Indian drugmakers get close to nod for Merck's Covid antiviral Molnupiravir

The significance of the Molnupiravir approval is that it could offer an affordable oral drug to treat Covid-19, and may even be effective against the Omicron variant

With the expert group having advised the US regulator to recommend the use of Merck’s antiviral drug molnupiravir for Covid, drug makers here are awaiting a final decision from the Indian regulator.

Molnupiravir approval assumes significance. It could offer an affordable oral drug to treat Covid. The drug developed by Merck with Ridgeback Biotherapeutics targets part of the virus called the ribonucleic acid polymerase. This part of the virus has not changed much after mutations in the Omicron variant.

However, according to the recent data published by Merck, the drug was found to be significantly less effective than previously thought. It reduced hospitalisations and deaths in its clinical trial of high-risk individuals by around 30 per cent.

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.

“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,” said a spokesperson for DRL.

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, these five pharmaceutical 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 here.

An expert panel of advisors to the US Food and Drug Administration (USFDA) on Tuesday voted to recommend the authorisation of Merck's antiviral pill for treatment of Covid. Last year, the USFDA had authorised the use of Gilead Sciences, Inc.’s injectable antiviral remdesivir to treat Covid.

In November, Sun Pharma had said that it was gearing up to launch molnupiravir under the brand name Molxvir in India.

Molnupiravir is the first oral antiviral approved by the UK’s Medicines and Healthcare products Regulatory Agency for the treatment of mild-to-moderate Covid in adults.

Kirti Ganorkar, chief executive officer of India business, Sun Pharma, had said, “The recent authorisation of molnupiravir, licensed from MSD and Ridgeback by the UK regulator, is a positive step. In line with our consistent efforts to accelerate access to new drugs for Covid treatment, we are gearing up to make Molxvir available to patients and health care providers across India at an economical price after approval by the DCGI. Molxvir will be manufactured at one of our plants in India and we have enough capacity to meet demand.”