On Thursday, the pharma regulator’s subject expert committee (SEC) will review applications for Molnupiravir, the world’s first treatment to treat symptomatic Covid.
The SEC has set an emergency meeting to evaluate the plans “under accelerated approval process.” According to an official, the committee would consider applications from at least eight Indian pharmaceutical companies.
Molnupiravir has shown potential in treating mild-to-moderate Covid-19 in adults, reducing the risk of hospitalization and death by roughly half. Natco, Dr. Reddy’s, Cipla, Sun Pharma, Hetero, and BDR Pharma are among the companies waiting for regulatory approval to launch the generic antiviral in India.
The process is essential since Merck and its partner Ridgeback’s antiviral oral pill is being hailed as a game-changer for high-risk patients and others with reduced immunity.
Pfizer, on the other hand, submitted an application to the US Food and Drug Administration on Tuesday for approval of its Paxlovid tablet, which is intended to treat Covid sufferers.