Image Credit: twitter.com/Cipla_Global
The clinical trials for the antiviral drug Molnupiravir will be held jointly under the supervision of five pharmaceutical companies- Cipla, Dr Reddy’s, Emcure, Sun Pharma and Torrent Pharma. After successful trials, the drug would be used to treat mild cases of COVID-19 in an outpatient setting.
In a unique mode of drug trials, the Subject Expert Committee(SEC) of the Indian drug regulator CDSCO has instructed Dr Reddy’s to conduct the clinical trials for the drug while the other companies would be required to show that their product is equivalent to the one used in the trials of Dr Reddy’s.
According to a joint statement released by the five pharma companies, “the parties will jointly sponsor, supervise and monitor the clinical trial in India.” The collaboration is the first of its kind to happen in the Indian pharma industry.
The clinical trial is expected to take place between June and September with 1200 patients from across the country. The aim of the trial is to investigate a new line of treatment for the COVID-19 pandemic.
Pharma majors Cipla, Dr. Reddy’s, Emcure, Sun Pharma & Torrent collaborate for #clinicaltrial of investigational anti-viral drug #molnupiravir for the treatment of mild #COVID19 in an outpatient setting in India. https://t.co/lITgH0avG2 pic.twitter.com/ebKnDwHZzw
— Cipla (@Cipla_Global) June 29, 2021
Molnupiravir is an oral antiviral that inhibits the replication of multiple RNA viruses including SARS-CoV-2. If the trial for the drug is completed successfully, the companies would go to the regulator individually to get their product approved for manufacture and supply to treat COVID-19.
Earlier this year, between March and April, the companies individually entered into a non-exclusive voluntary licensing agreement with Merck Sharpe Dohme(MSD) to manufacture and supply Molnupiravir to India and 100 other low and middle-income countries. MSD is currently studying the antiviral drug in a phase 3 trial on COVID-19 patients who have not been hospitalized.