India Profile Updated
April 28, 2022

The India profile in ClinRegs has been updated to include an amendment to the definition of “new drug” in the New Drugs and Clinical Trials Rules. (See Scope of Assessment)

Sources Added During this Update:

(Regulation) New Drugs and Clinical Trials (Amendment) Rules, 2022 (2022-CTRules-Amdt - Hindi and English) (Effective January 13, 2022)
Ministry of Health and Family Welfare

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