Five main pharma firms of India have entered into a collaboration for the clinical trial of oral anti-viral drug Molnupiravir for the therapy of mild COVID-19. Indian pharmaceutical firms that have joined hands for this are – Sun Pharmaceutical Industries, Cipla, Dr Reddy’s Laboratories, Emcure Pharmaceuticals Limited, and Hetero Labs. According to a release, these firms have individually signed a non-exclusive voluntary licensing agreement with Merck Sharpe Dohme (MSD) to manufacture and provide the drug in Indian and other nations.
As per the agreement, the pharma majors will jointly sponsor, supervise and monitor the clinical trial in India.
“As per the directive of the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization, 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 release stated.
Following the clinical trial protocol approval offered by the Drugs Controller General of India, the clinical trial is anticipated to take location among June and September. Around 1,200 patients will be recruited for the trial which aims to investigate however one more line of therapy of SARS-CoV-2, the virus accountable for COVID-19. The firms noted that this is the very first of its sort collaboration inside the Indian pharma market.
On effective completion of the clinical trial, every of these 5 firms will independently method authorities to seek approval for manufacturing and supplying the drug in India. Molnupiravir is an oral anti-viral that inhibits the replication of various RNA viruses like hugely infectious coronavirus.
Meanwhile, Moderna Covid-19 vaccine has been granted permission for restricted emergency use in India. The DCGI has granted permission to Mumbai-based pharmaceutical corporation Cipla to import Moderna vaccine. This will be the fourth Covid-19 vaccine to be accessible in the nation. Covishield, Covaxin and Sputnik are currently in use.