Strengthening Nigeria’s Medicines Quality Assurance System by Building Capacity, Sustainability and Partnerships

February 2016

The National Agency for Food and Drug Administration and Control (NAFDAC) is collaborating with the PQM program to strengthen Nigeria’s health system in sustainable ways and bolster its technical capacity in regulation and manufacture of quality-assured medicines.

Strengthening National Regulatory Systems

NAFDAC’s Central Drug Control Laboratory in Yaba, Lagos attained international accreditation in 2015 with PQM’s support, marking a major milestone in Nigeria’s fight against substandard and falsified medicines. According to NAFDAC’s former Director-General, Dr. Paul Orhii, the accreditation status is likely to have a “game-changing impact” in Nigeria and West Africa since Lagos is a major port of entry for medicines in the region.

The lab’s increased capacity is expected to enhance the country’s ability to safeguard the quality of its medicines, and protect the health and well-being of its citizens. The international accreditation status certifies the lab to serve as a testing and quality assurance reference center for drug manufacturers in the region, which may benefit the country economically.

In addition to strengthening their national laboratory, authorities in Nigeria are developing policies that help ensure the quality of medicines. With PQM’s support, Nigeria’s first documented Quality Assurance Policy was developed by the Federal Ministry of Health and adopted by the National Council on Health.  The policy establishes a framework for ensuring that:

  • procurement, storage, and distribution of medicines and other health products in Nigeria meet predetermined norms and standards in terms of safety, quality, and efficacy; 
  • products are monitored and maintained throughout supply chains;
  • consumers receive medicines and other health products appropriate to their clinical needs; and
  • adequate financing is available to implement, monitor, and evaluate the policy in collaboration with national and international partners.

Supporting the Local Manufacturing Sector to Increase the Supply of Quality-Assured Essential Medicines

PQM worked alongside local manufacturers in Nigeria to increase the availability of quality-assured medicines, particularly those that are essential to the health and well-being of women, newborns, and children. In 2014, as a result of PQM’s technical assistance, Chi Pharmaceuticals Ltd. achieved an acceptable level of compliance with WHO Good Manufacturing Practices (GMP) guidelines. This manufacturer produces zinc sulfate tablets for the Nigerian market to treat diarrhea, a leading cause of death among infants and young children. PQM also helped build capacity of local manufacturers of other essential medicines, including oral rehydration salts, amoxicillin dispersible tablet, and 7.1% chlorhexidine digluconate gel.