Investigational Therapy for restricted emergency use on Covid-19 patients

Drug Remdesivir has been included as an “investigational therapy” only for restricted emergency use on Covid-19 patients. The ministry of health and family welfare intimated the updated Clinical Management Protocol for Covid-19, in which the drug Remdesivir has been included as an “investigational therapy” only for restricted emergency use purposes along with off label use of Tocilizumab and Convalescent Plasma.

Key-Points:

Benefits: Use of Remdesivir under emergency use may be considered in patients with moderate disease (those on oxygen) but with no specified contraindications. This drug has still not been approved (market authorization) by the US Food and Drug Administration (USFDA), where like India it continues only under an Emergency Use Authorization.

According to the health ministry, Gilead, a biopharmaceutical company, had applied to the Indian Drug Regulatory Agency, namely CDSCO, for import and marketing of Remdesivir on May 29 and after due deliberations, permission under Emergency Use Authorization was granted on June 1 in the interest of patient safety and obtaining further data.