In a significant development, India’s top drug regulator has given nod to two domestic pharmaceutical companies--Cipla and Hetero for marketing authorization of anti-viral drug Remdesivir only for “restricted emergency use” on Covid-19 patients with moderate disease (those on oxygen), a senior government official told ANI.
With this development, India is soon to begin the domestic production of anti-viral drug remdesivir which would have efficacy, stability, safety for “restricted emergency use” on Covid-19 patients, official added.
Earlier, this month ANI had reported that the Central Drug Control Standard Organisation (CDCSO) office of DCGI had granted its permission to US based Gilead Sciences for marketing authorization of its anti-viral drug Remdesivir in India for “restricted emergency use” on hospitalized Covid-19 patients in the wake of virus pandemic.
On Saturday, ANI reported reported that DCGI granted domestic firm Glenmark Pharmaceuticals the permission to manufacture and market anti- viral drug favipiravir.
Gilead had signed non-exclusive voluntary licensing agreements with five generic pharma firms -- Cipla, Jubilant Life Sciences, Hetero, BRD and Mylan to manufacture and distribute remdesivir, a potential antiviral therapy for Covid-19.
Following which, the six domestic pharma giants--Cipla, Hetero Labs, BRD, Mylan, Jubilant Life Sciences, Dr. Reddy’s Labs approached to the India’s drug regulator to make and sell remdesivir in the country.