ObjectivesTo evaluate the pattern of substandard and falsified pharmaceutical products recall in Nepal.SettingWe analysed drug recall notices issued by the Department of Drug Administration (DDA), Nepal, and systematically reviewed peer-reviewed research articles during January 2010 to December 2020.ParticipantsThis study did not include human participants. However, data were collected from 72 drug recall notices issued by DDA and four research papers.ResultsA total of 346 pharmaceutical products were recalled during the reported period. The number of recalled pharmaceutical products has increased significantly over the past decade in Nepal. The most frequently recalled drugs were antimicrobials followed by gastrointestinal medicines, vitamins and supplements and pain and palliative medicines among others. Number of imported recalled drugs were slightly higher (42.2%) than domestic recalled drugs (40.7%). Sixty-two percentage of recalled drugs were substandard, 11% were falsified and remaining 27% were not registered at the DDA. Similarly, higher number of modern drugs (62%) were recalled than traditional ones (35%). Hand sanitisers used to minimise COVID-19 transmission contributed significantly to the list of recalled pharmaceutical products in 2020. Most of these sanitisers contained significant amounts of methanol (as high as 75% v/v) instead of appropriate amount of ethyl or isopropyl alcohol. The peer-reviewed research papers reported issues with labelling, unregistered drugs and drugs failed in several laboratory testing.ConclusionOur analysis showed that number of recalls of substandard and falsified drugs are increasing in Nepal. Since the recall data in this paper did not include number of samples tested and location of samples collected, more studies to understand the prevalence of substandard and falsified drugs in Nepal is recommended.

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.