Estimated prevalence of unregistered and falsified medicinal products in Malaysia: a nationwide cross-sectional study conducted from March to November 2023
Year: 2025
Type: article
Abstract: Background The global proliferation of unregistered and falsified medicinal products poses significant public health risks. In Malaysia, previous studies have shown concerning prevalence rates but are often limited to specific populations and targeted product brands, restricting the generalisability of the findings. This study aimed to determine the prevalence of unregistered and falsified medicinal products in Malaysian community pharmacies, General Practitioner (GP) clinics, and commercial premises, and to identify associated factors.Methods A cross-sectional study was conducted in Malaysia from March to November 2023. Medicinal products were sampled from community pharmacies, GP clinics, and commercial premises. Premises were selected using proportionate stratified random sampling and products within premises using convenience sampling. The MAL registration number and hologram on these products were analysed for registration status and authenticity. Data were analysed using descriptive and non-parametric tests (SPSS v.29), with p < 0.05 considered statistically significant.Results An examination of 27,137 samples from 1688 premises across Malaysia identified 270 unregistered and 30 falsified products. The prevalence of unregistered products was 0.11% in community pharmacies, 0.18% in GP clinics, and 2.95% in commercial premises. Falsified products were absent in community pharmacies and GP clinics but constituted 0.36% in commercial premises. Logistic regression revealed that region and premise category were significantly associated with the presence of unregistered and falsified products.Conclusion Unregistered and/or falsified medicines were present in all premise types, with higher prevalence in commercial premises. Enhanced efforts by enforcement authorities and stakeholders are necessary to improve the quality of medicine in Malaysia.
Authors: Khairul Anuar Abdul Karim, Asyraf Elmiza Ahmad, Mohd Zawawi Abdullah, Asniza Alias, Salina Setan, Manzatul Azrul Azrie Sulaiman, Nor Ilham ‘Ainaa Muhsin
Institution: Ministry of Health
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,390
OpenAlex ID: W4414476905