Barriers to and enablers of Pakistani pharmaceutical export to regulated markets: regulatory perspective

Background The pharmaceutical sector in Pakistan has grown over a period; however, there are certain barriers within the framework that regulate the growth and export of pharmaceuticals in the country. The purpose of this study was to highlight the current challenges for the pharmaceuticals’ export from Pakistan, especially to countries with stringent regulatory authorities (SRAs), from a regulatory perspective, and to identify the facilitators that may help resolve these challenges.Methods In this qualitative study, data were collected from the participants from the regional offices of Drug Regulatory Authority of Pakistan (DRAP), located in Lahore, Islamabad, and Quetta. Regulatory participants with a minimum experience of 6 years and the designation of an assistant director or above were recruited through purposive sampling. Semi-structured interviews were used to collect information from regulatory experts. Inductive thematic content analysis was employed to conclude the data.Data analysis generated 5 themes and 20 categories/codes. Poor export performance and pharmaceutical growth was attributed to barriers such as: inadequate industrial research and development, non-compliance with the current standards of good manufacturing practices (cGMP), absence of regulatory requirements for high-tech equipment, insufficient academia-industry collaboration, shortage of locally manufactured active pharmaceutical ingredients and lack of support from the government. Accreditation with international organisations such as the World Health Organisation and the Pharmaceutical Inspection Co-operation Scheme was considered deficient. DRAP, in coordination with the Trade Development Authority, could enhance pharmaceutical exports. Addressing the above challenges could boost the export and expand international market share of Pakistani Pharmaceuticals in countries with SRAs.Conclusion The cGMP compliance, regulatory assistance, and appropriate research and development, including bioequivalence studies, could contribute to export enhancement to SRA countries. Further, the exports from Pakistan to countries with SRAs could be enhanced with DRAP's coordination with the trade development authority of Pakistan.