India debates use of key anti-Covid pill

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and Ridgeback Biotherapeutics in the United States.

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It even excluded the drug from India's Covid-19 treatment protocol less than a fortnight after it secured an emergency authorisation for restricted use on Dec 28 from the Central Drugs Standard Control Organisation. The drug regulator has allowed 13 companies to market generic versions of molnupiravir.

The United States Food and Drug Administration cleared the drug on Dec 23 for the treatment of mild-to-moderate coronavirus disease in adults who are at high risk for progression to severe Covid-19 and for whom alternative treatment options are not accessible or clinically appropriate. The three individuals who had been prescribed the drug were young and double vaccinated - one was asymptomatic and two had mild symptoms. None of them had any comorbidities, nor had they received explanation detailing molnupiravir's risks.

However, data generated from all trial participants showed incidents of hospitalisation or death through the 29-day trial period were lower in the molnupiravir group than in the placebo group. Of the 709 people who received molnupiravir, 6.8 per cent were hospitalised or died compared to 9.7 per cent of the 699 who received a placebo.

There was no specific mention of South Asians in the trial, which also did not evaluate the drug's potential benefit in treating vaccine breakthrough infections as all trial participants were unvaccinated. "My concern is that a large proportion of people will end up taking molnupiravir and risk themselves for potential harms that significantly outweigh its proven benefits. The drug should not be part of routine practice," he said.Several Indian pharma companies have launched their versions of molnuprivair, promoting it through their well-oiled sales and publicity network.

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