The use of anti-viral drug, Remdesivir for treating the Covid-19 patients including adults and children has been approved by Central Drugs Standard Control Organisation.
Dr V G Somani, Drugs Controller General of India, approved the drug for administration as part of a maximum five-day regimen, according to the report.
According to sources, the drug has been manufactured by Gilead Sciences and will be imported by Mumbai-based Klinera Global Services from the manufacturing sites of Gilead, Jubilant HollisterStier and Patheon Manufacturing Services in the United States.
A senior Health Ministry official said on condition of anonymity that,“As per the data presented by the company so far, administering remdesivir for 10 days as opposed to five doesn’t have any beneficial effects, so why should patients consume it for an additional five days? There is also a potential risk of the mortality rate increasing with extended use, so the authority has been more stringent with its decisions compared to other countries. The approval paves the way for generic voluntary licence holders in our country to manufacture remdesivir. The restriction of administration of the drug to five days will save the patients a lot of money.”
Gilead Sciences has also declared the results from its Phase 3 SIMPLE trial earlier on monday, which laid down that hospitalised COVID-19 patients on remdesivir were 65 per cent were more improved by the eleventh day compared with those who were not on the drug.
A written informed consent is required of each patient or his representative for the use of drug Remdesivir and will only be used in hospital or institutional settings, according to sources.