The drug regulator’s subject expert committee (SEC) will examine applications on Thursday seeking marketing authorisation for Molnupiravir, the world’s first medicine to treat symptomatic Covid.
An urgent meeting of the SEC has been called to review the proposals “under accelerated approval process”. The committee will examine applications from at least eight Indian pharmaceutical companies, an official said. Molnupiravir has shown promise in the treatment of mild-to-moderate Covid-19 in adults, having nearly halved the risk of hospitalisation and death. Several firms, including Natco, Dr Reddy’s, Cipla, Sun Pharma, Hetero and BDR Pharma are awaiting the regulatory nod to introduce the generic antiviral in India.
The development assumes significance because the antiviral oral pill, developed by Merck and its partner Ridgeback, is touted as a game-changer for high-risk individuals and people with weakened immunity.