SEC no to clinical trial waiver for Pfizer’s Covid pill


The Subject Expert Committee (SEC) under India’s drug regulator turned down applications by Hetero Labs and Optimus Pharma to launch the generic version of ‘s Covid-19 antiviral drug paxlovid without local clinical trials. Both companies had approached the drug regulator last week seeking waivers.

The SEC asked the companies to conduct bioavailability and bioequivalence (BA/BE) studies and submit safety data at its meeting on Friday, said people with knowledge of the matter.

Hyderabad-based Optimus said there was no need for a separate trial as Pfizer was already doing it. Optimus said it would approach the drug regulator again, urging it to consider data from the Pfizer trial, which is also being held in India. A Hetero Labs executive said it will have to abide by what SEC says but a decision on local trials is yet to be taken.

“Pfizer is conducting a global study in which they have selected 14 different hospitals across India,” an Optimus spokesperson said. “We are going to submit information regarding the same as the study will look at how suitable the product is for the Indian population.”

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 authorisation (EUA) in many countries including Canada, UK, European Union,” the spokesperson said.

‘Need an Immediate Remedy’ | page 6

“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.

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 oral antiviral Covid-19 medication paxlovid in 95 middle and low income countries (LMICs), including India.

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