Cipla has received approval 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 on 24th February 2022. The company said in a statement to the National Stock Exchange.  

The company added, “Cipla Limited is the third company which has been granted such approval by CDSCO. Basis the approval, the Company will conduct Bioavailability and Bioequivalence (“BA/BE”) studies and submit safety data for review as per requisite timelines.

Earlier in December, the the U.S. Food and Drug Administration issued an Emergency Use Authorisation (EUA), for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (Covid-19) in adults and paediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe Covid-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of Covid-19 and within five days of symptom onset. 

Paxlovid is not authorized for the pre-exposure or post-exposure prevention of Covid-19 or for initiation of treatment in those requiring hospitalization due to severe or critical Covid-19. Paxlovid consists of nirmatrelvir, which inhibits a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations. Paxlovid is administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally twice daily for five days, for a total of 30 tablets. Paxlovid is not authorized for use for longer than five consecutive days.