Central Drugs Standard Control Organization (CDSCO)
12. May 2024The Central Drugs Standard Control Organization (CDSCO) is responsible for regulating pharmaceuticals and medical devices in India to ensure their safety, efficacy and quality. It is also responsible for the CDSCO certification of medical devices.
Reporting to the Ministry of Health and Family Welfare, the CDSCO plays a crucial role in regulating and controlling the manufacture, sale and distribution of medicines and medical devices in India.
Together with state regulators, the CDSCO is responsible for issuing licenses for certain specialized categories of critical drugs, such as blood and blood products, intravenous fluids, vaccines, and serums.
The CDSCO’s main tasks include:
Drug approvals and licensing: The CDSCO reviews applications for approval of new drugs, vaccines and biological products (CDSCO registration). It issues licenses to pharmaceutical manufacturers and ensures that regulatory standards are met.
Supervision of clinical trials: The organization oversees and regulates clinical trials conducted in India to ensure ethical practices and the safety of participants.
Drug standards and quality control: The CDSCO establishes and adheres to standards for drugs, including specifications for active pharmaceutical ingredients (APIs) and finished dosage forms. It conducts quality control inspections to verify compliance with these standards.
Medical Device Regulation: CDSCO deals with the regulation of medical devices, including their import, manufacture, and sale. It establishes guidelines for safety and performance standards for medical devices.
Pharmacovigilance: The organization monitors and evaluates the safety of drugs on the market and collects and analyzes information on adverse drug reactions (ADRs) to ensure timely intervention when safety concerns arise.
Export and Import Control: CDSCO regulates the export and import of pharmaceuticals and medical devices and ensures that these products meet the required quality and safety standards.
Licensing of blood banks and serum: The CDSCO is responsible for the approval and regulation of blood banks and sera to ensure the safety of blood and blood products.
Regulatory Compliance: The CDSCO ensures compliance with the Medicines and Cosmetics Act and the regulations that govern the manufacture, sale, and distribution of pharmaceuticals and cosmetics in India.
Overall, the CDSCO plays an important role in protecting public health by regulating the pharmaceutical and medical device industries to ensure the availability of safe, effective, and high-quality healthcare products in the country.
You can find more information on the CDSCO registration website.
