The Government of India has issued draft amendments to the New Drugs and Clinical Trials Rules, 2019 through G.S.R. 98(E), dated 2nd February 2026. The proposal omits sub‑rule (3) of Rule 17 and substitutes sub‑rule (4), requiring the designated authority to scrutinize applications in Form CT‑01 and either grant Ethics Committee registration in Form CT‑03 or reject with written reasons
The Government of India has issued draft amendments to the New Drugs and Clinical Trials Rules, 2019, through notification G.S.R. 98(E), dated 2nd February 2026.
These proposed rules, published after consultation with the Drugs Technical Advisory Board, are open for public comments within 30 days of Gazette publication.
The amendments, titled the New Drugs and Clinical Trials (Amendment) Rules, 2026, will come into force upon final notification.
The draft proposes changes to Rule 17. Specifically, sub‑rule (3) is to be omitted, and sub‑rule (4) is to be substituted. Under the revised provision, upon receiving an application in Form CT‑01, the designated authority will scrutinize the submitted documents and information.
If satisfied with compliance, it will grant final registration to the Ethics Committee in Form CT‑03. If requirements are not met, the application will be rejected with reasons recorded in writing.