Centre moves SC seeking to enforce ban on 344 fixed-dose-combination drugs

A fixed-dose-combination drug is a cocktail of two or more active drug ingredients in a fixed ratio of doses


The challenge was brought against an order passed by the Delhi high court last month which had quashed a government notification imposing a ban on 344 FDC drugs. Photo: HT
The challenge was brought against an order passed by the Delhi high court last month which had quashed a government notification imposing a ban on 344 FDC drugs. Photo: HT

New Delhi: The Centre moved the Supreme Court on Monday seeking to enforce a ban on 344 fixed-dose- combination (FDC) drugs.

The challenge was brought against an order passed by the Delhi high court last month which had quashed a government notification imposing a ban on 344 FDC drugs. An FDC is a cocktail of two or more active drug ingredients in a fixed ratio of doses.

A bench headed by Justice Dipak Misra said that the matter would be taken up after four weeks. The Centre had banned 344 FDC drugs on 10 March, 2016, citing health risks and lack of therapeutic justification.

In the verdict by Justice Rajiv Sahai Endlaw, the court found that the government had failed to consult statutory authorities like the Drug Testing Advisory Board and the Drugs Consultative Committee for the ban. It clarified that the verdict did not decide on the issue of the FDC drugs being risky to consumers.

It only found that proper procedure had not been followed for imposing the ban.

The government’s ban extended to about 6,000 brands and was based on a report by a six-member committee headed by Chandrakant Kokate.

The Kokate panel, which submitted its report on 20 January 2015, had termed 963 FDCs “irrational”, posing health threats.

Some of the major firms involved in the case include: Pfizer, Wockhardt Ltd, Alkem Laboratories Ltd, Cipla Ltd, Sanofi India Ltd, Sun Pharmaceutical Industries Ltd. The major brands included in the ban were P&G’s cold and cough drug Vicks Action 500 Extra, Piramal’s Saridon, Reckitt’s D Cold Total and Glenmark’s Ascoril-C.

Pharma companies soon moved the high court. Pfizer was the first to be granted a stay on the ban of its cough syrup Corex.

Other pharma companies that won interim relief were Wockhardt Ltd, Laborate Pharmaceuticals, Abbott India, Macleods Pharmaceuticals Ltd, Pfizer India, Procter and Gamble Hygiene and Health Care (P&G), Glenmark Pharmaceuticals Ltd, Reckitt Benckiser of India Ltd, Piramal Enterprises Ltd and Alembic Pharma Ltd.

The matter is likely to be heard after four weeks.

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