NEW DELHI: The central drug regulator has issued a notice of proven cause to the Serum Institute of India (SII) for not informing it about the pharmaceutical giant AstraZeneca that is pausing clinical trials of the Oxford vaccine candidate for Covid-19 in other countries and also for not presenting an analysis of the victims of “serious adverse events reported”.
The show of cause notice was issued after reports that human trials of the most promising Covid-19 vaccine candidate, which is being developed by the University of Oxford, were suspended after a participant from the UK had a reaction. adverse.
The Comptroller General of Drugs of India, Dr. VG Somani, in his notice of demonstrative cause has asked the SII why the permission granted to carry out phase 2 and 3 clinical trials of the candidate vaccine in the country will not be suspended until patient safety is established.
“Whereas, Serum Institute of India Pvt Ltd, Pune, has so far not informed the central licensing authority about the pause of the clinical trial conducted by AstraZeneca in other countries and has not provided a casualty analysis of the reported serious adverse event with the investigational vaccine for the continuation of phase 2 and 3 clinical trials of the vaccine in question in the country in light of safety concerns, “said the notice of proof of cause that PTI had access to.
“In view of the foregoing, I, Dr. VG Somani, Indian Comptroller General of Drugs and Central Licensing Authority, hereby give you an opportunity to prove cause, as provided in rule 30 of the Rules of New Medications and Clinical Trials, 2019, why the permission granted to August 2 will not be suspended until patient safety is established, “the notice also said.
The DGCI requested an immediate response saying otherwise “it will be interpreted that you have no explanation to offer and the measures deemed appropriate will be taken against you.”
In the notice of show of cause, the drug regulator also mentioned that clinical trials have been suspended in the countries where it is being carried out, that is, the US, the UK, Brazil and South Africa.
Last month, the DCGI had granted Pune-based IBS permission to conduct phase 2 and 3 human clinical trials of the coronavirus vaccine candidate.
AstraZeneca, the British-Swedish biopharmaceutical giant working with Oxford University to produce the vaccine, described the hiatus from trials as “routine” after what was “an inexplicable illness.”
Meanwhile, the Serum Institute of India (SII), which partnered with AstraZeneca to make the Oxford vaccine candidate for Covid-19, said on Wednesday that it is continuing trials in India.
Commenting on recent reports of AstraZeneca stopping trials in the UK, SII said in a statement: “We cannot comment much on the UK trials but they have been paused for further review and hope to restart soon.”
Furthermore, he said: “As far as the Indian trials go, it continues and we have not faced any problems.”
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