The Drug Controller General of India (DCGI) has issued a notice to the Pune-based Serum Institute of India (SII) on Wednesday. The notice asks why the company did not inform about the serious adverse consequences that have led its UK partner AstraZeneca to "temporarily halt" global clinical trials of the Oxford COVID vaccine candidate. While the trial is continuing at 17 places within the country.
The DCGI has further asked the Institute why the authority should suspend the SII's permission for clinical trials of the Covishield. The Controller General of India and the Central Licensing Authority ask you to give reasons under rule 30 of the new drugs and clinical trial rules, 2019, why the permission given to you for a clinical trial on 2nd August may be canceled till the safety of outpatient is established."
DCGI's Dr. V G Somani has asked why the permission given for second and third phase trials should not be postponed till the patients are protected. Earlier on Wednesday, the SII had said that no clear instructions have been received so far to stop the trial. DCGI says Pune's SII has not submitted an analysis of serious adverse outcomes for the continuation of clinical trials of Phase 2 and 3 in terms of safety.
The notice comes at a time when Serum Institute of India CEO Adar Poonawalla says clinical trials for the second and third phases will continue uninterrupted at all the 17 locations. While on Tuesday, a UK-based volunteer showed unexplained neurological side effects of the drug. "The vaccine is completely safe," Poonawalla said. As far as Indian trials are concerned, we did not face any kind of trouble. "We are working in accordance with the DGCI's instructions, and we have not been told to stop the tests so far," SII said in a statement. If DGCI has any concerns about security, we will follow the directions and standard protocols. A total of 100 volunteers in India have received the first dose of the Covishield vaccine test. If it is certified safe, it will be manufactured by the Serum Institute in India.
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