Mohammad Sofiqur Rahman1, Naoko Yoshida2, Hirohito Tsuboi2, Erina Maeda2, Andrea Vanessa Velasco Ibarra2, Theingi Zin3, Yoshio Akimoto4, Tsuyoshi Tanimoto5, Kazuko Kimura4. 1. Medi-Quality Security Institute, Graduate School of Medical Sciences, Kanazawa University, 920-1192, Kanazawa, Japan. rahmansofique@staff.kanazawa-u.ac.jp. 2. Department of Clinical Pharmacy and Healthcare Sciences, Kanazawa University, 920-1192, Kanazawa, Japan. 3. Department of Food and Drug Administration (FDA), Ministry of Health and Sports, Naypyidaw, Myanmar. 4. Medi-Quality Security Institute, Graduate School of Medical Sciences, Kanazawa University, 920-1192, Kanazawa, Japan. 5. Pharmaceutical and Medical Device Regulatory Science Society of Japan, 150-0002, Osaka, Japan.
Abstract
BACKGROUND: Poor quality medicines have serious implications for public health. The aim of this study was to explore the quality of the antidiabetic pioglitazone, using samples collected in China and Myanmar, and samples purchased online. METHODS: In this cross-sectional study, we examined samples (n = 163) collected from hospitals in Shanghai, China in 2012 (n = 44), products purchased via the internet and imported into Japan in 2013 (n = 59), and samples purchased in shops in Yangon, Myanmar in 2015 (n = 60). Collected samples were subjected to visual inspection, authenticity investigation and quality testing (potency, content uniformity and dissolution test) by high-performance liquid chromatography. Samples were rated as compliant or non-compliant based on the relevant pharmacopoeial acceptance criteria. RESULTS: Visual inspection of all samples revealed compliant products. However, responses from manufacturers during authenticity investigation were poor. Among the n = 44 samples from China, one was non-compliant in the potency test. Among the n = 59 samples personally imported into Japan, 38% of generic samples were found to be non-compliant. In Myanmar, 13.3% of samples were non-compliant. Non-compliant samples predominantly failed in the dissolution test. All non-compliant samples were generic. CONCLUSIONS: Despite the apparent satisfactory outcome on the samples from China, pioglitazone samples collected in Myanmar and purchased online for personal import into Japan included many substandard products, which failed quality assessment predominantly because of poor dissolution. Internet providers did not comply with Japanese regulations in various respects.
BACKGROUND: Poor quality medicines have serious implications for public health. The aim of this study was to explore the quality of the antidiabetic pioglitazone, using samples collected in China and Myanmar, and samples purchased online. METHODS: In this cross-sectional study, we examined samples (n = 163) collected from hospitals in Shanghai, China in 2012 (n = 44), products purchased via the internet and imported into Japan in 2013 (n = 59), and samples purchased in shops in Yangon, Myanmar in 2015 (n = 60). Collected samples were subjected to visual inspection, authenticity investigation and quality testing (potency, content uniformity and dissolution test) by high-performance liquid chromatography. Samples were rated as compliant or non-compliant based on the relevant pharmacopoeial acceptance criteria. RESULTS: Visual inspection of all samples revealed compliant products. However, responses from manufacturers during authenticity investigation were poor. Among the n = 44 samples from China, one was non-compliant in the potency test. Among the n = 59 samples personally imported into Japan, 38% of generic samples were found to be non-compliant. In Myanmar, 13.3% of samples were non-compliant. Non-compliant samples predominantly failed in the dissolution test. All non-compliant samples were generic. CONCLUSIONS: Despite the apparent satisfactory outcome on the samples from China, pioglitazone samples collected in Myanmar and purchased online for personal import into Japan included many substandard products, which failed quality assessment predominantly because of poor dissolution. Internet providers did not comply with Japanese regulations in various respects.
Authors: Paul N Newton; Abdinasir A Amin; Chris Bird; Phillip Passmore; Graham Dukes; Göran Tomson; Bright Simons; Roger Bate; Philippe J Guerin; Nicholas J White Journal: PLoS Med Date: 2011-12-06 Impact factor: 11.069
Authors: Patricia Tabernero; Michael Parker; Raffaella Ravinetto; Souly Phanouvong; Shunmay Yeung; Freddy E Kitutu; Phaik Yeong Cheah; Mayfong Mayxay; Philippe J Guerin; Paul N Newton Journal: Trop Med Int Health Date: 2016-05-20 Impact factor: 2.622