DTAB Agrees to Prohibit 16 FDCs Identified as Irrational

During its 92nd meeting held on April 24, 2025, DTAB reviewed a report submitted by a sub-committee chaired by Dr. Nilima Kshirsagar. The sub-committee was constituted specifically to re-evaluate these FDCs, which were among those considered irrational in the original Kokate Committee report. The official meeting minutes stated:

“The Board was apprised about the subcommittee report under Chairpersonship of Dr. Nilima Kshirsagar which declared all the 16 FDCs as irrational and recommended for prohibition as these may pose risk to the human beings.”

Following detailed deliberation, the DTAB endorsed the sub-committee’s recommendation, clearing the way for regulatory action that could lead to the withdrawal of marketing authorizations for these formulations. The Board noted;

“After detail deliberation, DTAB agreed with the recommendation of the subcommittee report.”

The development is part of a broader initiative that began in April 2023, when the Central Drugs Standard Control Organisation (CDSCO) issued a notice requesting manufacturers to submit detailed information on the 16 FDCs for further evaluation. The aim was to provide manufacturers an opportunity to present data supporting the safety and efficacy of these combinations.

List of 16 FDCs in 294 FDCs recommended as irrational by Prof. Kokate Committee.

Read Also: CDSCO Seeks Details of 16 FDCs Named as Irrational for Further Examination