The Drugs Controller General of India (DCGI) gave its assent “as part of accelerated approval process considering the emergency situation and unmet medical need in light of the Covid outbreak”, according to its letter to the company.
The drug will be available within a week, a company executive told ET.
The development gains significance as some parts of India are witnessing an upsurge in Covid-19 cases. The pricing hasn’t been announced yet.
Pfizer had last year 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.
Pill cuts hospitalisation risk by 85%
MPP last month announced a tie-up with 35 companies, including 19 drug manufacturers from India, to produce the generic version of Paxlovid, which is a combination of nirmatrelvir and ritonavir and administered orally. Hetero Labs is the first to have got approval.
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.