New Delhi: The Drugs Regulator General of India (DCGI) on Wednesday issued a show-cause notice to pharma giant Serum Institute of India (SII) seeking explanation as to why it did not halt the ongoing clinical trial of Covid vaccine till doubts about patients’ safety are cleared.
The DGCI also sent the notice to SII for not informing it about 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 from the DGCI after reports surfaced that the 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.
“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,” the notice reads.
After issuing the notice, the DGCI sought immediate reply from SII 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 such as 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.
On the other hand, the British-Swedish biopharmaceutical giant AstraZeneca 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”.
(With inputs from PTI)
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