Important for GS Prelims- Science & Technology
About DCGI
- Ministry: Ministry of Health & Family Welfare
- Organization: Heads the Central Drugs Standard Control Organization (CDSCO).
- Headquarters of CDSCO: New Delhi
- Current DCGI: Dr. Rajeev Singh Raghuvanshi.
Legal Basis
- Functions under the Drugs and Cosmetics Act, 1940.
- Also implements the New Drugs and Clinical Trials Rules, 2019 and the Medical Devices Rules, 2017.
Major Functions
- Approves new drugs and vaccines before marketing in India.
- Grants permission for clinical trials.
- Regulates the import of drugs into India.
- Prescribes standards for the quality, safety, and efficacy of drugs.
- Coordinates with State Drug Control Authorities for uniform implementation of drug laws.
- Acts as the Central Licensing Authority for specified categories of medical devices.
- Approves licences for products such as blood and blood products, vaccines, sera, and IV fluids.
DCGI vs CDSCO
| DCGI | CDSCO |
| Head of India’s drug regulatory system | National drug regulatory organization |
| Approves drugs, vaccines, clinical trials, and certain licences | Implements drug regulation and quality control across India |
| Functions under CDSCO | Functions under the Directorate General of Health Services (DGHS), Ministry of Health & Family Welfare |
Conclusion
- DCGI is India’s apex drug regulatory authority responsible for ensuring the safety, efficacy, and quality of drugs, vaccines, clinical trials, and specified medical devices.