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‘Govt must exercise caution on oral anti-virals’

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As India inches close to a possible approval of oral antiviral drugs like Merck’s molnupiravir to treat Covid-19, health experts want the Government to proceed with caution on its supply and pricing.

Flagging the concern of drug resistance, if there is unfettered use, experts suggest a more controlled distribution and stockpiling of these drugs by Government authorities.

Two oral antiviral drugs to traetb Covid — molnupiravir from Merck and paxlovid from Pfizer — are in various stages of regulatory approval across the world. And while the UK’s regulator gave molnupiravir a go-ahead earlier this month, the European regulator, on Friday, gave favourable advice on the drug, allowing member countries to procure it, at a time when the region is seeing a surge in cases.

Both the drugs are to be reviewed by the US Food and Drug Administration (FDA), while molnupiravir is presently being evaluated by the Drug Controller General of India (DGCI), as well.

“Affordability is not a big issue for people living in a place like Gurgaon and those who can claim insurance and medical reimbursement. The issue will be for those who consult government hospitals and community health centres for treatment,” Virender Yadav, Chief Medical Officer of Gurgaon told BusinessLine.

He added that more research was needed on whether those with co-morbidities could be given the medicine. Yadav also suggested that the drugs be supplied in a controlled manner by authorised distributors. Another antiviral, remdesivir, had seen a surge in prices and was scarce during the second wave, before the Government streamlined things.

Praveen Gupta, Director (Neurology), Fortis Memorial Research pointed out that since these drugs were to be given in the early phase of infection and everyone may not be willing to spend that much money. Stockpiling may not be cost-effective, he added, as these are expensive drugs and could be pegged at between $10 and $ 20 per person. Reports suggest the drug is pegged at $700 per patient (over ₹51,000), globally.

However, Vikramjeet Singh, Senior Consultant, Internal Medicine, Aakash Healthcare Super Speciality Hospital, said these drugs will be supplied in low- and middle-income countries through arrangements that would bring down the cost. Merck has pacts with about eight Indian drug companies on molnupiravir, for local supplies at reduced prices.

Antiviral drugs needed?

Viswesvaran Balasubramanian, Consultant Interventional Pulmonology and Sleep Medicine, Yashoda Hospitals, Hyderabad, said molnupiravir was the first oral antiviral that has shown to be highly effective when given to high-risk non-pregnant patients. There was a reduction in the risk of hospitalisation or death by about 48 per cent, he said.

“Though the Government is going at a very high pace to vaccinate maximum people as soon as possible, we need these pills as Covid infections are still there. These drugs are a very very promising cure for Covid treatment. So obviously these drugs are needed,” Vikramjeet Singh, of Aakash Healthcare, added.

Side-effects

Gupta of Fortis said there could be side-effects like fever, chills, breathing difficulty, nausea and headache.

“The usual side effects can be fever or allergy rash There can be a rare instances of liver problem in some patients,” said Singh.



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