India's Drug Regulator on June 20 gave permission to Hetero and Cipla to manufacture and market antiviral drug remdesivir for "restricted emergency use" on hospitalised COVID-19 patients, official sources said. This comes a day after the Drug Controller General of India (DCGI), considering the emergency and unmet need for medicines in light of the coronavirus outbreak, granted domestic firm Glenmark Pharmaceuticals the permission to manufacture and market favipiravir for "restricted emergency use" in mild to moderate cases.
"The approval to Hetero and Cipla was given on Saturday," a source said.
Hetero’s generic version of remdesivir will be marketed under the brand name ‘COVIFOR’ in India, as per the company's press release.
Written informed consent of each patient is required before the use of remdesivir and results of additional clinical trials, active post-marketing surveillance data and reporting of serious adverse events have to be submitted.