ICMR director-general Balram Bhargava. Image: YouTube screenshot
- Balram Bhargava enumerated six reasons for the ICMR’s refusal to include molnupiravir in India’s COVID treatment guidelines.
- Vinod K. Paul also indicated issues with molnupiravir pertaining to the DCGI’s approval, and a request that the Subject Expert Committee had made.
- Separately, Bhargava said India doesn’t have a shortage of tests – but at the same time advised against asymptomatic contacts of confirmed patients from getting tested.
New Delhi: The director-general of the Indian Council of Medical Research (ICMR), Balram Bhargava, took a strong stand against the use of the antiviral drug molnupiravir to treat COVID-19, at the Union health ministry’s press conference in Delhi on December 12.
This isn’t Bhargava’s first public opposition to the drug – he expressed issues with using molnupiravir at the last press conference as well – but this time he was clearer with the reasons for his position.
In December 2021, the Drug Controller General of India (DCGI) had considered and approved Merck’s application for molnupiravir in India. But Bhargava spelled out six reasons the drug won’t yet find a place in India’s official COVID-19 treatment guidelines, which ICMR sets out.
- Molupiravir has certain risk(s) that warrant caution.
- Experts present at a meeting of the National COVID-19 Task Force are of the opinion that there is rampant and irrational use of molnupiravir (in other countries).
- Both its known and unknown harms outweigh its stated benefits.
- Members of the same task force also reviewed the evidence currently available for molnupiravir and concluded, unanimously, that it shouldn’t be included in the national COVID-19 treatment guidelines.
- As more evidence emerges about the use of molnupiravir, experts will continue to review it.
- Molnupiravir’s current clinical window of application is too narrow – i.e. it can be used only among the elderly and among unvaccinated individuals with comorbidities. Experts haven’t observed any benefits among patients with diabetes and those who have recovered from COVID-19 and have been fully vaccinated.
Now, while the drug may not find a place in the treatment guidelines, its approval by the DCGI means pharmaceutical firms are free to manufacture and distribute it in the market. The principal limitation of not being included in ICMR guidelines is that government doctors can’t prescribe it.
According to Bhargava, the US drug regulator’s decision to approve the use of molnupiravir was based on only one trial in the US, with 1,433 participants. “Another trial was prematurely terminated for business reasons.”
He added that 12 clinical trials of molnupiravir have been registered in India, all yet to begin – implying that ICMR could change its mind based on their findings.
NITI Aayog member (health) Vinod K. Paul, who was also present at the press conference, said India’s stance on molnupiravir parallels those of Australia, Canada, Denmark and the UK, whose regulators have approved the drug but whose governments have left it out of their treatment guidelines.
Paul also said – related to point no. 6 of Bhargava’s list of reasons – that the US National Institutes of Health were using molnupiravir only among patients at high risk of getting severe COVID-19 or who had already been hospitalised.
According to him, DCGI had approved molnupiravir with similar conditions last year – but that it hasn’t placed any document in the public domain to this effect.
The Subject Expert Committee (SEC), of the Central Drug Standards Control Organisation, had recommended to the DCGI that the latter approve molnupiravir. It also asked the pharmaceutical firms that had applied for licences to manufacture molnupiravir in India to submit additional information to the DCGI:
- The specific category of COVID-19 patients likely to receive the greatest benefit from the drug,
- Details of their risk mitigation plan,
- A factsheet for the drug’s contents, terms of administration and indications, and
- A proposed package insert that specifies limitations in the drug’s use in non-technical language.
We don’t know if these manufacturers provided this information. The Wire Science checked the websites of at least three firms currently manufacturing molnupiravir and found no information pertaining to the SEC’s request. (For example, see this press release by Torrent Pharmaceuticals, another release by Cipla and this page on the Dr Reddy’s website.)
The Wire Science couldn’t verify if these firms were supplying the information with the packaged drug itself.
Testing and sequencing
While Bhargava and Paul were clear – for reasons that may or may not be borne out – about their position vis-à-vis molnupiravir, they couldn’t settle a bit of confusion that has arisen around testing. ICMR had previously recommended that the asymptomatic contacts of a confirmed COVID-19 patient wouldn’t have to get themselves tested.
Experts believed its rationale to be that in the event of a shortage, tests shouldn’t be ‘wasted’. However, on the January 12 presser, Bhargava unfolded a detailed presentation to convince his audience that the country wasn’t at all short on tests. His words were that test kits are “hugely and easily available”. Yet he still stuck to the position that asymptomatic contacts of a confirmed COVID-19 patient wouldn’t have to get tested – except if they were elderly, pregnant and/or had comorbidities.
The confusion arose from what he said next: that all contacts – symptomatic or asymptomatic – of a confirmed COVID-19 patient would have to quarantine themselves for at least one week.
The question is: since there is a surplus of test kits, why not test all contacts of a confirmed COVID-19 patient and quarantine only those who test positive – instead of advising against tests if one doesn’t have symptoms yet still push for a week’s quarantine?
Finally, government officials at the presser said the omicron variant appears to be rapidly replacing the delta variant as the dominant strain around the country: “In metros,” according to Paul, “it seems 80% of cases are due to the omicron variant,” Paul said. But he and his colleagues continued to remain opaque about the percentage of ‘positive’ samples in which genome-sequencing facilities have detected the omicron variant.