Clinical Trials

India is fast becoming a preferred destination for global clinical trials because of its technically qualified and English speaking manpower, doctors and hospitals, cost advantage, an ethnically diverse patient pool and so on. The Indian guidelines for research with human subjects are based on the Declaration of Helsinki, WHO, and the ICH guideline for GCP. In 1988, Schedule Y first inserted in the Drugs and Cosmetics Act, 1940 governs the conduct of clinical trials in India. As per the 2005 amended Schedule Y, Phase II, III and IV trials can be concurrently conducted in India and elsewhere. Earlier there was a phase lag of early phase clinical trials between India and the rest of the world. Clinical trials can be initiated only after DCGI grants permission and relevant Ethics Committee approves the same. Phase I data generated in another country is mandatory for permission to conduct Phase II trials or repeat Phase I trials in India. The DCGI now allows, on a case-by-case basis, foreign sponsors to include India in global multi-center Phase 1, Phase 2, and—subject to further approval— Phase 3 trials. However, to ensure that Indians are not the only ones exposed to a new drug, permission will not be granted to foreign companies for trials conducted exclusively in India. Post Marketing Surveillance (Phase IV) has been made mandatory.

Besides the DCGI, clearance and approval has to be sought from the Indian Council of Medical Research (ICMR) [vaccines and toxicological studies];  Institutional Biosafety Committee (IBSC), Review Committee on Genetic Manipulation (RCGM) [recombinant products] and Recombinant DNA Advisory Committee (RDAC) under the Department of Biotechnology; Genetic Engineering Approval Committee (GEAC) under Ministry of Environment, approval from the Directorate General of Foreign Trade (DGFT) [exporting biological samples including bacteria, fungi, parasites, viruses, plant pathogens, GMOs, toxins and rickettsials].