HYDERABAD: Molnupiravir — an antiviral oral drug which is being touted as a candidate for treatment of mild cases of Covid-19 and which can be prescribed in OP settings has now gone into clinical trial mode in India. Five pharma companies — Cipla, Dr Reddy’s, Emcure, Sun Pharma and Torrent will be collaborating to conduct the same between June to September, 2021. The announcement was made on Tuesday that the five companies will collaborate for the clinical trial of the investigational Molnupiravir for the treatment of mild Covid-19 in an outpatient setting in India.
Earlier, Between March and April this year, these five pharma companies had individually entered into a nonexclusive voluntary licensing agreement wi th Merck Sharpe Dohme (MSD) to manufacture and supply Molnupiravir to India and over 100 low and middle-income countries. Now, the five pharma companies have entered into a collaboration agreement, wherein the parties will jointly sponsor, supervise and monitor the clinical trial.
Amongst the five, Dr Reddy’s will conduct the clinical trial using its product, and the other four pharma companies will be required to demonstrate equivalence of their product to the product used by Dr Reddy’s in its clinical trial. Following the clinical trial protocol approval given by the Drugs Controller General of India, the clinical trial will be conducted for the treatment of mild Covid-19. It is expected to take place between June and September this year across India with the recruitment of 1,200 patients.
Such collaboration for a clinical trial is a first of its kind within the Indian pharma industry, and will aim to investigate yet another line of treatment in the collective fight against the pandemic. On successful completion of the clinical trial, each company will independently approach the regulatory authorities for approval to manufacture and supply Molnupiravir for the treatment of Covid-19 in India. Molnupiravir can inhibit the replication of multiple RNA viruses including SARS - CoV-2.