India's Central Drugs Standard Control Organization (CDSCO)
Headquartered in New Delhi, the CDSCO is India's main regulatory body for pharmaceuticals and medical devices. Within the CDSCO, the Drug Controller General of India (DCGI) is responsible for the regulation of pharmaceuticals and medical devices. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).
Licensing and classification of medical devices are handled by the Central Licensing Approval Authority (CLAA). The CLAA is also responsible for setting and enforcing safety standards, appointing notified bodies to oversee conformity assessment, conducting post-market surveillance and issuing warnings and recalls for adverse events.
The CDSCO establishes safety, efficacy, and quality standards for pharmaceuticals and medical devices. It publishes and updates the Indian Pharmacopeia, a list of regulated pharmaceuticals and devices. For all drug and device applications, the CDSCO appoints notified bodies to perform conformity assessment procedures, including testing, in order to ensure compliance with their standards. The CDSCO is also divided into several zonal offices which do pre-licensing and post-licensing inspections, post-market surveillance, and recalls when necessary.
In addition to its regulatory functions, the CDSCO offers technical guidance, trains regulatory officials and analysts, and monitors adverse events. The CDSCO works with the World Health Organization to promote Good Manufacturing Practice (GMP) and international regulatory harmony.
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