Mylan gets DCGI nod for remdesivir in India, to launch at Rs 4,800 per vial

The DCGI has approved the company's remdesivir 100 mg per vial for restricted emergency use in India as part of the regulator's accelerated approval process to address urgent, unmet needs amid the evolving the COVID-19 pandemic, Mylan said in a statement.

New Delhi: Pharmaceutical major Mylan NV on Monday said it has received approval from Indian drugs regulator DCGI to manufacture and market its remdesivir for restricted emergency use in the country for the treatment of COVID-19.

The drug will be priced at Rs 4,800 per 100 mg vial and would be available to the patients in this month, it added.

The company joins domestic pharma firm Cipla and Hetero who have already received permission from the Drug Controller General of India (DCGI) to manufacture and market remdesivir for the treatment of COVID-19.

The DCGI has approved the company's remdesivir 100 mg per vial for restricted emergency use in India as part of the regulator's accelerated approval process to address urgent, unmet needs amid the evolving the COVID-19 pandemic, Mylan said in a statement.

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, it added.

"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.

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.

"The approval by DCGI in India represents the first for Mylan in these 127 markets," Mylan said.

The company continues to work extensively toward expanding emergency use access for patients in the 127 low- and middle-income countries where it is licensed by Gilead Sciences to do so, it added.

"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," Mylan President Rajiv Malik said.

Mylan commends Gilead for their continued leadership on this front, and also applauds and is 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 added.

"Our approval is a significant milestone for Mylan, for the global public health community and, most importantly, for patients who are battling this pandemic," Malik said.

Domestic pharma major Cipla has already said it will price its generic version of antiviral drug remdesivir at less than Rs 5,000 per vial.

Hetero has also said that it has fixed a maximum retail price of Rs 5,400 per vial for the drug.

In May, domestic pharma firms Hetero, Cipla and Jubilant Life Sciences and pharma major Mylan had entered into non-exclusive licensing agreements with drug major Gilead Sciences Inc for manufacturing and distribution of remdesivir.

The medicine has been issued an Emergency Use Authorization (EUA) by the United States Food and Drug Administration (USFDA) to treat COVID-19 patients.

(PTI Report)