New Delhi: Remdesivir, the anti-viral drug that can potentially treat COVID-19, will be available in the Indian market by end of this month, sources have told NDTV.
The Drug Controller General of India had recently approved Remdesivir for “restricted emergency use” on severely ill hospitalised coronavirus patients.
Remdesivir, domestically manufactured, will now be widely available.
Remdesivir, an investigational anti-viral therapy developed by Gilead Sciences, was recently allowed by the centre in moderate cases of COVID-19, which means those on oxygen support. 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. Multiple additional clinical trials are still on for more data on the safety and efficacy of the drug as a treatment for the virus.
Gilead Sciences, the patent holder of the drug, had on May 29 applied to the Indian Drug Regulatory Agency for permission to import and market Remdesivir, PTI quoted the health ministry as saying.
Permission under emergency use authorization was granted on June 1 in the interest of patient safety and to draw more data, said the ministry.
Six companies had requested permission to manufacture and market the drug in India. Five of these have entered into an agreement with Gilead Sciences.
Remdesivir, which is administered as an injection, is not recommended for those with severe renal problems and in children less than 12, pregnant and lactating women, says the health ministry.