Quality of Antimalarial Drugs in Sudan: Results of Post-Marketing Surveillance

ABSTRACT

Background: Every government allocates a substantial proportion of its total health budget to drugs. This proportion tends to be greatest in developing countries, where it may exceed 40%. This indicates the importance of assuring the quality of medicines. This study was conducted to assess the quality of antimalarial drugs in Sudan. It was a part of a comprehensive study to test the quality of medicines in Sudanese market (post- marketing surveillance). Methods: Six states in Northern, Eastern, Western and Central Sudan were chosen for samples collection to represent all Sudanese market. The sampling procedure was designed in a way to determine whether these products were adversely affected by the transport and storage conditions at the periphery. Official inspectors (pharmacists) at state level were responsible for sample collection, coding and transportation to the National Drug Quality Control Laboratory at Khartoum for analysis. Results: The results identified several significant problems of substandard products in all states. They included percentage failures ranging from 0% to 100% for different antimalarial drug products. Conclusion: This data indicates significant problems of substandard antimalarial products circulating in the Sudanese market. This appears to be due to non-suitable distribution mechanisms as well as non-suitable storage conditions. Non-compliance with Good Manufacturing Practice (GMP) guidelines by manufacturers in production also seemed to have contributed to this