Nepal

The Department of Drug Administration (DDA) serves as the primary regulatory authority for all health products in Nepal, including pharmaceuticals, medical devices, diagnostics, and increasingly digital health tools. The DDA operates under the Drugs Act 2035 (1978) and its subsequent amendments, along with the Drug Regulations 2038 (1981), which together form the foundational legal framework governing product registration, licensing, import, export, manufacture, and distribution. All health products intended for the Nepali market must be registered with the DDA prior to sale or distribution, and foreign manufacturers must submit applications through a locally authorized representative or agent registered within Nepal. The review process involves technical assessment by DDA committees and may include laboratory testing, site inspections, and clinical or performance data evaluation depending on product category.

Key submission requirements include a valid Certificate of Pharmaceutical Product (CPP) or equivalent certificate of free sale from the country of origin, GMP certification, product dossiers generally aligned with Common Technical Document (CTD) or ACTD formats, and evidence of registration in the country of manufacture or a recognized reference country. A locally registered authorized agent or liaison is mandatory for all foreign applicants. Nepal has increasingly referenced WHO prequalification and approvals from stringent regulatory authorities such as the US FDA, EMA, and TGA to expedite review for certain product categories. Recent reforms have focused on improving post-market surveillance, strengthening pharmacovigilance systems with WHO support, developing a dedicated medical device regulatory framework, and digitizing the registration process through an online application portal to reduce administrative backlogs and improve transparency.

Public procurement of health products in Nepal is primarily coordinated through the Ministry of Health and Population (MoHP), with the Logistic Management Division (LMD) serving as the central procurement and supply chain body responsible for forecasting, tendering, warehousing, and distribution of essential medicines, diagnostics, and medical supplies to public health facilities nationwide. Procurement follows the Public Procurement Act 2063 (2007) and its regulations, with competitive tendering conducted at the federal level for large-volume purchases. Following Nepal's transition to a federal structure, provincial governments and local governments (Palikas) have gained increasing autonomy in health budget allocation and procurement for district-level facilities, creating a multi-tiered procurement landscape that can vary significantly in capacity and process across the seven provinces. National price lists and essential medicines lists guided by the Nepal National Formulary inform product selection and ceiling pricing in public tenders.

The private sector represents a substantial and growing channel for health product market access in Nepal, particularly in urban centers such as Kathmandu, Pokhara, and Biratnagar, where private hospitals, clinics, and retail pharmacy chains procure independently through licensed importers and distributors. Donor-funded and humanitarian channels play a significant role in the health product landscape, with organizations such as UNICEF, the Global Fund, USAID through its implementing partners, WHO, and Gavi supporting procurement and supply of vaccines, diagnostics, essential medicines, and reproductive health commodities, often operating through parallel or integrated supply chains alongside government systems. Nepal has expressed policy interest in promoting local pharmaceutical manufacturing under initiatives aligned with the South Asian Association for Regional Cooperation (SAARC) and national industrial policy, with some preferential considerations for domestically manufactured generics in public tenders, though implementation remains nascent and the country is still heavily dependent on imports, primarily from India and China.