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Today's Paper | April 30, 2026

Published 25 Feb, 2026 07:04am

Drap urged to avoid declaring drugs spurious until completion of full regulatory process

KARACHI: The 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.

It warned 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.

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.

Published in Dawn, February 25th, 2026

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