Implementation of Prior intimation System for Forms CT-10, CT-12 and CT-13 in pursuance of G.S.R. 46(E) dated 20.01.2026

The Directorate General of Health Services, CDSCO, issued a circular on 6 March 2026 regarding the implementation of a “prior intimation” system for applications submitted under Forms CT-10, CT-12, and CT-13. This system, introduced through Gazette Notification G.S.R. 46(E) dated 20 January 2026, requires stakeholders to submit applications for analytical and non-clinical testing via the NSWS portal.   The acknowledgment received from the portal will serve as valid prior intimation. However, the system excludes specific categories such as sex hormones, cytotoxic drugs, beta-lactams, biologics containing live microorganisms, and narcotic or psychotropic substances. For all other categories not covered under the amended rules, the existing system of prior approval will continue to apply.   This circular ensures clarity and compliance among stakeholders, streamlining regulatory processes while maintaining necessary safeguards for sensitive drug categories. It has been circulated to CDSCO divisions, state drug controllers, and stakeholders through the CDSCO website.