Central Drugs Standard Control Organisation information
Indian Apex Drug Regulatory Body
Central Drugs Standard Control Organisation
Organisation overview
Type
Regulatory body
Headquarters
New Delhi, India 28°37′56″N77°14′08″E / 28.632309°N 77.235531°E / 28.632309; 77.235531
Annual budget
₹3,358 crore (US$420 million) (2021 - 2022) [1]
Minister responsible
Mansukh Mandavia, Minister of Health and Family Welfare
Organisation executive
Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India
Parent department
Directorate General of Health Services, Ministry of Health and Family Welfare
Website
cdsco.gov.in and
www.cdscoonline.gov.in
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 Indian government has announced its plan to bring all medical devices, including implants and contraceptives under a review of the Central Drugs and Standard Control Organisation (CDSCO).
Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices and is positioning within the Ministry of Health and Family Welfare. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC). Divided into zonal offices, each one carries out pre-licensing and post-licensing inspections, post-market surveillance, and drug recalls (where necessary). Manufacturers who deal with the authority required to name an Authorized Indian Representative (AIR) to represent them in all dealings with the CDSCO in India.
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Global Information
(2021 - 2022) [1]