The Central Drugs Standard Control Organisation (CDSCO) has issued a communication to all State/UT Drugs Controllers regarding the procedure for subsequent applicants related to Fixed Dose Combinations (FDCs) declared as rational by the Prof. Kokate Committee and approved by the Drugs Controller General of India (DCG(I)).
Background and Update
This communication follows previous letters dated April 5, 2023, and February 6, 2023, which included a list of FDCs (Annexure-A) for which manufacturing licenses could be obtained directly from State Licensing Authorities. The CDSCO has now identified and corrected typographical errors in the earlier list, specifically at serial numbers 67, 134, 1704, 1819, and 1989.
The corrected and updated list supersedes the previously published list.
This communication clarifies the process for subsequent applicants seeking manufacturing licenses for the approved FDCs. All stakeholders are advised to refer to the revised list on the CDSCO website for accurate information.
