A day after the Drug Controller General of India (DCGI) gave emergency use authorisation (EUA) to make and sell versions of Merck and Ridgeback’s oral pill Molnupiravir — the first of its kind to treat Covid-19 patients — India's Sun Pharmaceutical Industries, Cipla and Torrent Pharma have announced to launch their versions in India in the backdrop of fast spreading Omicron variant.
While Sun Pharma will sell Molnupiravir under the brand name Molxvir in India, Torrent Pharma will sell it under the brand name Molnutor and Cipla will sell it as Cipmolnu. Strides Pharma Science will sell it under the brand Stripiravir.
Earlier this year, Merck, known as MSD outside the U.S. and Canada, had signed non-exclusive voluntary licensing agreements with over eight Indian companies to manufacture and supply generic versions of molnupiravir in over 100 low and middle-income countries (LMICs), including India. These include Aurobindo Pharma, Cipla, Dr Reddy’s Laboratories, Emcure Pharmaceuticals, Hetero Labs, Sun Pharmaceutical Industries, Torrent Pharmaceuticals, and Viatris.
In a first of its kind attempt in India in March and April, five of these companies — Cipla, Dr.Reddy’s Laboratories, Emcure Pharmaceuticals Sun Pharma and Torrent Pharmaceuticals — jointly collaborated to do the clinical trial of Molnupiravir in an out-patient setting in India. Dr. Reddy’s conducted the clinical trial using its product, and the other four pharma companies demonstrated equivalence of their product to the product used by Dr. Reddy’s in its clinical trial.
Molnupiravir is an oral anti-viral drug that inhibits the replication of multiple RNA viruses, including SARS-CoV-2. The drug is used for the treatment of non-hospitalised patients with confirmed Covid-19. The pill has been cleared by regulators in Denmark, Philippines and the U.K. to treat mild-to-moderate Covid-19 in adults.
Keeping in mind the high-risk population that may progress to severe disease, the U.S. Food and Drug Administration’s (US FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted 13 to 10 to recommend emergency authorisation of Molnupiravir for the treatment of mild to moderate Covid-19 in adults, though final trial data recently indicated its efficacy is low compared to Pfizer's oral anti-covid-19 pill Paxlovid.
“Molnupiravir is an important addition to the portfolio of oral therapies available for treating Covid-19 patients,” said Kirti Ganorkar, CEO of India business at Sun Pharma.
Sun, which will make available the drug across the country in a week's time, has not revealed price of the drug, but has said would sell it at an affordable price. The company is launching a toll-free helpline to ensure the availability of Molxvir to doctors and patients across India.
“We are pleased to partner with MSD to bring Molnupiravir to patients across India. Molnupiravir will be an important addition to our healthcare system’s ammunition in the fight against Covid-19,” said Aman Mehta, executive director – India, Torrent Pharma.
Cipla said it has adequate manufacturing capacities and a solid distribution mechanism in place to ensure speedy access to this effective treatment pan India. “This launch is yet another step in our endeavour to enable access to all treatments in Covid-19 care. We continue to be guided by the power of science to address the unmet needs of patients across the globe and bring care closer to the patients," said Umang Vohra, MD and global CEO, Cipla Limited.
“Molnupiravir demonstrated consistent efficacy across viral variants and has shown promising results. The drug helps reduce the number of hospitalisations and deaths in patients with mild to moderate disease at risk of progression to severe disease," said Dr P.P. Bose, Senior Consultant Pulmonologist at National Heart Institute and Fortis CDOC, New Delhi.
"The drug may be instrumental in stopping the spread of Covid-19 infections and possible worsening of the condition. Molnupiravir approval can be significant in offering an affordable oral drug to treat Covid 19 in India," he added.