The Drugs Controller General of India issued a show-cause notice to the Serum Institute of India for not informing it about AstraZeneca suspending the clinical trials of the Oxford vaccine candidate for COVID-19 in other countries and and also for not submitting casualty analysis of the "reported serious adverse events"
The notice was issued following reports that human trials of the most promising COVID-19 vaccine candidate, being developed by the University of Oxford, have been put on hold after a UK participant had an adverse reaction to it.
Dr V G Somani, Drugs Controller General of India, in his show-cause notice has asked SII as to why the permission granted for conducting phase 2 and 3 clinical trials of the vaccine candidate in the country be not suspended till patient safety is established.
"Whereas, Serum Institute of India Pvt Ltd, Pune, till now has not informed the central licensing authority regarding pausing the clinical trial carried out by AstraZeneca in other countries and also not submitted casualty analysis of the reported serious adverse event with the investigational vaccine for the continuation of phase 2 and 3 clinical trials of the subject vaccine in the country in light of the safety concerns," said the show-cause notice.
"In view of the above, I Dr V G Somani, Drugs Controller General of India and Central Licensing Authority hereby give you an opportunity to show cause as provided under rule 30 of the New Drugs and Clinical Trials Rules, 2019, why the permission granted to you August 2 shall not be suspended till patient safety is established," the notice further said.
The DGCI sought an immediate reply, saying else "it shall be construed that you have no explanation to offer and action deemed fit will be taken against you".
Meanwhile, SII which has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19, said it is continuing with the trials in India.
Commenting on the recent reports on AstraZeneca halting the trials in the UK, SII said in a statement, "We can't comment much on the UK trials, but they have been paused for further review and they hope to restart soon."...