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The Drugs and Cosmetics Act, 1940 is an act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India. [1] The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards. [2]
The Act is designed to fulfill India's treaty obligations under the Single Convention on Narcotic Drugs, Convention on Psychotropic Substances, and United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances. The Act has been amended three times - in 1988, 2001, and most recently in 2014.
The Drugs and Cosmetics Rules, 1945 are the rules which the government of India established for the implementation of the Drugs and Cosmetics Act, 1940. These rules classify drugs under given schedules and present guidelines for the storage, sale, display and prescription of each schedule. [1] [2]
The Act is designed to fulfill India's treaty obligations under the Single Convention on Narcotic Drugs, Convention on Psychotropic Substances, and United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances.There are 6 Chapters and 83 Sections in NDPS act 1985.
The Schedule J of the Drugs and Cosmetics Rules, 1945 of India contains "a list of diseases and ailments which a drug may not claim to prevent or cure".Under Rule 106 of the Drugs and Cosmetics Act, 1940, a drug cannot make claims to treat or prevent any of the diseases or reform the conditions listed.
Medicines in India are regulated by Central Drugs Standard Control Organization (CDSCO) Under Ministry of Health and Family Welfare. Headed by Directorate General of Health Services(India).CDSCO regulates pharmaceutical products through Drugs Controller General of India (DCGI) at chair. [citation needed] Drugs are classified under five headings.
Schedule H is a class of prescription drugs in India appearing as an appendix to the Drugs and Cosmetics Rules, 1945 introduced in 1945. These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor. The manufacture and sales of all drugs are covered under the Drugs and Cosmetics Act and Rules.
DCGI lays down the standard and quality of manufacturing, selling, import and distribution of drugs in India. Preparation and maintenance of national reference standard. To bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. Training of Drug Analysts deputed by State Drug Control Laboratories and other Institutions