‘Due process wasn’t followed’ — NAFDAC explains delay in approval of leprosy medications from India

The National Agency for Food and Drug Administration and Control (NAFDAC) has addressed concerns over the delay in approving leprosy medications for export to the country.

The delay left Nigeria without stock of multi-drug therapy (MDT) for leprosy for about a year, despite the medicines being donated by pharmaceutical company Novartis through a World Health Organization (WHO) programme.

Reports suggested that NAFDAC had required additional testing for doses produced by Sandoz, a Novartis spin-off, because they were manufactured in India.

WHO had requested a one-time waiver of this testing policy, which was granted in January.

In a statement on Monday, NAFDAC denied blocking or delaying the shipment, saying its procedures were aimed at ensuring quality and efficacy.

The agency said its clean report of inspection and analysis (CRIA) scheme requires products from high-risk countries such as India and China to undergo checks before export.

NAFDAC explained that a key requirement for CRIA processing is a certificate of pharmaceutical product (CoPP), which verifies that a medicine has passed quality inspections in its country of origin.

“The COPP is issued based on the WHO Guideline which requires that the issuing authority takes responsibility for assuring the receiving country that the certified data is authentic, that the manufacturing process of all batches of the medical products conform to GMP standards based on Inspections conducted by the issuing authority,” the statement reads.

“Unfortunately, due process was not followed in ensuring that the manufacturer of the said consignment of antileprosy drugs (Rifampicin) obtained this quality assurance document from the Indian Regulatory Authority.

“To remedy the situation, the WHO requested a waiver of this important documentation requirement. NAFDAC upon receipt of the appeal from the WHO, requested for the laboratory evaluation report of the consignment of Rifampicin from one of the NAFDAC approved CRIA Laboratories in India.

“This was to ensure that the said products had satisfactory quality, safety, and efficacy results before they can be shipped to Nigeria.”

The agency said based on the strength of the satisfactory laboratory result and on appeals, approval was granted for the release of the shipment of the medications for export to Nigeria.

NAFDAC said it is currently working with local industry to reduce the over dependence on imported finished pharmaceutical products.