The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory authority of India responsible for regulating pharmaceuticals, medical devices, cosmetics, and related products to ensure their safety, efficacy, and quality. It operates under the Ministry of Health and Family Welfare, Government of India, and functions through the provisions of the Drugs and Cosmetics Act, 1940 and its associated rules.
Key functions and roles of CDSCO include:
- Approval of new drugs and clinical trials, ensuring that drugs entering the Indian market meet necessary safety and efficacy standards.
- Regulation of manufacturing, import, sale, and distribution of drugs, cosmetics, and medical devices across India.
- Setting standards and specifications for drugs and medical devices.
- Control and quality monitoring of imported drugs and medical products.
- Coordination with state drug regulatory authorities for licensing, inspections, and enforcement to ensure uniform implementation.
- Granting licenses for specified critical drugs such as blood and blood products, intravenous fluids, vaccines, and sera.
- Oversight of clinical trials, pharmacovigilance, and post-market surveillance to safeguard public health.
- Regulation of cosmetics including safety and labelling requirements.
CDSCO is headed by the Drugs Controller General of India (DCGI) and is supported by 8 zonal offices, various sub-zonal offices, central testing laboratories, and port offices throughout India.
In essence, CDSCO is analogous to the FDA in the United States or the European Medicines Agency in the EU, serving as India’s paramount drug and medical device regulatory body with the mission to safeguard public health by ensuring the availability of safe, effective, and quality medical products.
If you need details on specific procedures like drug approval, clinical trial rules, or registration processes under CDSCO, those are available via their official portals and notifications.
License / Certification
Registration
Auxiliary