Abstract

The strategy of price liberalisation and privatisation had been implemented in Sudan over the last decade, and has had a positive result on government deficit. The investment law approved recently has good statements and rules on the aforementioned strategy in particular to pharmacy regulations. Under the pressure of the new privatisation policy, the government introduced radical changes in the pharmacy regulations. The 2001 Pharmacy and Poisons Act and its provisions established the Federal Pharmacy and Poison Board (FPPB). All the authorities of the implementation of Pharmacy and Poisons Act were given to this board. This article provides an overview of the impact of the pharmaceutical regulations on the quality of medicines on the Sudanese market from the perspective of the pharmacists working with drug importing companies. The information necessary to conduct the evaluation was collected from 30 pharmacists who are the owners or shareholders in medicines’ importing companies. The participants were selected randomly. 89% of respondents considered the medicines on the Sudanese market generally of good quality. The design of the research itself may be considered inadequate with regard to selection process. However, the authors believe it provides enough evidence, and the current pharmaceutical regulations have some loopholes. The Pharmacy, Poisons, Cosmetics and Medical Devices Act-2001 and its regulation should be enforced. The overall set-up including the Act itself needs to be revised.

Key words: Quality of medicines, drug importers, the Act, regulatory authorities, counterfeits medicines.

Abbreviation

Abbreviations: CMSPO, Central medical supplies public organisation; CRC, centre of regulation and competition; DAP, drug action programme; DOP, department of pharmacy;FGDOP, federal general directorate of pharmacy; FMOH, federal ministry of health; FPPB,federal pharmacy and poison board; GMP, good manufacturing practice; KS, Khartoum state;MOAR, ministry of animal resources; MOH, ministry of health; NGOs, non-governmental organizations; NDP, national drug policy; RDFs, revolving drug funds; SPSS, statistical package for social sciences; UK, united kingdom; USA, united states of America; WHO, world health organization