Global pharmaceutical major Mylan has got approval for its remdesivir from the Drug Controller General of India (DCGI) and will launch a generic version of Gilead Sciences' COVID-19 anti-viral in the country at Rs 4,800 for 100 mg/vial.
The drug will be launched under the brand name Desrem in India and will be available to patients later this month at about 80 per cent below the price tag for wealthy nations, the company said.
The approval for restricted emergency use is part of the DCGI's accelerated approval process to address urgent, unmet needs amid the evolving coronavirus pandemic.
Mylan will manufacture remdesivir in India at its injectables facilities which also make the product for the United States and have been inspected by the US Food and Drug Administration (FDA) for compliance with good manufacturing practices.
The company said it continues to work extensively toward expanding emergency use access for patients in the 127 low- and middle-income countries where it is licenced by Gilead Sciences to do so, subject to reviews by national regulatory bodies and the pre-qualification programme of the World Health Organisation (WHO).
The approval by DCGI in India represents the first for Mylan in these 127 markets.
Mylan President Rajiv Malik said the company 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," he said in a statement.
Mylan joins domestic pharma firm Cipla and Hetero which have already received permission from the DCGI to manufacture and market remdesivir for the treatment of Covid-19.
In May, domestic pharma firms Hetero, Cipla and Jubilant Life Sciences and pharma major Mylan had entered into non-exclusive licencing agreements with drug major Gilead Sciences Inc for manufacturing and distribution of remdesivir.
The medicine has been issued an emergency use authorisation by the US FDA to treat COVID-19 patients.