The Drug Regulatory Authority of Pakistan (DRAP) has sought an explanation from the University of Health Sciences (UHS) vice chancellor for going ahead with clinical trials of a potential coronavirus vaccine without prior approval.
Sources said the drug regulator issued a show-cause notice to Prof Dr Javed Akram to explain his position in this regard within three days’ time or else unilateral action will be taken against him.
They said the UHS VC didn’t apply to the DRAP’s Clinical Committee to conduct clinical trials of vaccine.
DRAP cleared that it has not approved any clinical trials and that clinical study without its approval breach Clinical Trial Bio-Study Rules 2017. It asked the UHS to immediately stop the clinical study of vaccines and explain as to why the university started clinical trials without approval from the drug regulator.
The show-cause notice warned that DRAP will initiate unilateral action if no response is submitted.
Earlier, the Punjab government had sought an explanation from the UHS on clinical trials.