Pursuant to Gazette Notification G.S.R. 46(E) dated January 20, 2026, amendments were made to the New Drugs and Clinical Trials Rules, 2019 introducing a system of “prior intimation” for certain activities. This system replaces the earlier process of prior approval for specific categories of applications under the Rules. The circular has been issued by the Central Drugs Standard Control Organization to inform stakeholders about the implementation mechanism of this prior intimation system.

All stakeholders are required to submit applications for analytical and non-clinical testing in Forms CT-10, CT-12 and CT-13 through the NSWS portal (www.nsws.gov.in) for the purpose of “prior intimation” as specified in Gazette Notification G.S.R. 46(E) dated January 20, 2026.

The prior intimation system shall not apply to the following categories:

• Sex hormones
• Cytotoxic drugs
• Beta-lactam drugs
• Biologics containing live microorganisms
• Narcotic and Psychotropic substances

Once an application in the requisite form is submitted on the NSWS portal, the acknowledgement of submission received from the portal or through email shall be treated as prior intimation, and the concerned applicant may proceed accordingly for further use as required.

For all other purposes or categories not covered under the amended rules, the system of prior approval shall continue to remain applicable.

This circular has been issued for information and compliance by all stakeholders.