poornima lagadapati
Active member
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).
SII has also been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events.
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).
SII has also been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events.