DTAB approves Sub-committee Report Suggesting Prohibition of 16 FDCs

A report from the Drugs Technical Advisory Board's (DTAB) subcommittee, led by Dr. Nilima Kshirsagar, found 16 fixed dose combinations (FDCs) to be irrational and suggested that they be banned because they could endanger human health. The DTAB concurred with this findings.

In its 92nd meeting, which took place on April 24, 2025, the Board also sent 29 fixed dose combinations that the Prof. Kokate Committee had determined to be irrational to the Kshirsagar subcommittee for additional review.

"The Board was apprised of the subcommittee report under chairpersonship of Dr. Nilima Kshirsagar which certified all the 16 FDCs as irrational and recommended for prohibition as these may cause harm to the human beings," the DTAB stated in reference to the 16 FDCs.

It further stated, "DTAB agreed with the suggestion of the subcommittee report after thorough deliberation."

It should be mentioned that the 86th meeting of the DTAB, held on April 13, 2021, reviewed the expert committee report of the Prof. Kokate Committee regarding the FDCs deemed irrational. The Committee's recommendations were largely accepted, and it was suggested that the subcommittee led by Dr. Nilima Kshirsagar conduct a thorough examination of the 16 irrational FDCs in accordance with the procedures.

Before presenting its recommendation to the Board, the subcommittee gathered data from the producers of these medications and looked into a number of associated factors.

At the most recent meeting, the Board also reviewed the report on the evaluation of FDCs pertaining to vitamin and mineral formulations, which the Prof. Kokate Committee deemed to be illogical.