Perception of Quality about Local Manufacturing of Drugs in Pakistan and Its Qualitative Analysis

S. Muhammad, A. Dayo, M. Ghoto, M. Arain, J. Abbas, R. Sultana, N. Hussain, N. Kumar
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Abstract

The new drug development process is very expensive, so initially when a new drug comes in the market the innovator pharmaceutical company gets the sole rights to manufacture the drug for specific time. But later, other pharmaceutical companies get the rights to manufacture that drug. This increases the number of generic drugs available in the market and decreases the cost of therapy. But this decrease in cost of medicine does not mean poor quality. The objective of this research work was to identify that different generic products from local and multinational firms available in the market are comparable in quality to each other and innovator product and are pharmaceutically equivalent. A comparative qualitative research was carried out on innovator and genetic marketed formulations of atenolol tablets from multinational and local pharmaceutical industries. A total of five products were selected and different in-vitro tests were performed and compared against British Pharmacopoeia standards. All the marketed formulations of atenolol tablets were as per standards of British Pharmacopoeia and complied with the weight variation, dimension, hardness, friability, disintegration, dissolutions tests and assay. All the marketed formulations of atenolol tablets from innovator, multinational and local industry companies were pharmaceutical equivalent and can be used interchangeably.
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巴基斯坦本地药品生产的质量认知及其定性分析
新药开发过程非常昂贵,所以一开始当一种新药进入市场时,创新制药公司获得了在特定时间内生产这种药物的独家权利。但后来,其他制药公司获得了生产这种药物的权利。这增加了市场上可获得的仿制药数量,并降低了治疗成本。但是药品成本的下降并不意味着质量差。这项研究工作的目的是确定市场上本地和跨国公司提供的不同非专利产品在质量上彼此相当,创新产品在药学上是等效的。对跨国和本地制药业的阿替洛尔片的创新配方和遗传配方进行了比较定性研究。总共选择了五种产品,并进行了不同的体外试验,并与英国药典标准进行了比较。所售阿替洛尔片的处方均按英国药典标准执行,并符合重量变异、尺寸、硬度、脆碎度、崩解度、溶出度试验和含量测定。创新者、跨国公司和当地工业公司生产的所有阿替洛尔片剂的市场配方都是等效的,可以互换使用。
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