CDSCO Notifies New Pathway For Clearance or Grant of Product Licence for Specified FDCs

The Central Drug Standard Control Organisation (CDSCO) has notified a new pathway for clearance or grant of product licence for specified FDCs. This notification was issued on January 11, 2024.

According to this notification, for the specified 3 FDCs the following pathway will be followed henceforth:

1. Documents required from manufacturers already holding licences from State Licensing Authorities (SLAs) prior to January 10, 2012:
   • Form CT-21 (duly filled, signed and stamped)
   • Fees through Bharatkosh (as specified in 6th Schedule of New Drugs and Clinical Trials Rules, 2019)
   • Name and composition of the FDC
   • Product Permission issued by SLA
   • Copy of Manufacturing license in Form 25/28
   • Phase IV trial protocol / commitment for conducting Active Post Marketing Surveillance study protocol
2. New manufacturers will require the following additional documents:
   • Stability studies data (6 months accelerated)
   • Test Specifications of the FDC along with Method of Analysis
3. All manufacturers having prior licences and who did not apply to DCG(I) must submit their applications at the earliest and not later than July 11, 2024. Failure to do so will result in their licences having no legal validity.
4. All manufacturers must comply with the specified recommendations of the expert committee for revision of the prescribing information/ label.

Moreover, for the specified 2 FDCs the following pathway will be followed henceforth for grant of product licence:

• Submission of fees to CDSCO through Bharatkosh for each FDC
• Submission of product manufacturing licence application to SLA along with details of FDCs, stability date for 6 months accelerated, test specification and method of analysis with label and other documents
• SLA shall grant the licence without NOC from DCG)I) if the conditions of licence under the Drugs and Cosmetics Rules are found to be fulfilled. The SLAs shall verify the quality of such FDCs before grant of licence.
• Such licenced manufactures shall submit periodic safety update reports (PSURs) to the Central Licensing Authority (CLA), i.e. DCG(I). Failure to do so will be considered a contravention of these rules.
• All manufacturers must comply with the specified recommendations of the expert committee for revision of the prescribing information/ label.