Pharma market access and compliance in Pakistan

The authors, from a Chinese law firm with a branch office in Pakistan, draw on years of practice across South Asia to provide this article for Chinese companies, multinational pharmaceutical groups and investors looking to expand into Pakistan’s healthcare market. This article assists potential clients in understanding Pakistan’s regulatory environment, market access requirements, and future development trends from a legal and compliance perspective, reducing entry risks and seizing business opportunities.

As a lower middle-income country, Pakistan has long faced challenges in ensuring drug quality and regulatory compliance. This article reviews the evolution of Pakistan’s pharmaceutical regulatory system: from the Drugs Act, 1940, to the establishment of the Drug Regulatory Authority of Pakistan (DRAP) under the DRAP Act, 2012, illustrating the gradual centralisation and modernisation of the regulatory framework.

In practice, Pakistan’s pharmaceutical market continues to face a series of prominent issues: low consumer confidence; a sustained decline in pharmaceutical exports; limited presence in international markets; and inefficiencies in drug registration, pricing and regulatory processes.

These issues present potential risks for companies entering the market, but also offer differentiated competitive opportunities for foreign pharmaceutical enterprises with compliance management capabilities and the ability to align with international standards.

Semi-regulated markets

Substandard and counterfeit drugs represent a major global public health hazard, particularly acute in lower middle-income countries. Although Pakistan has developed a pharmaceutical industry of considerable scale, limited public research, insufficient regulation, and inadequate information disclosure mean that companies often face heightened compliance and reputational risks due to unclear rules and a lack of transparency when entering the market. In international research and policy discussions, such countries are typically classified as “semi-regulated markets”.

The main characteristics of these markets include underdeveloped regulatory systems, relatively lax drug registration and market access requirements, inconsistent regulatory standards, weak enforcement, and a high risk of counterfeit drug circulation. At the same time, these markets generally exhibit a high degree of dependence on imported pharmaceuticals.

As a legal team with a longstanding focus on the South Asian market, the authors believe that Chinese pharmaceutical companies seeking to enter Pakistan must thoroughly understand the history and current state of its drug quality assurance and regulatory system. Only by clearly identifying compliance risks can companies seize opportunities for rapid market entry while effectively mitigating potential risks.

Regulation of medical products

Since ancient times, humans have relied primarily on herbal remedies for treatment. With technological advancement, a diverse range of medical systems has gradually emerged, including Unani, Ayurveda, homeopathy, allopathy and modern medicine. The Thalidomide tragedy, which occurred in Europe and the US in 1962, prompted a global tightening of drug regulation, establishing an international consensus that medicines must undergo safety and efficacy verification before being marketed.

In Pakistan, drug regulation originated with the Drugs Act, 1940, which was later replaced by the Drugs Act, 1976, to regulate the manufacture, distribution, sale, import and export of pharmaceuticals. The 18th Amendment of the Constitution in 2010 devolved health authority to the provinces, resulting in a period of regulatory fragmentation. To address this issue, the DRAP Act was enacted in 2012, establishing the DRAP and achieving unified federal regulation based on the 1976 legal framework.

However, as a typical “semi-regulated market”, Pakistan continues to face numerous challenges: insufficient consumer trust and a lack of public confidence in drug quality; a persistent decline in exports, with pharmaceutical exports decreasing annually due to quality concerns; and absence from international markets as Pakistani pharmaceuticals struggle to enter highly regulated markets such as the US, EU, Australia, Canada and Japan.

To reverse this situation, Pakistan must prioritise the production of high-quality medicines that meet international standards (such as those of the Food and Drug Administration, the WHO, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, and the Pharmaceutical Inspection Co-operation Scheme) in order to rebuild consumer trust, enhance export capacity, and increase foreign exchange earnings.

In recent years, Pakistan has begun to establish a national pharmacovigilance system through the DRAP. In November 2018, Pakistan became an official member of the WHO Programme for International Drug Monitoring (WHO-PIDM). Since its establishment in 1968, this global drug safety monitoring network has become an important mechanism for promoting the internationalisation of drug regulation.

For Chinese pharmaceutical companies, this trend presents both challenges and opportunities. The challenge lies in the reality that, when entering the Pakistani market, companies must still contend with insufficient alignment with international quality standards and significant differences in regulatory enforcement.

The opportunity is that, as the DRAP advances the construction of a national pharmacovigilance system, and with Pakistan’s accession to the WHO-PIDM, the country is gradually integrating into the international regulatory system, providing new space for foreign pharmaceutical companies to achieve differentiated competitive development through compliance and technological advantages.

This article reviews the historical development of Pakistan’s drug regulatory system, tracing its evolution from the early drug laws to the establishment of the DRAP in 2012, and demonstrates the country’s gradual move towards a more stringent compliance framework.

However, decentralised regulatory authority, outdated legislation and the prevalence of counterfeit drugs remain major risk factors for foreign enterprises entering the market.

As Pakistan advances legal modernisation, introduces more efficient testing and regulatory mechanisms, and continues to align with international standards, the market is moving towards greater transparency and predictability.

With the support of a professional legal team, and by establishing compliance measures in the early stages, companies can not only mitigate risks but also gain a first-mover advantage during the ongoing market reforms.

Donna Tang is a partner at TAHOTA Law Firm. She can be contacted by phone at +86 028 8662 5656 and by mail at donna.tang@tahota.com
Syed Abdullah Anwer is a senior associate at TAHOTA Law Firm. He can be contacted by phone at +92 0307 6619666 and by mail at tht.adm@gmail.com