Pakistan

The Drug Regulatory Authority of Pakistan (DRAP) is the primary national authority responsible for the regulation of therapeutic goods, including pharmaceuticals, medical devices, diagnostics, and increasingly digital health solutions. Established under the DRAP Act 2012, the authority operates under the broad oversight of the Ministry of National Health Services, Regulations and Coordination (NHSRC). DRAP administers the registration and market authorization process for all health products entering or manufactured within Pakistan, with product-specific pathways governed by the Drugs Act 1976 (and its amendments), the Medical Devices Rules 2017, and associated statutory regulatory orders (SROs). All health products require formal registration prior to marketing, and DRAP evaluates applications through its relevant divisions, including the Licensing Division, the Medical Devices and Diagnostics Division, and the National Control Laboratory for product testing where applicable.

Applicants seeking market authorization in Pakistan are generally required to appoint a local registered entity or authorized agent to liaise with DRAP and assume regulatory responsibility in-country. Dossier submissions are typically expected to conform to Common Technical Document (CTD) format for pharmaceuticals, while medical devices follow a risk-based classification framework broadly aligned with the Global Harmonization Task Force (GHTF) and IMDRF guidelines. DRAP has in recent years pursued a series of reforms to modernize its processes, including the phased rollout of an online eSAS (e-Submission and Authorization System) portal to digitize application tracking and reduce administrative bottlenecks. The authority has also introduced provisions for expedited review pathways for products registered with stringent regulatory authorities (SRAs) such as the US FDA, EMA, Health Canada, or TGA, though full reliance-based approvals remain limited and case-dependent. Post-market surveillance requirements, including mandatory adverse event reporting and product vigilance obligations, are increasingly being enforced.

Public sector health procurement in Pakistan operates across both federal and provincial tiers, reflecting the significant devolution of health responsibilities to the provinces following the 18th Constitutional Amendment in 2010. At the federal level, the Ministry of National Health Services, Regulations and Coordination oversees strategic policy and coordinates procurement for nationally managed programs such as the Expanded Programme on Immunization (EPI) and vertical health initiatives. Each of the four provinces, including Punjab, Sindh, Khyber Pakhtunkhwa, and Balochistan, as well as Azad Jammu and Kashmir and Gilgit-Baltistan, manages its own health department and conducts independent procurement through provincial health departments and dedicated procurement agencies. Punjab, for example, operates through the Punjab Healthcare Commission and the Punjab Primary and Secondary Healthcare Department, while Sindh manages procurement through its Health Department directorates. Tenders are typically governed by the Public Procurement Regulatory Authority (PPRA) rules at the federal level and corresponding provincial PPRA frameworks, with competitive open tendering being the standard method for government contracts. Price negotiations and lowest-price-compliant bidding remain dominant selection criteria in most public tenders, which can present challenges for innovative or premium-priced products.

The private sector constitutes a substantial portion of health spending in Pakistan, with a large network of private hospitals, clinics, diagnostic laboratories, and pharmacy chains procuring health products through commercial distributors and direct supplier agreements, largely independent of government tendering processes. Multinational and domestic distributors play a central intermediary role in this channel. Donor-funded procurement represents a critical segment, particularly for vaccines, diagnostics, and essential medicines, with agencies such as UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID, and Gavi, the Vaccine Alliance, channeling significant volumes of health products into Pakistan through government-aligned supply chains. Products procured through these mechanisms are generally subject to the prequalification standards of the procuring agency (such as WHO prequalification or equivalent SRA approval) rather than solely DRAP registration, though local regulatory clearance is often still required for in-country distribution. Pakistan has articulated policy preferences for local manufacturing and has introduced measures to incentivize domestic production, including tariff exemptions on raw materials for locally registered manufacturers and provisions within tender rules that may favor locally manufactured products under certain conditions, as part of broader industrial policy aligned with the Make in Pakistan agenda.