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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.
Drugs Controller General of India (DCGI) is the head of department of the Central Drugs Standard Control Organization of the Government of India responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India.
"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
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.
cdsco.gov.in /opencms /opencms /en /PvPI / The Pharmacovigilance Programme of India ( PvPI ) is an Indian government organization which identifies and responds to drug safety problems. [ 1 ] Its activities include receiving reports of adverse drug events and taking necessary action to remedy problems. [ 1 ]
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 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 Central Drug Standards Control Organisation (CDSCO), the drug regulatory authority of India conducted a nationwide survey in 2009 and announced that of "24,000 samples [that] were collected from all over India and tested. It was found that only 11 samples or 0.046% were spurious."