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.
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. 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.