Anti-Covid pill likely to get approved in India soon, DCGI reviewing data

The Drugs Controller General of India is reviewing the clinical data of molnupiravir, the world's first anti-Covid pill approved in the United Kingdom, for the treatment of Covid-19 in adults in India. Sun Pharmaceutical Industries said it is all set to introduce Merck Sharp Dohme (MSD) and Ridgeback's molnupiravir under the brand name Molxvir.

Sun Pharma is one of the companies in India with which Merck entered into voluntary licensing agreements.

"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-19 treatment, we are gearing up to make Molxvir available to patients and healthcare providers across India at an economical price post-approval by DCGI," Sun Pharma India Business CEO Kirti Ganorkar said in a statement.

The United States is also going through the data of molnupiravir.

Who can take this pill? Adults who are at risk of Covid can take this pill to avoid severe symptoms or hospitalisation. However, experts have warned that anti-Covid pills are not alternatives to vaccines. The pill can be taken within the first few days of Covid symptoms appearing.

Molnupiravir, as a small molecule, does not require cold storage like messenger RNA vaccines. In the Phase 3 trial by Merck, Molnupiravir significantly reduced the risk of hospitalisation or death by around 50 per cent in a planned interim analysis of the MOVe-OUT trial in at risk, non-hospitalised adult patients with mild-to-moderate COVID-19.

Based on the participants with available viral sequencing data (around 40 per cent of participants), molnupiravir demonstrated consistent efficacy across viral variants like Gamma, Delta and Mu.

(With PTI inputs)