Question
Explain the Approval process of Vaccines in India.
Answer :
Word Count : 356
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The approval process of vaccines in India is a structured and regulated procedure governed by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare. It ensures that vaccines meet the required standards of safety, efficacy, and quality before they are made available to the public. The process begins with preclinical studies, where the vaccine is tested on laboratory models to evaluate its immunogenicity, toxicity, and overall safety profile. Once satisfactory preclinical data is obtained, the manufacturer submits an application to the CDSCO for permission to conduct clinical trials in humans. Clinical trials in India are conducted in three phases. Phase I
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