New Delhi: Twenty-nine fixed-dose combination (FDC) drugs containing vitamins and minerals are under the scanner for potential ban due to lack of therapeutic justification.
These were among drugs flagged as “irrational” in 2015 by an expert panel constituted by the health ministry under CK Kokate. The list was recently referred for further examination to the Nilima Kshirsagar sub-committee set up by the Drugs Technical Advisory Board (DTAB), people in the know told ET.
“The list of 29 FDCs has been under review. The companies (manufacturing these) will be given a hearing. The decision will be taken in the best interest of consumers,” said a senior official on the condition of anonymity.
The crackdown on FDCs in the country had started in 2016.
The committee led by Kokate, the then vice-chancellor of KLE University, had declared many FDCs irrational that it said must be prohibited under the Drugs and Cosmetics Act, 1940, as safer alternatives were available.
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An FDC drug contains two or more active ingredients in a fixed dosage ratio. The drugs are deemed rational when claims for their benefits are supported by evidence-based data and well-designed clinical studies.
In 2016, the Centre banned 344 FDCs pursuant to the Kokate committee report submitted in January 2015. The committee said these FDCs posed health risks and hence should be banned, pushing some companies and pharma groups to challenge the government’s notification banning FDCs in court.In December 2017, the Supreme Court referred the matter to the DTAB for a fresh review on whether these drugs should continue to be marketed.
The top court suggested that the board decide whether the manufacture and sale of these drugs should be regulated, restricted or banned outright, and asked the committee to submit its report and recommendations to the government within six months.
An expert panel was later formed under the chairmanship of Kshirsagar, former chair of clinical pharmacology of Indian council of Medical Research, to review the safety and efficacy of these drugs. The panel, after considering these drugs “irrational”, citing safety issues and lack of therapeutic justification, recommended continuing the ban.
