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The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for cosmetics, pharmaceuticals and medical devices. It serves a similar function to the Food and Drug Administration (FDA) of the United States or the European Medicines Agency of the European Union .
Many developed countries set up their pharmacovigilance programs following the Thalidomide scandal in the 1960s. [2] India set up its program in the 1980s. [2] This general concept of drug safety monitoring went through different forms, but the Central Drugs Standard Control Organisation established the present Pharmacovigilance Program of India in 2010. [2]
"Drugs and Cosmetics Rules, 1945" (PDF). Central Drugs Standard Control Organization.Archived from the original (PDF) on 31 October 2005.; A Review on the Current Classification and Regulatory Provisions for Medicines in Drug & Cosmetic Act, in the light of Present Day Context Recommendations for Drugs & Cosmetics Rules with context of Drug Schedules
Clinical trials in India refers to clinical research in India in which researchers test drugs and other treatments on research participants.NDCTR 2019 and section 3.7.1 to 3.7.3 of ICMR guidelines [1] requires that all researchers conducting a clinical trial must publicly document it in the Clinical Trials Registry - India.
The regulatory status of vaccines, which determines their marketing and distribution, may be one of the following established by Anvisa: [15] Sanitary vaccine registration: definitive, for approved drugs; Temporary emergency use authorization: similar to a US Emergency Use Authorization; Exceptional import authorization
A re-registration process is currently underway for Salvadorans through March 9, 2025. Those receiving TPS are granted deferred enforced departure (DED) status, a temporary, discretionary ...
The CDSCO classifications of medical devices govern alongside the regulatory approval and registration by the CDSCO is under the DCGI. Every single medical device in India pursues a regulatory framework that depends on the drug guidelines under the Drug and Cosmetics Act (1940) and the Drugs and Cosmetics runs under 1945.
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