Health ministry updates: Rajesh Bhushan, Secretary, Health Ministry on being asked about the recent adverse event in the Serum Institute of India's vaccine trial: "Adverse event will not affect the timeline in any manner whatsoever. Whenever clinical trial starts, subjects are expected to sign prior informed consent form. This is global practice, it happens across all countries. Form tells subject about possible adverse events that may happen in case one decides to participate in trial.
"Clinical trials are multi-centric & multi-site. Each site has an Institutional Ethics Committee, which is independent of manufacturer or govt. In case of any adverse event, this Committee takes note and gives its report to Drug Controller General of India.
"Monitoring Board also monitors clinical trial from day to day basis and keep an eye on adverse events and report it. Drug Controller General analyses all reports and finds out whether there's a one-to-one co-relation between adverse event and vaccination.
"Adverse events do occur with drugs or vaccines or any other health intervention. It is the role of the regulator after collating all data to ascertain or refute whether there is a causal link between the event and intervention," ICMR DG Dr Balram Bhargava, said.