Drug Controller General of India (DCGI) under central drug standard control organization (CDSCO) has prime responsibility for regulating clinical trial in India. It is the sovereign function of the government to ensure safety, efficacy and quality of drugs supplied to the public. This function is performed by the Central Drugs Standard Control Organization (CDSCO). The role of CDSCO in early stages of drug development is minimal but it becomes more pronounced consequent to the lead obtained from animal pharmacology and toxicological studies and the need for its further testing on humans. The requirements of data submission on animal testing for permission to undertake Phase I, Phase II and Phase III clinical trials are laid down in Schedule Y of Drugs & Cosmetics rules.

Regulatory Environment in India

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