In an interesting development, Drug Controller General of India (DCGI) has ordered Serum Institute of India (SII) to stop its recruitment process for phase 2 and 3 clinical trials of the Oxford COVID-19 vaccine, reports PTI.
This reportedly comes in the backdrop of pharma giant AstraZeneca pausing the trials in other countries.
DCGI has also reportedly directed SII to increase the "safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report."
Following the order, the SII said in a statement that they are "reviewing the situation and pausing India trials till AstraZeneca restarts the trials."
The order issued by DCGI reportedly read, "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 to you suspend any new recruitment in the phase 2 and 3 clinical trial till further orders."
It further said, "Increase the safety monitoring of the subjects already vaccinated with the vaccine under trial and submit the plan and report."
