Evaluation of certain pre 1988 permitted Fixed Dose Combinations (FDCs) de novo for manufacture for sale in the country without due approval from Central Licensing Authority 24 Feb 2025

Manufacturers holding state licenses for certain 1988-permitted Fixed-Dose Combinations (FDCs) before October 1, 2012, but who did not seek approval from the Central Licensing Authority (DCGI), were required to submit applications for clinical trials or post-marketing surveillance. The deadline for submission expired on July 11, 2024, but many firms have not complied. The deadline has now been extended by three months for these manufacturers to submit their applications.