Renewed fight against fake drugs in Africa takes off

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WORRIED by the dearth of experts and available tools to combat falsified, substandard and counterfeit medicines in countries in Sub-Saharan Africa including Nigeria, the United States Pharmacopeial Convention (USP) has launched the Center for Pharmaceutical Advancement and Training (CePAT) in Accra, Ghana.

The new centre is the beginning of a series of global health initiatives to equip national and local regulatory authorities and officers, quality assurance and quality control professionals, manufacturers, and others in the pharmaceutical industry with knowledge and skills to promote access to good quality medicines. The new center is being launched as a Commitment to Action through the Clinton Global Initiative (CGI).

USP’s chief executive officer, Dr. Roger L. Williams, noted: “CePAT is a natural extension of USP’s core mission of establishing public standards for the quality of medicines, foods, and dietary supplements. As USP has become increasingly active throughout the world, the need to support efforts to provide good quality medicines to everyone who requires them has become more important. CePAT is a positive step in that direction, and has been realized in part through our strong working relationships with the Ghanaian and other Sub-Saharan African medicines regulatory authorities.”

Nigerians and many in Sub-Saharan Africa currently face a serious problem when it comes to accessing quality medicines. A 2013 report on the quality of uterotonics (oxytocin and ergometrine) in Ghana found that over 90 percent of the samples tested by United States Agency for International Development (USAID)-USP Promoting the Quality of Medicines Program (PQM) failed either the test for the active ingredient or sterility, and only three of the 26 products tested were officially registered with the Ghana Food and Drug Authority (FDA).

A 2010 study on the quality of anti-malarials in African countries, collaboratively conducted between the World Health Organization (WHO) and PQM, revealed that 44 percent of the samples collected in Senegal failed to meet quality standards. In Madagascar and Uganda, 30 percent and 26 percent of the samples failed, respectively. These reports, and others, underscore the seriousness of the issue and the need for trained professionals to improve access to quality medicines, which CePAT hopes to help ensure.

U.S. Ambassador to Ghana, Gene A. Cretz, noted: “Improvements in this area are critical, and I am proud that CePAT is playing a role in tackling this problem, and that the U.S. President’s Malaria Initiative and USAID activities laid the groundwork for establishing USP in Ghana.”

Vice president of USP’s Global Health Impact Programs (GHIP), who also oversees CePAT operations, Dr. Patrick H. Lukulay, said: “Serious public health issues related to poor quality medicines have been linked to lack of trained human resources, in countries with limited resources.

“With the centre, we want to bring the opportunity to improve local quality assurance systems by training national regulatory agencies and quality control professionals so they can fight the problem of fake and substandard medicines in a sustainable way.”

CePAT’s first course offerings are on Medicines Dossier Evaluation, Quality Control (including hands-on laboratory training) and Good Manufacturing Practices for Pharmaceuticals. Applications are subject to a pre-evaluation to ensure that the appropriate candidates are chosen, based on their potential role in providing access to good quality medicines in the Sub-Saharan African region.

CePAT in Accra, Ghana, was established by the U.S. Pharmacopeial Convention (USP) to help build human resource capacity in pharmaceutical quality assurance and quality control by training local professionals to serve as technical experts. Provided under USP’s Global Health Impact Programs (GHIP), CePAT delivers an integrated platform of training, laboratory services and consulting services to support and strengthen quality assurance systems in a sustainable way in countries in Sub-Saharan Africa.

The USP is a nonprofit, scientific, standards-setting organization that improves global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP’s standards are used worldwide.

CePAT was established as a Commitment to Action under the Clinton Global Initiative (CGI). Through this commitment, USP’s Global Health Impact Programs aim to engage new partners, replicate best practices and innovations, and find opportunities for future growth.

Established in 2005 by President Bill Clinton, the CGI, an initiative of the Clinton Foundation, convenes global leaders to create and implement innovative solutions to the world’s most pressing challenges. CGI Annual Meetings have brought together more than 150 heads of state, 20 Nobel Prize laureates, and hundreds of leading CEOs, heads of foundations and NGOs, major philanthropists, and members of the media. To date CGI members have made more than 2,300 commitments, which are already improving the lives of more than 400 million people in over 180 countries. When fully funded and implemented, these commitments will be valued at $73.5 billion

Author of this article: By Chukwuma Muanya and Bertram Nwannekanma