Pharma companies are awaiting DCGI nod to launch Covid-19 drug in India

Molxvir will be manufactured at one of our plants in India and we have enough capacity to meet the demand.”

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DCGI CDSCO

Last Updated on November 14, 2021 by The Health Master

MUMBAI: Sun Pharma said on Thursday it is gearing up to introduce antiviral Covid-19 drug, molnupiravir under the brand Molxvir at “an economical price” in India.

Other companies including Hetero, Cipla, Torrent, Dr Reddy’s are also readying plans to introduce the drug, being considered a potential game-changer due to it being an oral therapy.

The Drugs Controller General of India (DCGI) is currently reviewing clinical data of molnupiravir for the treatment of Covid-19 in adults in India, and is expected to give the nod over the next few days.

At present, antiviral drugs in use in COVID therapy, such as Remdesivir, are administered intravenously in hospital settings.

Molnupiravir, the antiviral therapy of Merck Sharpe Dohme (MSD) and its partner Ridgeback, has shown promise in the treatment of mild-to-moderate COVID-19 in adults, having nearly halved the risk of hospitalization.

Earlier this year, MSD had signed licensing agreements with five generic companies including Sun Pharma to manufacture and supply molnupiravir in India, and to over 100 low and middle-income countries.

Molnupiravir is the first oral antiviral approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of mild-to-moderate COVID-19 in adults, and is under review by the US Food and Drug Administration.

Kirti Ganorkar, CEO of India Business, Sun Pharma said: “In line with our consistent efforts to accelerate access to new drugs for COVID-19 treatment, we are gearing up to make Molxvir available to patients and healthcare providers across India at an economical price, post approval by DCGI.

Molxvir will be manufactured at one of our plants in India and we have enough capacity to meet the demand.”

Further, the US government is stockpiling 1.7 million treatment courses of molnupiravir, at about $700 per patient.

However, it is expected to cost at a fraction of the global cost in India, with certain domestic companies including Optimus Pharma manufacturing the raw materials in the country.

Health experts say it could be priced around $20 for the five-day course here.
Significantly, the first generic version perhaps globally of molnupiravir was launched recently media reports indicate in Bangladesh at about $33 per course.

“While Merck is expected to charge $700 for a five-day treatment course of molnupiravir, a new independent study by researchers at Harvard University has estimated the sustainable generic price for a treatment course to be $20.

Indian generic manufacturers competing with one another are expected to launch the drug after emergency use approval in India for less than $15 per treatment course, as the drug is not yet patented in India – this is a full 46 times less than what Merck plans to charge’’, a statement from medical humanitarian organisation Médecins Sans Frontières (MSF) said earlier.

Domestic companies including Cipla, Dr Reddy’s, Emcure, Sun Pharma and Torrent have already submitted the local clinical trials’ data regarding the safety and efficacy of the drug, after having jointly conducted studies, an earlier statement by the companies said.

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