Pakistan

The Drug Regulatory Authority of Pakistan (DRAP) is the primary national body responsible for the regulation of therapeutic goods, including pharmaceuticals, medical devices, diagnostics, and increasingly digital health products. Established under the DRAP Act 2012, the authority operates under the oversight of the Ministry of National Health Services, Regulations and Coordination (NHSRC). DRAP administers product registration, licensing, post-market surveillance, and quality control through its dedicated divisions, including the Drugs Division, Medical Devices Division, and the National Institute of Health (NIH) for certain biologics and vaccines. All health products intended for sale or distribution in Pakistan must obtain registration from DRAP prior to market entry, and unauthorized importation or manufacture is subject to legal penalties.

Submission requirements vary by product category but generally follow a structured dossier format aligned with the ASEAN Common Technical Dossier (ACTD) and increasingly referencing ICH Common Technical Document (CTD) standards, particularly for pharmaceuticals. Applicants that are foreign manufacturers are required to appoint a local authorized agent or registered importer who assumes legal responsibility for the product in Pakistan. DRAP has implemented several reforms in recent years, including a dedicated Medical Devices Registry, mandatory GMP certification for manufacturers, and the introduction of an online submission portal (DRAP e-Portal) to streamline application processing. Expedited review pathways are available for products pre-approved by stringent regulatory authorities (SRAs) such as the US FDA, EMA, or Health Canada, which can significantly reduce review timelines. The authority has also issued draft guidelines for the regulation of digital health and Software as a Medical Device (SaMD), signaling a growing focus on emerging health technologies.

Public procurement of health products in Pakistan is structured across federal and provincial tiers, reflecting the significant devolution of health responsibilities to provinces under the 18th Constitutional Amendment of 2010. At the federal level, the Ministry of National Health Services, Regulations and Coordination oversees national health programs and federal health facilities, while provincial health departments manage procurement for their respective public health systems. Each province, including Punjab, Sindh, Khyber Pakhtunkhwa, and Balochistan, operates its own procurement authority or health department tender board, often issuing annual or biannual tenders for essential medicines, medical devices, and diagnostic supplies. The Public Procurement Regulatory Authority (PPRA) at the federal level, and corresponding provincial PPRAs, establish the legal framework and procedural rules governing all public tenders, mandating open competitive bidding, published procurement plans, and defined evaluation criteria. Price negotiations and bulk purchasing arrangements are increasingly being utilized, particularly for high-volume essential commodities.

The private sector represents a substantial share of total health expenditure in Pakistan and serves as a critical procurement channel, operating through a network of distributors, wholesalers, and retail pharmacies largely concentrated in urban centers. Multinational and local manufacturers alike engage private hospital groups, diagnostic chains, and pharmacy networks through direct sales and distributor agreements. Donor-funded procurement represents an important parallel channel, with organizations such as UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID, and Gavi, the Vaccine Alliance, financing the procurement of vaccines, diagnostics, and essential medicines for targeted disease programs. These procurements often follow the procurement policies of the respective donor organization, which may require WHO prequalification or SRA approval rather than DRAP registration alone. Pakistan maintains a stated policy preference for locally manufactured products in public tenders where feasible, and the government has introduced incentive frameworks to encourage domestic pharmaceutical and device manufacturing, including reduced import duties on raw materials and support for GMP upgrades, as part of broader industrial and health self-sufficiency objectives.