, manufacture, distribution and sale of drugs and pharmaceuticals.

7. Recommendations of ‘DEC’ 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. Types of committees Health Survey and Development committee MUDALIAR committee 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 Health survey and development committee

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. Mudaliar committee

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. hathi committee

12. THANK YOU