On December 1, the Delhi High Court set aside the government’s ban on hundreds of fixed dose combination medicines that included drugs often taken to treat colds and coughs like Corex, Vicks Action 500 and D’Cold.

In his judgment, Justice Endlaw of the Delhi High Court quashed 344 statutory orders issued by the Ministry of Health & Family Welfare under Section 26A of the Drugs & Cosmetics Act. These statutory orders issued on March 10, 2016 prohibited the manufacture and sale of 344 fixed-dose-combination or FDC drugs.

As the name suggests, FDCs are combinations of existing drugs. The medical rationale for FDCs is to increase patient compliance where treatment of a disease requires patients to be treated with more than one drug. Instead of prescribing multiple tablets to the patient and risking the patient not consuming all of them as required, it makes sense to combine multiple drugs into a single medication – usually in the form of one tablet. The World Health Organisation has supported the development of FDCs in one of its reports, provided there is proof to substantiate the safety and efficacy of such combinations.

All FDCs are combinations of existing drugs which have already been approved. However, two drugs may work very differently when consumed independent of each other and when combined into one tablet. That is to say, two drugs which work perfectly well when administered independently to a patient can cause severe adverse reactions when combined into a FDC. It follows that FDCs should be well regulated by authorities. Once the need for a particular FDC has been established, its safety and efficacy must be proven. That has unfortunately not been the case in India.

India’s poor history of regulating FDCs

Since the mid-eighties, the medical community has expressed alarm with the large number of dangerous FDCs made available in India by both the foreign and domestic pharmaceutical industry. The National List of Essential Medicines prescribes only 16 FDCs. Yet, there are thousands of FDCs available in the Indian market in several different permutations and combinations. Over the last decade, the 59th report of the parliamentary Standing Committee on Health, Lancet and several other publications have pointed out shocking instances of irrational and dangerous FDCs being marketed in India.

So how and why did these FDCs flood the Indian market?

The Drug Price Control Order, which is promulgated under the Essential Commodities Act, 1955, vests in the government the power to regulate drug prices. This price-control was mostly limited to single-ingredient drugs mentioned on the National List of Essential Medicines and not to combination of such drugs as made available in the form of FDCs. When not subject to price control regulation under the DPCO, pharmaceutical companies are at liberty to set their own prices and earn higher profits. This is not good news in a country where a majority of the population is uninsured and pays for medical expenses out of their own pockets. According to the industry’s own estimates the impact of the FDC ban was Rs 5,000 crores. This figure does not include the several hundred FDCs which are being reviewed for a ban.

The regulatory framework for approving new drugs and FDCs in India remains ambiguous. The central government has claimed that state licensing authorities have been “approving” such drugs despite lacking the authority to do so. This is likely true. But, at the same time, some controversial FDCs have been authorised by the Central Drugs Standard Control Organisation, the central government body in charge of drug regulation, itself. In 2012, the Ministry of Health came under fire in the 59th Report of the Parliamentary Standing Committee on Health on the manner of approval of FDCs. The report stated:

  “The Committee is of the view that those unauthorized FDCs that pose risk to patients and communities such as a combination of two antibacterials need to be withdrawn immediately due to danger of developing resistance that affects the entire population. The Committee is of the view that Section 26A is adequate to deal with the problem of irrational and/or FDCs not cleared by CDSCO.”  

The Kokate Expert Committee report

The Standing Committee’s report had its effect and although the Ministry of Health ignored several other recommendations of the committee, on September 16, 2014 it set up an expert committee headed by Professor Chandrakant Kokate to examine the complaints against FDCs. The Kokate Committee examined 6,214 FDCs and in its final report which was submitted to the Central Government on February 10, 2016 recommended the outright banning of 1083 FDCs on the grounds that they were irrational combinations, while recommending a further study on several other FDCs which were found to be rational but lacking in data on safety and efficacy. Acting on these recommendations the Ministry of Health issued the 344 statutory orders referred to in the beginning of this article.

One of the 344 statutory orders banning fixed combination drugs.
One of the 344 statutory orders banning fixed combination drugs.

The pharmaceutical industry led by Pfizer, Abbot, Cipla, and Dr. Reddy’s promptly filed 454 petitions before the Delhi High Court and were represented by an army of lawyers led by 21 senior advocates, including Kapil Sibal and P Chidambaram and supported by 186 advocates.

Justice Endlaw had issued an interim stay on all 344 statutory orders on March 16, 2016. At the time, an article by Dhvani Mehta of the Vidhi Centre for Legal Policy published on Scroll.in
had predicted that the ban announced by the Ministry of Health would be upheld by the High Court given the nature of the powers vested in the government under Section 26A of the Drugs & Cosmetics Act, 1940. Unfortunately, Justice Endlaw has quashed all 343 statutory orders in his judgment on December 1, 2016. With respect, it is submitted that Justice Endlaw’s judgment is flawed and without basis in law.

The government’s power under Section 26A

Justice Endlaw has ruled that the central government is required to consult the two statutory bodies created under the Drugs & Cosmetics Act, 1940 before exercising its power under Section 26A and that it had banned the 343 FDCs without consulting these bodies. These two bodies are the Drugs Technical Advisory Board and the Drugs Consultative Committee. Justice Endlaw’s conclusion however has no basis in the text of the statute or in precedent. Section 26A does not require the central government to seek the advice of either body. Similarly Section 5 and Section 7 which create the the bodies do not impose any such obligation on the Central government. So why then did the High Court reach a conclusion to the contrary?

The Court cited six judgments on the execrcise of power under Section 26A to demonstrate how the Central Government had in previous cases, defended its actions under Section 26A on the grounds that it had consulted the Drugs Technical Advisory Board and the Drugs Consultative Committee. However, in all, except the one case, the issue of whether the two bodies needed to be consulted was not at issue because the government had already sought their advice. In the case of Cipla v. Union of India, a single judge of the Madras High Court had quashed a notification issued under Section 26A on the grounds that advisory board and consultative committee were not consulted.

However, as argued by the government and duly noted by Justice Endlaw there are two other judgments, one each from the Madras High Court and the Karnataka High Court which disagreed with the single judge’s ruling in the Cipla case: Macleods Pharmaceuticals Limited, v. Union of India and Lundbeck India Private Limited vs Union Of India. Both judges ruled that Section 26A allowed the central government to exercise its powers without consulting the two bodies.

Play

Rather than resolve the conflict between these judgments under the Drugs & Cosmetics Act, the Delhi High Court fell back on a litany of other judgments decided under other laws to conclude that if a statute created certain institutions, those institutions would have to be consulted prior to taking any decisions under that law. This line of reasoning is not convincing. The “golden rule” of statutory interpretation is that the black letter of the law is to be given a literal interpretation unless such a literal interpretation results in an absurd result, in which case the court can look beyond the black letter of the law. In this case, a literal reading of Section 26A does not result in an absurd result by any standard.

Precautionary principle

The absurd consequence of the Delhi High Court’s judgment is that hundreds of dangerous drugs continue to be available on the market despite a committee of experts finding these drugs to be irrational and dangerous for human beings. This is an unacceptable judicial result. Other judges faced with similar scenarios have invoked the precautionary principle to rule in favour of public health. In the Macleods Pharmaceuticals case referred to above, Justice V Ramasubramanian had held:

“It is well recognised that while dealing with arguments relating to improper and insufficient assessment of risk factors in cases concerning public health, the Courts are obliged to apply the “precautionary principle”.

As per this principle, where there is a scientific uncertainty on an issue of public health, regulators and courts should take precautionary measures to protect public health. The precautionary principle has been widely accepted in Indian environmental jurisprudence. There is no reason to not follow this principle while regulating dangerous drugs that have an impact on public health.

The author is a research associate at the School of Law, Singapore Management University.