DCGI gives nod to Mylan labs to manufacture remdesivir for 'restricted emergency use' on COVID-19 patients
Jul 02, 2020
New Delhi [India], July 2 : The Drug Controller General of India (DCGI) has granted permission to Mylan laboratories to manufacture and market the anti-viral drug remdesivir for 'restricted emergency use' on hospitalised COVID-19 patients, a senior government official said on Thursday.
Previously, DCGI had given approval to Cipla and Hetero to manufacture and market remdesivir. ANI had reported last month that the Central Drug Control Standard Organisation (CDCSO) office of DCGI had granted its permission to US based Gilead Sciences for marketing authorisation of its anti-viral drug remdesivir in India for 'restricted emergency use' on hospitalised COVID-19 patients.
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.
