US nod for Covid-19 drug molnupiravir raises hope for Indian approval

Oral medication targets ribonucleic acid polymerase, a part of the virus that has not changed much after mutations in the Omicron variant.

The USFDA’s approval on Thursday for Merck and Ridgeback Biotherapeutics' antiviral drug to treat Covid-19 paves the way for India to do the same soon.

Molnupiravir, an affordable oral drug, targets the ribonucleic acid polymerase, a part of the virus that has not changed much after mutations in the Omicron variant.

The subject expert committee (SEC) that is advising the Drugs Controller General of India (DCGI) had sought more data from a consortium of drugmakers--Dr Reddy’s Laboratories (DRL), Torrent Pharmaceuticals, Emcure Pharmaceuticals, Sun Pharmaceutical Industries (Sun Pharma), and Cipla.

“In its last meeting, the SEC had requested more data from all companies. On behalf of the consortium, we have submitted the data. We now await the next SEC meeting,” a spokesperson for DRL told 'Business Standard'.

These five drugmakers had come together in June to jointly sponsor, supervise, and monitor the clinical trial in India. Between March and April this year, the five companies had individually entered into a non-exclusive voluntary licensing agreement with Merck Sharp Dohme (MSD) to manufacture and supply molnupiravir to India and over 100 low- and middle-income countries.

This apart, drugmakers like Hetero Labs have also done trials independently on molnupiravir in India.

The US Food and Drug Administration (USFDA) had issued an emergency use authorization (EUA) for molnupiravir for the treatment of mild-to-moderate coronavirus disease in adults who are at high risk for progression to severe COVID-19, including hospitalisation or death.

The USFDA said molnupiravir should be initiated as soon as possible after Covid-19 is diagnosed and within five days of symptom onset. The drug is not authorised for use in people younger than 18.