The domestically produced remdesivir will now be more widely available. (File)
New Delhi:
Remdesivir, the antiviral drug for treatment with COVID-19, will be available on the market by the end of this month, sources told GalacticGaming.
The Drug Controller General of India or DCGI had recently approved Remdesivir for “restricted emergency use” in critically ill hospitalized coronavirus patients.
The domestically produced remdesivir will now be more widely available.
Remdesivir, an experimental antiviral therapy developed by Gilead, has received an Emergency Use Authorization (EUA) from the United States Food and Drug Administration to treat COVID-19. However, several additional clinical trials are still underway to obtain more data on the safety and effectiveness of the drug as a treatment for the virus.
The center recently authorized the use of Remdesivir and the off-label application of tocilizumab and convalescent plasma in moderate cases of COVID-19.
The Ministry of Health has stated that Remdesivir is included as “experimental therapy” only for the purpose of restricted emergency use, which means that it is subject to conditions.
In the United States, Remdesivir continues to be used only under emergency use authorization. Gilead Sciences applied to the Indian Medicines Regulatory Agency on May 29 for permission to import and market remdesivir, the health ministry said, quoted by PTI.
The authorization under an emergency use authorization was granted on June 1 in the interests of patient safety and obtaining additional data, the ministry said.
Six Indian companies have requested authorization to manufacture and market the drug in India. Five of them have signed an agreement with Gilead Sciences.
