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India with well trained skilled professionals and vast Pharma companies offers unique opportunities for conducting clinical trials. Due to significant cost reduction and increased pace and productivity of all R&D phases has brought considerable growth and impact to the favorable regulatory climate for conducting the clinical trials in India. Various institutions playing a prominent role in guiding the clinical trial in India include DCGI (drugs controller general of India), DBT (department of biotechnology), ICMR (Indian council of medical research, CBN (central bureau of narcotics), RCGM (review committee on generic manipulation) GEAC (genetic engineering approval committee). Currently the clinical trials are regulated by schedule Y of the drug & cosmetics rules, 1945.After the amendment of the D&C act in 2005, the schedule Y was extensively revised to bring the Indian regulations up to par with internationally accepted definitions and procedures