Punjab University College of Pharmacy, University of the Punjab, Lahore, Pakistan.
Faculty of Pharmaceutical Sciences, Qarshi University, Lahore, Pakistan.
PLoS One. 2024 Jul 19;19(7):e0305989. doi: 10.1371/journal.pone.0305989. eCollection 2024.
The pharmaceutical sector in Pakistan has grown over a period with export potential, however, there are certain barriers in the framework that regulate the growth and export of domestically manufactured pharmaceuticals. The purpose of this study was to highlight the current challenges that hinder the export of pharmaceuticals, especially to the countries with stringent regulatory authorities (SRA), as perceived by the domestic pharmaceutical industry experts, and to highlight the facilitators that may help to resolve the identified challenges.
In a qualitative study, the data were collected from the consented experts from the pharmaceutical industries in Lahore, Karachi, Peshawar, and Quetta. Industrial experts with a minimum of 10 years of experience and who were serving at managerial levels or above were recruited through purposive sampling. The semi-structured interviews were conducted for the collection of data from industrial experts. Thematic content analysis was applied to conclude the data.
Data analysis generated 4 themes and 16 codes. The export of pharmaceuticals, despite having greater potential was regarded as poor, which was attributed to the following: (a) inadequate industrial research and development, particularly on new molecules (b) non-compliance with the cGMP standards, (c) absence of high-tech equipment, (d) unwillingness of the pharmaceutical companies for bioequivalence studies on their generics, (e) unavailability of locally manufactured active pharmaceutical ingredients, (f) disruption in the supply of imported raw material, (g) poor international market perception about local pharmaceutical products and (h) lack of support from regulatory in process expedition. The respondents also suggested the measures for overcoming the above challenges to boost the export of domestic pharmaceuticals and expand their international market share in countries with SRA.
Export from Pakistan to the SRA countries can be enhanced with mandatory bioequivalence studies during generic registration. The pharmaceuticals export could effectively contribute to the national economy.
在过去的一段时间里，巴基斯坦制药行业在出口方面具有增长潜力，但在监管国内制药业增长和出口的框架中存在一些障碍。本研究的目的是突出国内制药行业专家认为阻碍药品出口，特别是对监管严格的国家（SRA）出口的当前挑战，并强调可能有助于解决已确定挑战的促进因素。
在一项定性研究中，从拉合尔、卡拉奇、白沙瓦和奎达的制药行业同意参与的专家那里收集数据。通过目的抽样招募了至少有 10 年经验并在管理级别或以上任职的工业专家。通过半结构化访谈收集工业专家的数据。应用主题内容分析来得出数据结论。
数据分析生成了 4 个主题和 16 个编码。尽管具有更大的潜力，但药品出口被认为很差，原因如下：(a) 工业研发不足，特别是在新分子方面；(b) 不符合 cGMP 标准；(c) 缺乏高科技设备；(d) 制药公司不愿意对其仿制药进行生物等效性研究；(e) 缺乏本地制造的活性药物成分；(f) 进口原料供应中断；(g) 当地药品在国际市场上的形象不佳；(h) 监管过程中缺乏支持加快速度。受访者还建议采取措施克服上述挑战，以促进国内药品出口，并在 SRA 国家扩大其国际市场份额。
通过在仿制药注册过程中强制进行生物等效性研究，可以提高巴基斯坦向 SRA 国家的出口。药品出口可以有效促进国家经济发展。
