Why there is delay in anti-leprosy drugs importation

The National Agency for Food and Drug Administration and Control (NAFDAC), has emphasised its commitment to due process in the importation of Rifampicin, an anti-leprosy drug, into Nigeria.

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NAFDAC’s Director-General, Mojisola Adeyeye, explained the agency’s position on the matter in a statement issued on Monday.

Mrs Adeyeye, a professor was responding to a BBC report titled “Vital leprosy drugs due in Nigeria after year delay”.

The report had suggested that NAFDAC had either delayed or prevented the importation of essential leprosy treatment.

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Mrs Adeyeye explained that before any drug could be imported into Nigeria, it must undergo rigorous testing, laboratory checks, and compliance with regulatory requirements.
“This was the case with Rifampicin, the medicine in question, which NAFDAC was accused of delaying,” she said.
“The BBC report also highlighted a request from the World Health Organisation (WHO) for NAFDAC to lift its new testing policy to expedite the importation of the medicine.”

Mrs Adeyeye clarified that her response is aimed at providing accurate information and dispelling any misinformation circulating regarding the agency’s actions.

She said NAFDAC was established to safeguard public health through a robust legal and regulatory framework, ensuring that only safe, effective and quality medicines were available in Nigeria.

She said one of the agency’s key initiatives is the Clean Report of Inspection and Analysis (CRIA) scheme which ensures that medicines from high-risk countries such as China and India, meet the required quality standards before being exported to Nigeria.
“This policy, in place since 2002 and strengthened in 2020, ensures that medicines imported into Nigeria meet the highest standards,” she said.
“A key component of this process is the submission of the Certificate of Pharmaceutical Products (CoPP), a document that verifies that a consignment of medicines has undergone thorough quality checks by the regulatory authority of the exporting country.
“Developed by WHO, the CoPP provides assurance that medicines comply with Good Manufacturing Practices (GMP) and meet safety, quality, and efficacy requirements.”

The NAFDAC boss clarified that the manufacturer of the Rifampicin consignment had failed to provide the necessary CoPP documentation, a critical part of the importation process.

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She said to address that, WHO requested a waiver for the required documentation, which NAFDAC reviewed.
“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 said.
“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.”

Additionally, Mrs Adeyeye stated that NAFDAC is collaborating with local pharmaceutical industries to reduce Nigeria’s dependence on imported medicines.

She said that the agency is strengthening regulatory systems and building local manufacturing capacity to ensure that quality medicines were available in Nigeria.

She reassured the public that NAFDAC would continue to ensure the availability of only safe, efficacious, and quality medicines for distribution, sale, and use within Nigeria.

(NAN)