The Drugs Controller General of India (DCGI) has directed Serum Institute of India(SII) to suspend recruitment for the phase 2 and phase 3 trials of the COVID-19 vaccine candidate as pharma company AstraZeneca has paused conducting trials in other countries.
AstraZeneca had paused trials as one of the volunteer had developed unexpected illness. Thus PTI,DCGI Dr. V G Somani directed the Serum Institute of India to increase the safety monitoring of the subjects already vaccinated as part of the trial and submit the plan and report.
Somani has also asked the SII to submit clearance from Data and Safety Monitoring Board (DSMB) in the UK as well as India to obtain clearance from DCGI prior to resumption of any future recruitment for the vaccine trial.
The order read as “In the view of the above, I Dr. V G Somani, Drugs Controller General of India, Central Licensing Authority, after careful examination of your reply and the recommendations of the DSMB in India, in exercise of the powers vested under Rule 30 of the New Drugs and Clinical Trials Rules, 2019, direct you to suspend any new recruitment in the phase 2 and phase 3 clinical trials till further orders. Increase the safety monitoring of the subjects already vaccinated with the vaccine under trial and submit the plan and report.”
