The Serum Institute of India (SII), which is conducting Oxford-AstraZeneca coronavirus vaccine phase 2 and 3 trials in India, has received a show-cause notice from the central drug regulator for not informing it about pharma giant AstraZeneca pausing the clinical trials of the Oxford vaccine candidate in other countries and also for not submitting casualty analysis of the "reported serious adverse events". The show-cause notice was issued following reports that human trials of the most promising coronavirus vaccine candidate, being developed by the University of Oxford, have been put on hold after a UK participant had an adverse reaction to it.
SII gets show-cause notice from DCGI | What we know
- The Drugs Controller General of India (DCGI), Dr VG Somani, 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 VG 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 it is 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.
- AstraZeneca, the British-Swedish biopharmaceutical giant in tie-up with the Oxford University to produce the vaccine, described the pause of trials as a "routine" one following what was “an unexplained illness".
- Meanwhile, Serum Institute of India (SII), which has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19, on Wednesday 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."
- It further said: "As far as Indian trials are concerned, it is continuing and we have faced no issues at all".
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