Why Pakistan’s Pharmaceutical Exports Lag Behind and How to Fix It– Asrar Qureshi’s Blog Post #1124

Why Pakistan’s Pharmaceutical Exports Lag Behind and How to Fix It– Asrar Qureshi’s Blog Post #1124

Dear Colleagues! This is Asrar Qureshi’s Blog Post 1124 for Pharma Veterans. Pharma Veterans Blogs are published by Asrar Qureshi on its dedicated site https://pharmaveterans.com. Please email to pharmaveterans2017@gmail.com  for publishing your contributions here.

Credit: Franz van Heerden

Credit: Pavel Danilyuk

Preamble

I have been personally involved in international pharmaceutical business for several years and here are my observation regarding poor export performance.

Despite having a vibrant pharmaceutical industry with over 700 manufacturing units and a population of 240 million, Pakistan’s pharmaceutical exports remain frustratingly low. In 2023, the country exported medicines worth only around \$300 million — a figure dwarfed by Bangladesh (US$ 2.2 billion) and India (US$ 25+ billion).

This underperformance raises a critical question: What is holding Pakistan’s pharma industry back from playing a bigger role in global healthcare markets? More importantly, what can be done to unlock its export potential?

In this post, we dissect the major barriers impeding export growth and offer concrete solutions that can help Pakistan's pharmaceutical sector step confidently onto the global stage.

The State of Pharmaceutical Exports in Pakistan

Historically, Pakistan has been reliant on its domestic market, with only a handful of firms pursuing exports — mostly to low-income countries in Africa, Central Asia, and Afghanistan. High-value regulated markets like the EU, US, and Japan have remained out of reach for most companies due to strict compliance requirements.

Yet Pakistan has raw ingredients for success: low manufacturing costs, experienced manpower, and a growing portfolio of generic formulations. But these strengths are underutilized. 

Barriers Holding Back Pharma Exports

Lack of Investment in Production Facilities

The biggest barrier is that even very high domestic turnover companies refuse to invest into their manufacturing facilities. They may expand production capacity by putting up more machines, but their investment in documentation and quality operations remains abysmal. 

The older companies have issues with the basic layout which makes it impossible to install proper air handling to ensure there would be no cross contamination. Over time, most companies have filled production area with locally fabricated machines which cannot be properly qualified for IQ, OQ, PQ.

Quality assurance and quality control have deficiencies which do not allow delivery of desired quality operations. Documentation is a significant area of deficient working. The overall emphasis is on producing volumes only.

Lack of International Regulatory Accreditation

A major roadblock is the absence of certifications from agencies like:

o US FDA (Food and Drug Administration),

o EMA (European Medicines Agency),

o WHO Prequalification Program

Without these, companies are barred from entering large, high-paying markets. Even in regional markets, buyers increasingly demand proof of international quality assurance. To date, Pakistan does not have a single pharmaceutical plant approved by the USFDA or EMA. One Lahore-based company had received European GMP certification for one section which they could hold only for couple of years. A few companies have recently qualified themselves for PIC/S certification.

Inconsistent GMP Compliance

Many manufacturing units still fall short of global GMP (Good Manufacturing Practice) standards. While some top-tier Pakistani firms comply with WHO GMP, this is not yet the industry norm. Issues like poor documentation, inadequate facilities, and weak quality control persist.

Low R&D and Innovation Output

Export competitiveness increasingly depends on innovation. However, most firms focus purely on generic manufacturing, with little value addition. There is no focus on specialty generics, biosimilars, or novel delivery systems. Of course, there are no incentives for patent challenges or advanced formulation research.

Lack of Market Intelligence and Export Strategy

Pharmaceutical companies have limited access to country-specific regulatory pathways, market intelligence for niche segments, and buyer databases or distributor networks abroad. The government’s trade officers often lack domain expertise, and trade missions rarely include pharma specialists.

Fragmented Industry Structure

Pakistan pharma market is very unevenly divided. Top 50 companies have over 95% market share while 650 companies have only 5% market. The resources are also unevenly divided, therefore. The bigger companies have resources to invest in international business if they wish; not all of them wish to though. Smaller companies do not have resources to pursue long cycle of international business because new registrations are taking 24 to 36 months even in less regulated countries. 

What Needs to Change: A Strategic Action Plan

Despite the many challenges, the solution is not out of reach. With the right mix of policy support, industry commitment, and international alignment, Pakistan can increase pharma exports exponentially.

Strengthen DRAP and Align with Global Standards

DRAP must be restructured to increase technical staff and audit capacity, adopt ICH, WHO, and EMA protocols, and facilitate pre-inspections and mock audits for exporters.

A DRAP recognized by WHO or EMA would dramatically improve the credibility of Pakistani pharmaceuticals.

Support Export-Focused Upgrades

The government should provide soft loans or subsidies for companies seeking WHO/FDA/EMA certifications, help firms cover costs for bioequivalence studies, quality labs, and clean room upgrades, create shared compliance facilities in pharma clusters.

Build Pharma Export Zones

Just like export processing zones, pharma-specific export zones could offer tax holidays, simplified regulations, centralized QC labs and cold chain storage, and effluent treatment facilities.

Invest in Workforce Development

Export success depends on regulatory professionals, pharmacovigilance experts, clinical documentation specialists, and R&D scientists. Government and universities should offer certified training programs in GMP, GLP, and regulatory affairs in collaboration with industry.

Launch a Pharma Branding and Diplomacy Drive

A “Made in Pakistan Pharma” campaign should promote top firms at international expos, publish global quality benchmarks and success stories, build digital pharma catalogues with multilingual support, and include pharma specialists in trade delegations. Formation of PharmEx Pakistan is a step in the right direction. 

Pakistan should offer grants for biosimilars, specialty generics, and formulation R&D, establish pharma innovation hubs at leading universities, and facilitate global partnerships through regulatory matchmaking. Even collaboration on clinical trials or joint ventures with multinational companies can elevate export credibility.

Sum Up

Pakistan’s pharmaceutical industry has the capacity, cost advantages, and talent to become a major global exporter — but only if it makes decisive moves to fix its regulatory, reputational, and structural issues. A unified effort from DRAP, the Ministry of Commerce, PPMA (Pakistan Pharmaceutical Manufacturers’ Association), academia, and exporters themselves is essential. The world needs affordable, high-quality medicines — and Pakistan should be part of that global solution.

Concluded.

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For most blogs, I research from several sources which are open to public. Their links are mentioned under references. There is no intent to infringe upon anyone’s copyrights. If, any claim is lodged, it will be acknowledged and recognized duly.