Sudan pharmacists reveal how exchange-rate rules strained medicine imports in 2020

Pharmacists responsible for regulatory affairs in Sudan’s pharmaceutical sector expressed near-unanimous concern that the exchange rate used for medicine pricing weakened companies’ capacity to keep importing medicines, according to a survey conducted during the country’s severe economic instability in 2020. Of 70 regulatory affairs pharmacists who completed the questionnaire, 69, or 98.6 percent, agreed or strongly agreed with that statement, and almost as many backed the involvement of relevant stakeholders when pricing regulations or exchange-rate mechanisms were developed. The study, published in Discover Health Systems, offers a detailed professional snapshot of how pricing and regulatory measures were perceived at a moment when currency depreciation and foreign-exchange shortages were squeezing Sudan’s medicine supply.

The survey was a descriptive cross-sectional study carried out between 6 May and 6 June 2020. The researchers attempted a census of all 100 eligible professionals identified through the Sudanese Society of Regulatory Affairs Pharmacists, whose members worked in regulatory-affairs functions within pharmaceutical importing or manufacturing companies. Seventy pharmacists completed the 45-item questionnaire, a response rate of 70.0 percent. Pharmacists employed by the National Medicines and Poisons Board (NMPB) or its affiliated State Directorates of Pharmacy were excluded, meaning the results capture the perspective of regulated companies rather than the regulator itself. Responses were summarized using frequencies and percentages, with item-specific denominators reported where responses were missing or nonclassifiable.

Company experiences reported by respondents pointed to concrete supply consequences. Nineteen respondents, 27.1 percent, said their companies had stopped importing an innovator medicine because the approved cost, insurance and freight (CIF) price was not accepted, and 16, or 22.9 percent, said an innovator medicine had been registered but never subsequently imported for the same reason. For generic medicines the figures were higher: 33 respondents, 47.1 percent, reported cessation of importation, and 30, or 42.9 percent, reported registration without subsequent importation because approved CIF prices were not accepted. Twelve respondents, 17.1 percent, reported that a locally manufactured medicine had ceased production because the approved price was not accepted.

Views on the regulatory system itself were differentiated rather than uniformly negative. Thirty-four respondents, 48.6 percent, agreed or strongly agreed that NMPB technical measures achieved their intended regulatory objectives, while 26, or 37.1 percent, disagreed. Support for specific quality-assurance mechanisms was strong: 69 respondents, 98.6 percent, backed post-marketing surveillance, 50, or 71.4 percent, supported laboratory testing as part of medicine registration, 52, or 74.3 percent, agreed that application of the Common Technical Document supported registration of safe, effective and quality medicines, and the same proportion supported bioequivalence studies where equivalence of generic medicines could not be established through dissolution testing.

Confidence in the overall effectiveness of existing measures was more mixed. Twenty-two respondents, 31.4 percent, agreed that NMPB measures limited the circulation of poor-quality medicines, but 29, or 41.4 percent, disagreed or strongly disagreed, and 19, or 27.1 percent, were unsure. Only 20 respondents, 28.6 percent, expressed agreement with a statement indicating full confidence in current NMPB systems and procedures for ensuring medicine quality, while 26 disagreed and 24 were unsure. When asked separately to rate the quality of medicines circulating in pharmacies, just seven respondents, 10.0 percent, rated it as high, 48, or 68.6 percent, rated it fair or acceptable, and 11, or 15.7 percent, rated it low.

Respondents also expressed concerns about selected administrative measures. Fifty-six respondents, 80.0 percent, agreed or strongly agreed that selected administrative measures adopted during the preceding few years had not achieved their intended regulatory objectives. Fifty-five, or 78.6 percent, agreed that bonus arrangements primarily benefited pharmacies and could influence brand-specific dispensing practices, and 42, or 60.0 percent, agreed that a large number of medicine distributors could contribute to the circulation of poor-quality and falsified medicines. Fifty-one, or 72.9 percent, agreed with the stated benefits of setting a ceiling on the number of registered medicines within therapeutic groups.

On pricing solutions, opinion was divided. Fifty-two respondents, 74.3 percent, agreed that high registered CIF prices contributed to price distortions and the use of bonus quantities. For the item concerning implementation of the exchange-rate provision in the 2010 pricing regulations, 59 participants provided classifiable responses, and of these 51, or 86.4 percent, agreed that non-implementation of the provision, together with difficulties obtaining foreign currency, contributed to medicine-supply disruption. Yet 42 of the full sample, 60.0 percent, agreed that applying the exchange-rate determination mechanism in the 2010 regulations would address the pricing problem, while 21 were unsure, and respondents were evenly split, 35 to 35, on whether reinstating and implementing those regulations more generally would do so. Thirty-nine respondents, 55.7 percent, reported having reviewed the 2010 Registered Pharmaceutical Preparations Pricing Regulations.

The authors place these findings in the macroeconomic context of Sudan at the time. The International Monetary Fund documented substantial macroeconomic imbalances, inflation, exchange-rate distortions and foreign-exchange shortages during the years preceding the survey, and pharmaceutical suppliers faced difficulties obtaining foreign currency. Central Bank of Sudan data show a marked widening of the gap between official and parallel-market exchange rates in the later years of the period, including in 2020. Medicine shortages were reported during 2020 amid multiple pressures, including the early COVID-19 pandemic, which coincided with the survey window and may have affected both supply and participants’ perceptions independently of domestic regulatory measures.

The study’s authors are careful to emphasize that the survey measured perceptions and self-reported professional experiences rather than objective market outcomes. It did not examine company financial records, actual import volumes, product-level availability, procurement prices, stock-outs, or patient-level affordability, and it did not undertake medicine-quality testing or inspect regulatory records. The respondents’ perceptions therefore cannot establish causal effects of regulatory policies on medicine availability, affordability or quality. Because participants worked in importing and manufacturing companies and interacted professionally with regulatory processes, their interpretations could have been influenced by their organizational experiences and interests, and nonresponse bias cannot be excluded since 30 of the 100 invited professionals did not participate and no comparison data were available.

Several further limitations shape the interpretation. The findings describe conditions during a defined historical period in 2020 and should not be read as describing Sudan’s current pharmaceutical system, particularly given the profound changes that have occurred since. The questionnaire covered heterogeneous domains and showed only modest internal consistency, with a Cronbach’s alpha of 0.602, and numerical follow-up questions about numbers of affected products contained inconsistencies that prevented reliable aggregation and were excluded from the final analysis. The authors conclude that future studies should combine perspectives from regulators, suppliers, purchasers, healthcare professionals and patients with objective longitudinal data on medicine prices, availability, importation, production and quality, in order to provide a stronger basis for designing pharmaceutical policies that balance affordability, quality assurance and sustainable medicine supply during periods of economic instability.

Subject of Research: Regulatory affairs pharmacists' perspectives on pharmaceutical pricing and regulatory measures in Sudan during economic instability in 2020

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

Article References: Ali, G. K. M., Abuelrish, Y. A. M., Shigidi, M. A. M., & Alfadl, A. A. (2026). Regulatory affairs pharmacists’ perspectives on pharmaceutical pricing and regulatory measures during economic instability in Sudan. Discover Health Systems, 5(1), Article 87. https://doi.org/10.1007/s44250-026-00430-y

Image Credits: AI Generated

DOI: 10.1007/s44250-026-00430-y

Keywords: Sudan, pharmaceutical pricing, regulatory affairs pharmacists, exchange rate, medicine supply, National Medicines and Poisons Board, cross-sectional survey, foreign currency, quality assurance, medicine importation, CIF prices, health systems