The Ministry of Health and Family welfare amended the New Drugs and Clinical Trials Rules, 2019 in consultation with the Drugs Technical Advisory Board, DTAB, and specified non-clinical testing methods to assess the safety and efficacy of a new drug or investigational new drug.
source https://www.pharmatutor.org/pharma-news/2022/health-ministry-specifies-non-clinical-testing-methods-for-new-drug
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