Following the clinical trial protocol approval given by the Drugs Controller General of India, the clinical trial is expected to take place between June and September.
Five major pharma companies of India have entered into a collaboration for the clinical trial of oral anti-viral drug Molnupiravir for the treatment of mild COVID-19. Indian pharmaceutical companies 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 companies have individually signed a non-exclusive voluntary licensing agreement with Merck Sharpe Dohme (MSD) to manufacture and supply the drug in Indian and other countries.
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 said.
Following the clinical trial protocol approval given by the Drugs Controller General of India, the clinical trial is expected to take place between June and September. Around 1,200 patients will be recruited for the trial which aims to investigate yet another line of treatment of SARS-CoV-2, the virus responsible for COVID-19. The companies noted that this is the first of its kind collaboration within the Indian pharma industry.
On successful completion of the clinical trial, each of these five companies will independently approach authorities to seek approval for manufacturing and supplying the drug in India. Molnupiravir is an oral anti-viral that inhibits the replication of multiple RNA viruses including highly 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 company Cipla to import Moderna vaccine. This will be the fourth Covid-19 vaccine to be available in the country. Covishield, Covaxin and Sputnik are already in use.