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
Doctors are hopeful that Pfizer
’s anti-Covid oral drug Paxlovid, which is expected to be available this week in India, is likely to play a key role if Covid19 cases rise in India due to the new Omicron sub-lineage.
Hyderabad-based Hetero has already received the DCGI approval to launch the drug in India on April 21, and sources indicated that the drug may be available as soon as this week across the country.
The pricing in India is expected to be competitive, but Hetero has not disclosed the pricing of their version of Pfizer
’s oral drug – a combination therapy of nirmatrelvir and ritonavir.
In March, the Medicines Patent Pool (MPP) had signed a 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, Granules, Macleods, Sun Pharma, and 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.
Doctors, however, are upbeat about the drug’s availability as Covid19 cases in India are rising thanks to an Omicron sub-lineage BA.2.12.1.
“The introduction of Paxlovid in India is a very welcome addition to the Covid19 drugs arsenal. The studies have shown that this is a powerful agent in non-hospitalised patients in the early stages of Covid19 to reduce the risk of hospitalisation or death by 89 per cent. This is one of the most powerful oral therapies now available to combat Covid19 infections,” said Praveen Gupta, principal director, and head, the department of neurology, Fortis Memorial Research Institute, Gurugram.
He, however, cautioned that this combination of Ritonavir with nirmaltavir is shown to have some drug interactions. “Therefore, one must consult their doctor before taking this medicine, especially the ones who are on multiple concurrent medicines,” Gupta added.
Rahul Pandit, director-critical care, Fortis Hospital in Mumbai, and Member of the National Covid-19 Task Force said that Paxlovid’s generic version will be a useful drug for Covid patients.
Doctors do not think that Paxlovid is likely to face the same fate as Merck’s molnupiravir, which saw a debate around the drug’s safety.
“This is an early-stage treatment which should be started as soon as possible as the onset of symptoms, and the dosing is twice daily for five days. This drug being more efficacious and not having the same safety concerns as molnupiravir, it is unlikely to meet the same fate as the latter. If the Covid19 wave rises in India now, Paxlovid is likely to become an important tool,” Gupta said.
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 the 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.
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