USAID/Ghana

Spurious, falsely labeled, and counterfeit malaria medicines pose a major public health risk. Their composition may be dangerous, they may contain insufficient amounts of active ingredients, or they may lack active ingredients altogether. The use of such medicines contributes to increased anti-microbial resistance and results in treatment failure or even death for patients.

In Ghana, the President’s Malaria Initiative (PMI) has been supporting capacity building for the Ghana Food and Drugs Authority (GH-FDA) through staff trainings and technical assistance for quality control of medicines. At sentinel sites throughout the country, trained GH-FDA laboratory staff conduct field tests to identify products that are potentially counterfeit or substandard. As a result of these efforts, the overall failure rate for antimalarial medicines in the marketplace fell from 18 percent in 2010 to 4 percent in 2013.

During fiscal year 2014, appropriate quality control trainings and technical assistance were provided to strengthen the competence of GH-FDA staff. An internationally recognized accrediting body based in the United States was then invited to assess GH-FDA’s capacity in eight key quality control tests. Conducting quality testing of medicines requires complex methods and procedures that must be followed meticulously to ensure accurate results. GH-FDA fulfilled the requirements and has attained the internationally recognized ISO/IEC 17025:2005 accreditation. Such accreditation demonstrates the technical competence of a laboratory and its implementation of laboratory quality management systems. With this accreditation, the GH-FDA has demonstrated that its technical operations and administrative systems are functioning at the highest quality levels by international standards, producing accurate, valid results that can be trusted by the international community.

USAID/Ghana

PMI’s technical and financial assistance were instrumental in helping the GH-FDA to achieve this important milestone. This accreditation ensures the GH-FDA will be able to provide trustworthy data to Ghana’s Ministry of Health as well as accurately monitor medicine quality to prevent sub-standard and counterfeit medicines from circulating in the market. Newly positioned as one of Africa’s elite laboratories in the area of pharmaceutical quality control, the GH-FDA’s contributions will extend beyond Ghana to other countries in the region.