Sun Pharmaceutical Industries on Tuesday announced that one of its wholly owned subsidiaries has received emergency use authorisation (EUA) from the Drugs Controller General of India (DCGI) to manufacture and market a generic version of Merck's anti-Covid pill Molnupiravir in India.
Sun Pharma will launch Molnupiravir under the brand name Molxvir in India, within a week, the company said in a statement.
Amid the ongoing resurgence of new Covid-19 cases in India, an expert panel of the Central Drugs Standard Control Organisation on Tuesday approved Merck's anti-viral drug molnupiravir for restricted use in emergency situations.
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, based on the review of clinical data of molnupiravir has approved molnupiravir for treatment of adult patients with Covid-19, with oxygen saturation less than 93 per cent and who have 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.
Ganorkar added that the company is in the process of launching a toll-free helpline to ensure the availability of Molxvir to doctors and patients across India.
"Our endeavour is to make the product available in a week's time," she said.
The recommended dose of the drug is 800 mg twice a day for five days. The duration of treatment of molnupiravir is much shorter compared to other therapies which is a significant advantage as it reduces the pill burden and enhances compliance.
Molnupiravir is an oral anti-viral that inhibits the replication of multiple RNA viruses including SARS-CoV-2. The drug is used for the treatment of non-hospitalised patients with Covid-19 globally.
Molnupiravir has been developed by Merck and Ridgeback Biotherapeutics. The US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have granted the pill EUA.