Central Drugs Standard Control Organisation (CDSCO), India’s top drug regulatory body has given green signal for the use of antiviral medication remdesivir for the treatment of severe Coronavirus cases. According to sources, this drug is manufactured by American biopharma Gilead Sciences and is imported by Mumbai’s Klinera Global Services. CDSCO has decided to extend its use to 10 days.
A senior Health Ministry official said, “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 increases 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,” the official added.
Gilead Sciences announced on Monday that hospitalised COVID-19 patients on remdesivir are 65% more likely to show clinical improvement by the 11th day in comparison to those who were not on the drug.
Remidesivir will be used and administered by the hospitals only after receiving “written informed consent” from the patients or their representatives. The packaging of the product will have to specify the risks involved in its consumption in patients with renal and hepatic impairment.
CDSCO will collect, process and forward the information on adverse reactions caused by the use of this drug in the country.