Pharmaceutical Legislations PDF

PHARMACEUTICAL LEGISLATIONS RABIA AQEEL FACULTY OF PHARMACY INTEGRAL UNIVERSITY LUCKNOW Pharmaceutical jurisprudence is the study of laws and regulations that affect the pharmacy profession, including the procurement, manufacturing, and distributi...

PHARMACEUTICAL LEGISLATIONS RABIA AQEEL FACULTY OF PHARMACY INTEGRAL UNIVERSITY LUCKNOW Pharmaceutical jurisprudence is the study of laws and regulations that affect the pharmacy profession, including the procurement, manufacturing, and distribution of drugs and pharmaceuticals. It also covers the code of pharmaceutical ethics, which guides pharmacists in their professional conduct. Pharmaceutical jurisprudence is important for pharmacists to understand the legal aspects of their profession. It can help them understand how to: Ensure drug safety Provide comprehensive services to patients Maintain high ethical standards Avoid practices like self-medication, advertising exaggerated health claims, or secret arrangements with doctors Pharmaceutical jurisprudence courses may cover legislation such as the Drugs and Cosmetics Act, the Pharmacy Act, the Dangerous Drugs Act, and the Medicinal and Toilet Preparation Act.  Pharmaceutical Legislations Pharmaceutical law is a hybrid piece of legislation that addresses both social and economic issues. 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. INTRODUCTION At the end of the 19th century and early 20th century use of allopathy system increases. Drugs 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 and selling Excellent dumping of drugs Drugs are badly adultered Instead of quinine, chalk tablets are used Drugs like satonine were badly adultered 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 quacks, of quacks doctors, quack medicine mongers, quacks dentists, quacks of medicines, quacks of opticians, quack of faith healers". There was practically no legislation to control on drugs as well as on the pharmacy profession. ORIGIN AND NATURE OF PHARMACEUTICAL LEGISLATION IN INDIA Earlier, the allopathic system of medicine was brought by Britisher's 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.  DRUGS ENQUIRY COMMITTEE On representation from the Indian people, the Viceroy appointed a committee on 11th August 1930, under the chairmanship of Col. RN Chopra. This committee also called its Viceroy Committee/RN Chopra Committee/Drug Enquiry Committee. The report was published in 1931. Aspects 1. To enquire into the extent to which drugs and chemicals of impure quality or defective strength, particularly those recognized by the British Pharmacopoeia are imported, in the public interest, of controlling such importation, manufacture and sale and to make recommendations. 2. Recommendations to overcome the above. 3. The enquire into the necessity of legislation to restrict the profession of pharmacy to duly qualified persons and to make recommendations. Scope and Objectives Drug Bill was introduced in 1940 in legislative assembly, and Drug Bill 1940 was passed, which came to force in 1947. Since then Drugs and Cosmetics Act was amended many times and at present it covers the provisions related to drugs, cosmetics, Ayurvedic, including Unani and Homeopathic medicines. The present Drugs and Cosmetics Act is an improved version of the Drugs and Cosmetics Act, 1940. The main objective of this Act was to regulate the import, manufacture, distribution and sale of drugs and cosmetics in India. The central government made several rules entitled the Drugs and Cosmetics Rules, 1945. These Act and Rules were amended from time to time. The Pharmacy Act, 1948 was passed with the main objective to regulate the profession of pharmacy in India.  In 1954, the Drug and Magic Remedies Act was passed with the main aim to control certain types of advertisements related to drug and to prohibit certain types of advertisements related to magic remedies. Medicinal and Toilet Preparations (Excise Duty) Act, 1955 was passed providing for the levy and collection of duties of excise on medicinal and toilet preparations containing alcohol, opium Indian hemp or other narcotic drugs. Central government implemented Drug Price Control Order1987. In 1985, the Narcotic Drugs and Psychotropic Substances Act, was passed. The main objective of this Act was to consolidate and amend the laws relating to Narcotic Drugs and Psychotropic Substances. HATHI COMMITTEE Important milestone in pharmaceutical legislation history is Hathi Committee appointed Chairman—Jaisukh Lal Hathi. This committee covered all the aspects of licensing, price control, imports, role of foreign sector quality control. Other Acts These were included 1.Prevention of food Adulteration Act, 1954 and Rules. 2. The Industries (Development and Regulations) Act, 1951. 3. The Industrial Employment (Standing Order) Act, 1946 and Rules. 4. Industrial Dispute Act, 1947. 5. Factory Act, 1948. 6. The Indian Patent and Design Act, 1970. 7.The Trade and Merchandise Mark Act, 1958. & The Epidemic Disease Act, 1897.