NAFDAC Explains Delayed Approval Of Leprosy Drug In Nigeria
The National Agency for Food and Drug Administration and Control (NAFDAC) has stated that the delay in approving a leprosy drug in Nigeria was to ensure its safety and efficacy.
A publication titled ‘Vital Leprosy Drugs Due in Nigeria After Year-Long Delay’ reported that the World Health Organization (WHO) had requested NAFDAC to lift its new testing policy and grant permission to import anti-leprosy medicine for patients in need.
Following the report, the agency responded with a detailed explanation to clarify what transpired and dispel misinformation suggesting it had prevented or delayed the entry of the medicines into Nigeria.
NAFDAC, established to safeguard public health through a legal and regulatory framework, ensures the availability of safe, effective, and high-quality medicines.
As part of the mandate, the agency implemented the Clean Report of Inspection and Analysis (CRIA) Scheme which ensures that products from high-risk countries, such as China and India, meet quality requirements before being exported to Nigeria.
This was disclosed in a press statement signed by the Director-General of NAFDAC, Mojisola Adeyeye, and made available to THE WHISTLER on Monday.
According to the statement, the policy has been in place since 2002 but was strengthened in 2020 to reinforce its objectives.
It added that for medicines to be exported to Nigeria, a key requirement for processing the CRIA is the submission of a Certificate of Pharmaceutical Products (CoPP).
The CoPP is a quality assurance document presented to the receiving regulatory authority, confirming that a consignment of medicines has undergone validated quality and inspection checks by the regulatory authority of the exporting country.
Adeyeye explained that the CoPP certification scheme was developed by the WHO as an international voluntary agreement. It assures receiving countries that medicines in international trade have met Good Manufacturing Practice (GMP) requirements and comply with quality, safety, and efficacy standards.
She further stated that the CoPP is issued based on WHO guidelines, requiring the issuing authority to certify the authenticity of the data and ensure that the manufacturing process of all batches conforms to GMP standards based on inspections.
According to Adeyeye, due process was not followed in ensuring that the manufacturer of the said consignment of anti-leprosy drugs (Rifampicin) obtained this quality assurance document from the Indian Regulatory Authority.
She explained that the WHO, in an attempt to remedy the situation, requested a waiver for this essential documentation requirement. Upon receiving the WHO’s appeal, NAFDAC requested a laboratory evaluation report of the Rifampicin consignment from one of its approved CRIA laboratories in India.
The NAFDAC chief stated that the intent was to ensure the product met satisfactory quality, safety, and efficacy standards before being shipped to Nigeria. She added that based on the satisfactory laboratory results, as well as appeals and assurances from stakeholders, approval was granted for the shipment of Rifampicin to Nigeria to replenish depleted stock for patients in need.
She further said that the agency is actively working with local pharmaceutical industries to reduce Nigeria’s dependence on imported finished pharmaceutical products through regulatory systems strengthening and capacity building for local manufacturers in Nigeria.
NAFDAC Explains Delayed Approval Of Leprosy Drug In Nigeria is first published on The Whistler Newspaper
