Pilot study of essential drug quality in two major cities in India.
Pilot study of essential drug quality in two major cities in India.
复制标题
DOI：
10.1371/journal.pone.0006003
复制
发表时间：
2009-06-23
期刊：
影响因子：
3.7
通讯作者：
Attaran A
中科院分区：
文献类型：
--
作者：
Bate R;Tren R;Mooney L;Hess K;Mitra B;Debroy B;Attaran A
印度在全球医药市场上的影响力越来越大。药品监管体系的关键部分由各州控制，每个州都有自己的执法标准，但并不总是与其他标准一致。在印度德里和金奈两个主要城市进行了一项试点研究，以探讨市场上存在的不合格和假冒药品的问题/假设/程度，并讨论印度邦政府和联邦政府如何改进药品监管，更重要的是加强监管执法，以打击这些药品。抗疟疾、抗生素和抗分枝杆菌药物的随机样本来自印度德里和金奈市区和郊区的药店。采用半定量薄层层析法和崩解试验法测定有效成分的浓度，并与国际通行标准进行比较。来自德里的所有检测样本中，有12%没有通过一项或两项测试，而且不合格。在来自金奈的所有样品中，有5%的样品没有通过一项或两项测试，不合格。观察到药店之间的空间异质性，一些药店有或多或少的不合格药品(分别为30%和0%)，产品异质性也是如此，一些药品或多或少地不合格(分别为12%和7%)。在一项使用敏感性较低的基本现场部署技术而不是最先进的实验室技术的研究中，德里和金奈的不合格药物流行率被证实与印度政府目前的估计大致一致。然而，存在重要的空间和产品异质性，这表明印度的不合格药品问题并不是无处不在的，而是由少数制造商和药店推动的，这些制造商和药店在监管不力的环境中蓬勃发展。印度的药品监管体系很可能需要针对国内消费进行改进，因为印度是发达国家和发展中国家日益重要的药品出口国。一些疾病负担沉重的贫穷国家药品监管体系薄弱，从印度进口许多艾滋病毒/艾滋病、结核病和疟疾药物。
India is an increasingly influential player in the global pharmaceutical market. Key parts of the drug regulatory system are controlled by the states, each of which applies its own standards for enforcement, not always consistent with others. A pilot study was conducted in two major cities in India, Delhi and Chennai, to explore the question/hypothesis/extent of substandard and counterfeit drugs available in the market and to discuss how the Indian state and federal governments could improve drug regulation and more importantly regulatory enforcement to combat these drugs. Random samples of antimalarial, antibiotic, and antimycobacterial drugs were collected from pharmacies in urban and peri-urban areas of Delhi and Chennai, India. Semi-quantitative thin-layer chromatography and disintegration testing were used to measure the concentration of active ingredients against internationally acceptable standards. 12% of all samples tested from Delhi failed either one or both tests, and were substandard. 5% of all samples tested from Chennai failed either one or both tests, and were substandard. Spatial heterogeneity between pharmacies was observed, with some having more or less substandard drugs (30% and 0% respectively), as was product heterogeneity, with some drugs being more or less frequently substandard (12% and 7% respectively). In a study using basic field-deployable techniques of lesser sensitivity rather than the most advanced laboratory-based techniques, the prevalence of substandard drugs in Delhi and Chennai is confirmed to be roughly in accordance with the Indian government's current estimates. However, important spatial and product heterogeneity exists, which suggests that India's substandard drug problem is not ubiquitous, but driven by a subset of manufacturers and pharmacies which thrive in an inadequately regulated environment. It is likely that the drug regulatory system in India needs to be improved for domestic consumption, and because India is an increasingly important exporter of drugs for both developed and developing countries. Some poor countries with high burdens of disease have weak drug regulatory systems and import many HIV/AIDS, tuberculosis and malaria drugs from India.
DOI：
10.1016/j.trstmh.2006.01.003
发表时间：
2006-11-01
影响因子：
2.2
作者：
Lon, C. T.;Tsuyuoka, R.;Smine, A.
通讯作者：
Smine, A.
影响因子：
3.7
作者：
Bate, Roger;Coticelli, Philip;Tren, Richard;Attaran, Amir
通讯作者：
Attaran, Amir