Guidance for approval COVID-19 Vaccines in India for restricted use in emergency situation

Drugs and Cosmetics Act, 1940 and New Drugs and Clinical Trials Rules, 2019

Notice X-11026-07-2020-PRO


Government of India, Directorate General of Health Services has issued guidance for approval of COVID-19 Vaccines in India for restricted use in emergency situation which are already approved for restricted use by US FD, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL)