The National Agency for Food and Drug Administration and Control (NAFDAC) has provided clarification on the delay in approving the importation of leprosy drugs into Nigeria. The agency cited strict regulatory procedures and quality assurance measures as the primary reasons for withholding approval. NAFDAC emphasized its commitment to ensuring that all medicines entering the country meet the necessary safety and efficacy standards.
According to the agency, the delay was due to the failure of the drug manufacturer to provide a Certificate of Pharmaceutical Product (CoPP), a critical document confirming the medicine’s approval in its country of origin. The drug, sourced from India, required further evaluation to verify its quality before being allowed into Nigeria. NAFDAC maintained that skipping this process could pose significant health risks to patients.
The World Health Organization (WHO) intervened, requesting a waiver for the CoPP requirement to address the urgent shortage of leprosy medication. In response, NAFDAC requested independent laboratory testing in India to confirm the safety of the drug. Once the test results met regulatory standards, the agency granted approval for the shipment to proceed.
Despite criticisms that the delay left many patients without treatment, NAFDAC defended its decision, stating that due diligence is crucial in preventing the distribution of substandard or harmful medications. The agency reiterated that all imported medicines, especially those for critical diseases, must comply with Nigeria’s regulatory framework.
With approval now granted, the long-awaited shipment of leprosy drugs is expected to arrive in Nigeria soon. Health officials have assured that distribution will begin immediately to ensure that patients who have gone months without treatment can receive the necessary medication as quickly as possible.
