The broad-spectrum antiviral agent remdesivir (GS-5734; Gilead Sciences, Inc) is an inhibitor of the viral RNA-dependent, RNA polymerase with inhibitory activity against SARS-CoV and the Middle East respiratory syndrome (MERS-CoV). The US FDA issued EUA (Emergency use authorization) of remdesivir to allow emergency use of the agent for severe COVID-19 (confirmed or suspected) in hospitalized adults and children. EUA for remdesivir was based on preliminary data analysis of the Adaptive COVID-19 Treatment Trial (ACTT) which was announced April 29, 2020. The analysis included 1,063 hospitalized patients with advanced COVID-19 and lung involvement, showing that patients who received remdesivir recovered faster than similar patients who received placebo.
CDSCO also has approved Restricted Emergency Use of Remdesivir Injectable On May 1, 2020. Remdisivir formulations are required to be supplied for use only to the hospital/ institutions to ensure proper use of the drug as recommended along with informed consent of the patient or his /her representative in the prescribed form is mandatory before initiating the treatment. Cipla is marketing Remdesivir under its brand name CIPREMI and Hetero under its brand name COVIFOR both these will be marketed in India only.