Mylan gets DCGI nod for remdesivir

NEW DELHI: Mylan NV said on Monday that it had received approval from the Drug Controller General of India (DCGI) to manufacture and market remdesivir for treatment of the coronavirus disease (Covid-19), making it the third company after Cipla Ltd and Hetero Drugs Ltd to get the regulatory nod to make and sell US-based Gilead Sciences Inc.’s patented anti-viral drug in India.

The Mylan drug will be launched under the brand name DESREM in India and will be available to patients at a price of ₹4,800 per 100mg vial. The cost of treatment for five days is around ₹20,000 and ₹30,000 in India.

The drugs controller has been granting accelerated approvals under emergency use authorisation to address urgent needs amid the evolving Covid-19 pandemic. The emergency authorisation allows products to be used for treatment without full data on their safety and efficacy, which has to be still submitted as trials continue.

The Mylan’s drug will be available in retail at hospitals on a valid doctor’s prescription, said the company. It is approved for the treatment of suspected or laboratory confirmed incidences of Covid-19 in hospitalized patients with severe illness.

“Mylan and Gilead Sciences have partnered for many years to make high quality medicines available to people…and have made significant progress to reduce the incidence of infectious diseases, including HIV/ AIDS, around the world… Developing DESREM™ and bringing it to patients in India with such unprecedented speed is a testament to the strength of our global operations and scientific capabilities and our commitment to serving patients who continue to rely on us during this time...,” said Rajiv Malik, Mylan president.