Central Drug Standard Control Organisation (CDSCO) regulates the clinical trials and approval of investigational new drugs in India.
The proposal for initiating trials, review of clinical trial results and recommendations for marketing authorization is done through a committee called Investigational New Drug (IND) Committee formed by CDSCO.
Preclinical trials are performed on animals, and they are regulated by guidelines prescribed by the Committee for the Purpose of the Control and Supervision of Experiments on Animals (CPCSEA) in India.
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