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The central drug regulator has issued a notice of proven cause to the Serum Institute of India (SII) for not informing it that the pharmaceutical giant AstraZeneca has paused clinical trials of the Oxford vaccine candidate for Covid-19 in other countries and also for not presenting victims . analysis of “reported serious adverse events”.
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.
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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.
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The DGCI requested an immediate response, saying otherwise “it will be interpreted that it has no explanation to offer and the measures deemed appropriate against it will be taken.”
In the notice of show of cause, the drug regulator also mentioned that clinical trials have been suspended in the countries where they were carried out, namely the US, UK, Brazil and South Africa.
Regarding the notice of cause of the show issued by DCGI, Serum Institute of India (SII) said in a statement: “We are following DCGI’s instructions and have not been told so far to stop testing. If DCGI has any safety concerns, We will follow your instructions and adhere to standard protocol. “
Last month, the DCGI had granted Pune-based IBS permission to conduct phase 2 and 3 human clinical trials of the coronavirus vaccine candidate.
Read: In the race for the coronavirus vaccine, safety trumps speed
AstraZeneca, a British-Swedish biopharmaceutical giant in partnership with Oxford University to produce the vaccine, described the hiatus from trials as “routine” after what was “an unexplained illness.”
Earlier in the day, SII, which partnered with AstraZeneca to make Oxford’s candidate vaccine for Covid-19, said 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.”
In addition, he said: “As far as the trials in India are concerned, it continues and we have not faced any problems.”
