In what international experts on quality of medicine have described as a groundbreaking development, the National Agency for Food and Drug Administration and Control (NAFDAC) and the United States Pharmacopeia (USP), with the assistance of the United States Agency for International Development (USAID) have agreed to work on a road map that will act as a guide towards ensuring the quality monitoring of medicines in Nigeria.
plan that will strengthen the regulatory capacity of NAFDAC to carry out its mandate of effectively safeguarding the health of the public, increase supply of quality medicines into the Nigerian health system and combat counterfeit and sub-standard medicines in the drug supply chain.
At the stakeholders meeting to review this roadmap, NAFDAC Director General, Dr. Paul Orhii, who was represented by the Director, Drug Evaluation and Research, Mrs. Hauwa Keri said this initiative will strengthen NAFDAC’s regulatory capacity to monitor the quality of medicines in Nigeria and stated that the advent of globalization has made it paramount for organizations to harness the benefits of international collaboration and cooperation in addressing issues of common concern.
He said: “Our desire and pledge to bring international standards to bear on our regulatory activities propelled NAFDAC to sign Technical Assistance Programme (TAP) agreement with USP to further strengthen our regulatory capacity and effectively combat the incidence of counterfeit and substandard medicines in Nigeria. We strongly believe that this programme provides us the opportunity to benefit from the wealth of experience of the officials of USP and better position the Agency to carry out its responsibilities, especially as relates to quality monitoring of medicines and other regulated products.”
Dr. Patrick Lukulay, Vice-president, Global Health Impact Programs (GHIP) and Adviser with USP said the road map is aimed at increasing the capacity of regulatory agencies and local pharmaceutical companies to fill the vacuum in the supply of quality drugs within their countries, adding that it is already implemented in Asia, Latin American countries and other developing parts of the world.
Stressing that the road map “put a big emphasis on local pharmaceutical companies to produce medicines for their people” he said USP plans to work with local pharmaceutical industries in Nigeria by providing technical assistance and increasing the readiness of local pharmaceutical industries for international inspection that would fast track their gaining WHO-Prequalification, which would be an endorsement of the quality of their products.
Dr. Abdelkrim Smine, Program Consultant with USP said the road map when put into action will help regulators and manufacturers to quickly detect fake and counterfeit medicines with a view to carrying out effective enforcement that would take such medicines out of the drug supply chain. He reviewed the latest methods applied in detecting fake and counterfeit drugs and introduced recent technologies that have been deployed to make detection easy.
Dr. Smine also said USP will be working with NAFDAC to ensure its laboratories are linked to an international network of laboratories that will be carrying out vital tests and making important pronouncements within its regulatory environment.
USP is the only non-governmental pharmacopeia in the world and has been in existence for the past 200 years.
