CDSCO Launches Additional Forms on National Single Window System (NSWS Portal)

The Central Drugs Standard Control Organization (CDSCO) has launched additional forms on the National Single Window System (NSWS) Portal. A notice of this decision was issued on January 16, 2024.

It may be recalled that the CDSCO had launched a National Single Window System (NSWS) Portal on January 1, 2024. This portal has been designed to build a system that functions as a one-stop shop for all the approvals required by the investor and facilitates ease of doing business.

The NSWS Portal for CDSCO is independent of the SUGAM Portal or the cdscomdonline portal. From January 1, 2024, the following three activities under the Medical Devices Rules, 2017 were made live on the NSWS Portal:

• application for grant of certificate of registration of a notified body- Form MD -01
• application for licence to manufacture medical device for clinical investigations, test, evaluation, examination, demonstration or training- Form MD -12
• application for licence to import medical device for clinical investigations, test, evaluation, examination, demonstration or training- Form MD -16

Now, by the present notice the CDSCO has made the following applications for grant of permission/ licence live on the NSWS Portal from January 16, 2024:

• manufacture new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis- Form CT -10
• manufacture formulation of unapproved active pharmaceutical ingredient for test or analysis or clinical trial or bioavailability or bioequivalence study- CT-12
• manufacture unapproved active pharmaceutical ingredient for development of formulation for test or analysis or for clinical trial or bioavailability or bioequivalence study- Form CT -13
• import new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis- Form CT -16
• import drugs for purpose of examination, test and analysis – Form 12 (This will be live from January 24, 2024)

Hence, all concerned stakeholders shall submit the above applications only through the NSWS Portal. The existing SUGAM online portal for these activities will be disabled from February 10, 2024.

The notice also include a user guide to help facilitate the transition to the NSWS Portal.