Hetero Labs, Optimus proposal to launch generic Paxlovid rejected by CDSCO panel: Report
New Delhi: In a major setback to Hetero Labs and Optimus Pharma, Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has rejected the pharma firms' application to introduce the generic version of Pfizer's Covid-19 antiviral medicine Paxlovid without clinical data.
As per a recent media report in The Economic Times, the expert panel has further directed the drug makers to complete bioavailability and bioequivalence (BA/BE) tests and provide safety data at its meeting on Friday.
According to persons familiar with the matter, Hetero and Optimus moved applications with the Indian drug regulator last week seeking waiver.
Also Read: Fate Of Pfizer COVID Pill Paxlovid To Be Decided By EU Regulator By January End: Report
Hyderabad-based Optimus stated that a separate trial was unnecessary because Pfizer was already performing one. Optimus said it would contact the pharma authority again, requesting that data from the Pfizer trial, which is also taking place in India, be considered.
"Pfizer is conducting a global study in which they have selected 14 different hospitals across India," an Optimus spokesperson told ET.
"We are going to submit information regarding the same as the study will look at how suitable the product is for the Indian population," he added.
Conducting another trial would mean delays in launching the drug, Optimus said. Keeping in view the present scenario, the aim should be to introduce it quickly, it said. "Pfizer has already received emergency use authorization (EUA) in many countries including Canada, UK, European Union," the spokesperson 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 spokesperson added.
Once it gets approval, the company will be able to introduce the medicine within a month. Optimus has the capacity to produce 50 million tablets per month. "We are just putting our efforts to bring this product into the Indian market," said the spokesperson.
Meanwhile, Hetero Labs official stated that the company will have to follow the SEC's rules, but a decision on local trials is yet to be made.
