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.

Prevalence estimates of substandard drugs in Mongolia using a random sample survey.

To determine the prevalence of substandard drugs in urban (Ulaanbaatar) and rural (selected provinces) areas of Mongolia, samples of 9 common, therapeutically important drugs were collected from randomly selected drug outlets in Ulaanbaatar and 4 rural provinces by "mystery shoppers". Samples were analyzed by visual inspection, registration status, and biochemical analysis. Samples failing to meet all Pharmacopeia quality tests were considered substandard.