Obaid Ali
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Karachi.
Pak J Pharm Sci. 2009 Apr;22(2):220-9.
The quality of pharmaceuticals is a global concern, counterfeit/ poor quality/ substandard medicines can cause harms in various ways: In a number of developing countries including Pakistan there is reportedly a high incidence of the availability of substandard drugs. The majority of these reports do not contain quantitative data to support these claims, nor do they describe the methodology employed for the quality assessment. Quality of drugs available in Pakistan are being questioned and topic of discussion in local news paper, TV channels in general public including journalist and physicians due to disparity of price among same generics, lack of knowledge for such science and unknown reasons. Since, quality of drugs can neither be assessed by naked eye or by every one therefore, randomly selected, 96 samples of different strength of injection ceftriaxone sodium and its generic, a widely used third generation cephalosporin in Pakistan since 1982 and 1994 till date respectively included in the said study to know the reality. 15.62% of ceftriaxone injection was found to be out of specification, however, not a single sample was found fake (spurious) out of 96 tested samples. Nevertheless, quality is a wide ranging concept covering all matters that individually or collectively influence the excellence of a product hence price and other related issues are also analyzed in the study.
药品质量是一个全球关注的问题，假冒/质量差/不合格药品会以各种方式造成危害：据报道，在包括巴基斯坦在内的一些发展中国家，不合格药品的供应发生率很高。这些报告大多没有包含支持这些说法的定量数据，也没有描述用于质量评估的方法。由于同一仿制药之间价格存在差异、公众包括记者和医生缺乏相关科学知识以及不明原因，巴基斯坦市场上药品的质量受到质疑，并成为当地报纸、电视频道上的讨论话题。由于药品质量既不能通过肉眼评估，也不是每个人都能评估，因此，在该研究中随机抽取了96份不同规格的头孢曲松钠注射液及其仿制药样本，头孢曲松钠自1982年起在巴基斯坦广泛使用，其仿制药自1994年至今也在使用，以了解实际情况。结果发现15.62%的头孢曲松注射液不符合规格，但在96份测试样本中未发现一个假药（伪造品）。然而，质量是一个广泛的概念，涵盖所有单独或共同影响产品卓越性的事项，因此该研究还分析了价格和其他相关问题。
