HESE are not hollow words of courtesy.
They are an acknowledgement of real, measurable, and irreversible progress that is already showing in export numbers, in certified plants, in shorter timelines, and in a pharmaceutical sector that for the first time in yearsis looking forward rather than backward. The Paradigm shift has been the long awaited policy decision of deregulating non-essential medicines where the Government and SIFC played a pivotal role that has changed the pharmaceutical landscape for Pakistan to compete internationally and significantly improve locally. The Pakistan pharmaceutical industry stands at a historic inflection point, and it does so not by accident, but because of the courageous, coordinated, and sustained policy actions of a government that chose reform over inertia.
PPMA wishes to place on record its sincere and profound appreciation to: The Honorable Prime Minister of Pakistan Mr Shahbaz Sharif For providing the highest-level of political will, reform agenda, implementation of internationally recognised policies and its continued sustainability that is proving transformational for the pharmaceutical sector in Pakistan. This is recognised by the global investors and has boosted the confidence of local and multinational pharmaceutical companies operating in Pakistan. Under the leadership of Prime Minister, Pakistan’s Pharmaceutical sector has gained confidence that it will be treated at par with other sectors in policy support and continuity for expanding exports and earning much needed precious foreign exchange for Pakistan.
Honorable Federal Minister Mr Syed Mustafa Kamal For his personal and sustained commitment and leadership to transform Drap into a globally benchmarked regulatory authority aligned with WHO standards and the nation’s economic aspirations. At the same time, he has been instrumental in aligning international benchmarks with the local regulatory environment and supporting a level playing field to the pharma industry in Pakistan. The Health Ministry has provided complete access to the pharma sector and is progressing at an outstanding pace to transform Pakistan’s pharmaceutical landscape to attain excellence and compete globally.
Drap CEO Dr Obaidullah and the Drap team For his leadership, operational excellence, technical rigor, institutional persistence, and as a changed management champion that transforme d reform ambitions into measurable, auditable achievements. He was bestowed upon a Reform Champion Award by the honorable prime minister of Pakistan.
Special Investment Facilitation Council (SIFC) For cutting through decades of inter-ministerial delay, aligning cross-government priorities, and providing the whole-of-government coordination architecture that Pakistan’s pharmaceutical sector has long needed, and played an instrumental role in facilitating deregulation policy for non-essential medicines within a very short time in bringing Pakistan at par with the global policy framework that was facing challenges for over two decades.
The breakthrough: price deregulation of non-essential medicines In 2024, the government of Pakistan made one of the most consequential industrial policy decisions in the sector’s history: it deregulated prices for non-essential medicines. For a sector operating under blanket price controls for decades that suppressed margins, deterred investment, and made international certification financially unviable, this single reform proved transformational.Landmark achievements: Drap’s reform record 2022-2026 Each achievement below represents a milestone in Pakistan’s pharmaceutical regulatory transformation charted here as a reform timeline that maps the journey from a constrained, paper-based, nationally inconsistent system to a digitised, internationally aligned, export-ready regulatory authority.
1Digitisation e-App implementation for core regulatory functions Drap developed and deployed electronic application systems across registration, licensing, costing, pricing, and import/export eliminating paper bottlenecks, reducing approval timelines, improving audit trails, and establishing a transparent, traceable regulatory workflow that directly improves Pakistan’spharmaceutical ease of doing business.
2Digitisation Pakistan Single Window (PSW) Integration Drap integration with PSW created a single unified interface for all regulatory clearances removing duplication, reducing documentation burden, accelerating time-to-market, and making Pakistan’s pharmaceutical regulatory system a genuine trade facilitation asset rather than a trade barrier.
3Digitisation e-Office and paperless digital operations The implementation of e-Office systems at Drap headquarters and field offices established paperless workflows, digital document management, and electronic communication channels modernising Drap’s governance infrastructure and aligning it with Pakistan’s digital (URAAN) transformation agenda.
4Policy API Policy (2022) and National Vaccine Policy (2025) The API Policy promotes domestic manufacturing of priority pharmaceutical raw materials, reducing critical import dependencies. The Vaccine Policy targets indigenous production of EPI vaccines, reducing reliance on costly international procurement and positioning Pakistan for vaccine exports to regional and African markets.
5Policy Modernised regulations and ethical marketing guidelines A comprehensive overhaul of pharmaceutical regulations including ethical marketing guidelines aligned with international standards protects patients, healthcare professionals, and the integrity of medical decision-making from inappropriate commercial influence, strengthening public trust and Pakistan’s regulatory reputation.
6Pharmacovigilance WHO-recognised National Pharmacovigilance Centre The establishment of a WHO-recognised National Pharmacovigilance Centre supported by centres across all federating units places Pakistan’s post-market drug safety surveillance on internationally accepted footing, ensuring adverse drug reactions are detected, assessed, and acted upon for the protection of millions of Pakistani patients.
7Pharmacovigilance Pharmacovigilance rules operationalised and PRAEC activated The activation of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) provides Pakistan with a scientific, evidence-based mechanism for evaluating post-market safety signals recommending labelling changes, safety alerts, and market withdrawals where warranted, mirroring the function of the world’s most advanced regulatory authorities.
8Pharmacovigilance VigiFlow deployed for National Adverse Event Reporting National deployment of VigiFlow the WHO’s internationally standardised adverse event reporting platform places Pakistan within the global pharmacovigilance network, enabling real-time ADR reporting, signal detection, and integration with the WHO Programme for International Drug Monitoring.
9Quality ISO 9001:2015 certification and QMS institutionalisation DrapISO9001:2015certificationandinstitutionalisationofQualityManagement Systems across all divisions establishes a culture of systematic, process-driven governance within the regulator itself demonstrating to international partners, industry, and the public that Drap operates to internationally recognised standards.
10-Quality Provincial drug control capacity building Systematic training and QMS capacity building for provincial and state drug control administrations has transformed Pakistan’s regulatory architecture from a fragmented federal-provincial structure into a nationally coherent system capable of consistent enforcement across all jurisdictions.
11Governance Strengthened federal-provincial regulatory coordination Formalised coordination mechanisms between Drap and provincial/state administrations through task forces and harmonised implementation frameworks ensure that federal regulatory standards translate into consistent, auditable enforcement across all of Pakistan’s federating units.12Global partnerships International technical partnerships with WHO and global bodies Sustained engagement with WHO, UNDP, USP, and the Fleming Fund for technical capacity building has brought global regulatory expertise into Pakistan’s national system accelerating alignment with internationally recognised good regulatory practices at a fraction of the cost of independent development.
13Global partnerships WHO GBT benchmarking completed PIC/s GMP adopted Completion of WHO Global Benchmarking Tool assessment charts Pakistan’s pathway to Maturity Level 3 designation. Simultaneously, adoption of PIC/s GMP standards replacing the outdated Schedule B-II framework directly unlocks access to European, Australian, Canadian, and other regulated export markets through mutual recognition agreement s.
14Access Expanded access to essential medicines and health technologies Accelerated registration pathways for WHO-prequalified products, public health emergency provisions, and expanded Market Authorisation coverage across all therapeutic categories ensures that Pakistani patients have timely access to essential medicines, biologics, vaccines, and advanced therapeutics.
15Regulation Alternative medicine and health product regulation enhanced The review and enhancement of Alternative Medicines and Health Products (Enlistment) Rules 2014 protect consumers from unregulate d health products, provides clear regulatory pathways for legitimate manufacturers, and aligns Pakistan’s health product oversight with international consumer safety standards.
16Reform Resolution of the Director’s Liability Framework The resolution of the Director’s Liability issue removes a critical impediment to industry investment by aligning Pakistan’s liability framework with global best practices focusing on scientific investigation, product recall, root cause analysis, and CAPA implementation rather than unnecessary criminal exposure for industry professionals.
17Anti-counterfeiting Serialisation and track-and-trace for anti-counterfeiting Drap’s deployment of product-level serialisation and end-to-end supply chain trackand-trace technology protects patients from counterfeit and spurious medicines, deters criminal supply chain infiltration, and strengthens confidence in Pakistanmanufactured products both domestically and in international export markets.
Drap Strategic Plan 2026-2030: the road ahead The National Regulatory System Strategic Plan 2026-2030 is Pakistan’s most comprehensive, rigorously develope d, and internationally aligne d regulatory planning document to date a time-bound, KPI-driven implementation framework built on WHO Global Benchmarking Tool architecture.Pharmex Pakistan: global staging of Pakistan pharma PharmEx Pakistan, the dedicated Pharmaceutical Export Promotion Council under TDAP has been formally acknowledged by Drap and SIFC as the strategic vehicle for Pakistan’s global pharmaceutical export ambition. Modelled on our next door neighbors’ Pharmexcil (instrumental in $28B exports), PharmEx will coordinate regulatory compliance, market access, export financing, and unified Pakistan Pharma branding across the EU, Africa, Middle East, and ASE AN.DRAP’s 17 reforms are not institutional milestones alone, they are the foundation upon which Pakistan’s $10 billion pharmaceutical export future will be built base d on continuity of policies and most importantly deregulation of non-essential medicines together with aligning with Global International Benchmarks.