Government likely to ban over 150 fixed dose combination drugs

More than 150 combination drugs have been found to lack therapeutic justification and have been recommended to be banned by an expert panel, two people aware of the matter said.

The Chandrakant Kokate-led expert panel, which was probing the efficacy of about 500 fixed dose combinations (FDCs) drugs, submitted its report to the Drug Technical Advisory Board (DTAB) on April 2, the people said, requesting anonymity.

“The report has suggested quite a number of FDCs are irrational and hence recommended them to be banned,”one of the two people cited above said.

DTAB, the government’s top advisory body on drugs, has formed a sub-committee to review the panel’s report and “validate the findings before the government takes a final decision on the fate of these drugs”, another person said.

The report, if accepted by the government, could deal another blow to domestic drug makers. Therapeutic benefits of many combination medicines sold in India are suspected to be doubtful and some may even pose health risks, prompting the government to launch a crackdown on such “irrational” drugs. The government banned 344 such combination drugs in 2016.

The 500 or so FDCs made up the second batch of combination drugs that were examined by the Kokate panel. A FDC drug contains two or more active ingredients in a fixed dosage ratio.

The sub-committee to review the panel’s report has been formed under the chairmanship of Nilima Kshirsagar,

chair of clinical pharmacology at the Indian Council of Medical Research.

Dr CM Ghulati, a well-known health expert and editor of medical journal MIMS, said “the Kokate committee earlier examined only certain FDCs. However, there were other FDCs which are in the market but not screened and therefore, we landed up in a situation where a relatively better FDC got banned by Kokate committee while a relatively worse FDC continue to be sold even today.”

The government’s ban in 2016 was imposed after a report submitted by a panel led by Kokate, vice-chancellor of KLE University, Karnataka. The committee said that these FDCs posed health risks and hence be banned, prompting some companies to challenge the government’s ban in the High 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 sold. The apex court suggested that the DTAB should 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 then formed under the chairmanship of Kshirsagar to review the safety and efficacy of these drugs. The panel recommended continuing with the ban. The panel also found that many FDCs were formulated without due diligence, with dosing mismatches that could result in toxicity.

During the course of the review, the committee received representations from the All India Drugs Action Network, the Federation of Pharma Entrepreneurs, the Indian Drugs’ Manufacturers Association, the Indian Association of Dermatologists Venereologists and Leprologists and Abbott Healthcare Pvt. Ltd.

The Union health ministry’s ban on FDCs included painkillers, anti-diabetic, respiratory and gastro-intestinal medicines. The ban covered about 6,000 brands from major pharma firms.

First Published:
Apr 08, 2019 04:02 IST

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