Govt panel to review EUA application for generic Covid-19 pill

MUMBAI: The subject expert committee (SEC) under India's drug regulator is expected to review the EUA applications of drug companies seeking approval for Merck’s antiviral pill, Molnupiravir, on Thursday.

Several companies including Natco, Dr Reddy’s, Cipla, Sun Pharma, Hetero and BDR Pharma are awaiting regulatory nod to introduce the generic antiviral in India, which is expected to be available at affordable prices. The drug, being considered a potential game changer in treating mild Covid-19 infections, could become the first oral antiviral pill to be launched here in India.

At present, antiviral drugs used in Covid therapy such as remdesivir, are administered intravenously, and in hospital settings.

Though pricing details were not available, experts believe the cost of the full five-day course could be around Rs 1,200-1,500 in India, given the intense competition. This is a fraction of the price charged in the United States and the United Kingdom.

The SEC is expected to study the trials’ data submitted by the companies, and give recommendations to the Drugs Controller General of India who will take a final call on the applications.

Molnupiravir, the antiviral therapy of Merck Sharpe Dohme (MSD) and its partner Ridgeback, has shown promise in the treatment of mild-to-moderate Covid-19 in adults, having nearly halved the risk of hospitalisation and death. Though the antiviral is yet to be approved by the US Food and Drug Administration, prospects of an approval here have been bolstered by a recent “conditional” nod by the UK Medicines and Healthcare products Regulatory Agency, sources told TOI.

Earlier in June, MSD signed licensing agreements with five generic companies — Sun Pharma, Cipla, Torrent, Emcure and Dr Reddy's — to manufacture and supply Molnupiravir in India, and to over 100 low and middle-income countries. Hetero, Natco and BDR Pharma have also submitted the clinical trials’ data to the regulator.

Dr Reddy’s led the joint Phase-3 clinical trial of Molnupiravir in India for the five companies licensed by MSD. “The trial is on mild Covid-19 in an outpatient setting, and in Indian terms, comparable to the mild-to-moderate category, studied by Merck and Ridgeback. We are closely following developments related to approval in countries around the world and in India,” a company spokesperson had said earlier.

Further, the US government is stockpiling 1.7 million treatment courses of Molnupiravir at about $700 per patient. However, it is expected to cost at a fraction of the global cost in India, with certain domestic companies including Optimus Pharma manufacturing the raw materials in the country.

Significantly, the first generic version of Molnupiravir, perhaps globally, was launched recently, media reports indicate, in Bangladesh at about $33 per course.