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Amended by. 1955, 1964, 1972, 1982, 1986, 1995. Summary. An act to regulate import, manufacture, distribution and sale of Drugs and Cosmetics. Status: In force. The Drugs and Cosmetics Rules, 1945 are the rules which the government of India established through the Drugs and Cosmetics Act, 1940. These rules classify drugs under given schedules ...
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 related Drugs and Cosmetics Rules ...
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of ...
The Controlled Substances Act ( CSA) is the statute establishing federal U.S. drug policy under which the manufacture, importation, possession, use, and distribution of certain substances is regulated. It was passed by the 91st United States Congress as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970 and signed into ...
Schedule J. 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. [1]
The U.S. Kefauver–Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed as ...
Schedule H. 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 ...
Federal Food, Drug, and Cosmetic Act (1938) – Replaced the 1906 Pure Food and Drugs Act with new and stronger provisions including: Extending control to cosmetics and therapeutic devices. Requiring new drugs to be shown safe before marketing-starting a new system of drug regulation.