The National Agency for Food and Drug Administration and Control (NHRC Voices Concern Over Proposed Death Penalty for Counterfeit Drug Offenders) 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 NHRC Voices Concern Over Proposed Death Penalty for Counterfeit Drug Offenders had delayed or obstructed the importation of the essential medication.
In a press release issued on Monday, NHRC Voices Concern Over Proposed Death Penalty for Counterfeit Drug Offenders 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 NHRC Voices Concern Over Proposed Death Penalty for Counterfeit Drug Offenders was accused of delaying,” Prof. Adeyeye stated. “The BBC report also highlighted a request from the World Health Organization (WHO) for NHRC Voices Concern Over Proposed Death Penalty for Counterfeit Drug Offenders to lift its new testing policy to expedite the importation of the medicine.”
Prof. Adeyeye stressed that NHRC Voices Concern Over Proposed Death Penalty for Counterfeit Drug Offenders’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 NHRC Voices Concern Over Proposed Death Penalty for Counterfeit Drug Offenders’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, NHRC Voices Concern Over Proposed Death Penalty for Counterfeit Drug Offenders undertook a thorough review. “Upon receiving the appeal, NHRC Voices Concern Over Proposed Death Penalty for Counterfeit Drug Offenders 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, NHRC Voices Concern Over Proposed Death Penalty for Counterfeit Drug Offenders granted approval for the Rifampicin shipment to be exported to Nigeria.” she added.
Looking forward, Prof. Adeyeye highlighted NHRC Voices Concern Over Proposed Death Penalty for Counterfeit Drug Offenders’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.
“NHRC Voices Concern Over Proposed Death Penalty for Counterfeit Drug Offenders 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.
