The Drug Controller General of India or DCGI had recently approved Remdesivir for “restricted emergency use” on severely ill hospitalised coronavirus patients.
Domestic-manufactured Remde Sivir will now be more widely available.
Remdesivir, the antiviral drug for COVID-19 treatment, will be available in the market by end of this month.
The Drug Controller General of India or DCGI had recently approved Remdesivir for “restricted emergency use” on severely ill hospitalised coronavirus patients.
Domestic-manufactured Remdesivir will now be more widely available.
Remdesivir, an investigational anti-viral therapy developed by Gilead, received Emergency Use Authorisation (EUA) by the US Food and Drug Administration to treat COVID-19. However, multiple additional clinical trials are still on for more data on the safety and efficacy of the drug as a treatment for the virus.
The centre had recently allowed the use of Remdesivir and off-label application of tocilizumab and convalescent plasma in moderate cases of COVID-19.
The health ministry had said Remdesivir was included as an “investigational therapy” only for the purpose of restricted emergency use, which means it is subject to conditions.
In the US, Remdesivir continues to be used only under emergency use authorization. Gilead Sciences had on May 29 applied to the Indian Drug Regulatory Agency for permission to import and market remdesivir.
Permission under emergency use authorization was granted on June 1 in the interest of patient safety and obtaining further data, said the ministry.
Six Indian companies have sought permission to manufacture and market the drug in India. Five of these have entered into an agreement with Gilead Sciences.
