Centre says Covid antiviral drug Molnupiravir has ‘major safety concerns’

The government has not added Merck’s coronavirus pill in its national treatment protocol for the disease due to some “major safety concerns”, Balram Bhargava, head of the state-run Indian Council of Medical Research, said at a press briefing on Wednesday.

“We have to remember that this drug has major safety concerns … so it is not included in the national task-force treatment,” Bhargava said.

Hyderabad-based Dr Reddy’s Laboratories Ltd plans to launch its generic version of the Merck drug, called molnupiravir, from early next week.

Molflu (Molnupiravir) will be priced at 35 per capsule, a spokesperson of the Hyderabad-based drug maker said in a statement.

With 10 capsules per strip, the total course of 40 capsules over 5 days would cost 1,400, making it among the most affordable treatment options available to patients, it added.

“Molflu is expected to be available from early next week in pharmacies throughout the country with particular focus on states with high caseload of COVID-19,” the spokesperson noted.

Last 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 of Molnupiravir in India, and presented its findings to the Subject Expert Committee.

Last week, Dr Reddy’s received emergency-use authorisation from the Drugs Controller General of India (DCGI) to manufacture and market oral antiviral drug Molnupiravir capsules 200 mg for the treatment of adult patients with COVID-19 who have high risk of progression of the disease including hospitalisation or death.

Molflu will be manufactured at a USFDA-approved facility, and the drug maker has made adequate capacity preparations to ensure that it is able to help patients in need, it said.

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