Govt moves SC to enforce ban on 344 Fixed Dose Combination drugs

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NEW DELHI: The Centre moved the Supreme Court on Monday seeking to enforce a ban on 344 fixed dose combination (FDC) drugs, challenging a Delhi HC order which had last month overturned a government notification on the issue.

The health ministry challenged the order against the notification which imposed ban on 344 FDC drugs including popular cough syrups based on codine like Phensedyl and Corex. The ministry had prohibited manufacturing and sale of these medicines in March last year alleging they were found to be without any therapeutic efficacy or use. Also there were concerns about misuse of such medicines considered unsafe for mass consumption.

A bench headed by Justice Dipak Misra said the matter would be taken up after four weeks. The Delhi HC verdict said the government had failed to consult statutory authorities like the Drug Technical Advisory Board and 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.

“We have told the apex court that ours was a legislative action taken in favour of public health safety and does not require any consultation with any other authority. DTAB or DCC (Drugs Consultative Committee) are consulted for rule making and not for action under Section 26 (A) of the Drugs and Cosmetics Act,” a health ministry official told TOI.
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Courts letting the banned drugs being continued to be produced on technical grounds is poor judgement.R K Sharma,

The government’s ban had impacted about 6,000 brands. The health ministry’s decision was based on a report by a six-member committee headed by Chandrakant Kokate. An FDC contains two or more drugs combined in a fixed ratio of doses and available in a single dosage form. Health experts say many unapproved FDCs are sold in India, mostly in the analgesics, anti-depressants and psychotic condition segment. Industry estimates suggest the move may impact pharmaceutical sales to the tune of around Rs 1,500 crore.

A 2015 study published in PLOS Medicine journal showed over 12% of non-steroidal anti-inflammatory FDCs contain drugs that were either withdrawn from market or have had their use restricted.