Central Drugs Standard Control Organisation
Indian Apex Drug Regulatory Body
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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.
Divisions
Central Drugs Standard Control Organization has 8 divisions:
- BA/BE
- New Drugs
- Medical Device & Diagnostics
- DCC-DTAB
- Import & Registration
- Biological
- Cosmetics
- Clinical Trials
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Criticism
The CDSCO has been criticized for having far lower standards for drug approval than the United States' Food and Drug Administration and European Union's European 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.