The Ministry of Health and Family Welfare (MoH&FW) on February 03, 2026, issued Draft New Drugs and Clinical Trials (.. Amendment) Rules, 2026, further to amend the New Drugs and Clinical Trials Rules, 2019.
The following has been stated: -
•The sub-rule (3) of rule 17 shall be omitted.
•The sub-rule (4) of rule 17 shall be substituted, namely: ―
“On receipt of application in Form CT-01 under sub-rule (1), the authority designated under sub-rule (1) shall scrutinise the documents and information furnished with the application, and if satisfied that the requirements of these rules have been complied with, grant final registration to Ethics Committee in Form CT-03; or if not satisfied, reject the application, for reasons to be recorded in writing”.
Objections and suggestions, if any, may be submitted within 30 days from February 05, 2026.
The detailed notification is given in the document below.
[Notification No.: G.S.R. 98(E)]
