The National Agency for Food and Drug Administration and Control (NAFDAC) has provided clarification on the status of 101 withdrawn drugs in Nigeria. This move aims to enhance public understanding and stakeholder awareness of the regulatory actions taken regarding these products.
NAFDAC released a statement explaining that terms such as “withdrawn,” “suspended,” and “cancelled” signify distinct regulatory measures implemented to ensure the quality, safety, and compliance of drugs. A “withdrawn” product refers to one whose registration has been voluntarily discontinued by the manufacturer, often due to commercial or market-related reasons rather than safety concerns. On the other hand, “suspended” products are those whose registration has been temporarily halted pending regulatory compliance, while “cancelled” products are those whose approvals have been fully revoked due to safety, quality, or poor manufacturing practices.
The agency emphasized that publishing lists of withdrawn products is a global best practice aimed at preventing counterfeiting and ensuring that delisted products are removed from circulation. NAFDAC listed examples of affected products across various categories, including antimalarials, antimicrobials, diabetes medicines, eye drops, and injectables. Notable examples include Artemether/Lumefantrine 40mg/240mg Tablets and ASAQ (Artesunate Amodiaquine Winthrop) Tablets, which were withdrawn voluntarily by their respective manufacturers for commercial reasons.
Other affected products include Flagyl Suspension and Tablets, which are no longer approved for manufacture or sale, and Norditropin Growth Hormone Injectables, which have been delisted following a regulatory review. In the diabetes category, Januvia and Janumet have been withdrawn from the market, while Amaryl M Tablets and Amaryl M SR were voluntarily withdrawn by Sanofi Aventis Nigeria Ltd.
NAFDAC reaffirmed its commitment to public safety, stating that it “remains committed to safeguarding the health of Nigerians through continuous post-market surveillance and regulatory enforcement to ensure that only safe, quality, and efficacious products are available to the public.” This clarification underscores the agency’s efforts to maintain transparency and protect public health by ensuring the removal of unsafe or ineffective drugs from the market.