The Central Drugs Standard Control Organization (CDSCO) has issued a final notice to manufacturers of certain pre-1988 permitted Fixed Dose Combinations (FDCs), urging them to submit applications for Phase IV Clinical Trial protocols or Active Post Marketing Surveillance within three months. This notice was issued on February 24, 2025.
This notice is a continuation of the CDSCO’s efforts to evaluate FDCs that were permitted before 1988 and are being manufactured and sold in the country without due approval from the Central Licensing Authority.
Background
On January 11, 2024, the CDSCO issued a notice requiring manufacturers holding licenses from State Licensing Authorities for such FDCs before October 1, 2012, and who had not applied to the Drugs Controller General (India) [DCG(I)], to submit their applications. The deadline for these applications was July 11, 2024.
Lack of Compliance & Final Opportunity
Despite the previous notice and the lapse of approximately 12 months, the CDSCO has observed that a significant majority of firms have failed to submit their applications.
Therefore, the CDSCO has decided to provide a final opportunity for manufacturers/stakeholders holding licenses prior to October 1, 2012, to submit applications related to category ‘d’ FDCs. They are given three months from the date of this notice to comply, i.e. until May 24, 2025.
Regulatory Action
The CDSCO has emphasized that this is a final call. Without prejudice to the legal validity of existing product licenses, all concerned manufacturers/stakeholders are strongly urged to submit their applications within the specified timeframe. Failure to do so will result in appropriate regulatory action being recommended by the CDSCO.
