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The United States Federal Food, Drug, and Cosmetic Act 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. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.
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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. 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. The related Drugs and Cosmetics Rules, 1945 contains provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule.
Schedule X is a class of prescription drugs in India appearing as an appendix to the Drugs and Cosmetics Rules introduced in 1945. These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor. Also, the retailer has to preserve the prescription for a period of two years.
Online pharmacy laws in India are still in nascent stage and there are no dedicated online pharmacy laws in India. The Information Technology Act 2000 governs some of the legal issues pertaining to online dealings but it is silent on the aspect of online pharmacy. As a result, illegal online pharmacies have been increasing in India. It has been said that, if properly regulated, online pharmacies in India could prove beneficial to various stakeholders.
The Drugs and Cosmetics Rules, 1940 are the rules which the government of India established through 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.
References
- ↑ "Functions undertaken by Central/State Government". CDSCO, Directorate General of Health Services, Ministry of Health and Family Welfare, GoI. Archived from the original on 29 January 2011. Retrieved 23 February 2015.
- ↑ "DRUGS AND COSMETICS (2ND AMENDMENT) RULES, 2006" (PDF). Department of Health. New Delhi: Ministry of Health and Family Welfare of GoI in The Gazette of India (extraordinary) Part-II, section 3, sub-section (i) vide G.S.R. 160(E), dated 16 March, 2006. 16 March 2006. Archived from the original (PDF) on 21 February 2007. Retrieved 23 February 2015.
- ↑ "Stricter rules for antibiotics use coming". theindiadaily.com. Archived from the original on 30 October 2010.