The National Agency for Food and Drug Administration and Control (NAFDAC) has clarified that the delay in approving the importation of a leprosy medication into Nigeria was due to its commitment to due diligence, contrary to the impression created by the British Broadcasting Corporation (BBC) in a recent report.
In its recent publication titled ‘Vital Leprosy Drugs Due in Nigeria After a Year-Long Delay’, the BBC reported that the World Health Organization (WHO) had urged NAFDAC to lift its new testing policy, which had delayed the importation of anti-leprosy medicines for a year, and grant approval for their importation to aid patients in need.
In response to the misleading impression created by the publication, the agency reaffirmed its commitment to protecting public health, emphasizing that all medicines intended for export to Nigeria must undergo thorough due diligence and that no external appeals will override this process without scientific evidence.
In a statement on Monday, the agency’s Director General (DG), Prof. Mojisola Adeyeye, said her response was to provide clear and accurate details on what transpired and to dispel the misinformation in circulation that NAFDAC prevented/delayed the entry of the medicines into Nigeria.
She said: “NAFDAC was set up to safeguard public health through a legal and regulatory framework that would ensure the availability of safe, efficacious, and quality medicines.
“On the strength of this mandate, NAFDAC set up the Clean Report of Inspection and Analysis (CRIA) Scheme to ensure that products leaving high-risk countries like China and India meet quality requirements before they are exported to Nigeria.
“This policy has been in place since 2002 but was strengthened in 2020 to guarantee that the purpose of setting up the scheme is achieved.
“For medicines to be exported to Nigeria, one of the requirements for processing the CRIA is the submission of a Certificate of Pharmaceutical Products (CoPP).
“The CoPP is a quality assurance document presented as an export document to the receiving regulatory authority that a consignment of medicines has undergone validated quality and inspection checks by the regulatory authority of the exporting country.
“The COPP certification scheme was developed by the WHO as an international voluntary agreement that provides assurance to receiving countries to rely on the document as a proof that medicines moving in international trade have undergone necessary Good Manufacturing (GMP) requirements and an attestation as meeting, quality, safety, and efficacy requirements.
“The COPP is issued based on the WHO Guideline which requires that the issuing authority takes responsibility for assuring the receiving country that the certified data is authentic, that the manufacturing process of all batches of the medical products conform to GMP standards based on Inspections conducted by the issuing authority.
“Unfortunately, due process was not followed in ensuring that the manufacturer of the said consignment of antileprosy drugs (Rifampicin) obtained this quality assurance document from the Indian Regulatory Authority.
“To remedy the situation, the WHO requested a waiver of this important documentation requirement.
“NAFDAC, upon receipt of the appeal from the WHO, requested for the laboratory evaluation report of the consignment of Rifampicin from one of the NAFDAC-approved CRIA Laboratories in India.
“This was to ensure that the said products had satisfactory quality, safety, and efficacy results before they can be shipped to Nigeria.
“On the strength of the satisfactory laboratory result and based on appeals, assurances, and the need to replenish stock out of the product for patients who need them, approval was granted for the release of the shipment of Rifampicin for export to Nigeria.
“NAFDAC is currently working with local industry to reduce the over-dependence on imported finished pharmaceutical products through regulatory systems strengthening and capacity building for local pharma manufacturers in Nigeria.
“This is, therefore, to assure the public that NAFDAC will continue to ensure that only quality, safe and efficacious medicines are available for distribution, sale and use within Nigeria
