A bench of the Supreme Court consisting of Justices Rohinton Nariman and S K Kaul is currently hearing an appeal against the judgment by a single judge of the Delhi High Court setting aside the government’s ban of 344 fixed dose combination (FDC) drugs. The high court had set aside the ban on the grounds that the government did not consult the statutory bodies established under the Drugs & Cosmetics Act, 1940, (DCA) before issuing the ban orders under Section 26A of Act. This is a high stakes litigation for public health in India and if the Supreme Court does uphold the government’s ban, it will mark a milestone in the battle to restore the rule of law to the shockingly unregulated FDC market.
These drugs, which are a combination of one or more drugs, are useful in increasing patient compliance by reducing the number of tablets or pills that a patient has to consume. If a patient has to consume three or four different tablets or pills, the chances of them forgetting to consume one or two of them are high — the logic therefore is to combine them into one tablet or pill and you can increase patient compliance. Except the problem in India is that the pharmaceutical industry has turned to FDCs to escape price control. Back in the day when Drug Price Control Orders established prices of drugs with single ingredients, the pharmaceutical industry decided to combine different drugs into a FDC, thereby creating a new product that would be outside the purview of price control. The problem with this approach is that chemistry does not take kindly to simply adding two or more existing drugs to each other. Just because two drugs individually cure fever and a cold, does not mean that once you combine both drugs into one, the resultant FDC would automatically cure both fever and cold. Chances are that the active ingredients might interact with each other to create a volatile and possible toxic combination in the body. FDCs thus should be tested — something that is never done in India. Physicians in India and abroad have been screaming themselves hoarse about the dangers of these unregulated FDCs and publishing papers on the dangers of these drugs in journals like the Lancet & PLoS Med. Such concerns are, however, far away from the minds of the pharmaceutical industry bosses, who think nothing of selling drugs in India which would never be allowed in any other market.
The question is how exactly did these drugs get approved by the Indian regulators without clinical trials? That is still a mystery. The central government’s regulator claims that state regulators have been approving these new FDCs, despite the fact that only the central government regulator can approve “new drugs”, including FDCs. When Reuters’ journalists investigating the issue asked the Uttarakhand drug regulator for a copy of the licence issued to a pharmaceutical company allowing it to manufacture a particularly dangerous combination of cefixime and azithromycin, the regulator claimed it could not find a copy of the licence that it had issued! There has been no inquiry by the central government on this issue till date. This is but one example of the opaque decision making among the guardians of public health often to protect vested industry interests.
The reason the government was forced into banning these 343 FDCs is because in 2012, the Parliamentary Standing Committee Report on Health & Family Welfare tabled a scathing and stunningly well-written report that excoriated the government for the thousands of illegal FDCs sold in the Indian market. That report led to the health ministry setting up a committee headed by professor Kokate, which, after examining 6,214 brands of FDCs on the Indian market, recommended the outright banning of 1,083 FDCs with recommendations for studying the remaining in more details. The ministry then issued 344 statutory orders (SO) on March 10, 2016, banning 344 FDCs, only to be challenged by the entire industry and their army of lawyers — literally so, since the Delhi High Court judgment quashing the SOs records the names of 21 senior advocates and 186 advocates. The push-back from the pharma industry has been enormous and a few months later joint secretary K L Sharma, who signed off on the SOs banning the FDCs and who was pushing for tighter regulations on the industry overall, was shunted away to the National Commission for Women in what is presumed to be a punishment posting.
This is not the first time that a bureaucrat has tried to take on the industry on the bans of FDCs. In 2007, the government had moved to ban over 294 FDCs but the industry managed to get a temporary stay from the Madras High Court and the case remained in suspended limbo with no final judgment rendered on merits. A lot therefore is riding on the outcome of the Supreme Court’s judgment in this FDC case. If the Supreme Court interprets Section 26A of the DCA as a legislative and not a quasi-judicial power, it will mean that the government can ban any dangerous drug without giving the industry a hearing and without passing a reasoned order. This is not an uncommon or undesirable proposition in regulatory law dealing with poisonous and hazardous material. Unlike quasi-judicial adjudication which requires the government to give a fair hearing to both sides and pass a reasoned order that can be subject to heightened judicial review, a legislative exercise of power is the equivalent of making law and the government is not required to hear parties or pass reasoned orders, thereby reducing the scope of judicial review. There is at least one decision of the Madras High Court (Mcleods vs Union of India) which has held Section 26A to be a legislative power and rightly so. This clarity on Section 26A is much required for effective drug regulation.
The more complicated question for the government is whether it has a road map to reign in the FDCs because we all know that if this ban on 344 FDCs is upheld, the industry will introduce newer FDCs into the Indian market. The central drug regulator and the myriad of state licensing authorities have shown that they are more than happy to work hand-in-glove to further the industry’s interests. After all, the government has been grappling with this issue since 1979 when the first committee was set up to reign in FDCs. If the government is serious about curbing this problem, it needs to amend the Drugs & Cosmetics Act making it a criminal offence for the industry to market any drug, FDC or otherwise, without the approval of the central drug regulator. Astonishingly, there is no such provision under the law thereby necessitating ex-post regulation under Section 26A where the burden is on the government to prove that a drug lacks therapeutic justification rather than the industry to prove the drug is therapeutically justified. India is the only country in the world where this burden is on the government — elsewhere, the industry is under an obligation to prove that a drug is safe and if they market without proving such safety and getting approval, they will be prosecuted with the full force of law.
It is time that both the Supreme Court and Parliament restored the rule of law to the Indian pharmaceutical industry.