Nepal

The Department of Drug Administration (DDA) is the primary regulatory authority in Nepal responsible for the registration, licensing, and quality control of health products including pharmaceuticals, medical devices, diagnostics, and increasingly digital health tools. The principal governing legislation is the Drug Act 2035 (1978) and its subsequent amendments, supplemented by the Drug Regulation 2038 (1981) and various DDA directives. All health products must be registered with the DDA before they can be legally imported, marketed, or distributed in Nepal. The registration process involves submission of a product dossier to the DDA, technical review by the registration committee, and where required, laboratory testing of product samples. The DDA also oversees post-market surveillance, pharmacovigilance, and the licensing of manufacturers, importers, and distributors.

Applications for product registration must be submitted through a locally registered authorized agent or importer, as foreign manufacturers cannot apply directly without local representation. Nepal generally accepts dossiers aligned with the Common Technical Document (CTD) format, though full ICH-CTD compliance requirements may vary by product category. For pharmaceuticals, the DDA requires Certificate of Pharmaceutical Product (CPP) documents issued by the country of origin, evidence of Good Manufacturing Practice (GMP) certification, and product stability and quality data. Medical devices and diagnostics are subject to a separate classification and registration pathway, with requirements evolving as the DDA strengthens its regulatory framework. In recent years, Nepal has undertaken regulatory modernization efforts, including steps toward harmonization with WHO prequalification standards and participation in regional regulatory convergence initiatives under the South Asian region, aiming to reduce duplication and improve review efficiency.

Public procurement of health products in Nepal is governed by the Public Procurement Act 2063 (2007) and overseen at the federal level primarily through the Ministry of Health and Population (MoHP) and its implementing arm, the Logistic Management Division (LMD). The LMD is responsible for the central procurement, warehousing, and distribution of essential medicines, medical supplies, and health commodities to public health facilities across the country. Procurement is conducted through competitive tendering processes in accordance with Public Procurement Regulations, with large-value tenders typically requiring open bidding. Following Nepal's transition to a federal structure under the 2015 Constitution, procurement responsibilities have been partially devolved to provincial health directorates and local government units, creating a multi-tiered procurement landscape that can vary significantly in capacity and process across the seven provinces.

The private sector represents a substantial and growing channel for health products in Nepal, particularly in urban centers such as Kathmandu, Pokhara, and Biratnagar, where private hospitals, clinics, and pharmacy chains procure directly from licensed importers and distributors. Donor-funded procurement plays a critical role in the Nepali health system, with organizations such as UNICEF, the Global Fund (for HIV, tuberculosis, and malaria programs), USAID through its implementing partners, and Gavi (for vaccine supply) collectively financing and supplying a significant share of essential health commodities. These agencies often procure through their own international mechanisms, bypassing or complementing the national tender system. Nepal does not currently enforce a strict local manufacturing preference policy, but the government has expressed strategic interest in supporting domestic pharmaceutical production through incentives and regulatory facilitation, particularly for essential medicines, as part of its broader health self-reliance agenda.