Global pharmaceutical major Mylan NV said that it has received the approval of Drug Controller General of India (DCGI) for launching generic version of anti-coronavirus drug remdesivir. The company will roll out 100 mg per vial dosage of remdesivir in the country at Rs 4,800 for restricted emergency use.
"The drug is approved for the treatment of suspected or laboratory confirmed incidences of COVID-19 in adults and children hospitalised with severe presentations of the disease. The drug will be launched under the brand name DESREM in India and will be available to patients in July at a price of Rs 4,800, which is more than 80 per cent less than the price at which the branded version of this product will be available to governments in the developed world," Mylan said in a statement.
Remdesivir is an investigational drug developed by US-based Gilead Sciences and is one of the few medicines effective in treating coronavirus patients. So far, it has secured approvals for emergency use from US Food and Drug Administration (USFDA) and conditional approval from the European Commission.
Mylan has been licensed by Gilead for marketing the drug in 127 low- and middle-income countries, including India. The company will manufacture remdesivir at its injectables facilities in India, Mylan said in its statement.
"Mylan and Gilead Sciences have partnered for many years to make high quality medicines available to people who need them and have made significant progress to reduce the incidence of infectious diseases, including HIV/AIDS, around the world. We commend Gilead for their continued leadership on this front, and also applaud and are proud to continue partnering with the DCGI for its ongoing efforts to accelerate access to critical medicine for patients with COVID-19 in India," said Mylan President Rajiv Malik.
Mylan is the third company to launch the generic version of remdesivir in India after Cipla and Hetero Labs. Cipla has priced its version Cipremi at Rs 5,000, whereas Hetero has priced its remdesivir version, Covifor at Rs 5,400.
Gilead, on the other hand, has priced remdesivir at $2,340 for a 5-day regimen for direct government purchases by developed countries, sparking outrage from some quarters. The company has also entered a deal with the US government for supplying almost its entire global remdesivir, 500,000 treatment courses, till September. On average, a treatment course of remdesivir is 6.25 vials.