After US authorised Merck’s Covid pill, Sun Pharmaceutical Industries on Tuesday its subsidiaries have received emergency use authorisation (EUA) from the Druga Controller General of India to manufacture and market the generic version of the pill Molnupiravir in India.
An expert panel of Central Drugs Standard Control Organisation on Tuesday approved Molnupiravir for restricted use in emergency situations as Sun Pharma, in a statement, said under the brand name Molxvir, they would launch Molnupiravir within a week.
Earlier this year, the Sun Pharma had signed a non-exclusive voluntary licensing agreement with US-based Merck to manufacture and supply a generic version of Molnupiravir in over 100 low and middle-income countries (LMICs) including India.
The DCGI, after analysis clinical data, approved Molnupiravir for treatment of adult Covid-19 patients with oxygen saturation of less than 93 per cent coupled with high risk of progression of the disease, including hospitalisation or death.
“Molnupiravir is an important addition to the portfolio of oral therapies available for treating Covid-19 patients. In line with our consistent efforts to accelerate access to new drugs for Covid-19 treatment, we will make Molxvir available to patients at an affordable price,” said Kirti Ganorkar, CEO of India Business, Sun Pharma, in a statement, adding that a toll free helpline will be launched to ensure availability of the drug to doctors and patients.
The recommended dose of the drug is 800 mg twice a day for five days and the treatment duration is relatively shorter, reducing pill burden and enhances compliance. The pill is for non-hospitalisation cases.
Molnupiravir has been developed by Merck and Ridgeback Biotherapeutics.