India’s central drug regulator has issued a show-cause notice to Serum Institute of India (SII) for failing to inform it about UK-based pharma giant AstraZeneca pausing global clinical trials of the Oxford vaccine candidate for Covid-19 in the US, UK, Brazil.and South Africa and also for not submitting a casualty analysis of the “reported serious adverse events”.
Drugs Controller General of India Dr V G Somani has asked SII why the permission granted for conducting phase 2 and 3 clinical trials of the vaccine candidate in the country should not be suspended till patient safety is established.
“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,” it read.
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”.
“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,” said SII in a statement.
The Pune-based vaccine major had got DCGI nod to conduct Phase 2 and 3 clinical trials of the AstraZeneca Covid-19 vaccine, which was developed in partnership with the University of Oxford.