Cipla gets CDSCO panel nod to conduct Indian trials of Paxlovid
New Delhi: In a significant development, drug-major Cipla has got a green signal from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to conduct local trials on the anti-Covid-19 pill Paxlovid.
The SEC of the Central Drugs Standard Control Organization has granted Cipla permission to perform bioavailability and bioequivalence (BA/BE) trials for the anti-Covid-19 pill Paxlovid, as per the report published by ET.
A government official told ET that Cipla will conduct research on 44 people and will shortly submit the results to the regulatory authority.
With this approval, Cipla became the third company to proceed with BA/BE studies in preparation for the launch of generic Paxlovid. The same trials are being conducted by Hetero Labs and Optimus Pharma.
Paxlovid is an investigational SARS-CoV-2 protease inhibitor antiviral therapy, developed by Pfizer Inc. for treating mild-to-moderate COVID-19 in adults and children 12 years and older, who are likely to be at greater risk for severe infection.
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