The Central Drugs Standard Control Organization (CDSCO) on April 21, 2026 implemented the Prior Intimation System for submission of Form CT-05 applications (for export purposes only) pursuant to Gazette Notification G.S.R. 50(E) dated January 21, 2026. The amendment to the New Drugs and Clinical Trials Rules, 2019 comes into force after completion of the prescribed 90-day period.
Under the revised framework, eligible bioavailability and bioequivalence studies—specifically standard study designs on oral dosage forms (excluding certain restricted drug categories) and already approved in specified global jurisdictions—can be initiated through prior intimation instead of prior approval. Applications must be submitted online via the Sugam portal in Form CT-05 along with Ethics Committee approval, with a minimum sample size of 18 participants.
The acknowledgment generated upon submission of Form CT-05 shall be treated as valid prior intimation, enabling applicants to proceed accordingly, while cases outside the scope of the amendment will continue under the existing approval system. Compliance and record maintenance by Ethics Committees will be subject to regulatory review.
[G.S.R. 50(E)]
