Days after the Drug Controller General of India gave permission for itolizumab drug by Biocon to be used for treatment of moderate to severe Covid-19 patients, the Union health ministry said the drug has not been included in the national treatment protocol.
According to the statement issued by the health ministry, the National Task Force on Covid-19 is of the opinion that there is “very less evidence in favour of this medicine.”
Time of India reported that several independent experts have also questioned Biocon’s use of just 30 patients for the trial. According to the report, Biocon said that itolizumab was approved previously for psoriasis, and this was only a label extension. It also said the emergency procedures for getting a clearance for use on Covid-19 patients were as per international norms.
“We will provide National Covid Task Force large real world data to enable the committee to reconsider its decision on inclusion of itolizumab in the protocol. Nearly 1,000 patients have used the drug across the country with good outcome data," Biocon said in response to Centre’s announcement.