The central drug regulator has issued a notice to Serum Institute of India for not informing it about pharma giant AstraZeneca pausing the clinical trials of the Oxford vaccine candidate for Covid-19 in other countries and also for not submitting casualty analysis of the "reported serious adverse events".
The notice was issued following reports that the human trials of the Covid-19 vaccine candidate being developed by the University of Oxford have been put on hold after a British participant had an adverse reaction to it.
The Drugs Controller General of India, Dr VG Somani, in the notice asked SII as to why the permission granted for conducting phase 2 and 3 clinical trials of the vaccine candidate in the country not be suspended till patient safety is established.