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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.
The subject expert committee of CDSCO has recommended the grant of permission for manufacturing and marketing of Desidustat 25 mg and 50 mg tablets in India, based on some conditions related to package insert, phase 4 protocols, prescription details, and GCP. [3] Clinical trials on desidustat have been done in India and Australia. [4]
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 ]
"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
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.
f. New e-pharmacies have to be registered with the Central Drugs Standard Control Organization (CDSCO), India's apex drug regulator and central licensing authority. g. E-pharmacies have to take only one license in any state and can sell drugs all over the country even if they have one license. h.
CDSCO regulates drugs, diagnostics, devices, and cosmetics, and also is responsible for the safety, efficacy, and quality standards for pharmaceuticals and medical devices. DCGTI is advised by the Drug Technical Advisory Board DTAB and the Drug Consultative Commission DCC .