Local companies to start trials of Covid drug

In a first of its kind in Indian drug industry, five leading pharmaceutical companies have joined hands to run clinical trials for a Covid-19 drug. Cipla, Dr Reddy’s Laboratories, Emcure Pharmaceuticals, Sun Pharmaceutical and Torrent Pharmaceuticals will collaborate for clinical trial of investigational oral antiviral drug Molnupiravir for the treatment of mild Covid-19 in an outpatient setting in the country, the companies said in a joint statement on Tuesday.Merck or Merck Sharpe Dohme (MSD), the innovator, has already issued a voluntary licence to these companies to manufacture and supply Molnupiravir to India and over 100 low and middle-income countries (LMICs). Molnupiravir, which inhibits replication of multiple RNA viruses including SARS-CoV-2, is under phase-3 trial in the US.The five pharma companies have entered into a collaboration agreement wherein the parties will jointly sponsor, supervise and monitor the clinical trial in India. As per the directive of subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO), 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, the statement said. The trial is expected to take place between June and September this year across the country with participation of 1,200 patients. On successful completion of the trial, each company will independently approach regulatory authorities for approval to manufacture and supply Molnupiravir for the treatment of Covid-19 in India.Merck has tied up with the US government for the supply of Molnupiravir, which is awaiting the emergency use authorisation (EUA) or approval by the US Food and Drug Administration (FDA). The US government has entered into a $1.2-billion deal with Merck for supply of the antiviral.

from Economic Times https://ift.tt/3jsS36Y