India to become global hub for production of COVID-19 antiviral generic drugs: Fitch

India will become the largest global hub for production of Covid-19 antiviral generic drugs such as molnupiravir, Fitch Solutions said on Friday as the country braces for rising infection rates due to omicron-variant led third wave.

Big pharmaceutical companies in the country like Cipla Ltd, Sun Pharmaceutical Industries Ltd and Dr Reddy’s Laboratories are set to release molnupiravir capsules in the coming weeks following Indian drug regulator’s emergency use approval, Fitch added.

Fitch Ratings Inc. is an American credit rating agency and is one of the “Big Three credit rating agencies”, the other two being Moody's and Standard & Poor's. It is one of the three nationally recognized statistical rating organizations designated by the U.S. Securities and Exchange Commission in 1975.

Increased access to molnupiravir will keep hospitalisations and deaths in India to a manageable level as Omicron infections rise, Fitch Solutions said in a report.

Union Health Minister Mansukh Mandaviya last week said that a total of 13 companies in India will make molnupiravir. Those granted authorisation by the Drugs Controller General of India (DCGI) include Dr Reddy's Laboratories, Torrent Pharmaceuticals, Cipla, Sun Pharma, Natco Pharma, Viatris, Hetero Drugs and Mankind Pharma.

According to Fitch, other pharma firms in the country are also expected to follow suit. The anti-Covid pill molnupiravir, which has been developed by US based Merck & Co and Ridgeback Biotherapeutics, costs $712 in the United States. While in India the 5-day treatment will be highly affordable with Dr Reddy pricing the full treatment for Rs 1400 ($18.79) or Rs 35 a tablet for the generic version.

“With this relatively low cost, we expect molnupiravir generic versions to significantly increase access in India and other LMICs (low and middle income countries) after regulatory approvals,” Fitch said.

According to Fitch, the generic antiviral pill will also help in simplifying current supply-chain related challenges. “Moreover, these oral antiviral drugs will lead to lower costs of transport and distribution compared with Covid-19 intravenous antivirals such as Ronapreve (casirivimab/imdevimab) or Veklury (remdesivir). Having a solid, compact form, oral drugs, does not need … glass vials, and the tablets can be tightly packed without risk of breakage,” the rating agency added.

“This will make India the largest global hub for Covid-19 antiviral generic drug productions,” it said. “The efficacy of molnupiravir during its MOVe-OUT phase III trial has been largely promising, with a 50 reduction in hospitalisation and death in early-stage infections.” However, safety concerns remain on its risk of inducing harmful mutagenesis if the drug is prescribed globally, creating the potential for new Covid-19 strains.