Explain the Approval process of Vaccines in India

The approval process of vaccines in India is a multi-tiered and highly regulated procedure that ensures the safety, efficacy, and quality of vaccines. The process is governed by the Central Drugs Standard Control Organization (CDSCO), functioning under the Directorate General of Health Services, Ministry of Health and Family Welfare. The Drugs and Cosmetics Act, 1940, and its accompanying rules form the legal framework for vaccine approval.

Preclinical Studies

Before human testing, vaccine candidates undergo preclinical studies, including in vitro and in vivo ______ ____ ____ ____ _______.
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