Hetero Labs, Optimus proposal to launch generic Paxlovid rejected by CDSCO panel: Report

"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.