NAFDAC Approves Antileprosy Drug Import After Quality Assurance Checks

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The National Agency for Food and Drug Administration and Control (NAFDAC) has refuted claims that it delayed the importation of critical antileprosy medications into Nigeria, insisting that its actions were based on strict quality control protocols.

In response to a recent BBC report titled “Vital Leprosy Drugs Due in Nigeria After Year Delay,” NAFDAC issued a statement on Tuesday via its official X handle, emphasizing its commitment to ensuring that only safe and high-quality medicines enter the country.

The agency clarified that its Clean Report of Inspection and Analysis (CRIA) Scheme, implemented in 2002 and strengthened in 2020, mandates rigorous testing for drugs imported from high-risk countries such as India and China. A crucial part of this process, NAFDAC explained, is the Certificate of Pharmaceutical Product (COPP)—an internationally recognized document issued by the exporting country’s regulatory body.

According to NAFDAC, the delay in importing the antileprosy drugs stemmed from the manufacturer’s failure to obtain the COPP from Indian authorities. However, following an appeal from the World Health Organization (WHO), the agency requested laboratory evaluation results from a certified CRIA lab in India. Upon receiving satisfactory test reports, NAFDAC approved the release of the medicines for export to Nigeria.

The agency reiterated its stance on balancing patient needs with regulatory compliance and reaffirmed its efforts to reduce Nigeria’s dependence on imported medicines by strengthening local pharmaceutical production.

“We remain dedicated to ensuring that only safe, effective, and high-quality medicines are available for use in Nigeria,” NAFDAC stated.

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