Serum Institute of India gets DCGI nod to resume Oxford COVID vaccine's clinical trial
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Drugs Controller General of India (DCGI) Dr VG Somani on Tuesday gave permission to Serum Institute of India to resume the clinical trial of the Oxford COVID-19 vaccine candidate in the country while revoking its earlier order of suspending any new recruitment for phase two and three trial. The DCGI, however, put certain conditions like taking extra care during screening, providing additional information in informed consent and close monitoring for adverse events during follow-up of the study which has to be "scrupulously" followed by the Serum Institute of India (SII).
Drugs Controller General of India (DCGI) Dr VG Somani on Tuesday gave permission to Serum Institute of India to resume the clinical trial of the Oxford COVID-19 vaccine candidate in the country while revoking its earlier order of suspending any new recruitment for phase two and three trial. The DCGI, however, put certain conditions like taking extra care during screening, providing additional information in informed consent and close monitoring for adverse events during follow-up of the study which has to be "scrupulously" followed by the Serum Institute of India (SII).
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