The Drug Regulatory Authority Pakistan (DRAP) has given a show-cause notice to the University of Health Sciences (UHS), Vice-Chancellor, for masterminding clinical preliminaries of a potential coronavirus immunization without its endorsement.
The notification was served to Professor Dr. Javed Akram on Monday, requesting that he clarify his situation in such manner. The VC has been given three days to react or confront lawful activity.
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The notification referenced that the UHS VC went on with the clinical preliminaries without getting endorsement from the DRAP’s Clinical Committee.
As indicated by Clinical Trial Bio-Study Rules 2017, earlier endorsement from DRAP is required for such exercises. The administrative body, in any case, explained that it has not endorsed any preliminary in the nation nor has anybody applied for one.
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Practicing its position, the DRAP has asked the UHS to promptly stop the clinical investigation of antibodies and disclose concerning why the procedure was begun in any case without the medication controller’s assent.
Prior, the Punjab government had likewise protested the UHS’ one-sided exercises and had looked for a clarification from the VC on clinical preliminaries.
