India has approved Gilead Sciences Inc's antiviral drug remdesivir for emergency use in treating COVID-19 patients, the Lav Agarwal, joint secretary in the health ministry said today.
Remdesivir is the first drug to show improvement in COVID-19 patients in formal clinical trials. It was granted emergency use authorization by the US Food and Drug Administration last month and has received approval by Japanese health regulators.
“The DCGI gave an emergency use permission for remdesivir... and this was based on evidence that was provided by the company to support its use against covid-19," Agarwal said.
"(Remdesivir) approved on June 1 under emergency use with condition for five dose administration," the Drugs Controller General of India said.
In India, Gilead has given voluntary license for production of remdesivir to Cipla, Jubilant Life Sciences, Hetero Drugs and Mylan under a royalty-free arrangement till an alternative drug is found.
Gilead Sciences had on Monday reported that remdesivir showed modest benefit in patients with moderate COVID-19 given a five-day course. While those who received it for 10 days in the study did not fare as well, the company said.
Dr. Daniel McQuillen, an infectious disease specialist at Lahey Hospital & Medical Center in Burlington, Massachusetts, said it was difficult to draw a conclusion on why the patients on the shorter course outperformed those on the longer one until the full data is released. The trial results "confirm our and others' anecdotal experience," McQuillen said in an email.
India's COVID-19 count inched towards 2 lakh-mark on Tuesday. The total number of active cases in the country stood at 97,581. At least 95,527 was recovered from the disease. Maharashtra was the worst-affected state by coronavirus pandemic. The state so far reported 70,013 COVID-19 cases and 2,362 deaths.
(With inputs from agencies)