The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a clarification to help Nigerians better understand its recent publication listing 101 drugs that have been withdrawn, suspended, or cancelled by the agency.
According to a statement signed by the Director-General, Prof. Mojisola Adeyeye, the move was necessary to provide clarity on the regulatory status of the affected products and safeguard public health.
Prof. Adeyeye explained that the three classifications; withdrawn, suspended, and cancelled represent distinct regulatory actions with different implications for manufacturers and consumers.
Explanation of Classifications
- Withdrawn: This applies when a company voluntarily discontinues a product, often for commercial or market reasons rather than safety or quality concerns. For example, Artemether/Lumefantrine 40mg/240mg tablets by Healthline Limited and ASAQ (Artesunate Amodiaquine Winthrop) tablets by Sanofi Aventis Nigeria Ltd were voluntarily withdrawn for business-related reasons.
- Suspended: Products under suspension are those whose registration has been temporarily halted due to non-compliance with regulatory standards. These cases remain under review until the manufacturer addresses the identified issues and meets compliance requirements.
- Cancelled: This classification means a product’s registration has been fully revoked and it is no longer approved for manufacture, importation, sale, or use in Nigeria. Cancellations often follow findings related to safety concerns, poor manufacturing practices, or quality control failures.
NAFDAC said publishing such lists aligns with global best practices aimed at preventing the circulation of counterfeit or unsafe products and ensuring that discontinued medicines are not illegally sold.
Examples of Affected Products
Among the affected medicines are several well-known brands. Flagyl Suspension and Tablets (400mg) are no longer approved for use or sale, though other Metronidazole formulations remain registered.
In the antimalarial category, Artemether/Lumefantrine and ASAQ tablets were withdrawn voluntarily, while Penicillin G Sodium Sandoz Powder (1,000,000 IU) was also discontinued by Novartis Nigeria Ltd. Elisa Eye Drops (Chloramphenicol), however, had its approval revoked following regulatory action.
For diabetes medications, Januvia (50mg & 100mg), Janumet (50mg/850mg), and Amaryl M Tablets (1mg, 2mg, and 4mg SR) were among those withdrawn. Other delisted products include Aprovasc (150mg/5mg), Coaprovel (300mg/25mg), and Abacavir Sulfate/Lamivudine (60mg/30mg) tablets.
The agency also removed Norditropin Growth Hormone Injectables and Insulin Injectables after regulatory reviews, as well as Cryomarex Rispens HVT Vaccine due to compliance issues.
NAFDAC’s Ongoing Enforcement
BSGISTNEWS reports that NAFDAC reaffirmed its commitment to protecting public health and cracking down on counterfeit and substandard medical products.
In recent months, the agency destroyed over ₦15 billion worth of counterfeit, expired, and banned drugs in Ibadan, including Analgin, Co-codamol, Tramadol, Oxytocin, and expired vaccines. Another ₦1.2 billion worth of unregistered Malamal Forte malaria drugs were seized from a warehouse in Ilasa-Oshodi, Lagos.
Similarly, at Lagos Trade Fair Market, NAFDAC confiscated banned and unregistered cosmetics and pharmaceuticals worth ₦1.5 billion, many of which had bypassed safety testing or were smuggled into the country.
The agency warned that individuals or organisations aiding illegal importation, sale, or concealment of such products risk prosecution under Nigerian law.
