KARACHI: In a development with far-reaching implications for public health, pharmaceutical exports, and regulatory credibility, the Central Drug Testing Laboratory (CDL), Karachi, operating under the Drug Regulatory Authority of Pakistan, has officially secured prequalification from the World Health Organization.
This milestone, also highlighted in DRAP’s official communication, positions Pakistan’s drug quality testing system on the global map—at a time when ensuring the quality, safety, and efficacy of medicines remains a critical concern for both patients and policymakers.
What the WHO recognition actually means for Pakistan
WHO prequalification is not a routine certification. It is one of the most stringent global validation systems for quality control laboratories, requiring compliance with internationally accepted standards for testing accuracy, quality management, and technical reliability.
For patients in Pakistan, this translates into a simple but powerful outcome:
⇒ Medicines tested at CDL Karachi are now validated against global benchmarks, not just local standards.
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Not the first in Pakistan—but a major public sector milestone
While this is a landmark achievement, it is not the first WHO-prequalified laboratory in Pakistan.
The Pakistan Drugs Testing and Research Centre (PDTRC), a facility based in Lahore, secured WHO prequalification back in 2019 .
What makes CDL Karachi’s achievement particularly significant is that it represents:
✔️ One of the first major public-sector regulatory laboratories in Pakistan to reach this level
✔️ A direct strengthening of the national regulatory system under DRAP
✔️ A long-awaited upgrade following years of WHO recommendations to improve Pakistan’s drug testing capacity
This effectively bridges a critical gap between private capability and public regulatory oversight.
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A long journey shaped by reforms and global scrutiny
The road to this achievement has been shaped by years of reforms. Following past concerns over substandard and counterfeit medicines, WHO assessments had highlighted the need to upgrade Pakistan’s drug testing laboratories.
In response, CDL Karachi underwent significant transformation—modernizing infrastructure, introducing advanced analytical equipment, and aligning operations with ISO standards and WHO guidelines .
These upgrades were not just technical—they were foundational to restoring trust in Pakistan’s drug regulatory ecosystem.
DRAP leadership calls it a turning point
Dr Obaidullah, Chief Executive Officer of DRAP, congratulated the CDL team, describing the achievement as a major step toward strengthening the national regulatory framework.
According to DRAP, this recognition reinforces its commitment to ensuring that medicines available in Pakistan are tested with accuracy, integrity, and transparency, aligning with global expectations.
Why this matters beyond laboratories
This development is not just about a single lab—it carries wider implications:
- For patients: Greater confidence in the medicines they consume
- For doctors: Stronger assurance in prescribing decisions
- For regulators: Enhanced ability to detect substandard and counterfeit drugs
- For exporters: Improved credibility in international pharmaceutical markets
At a time when global supply chains demand strict compliance, this recognition gives Pakistan a stronger footing in competing internationally.
A boost for “Made in Pakistan” pharmaceuticals
One of the most strategic outcomes of this milestone is its impact on exports. With WHO-prequalified testing now available within the public regulatory system, Pakistani pharmaceutical manufacturers gain a powerful tool to demonstrate compliance with international standards.
This can significantly improve access to regulated markets and international procurement programs, where quality assurance is non-negotiable.
What comes next
While CDL Karachi’s achievement marks a major breakthrough, experts emphasize that it should be seen as a starting point, not the endpoint.
Expanding WHO-standard capabilities to other public laboratories, strengthening provincial testing systems, and maintaining continuous compliance will be key to sustaining this progress.
A defining moment for Pakistan’s healthcare system
At its core, this milestone is about trust—trust in medicines, trust in institutions, and trust in the systems that protect public health.
With WHO prequalification now secured, Pakistan has taken a decisive step toward ensuring that the medicines its people rely on—and the products it exports to the world—meet the highest standards of quality, safety, and efficacy.
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