Promoting the Quality of Medicines in Nigeria

An abundance of poor-quality medical products in low- and middle-income countries—including Nigeria—makes it hard to effectively treat and prevent public health threats. Detecting substandard and falsified medicines and removing them from the market, while increasing the availability of quality-assured medicines, is critical to combating treatable diseases.

In 2014, PQM began delivering technical assistance aimed at strengthening the medicines quality systems in Nigeria. Since building effective systems requires collaboration, PQM works with the National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria-based manufacturers, and a variety of local partners to establish the foundations essential to ensuring the quality of medicines. Together, we strengthen regulatory capacity and increase the supply of quality-assured priority medicines.

Areas of Focus

Strengthen national regulatory systems

PQM helps advance Nigeria’s national policies for quality assurance of medical products. In collaboration with the Federal Ministry of Health, PQM supported the development of Nigeria’s first documented Quality Assurance Policy. Adopted by the National Council on Health, this policy mandates quality assurance and quality control considerations throughout Nigeria’s pharmaceutical supply chain.

“The National Policy on Quality Assurance for Medicines and other Health Products (NQAP) is a legacy befitting the management of the Federal Ministry of Health [of Nigeria] and its development partners, such as USAID/Nigeria, USP/PQM and others. It marks a very important and timely step in the development of the national health sector toward ensuring that health products in our country are not only quality-assured but effective, affordable, and safe for use.”
- National Quality Assurance Policy for Medicines and Other Health Products 2015, page 3

Increase capacity to detect substandard, falsified, and unapproved medical products

PQM helps improve the technical skills of personnel in Nigeria’s national quality control laboratories (NQCLs) and strengthen their testing capacity so NAFDAC can detect poor-quality medicines. Now, three NQCLs—located in Yaba, Agulu, and Kaduna—are ISO 17025:2005 accredited, verifying their abilities to deliver accurate and reliable test results according to international standards.

“The PQM program has supported NAFDAC to conduct surveys on quality medicines to generate reliable data and take regulatory actions required to protect public health and improve quality of life.”
- Yetunde Oni, former Acting Director General of NAFDAC

Increase supply of quality-assured essential medicines

PQM is supporting 11 Nigeria-based manufacturers in building their capacity to produce medicines according to good manufacturing practices (GMPs). With PQM help, seven of these manufacturers have received NAFDAC approval to market one or more priority medicines for the prevention or treatment of malaria, pneumonia, umbilical cord infection, and diarrhea in Nigeria. The supply of essential medicines may also increase in other low- and middle-income countries because two of these manufacturers are exporting their products to neighboring countries.

In collaboration with the Chlorhexidine Working Group, PQM helped a Nigerian manufacturer produce quality-assured WHO-recommended 7.1% CHX digluconate gel, which is used to prevent deadly umbilical cord infections in newborns. The company became the first in Africa to produce the gel and has already sold more than 2.7 million tubes domestically, with additional exports to six other African countries expected.

Increase evidence-based decision-making

PQM helps NAFDAC collect and use information from incidences of poor-quality medicines, including laboratory findings from its ISO 17025:2005-accredited NQCLs. NAFDAC can use this information to take regulatory actions when needed, monitor threats to medicines quality, and apply resources to high-risk areas within the supply chain.

The Agulu Zonal laboratory recently analyzed samples of oxytocin, a priority medicine that saves lives by preventing and treating postpartum hemorrhage. The laboratory found that 74 percent of the samples failed quality control tests. While the result is not necessarily representative of the quality of oxytocin across the country, NAFDAC understood that it could be a sign of a bigger problem. NAFDAC quickly organized a meeting to determine what caused the quality issues, held a workshop on good storage and distribution practices for registered oxytocin injection producers, and confiscated 1,183 ampoules of poor-quality oxytocin.