In a first of kind its initiative, five large Indian pharmaceutical companies Cipla, Dr Reddy's, Emcure, Sun Pharma and Torrent Pharma have joined hands to conduct clinical trials of COVID-19 oral antiviral drug Molnupiravir for the treatment of mild COVID-19 in an outpatient setting 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 parties will jointly sponsor, supervise and monitor the clinical trial in India.
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 in an outpatient setting. It is expected to take place between June and September this year across India with the recruitment of 1,200 patients.
Between March and April this year, these five pharma companies had individually entered into a non-exclusive voluntary licensing agreement with Merck Sharpe Dohme (MSD) to manufacture and supply Molnupiravir to India and over 100 low and middle-income countries (LMICs).
"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 COVID-19 pandemic," the five companies said in a joint statement.
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 is an oral anti-viral that inhibits the replication of multiple RNA viruses including SARS-CoV-2.
It is presently being studied by MSD (Called as Merck in US), through a collaboration with Ridgeback Biotherapeutics, in a Phase III trial for the treatment of non-hospitalized patients with confirmed COVID-19 globally.
