The National Agency for Food and Drug Administration and Control (NAFDAC) has reaffirmed its commitment to stringent regulatory processes in the importation of antileprosy medicine, Rifampicin, into Nigeria.
This statement comes as a direct response to a recent BBC report titled “Vital leprosy drugs due in Nigeria after year delay,” which alleged that NAFDAC had delayed or obstructed the importation of the essential medication.
In a press release issued on Monday, NAFDAC Director-General, Prof. Mojisola Adeyeye, clarified the agency’s position, emphasizing the necessity for rigorous testing, laboratory verification, and adherence to established regulatory requirements before any drug can be imported into the country.
“This was the case with Rifampicin, the medicine in question, which NAFDAC was accused of delaying,” Prof. Adeyeye stated. “The BBC report also highlighted a request from the World Health Organization (WHO) for NAFDAC to lift its new testing policy to expedite the importation of the medicine.”
Prof. Adeyeye stressed that NAFDAC’s primary mandate is to safeguard public health through a robust regulatory framework, ensuring the availability of safe, effective, and quality medicines for the Nigerian population.
A cornerstone of NAFDAC’s import control mechanism is the Clean Report of Inspection and Analysis (CRIA) Scheme, particularly applied to medicines originating from high-risk countries such as China and India. This policy, initiated in 2002 and reinforced in 2020, mandates that imported medicines meet stringent quality standards before entering Nigeria.
The scheme crucially relies on the submission of the Certificate of Pharmaceutical Products (CoPP), a document developed by WHO to confirm that a medicine consignment has undergone rigorous quality checks by the regulatory authority of the exporting country, adhering to Good Manufacturing Practices (GMP) and meeting safety, quality, and efficacy requirements.
“The manufacturer of the Rifampicin consignment had failed to provide the necessary CoPP documentation, a critical part of the importation process,” Prof. Adeyeye explained.
Following WHO’s request for a waiver due to this missing documentation, NAFDAC undertook a thorough review. “Upon receiving the appeal, NAFDAC requested a laboratory evaluation of the Rifampicin consignment from one of its approved CRIA laboratories in India to ensure the product met the necessary quality, safety, and efficacy standards,” she stated.
“Following satisfactory laboratory results, assurances, and the need to replenish the stock of the medicine for Nigerian patients, NAFDAC granted approval for the Rifampicin shipment to be exported to Nigeria.” she added.
Looking forward, Prof. Adeyeye highlighted NAFDAC’s collaborative efforts with local pharmaceutical industries to reduce Nigeria’s reliance on imported medicines. The agency is actively strengthening regulatory systems and fostering local manufacturing capacity to guarantee the availability of quality medicines within the country.
“NAFDAC will continue to ensure the availability of only safe, efficacious, and quality medicines for distribution, sale, and use within Nigeria,” Prof. Adeyeye concluded, reassuring the public of the agency’s unwavering commitment to public health.
