Supreme Court restrains Ministry of Health from taking a call on 15 banned FDC drugs

The 15 FDCs include those of big brands like Abbott Healthcare's Phensydyl, Paras Pharmaceutical's D-Cold Tablet, Alkem's Sumo, Franco-Indian Pharmaceutical's Grilinctus and Cipla's NoCold, amongst others.

New Delhi: The apex court has restrained the health ministry from taking a decision on fifteen fixed dose Combination drugs and thereby acting on panel recommendations to restrict the sale of those FDCs. These drugs were manufactured before September 1988

Medical Dialogues had earlier reported that India's Pharmaceuticals industry had been reeling under the Health Ministry's Gazette notification issued on March 12, 2016, banning 344 fixed dose drug combinations. Many of them popular brands of over the counter antipyretic (used to prevent or reduce fever) and anti-inflammatory drugs sold for years now.

The ban covered about 6,000 brands and major pharma houses including Pfizer Ltd., Sun Pharmaceutical Industries Ltd., Cipla Ltd., Sanofi India Ltd., Alkem Laboratories Ltd, and Wockhardt Ltd.

Read also: List of Banned Fixed Dose Composition drugs

ET reports that the court has said that the government can still look into the safety of these 15 drugs, known as fixed-dose combinations (FDCs), but would have to initiate a fresh investigation in case it wants to ban them.

It will provide relief to several pharmaceutical companies including Abbott, Cipla, and Intas and will bring several popular cough syrups, painkillers and cold medication out of the health ministry's impending ban list

The order of the court came in response to a case filed by Abbott and Griffon Laboratories which had challenged a decision by the Drugs Technical Advisory Board (DTAB) subcommittee to study these 15 FDCs despite previous orders by the apex court that had said these combinations were not to be considered by the panel.

The order was given by a Bench led by justice RF Nariman. The Drugs Technical Advisory Body (DTAB) had submitted a report to the Ministry to ban over 349 FDCs. The 15 FDCs include those of big brands like Abbott Healthcare's Phensydyl, Paras Pharmaceutical's D-Cold Tablet, Alkem's Sumo, Franco-Indian Pharmaceutical's Grilinctus and Cipla's NoCold, amongst others.

The two pharma majors had asked the apex court to restrain the government from acting upon or implementing in any manner any recommendation of the DTAB/sub-committee which without any authority examined the 15 pre-1988 FDCs whose notifications were quashed by the top court.

Quoting the Abbott application, Financial Express reports that "The sub-committee under the chairmanship of Nilima Kshirsagar did not even discuss or notice that pre-1988 FDCs were to be kept outside the purview of the re-examination. Although the 2016 notifications on 15 pre-1988 FDCs had been quashed, the DTAB referred to all FDCs as 'banned' showing its complete ignorance of the SC judgment."

In December 2016, Justice Rajiv Sahai Endlaw of the Delhi high court had quashed the notification, holding that the government had failed to consult statutory authorities like the Drug Testing Advisory Board and the Drugs Consultative Committee for the ban. The court, however, did not rule on whether FDC drugs are harmful to consumers.

Read also: Big Relief to Pharma Companies: Delhi HC quashes ban on FDC drugs

The ban on FDC drugs was enforced following a recommendation by a six-member committee headed by Chandrakant Kokate that found these drug combinations to be irrational and posing health risks.