Pakistan

The Drug Regulatory Authority of Pakistan (DRAP) is the primary national regulatory body responsible for overseeing the registration, import, export, and quality control of health products including pharmaceuticals, medical devices, diagnostics, and increasingly digital health solutions. DRAP was established under the DRAP Act 2012, which consolidated and replaced earlier fragmented regulatory frameworks. The authority operates through specialized divisions, including the Drugs Division, Medical Devices Division, and the Biologics and Natural Products Division, each managing category-specific approval pathways. All health products intended for the Pakistani market must be registered with DRAP prior to commercialization, and the general approval process involves dossier submission, technical evaluation, quality laboratory testing where applicable, and a final licensing decision by the relevant licensing board.

DRAP generally accepts dossiers prepared in accordance with the Common Technical Document (CTD) format, and applications aligned with ACTD (ASEAN Common Technical Dossier) standards are also considered, reflecting Pakistan's engagement with regional harmonization efforts. A local registered agent or in-country representative is mandatory for all foreign manufacturers seeking product registration, and such representatives bear legal responsibility for the product within Pakistan. DRAP has in recent years pursued notable reforms including the introduction of an online e-portal for dossier submission, expedited review pathways for products prequalified by the World Health Organization (WHO PQ) or approved by stringent regulatory authorities (SRAs) such as the US FDA, EMA, or Health Canada, and updated medical device regulations published in 2021 that introduced a formal risk-based classification system for devices. Fee structures and timeline adherence remain areas of ongoing reform under DRAP's broader modernization agenda.

Public sector procurement of health products in Pakistan is conducted through a multi-tiered structure reflecting the country's federal governance model. Following the 18th Constitutional Amendment of 2010, significant health authority was devolved to the four provinces (Punjab, Sindh, Khyber Pakhtunkhwa, and Balochistan) as well as Azad Jammu and Kashmir and Gilgit-Baltistan, meaning that provincial health departments and their respective procurement agencies manage the majority of public health product purchasing. At the federal level, the Ministry of National Health Services, Regulations and Coordination (NHSRC) retains responsibility for national health programs, federal hospitals, and coordination with international partners. Tenders are typically issued through provincial procurement regulatory authorities and are governed by the Public Procurement Regulatory Authority (PPRA) rules at the federal level, with analogous provincial PPRAs operating independently. Price negotiations for pharmaceuticals are subject to DRAP-regulated maximum retail prices, and public procurement is largely price-sensitive, with lowest-price technically compliant bids frequently favored in open competitive tenders.

The private sector represents a substantial share of health product consumption in Pakistan, driven by a large out-of-pocket expenditure base and a dense network of private hospitals, clinics, and retail pharmacy chains, making it a commercially significant channel alongside the public sector. Distribution in the private market is managed through licensed importers, distributors, and stockists operating under DRAP authorization. Pakistan also benefits from significant donor-funded procurement channels: UNICEF and the United Nations Population Fund (UNFPA) support maternal and child health commodity procurement, the Global Fund finances anti-tuberculosis, malaria, and HIV program supplies, and USAID channels health commodities through programs such as the Global Health Supply Chain initiative. Gavi, the Vaccine Alliance supports vaccine procurement for the Expanded Programme on Immunization (EPI). Local manufacturing preference policies exist in principle, with DRAP and the government encouraging domestic production through preferential pricing considerations and support for local Good Manufacturing Practice (GMP) upgrading, although robust enforcement of local preference margins remains inconsistent across procurement categories.