Date of Publication: 05-Feb-2026 (Official Gazette)
INTELLIGENCE OVERVIEW
Agency: Ministry of Health & Family Welfare – India/ The Gazette of India
The Ministry of Health and Family Welfare (MoHFW), India, has issued a draft notification (G.S.R. 98(E)) proposing amendments to the New Drugs and Clinical Trials Rules, 2019, focused on the registration process of Ethics Committees.
The draft removes Rule 17(3) and revises Rule 17(4) to clarify that competent authorities will grant or reject final Ethics Committee registration (Form CT-03) based on scrutiny of applications submitted in Form CT-01, with reasons recorded in writing for any rejection.
Keywords: Clinical Trials, Ethics Registration, Regulatory Compliance
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