The National Agency for Food and Drugs Administration and Control (NAFDAC) has made some clarifications to a publication by the British Broadcasting Corporation titled ‘Vital leprosy drugs due in Nigeria after year delay’, saying that the publication does not properly reflect what transpired in the process of importing the affected drugs to Nigeria.
The BBC report stated that the World Health Organization (WHO) had requested that NAFDAC should lift its new testing policy and grant permission to import anti-leprosy medicines for patients who needed the medicines.
In a response by the Director-General of the agency, Prof. Mojisola Adeyeye, through a statement issued on Monday, the management maintained that the 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.
Adeyeye stated that NAFDAC was set up to safeguard public health through legal and regulatory framework that would ensure the availability of safe, efficacious, and quality medicines, adding that 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.
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According to her, 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, and 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 Director-General stated that the CoPP remained 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.
Adeyeye further clarified: “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 Practice (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 conforms 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”, the Director-General added.
She hinted that the agency was currently working with local industry to reduce the over dependence on imported finished pharmaceutical products through regulatory systems strengthening and capacity building for local pharmaceuticals manufacturers in Nigeria.
Adeyeye pointed out that the clarification on the BBC’s publication was to assure the public that NAFDAC would continue to ensure that only quality, safe and efficacious medicines are available for distribution, sale and use within Nigeria.
