PHARMACEUTICAL LEGISLATION JURISPRUDENCE.pptx

PHARMACEUTICAL LEGISLATION JURISPRUDENCE

1. PHARMACEUTICAL LEGISLATION IN INDIA

2. Content Introduction Origin/History and Nature of Pharmaceutical Legislation Drug Enquiry C ommittee (1930) Health survey and development committee- Mudaliar committee (1959) and Hathi Committee (1994)

3. Introduction At the end of the 19 th century and early 20 century use of Allopathy system increase. Drug of natural origin: Veg , mineral oil and animals At that time, profit became main motive than service Overdose of quinine Using croton oil in eye instead of atropine solution In adequate dispensing of drugs Drugs are badly adulterated Instead of quinine, chalk tablet is used Potent drugs like Antimony, Arsenic and Digitalis marketed without any standards Leading article published by Indian medical Gazette (1927-1929) “India become a land of land of quacks, of quacks doctors, quack medicine, quacks dentists, quacks of opticians, quack of faith healers”. There was practically no legislation to control on drugs as well as on the pharmacy profession.

4. Legislation/ Law related to Pharmacy Profession/Pharmacist

5. A BRIEF REVIEW Earlier, the allopathic system of medicine was brought by Britishers to our country Allopathy medicines were mainly imported In 1811 , first chemist shop opened by Mr. Bathgate , who came to India with east India company in Calcutta. In 1901, Bengal Chemical and Pharmaceutical works, a small factory was started in Calcultta by Acharya P.C Roy. They 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 The Poison Act 1919

6. Drug Enquiry Committee (DEC) Early 20 th century, there were wide spread cases of adulterated, spurious and substandard drugs being manufactured and imported into the country. In 1929 , a resolution was passed by the Council of State to recommend to the Governor-General in Council to urge all provisional governments to take immediate steps To control indiscriminate use of drugs and To legislate for the standardization of the preparation and sale of drug. Committee known as the Drug Enquiry Committee (DEC)/Chopra committee/viceroy committee under the Chairmanship- Colonel Ram Nath Chopra. Established in 1930.

7. Aspects Enquire the extend to which drugs of impure quality or defective strength were being imported, manufacture or sold in India. Recommend steps for controlling such import, manufacture and sale in public interest. Enquire into the necessity of legislation to restrict the profession of pharmacy to qualified persons and to make recommendations.

8. Recommendation of the Chopra Committee

9. Outcomes of this committee’s report (Central) Enactment of Import of Drugs bill 1937 Passage of Drugs & Cosmetic Act 1940 and Rules-1945 The Pharmacy Act 1948 Drugs and Magic Remedies (OA) Act 1954 and Rules 1955 Medicinal & Toilet Preparations (Excise Duties) Act 1955 and Rules 1956 Drug testing Laboratories setup in State and Central Advisory boards (DTAB & DCC) Setup Indigenous System of medicines are brought within the D & C Act 1940. Compulsion for registration of all the drugs and formulation sold in India Indian Pharmacopoeia and its development The Narcotic and Psychotic substances Act 1985 was passed.

10. Just after the publication of the report in 1931, Prof. M.L Schroff (Prof. Mahadeva Lal Schroff ) initiated pharmaceutical education at university level in the Banaras Hindu University. In 1935 , United Provision Pharmaceutical Association was established which was later converted into the Indian Pharmaceutical Association. The Indian journal of Pharmacy was started by Prof. M.L Schroff in 1939. Father of Pharmacy in India- M.L Schroff Father of pharmacy in USA- William Procter Jr.

11. Mudaliar Committee A Health Survey and Planning Committee ( Mudaliar Committee) It was appointed in June, 1959 under Chairmanship of Dr. A. L Mudalair Objectives: To assess the performance in health sector since the submission of Bhore Committee report. Submitted its report in 1961.

12. Recommendations Inclusion of indigenous system of medicine under the preview of D & C Act 1940. Found the conditions in PHCs to be unsatisfactory and suggested that the PHC, already established should be strengthened before new ones are opened Strengthening of sub divisional and district hospitals was also advised. Curative, preventive and promotive services should be all provided at the PHC Also recommended that an All India Health service should be created to replace the erstwhile Indian Medical service.

13. Outcomes of the committee’s report Based on its recommendations, drug prepared according to indigenous system of medicine were brought within the preview of D & C Act, 1940. All the health services were improve as per the recommendations.

14. Hathi Committee Important milestone of Pharmaceutical Legislation history of India is Hathi Committee, 29th June 1974. Consisting of 15 members under Chairmanship of Mr. Jaisukh Lal Hathi . Covered all the aspects ranging from licensing, price control, import, national use of essential medicines, import of medicines and their quality control, etc. Objectives: To take a comprehensive look into the drug industry To ensuring that all essential drugs are made available to the consumers at reasonable prices

15. Recommendations The Hathi Committee  emphasized the achievement of self-sufficiency in medicines and Abundant availability at reasonable prices of essential medicines

16. Report submitted in 1975

17. Report submitted in 1975 Complete report : https://pharmaceuticals.gov.in/sites/default/files/Hathi_Committee_report_1975_0.pdf