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In a unique alliance between drug-makers, India’s five leading pharma majors have collaborated to conduct clinical trials of investigational oral anti-viral drug, Molnupiravir, for the treatment of mild Covid infection.
The pharma collaboration includes Cipla Limited, Dr Reddy’s Laboratories Ltd, Emcure Pharmaceuticals Limited, Sun Pharmaceutical Industries Limited and Torrent Pharmaceuticals Limited.
The trials are expected to take place between June and September this year across India with the recruitment of 1,200 patients, said an official statement.
Deal with MSD
Between March and April, 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).
The announcement further said that the five pharma companies will jointly sponsor, supervise and monitor the trials in India.
As per the directive of the Subject Expert Committee of the Central Drugs Standard Control Organisation, 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 trial.
Outpatient setting
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.
“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 pandemic,” it added.
Regulatory approval
On successful completion of the clinical trials, each company will independently approach the regulatory authorities for approval to manufacture and supply Molnupiravir for the treatment of Covid in India.
Molnupiravir, under study by MSD, is an oral anti-viral that inhibits the replication of multiple RNA viruses, including SARS-CoV-2.
MSD is investigating the drug through a collaboration with Ridgeback Biotherapeutics in a Phase III trial for the treatment of non-hospitalised patients with Covid globally.
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