DGCI’S SHOW CAUSE NOTICE TO SII FOR HOLDING COVISHIELD TRIALS

The Drugs Controller General of India (DCGI) has issued a show cause notice to the Serum Institute of India (SII). The SII is manufacturing Oxford University’s vaccine ‘Covishield’, in collaboration with the UK’s AstraZeneca. Regarding the show cause notice issued by the DCGI, SII said, “We are going by DCGI’s direction and so far have […]

by Shalini Bhardwaj - September 12, 2020, 1:17 pm

The Drugs Controller General of India (DCGI) has issued a show cause notice to the Serum Institute of India (SII). The SII is manufacturing Oxford University’s vaccine ‘Covishield’, in collaboration with the UK’s AstraZeneca.

Regarding the show cause notice issued by the DCGI, SII said, “We are going by DCGI’s direction and so far have not been told to pause the trials. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols.”

The UK-based pharmaceutical giant AstraZeneca paused the trials of the vaccine on 8 September after one of the recipients of the vaccine in the UK developed an “unexplained illness”. However, in India, none of the volunteers have shown any signs of health-related complications after receiving the vaccine from SII.