Assessment of quality of essential medicines in public health care facilities of Nepal: Findings of nationwide study
Neelam Dhakal, Pradip Gyanwali, Baburam Humagain, Rajendra BC, Nisha Jha, Phoolgen Sah, Amita Pradhan, Meghnath Dhimal, Anjani Kumar Jha
PLOS Global Public Health · 2023 · DOI: 10.1371/journal.pgph.0001841
Countries: Nepal
What Was Studied
This nationwide descriptive study, conducted by the Nepal Health Research Council (NHRC) and partners, assessed the quality of essential medicines supplied to Nepal's public health facilities. Between June 2018 and April 2019 (Mustang district data was collected in April 2019 due to access barriers), researchers used lottery and random-number-generator methods to select 21 districts across all 7 provinces and all three ecological zones (Terai, Hill, Mountain), and randomly sampled 63 facilities — one zonal/regional/district hospital, one Primary Health Care Centre (PHCC), and one Health Post (HP) per district — plus 5 Regional Medical Stores (RMS). Face-to-face interviews and observation checklists assessed medicine storage conditions (protection from sunlight, humidity, heat, ventilation) against Management Division guidelines, and digital instruments measured store-room temperature and humidity. In total, 244 batches of 20 essential-medicine generics were collected and tested for identification, weight variation, content uniformity, dissolution, disintegration, friability, fill volume, assay, and pH at the National Medicine Laboratory (NML) against USP, IP, or BP pharmacopeial standards.
What They Found
Of 244 medicine batches tested at the National Medicine Laboratory, 37 (15.2%) failed pharmacopeial quality standards — including commonly used medicines such as ciprofloxacin eye/ear drops, iron supplement tablets, metformin, metronidazole, paracetamol tablets/suspension, and povidone-iodine solution. Batches supplied through the federal government channel accounted for 62.2% (23 of 37) of substandard batches, versus 37.4% (14 of 37) procured by local health facilities/governments. Storage conditions were poor nationwide: only 13% (8 of 62) of health facilities met all Management Division storage guidelines (protection from sunlight, humidity, heat, ventilation), and recorded temperatures reached up to 37°C (against a recommended 15-25°C range) and humidity up to 86% (against a recommended ≤60%) — conditions that can accelerate drug degradation. Only 3 of 5 (60%) Regional Medical Stores met all storage guidelines.
What This Means for Nepal
These findings should inform Nepal's federalism-era drug quality assurance reforms in concrete ways: (1) the DDA and Department of Health Services should introduce mandatory pre-distribution batch testing at the National Medicine Laboratory for centrally procured medicines entering the Free Drug List / National List of Essential Medicines (6th revision, 2021) supply chain, since federal-channel batches accounted for the majority of failures; (2) MoHP and provincial/local governments should jointly fund basic storage infrastructure — thermometers, hygrometers, and climate-controlled stores — at Health Posts, PHCCs, and Regional Medical Stores, since only 13% of facilities met Management Division storage standards and store-room temperatures reached 37°C; and (3) NHRC and DDA should repeat this surveillance periodically and disaggregate by province, given the well-documented unevenness in local-government capacity to manage devolved 'basic health and sanitation' functions (Schedule 8) since the 2017 federal transition.
Contextualisation
Nepal's Free Drug List supplies roughly 98 essential medicines free of charge at public facilities under a system where the Department of Drug Administration (DDA) holds the federal (Schedule 5) mandate — via the Drugs Act 1978, Section 12 — to enforce quality standards, separate from the facility-level procurement and storage duties that Schedule 8 devolves to local governments. This nationwide NHRC study is the first to test the quality of these free, publicly-supplied essential medicines rather than commercially purchased drugs, finding 15.2% substandard — with the federal supply channel (62.2% of failures) implicated more than local-government procurement (37.4%), directly bearing on how quality-assurance responsibility should be divided across Nepal's three-tier federal health system.