Pharma and medical device exports surge as DRAP drives regulatory reforms
ISLAMABAD: In a significant development for Pakistan's healthcare sector, the Drug Regulatory Authority of Pakistan (DRAP) has announced a 34% increase in pharmaceutical and medical device exports. This growth is largely attributed to the wide-ranging regulatory reforms implemented by DRAP, which have streamlined processes, enhanced transparency, and created a more efficient system for approval and registration.
According to DRAP, these reforms have not only strengthened the regulatory framework but also resulted in billions of rupees in savings, benefiting the public. Improved transparency and efficiency have ensured timely access to modern and life-saving medical technologies for patients across Pakistan. The authority has successfully digitized nearly 70% of its regulatory operations, with an ambitious goal to reach 100% digitization by March 2026.
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Key initiatives like the Online Medical Devices Registration System and e-Office have minimized human errors, reduced delays, and fostered transparency, making the regulatory processes faster and more reliable. As part of these reforms, DRAP has also significantly reduced timelines for export registrations. The duration for export registration of medicines has been reduced from 60 days to just 10 days, while Free Sale Certificates (FSC) and Certificates of Pharmaceutical Product (CoPP) are now issued in five days instead of the previous 30-day timeframe. Similarly, the registration period for medical devices has been cut to just 20 days.
Economic impact, international recognition
This surge in pharmaceutical exports is seen as a positive development for Pakistan’s economy. DRAP continues to work toward making the country self-sufficient in pharmaceuticals, with plans to encourage both domestic and foreign investment in the sector. Through initiatives like the one-window facility, the authority is simplifying and streamlining the registration and approval processes to ensure growth.
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In recognition of these reforms, the Drug Regulatory Authority of Pakistan was awarded the Reform Champion Award by Prime Minister Muhammad Shehbaz Sharif in December 2025. This award acknowledges the significant strides made by DRAP in improving healthcare systems and processes in the country.
New initiatives for pharmaceutical innovation
DRAP has also introduced a fast-track approval mechanism for new therapies and cancer treatment products, reducing the approval period for these critical medicines to just three months. Additionally, the national quality control laboratory network has been established to ensure the quality of medicines. A draft national vaccine policy has been prepared, and work is progressing on a roadmap for local production of Active Pharmaceutical Ingredients (API).
Alignment with international standards
Provincial drug testing laboratories have received ISO 17025 certification, and efforts are underway to align these labs with World Health Organization (WHO) standards. These moves reflect DRAP’s commitment to not only meeting national healthcare needs but also complying with international benchmarks.
A promising future for Pakistan’s pharmaceutical sector
The success of DRAP’s reforms is clear, with tangible improvements seen in export growth and regulatory efficiency. The authority’s commitment to ongoing reforms promises to further enhance patient safety, ensure timely access to critical treatments, and create a more robust pharmaceutical sector in Pakistan.
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