The Central Drugs Standard Control Organization (CDSCO), India’s regulatory body for cosmetics, pharmaceuticals, and medical devices, has rejected Hetero Labs and Optimus Pharma’s application to launch generic versions of Paxlovid, according to Medical Dialogues.
Paxlovid, developed by Pfizer, is one of the COVID antiviral pills approved by the U.S. Food and Drug Administration (FDA). It contains nirmatrelvir and ritonavir. The drug is advised for the treatment of mild to moderate COVID infection in adults.
The Subject Expert Committee (SEC), which is function under CDSCO, directed the companies to complete bioavailability and bioequivalence tests and provide safety data at its meeting today, according to a report by Economic Times (ET).
Optimus said there is no need for a separate trial because Pfizer has already performed it. The company said it would contact the pharma authority again and request the data from the Pfizer trial, which is also conducted in India.
A representative of Optimus told ET, “Pfizer is conducting a global study in which they have selected 14 different hospitals across India. We are going to submit information regarding the same as the study will look at how suitable the product is for the Indian population.”
The company said conducting another clinical trial means delaying the launch of generic Paxlovid. “Pfizer has already received emergency use authorization (EUA) in many countries including Canada, UK, European Union,” the rep said.
“The drug works well in emergency situations so we are going to request the drug regulator again for the clinical trial waiver because in the current scenario we need an immediate remedy for our people,” the rep added.
On the other hand, Hetero said that the company will follow the SEC’s decision.
Meanwhile, Bangladesh drugmaker Beximco Pharmaceuticals has become the first company to launch generic Paxlovid, according to ET.
On Thursday, Bangladesh’s drug regulatory body granted emergency use authorization for the COVID antiviral drug to treat mild-to-moderate Covid-19 in adults and children aged 12 and above. Beximco will market generic Paxlovid under the brand name Bexovid.
