The Drug Regulatory Authority Pakistan (DRAP) has issued a show-cause notice to the University of Health Sciences (UHS), Vice-Chancellor, for arranging clinical trials of a potential coronavirus vaccine without its approval.
The notice was served to Professor Dr. Javed Akram on Monday, asking him to explain his position in this regard. The VC has been given three days to respond or face legal action.
The notice mentioned that the UHS VC went on with the clinical trials without getting approval from the DRAP’s Clinical Committee.
According to Clinical Trial Bio-Study Rules 2017, prior approval from DRAP is required for such activities. The regulatory body, however, clarified that it has not approved any trial in the country nor has anyone applied for one.
Exercising its authority, the DRAP has asked the UHS to immediately halt the clinical study of vaccines and explain as to why the process was started in the first place without the drug regulator’s consent.
Earlier, the Punjab government had also objected to the UHS’ unilateral activities and had sought an explanation from the VC on clinical trials.