A cross-sectional analysis of falsified, counterfeit and substandard medicines in a low-middle income country.

Background: High prevalence of falsified, counterfeit and substandard medicines pose a threat to public health and treatment failure. This study aimed to investigate the quality of selected essential medicines available in Mongolia.

Methods: A cross-sectional study collected essential medicines from pharmacy outlets in Mongolia, during June and July, 2017. These products were then submitted for pharmacopoeial analysis and registration status.

Results: A total of 1770 samples from 118 pharmacy entities were purchased from wholesalers in urban and rural areas. Pharmacopoeial analysis found 179 (10.1%) samples or eleven product groups were unacceptable. The prevalence of substandard locally produced medicines (n = 105, 5.9%) was higher than imported equivalents [(n = 74, 4.17%, p = 0.0001)]. Approximately one-third of all unacceptable tests were related to assay (n = 73, 30.8%) and weight variation. Of 1770 samples, 76 (4.3%) were unregistered and the prevalence of unregistered samples was 3.8% in Ulaanbaatar city and 5.8% in rural areas, respectively.

Conclusions: This study has indicated that falsified and substandard medicines are prevalent in Mongolia. Considerable effort is required by regulatory authorities, private manufacturers, as well as importers to increase the quality of essential medicines in Mongolia.