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Indian firm gets DCGI nod to resume clinical trial of COVID-19 vaccine

sII has also been asked to submit to the DCGIs office details of medication used in accordance with the protocol for management of adverse events.

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This picture has been used for representational purposes

This picture has been used for representational purposes

Drugs Controller General of India (DCGI) Dr V G Somani on Tuesday gave permission to Serum Institute of India to resume 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 have to be "scrupulously" followed by Serum Institute of India (SII).

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