Incidences of poor-quality pharmaceutical products in Nepal

Neupane, A.; Bastakoti, M.; Tamang, S.; Giri, B.

Pharmaceutical products are used to treat, prevent, and save lives of millions of people globally. However, pharmaceutical products known as substandard and falsified that do not meet regulatory standards and quality threaten the health of the population of today and future leading to socio-economic hardship, drug resistances and put life of patients in danger. We analyzed the recall notice from 2010 to 2020 issued by the department of drug administration (DDA), government of Nepal to understand the overview of substandard and falsified pharmaceutical products in Nepal. The number of recalled pharmaceutical products has significantly increased over the past decade in Nepal (p-value< 0.05). The most recalled drugs were antimicrobials followed by gastrointestinal medicines, vitamins and supplements, pain and palliative medicines among others. Number of recalled drugs manufactured by domestic pharmaceutical producers and imported ones were not significantly different. Majority of imported recalled drugs originated from India. Sixty-two percentage of recalled drugs were substandard, 11% were falsified and remaining 27% were not registered at the DDA. Similarly, sixty percentage of recalled drugs were modern and 35% were traditional ones. The hand sanitizers used to minimize the COVID-19 transmission contributed significantly to the list of recalled pharmaceutical products in 2020. Most of these sanitizers contained significant amount of methanol instead of ethyl alcohol or isopropyl alcohol. We also reviewed peer-reviewed research papers that reported data of substandard and falsified drugs. Only four such papers were found in literature. These papers reported issues with labeling, unregistered drugs and drugs failed in a number of laboratory testing. Since the recall data did not include number of samples tested and location of sample collected, a systematic study to understand the prevalence of substandard and falsified drugs in Nepal is recommended.