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| Organisation overview | |
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| 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$400 million) (2021 - 2022)[1] |
| Minister responsible | |
| Organisation executive |
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| Parent department | Directorate General of Health Services,Ministry of Health and Family Welfare |
| Website | cdsco |
TheCentral Drugs Standard Control Organisation (CDSCO) isIndia's national regulatory body forcosmetics,pharmaceuticals andmedical devices. It serves a similar function to theFood and Drug Administration (FDA) of theUnited States or theEuropean Medicines Agency of theEuropean Union. The Indian government has announced its plan to bring all medical devices, includingimplants andcontraceptives under a review of the Central Drugs and Standard Control Organisation (CDSCO).
Within the CDSCO, theDrug Controller General of India (DCGI) regulates pharmaceutical and medical devices and is positioning within theMinistry 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:
The CDSCO has been criticized for having far lower standards for drug approval than theUnited States'Food and Drug Administration andEuropean Union'sEuropean Medicines Agency. In a 2015 interview, the current Drugs Controller General, G. N. Singh, admitted that if the CDSCO held Indian pharmaceutical manufacturers to American standards, most would fail.[10][11]
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