The drug regulatory authority has expressed concern over 29 multivitamin medicines on charges of irrational combination. The Central Drugs Standard Control Organisation (CDSCO), the central drug regulatory authority, has taken this step to ensure drug safety and rational use following the recommendations of the Kokate Committee under the Drugs Technical Advisory Board (DTAB) of the Union Health Ministry.
A decision has been made to re-examine these 29 so-called irrational fixed-dose combination (FDC) drugs identified by the Kokate Committee. For this purpose, the matter has been referred to a sub-panel formed under DTAB.
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The expert committee formed by the Union Health Ministry in 2015, led by CK Kokate, had identified several drug combinations as irrational. It has been learned that a fresh evaluation initiative has been taken regarding 29 FDCs from that list.
Sub-committee to re-evaluate safety and efficacy
A recent report stated that this matter has been sent to a sub-committee led by Neelima Kshirsagar under DTAB for re-evaluation. Earlier, DTAB had also recommended banning 16 such FDC drugs that the same committee had identified as irrational. These decisions are primarily being taken on questions of patient safety and drug efficacy.
According to experts, FDCs made by mixing multiple components are considered rational only when their clinical benefits and advantages are established through evidence-based research. In 2016, based on the Kokate Committee's recommendations, the central government had banned 344 drug combinations.
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The reason given was that those drugs lacked adequate therapeutic rationale and safe alternatives were already available in the market. Experts view the decision to review these 29 FDCs afresh as a step to further strengthen the drug control system.
