Serum Institute of India (SII) has paused clinical trials for the Covid-19 vaccine in India after receiving notice from the central drug regulator over Oxford vaccine trial.

The Drugs Controller General of India (DCGI) had issued a show-cause notice to the SII 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 show-cause notice was issued yesterday 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, the 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 accessed by PTI.

"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".

In the show-cause notice, the drug regulator also mentioned that the clinical trials have been put on hold across countries where they were conducted i.e. USA, UK, Brazil and South Africa.

Last month, the DCGI had granted permission to the Pune-based SII to conduct Phase 2 and 3 human clinical trials of the coronavirus vaccine candidate.

Story Courtesy - www.theweek.in