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Open AccessArticle

Substandard and Falsified Medicines in Myanmar

Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa 920-1192, Japan
Medi-Quality Security Institute, Graduate School of Medical Sciences, Kanazawa University, Kakuma-machi, Kanazawa 920-1192, Japan
Pharmaceutical and Medical Device Regulatory Science Society of Japan, Osaka 150-0002, Japan
Department of Food and Drug Administration, Naypyidaw 15000, Myanmar
Author to whom correspondence should be addressed.
Pharmacy 2020, 8(1), 45;
Received: 28 January 2020 / Revised: 6 March 2020 / Accepted: 17 March 2020 / Published: 19 March 2020
Background: substandard and falsified medicines (SFMs) are a threat to public health. The availability of SFMs in Myanmar was reported by the World Health Organization (WHO) in 1999, but there have been few systematic surveys on falsified medicines in Myanmar since then. The aim of this study is to examine the extent of SFMs for sale in Myanmar. Methods: target medicines were tablets of candesartan, metformin, and pioglitazone, and infusions of ciprofloxacin and levofloxacin. Samples were collected from hospitals, pharmacies, and wholesalers located in the Mandalay region in 2015. We carried out observation testing, authenticity investigation, and quality testing to search for SFMs, and analyzed the relationship between SFMs and the price and store type. Results: There were no falsified medicines found in the authenticity check, though there remained a problem due to low response rates from manufacturers and regulatory authorities. In the quality test, some tablets of metformin and pioglitazone made in India failed the dissolution test. Conclusions: although no serious problems were found, some substandard medicines were detected. Regular surveys to monitor SFMs are therefore recommended, together with further regulatory guidance to improve conditions in all medicine manufacturers, distributors, and pharmacies. View Full-Text
Keywords: falsified medicines; substandard medicines; Myanmar; authenticity; distribution falsified medicines; substandard medicines; Myanmar; authenticity; distribution
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Sakuda, M.; Yoshida, N.; Takaoka, T.; Sanada, T.; Rahman, M.S.; Tanimoto, T.; Zin, T.; Kimura, K.; Tsuboi, H. Substandard and Falsified Medicines in Myanmar. Pharmacy 2020, 8, 45.

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