The National Agency for Food and Drug Administration and Control (NAFDAC) has issued an official clarification regarding the status of 101 pharmaceutical products recently removed from the Nigerian market.
In a statement posted on its official X (formerly Twitter) account on Tuesday, the agency said the move aims to provide the public and industry stakeholders with a clearer understanding of the regulatory actions applied to the listed products.
NAFDAC explained that the terms “withdrawn,” “suspended,” and “cancelled” each reflect distinct regulatory decisions taken to ensure drug safety, quality, and regulatory compliance.
- “Withdrawn” products are those whose registrations have been voluntarily discontinued by the Marketing Authorisation Holders (MAHs), usually for commercial or strategic reasons, and not necessarily due to safety or efficacy concerns.
- “Suspended” refers to temporary registration halts, typically pending the resolution of regulatory or compliance issues.
- “Cancelled” applies to drugs whose approvals have been fully revoked—often as a result of safety risks, poor manufacturing standards, or other serious violations. These products are no longer authorised for manufacture, import, distribution, or sale in Nigeria.
NAFDAC emphasized that publishing such lists is in line with global best practices. It serves to prevent counterfeit circulation and to ensure that de-registered or substandard products do not remain on pharmacy shelves or reach consumers.
Examples span several therapeutic classes, including antimalarials, antimicrobials, diabetes medications, eye drops, and injectables.
Among the notable cases:
- Artemether/Lumefantrine 40mg/240mg Tablets and ASAQ (Artesunate-Amodiaquine Winthrop) Tablets were voluntarily withdrawn by Healthline Limited and Sanofi Aventis Nigeria Ltd, respectively, for commercial reasons.
- Flagyl Suspension and Tablets (400mg) have had their registrations cancelled, meaning they are no longer approved for production or sale.
- Norditropin Growth Hormone Injectables have also been delisted following a regulatory review.
NAFDAC reiterated its commitment to public health and urged healthcare providers, pharmacists, and distributors to stay informed and comply with updated regulatory guidelines.
