Nepal

The Department of Drug Administration (DDA) under the Ministry of Health and Population serves as the primary regulatory authority overseeing the registration, quality control, and market authorization 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), along with the Drug Registration Regulation 1981 and subsequent directives and guidelines issued by the DDA. All health products intended for sale or distribution in Nepal must be registered with the DDA prior to market entry, and applicants are required to submit a dossier demonstrating safety, efficacy, and quality. The DDA conducts technical evaluation of submissions and may request additional data, laboratory testing, or inspections before granting a Certificate of Registration, which is typically valid for five years and subject to renewal.

Dossier submissions to the DDA are generally expected to follow formats aligned with the Common Technical Document (CTD) or ASEAN Common Technical Dossier (ACTD) standards, though Nepal has historically applied its own local guidance that does not fully mirror ICH requirements. Applicants must designate a local authorized agent or registered importer, as foreign manufacturers cannot register products directly without a Nepali legal representative. Recent reforms have included efforts to strengthen post-market surveillance, introduce risk-based classification frameworks for medical devices, and streamline registration procedures for essential medicines and diagnostics. Nepal has also engaged with regional regulatory harmonization initiatives under the South Asian Association for Regional Cooperation (SAARC) framework, though full harmonization remains a work in progress. Digital health products and in-vitro diagnostics occupy an evolving regulatory space, with specific guidelines still being developed.

Public procurement of health products in Nepal is primarily managed through the Ministry of Health and Population (MoHP), with the Logistic Management Division (LMD) serving as the central procurement and distribution arm for essential medicines, vaccines, medical devices, and supplies destined for government health facilities. Procurement follows the Public Procurement Act 2007 and Public Procurement Regulations 2007, administered under the oversight of the Public Procurement Monitoring Office (PPMO). Nepal has undergone significant federal restructuring since the 2015 Constitution, resulting in a three-tier governance system comprising federal, provincial, and local levels. Procurement authority has been partially devolved, with provincial health directorates and local governments now responsible for some procurement decisions, though the LMD retains central coordination for large-scale national programs, including immunization and essential medicine supply chains.

Donor-funded procurement channels play a substantial role in Nepal's health product landscape. Organizations such as UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID, the World Health Organization (WHO), and Gavi, the Vaccine Alliance provide significant financing and often procure health products through their own international procurement mechanisms, bypassing the national tender system. These donor channels are particularly prominent in areas such as vaccines, HIV/TB/malaria commodities, reproductive health supplies, and diagnostics. The private health sector, which is substantial in urban areas, procures through licensed importers and distributors operating under DDA authorization. Nepal does not yet have a formalized local manufacturing preference policy comparable to some larger markets, but the government has expressed strategic interest in strengthening domestic pharmaceutical manufacturing capacity, and locally produced products registered with the DDA may benefit from informal procurement preferences in government tenders. Suppliers entering the public market are advised to ensure DDA registration is current and to engage with both the LMD and relevant provincial health authorities.