Agency Name: | Central Drugs Standard Control Organisation |
Type: | Organisation |
Headquarters: | New Delhi, India |
Region Code: | 110004 |
Coordinates: | 28.6323°N 77.2355°W |
Budget: | (2021 - 2022) [1] |
Minister1 Name: | Mansukh Mandavia |
Minister1 Pfo: | Minister of Health and Family Welfare |
Chief1 Name: | Dr. Rajeev Singh Raghuvanshi |
Chief1 Position: | Drugs Controller General of India |
Agency Type: | Regulatory body |
Parent Department: | Directorate General of Health Services, Ministry of Health and Family Welfare |
Website: | and |
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.
Central Drugs Standard Control Organization has 8 divisions: