Dr Reddy’s laboratories gets DCGI’s nod to launch Molnupiravir capsules in India

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Hyderabad (Telangana): Drugs Controller General of India (DCGI) on Tuesday, December 27, 2021, approved Dr Reddy’s laboratories for the emergency-use authorization) to manufacture and market the oral anti-viral drug Molnupiravir capsules 200mg for the treatment of adult patients with COVID-19, who have oxygen saturation levels less than 93 per cent and who have a high risk of progression of the disease including hospitalization or death, according to a press release.

Co-Chairman and Managing Director, Dr Reddy’s, G.V. Prasad, is quoted saying in the press release that, “Molnupiravir is a continuation of our constant effort since the start of the pandemic to ensure access to every possible treatment option against COVID-19 from prevention to mild, moderate and severe disease for patients in India and around the world.”

He added, “The approval to launch molnupiravir is an important development not only as a treatment option but also for the collaborative manner in which Indian pharma companies came together. Throughout the pandemic, we have sought to create diverse collaborations and partnerships to meet unmet medical needs of as many patients as possible globally.”

Earlier this year, Dr Reddy’s 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).

In a first-of-its-kind collaboration in the Indian pharmaceutical industry, a Dr Reddy’s-led consortium of pharma companies collaborated to jointly sponsor, supervise and monitor the Phase III clinical trial in India and presented its findings to the Subject Expert Committee (SEC).

Molnupiravir is an oral antiviral that inhibits the replication of multiple RNA viruses including SARS-CoV-2. It has been studied by Merck and Co., Inc., in collaboration with Ridgeback Biotherapeutics in a Phase III trial for the treatment of non-hospitalized patients with confirmed COVID-19 globally. It has received approvals from regulatory authorities in the U.K., U.S and Japan.