Marketed under the brand name Veklury, remdesivir is approved for treatment of COVID-19 in adults and adolescents aged 12 years and over and weighing at least 40kg, with pneumonia requiring supplemental oxygen. The approval by DCGI in India represents the first for Mylan in these 127 markets.
The company will manufacture remdesivir in India at its injectables facilities, which also make products for the US and have been inspected by the United States Food and Drug Administration (USFDA) for compliance with good manufacturing practices, it added. In a survey conducted by LocalCircles, which received 8,329 responses, 93 per cent consumers from 233 districts of India said the legal metrology and drug inspectors should be directed to immediately act against such black marketing of the Remdesivir, which at this point in time, could be termed as a life-saving drug, the letter mentioned.
Gilead has an obligation to make the drug available to European countries where people took on the risk of participating in human trials without knowing whether the medicine would work, according to Andrew Hill, a senior research fellow at the University of Liverpool.
Spahn said he was working to ensure the drug could be produced in Europe.
So far, the DCGI office has given manufacturing and marketing permissions for the drug to Hetero Drugs, Cipla and Mylan. Gilead has signed similar licensing agreements with four other generic pharmaceutical manufacturers based in India and Pakistan.
Last week president Donald Trump said he had bought the world's entire supply of remdesivir from Gilead. As the situation around COVID-19 continues to evolve, Mylan's priorities remain protecting the health and safety of its workforce, continuing to produce critically needed medicines, deploying our resources and expertise in the fight against COVID-19 through potential prevention and treatment efforts, and supporting the communities in which we operate.
European Union prices have not been announced and may vary from state to state, while remdesivir costs $3,120 for a course. That's the message the rest of the world got from the Trump administration's deal to lock up nearly all doses of Gilead Sciences' COVID-19 treatment remdesivir in the coming months for the U.S.