DCGI NOD FOR EMERGENCY USE OF REMDESIVIR

NEW DELHI: Drug Controller General of India VG Somani has approved the use of Gilead Sciences Inc’s novel drug remdesivir to treat covid-19 patients, Lav Aggarwal, joint secretary in the health ministry, said on Tuesday.

“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 c ovid -19,” Ag g aw al said at a press conference.

Aggarwal said further details on the protocols for use of the intravenous drug will be provided by the government in due course.

In India, Gilead has given voluntary licence for production of remdesivir to Cipla, Jubilant Life Sciences, Hetero Drugs and Mylan under a royalty-free arrangement till an alternative drug is found or until the World Health Organization removes the designation of ‘Public Health Emergency of International Concern’ for the covid-19 pandemic.

Gilead’s remdesivir was earlier under trial for Ebola, but the drug could not pass clinical trials. However, the covid-19 pandemic has given a fresh life to the drug, which experts have said is complex to manufacture.

Gilead Sciences Inc Monday said that its phase 3 clinical trial in hospitalised patients with moderate Covid-19 pneumonia showed that a five-day treatment course of remdesivir resulted in greater clinical improvement as compared to standard care alone.