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.
Paxlovid contains the active substances Nirmatrelvir (PF-07321332) and ritonavir. Nirmatrelvir is active against the virus that causes COVID-19. Ritonavir prolongs the therapeutic effect of PF-07321332.
Paxlovid reduces the ability of SARS-CoV-2 (the virus that causes COVID-19) to multiply in the body. The active substance PF-07321332 blocks the activity of an enzyme needed by the virus to multiply. Paxlovid also contains a low dose of the medicine ritonavir, which slows the breakdown of PF-07321332, enabling it to remain longer in the body at levels that affect the multiplication of the virus. Together, the active substances can help the body overcome the virus infection, and prevent the disease from becoming severe.
Earlier, the Medical Dialogues Team had reported that the FDA had given approval for Emergency Use Authorisation (EUA) for Paxlovid, 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.
Furthermore, it was reported that China's medical products regulator gave conditional approval for Pfizer's COVID-19 drug Paxlovid, making it the first oral pill specifically developed to treat the disease in the country.
US drug major, Pfizer has secured emergency use permission (EUA) in about 40 countries, including Canada, the UK, and the European Union.
