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Explained: What is the process for Pfizer’s Covid oral drug Paxlovid to come to India?

Pfizer's Covid-19 antiviral drug Paxlovid has received emergency use authorisation in the United States. Several Indian drug manufacturers are already planning to manufacture the generic version on it.

Written by Kaunain Sheriff M , Edited by Explained Desk | New Delhi |
Updated: December 23, 2021 12:53:57 pm
Paxlovid, Pfizer's Covid-19 pill, is seen manufactured in Ascoli, Italy. (Pfizer/Handout via Reuters)

On Wednesday, US Pharma Giant Pfizer received USFDA emergency use authorisation (EUA) for its Covid-19 antiviral treatment Paxlovid, for use in both high-risk adults and high-risk pediatric patients 12 years of age and older, weighing at least 40 kg. The development is likely to result in many Indian drugs manufacturers starting the generic production of the anti-viral pill. So, what is the process for Paxlovid to enter India?

First, what is Paxlovid?

It is an antiviral Covid-19 treatment candidate, PF-07321332, which is administered in combination with low dose HIV medicine ritonavir.

On Wednesday, it received a EUA based on the clinical data that it showed a reduced risk of hospitalisation or death by 89 per cent, within three days of symptom onset; and 88 per cent, within five days of symptom onset, as compared to the placebo group.

Significantly, European Medicines Agency (EMA) has also issued advice that Paxlovid can be used to treat adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease.

Are Indian companies manufacturing Pfizer’s antiviral drug?

Yes. Several Indian drug manufacturers are already planning to manufacture the generic version on Paxlovid. There are reports that Indian Pharma giants Sun Pharma, Dr Reddy’s, and Optimus Pharma are exploring the possibility to manufacture the Covid-19 pill.

What is the process for manufacturing the generic version of Paxlovid?

On November 16, Pfizer announced a deal with the United Nation’s backed public health orgnanisation Medicines Patent Pool (MPP). Under the deal, it signed a voluntary license agreement for Covid-19 oral antiviral treatment candidate Paxlovid. The agreement will facilitate the production and distribution of Paxlovid by granting sub-licenses to qualified generic medicine manufacturers.

Under the agreement, Pfizer expects Paxlovid to reach 95 countries, covering up to approximately 53 per cent of the world’s population. This will include all low- and lower-middle-income countries and some upper-middle-income countries, including India.

Significantly, Pfizer will not receive royalties on sales in low-income countries, and will further waive royalties on sales in all countries covered by the agreement while Covid-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization.

Similarly, Indian drug manufactures will have to sign an agreement under this deal for generic manufacturing of Paxlovid in the country.

Will Indian drug manufacturers have to conduct clinical trials?

Currently, yes. The companies will be asked to conduct the late phase 3 trials on Indian participants. It is likely to be on the lines of the clinical trials being conducted on Molnupiravir , a Covid-19 antiviral drug developed by Merck.

Cipla Ltd, Dr Reddy’s Laboratories Ltd (DRL), Emcure Pharmaceuticals Ltd, Sun Pharmaceutical Industries Ltd, and Torrent Pharmaceuticals Ltd announced that they are collaborating for a trial of molnupiravir for the treatment of mild Covid in an outpatient setting.

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