NAFDAC’s Drug Control Lab Gets International Accreditation

NAFDAC DG, Paul Orhii

NAFDAC DG, Paul Orhii

The U.S. Agency for International Development (USAID)’s Director in Nigeria, Michael T. Harvey, today presented the International Organization for Standardization quality certificate to the National Agency for Food and Drug Administration and Control (NAFDAC) Central Drug Control Laboratory in Yaba, Lagos. This is the latest example of USAID’s ongoing effort to contribute to the quality of medicines in Nigeria and the West Africa sub-region.

Nigeria is one of over 50 countries receiving technical and financial assistance through USAID’s $110 million “Promoting the Quality of Medicines” program, implemented by the U.S. Pharmacopeial (USP) Convention. The program works with regulatory authorities in developing countries around the world to safeguard the quality of medicines, with a particular focus on priority medicines for treating malaria, HIV/AIDS, and tuberculosis.

“Obtaining this world-class accreditation is a laborious process that demonstrates a strong commitment to excellence at every level of the laboratory,” said USAID/Nigeria’s Mission Director Harvey. “The NAFDAC Central Drug Control Laboratory’s dedication to continuous improvement will put it in a position to contribute to improving access to good quality medicines, especially antimalarials.”

A report from the International Policy Network documents an alarming number of people killed worlwide every day by fake medicines, especially in developing countries. The report estimates that fake tuberculosis and malaria drugs alone kill 700,000 people a year, including in Nigeria. Tackling the scourge of illegal medicines in Nigeria is a daunting task. But Nigeria has taken concrete steps to stop the menace, with the international certificate laying credence to NAFDAC’s efforts.

The American National Standards Institute-American Society of Quality National Accreditation Board based in Washington, D.C. awarded accreditation to the NAFDAC laboratory. “We want to express our congratulations to NAFDAC,” said Dr. Bill Hirt, Director of Accreditation for the board. “We found excellent facilities and document systems, and highly proficient and professional staff. It was heartening to see the effective partnership of the US Pharmacopeia program plus the generous financial backing and oversight of the USAID. In the eyes of the global technical community, NAFDAC can rightfully consider themselves ‘world class’.”

“Pharmaceutical service is one of the pillars of the health care industry in Nigeria,” noted Dr. Paul Orhii, Director General of NAFDAC. “The accreditation will support not only Nigeria’s own pharmaceutical industry, 80 percent of which is located in or around the commercial capital Lagos, it will also help monitor the quality of imported products and help ensure that only safe, quality medicines are distributed to its nearly 170 million citizens. Plus, as an internationally accredited quality lab, NAFDAC laboratory can contribute to the quality of medicines in the entire region by serving as a reference for pharmaceutical manufacturers seeking World Health Organization product prequalification.”

“Much of the laboratory work essential to quality testing medicines entails complex methods and procedures that must be followed meticulously to ensure accurate results. The importance of this accuracy cannot be understated,” said Patrick Lukulay, Ph.D, Director of the program. “With this accreditation, the NAFDAC laboratory demonstrates 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.”

The accreditation of the laboratory in Nigeria is particularly important, because Lagos is a primary port of entry for medicines, not just for Nigeria, but also for all of West Africa. Over 60 percent of the medicines in Nigeria are tested at the laboratory.

The laboratory accreditation is just one of many ways USAID is building technical capacity in an effort to improve the quality of medicines on the continent. To promote sustainability and strengthen pharmaceutical testing capabilities the program trains hundreds of regulatory and pharmaceutical industry professionals in Africa.

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