DRAP urged to follow full process before declaring medicines substandard

KARACHI: Pakistan’s pharmaceutical industry has urged the Drug Regulatory Authority of Pakistan (DRAP) to avoid publicly declaring medicines substandard or spurious until the full regulatory process, including appellate re-testing, is completed, warning that premature announcements are hurting public trust, damaging the credibility of local manufacturers and undermining Pakistan’s drug exports.

In a statement issued on Tuesday, representatives of the Pakistan Pharmaceutical Manufacturers Association (PPMA) said that public notices declaring therapeutic products substandard on the basis of initial Drug Testing Laboratory (DTL) findings were often issued before companies were given the chance to seek re-testing from appellate laboratory, which is National Institute of Health (NIH).

They said several products initially declared substandard by provincial DTLs were later found to be compliant and fit for consumption when tested at NIH, but by then the reputational damage had already been done.

PPMA officials said that while post-marketing surveillance and quality testing were essential for patient safety, the manner in which preliminary results were being communicated was creating unnecessary alarm 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, adding that such communication also affects doctors’ prescribing behaviour and pharmacists’ dispensing decisions.

The industry warned that the impact of premature public notices was not limited to the domestic market. The PPMA representatives said exports of Pakistani pharmaceutical products to Afghanistan had already come to a halt, calling it a serious blow to the country’s struggling export sector.

They said frequent public announcements of substandard drugs, without completion of due process, were being picked up by international buyers and regulators, who often treated preliminary findings as final regulatory outcomes.

“In a globalised pharmaceutical market, information travels fast. When preliminary laboratory observations are publicly circulated without context, overseas regulators and import authorities may misinterpret them as final decisions. This leads to additional scrutiny, delayed consignments, suspension of procurement by distributors and, in some cases, complications in product registrations abroad,” the PPMA said, warning that Pakistan’s pharmaceutical compliance image and credibility were at stake.

Industry representatives emphasised that Pakistan’s regulatory framework already provides for a multi-step process to ensure scientific accuracy and procedural fairness. Under the existing system, post-marketing surveillance samples are tested by government DTLs, and manufacturers have the right to seek appellate analysis by independent laboratories if they contest the initial findings. Final determinations, they argued, should be communicated only after this complete process is concluded.

They warned that circulating unresolved test results through media channels could create confusion and anxiety among patients, particularly those dependent on life-saving or long-term therapies.

“Beneficial and widely used treatments may be wrongly perceived as unsafe, even when subsequent testing clears them. This undermines confidence in the healthcare system and in essential medicines,” a PPMA official said.

The pharmaceutical industry said it fully supported strong quality surveillance, strict enforcement against genuinely substandard or spurious medicines, and transparent regulation to protect patient safety. However, it called on DRAP to adopt a more balanced communication approach that clearly distinguishes between preliminary laboratory observations and final regulatory conclusions, and that reflects the existence of appellate review mechanisms.

The PPMA urged the regulator to refrain from issuing public notices on substandard products until due process had been completed and final, verified conclusions reached. It said responsible communication was a critical part of an effective regulatory system and was necessary to protect patient trust, ensure healthcare stability and safeguard Pakistan’s growing pharmaceutical export ambitions.

“Patient safety and quality assurance remain shared objectives of regulators, industry, healthcare professionals and the media,” the association said. “But ensuring that complete scientific evaluations are concluded before public interpretation is amplified will help avoid unnecessary alarm at home and reputational harm abroad.”

Copyright Business Recorder, 2026