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Serum Institute issues DCGI notice on trial of Oxford COVID-19 vaccine trial

new Delhi: Serum Institute of the Central Drug Regulator Serum Institute of not providing information regarding the discontinuation of clinical trials of Oxford Kovid-19 vaccine in other countries by pharma company AstraZeneca and reports of “serious adverse effects” of the vaccine India has issued a show cause notice. The Drug Controller General of India has asked the Serum Institute in a show cause notice not to suspend the permission given for Phase II and Phase III vaccine testing in the country until patients’ safety is guaranteed. Also Read – School In Coronavirus: The school is running in this school even in the Corona period …

A show-cause notice was issued after reports surfaced that a person involved in vaccine testing in the UK had an adverse effect on the Kovid-19 vaccine. This vaccine is being developed by the University of Oxford. Also Read – Covid-19 Test: This Airlines Offers Unique Offer, Make Corona Test At Home

Drug Controller General of India, Dr. V.G. Somani has asked the Serum Institute in the show cause notice not to suspend the permission given for Phase II and Phase III vaccine testing in the country until the safety of patients is guaranteed. Also Read – Covid 19 Vaccine: Russia needs help in production of Sputnik Vaccine, seeks help from India

According to the show cause notice received, “Serum Institute of India Private Limited has not yet reported the Central License Authority suspending vaccine testing in other countries by AstraZeneca and there are no reports regarding its adverse effects on patients.” Is assigned. “

The notice asks the Serum Institute under provision 30 of the New Drugs and Clinical Trials Rules, 2019, why the approval of the test given on August 2 should not be postponed until the safety of the patients is decided.