The Central Drugs Standard Control Organization (CDSCO) on March 06, 2026, issued a circular regarding the implementation of the Prior intimation System for Forms CT-10, CT-12, and CT-13.
The following has been stated: -
•Following Gazette Notification G.S.R. 46(E) dated January 20, 2026, amendments to the New Drugs and Clinical Trials Rules, 2019 introduce a prior intimation system for analytical and non-clinical testing applications.
•Stakeholders must submit Forms CT-10, CT-12, and CT-13 through the National Single Window System (NSWS) portal, where the acknowledgment will serve as proof of prior intimation.
•However, this system does not apply to sex hormones, cytotoxic drugs, beta-lactam drugs, biologics with live microorganisms, and narcotic or psychotropic substances.
•For categories not covered under the amendment, the existing prior approval system will continue to apply.
[Circular No: IT/MISC/001/2026]
