9 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 2026-Mar-06 57 KB

LT/mMt SC/oot/ 2.026 Government of India. Directorate General of Health Services Central Drugs Standard Control Organization O/o Drugs Controller General (I)

;

FDA Bhawan, New Delhi Date: 06.03.2026

CIRCULAR

Subject: 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 — reg.

In pursuance of Gazette Notification G.S.R. 46(E) dated 20th January 2026, amendments have been made to the New Drugs and Clinical Trials Rules, 2019 introducing the system of “prior intimation”.

Accordingly, it is hereby informed that all the stakeholders shall submit application for analytical and non-clinical testing in Forms CT-10, CT-12 and CT-13 as the case may be at NSWS portal (www.nsws.gov.in) for the “prior intimation” purpose as specified in the above gazette notification.

It is hereby further informed that, as mentioned in gazette notification, this prior intimation system shall not apply to the following categories:

• e« Sex hormones

• e Cytotoxic drugs

• e Beta-lactam drugs e Biologics containing live microorganisms e Narcotic and Psychotropic substances

It may also be noted that once the application in requisite form is submitted at NSWS portal, the acknowledgment of application submission received from the portal/email may be treated as a prior intimation and the concerned applicant can accordingly use this intimation for further use as required. For all other purposes or categories not covered under the amended rules, the system of prior approval shall remain applicable.

This circular is issued for information and compliance by all stakeholders.

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Copy for information and necessary action to:

1. All Divisions, Zonal/Sub-Zonal offices of CDSCO.

2. All State/UT Drug Controllers.

3. US(DR) Section

• 4, Office of JSCDR)

5. All stake holders though CDSCO website.