ISLAMABAD: Pakistan’s pharmaceutical industry has urged Drug Regulatory Authority of Pakistan (DRAP) to avoid publicly declaring medicines substandard or spurious until the full regulatory process, including appellate re-testing, has been completed.
The industry warned premature announcements are eroding public trust, damaging credibility of local manufacturers, and undermining Pakistan’s pharmaceutical exports.
In a statement issued on Tuesday, representatives of Pakistan Pharmaceutical Manufacturers Association (PPMA) said public notices declaring therapeutic products substandard based on initial findings from Drug Testing Laboratories (DTLs) were often issued before companies were given an opportunity to request re-testing by National Institute of Health (NIH).
They noted several products initially declared substandard by provincial DTLs were later found compliant and fit for consumption when tested at NIH.
However, by that time, reputational damage had already occurred.
PPMA officials emphasised while post-marketing surveillance and quality testing are essential for patient safety, the way preliminary results are communicated is causing unnecessary concern among patients and healthcare providers.
“When interim findings are announced as final decisions, people lose confidence in widely used medicines even if those products are later cleared through the appellate process”, an industry representative said.
He said such communication also affects doctors’ prescribing behaviour and pharmacists’ dispensing decisions.
