In its June 13th, 2020 guidelines for Clinical Management Protocol for COVID-19, the Union Health Ministry as a part of investigational therapy added ‘Remdesivir’ only for restricted emergency use. A week after, on 21st June 2020, Hetero and Cipla Pharmaceuticals granted approval by the Drug Controller General of India for the production and marketing of the antiviral drug under its respective generic names.
The United States-based biopharmaceutical company, Gilead Sciences is the developer of the drug. In May 2020 Cipla was granted the voluntary non-exclusive by Gilead Science for manufacturing and marketing of the drug in India under generic drug name ‘CIPREMI’. Japan was the first country to approve Remdesivir drug as a treatment for COVID-19.
At present Remdesivir is only available in the injectable method. On 22nd June 2020, Gilead Sciences had announced had it will soon start Phase I trial for the inhaled version of Remdesivir.
In May 2020, clinical trials conducted under ACTT-1 (Adaptive COVID-19 Treatment Trial) with Remdesivir in more than 60 centers across the United States, Asia, and Europe had shown promising results when compared with the patients who were given placebo. During the trails a total of 1063 patients were given Remdesivir, the mortality rate was 7.1 %.