India is set to become one of the largest global hubs for generic COVID-19 antiviral drugs after the nation’s drug regulatory body grants emergency use authorization (EUA) to several pharmaceutical companies to manufacture generic molnupiravir, according to Fitch Solutions.
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In India, access to generic molnupiravir pills will reduce hospitalizations and deaths, as Omicron continues to affect the whole nation.
The Drugs Controller General of India (DCGI) granted EUA to companies such as Dr. Reddy’s Laboratories, Cipla, Torrent Pharmaceuticals, Sun Pharma, Viatris, Natco Pharma, Hetero Drugs, and Mankind Pharma.
Merck and Ridgeback Biotherapeutics market molnupiravir under the brand name Lagevrio. In the United States, the Food and Drug Administration (FDA) approved molnupiravir in December 2021, making it the first-ever oral antiviral pill for high-risk adults with mild to moderate COVID-19.
Dr. Reddy’s, Cipla, and Sun Pharma are set to release generic molnupiravir pills in the coming weeks.
Fitch said, “This will make India the largest global hub for COVID-19 antiviral generic drug productions. The efficacy of molnupiravir during its MOVe-OUT phase III trial has been largely promising, with a 50 reduction in hospitalization and death in early-stage infections.”
In India, there has been a recent surge in daily cases driven by Omicron, which is now set to overtake Delta as the dominant strain.
Fitch said quoting Our World In Data, “Moreover, India continues to lag behind in its COVID-19 Vaccine rollout target as 44.5% of the population has been fully vaccinated. Therefore, given the slow vaccination and recent sharp rise in COVID-19 cases, generic versions of molnupiravir could significantly reduce risk of hospitalization admission or deaths.”
It also said that generic molnupiravir would increase access in India as well as other low- and middle-income countries (LMICs).
In the United States, a full five-day treatment course with Lagevrio costs around $712. In India, generic molnupiravir is expected to cost between $19 and $22 for a five-day course, which is significantly lower.
Fitch said, “With this relatively low cost, we expect molnupiravir generic versions to significantly increase access in India and other LMICs after regulatory approvals.” Moreover, generic molnupiravir pills will lead to lower costs of transport and distribution than other antivirals used for COVID, such as casirivimab/imdevimab or remdesivir.
