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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.
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.
Analysis of Cosmetics received as survey samples from CDSCO (central drug standard control organisation) With the notification of Medical Device Rules 2017 by the Government of India, DCGI will also act as Central Licensing Authority (CLA) for the medical devices which fall under the purview of these rules.
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.
"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
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A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug).