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Drug Controller Issues Show Cause Notice To SII Over Vaccine Testing

The Covid-19 vaccine search has led to a hiccup in the process where a UK participant reportedly developed reaction during the trials. Serum Institute of India responds saying it cannot comment on UK trials

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A show-cause notice has been issued to Serum Institute of India (SII) for not informing the Drugs Controller General of India (DCGI) about pharma company AstraZeneca suspending clinical trials of the Oxford vaccine candidate for Covid-19 in other countries and also for not sharing the casualty analysis of the events that have been reported. As per news reports, one UK participant in the trial had an adverse reaction.

AstraZeneca, the British-Swedish biopharmaceutical company in tie-up with the Oxford University to produce the vaccine, described the pause of trials as a "routine procedure". SII, which has partnered with AstraZeneca for manufacturing the Oxford vaccine for COVID-19, said it is continuing with the trials in India.

The DCGI head V G Somani has asked SII as to why permission granted for conducting phase-2 and phase-3 clinical trials of the vaccine on selected candidates in India be not suspended till patient safety is established. 

Responding to the notice, 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. "It also said: "As far as Indian trials are concerned, it is continuing and we have faced no issues at all".

The notice read: “In view of the incident 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.”

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