The India’s Central Drugs and Clinical Trial Regulator, The Central Drugs Standard Control Organization (CDSCO), has issued a public notice that it will no longer accept application for grant of permission to import or manufacture new drugs, unapproved active pharmaceutical ingredients (APIs) of new drugs, or investigational new drugs, which are to be used in laboratory tests or analysis or in domestic or global clinical trials conducted in India. Such applications, from 16th January 2024, will have to be made through the National Single Window System (NSWS) portal only.
What is NSWS portal?
The NSWS portal is a digital platform established by the Indian Government with the aim to act as a single window for all the approvals. The portal enables the investors (manufacturers, importers, traders etc.) to obtain registrations and approvals according to their business requirements.
Which applications for permission in relation to clinical trials will be accepted through the NSWS portal only?
From 16th January 2024, the below mentioned applications in relation to import and manufacture of unapproved APIs, new drugs and investigational new drugs will have to be filed through NSWS portal only:
- Application for grant of permission to manufacture new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis (Form 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 (Form CT-12).
- Application for grant of permission to manufacture unapproved active pharmaceutical ingredient for development of formulation for test or analysis or clinical trial or bioavailability or bioequivalence study (Form CT-13).
- Application for grant of licence to import new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis (Form CT-16).
- Also, an application for licence to import drugs for purpose of examination, test or analysis (Form-12) was also made live on NSWS portal from 24th January, 2024.
What will happen to the applications that were already filed on Sugam portal before 16th January 2024?
The above-mentioned applications that were filed on the Sugam portal will be processed through that portal only. Any new application post 16th January 2024 should be filed through NSWS portal only. The Sugam portal will be disabled for the filing of these applications after 10th February 2024
Is there any official guidance available to ease the new filings through NSWS portal?
A user guide for the filing of application through NSWS portal for the above-mentioned regulatory approvals is made available along with the notice.
What are the other applications which may be made through NSWS Portal?
On 1st January 2024, CDSCO issued a notice that certain medical device regulatory applications, including application for permission to import or manufacture medical device for clinical investigations, will not be accepted on the current medical device CDSCO portal (CDSCO MD-Online portal) after 15th January 2024. Instead, such applications will be accepted through the NSWS portal only.
For more details, please refer our article which covers this update: New portal for medical devices registration in India (NSWS)
Conclusion:
Sponsors of clinical trials, clinical research organizations (CROs), and various drug testing and analytical laboratories in India, which import unapproved APIs for testing and analysis, or for use in clinical trials, should take note of this very important development, in order to avoid any surprise which may impact the drug development and clinical trial timelines.
At a high-level, it is now clear that, in near future, CDSCO will transition all application forms for all pharmaceutical and medical device licenses and permissions to NSWS.