The FDC Drugs Ban Will and Must Go to the Supreme Court

08 June 2016
In India, the regulatory landscape for drugs lacks a clear hierarchy across the board, and has directly led to a status quo where the centre and states have both passed the buck on the supervision of Fixed Dose Combination, or FDC, drugs.
Dhiraj Singh / Bloomberg / Getty Images

On the afternoon of 21 March 2016, the courtroom 12 of the Delhi High Court was packed with senior advocates, advocates and their juniors carrying sheaves of files. Justice Rajiv Sahai Endlaw, who was presiding over the court, was about to hear at least 164 pleas filed by 64 pharmaceutical companies. The companies were all asking for the revocation of a recent notification issued by the centre. Almost two weeks earlier, on 10 March, the central government had passed a notification banning the sale and manufacturing of 344 Fixed Dose Combination, or FDC drugs—combinations of two or more active pharmaceutical ingredients in fixed ratios, given in the form of a single dose. Major Indian drugs such as Piramal Healthcare’s Saridon, Pfizer’s Corex, D’Cold Total, Vicks Action 500 Extra, Merck India’s Nasivion fell under the list of the banned FDCs.

The advocates of the pharma companies had presented the matter before the court early in the morning as “urgent,” so that it could be taken up that very day. After considering its roster of cases, the court slotted the hearings for that afternoon, at 2.45pm.

By 2.15pm—when the lunch break ends—the courtroom had already filled up with the small army of pharma lawyers. According to an order he issued later that day, other lawyers whose matters Justice Endlaw was supposed to hear between 2.15 and 2.45pm were unable to enter the courtroom, forcing the judge to adjourn their cases. The court staff’s repeated requests to the company of pharma lawyers to leave the courtroom had little effect. Exasperated with the crowd, the judge left the courtroom requesting that decorum should be restored. Eventually, the judge held the proceedings in his chambers in the presence of, he wrote, “whichever counsels were in the front row and / or could reach” it. There, he adjourned the proceedings and called on the registrar general of the court to ensure that the situation was “not repeated.”

This was a rare occurrence. I have reported on matters from the Delhi High Court for some time now, and while courtrooms packed to the brim are common, a judge recording their displeasure with the discipline of the court is not. But the reason for the eagerness of the pharma companies’ advocates to be heard—even at the risk of displeasing the bench—was evident. Had the centre’s notification gone uncontested, pharma companies in India stood to lose about Rs 3,000 crore annually—a dent of 20 percent in their profits, according to an April 2016 EPW article. On 14 March, the court issued a stay on the centre’s notification, temporarily lifting the ban for Delhi. On 2 June, it reserved its judgment on the pharma companies’ plea challenging the notification.

The 10 March order and the ensuing hearings were only a recent development in what has been a long-standing issue with FDC regulation in India. While FDC cocktails have been known to be effective in handling chronic diseases that require many anti-bacterials at once (such as malaria, tuberculosis and AIDS), they can also have adverse side-effects if the combination is “irrational”—therapeutically not justified, or not efficacious. In high doses, FDCs can also aggravate existing conditions; sometimes, they can even cause anti-bacterial resistance to develop in patients. In India, the regulatory landscape for drugs lacks a clear hierarchy across the board, and has directly led to a status quo where the centre and states have both passed the buck on FDC supervision. With both public health and crores of money at stake, a decisive verdict on the matter can, and likely will, only be made by the Supreme Court.

Kaushal Shroff is a staff writer at The Caravan.

Keywords: Drugs FDC pharma regulations CDSCO