Madagascar

Madagascar, an island located off the east coast of Mozambique, has a population of approximately 18 million people (2005), divided between urban (20%) and rural (80%) areas. Road access to villages remains a major concern and often limits or denies the rural population access to public health facilities, including medicines.

USP DQI first visited Madagascar in 2003, responding to a request from the country's Ministry of Health and through support from USAID to assess the overall status of the drug quality control program and determine what technical support and capacity-building USP DQI could provide. Working with the Agence du Médicament de Madagascar, the country's drug regulatory authority, USP DQI established a plan to provide technical support, training in laboratory diagnosis and good laboratory practices, organization of a drug monitoring and evaluation program, and further development of its drug quality assurance program.

The drug quality assurance program in Madagascar has made great strides since it was created in 1998. The Agence set up a Quality Control laboratory in 2002 which has participated in USP DQI training workshops centered on Good Laboratory Practices, High Pressure Liquid Chromatography, Dissolution, Ultraviolet, and Titration procedures. With the help of the World Health Organization and USP DQI, the administration has also upgraded their registration practices using specialized software to register medicines.

The Agence du Médicament is somewhat limited, however, by its physical location. Situated in Madagascar's capital city of Antananarivo, geographically in the center of the country, the Agence has routinely analyzed for quality only medicines from the central region. In order to meet the goal of improving drug quality nationwide, USP DQI introduced the use of Minilabs, a self-contained and mobile laboratory made by German Pharma Health Fund, to take a preliminary look at the quality of medication in a decentralized fashion. In 2006, a program of sampling and testing of medicines was launched in four selected provinces outside the capital city where medical students from the Faculty of Medicine of Antananarivo will use the Minilabs at different sentinel sites to regularly test drug quality in the marketplace. USP DQI, the Agence, and the Faculty of Medicine continue to monitor the progress of work and any difficulties encountered.

With these collaborative efforts and the continued support from the Madagascar Ministry of Health, USP DQI, USAID's Country Mission, the Agence du Médicament, and the Quality Control Laboratory have successfully played a major role in assuring the quality of medicines in Madagascar. The Agence and its partners have also begun to build a pharmacovigilance program that will routinely collect data on adverse events connected with medicines that have been approved and are circulating in the marketplace within the general patient population.

Madagascar Drug Quality Assessment (863KB)—Using a newly developed assessment tool to guide their evaluation, USP DQI drug quality experts collected information and analyzed the overall status of the country's drug quality program. This report gauges how the existing drug regulatory authority functions, identifies strengths and weaknesses of the country's drug quality systems, and makes recommendations to authorities responsible for designing and developing appropriate drug QA/QC systems that are adaptable to their political and socio-economic conditions.