COVID-19: Hetero, Cipla get green signal to manufacture antiviral drug Remdesivir
The Central Drugs Standard Control Organisation’s (CDSCO), country’s top drug regulatory body, on Saturday gave emergency use approval to two Indian drugmakers. As per The Indian Express, the drug regulatory body gave the green signal to manufacture and market generics of Gilead Science’s Remdesivir. Cipla and Hetero Drugs have been allowed to make as well as supply the injectable medicine, which can be used for the treatment of the suspected or laboratory-confirmed cases of COVID-19 “with severe disease”.
“Hetero and Cipla have just got approval. The documents and samples they had submitted were extensively assessed before the approval was granted,” a senior Health Ministry official told The Indian Express on the condition of anonymity.
So far, Cipla and Hetero have not officially confirmed it.
Four other companies namely, BDR Pharmaceuticals, Jubilant Life Sciences, Mylan Laboratories and Dr. Reddy’s Laboratories — are yet to be granted approvals.
This is crucial considering that there has been a surge in demand of the drug in the country but there is little clarity on the supply. Earlier, when Gilead got the nod, it had stated that there was “limited global supply” of the medicine. Fresh supply is anticipated in July.
The health ministry in its latest protocol has described the use of Remdesivir as investigational therapy on COVID-19 patients.
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