UHS Lahore gets three-year license to hold COVID-19 vaccine trial
LAHORE: The Drug Regulatory Authority of Pakistan (DRAP) on Friday issued a three-year license to the University of Health Sciences (UHS) Lahore to conduct COVID-19 vaccine trails, ARY NEWS reported.
The UHS was given license by the DRAP so that it could be used as a site for the phase-III clinical trial of a Chinese vaccine. The permission included a trial of the vaccine on humans for three years at the UHS.
It is pertinent to mention here that on August 10, the Drug Regulatory Authority of Pakistan (DRAP) 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 the 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. The Punjab government had sought an explanation from the UHS on clinical trials.