Pharmaceutical legislation in India

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. 2 Ravikumar 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. 3 Ravikumar R Patil

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, 9 th March 1927, The British Govt. work on drug legislation & passed the resolution. On that 11 th August 1930 constituted D.E.C under chairmanship of Col. R. N. Chopra. 4 Ravikumar R Patil

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. 5 Ravikumar R Patil

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pressurised from Indian public, the British rulers introduced Import of Drug Bill in 1937 with limited reference, later withdrawn this bill due to public criticism.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 & Cosmetics Act, 1940. 6 Ravikumar 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) S trengthening of the provisions of Drug Act More drug control laboratories for strengthening of infrastructure for drug regulation. 7 Ravikumar 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. 8 Ravikumar R Patil

9. Hathi Committee Under the leadership of Jaisukh L al 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. Detail procedure for functioning of hospital pharmacy. 9 Ravikumar 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 base of regional services. 10 Ravikumar 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. 11 Ravikumar R Patil

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