Prior Intimation System Under NDCT Rules Won't Apply to Hormones, Cytotoxics, Beta-Lactams, Certain Biologics: CDSCO

New Delhi: The Central Drugs Standard Control Organization (CDSCO) has issued a circular announcing the implementation of a "prior intimation" system for specific applications related to analytical and non-clinical testing under the New Drugs and Clinical Trials Rules, 2019.

However, CDSCO has clarified that the prior intimation system will not apply to certain sensitive categories of drugs, which will continue to require prior regulatory approval. These include sex hormones, cytotoxic drugs, beta-lactam drugs, biologics containing live microorganisms, and narcotic and psychotropic substances.

The move follows amendments introduced through Gazette Notification G.S.R. 46(E) dated January 20, 2026.

Earlier, the Medical Dialogues Team reported that with an aim to streamline regulatory processes while maintaining oversight on the manufacture of new and investigational drugs for research purposes, the Ministry of Health and Family Welfare (MoHFW), through a recent Gazette notification, amended the New Drugs and Clinical Trials (NDCT) Rules, 2019 to introduce a system of "prior intimation" for certain categories of drug manufacturing and to significantly shorten approval timelines.

Now, in line with the above, the recent notification stated,

"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.'

It is hereby informed that all the stakeholders shall submit applications for analytical and non-clinical testing in Forms CT-10, CT-12 and CT-13, as the case may be, at the NSWS portal (https://www.nsws.gov.in) for the “prior intimation” purpose as specified in the above Gazette Notification."

According to the circular issued by the office of the Drugs Controller General of India (DCGI), stakeholders will now be required to submit applications for analytical and non-clinical testing through Forms CT-10, CT-12, and CT-13 via the National Single Window System (NSWS) portal (www.nsws.gov.in).

This submission will serve as a prior intimation to the regulatory authority.

It is hereby further informed that, as mentioned in the Gazette Notification, this 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

The circular further noted that once the application in the requisite form is submitted at the NSWS portal, the acknowledgement of application submission received from the portal/email may be treated as prior intimation, and the concerned applicant can accordingly use this intimation for further use as required.

To view the official notice, click the link below:

https://medicaldialogues.in/pdf_upload/2026/03/09/skm558e26030618270-1-331900.pdf