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Mylan gets license for remdesivir in India

Chemical structure of remdesivir. Image credit: Hbf878 / CC0
Chemical structure of remdesivir. Image credit: Hbf878 / CC0

The Union Ministry of Health and Family Welfare has revised guidelines for remdesivir use in cases of COVID-19, whilst Mylan has been given the nod to produce the antiviral drug in the country.  

Last month, India approved restricted emergency remdesivir use for the treatment of moderate cases of COVID-19 – the disease caused by severe acute respiratory coronavirus 2 (SARS-CoV-2) or simply coronavirus. Per the latest guidelines, the antiviral medication – marketed by Gilead – should be administered over a five-day period, at an intravenous dosage of 200 mg on the first day and 100 mg intravenously for the four days thereafter. Earlier guidelines for remdesivir use for the treatment of COVID-19 outlined a six-day treatment protocol. Remdesivir is not to be prescribed to those under the age of twelve, pregnant women, those with kidney impairment and those with high liver enzymes.

Remdesivir use in the treatment of patients hospitalised with advanced COVID-19 was adopted following promising results of a research trial. It found that “remdesivir was better than placebo from the perspective of the primary endpoint, time to recovery, a metric often used in influenza trials. Recovery in this study was defined as being well enough for hospital discharge or returning to normal activity level.”

Following the results of the trial, four drugmakers applied for a license to manufacture and distribute remdesivir. A government official told ANI in mid-June that “their applications are being thoroughly studied and examined day and night. It had certain shortcomings for which the respective pharma companies are furnishing their report. The testing of the drug’s molecular compound will be done at our government laboratory. When it fulfills the safety parameters at the dose, India would soon have the benefit of its domestic product…which have efficacy, stability and safety for ‘restricted emergency use’ on COVID-19 patients.”

Drug manufacturer Mylan has now received the Government’s nod to produce and distribute a generic remdesivir product, priced at Rs 4,800 per every 100 mg vial. Two other drugmakers – Cipla and Covifor – have launched generic versions of remdesivir, priced at less than Rs 5,000 and Rs 5,400 respectively. Remdesivir is available from Mylan under the brand name Desrem; from Cipla as Cipremi; and from Hetero as Covifor.

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