Five Indian generic drugmakers, including Cipla and Dr Reddy’s Laboratories, said on Tuesday they would jointly conduct a clinical trial of Merck & Co’s anti-viral drug to treat mild COVID-19 in non-hospitalized patients in India.
Between March and April, each of these companies, which also include Sun Pharmaceutical Industries, Torrent Pharmaceuticals and privately held Emcure Pharmaceuticals, partnered with Merck to expand production of the drug, molnupiravir.
The partnership gives the companies license to supply molnupiravir to India and more than 100 low- and middle-income countries following approvals or emergency authorization by local regulatory agencies, Merck said in late April.
On Tuesday, the Indian companies said they will jointly sponsor, supervise and monitor the clinical trial in the country, expected to take place between June and September this year in 1,200 patients.
They will then independently approach regulatory authorities for approval to manufacture and supply the drug in India.
Molnupiravir is an antiviral therapy Merck is developing with Ridgeback Biotherapeutics for the treatment of non-hospitalized COVID-19 patients.
Coronavirus cases in India have declined from a devastating peak in April and May. However, health experts have said that the country should brace for a third wave by October.