US Helping African Countries Improve Medicine Regulation

U.S. Pharmacopeial Convention (USP) is providing five sub-Saharan African countries with technical aid to improve the public access to high quality, affordable medicines, announced the organization on February 8th, 2011.

USP has launched a pilot Technical Assistance Program (TAP) to provide developing countries with capacity building in medicine quality evaluation. Participating countries will be provided with a comprehensive package of pharmaceutical reference standards, documentary standards and technical training.

The program hopes to eventually include other countries, however the first to benefit are sub-Saharan Ethiopia, Ghana, Kenya, Senegal and Sierra Leone. Each country has committed to improving public health by monitoring drug quality, and many of the pilot countries have worked with USP’s Promoting the Quality of medicines program, funded by USAID, which collaborates with local authorities to detect and remove substandard and fake medicine from the market through technical expertise and public awareness development.

“I am very pleased that USP is able to launch this important pilot program in support of vulnerable populations,” said Roger L. Williams, M.D., USP’s chief executive officer. “The ability to test essential medicines using good quality standards is a crucial component of efforts to improve public health. The countries in this pilot are committed to strengthening drug quality and lack of key resources should not stand in their way. As a physician, I’m particularly interested in the broadest possible access to high quality, affordable medicines.”

National pharmacopeias typically sell reference and documentary standards for use by pharmaceutical manufacturers and quality control laboratories. Laboratories with limited resources may have to fall back on outdated, secondary or inadequately documented standards, which compromises quality testing. The USP TAP is intended to make such measures unnecessary.

“In Ghana, we are committed to improving public health by many means, and one very important approach is helping to ensure that the medicines people take are of good quality,” said Stephen Opuni, M.D., chief executive officer of the Ghana Food and Drugs Board. “We have worked extensively with USP’s PQM to identify and remove substandard and counterfeit drugs from our markets. This new USP initiative will help us to test drugs against the most modern and scientifically established standards, which in turn will strengthen our public health programs. While I speak only for Ghana, the same is true for the other countries in this pilot program as well.”

Patrick Lukulay, Ph.D., director of the PQM program, agreed: “USP’s Technical Assistance Program will increase the extent and scope of quality control and regulators will be able to exercise better oversight of medicines quality in their markets. Additionally, testing against modern standards will help resource-constrained countries to, in effect, collaborate in the fight against counterfeit and substandard medicines. These efforts complement our work supported by USAID.”

At the end of the 12-month pilot, USP and the five medicines quality control laboratories will assess progress ultimately for improved access to quality medicines. USP will closely measure the pilot and may extend it to other countries if it is successful.