The Food and Drugs Authority (FDA) has responded to a BBC Africa Eye investigation exposing the export of unapproved drugs containing tapentadol and carisoprodol by India’s Aveo Pharmaceuticals to West African countries, including Ghana.
The FDA clarified that it has not registered or approved these substances for medical use in Ghana.
Tapentadol, a potent opioid, and carisoprodol, a muscle relaxant, pose significant health risks, including addiction and severe side effects such as respiratory collapse and confusion.
According to the FDA, its Centre for Import and Export Control has not processed any import permits for these substances, making their presence in Ghana illegal.
In December 2023, authorities intercepted a container bound for Niger, seizing large quantities of unapproved drugs, including 181 cartons of Royal 225mg (Tapentadol and Carisoprodol) and 90 cartons of Tafradol 120mg.
The seized products were destroyed following a court order in January 2025.
The FDA has also taken action against local entities linked to Aveo Pharmaceuticals. Samos Pharma, a registered importer, has been directed to cease collaborations with Aveo Pharmaceuticals and its exporter, Westfin International Private Limited.
Additionally, the FDA has suspended product registration applications from Masters Pharmaceutical Limited, which had engaged Aveo Pharmaceuticals as a contract manufacturer.
These measures underscore the FDA’s commitment to protecting public health by preventing the importation and distribution of unapproved and potentially dangerous pharmaceuticals in Ghana.
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