Sun Pharma receives DCGI approval to market Molnupiravir for COVID-19 treatment in India

Sun Pharmaceutical Industries Limited today announced that one of its wholly-owned subsidiaries has received Emergency Use Authorization (EUA) from the Drugs Controller General of India (DCGI) to manufacture and market a generic version of MSD (a trade name of Merck & Co., Inc, Kenilworth, NJ, USA) and Ridgeback's molnupiravir under the brand name Molxvir® in India.

Earlier this year, the Mumbai-based drug major had signed a non-exclusive voluntary licensing agreement with MSD to manufacture and supply a generic version of molnupiravir in over 100 low and middle-income countries (LMICs) including India.

The Drugs Controller General of India (DCGI), based on the review of clinical data of molnupiravir has approved molnupiravir for treatment of adult patients with COVID-19, with SpO2 > 93 per cent and who have a 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," said Kirti Ganorkar, CEO of India Business, Sun Pharma. "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. We are also 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."

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 has been developed by MSD and Ridgeback Biotherapeutics. It has been approved by the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Emergency Use Authorization (EUA).

Molxvir is a registered trademark of Sun Pharma.