Pakistan’s pharma, medical device exports surge 34% amid DRAP regulatory reforms: Report

ISLAMABAD, Jan 15 (APP):The Drug Regulatory Authority of Pakistan (DRAP) has unveiled a report highlighting a significant 34 percent increase in pharmaceutical and medical device exports, attributing the growth to wide-ranging regulatory reforms and enhanced transparency in approval and registration processes.

According to DRAP, the reforms have not only strengthened the regulatory framework but also resulted in billions of rupees in savings, with the direct benefits reaching the public.

 The authority noted that improved transparency and efficiency are ensuring timely access to modern and life-saving medical technologies for patients.

DRAP has digitized nearly 70 percent of its regulatory operations and aims to achieve 100 percent digitization by March 2026. Initiatives such as the Online Medical Devices Registration System and the e-Office have reduced human error, minimized delays, and enhanced transparency.

The authority has also significantly reduced timelines to facilitate exports. The duration for export registration of medicines has been reduced from 60 days to just 10 days, while certificates such as the Free Sale Certificate (FSC) and Certificate of Pharmaceutical Product (CoPP) will now be issued within five days instead of 30. The registration period for medical devices has similarly been reduced to around 20 days.

DRAP stated that the 34 percent increase in pharmaceutical exports is a positive development for the national economy. Efforts are underway to make Pakistan self-sufficient in pharmaceuticals through a one-window facility and by encouraging domestic and foreign investment.

According to the government’s review platform, business.gov.pk, regulatory processes have been simplified and made more effective as a result of DRAP’s reforms. A fast-track approval mechanism for new therapies and cancer treatment products has also been introduced, reducing the approval period to three months.

To ensure the quality of medicines, a national quality control laboratory network has been established. In addition, a draft national vaccine policy has been prepared, while work is in progress on a roadmap for local production of Active Pharmaceutical Ingredients (API).

Provincial drug testing laboratories have been certified to ISO 17025, with further steps underway to align them with World Health Organization (WHO) standards.

Reaffirming its commitment, DRAP stated that it will continue to introduce reforms to enhance transparency and improve registration and approval systems. In recognition of these efforts, the Drug Regulatory Authority of Pakistan was awarded the Reform Champion Award by Prime Minister Muhammad Shehbaz Sharif in December 2025.