The Impact of the pharmaceutical regulations on the quality of medicines on the Sudanese market: Importers’ perspective

Gamal K. M. Ali¹ and Abdeen M. Omer²*

¹Former Department of Pharmaceutical Services and Planning Manager, Federal Ministry of Health, Khartoum, Sudan.

²Occupational Health Administration, Ministry of Health, Khartoum, Sudan.

*Corresponding author E-mail: abdeenomer2@yahoo.co.uk

Accepted 27 July, 2012

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 above 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 are 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.

Keywords: Counterfeits Medicines, Drug Importers, and Quality of Medicines, Regulatory Authorities.