Pakistan

The Drug Regulatory Authority of Pakistan (DRAP) is the primary national body responsible for regulating therapeutic goods, including pharmaceuticals, medical devices, diagnostics, and increasingly digital health products. Established under the DRAP Act 2012, which superseded the Drugs Act 1976, DRAP operates under the Ministry of National Health Services, Regulations and Coordination (NHSRC). The general approval process requires product registration prior to import, manufacture, or sale. Applications are submitted to the relevant DRAP division, evaluated by technical committees, and approved by the Licensing Board or the Federal Cabinet Committee on Registration depending on product category and complexity. Medical devices and in-vitro diagnostics fall under a separate regulatory framework introduced through the Medical Devices Rules 2017, which established a risk-based classification system (Class A through D) aligned broadly with GHTF and IMDRF principles.

Key submission requirements vary by product category but generally follow the Common Technical Document (CTD) format for pharmaceuticals, while medical device dossiers follow a technical file structure consistent with international frameworks. Foreign manufacturers must appoint a locally registered legal manufacturer or authorized agent in Pakistan to act as the local representative and assume regulatory responsibility. DRAP has progressively implemented reforms to streamline registration, including a shift toward an online submission portal (DRAP e-Portal) and the introduction of abridged and verification-based registration pathways for products already approved by stringent regulatory authorities (SRAs) such as the US FDA, EMA, Health Canada, and TGA. The National Essential Medicines List (NEML) is periodically updated and serves as a reference framework influencing registration prioritization and procurement eligibility.

Public sector procurement in Pakistan operates through a multi-tiered structure reflecting the country's federal system. At the federal level, the Ministry of National Health Services, Regulations and Coordination oversees national health programs and procures health commodities for vertical programs such as the Expanded Programme on Immunization (EPI), the National TB Control Programme, and the HIV/AIDS Control Programme. Provincial health departments, empowered significantly by the 18th Constitutional Amendment of 2010 which devolved health responsibilities to the provinces, conduct their own procurement for public health facilities through provincial health departments and dedicated procurement authorities. Punjab, Sindh, Khyber Pakhtunkhwa, and Balochistan each maintain separate budgetary allocations and tendering mechanisms. Procurement is governed by the Public Procurement Regulatory Authority (PPRA) rules at the federal level and corresponding provincial PPRA frameworks, which mandate open competitive tendering, published tender notices, and defined evaluation criteria emphasizing both technical compliance and lowest evaluated price.

The private sector constitutes a substantial share of health product consumption in Pakistan, operating through a network of distributors, wholesalers, and retail pharmacies largely concentrated in urban centers. Private hospital and clinic procurement occurs independently through commercial channels without centralized coordination. Donor-funded procurement represents a critical parallel channel, particularly for essential medicines, vaccines, diagnostics, and health technologies targeting priority disease areas. UNICEF supports procurement for maternal and child health commodities and vaccines under the EPI. The Global Fund finances procurement of HIV, TB, and malaria commodities, often channeled through international procurement agents including UNDP and IDA Foundation. USAID and its implementing partners support supply chain strengthening and direct commodity procurement through mechanisms such as the Global Health Supply Chain program. Gavi, the Vaccine Alliance, provides co-financing for vaccine procurement for the national immunization program. Local manufacturing preference policies exist in principle within public tender criteria, with locally manufactured products sometimes afforded price preference margins, and DRAP registration requirements effectively mandate local establishment of a representative entity, indirectly incentivizing local partnerships and, in some cases, local production.