Pak pharma firms win WHO prequalification, PIC/S recognition to begin export in regulated high-end markets

KARACHI: At least 8 pharmaceutical companies from Pakistan have won prestigious international recognition for producing quality medicine of global standards, including WHO prequalification, PIC/S recognition, and MHRA (Medicines and Healthcare products Regulatory Agency) accreditation in recent times.

This has opened doors for them to expand the country’s exports to the regulated high-end world markets including the United States (US), Europe and the Gulf Cooperation Council (GCC) countries - a step towards achieving the $30 billion export target by the industry in five years.

“Another 10 to 15 companies are expected to receive such global certifications over the next one to two years,” Pakistan Pharmaceutical Manufa cturers Association (PPMA) chairman Tauqeer Ul Haq said while speaking at the 8th Pakistan Pharma Summit and 4th Pharma Export Summit and Awards 2025 (PESA 2025) this week in Islamabad.

A former chairman of the association, Haroon Qasim estimated that top 100 companies – out of a total of around 800 firms in the country – could easily go for the international certifications.

He said his company PharmEvo received an outstanding response from international visitors at the Arab Health exhibition held recently at the Dubai World Trade Centre after it had received WHO prequalification.

“A big number of delegates visited our stall in the wake of the prequalification this time. We are now exporting into 30-35 countries at present compared to around 2-3 countries before the prequalification,” he said.

Another former chairman Kaiser Waheed said people asked them why Pakistani firms had not exported to Europe and the US and why there had not been a single firm certified by the US Food and Drug Administration (FDA) like India.

“I don’t know why. This is perhaps because we don’t have such global institutions in the country and expect the pharma industry to come up to global standards,” he said.

However, some eight Pakistan-based pharma companies or groups have achieved WHO and MHRA qualifications. “You may call it the first step to the moon.”

To overcome the shortcomings in the industry, PPMA organised a workshop to train and upgrade industry people and graduate them to WHO (World Health Organization) prequalification, PIC/S (Pharmaceutical Inspection Co-operation Scheme) recognition and MHRA accreditation.

Waheed informed this while speaking at an official Post-Event Workshop of the 8th PPMA Pharma Summit on Friday in Karachi titled ‘Pathways to Regulated Markets: A Practical Guide for Pakistani Pharma Manufacturers’

Copyright Business Recorder, 2025