For an overview of clinical research regulations, see the ClinRegs report.
Governing Agencies and Ethics Review Structure
- Indian Council of Medical Research (ICMR)
- Central Drugs Standard Control Organization, Office of Drugs Controller General of India (DCGI)
- Clinical Trials Registry – India
- In India, the Drugs Controller General of India (DCGI), head of the Central Drugs Standard Control Organization (CDSCO), is the regulatory authority responsible for clinical trial oversight, approval and inspections.
- For genetic research, see Department of Biotechnology
- The Independent Ethics Committee is responsible for the review and approval of all human subjects research conducted in India. They also ensure protection of the rights, safety and well-being of human subjects involved in a research project as well as provide public assurance of that protection.
- Guidelines for preparing Standard Operating Procedures (SOP) for Institutional Ethics Committee for Human Research
- Drugs & Cosmetics Act, 1940 (2005)
Local Research Institutions
- Tata Memorial Hospital
- Jaslok Hospital
- Wellspring Hospital
- St. John’s Medical College
- Sangath Centre for Child Development and Family Guidance
- Geeta Bhavan Hospital & Intensive Care Unit