Nepal

The Department of Drug Administration (DDA) is the primary regulatory authority responsible for the registration, quality control, and post-market surveillance of health products in Nepal, including pharmaceuticals, medical devices, diagnostics, and increasingly digital health tools. The principal governing legislation is the Drug Act 1978 (amended) and its associated Drug Regulations 1981, supplemented by device-specific guidelines issued by the DDA. All health products intended for the Nepali market must be registered with the DDA prior to import, sale, or distribution. The registration process involves submission of a product dossier, laboratory testing by the National Medicines Laboratory (NML) or an approved facility, and technical review by DDA committees. Products originating from countries with recognized stringent regulatory authorities (SRAs) such as the US FDA, EMA, or TGA may benefit from expedited review pathways, though full local registration remains mandatory.

Applicants are required to appoint a local authorized agent or representative who assumes legal responsibility for the product within Nepal. Dossier submissions are generally expected to follow the Common Technical Document (CTD) format, although full ICH-CTD compliance is not uniformly enforced and ACTD-aligned submissions are also accepted for products registered in WHO member states. Supporting documentation typically includes certificates of pharmaceutical product (CPP), good manufacturing practice (GMP) certificates, labeling compliant with DDA requirements, and stability data relevant to Nepal's climatic conditions (ICH Zone IVb). The DDA has undertaken modernization efforts in recent years, including piloting an online registration portal and aligning certain review pathways with WHO prequalification status to improve access to essential medicines and diagnostics. Medical devices and in-vitro diagnostics remain subject to evolving regulatory frameworks, and device-specific classification and registration guidelines continue to be developed.

Public procurement of health products in Nepal is coordinated primarily through the Ministry of Health and Population (MoHP) and its subsidiary bodies, including the Logistics Management Division (LMD), which is the central agency responsible for the quantification, procurement, warehousing, and distribution of essential medicines and health commodities to public health facilities nationwide. National-level procurement is governed by the Public Procurement Act 2007 and its regulations, administered with oversight from the Public Procurement Monitoring Office (PPMO). Procurement is largely conducted through open competitive tendering processes, and supplier eligibility typically requires DDA registration, valid GMP certification, and compliance with national quality standards. Following Nepal's transition to a federal structure in 2015, provincial and local governments have gained increasing authority to procure health commodities independently, creating a multi-tiered procurement landscape that varies in capacity and transparency across the seven provinces.

Donor-funded and multilateral procurement channels play a significant role in Nepal's health commodity supply, particularly for vaccines, HIV/AIDS, tuberculosis, and malaria-related products. UNICEF, the Global Fund, and USAID/PEPFAR-affiliated mechanisms support procurement through their own supply systems, often bypassing national tender processes and leveraging international quality assurance standards such as WHO prequalification. Gavi, the Vaccine Alliance, supports Nepal's immunization program through co-financed vaccine procurement channeled via UNICEF Supply Division. The private sector health market is substantial and growing, served by licensed importers and distributors who procure independently from international manufacturers following DDA registration. Nepal has articulated policy ambitions to promote domestic pharmaceutical manufacturing, including preferential consideration for locally manufactured products in public tenders where quality and availability criteria are met, though implementation of local preference policies remains inconsistent and the domestic manufacturing base is still limited in scope.