BACKGROUND: Many countries are having problem of substandard and counterfeit drugs which results in life threatening issues, financial loss of consumers and loss in trust on health system. This study is concerned with the assessment of drugs quality available in the Nepalese market. METHODS: A cross sectional survey was carried out in Kathmandu valley. Five different brands from each eight molecules of drugs (Paracetamol tablet, Cloxacillin capsule, Amlodipine tablet, Metformin tablet, Losartan tablet, Cefixime tablet, Ofloxacin tablet, Carbamazepine tablet) were purposively selected. Registration compliance was verified from Department of Drug Administration (DDA) and laboratorial analysis was done in two different laboratories. RESULTS: Out of 40 drug samples, 90% did not comply with the existing regulatory requirement on labeling and 42.5% brands did not mention about the pharmacopoeial standard. There was no uniformity in mentioning the selflife. Similarly, large variation was seen on price of same generic drugs. Laboratory analysis showed that 40% samples failed to meet the standard among domestic companies and 28% among imported brands. Altogether 32.5% samples were found to be of substandard quality. Only the result of one sample matched with both laboratories. This indicates that there was variation in the selected two laboratories. CONCLUSIONS: The result of this survey indicates that, substandard medicines are available in Nepalese market. Moreover, there is weak regulation and no uniformity in similar pharmaceutical products. A larger study is required to access the quality of pharmaceutical products in the Nepalese market with testing of products in more than two independent laboratories.
BACKGROUND: Many countries are having problem of substandard and counterfeit drugs which results in life threatening issues, financial loss of consumers and loss in trust on health system. This study is concerned with the assessment of drugs quality available in the Nepalese market. METHODS: A cross sectional survey was carried out in Kathmandu valley. Five different brands from each eight molecules of drugs (Paracetamol tablet, Cloxacillin capsule, Amlodipine tablet, Metformin tablet, Losartan tablet, Cefixime tablet, Ofloxacin tablet, Carbamazepine tablet) were purposively selected. Registration compliance was verified from Department of Drug Administration (DDA) and laboratorial analysis was done in two different laboratories. RESULTS: Out of 40 drug samples, 90% did not comply with the existing regulatory requirement on labeling and 42.5% brands did not mention about the pharmacopoeial standard. There was no uniformity in mentioning the selflife. Similarly, large variation was seen on price of same generic drugs. Laboratory analysis showed that 40% samples failed to meet the standard among domestic companies and 28% among imported brands. Altogether 32.5% samples were found to be of substandard quality. Only the result of one sample matched with both laboratories. This indicates that there was variation in the selected two laboratories. CONCLUSIONS: The result of this survey indicates that, substandard medicines are available in Nepalese market. Moreover, there is weak regulation and no uniformity in similar pharmaceutical products. A larger study is required to access the quality of pharmaceutical products in the Nepalese market with testing of products in more than two independent laboratories.
Entities:
Keywords:
Counterfeit medicine; substandard medicine; quality of drugs.