ICMR task force meets to discuss inclusion of Pfizer’s Paxlovid for Covid treatment

The Indian Council of Medical Research’s (ICMR) National Task Force on Covid-19 is likely to meet this week to review data available on antiviral drug Paxlovid to decide on its inclusion in the treatment guidelines, people aware of the matter told ET.

Last week, India’s drug regulator had approved Pfizer’s Paxlovid for restricted emergency use against Covid-19 amid a rise in infections in the country. Hyderabad-based Hetero Labs will manufacture the generic version of the drug, touted as a game changer in the fight against the disease.

“We are regularly looking into the new drugs and new therapies and will be reviewing Paxlovid soon,” said Samiran Panda, head of epidemiology and infectious diseases at ICMR.

Pfizer’s Paxlovid contains Nirmatrelvir, which inhibits a SARS-CoV-2 protein to stop the virus from replicating, and Ritonavir, which slows down Nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations. It’s administered as three tablets—two of Nirmatrelvir and one of Ritonavir—taken together orally twice daily for five days (30 tablets in total).

Antiviral drug Molnupiravir, earlier failed to convince the ICMR for its inclusion in India’s national Covid-19 treatment protocol due to “safety concerns”, even as it received an emergency use authorisation (EUA) from the drug regulator.

Hetero Labs is likely to launch the generic version of Paxlovid this week. It is working on the price of the pill, people in the know told ET.

The drug has been “strongly recommended” by the World Health Organization (WHO) in patients with mild and moderate forms of coronavirus disease (Covid-19) at the highest risk of hospitalisation. The recommendation is based on data from two randomised controlled trials showing that the risk of hospital admission is reduced by 85% following the administration of the drug in a high-risk group.

The UN agency has, however, recommended against its use in Covid patients at lower risk of hospitalisation, stating the benefits were found to be negligible.

The US Food and Drug Administration (FDA) has authorised its use to treat high-risk, mild-to-moderate Covid-19 in adults and paediatric patients above 12 years of age weighing at least 40 kg.

Last year, Pfizer had announced a deal with MPP, a UN-backed body, to issue royalty-free voluntary licences to manufacture generic versions of Paxlovid in 95 middle- and low-income countries, including India.

MPP last month announced a tie up with 35 companies, including 19 drug manufacturers from India, to produce the generic version of Paxlovid. Hetero Labs is the first to have got approval in the country so far.

Among the other companies that have got approval are Torrent Pharma, Cadila Pharma, Biocon, Strides, Glenmark, Emcure, Granules, Macleods, Sun Pharma, and Cipla.

The drug is available by prescription only and should be initiated as soon as possible after the diagnosis of Covid-19 and within five days of onset of symptoms.

(With inputs from health)