The Central Drug Standard Control Organisation (CDSCO) has granted approval for the emergency use of ‘remdesivir’ to treat novel coronavirus disease (COVID-19) patients. However, the Union Ministry of Health and Family Welfare (MoHFW), in a conference on June 2, 2020, could not share details of the evidence on the basis of which this authorisation was granted.
- The government also did not provide clarity about whether remdesivir should be given to only severe patients.
- The Indian Council of Medical Research (ICMR) is a participating agency in the ‘Solidarity Trial’— a global trial anchored by the World Health Organization — for this drug. The trial is ongoing.
- The US Food and Drug Administration (US FDA) had granted an emergency use authorisation for remdesivir to be used for treating COVID-19 patients.
This was granted on the basis of a randomised control trial (RCT) conducted by US-based National Institute of Disease and Infectious Diseases (NIAID) and an observational study by Gilead Inc itself.