Pune : Central drug regulator Drug Controller General of India after the closure of clinical trials of the Oxford COVID-19 vaccine in other countries by the pharma company Astra Zen and in relation to ‘news of serious adverse effects’ of the vaccine, Serum Institute of India has been issued a ‘showcause’ notice for not giving information. This vaccine is being developed by the University of Oxford.
Drug Controller General of India, Dr. V.G. Somani has asked the Serum Institute in the showcause notice not to suspend the permission given for Phase II and Phase III vaccine testing in the country, till the safety of patients is guaranteed. In fact, ‘Serum Institute of India Private Limited has not yet reported to the Central Licensing Authority that AstraZeneca has suspended vaccine testing in other countries and has not submitted any reports regarding its adverse effects on patients.’
The notice asks the Serum Institute under provision 30 of the New Drugs and Clinical Trials Rules, 2019, why the approval of the test given on August 2 should not be postponed until the safety of the patients is decided. Calling the immediate reply, the DGCI said, “If we do not get the answer, it will be assumed that you have nothing to say and then appropriate action will be taken against you.”
In the showcause notice, the Indian regulator has also said that clinical trials in all the countries have been stopped. It is worth noting that this vaccine of the company was also being tested in USA (UK), UK (UK), Brazil (South Africa) and South Africa.
Regarding the showcause notice issued by DCGI, the Serum Institute of India said in a statement, “We are working as per the instructions of DCGI and we have not been asked to stop the trial yet. If DCGI has any security concerns, we will follow their instructions and follow the standard procedure. ‘
The regulator last month allowed the Serum Institute in Pune to conduct human clinical trials of Phase II and III of the coronavirus infection vaccine.
The British-Swedish biopharma company AstraZeneca has tied up with the University of Oxford to produce the vaccine and has cited the reason for stopping the test as it is a normal procedure after the ‘unknown disease’.
The Serum Institute, which had tied up with AstraZeneca for the production of the Oxford vaccine, said it would continue testing in India. Regarding AstraZeneca’s withholding of tests in the UK, the Serum Institute said in its statement, “We cannot comment too much on the trials taking place in the UK, but they are currently paused for review and are expected to start early.”
“As far as testing is done in India, it is going on and we have not faced any problems so far,” the statement said.