India is the world’s largest generic drugs manufacturer, and exports drugs worth $17.3Bn (2017-18). And India manufactures 70 per cent of the world’s hydroxychloroquine (HCQ), according to the Indian Pharmaceutical Alliance. The decade old drug has taken centrestage in the last few months in the world’s fight against the novel coronavirus.
The anti-malaria drug chloroquine and hydroxychloroquine also used to treat certain auto-immune and arthritis conditions is being used in treating symptoms associated with the novel coronavirus. This is a cheap and widely used drug especially in low-income countries.
In May 2020, the Indian Council of Medical Research (ICMR) recommended use of the HCQ as a preventive medication for Covid19 for asymptomatic healthcare workers in non-Covid hospitals and frontline staff on surveillance duty in containment zones and paramilitary/police personnel involved in coronavirus related field work.
While globally, the scientific community and medical experts are divided about the efficacy of HCQ; the twists and turns in the ongoing controversy are being questioned for Western bias. The medical community acknowledges that big pharma in many parts of the world are reeling with the overt dependence on supply of HCQ from India and the prominence our domestic pharma industry has gained.
More than 3,500 patients have been recruited in 35 countries for the World Health Organisation’s (WHO) Solidarity Trial of which India is a part, over 400 hospitals were actively recruiting patients as of early June.
Did the official United Nations health body react too quickly to temporarily pause the HCQ arm of its ongoing Solidarity Trial and then resume it after the much-touted published studies by some of the world’s most reputed medical publications – the Lancet and the New England Journal of Medicine retracted their reports following the Surgisphere data scandal?
Commentators are even asking if political leanings influenced the authors of the two studies to possibly overlook obvious flaws in the data.
Doctors I spoke to admit there’s always been bias – and it’s more pronounced during periods of health emergencies when the rapid pace of India’s generic drug supply is able to match increase in global demand and even gets validation from foreign governments. This scenario is in some ways reminiscent of the decade-long disparities in access to affordable HIV/AIDS treatment in the 1990s with rich countries monopolising drugs and vaccine patents that made the antiretrovirals (ARVs) unaffordable for low income countries.
This was until the sustained efforts by former South African President Nelson Mandela overturning a law that restricted the import of cheap, generic versions of patented medicines including those effective in treating HIV/AIDS. In 2001, Indian pharma company, Cipla’s Chairman Dr. Yusuf Hamied offered to sell a combination of ARVs at a low price of just $1 a day, as compared to the staggering prices by Western pharma multinationals, but faced much opposition by the same drug makers who held patents and had the backing of the Bush administration.
To contextualize, Indian drugs cost 33 per cent less in comparison to their U.S counterparts.
Biocon (an Indian pharmaceuticals major) Chairperson and Managing Director Kiran Mazumdar-Shaw has even remarked, “From HCQ to remdesivir, I am skeptical about a number of repurposed drugs being either pushed or poo-pooed. All over the world, the Covid-19 conversation is slowly moving from concerns around the economy to strengthening homegrown scientific innovation. I feel India is suffering from a colonial hangover”.
The controversy is also diverting attention away from the RCTs (randomized controlled trials) and clinical studies underway to check if the drug does more harm than good. HCQ is now probably the most widely studied drug to treat Covid-19. The world is divided on the usage and effectiveness of this drug; as of early this month India and Venezuela continue to use it as a preventive measure. Russia, Bahrain, Oman and the United Arab Emirates have not yet suspended the use of HCQ while Brazil, Algeria, Morocco, Turkey, Jordan, Romania, Portugal, Kenya, Senegal, Chad and the Republic of Congo are promoting its usage to fight the virus.
Yes, there are conflicting reports about its use, however in the absence of any outcomes from credible, verified clinical trials – many still ongoing – dismissing initial findings isn’t the most feasible thing to do either. Professor Bruce Biccard, national co-principal investigator, part of the Crown Coronation trial has said this about HCQ, “There is good evidence that chloroquine should have good antiviral properties, and there is nothing to suggest that it can’t be used for prophylaxis”. In a fast-moving pandemic, as situations evolve, learnings on the fly are common.
Here is a truncated timeline of what unfolded after the ICMR and other studies advocated the mass use of HCQ as a prophylactic – as a preventive line of treatment for frontline workers who are treating Covid19 patients.
May 19: Trump publicly acknowledges he’s taking HCQ with a combination of other medicines as a preventive measure
May 22: ICMR recommends use of HCQ as preventive medication for frontline workers
May 22: Lancet publishes paper that a large observational study shows HCQ offers no benefit to Covid19 patients
May 23: WHO pauses HCQ arm of Solidarity Trial
June 3: Lancet issues expression of concern, retracts published paper
June 3: WHO resumes the HCQ arm of its Solidarity Trial
Sources:
https://www.politico.com/prescriptionpulse/2020/06/05/a-tumultuous-week-in-hydroxychloroquine-489439
(Prachi Jatania is a former journalist, now working at the intersection of public affairs, communications, and content marketing. She is a University of Cambridge alumnus, has worked for the UK government in India & crafts strategic communications advisory for global brands and non-profits).