Important for UPSC Prelims: Governance | Health
About CDSCO
- The Central Drugs Standard Control Organisation (CDSCO) is India’s National Regulatory Authority (NRA) for drugs, medical devices, and cosmetics.
- It functions under the Drugs and Cosmetics Act, 1940.
- It regulates the approval, import, manufacture, sale, and distribution of drugs and notified medical devices.
- It ensures that medicines available in India are safe, effective, and of standard quality.
Administrative Setup
- Nodal Ministry: Ministry of Health & Family Welfare
- Administrative Control: Directorate General of Health Services (DGHS)
- Headed by: Drugs Controller General of India (DCGI)
- Headquarters: New Delhi
Major Functions of CDSCO
- Approves new drugs before marketing in India.
- Grants permission for clinical trials.
- Prescribes standards for drugs and medical devices.
- Regulates the quality of imported drugs.
- Coordinates the activities of State Drug Control Organisations.
- Conducts post-market surveillance and orders drug recalls when required.
Licensing Responsibilities
- CDSCO: Approval of new drugs, clinical trials, import licences, and regulation of certain specialised drugs.
- State Drug Control Authorities: Licensing of manufacture, sale, and distribution of most drugs.
- Joint Responsibility: Licensing of blood and blood products, vaccines, sera, and IV fluids.
Conclusion
- CDSCO is the cornerstone of India’s drug regulatory system, ensuring that medicines reaching the public are safe and of standard quality.
| This concept has been mentioned in the following article: LAG-3-based Dual Immunotherapy (RELOPDUO): A New Approach in Cancer Treatment |