Regulatory affairs pharmacists’ perspectives on pharmaceutical pricing and regulatory measures during economic instability in Sudan

Pharmaceutical pricing and regulatory measures must balance affordability, sustainable medicine supply, and quality assurance during economic instability. This study described regulatory affairs pharmacists’ perspectives and reported experiences regarding pharmaceutical pricing and selected regulatory measures in Sudan. A descriptive cross-sectional survey was conducted from 6 May to 6 June 2020 among regulatory affairs pharmacists working in pharmaceutical importing and/or manufacturing companies in Sudan. An attempted census of 100 eligible professionals identified through the Sudanese Society of Regulatory Affairs Pharmacists yielded 70 completed questionnaires. Responses to the 45-item questionnaire were summarized using frequencies and percentages. Thirty-four respondents (48.6%) agreed or strongly agreed that National Medicines and Poisons Board technical measures achieved their intended regulatory objectives, while 29 (41.4%) disagreed that existing measures limited the circulation of poor-quality medicines. Agreement was high regarding the importance of post-marketing surveillance (98.6%) and stakeholder involvement in regulatory and pricing decisions (97.1%). Sixty-nine respondents (98.6%) agreed that the exchange rate used for medicine pricing weakened companies’ capacity to continue importing medicines. Reported company experiences included cessation of innovator-medicine importation (27.1%) and generic-medicine importation (47.1%) because approved CIF prices were not accepted. The findings document regulatory affairs pharmacists’ perspectives and professional experiences during economic instability in Sudan in 2020. Respondents expressed concerns regarding pharmaceutical pricing, foreign-currency constraints, medicine supply, regulatory processes, quality assurance, and stakeholder engagement. Because the study measured perceptions and reported experiences rather than objective market outcomes, causal policy effects cannot be inferred.