DTAB Sub-Panel to Reassess 29 'Irrational' FDCs Flagged by Kokate Committee: Report
New Delhi: In a major move to strengthen drug safety and rational prescribing practices, regulators have initiated a renewed examination of 29 fixed-dose combination (FDC) medicines containing vitamins and minerals. The scrutiny centers on whether these formulations have adequate therapeutic justification and evidence-based support.
According to a recent media report by The Economic Times, the list of 29 FDCs, earlier flagged as "irrational" in 2015 by a health ministry-appointed expert committee led by C.K. Kokate, has been referred for further evaluation to the Nilima Kshirsagar sub-committee constituted under the Drugs Technical Advisory Board (DTAB).
Last year the Medical Dialogues Team had reported that the Drugs Technical Advisory Board (DTAB) had recommended a ban on 16 fixed-dose combinations (FDCs) that were previously flagged as irrational by the expert panel led by Prof. C.K. Kokate. During its 92nd meeting held on April 24, 2025, DTAB reviewed a report submitted by a subcommittee chaired by Dr. Nilima Kshirsagar. The subcommittee was constituted specifically to reevaluate these FDCs, which were among those considered irrational in the original Kokate Committee report.
The Kokate-led committee, chaired by the then Vice-Chancellor of KLE University, had classified several fixed-dose combinations (FDCs) as irrational, recommending their prohibition under the Drugs and Cosmetics Act, 1940, noting that safer therapeutic alternatives were already available.
An FDC is a formulation that combines two or more active ingredients in a predetermined dosage ratio. Such combinations are considered rational only when their claimed clinical advantages are substantiated by robust evidence-based data and properly designed clinical studies.
India’s regulatory action against questionable FDCs dates back to 2016, when the central government banned 344 combinations based on the Kokate committee’s findings. The panel had concluded that many of these drugs lacked a sound therapeutic rationale and that safer alternatives were available. By definition, an FDC combines two or more active ingredients in a fixed ratio and is considered rational only when its clinical benefits are validated through well-designed studies.
The 2016 prohibition led to widespread legal challenges by pharmaceutical companies. In December 2017, the Supreme Court directed the DTAB to conduct a fresh scientific review to determine whether the banned drugs should continue to be marketed, be restricted, or face an outright ban. The court instructed the board to submit its recommendations within six months.
Following this directive, an expert committee chaired by Nilima Kshirsagar, former head of Clinical Pharmacology at the Indian Council of Medical Research (ICMR), reassessed the safety and efficacy of the disputed FDCs. The committee reaffirmed earlier concerns, citing safety issues and lack of therapeutic justification, and recommended continuation of the ban, reports ET.
