The Drugs Controller General of India (DCGI) has directed the Serum Institute of India (SII) to suspend new recruitment in phase 2 and phase 3 clinical trials of the Oxford COVID-19 vaccine candidate until further orders, news agency PTI reported on Friday, 11 September.
The DCGI, the apex body responsible for overseeing clinical trials, has also called for enhanced safety monitoring of those who have already received the dosage, following a pause in the trials of the vaccine abroad.
Trials Paused
This comes after the Serum Institute, the Indian manufacturer of the Oxford vaccine, said on Thursday that it was officially pausing its India trials as per the instructions by DCGI.
“We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI's instructions and will not be able to comment further on trials. You can connect with DCGI for more updates on this front,” SII had said in a statement.
Pharmaceutical firm AstraZeneca on Wednesday had paused its clinical trial for the vaccine as one person from the UK had developed neurological symptoms, reports said.
DCGI’s Show Cause Notice
Following AstraZeneca's pause, SII had initially put out a statement saying they were not pausing the Phase 2-3 trials in India.
Subsequently, the DCGI, issued a show cause notice to SII for failing to inform them about the pausing of the trial by AstraZeneca.
The notice read, "In view of the above, Drugs Controller General of India and Central Licensing Authority hereby give you an opportunity to show cause... why the permission granted to you on 2 August shall not be suspended till patient safety is established."
Serum had then reacted saying they were simply following DCGI's directives.
“We are going by DCGI’s direction and so far were not told to pause the trials. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols,” it had said.
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