ICMR’s chequered role in Covid pandemic — from 15 August vaccine deadline to plasma flip-flop

India’s apex medical research organisation has been accused of straying from path of science to take questionable stands, often with undertone of ‘nationalism’.

Dr Balram Bhargava, Director General of the ICMR | Photo: ANI

New Delhi: In one of the first Covid briefings on 22 March, ICMR Director General Dr Balram Bhargava was asked a question about India’s testing regimen being restricted at the time, despite the WHO advice to “test, test, test”. Bhargava responded that India’s principle was “isolate, isolate, isolate”. Several months on, government officials are now asking citizens to come forward and test.

On 14 October, Dr Bhargava had said India is taking 100 days as the “cut-off” for re-infection, giving rise to a barrage of criticism. Internationally, the fool-proof method of deciding whether reinfection has taken place is to do a genome sequencing of the virus causing the first and second infections.

Then, on 8 December, replying to a question from ThePrint on how the drug regulator could consider emergency use authorisation for the Covid vaccine ‘Covaxin’ manufactured by Bharat Biotech without any phase-III testing data, Dr Bhargava said vaccines are approved on the basis of risk-benefit ratio. However, such decisions are usually based on data on safety and immunogenicity. This has also been the case with expedited approvals in other countries for Covid vaccines.

These examples from three different stages of the pandemic have one common thread — how ICMR, India’s apex medical research organisation, appeared to stray from the path of science repeatedly to take questionable stands, often with an undertone of “nationalism”.

ThePrint reached the ICMR through phone calls, an email and a text message for an official comment for this report, but did not receive one till the time of publication.

Criticism from The Lancet

In a rare and scathing critique of an Indian scientific organisation, The Lancet journal in September came down heavily on ICMR’s propensity to take apparently politically expedient positions, singling out Dr Bhargava’s letter to roll out an indigenous Covid vaccine on a six-week deadline from the start of phase-I clinical trials.

“This pressure to avoid negative news, and to offer reassurance, appears to have been felt by several professional scientific organisations in India. The ICMR has been singled out by experts for straying from scientific evidence, appearing at worst politically motivated and at best overly optimistic,” The Lancet wrote.

“A letter from the Director General of the ICMR, Balram Bhargava, said that the ICMR envisaged launching a coronavirus vaccine on 15 August (Indian Independence Day; a deadline considered unrealistic by most medical experts); ICMR has supported treatment with hydroxychloroquine despite insufficient evidence; and news reports claim that data on coronavirus infection were removed from a scientific paper,” it added.

Little original research, often unheeded

ICMR insiders say Bhargava’s letter was down to his “impetuosity” rather than any actual lack of scientific rigour. But there is criticism about ICMR not quite doing as much original research during the pandemic as its mandate would have required it to do.

“Overall, the ICMR has played a very positive role (during the pandemic). Not all its decisions have been right. I also wish it had encouraged more fundamental research on the virus. There has been some sporadic work, but look at the work done in China on the virus and look at what we have done… there is a lot of difference,” said Dr Ashok Rattan, who retired from the All India Institute of Medical Sciences as an additional professor of microbiology, and currently works for Pathkind Labs.

Rattan pointed to ICMR’s initial decision to do serological tests in hotspots, the import of faulty antibody testing kits from China that eventually had to be returned, and the body’s continued reluctance to make cycle threshold values mandatory in Covid test reports as some of the faulty decisions.

But he also defended some of the ICMR’s work. “Fighting this pandemic has been like drinking water from a hosepipe — one has to sift through so much information and decide what a practical course of action is. To that extent, ICMR’s central role has been very important. The way we have ramped up testing from one laboratory at the start to 2,000-odd laboratories now has been very good,” Rattan said.

Criticism of ICMR research

The original research the ICMR has produced has also come under criticism, and has occasionally been set aside during policymaking.

A recent example was when ICMR’s research concluded that convalescent plasma therapy was of no benefit to Covid patients. The research was ignored and a fresh set of guidelines issued on the therapy, reportedly after Home Minister Amit Shah’s backing for the therapeutic option during one review meeting.

According to sources, the conviction that some AIIMS doctors had in plasma therapy upended the findings of ICMR’s paper that came out in the prestigious scientific publication British Medical Journal (BMJ), and it was forced to draw up new guidelines on plasma therapy.

Another ICMR paper that was criticised was on the role of the BCG vaccine in preventing Covid. While the plasma study was accused of being inconclusive as it had not looked at specific SARS-CoV-2 antibodies, the one on the BCG vaccine merely explored how the vaccine stirs up the immune system without specifically looking at whether it bolsters the body’s defence against the novel coronavirus.

ICMR’s role in Covid pandemic

ICMR, as the convenor of the Covid-19 task force, has played a role in bringing together the best minds in India to firm up strategy, while multiple ICMR laboratories across the country have stood out during the pandemic.

The National AIDS Research Institute (NARI), for example, was a part of the World Health Organization’s multi-country solidarity trial, and the National Institute of Virology has played a central role both in testing and vaccine development. In fact, the virus strain on which Bharat Biotech’s Covaxin is based came from the NIV.

However, the exercise of validation of testing kits has remained a largely central activity. Last week, Dr Bhargava and Health Secretary Rajesh Bhushan, in a joint letter to states, warned about the possibility of inconsistency in the performance of antigen testing kits.

For a long time now, experts have been pressuring the ICMR to come out with a clinical algorithm for Covid diagnosis rather than relying on tests which are prone to false results. That has not happened so far.

It also took the ICMR almost nine months to set up a Covid-19 clinical registry.

A senior doctor at a central government-run hospital in Delhi said: “While the ICMR approach to the pandemic was delayed and probably its recommendations seemed like endorsing the US FDA, it has also helped to give India-centric recommendations, like the futility of plasma.”

The doctor further criticised the ICMR, saying: “The delay in assessing the situation has probably occurred because it has more armchair experts than people actually seeing and handling cases.”

On the biggest issue in the future, India’s Covid-19 vaccination strategy, the doctor said it needs to be “based on firm evidence and assessment of delayed immunity markers of the vaccine, as there is no second chance if this goes wrong”.