MEDICAL LAW

The Delhi High Court allows 344 potentially dangerous combination drugs to remain in the market

The health ministry had ordered the manufacture and sale of these drugs to be stopped, a move which the pharmaceutical industry opposed in court.

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.

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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.

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Swara Bhasker: Sharp objects has to be on the radar of every woman who is tired of being “nice”

The actress weighs in on what she loves about the show.

This article has been written by award-winning actor Swara Bhasker.

All women growing up in India, South Asia, or anywhere in the world frankly; will remember in some form or the other that gentle girlhood admonishing, “Nice girls don’t do that.” I kept recalling that gently reasoned reproach as I watched Sharp Objects (you can catch it on Hotstar Premium). Adapted from the author of Gone Girl, Gillian Flynn’s debut novel Sharp Objects has been directed by Jean-Marc Vallée, who has my heart since he gave us Big Little Lies. It stars the multiple-Oscar nominee Amy Adams, who delivers a searing performance as Camille Preaker; and Patricia Clarkson, who is magnetic as the dominating and dark Adora Crellin. As an actress myself, it felt great to watch a show driven by its female performers.

The series is woven around a troubled, alcohol-dependent, self-harming, female journalist Camille (single and in her thirties incidentally) who returns to the small town of her birth and childhood, Wind Gap, Missouri, to report on two similarly gruesome murders of teenage girls. While the series is a murder mystery, it equally delves into the psychology, not just of the principal characters, but also of the town, and thus a culture as a whole.

There is a lot that impresses in Sharp Objects — the manner in which the storytelling gently unwraps a plot that is dark, disturbing and shocking, the stellar and crafty control that Jean-Marc Vallée exercises on his narrative, the cinematography that is fluid and still manages to suggest that something sinister lurks within Wind Gap, the editing which keeps this narrative languid yet sharp and consistently evokes a haunting sensation.

Sharp Objects is also liberating (apart from its positive performance on Bechdel parameters) as content — for female actors and for audiences in giving us female centric and female driven shows that do not bear the burden of providing either role-models or even uplifting messages. 

Instead, it presents a world where women are dangerous and dysfunctional but very real — a world where women are neither pure victims, nor pure aggressors. A world where they occupy the grey areas, complex and contradictory as agents in a power play, in which they control some reigns too.

But to me personally, and perhaps to many young women viewers across the world, what makes Sharp Objects particularly impactful, perhaps almost poignant, is the manner in which it unravels the whole idea, the culture, the entire psychology of that childhood admonishment “Nice girls don’t do that.” Sharp Objects explores the sinister and dark possibilities of what the corollary of that thinking could be.

“Nice girls don’t do that.”

“Who does?”

“Bad girls.”

“So I’m a bad girl.”

“You shouldn’t be a bad girl.”

“Why not?”

“Bad girls get in trouble.”

“What trouble? What happens to bad girls?”

“Bad things.”

“What bad things?”

“Very bad things.”

“How bad?”

“Terrible!!!”

“Like what?”

“Like….”

A point the show makes early on is that both the victims of the introductory brutal murders were not your typically nice girly-girls. Camille, the traumatised protagonist carrying a burden from her past was herself not a nice girl. Amma, her deceptive half-sister manipulates the nice girl act to defy her controlling mother. But perhaps the most incisive critique on the whole ‘Be a nice girl’ culture, in fact the whole ‘nice’ culture — nice folks, nice manners, nice homes, nice towns — comes in the form of Adora’s character and the manner in which beneath the whole veneer of nice, a whole town is complicit in damning secrets and not-so-nice acts. At one point early on in the show, Adora tells her firstborn Camille, with whom she has a strained relationship (to put it mildly), “I just want things to be nice with us but maybe I don’t know how..” Interestingly it is this very notion of ‘nice’ that becomes the most oppressive and deceptive experience of young Camille, and later Amma’s growing years.

This ‘Culture of Nice’ is in fact the pervasive ‘Culture of Silence’ that women all over the world, particularly in India, are all too familiar with. 

It takes different forms, but always towards the same goal — to silence the not-so-nice details of what the experiences; sometimes intimate experiences of women might be. This Culture of Silence is propagated from the child’s earliest experience of being parented by society in general. Amongst the values that girls receive in our early years — apart from those of being obedient, dutiful, respectful, homely — we also receive the twin headed Chimera in the form of shame and guilt.

“Have some shame!”

“Oh for shame!”

“Shameless!”

“Shameful!”

“Ashamed.”

“Do not bring shame upon…”

Different phrases in different languages, but always with the same implication. Shameful things happen to girls who are not nice and that brings ‘shame’ on the family or everyone associated with the girl. And nice folks do not talk about these things. Nice folks go on as if nothing has happened.

It is this culture of silence that women across the world today, are calling out in many different ways. Whether it is the #MeToo movement or a show like Sharp Objects; or on a lighter and happier note, even a film like Veere Di Wedding punctures this culture of silence, quite simply by refusing to be silenced and saying the not-nice things, or depicting the so called ‘unspeakable’ things that could happen to girls. By talking about the unspeakable, you rob it of the power to shame you; you disallow the ‘Culture of Nice’ to erase your experience. You stand up for yourself and you build your own identity.

And this to me is the most liberating aspect of being an actor, and even just a girl at a time when shows like Sharp Objects and Big Little Lies (another great show on Hotstar Premium), and films like Veere Di Wedding and Anaarkali Of Aarah are being made.

The next time I hear someone say, “Nice girls don’t do that!”, I know what I’m going to say — I don’t give a shit about nice. I’m just a girl! And that’s okay!

Swara is a an award winning actor of the Hindi film industry. Her last few films, including Veere Di Wedding, Anaarkali of Aaraah and Nil Battey Sannata have earned her both critical and commercial success. Swara is an occasional writer of articles and opinion pieces. The occasions are frequent :).

Watch the trailer of Sharp Objects here:

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This article was published by the Scroll marketing team with Swara Bhasker on behalf of Hotstar Premium and not by the Scroll editorial team.