Questionable decision
The Delhi High Court's order setting aside a ban on fixed dose combination drugs is questionable and should be challenged
The Delhi High Court quashes a ban on fixed dose combination drugs, exposing patients to a host of new dangers
ADECADE-LONG campaign to ban unsafe and unnecessary fixed dose combination (fdc) drugs or combo drugs was torpedoed by the Delhi High Court last month when a single judge, Justice Rajiv Sahai Endlaw, quashed a Union Ministry of Health order banning 344 fdcs. That order was issued in March 2016 based on the recommendations of the Kokate Committee which was set up to examine the controversial issue of fdcs that have swamped the Indian market for long years now. Most of these drugs are banned in other countries and put patients at risk.
fdc is a combination of two or more active pharmaceutical ingredients in a fixed dose to form a single drug. For drug multinationals such as Pfizer, Abbott, GlaxoSmithKline, the Endlaw decision was a significant victory since it would allow them to continue pushing their branded products which are sold over the counter, and rake in handsome profits for these companies. We have all at one time or the other used popular brands like Corex, Phensedyl and Vicks Action 500 Extra. There are a host of others which many of us consume regularly—Crocin Cold & Flu, D-Cold Total, Sumo, Chericof…
The list is endless, and the problem is that combo drugs are either unsafe or not tested for efficacy, which means that they are not any better than the original ingredients. According to a study by the clinical pharmacology department of Queen Mary University of London, there are as many as 3,000 branded antiinflammatory medicines, of which more than 1,000 had been made from unapproved formulations.
But mncs along with Indian drug majors have been opposing the ban strenuously because their bottom line will take a beating. For instance, Corex brought in revenues sales of about 176 crore in the nine months ended December 2015, while Abbott’s Phensedyl accounts for slightly over three per cent of the company’s $1 billion revenue from India. This combo drug has grabbed a third of the Indian cough syrup market.
fdcs are not just unnecessary but also irrational. Many are crazy combinations. As one pharmacologist said in response to the Queen Mary University study, the fdcs “could give nightmares to any doctor who has some understanding of the concept of the rational use of medicine. It is simply beyond comprehension… Even antimicrobials are being combined weirdly, which is a grave challenge for crusaders against antimicrobial resistance”.
However, drug firms argued that the Kokate Committee had not issued them a show cause notice or any meaningful opportunity to be heard, both points which the government disputed with evidence. They also claimed the committee’s conclusion was not validated scientifically. Led by Pfizer, the firms said that under the law, the government should have consulted the Drugs Technical Advisory Board and the Drugs Consultative Committee before banning the 344 fdcs.
The government rebutted this claim by arguing that the law in question, Section 26A of the Drugs and Cosmetics Act, does not mandate a consultation with these bodies before deciding on a ban. But agreeing with the petitioners, Justice Endlaw chose to quash the ban saying due procedure had not been followed. Some legal eagles have termed this is a flawed judgement and expect it to be reversed by a division bench.
Also curious was the court’s finding that there was no “grave urgency” to ban the drugs since most fdcs have been in the market for a long time. Incidentally, not a single one of these fdcs is sold in any of the developed countries which, pharma experts point out, have approved just over 200 rational fdcs after careful scrutiny. India, on the other hand, has allowed over 900 irrational fdcs.
The government appears firm on appealing the ruling in the Supreme Court. It must do so at the earliest. Otherwise it will leave millions of patients at risk.