Pakistan’s pharmaceutical trade has entered a new digital era. The Drug Regulatory Authority of Pakistan (DRAP), one of the country’s most critical yet complex regulatory bodies, is fully integrated into the Pakistan Single Window (PSW) platform. This reform enables real-time approvals, eliminates redundant paperwork, and improves access to essential medicines, reducing trade costs and clearance delays. As part of the PSW team leading this integration, I have witnessed how digital public infrastructure can reshape systems and outcomes for people. 

Conceptualized in early 2019, the DRAP Clearance Gateway has transformed how pharmaceutical imports, exports, and registrations are processed in Pakistan. With a real-time, paperless system, legacy manual submission of No Objection Certificates, permits, and licences have been eliminated. Integration allows pharmaceutical firms, hospitals, and regulatory authorities to operate within a unified, transparent ecosystem. 

The data underscores the impact: 72,661 drug registration applications have been approved, alongside over 26,800 release orders. Import and export permits have also been digitised, with 106 export permits and 23 import permits already processed. Across licence categories—DIL, DML, DSL—over 29,000 applications have been handled with real-time tracking. The issuance of Free Sale Certificates (FSC), Certificates of Pharmaceutical Product (COPP), and Good Manufacturing Practice (GMP) certificates is now fully digitized. 

A significant enhancement was the creation of 20,000 unique product codes by extending the national customs tariff to 12 digits. This advancement facilitates accurate classification, regulatory oversight, and supply chain traceability across pharmaceutical and non-pharmaceutical products. 

The platform directly connects with key government entities, including the Federal Board of Revenue (FBR), Securities and Exchange Commission of Pakistan (SECP), Pakistan Customs, and State Bank of Pakistan. As soon as an application is submitted, licensing, tax compliance, and document verification are completed in real time, dramatically cutting approval times and removing the need for in-person visits. 

However, this digital reform was not just a technological shift but a governance milestone. More than 200 dedicated change management sessions were conducted nationwide to ensure inclusive participation from stakeholders, including pharma companies, hospitals, INGOS, customs agents, and DRAP officers. A 24/7 support helpline, WhatsApp groups, and over 500 resolved support tickets reflect the commitment to a smooth transition. 

Following the successful launch, PSW and DRAP formalized their collaboration through a Memorandum of Understanding. I gratefully acknowledge the dedicated efforts of DRAP’s technical focal team, whose cooperation was critical to overcoming legacy data challenges and institutional complexity. 

The reform has earned recognition nationally and globally. At the international forums, including UNCEFACT, I was honoured to present this transformation as a case study in agile, inclusive, and scalable regulatory reform. Earlier experiences with digital platforms like the Trade Information Portal of Pakistan informed the strategic design of this initiative. 

Looking ahead, PSW has successfully launched the DRAP Export Clearance Gateway. All export-related international certificates—including FSC, COPP, and GMP—are now issued through PSW. The next phase includes the rollout of dynamic dashboards for regulators and deeper integration with customs valuation and audit modules. 

This reform is more than a system upgrade. It reflects a national commitment to more innovative, citizen-oriented governance. It stands as a powerful example of how digital infrastructure, when designed around user needs and driven by collaboration, can make public services more accessible, transparent, and responsive to both commerce and public health. 

By Umair Mahmood Siddiqui, Domain Officer PSW, Project Lead DRAP, TIPP