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本文引用的文献

1
Commentary: will generic drug stores improve access to essential medicines for the poor in India?评论:平价药店能否改善印度贫困人口获取基本药物的状况?
J Public Health Policy. 2010 Jul;31(2):178-84. doi: 10.1057/jphp.2010.2.
2
Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration.比较仿制药和创新药:对美国食品药品监督管理局12年生物等效性数据的综述
Ann Pharmacother. 2009 Oct;43(10):1583-97. doi: 10.1345/aph.1M141. Epub 2009 Sep 23.
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Patients' perceptions of generic medications.患者对仿制药的看法。
Health Aff (Millwood). 2009 Mar-Apr;28(2):546-56. doi: 10.1377/hlthaff.28.2.546.
4
Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis.心血管疾病中使用的仿制药和品牌药的临床等效性:一项系统评价和荟萃分析。
JAMA. 2008 Dec 3;300(21):2514-26. doi: 10.1001/jama.2008.758.
5
People's views on the level of agreement of generic medicines for different illnesses.人们对不同疾病通用药物的认同程度的看法。
Pharm World Sci. 2008 Oct;30(5):590-4. doi: 10.1007/s11096-008-9247-y. Epub 2008 Aug 14.
6
Prices & availability of common medicines at six sites in India using a standard methodology.采用标准方法对印度六个地点常见药品的价格及可获得性进行的研究。
Indian J Med Res. 2007 May;125(5):645-54.
7
Patients' attitudes towards and experiences of generic drug substitution in Norway.挪威患者对通用名药物替代的态度及体验
Pharm World Sci. 2006 Oct;28(5):284-9. doi: 10.1007/s11096-006-9043-5. Epub 2006 Nov 17.
8
Encouraging the use of generic medicines: implications for transition economies.鼓励使用通用药物:对转型经济体的影响
Croat Med J. 2002 Aug;43(4):462-9.
9
Trends of generic substitution in community pharmacies.社区药房的非专利药替换趋势。
Pharm World Sci. 1999 Dec;21(6):260-5. doi: 10.1023/a:1008781619011.
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From the Food and Drug Administration.来自美国食品药品监督管理局。
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对印度同厂家部分名牌与名牌仿制药的价格和质量的对比评估。

A comparative evaluation of price and quality of some branded versus branded-generic medicines of the same manufacturer in India.

机构信息

Department of Pharmaceutical Sciences, M. D. University, Rohtak, Haryana, India.

出版信息

Indian J Pharmacol. 2011 Apr;43(2):131-6. doi: 10.4103/0253-7613.77344.

DOI:10.4103/0253-7613.77344
PMID:21572645
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3081449/
Abstract

OBJECTIVE

To compare and evaluate the price and quality of "branded" and branded-generic equivalents of some commonly used medicines manufactured by the same pharmaceutical company in India.

MATERIALS AND METHODS

FIVE COMMONLY USED MEDICINES: alprazolam, cetirizine, ciprofloxacin, fluoxetine, and lansoprazole manufactured in branded and branded-generic versions by the same company were selected. Price-to-patient and price-to-retailers were found for five "pair" of medicines. Both quantitative and qualitative analysis were performed following the methods prescribed in the Indian Pharmacopoeia 2007 on five pair of medicines. The tests performed were identification test, chemical composition estimation test, uniformity of contents test, uniformity of weight, and dissolution studies.

MAIN OUTCOME MEASURES

Price-to-patient, retailer mark-up and qualitative analysis of branded and branded-generic medicines.

RESULTS

Retailer margin for five branded medicines were in the range of 25-30% but for their branded-generics version manufactured by the same company it was in the range of 201-1016%. Price-to-patient for the branded version of cetirizine, fluoxetine, ciprofloxacin, lansoprazole, and alprozolam was higher by 41%, 33%, 0%, 14%, and 31% than branded-generic. Both versions of five medicines were within their permissible range for all the quantitative and qualitative parameters as prescribed in Indian Pharmacopoeia.

CONCLUSION

Difference in price-to-patient was not as huge as it is expected for generics but margins for retailer were very high for branded-generics. Quality of branded-generics is same as for their branded version. The study highlights the need to modify the drug price policy, regulate the mark-ups in generic supply chain, conduct and widely publicize the quality testing of generics for awareness of all stakeholders.

摘要

目的

比较和评估一些常用药品的“品牌”和品牌仿制药在印度同一家制药公司制造的价格和质量。

材料和方法

选择五种常用药品:阿普唑仑、西替利嗪、环丙沙星、氟西汀和兰索拉唑,均由同一家公司生产的品牌和品牌仿制药版本。为五对药品找到患者价格和零售商价格。按照 2007 年印度药典规定的方法对五对药品进行了定量和定性分析。进行的测试有鉴别试验、化学成分估计试验、含量均匀度试验、重量均匀度和溶出度研究。

主要观察指标

品牌和品牌仿制药的患者价格、零售商加价和定性分析。

结果

五种品牌药品的零售商利润率在 25%-30%之间,但同一家公司生产的品牌仿制药版本的利润率在 201%-1016%之间。西替利嗪、氟西汀、环丙沙星、兰索拉唑和阿普唑仑品牌药品的患者价格比品牌仿制药高 41%、33%、0%、14%和 31%。五种药品的所有定量和定性参数均在印度药典规定的允许范围内。

结论

与预期的仿制药相比,患者价格差异并不巨大,但品牌仿制药的零售商利润率非常高。品牌仿制药的质量与品牌版本相同。该研究强调需要修改药品价格政策,规范仿制药供应链的加价,对仿制药进行广泛宣传和质量检测,以提高所有利益相关者的意识。