The Central Drugs Standard Control Organisation (CDSCO) on January 16, 2024, launched additional Forms on the National Single Window System (NSWS) Portal.
The following additional Forms have also been developed and will be made 'Live' on NSWS w.e.f. January 16, 2024:-
• Application for grant of permission to manufacture new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or examination, test and analysis- CT-10.
• Application for grant of permission to manufacture formulation of unapproved active pharmaceutical ingredient for test or analysis or clinical trial or bioavailability or bioequivalence study-CT-12.
• Application for grant of permission to manufacture unapproved active pharmaceutical ingredients for the development of a formulation for test or analysis or clinical trial or bioavailability or bioequivalence study-CT-13.
• Application for grant of licence to import new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or examination, test and analysis -CT- 16.
It is also stated that Form 12 i.e. 'Application for licence to import drugs for purpose of examination, test or analysis' will also be made 'Live' on January 24, 2024.
Given the above, it is requested that all concerned stakeholders henceforth submit applications related to above said five activities through the NSWS portal only and the existing SUGAM online portal for the said activities will be disabled w.e.f. February 10, 2024.
[Notification No. IT-13011(11)/1/2023-eoffice]
