Bate Roger, Mooney Lorraine, Hess Kimberly, Milligan Julissa, Attaran Amir
American Enterprise Institute, Washington DC, USA,
Africa Fighting Malaria, London, UK.
Res Rep Trop Med. 2012 Jul 13;3:57-61. doi: 10.2147/RRTM.S33108. eCollection 2012.
Some medicines for sale in developing countries are approved by a stringent regulatory authority (SRA) or the World Health Organization (WHO) prequalification program; many of these are global brands. This study ascertains whether medicines approved by SRAs or the WHO perform better in simple quality tests than those that have not been approved by either.
Over the past 4 years, 2652 essential drugs (products to treat malaria, tuberculosis, and bacterial infections) were procured by covert shoppers from eleven African cities and eight cities in a variety of mid-income nations. All samples were assessed using the Global Pharma Health Fund eV Minilab protocol to identify whether they were substandard, degraded, or counterfeit.
The failure rate among SRA-approved products was 1.01%, among WHO-approved products was 6.80%, and 13.01% among products that were not approved by either. African cities had a greater proportion of SRA- or WHO-approved products (31.50%) than Indian cities (26.57%), but they also experienced a higher failure rate (14.21%) than Indian cities (7.83%). The remainder of cities tested had both the highest proportion of approved products at 34.46% and the lowest failure rate at 2.70%. Products made in Africa had the highest failure rate at 25.77%, followed by Chinese products at 15.74%, Indian products at 3.70%, and European/US products, which failed least often, at 1.70%. Most worrying is that 17.65% of Chinese products approved by the WHO failed.
The results strongly indicate that approval by either an SRA or the WHO is correlated with higher medicine quality at a statistically significant level. The comparatively high failure rates among WHO-approved products suggest there may be some weakness in post-marketing surveillance of these products, especially of Chinese-made WHO-approved products. The discrepancy between the failure rate of WHO-approved products from India (2.39%) and China (17.65%) is cause for concern. It is possible that more of the failures originating in China are counterfeit products, but this cannot be ascertained without greater help from the manufacturers themselves.
在发展中国家销售的一些药品已获得严格监管机构（SRA）或世界卫生组织（WHO）预认证项目的批准；其中许多是全球知名品牌。本研究旨在确定经SRA或WHO批准的药品在简单质量检测中是否比未经两者任何一方批准的药品表现更好。
在过去4年里，暗访人员从11个非洲城市和8个中等收入国家的城市采购了2652种基本药物（用于治疗疟疾、结核病和细菌感染的产品）。所有样本均按照全球药品健康基金电子微型实验室方案进行评估，以确定它们是否为不合格、变质或假冒产品。
SRA批准的产品不合格率为1.01%，WHO批准的产品不合格率为6.80%，未经两者任何一方批准的产品不合格率为13.01%。非洲城市中SRA或WHO批准的产品比例（31.50%）高于印度城市（26.57%），但其不合格率（14.21%）也高于印度城市（7.83%）。其余接受检测的城市批准产品比例最高，为34.46%，不合格率最低，为2.70%。非洲生产的产品不合格率最高，为25.77%，其次是中国产品，为15.74%，印度产品为3.70%，欧洲/美国产品不合格率最低，为1.70%。最令人担忧的是，WHO批准的中国产品中有17.65%不合格。
结果有力地表明，经SRA或WHO批准与药品质量在统计学显著水平上呈正相关。WHO批准产品的相对较高不合格率表明，这些产品的上市后监管可能存在一些薄弱环节，尤其是经WHO批准的中国制造产品。印度（2.39%）和中国（17.65%）经WHO批准产品的不合格率差异令人担忧。有可能更多源自中国的不合格产品是假冒产品，但如果没有制造商自身提供更多帮助，这一点无法确定。
