ICMR’s gaffe: Political objectives or bureaucratic deference can’t compensate for scientific rigour

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The worst traits of Indian bureaucracy were evident in the Indian Council of Medical Research’s myopic attempt to launch a Covid-19 vaccine with an August 15 deadline. In his attempt to bridge the scientific and administrative imperatives of his office, ICMR’s director-general Balram Bhargava fell between the two stools. Horrified experts pointed out that a vaccine cannot be launched by then without giving the short shrift to clinical trials. Even the most optimistic estimates are veering towards an end of year or early 2021 launch for a few vaccine candidates, after shrinking timelines to the maximum extent possible. Injecting a vaccine into the general population without rigorously ensuring safety and efficacy will be dangerously counterproductive.

Science and data cannot be subordinated to political deadlines. Yet, populist governments continue to coax domain experts down that path. Bhargava’s letter to hospitals selected for clinical trials makes no secret of political pressures. He notes the indigenous vaccine jointly developed by Bharat Biotech and ICMR was among the government’s “top priority projects which is being monitored at the topmost level”. After strictly advising the hospitals to fast track all approvals for initiation of clinical trials and starting “subject enrolment” (“participant enrolment” would be ethically appropriate), the letter warns bluntly that “non-compliance will be viewed very strictly”.

A press release subsequently clarified that the letter solely aimed to cut “unnecessary red tape” without compromising safety, best practices and rigour. But questions remain. For starters, ICMR didn’t disavow the August 15 deadline. The criteria for selecting the hospitals, including their facilities, have also been questioned. Cutting red tape should not lead to a situation where hospital ethics committees are under duress, researchers go easy on informed consent for participants, outcomes are fudged or pre-decided, and dissent faces disciplinary actions.

The long rope to the politically influential Baba Ramdev, for a drug originally marketed as a corona cure and later as an immunity booster while retaining a misleading name, also fits into a pattern. The disastrous consequences of Lysenkoism, the ideas of Soviet agrobiologist Trofim Lysenko who tried to subordinate science to Marxist-Leninist principles, are pertinent to recall here. Certainly, India and the world need a cure for Covid-19 fast. But it is for science, not politics, to decide parameters that force the pace of vaccine research. ICMR must shore up its credibility for the long road ahead.

This piece appeared as an editorial opinion in the print edition of The Times of India.

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