Pfizer’s anti-Covid drug Paxlovid can be available in India anytime now as Hyderabad based Hetero has just received approval from the Indian drug regulator to launch the drug here.
This assumes significance as coronavirus (Covid-19) cases are on the rise in the country, especially in the National Capital Region (NCR).
A company source said that they have received a letter from the Drugs Controller General of India (DCGI) on April 21, and they are ready to launch the drug anytime now.
In March, the Medicines Patent Pool (MPP) had signed license agreement with 35 generic drug makers to manufacture the generic version of Pfizer’s oral COVID-19 treatment nirmatrelvir, which in combination with a low dose of ritonavir can be supplied in 95 low- and middle-income countries. Of this, 19 firms are Indian including Torrent Pharma, Cadila Pharma, Hetero, Biocon, Strides, Glenmark, Emcure, Granules, Macleods, Sun Pharma, Cipla among others.
The other companies too, are in the process of obtaining the necessary approvals from the DCGI to launch the Covid drug in India.
MPP is an UN-based public health organisation working to increase access to life-saving medicines for low and middle-income countries (LMICs). MPP has an agreement with PF Prism Holdings BV (Pfizer) that grants MPP the rights to sub-licence manufacture and commercialisation rights to sub-licencees in 95 LMICs that cover 53 per cent of the world’s population.
Paxlovid is administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally twice daily for five days, for 30 tablets. The prescription drug should be initiated as soon as possible after the diagnosis of Covid-19 and within five days of symptom onset.
The World Health Organization has “strongly recommended” Pfizer’s oral antiviral drug for patients with non-severe Covid-19 who are at highest risk of hospitalisation.
The WHO statement said : “Pfizer’s oral antiviral drug (a combination of nirmatrelvir and ritonavir tablets) is strongly recommended for patients with non-severe covid-19 who are at highest risk of hospitalisation, such as unvaccinated, older, or immunosuppressed patients, with lack of vaccination as an additional risk factor to consider.”
In fact, Paxlovid has been recommended over Gilead’s remdesivir and Merck’s molnupiravir.