Last Updated on December 31, 2023 by The Health Master
Pharmaceutical major, Cipla has got a go-ahead from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to conduct local trials on the anti C-19 pill Paxlovid.
In its meeting held this week, the SEC granted approval to the company to conduct bioavailability and bio equivalence (BA/BE) studies.
“Cipla will carry study on 44 participants and soon share data with the regulatory authority,” a government official said.
Cipla is the third company to have gone ahead with conducting BA/BE studies for the launch of generic Paxlovid.
Hetero Labs and Optimus pharma are also conducting the same trials.
“While the active pharmaceutical ingredient (API) is ready, the formulation will take time. We are in the process of starting a study to evaluate the safety of the product,” an Optimus executive had earlier told ET.
The companies will conduct BA/BE studies and submit safety data for review to the drug regulator in a few months.
Pfizer is also conducting a global study as part of which they have selected 14 different hospitals across India.
Pfizer has already received emergency use authorisation (EUA) in about 40 countries including Canada, UK and the European Union. China is the latest country to have given conditional approval to Pfizer’s Paxlovid to treat adults with mild to moderate illness and a high risk of developing severe disease.
US drug giant Pfizer had last year announced a deal with MPP, a UN-backed public health organisation, to issue royalty free voluntary licences to manufacture generic versions of Paxlovid, an oral antiviral C-19 medication, in 95 middle and low income countries (LMICs), including India.
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