Five India pharma cos join hands for clinial trial of oral anti-COVID drug

In a first of its kind initiative in the Indian pharma industry, five major firms -- Cipla, Sun Pharmaceutical Industries, Dr Reddy's Laboratories, Emcure Pharmaceuticals and Torrent Pharmaceuticals -- are going to collaborate for clinical trial of an anti-viral oral drug under development, Molnupiravir, to cure mild COVID-19 patients.

The five pharma companies 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.

Following clinical trial protocol approval from the Drugs Controller General of India (DCGI), the clinical trial will be conducted for treatment of mild COVID-19 in an outpatient setting. It is expected to take place between June and September this year across India with recruitment of 1,200 patients.

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On successful completion of clinical trial, each company will independently approach the regulatory authority for approval to manufacture and supply Molnupiravir for treatment of COVID-19 in India.

Between March and April this year, these five pharma companies had individually entered into a non-exclusive voluntary licensing agreement with innovator Merck Sharpe Dohme (MSD) to manufacture and supply Molnupiravir to India and over 100 low and middle-income countries (LMICs).

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, through a collaboration with Ridgeback Biotherapeutics, in a Phase III trial for treatment of non-hospitalised patients with confirmed COVID-19 globally. MSD is expected to approach the US Food and Drug Administration in the second half of 2021 for emergency use clearance. The drug was initially developed to treat influenza.

MSD had signed voluntary licensing pacts with Aurobindo Pharma, Cipla, Dr Reddy's Laboratories, Emcure Pharmaceuticals, Hetero Labs, Sun Pharmaceutical Industries, Torrent Pharmaceuticals and Viatris for its license in India.

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