Remdesivir reportedly approved for COVID-19 treatment in India
Remdesivir has been approved by India's top drug regulator for "restricted emergency use" on COVID-19-infected adults and children. The approval process of the drug, according to PTI's sources familiar with the development, was fast-tracked in light of the sporadic spike in cases of the disease across India, and the deaths stemming from them. Here is all you need to know about it.
Developed by Gilead Life Sciences, Remdesivir is an anti-viral drug that is being closely monitored as a potential treatment for COVID-19 in clinical trials around the world. In the US, it helped sick patients recover in 11 days, four days sooner than other placebo-involved treatments, and was subsequently cleared by the Food and Drug Administration (FDA) for emergency use.
A separate study published in The New England Journal of Medicine had also found that two out of three critically ill COVID-19 patients who were on oxygen support showed signs of improvement with Remdesivir.
Now, given the spike in COVID-19 cases and the lack of a proven therapy, Dr. VG Somani, the Drugs Controller General of India, has approved Remdesivir for "restricted emergency use." As part of this, sources say, the drug will be used to treat suspected or laboratory-confirmed cases of COVID-19 in adults and children hospitalized with severe symptoms, with appropriate safeguards.
With this, the COVID-19 drug can be sold "on the prescription of specialists for use in [a] hospital or institutional set-up." The approval was fast-tracked by special provisions under the New Drug and Clinical Trial Rules, 2019, which allows for skipping clinical trials. However, Dr. Somani did consult the expert committee of the Central Drugs Standard Control Organization he heads before clearing the medication.
That said, it must be noted that the medicine, which is administered as an injection, has been approved for a maximum 5-day regimen. "Administering Remdesivir for 10 days...doesn't have any beneficial effects, so why should patients consume it for an additional five days? There is also a potential risk of mortality rate increasing with extended use," a Health Ministry official told The Indian Express.
The move to approve Remdesivir comes as India's COVID-19 cases inch closer to the 2 lakh mark. So far, at least 5,606 people in the country have died from the disease.