January 5, 2021The PrinthealthCovid-19science

Covaxin was approved for extra-scientific reasons

India’s healthcare and pharmaceutical industry has the potential to realise the numerous opportunities in a post-pandemic, less China-reliant world. To capture these opportunities, it is more important for the healthcare governance system to be — and be seen as — professional, honest, and transparent.

The Print This is an unedited cut of my weekly column in The Print (2018-2021)

Other than to the highly credulous, it is pretty obvious that the Drugs Controller General of India’s approval’ for Bharat Biotech’s indigenous vaccine candidate, Covaxin, was announced for extra-scientific reasons. It has neither completed Phase 3 clinical trials, nor has the safety and efficacy data been published. In fact, the drug regulator has not so much approved the vaccine for general public use, but rather granted permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode…”.

Again, other than to the highly credulous, it is pretty obvious that such an approval’ was announced alongside that of the Serum Institute’s Covishield for political reasons. The Narendra Modi government did not want to lose the opportunity to score political points: that India has produced an indigenous vaccine under the leadership of Prime Minister Narendra Modi.

In other words, it’s a jumla. And an effective one at that. It reinforces the government’s narrative of Atmanirbhar Bharat. Plus, anyone who questions the decision can be attacked for not being patriotic, nationalistic, or proud-of-our-scientists enough.

Politics or science

What is amusing is that just like in the story of the Emperor’s New Clothes, a lot of people — including experts — are going out of their way to justify the decision on scientific or public health grounds. It is one thing for politicians and political commentators to do this, quite another when scientific experts and public officials undermine their personal reputations and institutional credibility by offering implausible technical justifications. It would have been far more honest to admit that there is a strong political imperative to fast-track an indigenous vaccine, and that the regulators have accommodated it while minimising the risks to the public.

At a time when even the Indian republic’s top judiciary is unable to resist the tide, the drug regulators have done well to ring-fence their grant of permission using clever language to restrict the use of the vaccine before the trials are completed and the results are out. It is quite likely that the actual large-scale rollout of Bharat Biotech’s Covaxin will happen after the trials are completed.

The Modi government is likely to have assessed that the political risks of the move are low enough and can be managed. The vaccine is perhaps quite safe and effective. If problems are detected in the ongoing Phase 3 trials, its use in the public vaccination programme can quietly be discontinued. If problems are detected later, the short span of public memory and the government’s dominance over public discourse can be relied upon to shift attention to other matters. To its credit, the government has already put in place a national vaccination plan down to the grassroots, and it will start doing its job in a matter of days now.

If the risks to public health and the political health of the Modi government are somewhat contained, the risks to India’s international credibility as a healthcare and pharmaceutical player are not. Even if Bharat Biotech’s Covaxin is safe and effective, it does not serve the national interest for regulators to claim 110% safety based on an unpublished internal report submitted by a group of experts whose very names have not been announced. Trust us, we are experts” or Have faith in Indian scientists” might work to silence domestic sceptics, but it won’t cut the ice with foreign countries. That the Russian and Chinese vaccines have fewer takers than Western ones is because the latter demonstrate massively higher levels of transparency and scientific probity.

Time for Indian healthcare to step up

It is certainly a matter of pride that India is one of the world’s leading vaccine and drug manufacturers, and the Narendra Modi government must do everything in its power to promote the indigenous industry. But it should remember that the most basic dharma is ahimsa”, and in medical practice primum non nocere”. Both mean the same thing: do no harm”.

As I wrote last August, amid reports of Indian Council of Medical Research (ICMR) calling for a vaccine to be announced before trials, The Modi government must not damage India’s competitive advantage in vaccines and pharmaceuticals through absurd benchmarks that will not be trusted by other countries…The greater the official transparency, the greater the credibility of the vaccines and treatments developed in India. Indeed, the credibility of India’s medical and pharmaceutical regulatory authorities is of strategic importance. Beyond protecting Indians, indigenously developed vaccines and treatments have global potential.”

The rest of my The Print columns are here

Few in India or abroad doubt the prowess of our scientists or entrepreneurs. When it comes to health, more than any other subject, what people worry most about is the system”. India’s healthcare and pharmaceutical industry has the potential to realise the numerous opportunities in a post-pandemic, less China-reliant world. To capture these opportunities, it is more important for the healthcare governance system to be — and be seen as — professional, honest, and transparent.



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