Pakistan’s drug, medical device exports jump 34% after regulatory reforms

Pakistan’s exports of pharmaceuticals and medical devices rose 34% following regulatory reforms introduced by the Drug Regulatory Authority of Pakistan, reflecting faster approvals, greater transparency and expanded digitalization, the authority said Wednesday.

DRAP said the increase was driven by streamlined regulatory procedures, improved transparency and the digitalization of approval and registration processes. The reforms have facilitated trade and generated savings worth billions of rupees by making the system more efficient, the authority said, while also enabling quicker access to modern and life-saving medical technologies for the public.

As part of its modernization drive, DRAP has digitized nearly 70% of its regulatory operations and aims to reach full digitalization by March 2026. Initiatives such as an online medical devices registration system and the introduction of an e-Office platform have reduced human error, processing delays and procedural bottlenecks, while strengthening oversight and transparency.

To support exports, the authority has sharply reduced certification timelines. Export registration for pharmaceuticals has been cut to 10 days from 60, while key export documents, including Free Sale Certificates and Certificates of Pharmaceutical Product, are now issued within five days, compared with 30 previously. Registration of medical devices has also been shortened to about 20 days.

DRAP said the 34% rise in pharmaceutical exports is a positive development for the national economy, adding that ongoing efforts under a one-window facilitation framework and investment-friendly policies are aimed at strengthening self-reliance in the pharmaceutical sector.

According to the government’s business facilitation portal, the reforms have simplified and reinforced regulatory processes. DRAP has also introduced a fast-track approval mechanism for new therapies and cancer-related products, reducing approval timelines to three months.

To improve drug quality, a national network of quality control laboratories has been established, the authority said. It added that a draft National Vaccine Policy has been prepared, while work continues on a roadmap for local production of active pharmaceutical ingredients. Provincial drug testing laboratories are also being upgraded to meet ISO 17025 and World Health Organization standards.

DRAP said it remains committed to further enhancing transparency and efficiency in its registration and approval systems.

In recognition of the reform drive, Prime Minister Muhammad Shehbaz Sharif awarded DRAP the “Reform Champion Award” in December.