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.
In India, the Central Drug Standard Control Organisation, or the CDSCO approves new drugs to be introduced in the market. Once the CDSCO has granted approval, the state regulatory bodies—36 in all, one for each state and union territory—give out licenses for sale and manufacture of drugs. The resulting system, rife with red tape, malfunction and massive corruption, is afflicted with malaise such as a lack of an effective drug recall system for substandard drugs and a high number of irrational FDCs. For instance, in the past, many drug manufacturers have continued to make and sell FDCs after obtaining state licenses, even when CDSCO approval for the drug was pending.
The dangers of unregulated FDCs are widely acknowledged. A 2014 article from the Journal of Clinical and Diagnostic Research says that the FDC drugs’ contribution to creating resistant strains of bacteria in patients is becoming “a lethal problem.” It cites as an example the emergence of a strain, salmonella typhi—the bacteria that causes typhoid—that is resistant to ciprofloxacin, the antibiotic used to treat it. This, the article notes, has made the treatment of typhoid not only “difficult but also expensive.” It goes on to list examples of irrational FDCs: two anti-hypertensives that have the same effect but are combined, seemingly for no medical reason; cough and cold remedies that contain drugs such as phenylpropanolamine, which was banned due to its potential to cause strokes. A 2010 study on FDC drugs in India found that over 1,356 unsafe FDC formulations were being sold under 4,559 pharmaceutical brands. Another study carried out by the PLOS Medicine in 2015, showed that the sale of these FDC drugs in 2011-12 alone came to Rs 41,618 crore.
This is not the first time that the Drug Controller General of India, which is responsible for the approval of licenses of specific categories of drugs, has cracked down on the FDCs in the Indian market. Since the 1980s, the medical community and drug activists have been calling for a ban on FDCs. In 2007, the DCGI had directed the state drug regulators to withdraw 294 FDCs from the markets that did not have his approval. However, even then, the manufacturers got a stay order in their favour from the Madras High Court. After nine years, the matter is still being heard in the court.
The most recent effort to ban FDCs that did not have therapeutic justification was set into motion by a parliamentary committee. The committee’s 2012 report pulled up the ministry for health and family welfare for failing to rein in a large number of FDCs circulating in the Indian market without an approval from the CDSCO.
In January 2013, the CDSCO sent a letter to all state and union territory drug controllers asking them to order all the drug manufacturers under their jurisdiction to prove the safety and efficacy of their FDCs within 18 months. In 2014, the government set up the Chandrakant Kokate committee, an expert committee that would review these submissions. By the end of the 18-month period, in July 2014, the Kokate committee had received over 6,220 applications for consideration.
After examination, the Kokate committee found 963 drugs to be irrational. Acting on the committee’s detailed report, the central government issued a show-cause notice to the manufacturers of these drugs. Once their replies were filed, the committee called on domain expert medical specialists from reputed hospitals such as AIIMS, Safdarjung Hospital, Ram Manohar Lohia Hospital and Maulana Azad Medical College to help assess the drugs.
Even after the second examination, the committee found, in February this year, that the FDCs in question to be medically inappropriate and ineffective. This was soon followed by the 10 March order, in which the central government banned 344 of the 963 drugs. The government stated that the ban was instituted because the drug combinations were “likely to involve risk to human beings” at a time when “safer drugs were available.” (Formal orders on the remaining FDCs are likely to be passed soon. A March Business Standard report noted that, had all the 963 drugs been banned at once, the estimated loss would have been to the tune of Rs 10,000 crore.)
Despite the opportunities given to the pharma companies to appear before and file replies to the Kokate committee, the companies’ advocates told the Delhi high Court that the expert committee lacked statutory backing—that it was not formed under a law—and that it did not make enquiries of them. In response to these allegations, the government told the court that interim order passed in the favour of the companies should be vacated and that their only objective is “to gain profits and the petition has been filed only to gain time and obstruct the legitimate functions of the Government of India.”
The Delhi High Court passed a stay order on 14 March. The reasoning employed was curious. It said that the centre’s notification apart from “generally stating that the use of the said drug is ‘likely to involve risk to human beings’ does not disclose any grave urgency.”
The high court order came as a relief at a time when two other High Courts in the country—Madras and Kerala—have passed orders against the drugs companies. On 19 March, the Kerala High Court granted two weeks time to the chemists and druggists to return the banned drugs to the distributors. On 22 March, the Madras High Court refused to stay the notification.
As things stand, these orders passed by discrete High Courts will be applicable only within their states. Uniformity across India in respect of the operation of the order will come through only when an appeal is filed before the Supreme Court. The government is reportedly planning to move the SC, in a move that will club all the pharma company appeals together
One way or the other, the matter is bound to land up before the apex court. The Delhi High Court judgment will be appealed by the party in whose favour, the judgement isn’t. The government has already made its intention to file an appeal in the Supreme Court quite clear. Whenever the appeal is lodged before the apex court, the hope is that it will result in a judgment that settles the dust on the fate of FDCs in India, and consequently stems the pharma companies’ practice to earn profits at the cost of millions of patients.
Kaushal Shroff is a staff writer at The Caravan.