NAFDAC Clears the Air: What “Withdrawn,” “Suspended,” and “Cancelled” Drugs Mean for Nigerians.
The National Agency for Food and Drug Administration and Control (NAFDAC) has issued an important clarification regarding its recent publication of a list of 101 drugs that have had their regulatory status changed. The move is a crucial step in protecting public health and preventing unsafe or discontinued medicines from reaching the market.
NAFDAC, under the leadership of Director-General Prof. Mojisola Adeyeye, emphasized that publicly sharing the list of withdrawn, suspended, or cancelled products is a global best practice aimed at curbing the circulation of counterfeits.
NAFDAC’s Three Classifications Explained
To ensure consumers and manufacturers understand the regulatory status of the affected products, NAFDAC clearly defined the three classifications:
Key Drugs and Categories Affected
The list of 101 products includes several major brands across different therapeutic categories.
Key Withdrawals (Commercial Reasons):
Antimalarials: Artemether/Lumefantrine 40mg/240mg (Healthline Limited) and ASAQ (Artesunate Amodiaquine Winthrop) tablets (Sanofi Aventis).
Diabetes Drugs: Januvia (50mg & 100mg), Janumet (50mg/850mg), and Amaryl M Tablets (1mg, 2mg, and 4mg SR) were all voluntarily withdrawn.
Other Medicines: Aprovasc (150mg/5mg) and Coaprovel (300mg/25mg) tablets.
Notable Cancellations (Regulatory Action):
Antimicrobial: Elisa Eye Drops (Chloramphenicol) had its approval revoked due to regulatory action.
Essential Medicines: Flagyl Suspension and Tablets (400mg) are specifically listed as no longer approved for use or sale (though other Metronidazole formulations remain registered).
NAFDAC’s War Against Counterfeits
NAFDAC’s clarification comes as the agency intensifies its nationwide crackdown on illegal and expired medical products. Recent high-profile operations include:
N15 Billion Destruction: In October, the agency destroyed counterfeit, expired, and banned drugs—including codeine cough syrups, Tramadol, and expired vaccines—worth over N15 billion in Ibadan, Oyo State.
Major Seizures: High-volume seizures included a container falsely labelled as diclofenac but packed with over 100,000 tablets of anti-malaria drugs, and N1.2 billion worth of unregistered Malamal Forte malaria medicines found concealed in Lagos.
The agency’s message is clear: the published list is a crucial step in ensuring that discontinued or non-compliant drugs do not circulate, especially as NAFDAC aggressively combats the influx of dangerous counterfeit products.
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