The Food and Drugs Authority (FDA) has responded to a recent BBC Africa Eye investigation that uncovered the export of unapproved drugs containing tapentadol and carisoprodol by India’s Aveo Pharmaceuticals to West African countries, including Ghana.
The FDA asserts that it has neither registered nor approved these substances for medical use within the nation.
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.
The FDA’s Centre for Import and Export Control has not processed any import permits for products containing these substances, rendering their presence in Ghana illegal.
In December 2023, authorities intercepted a container en route to Niger, discovering substantial quantities of unapproved drugs, including 181 cartons of Royal 225mg (Tapentadol and Carisoprodol) and 90 cartons of Tafradol 120mg.
These illicit products were seized and destroyed following a court order in January 2025.
The FDA said it has also taken action against local entities involved with 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 the processing of product registration applications from Masters Pharmaceutical Limited, which had engaged Aveo Pharmaceuticals as a contract manufacturer.
These measures underscore the FDA’s commitment to safeguarding public health by preventing the importation and distribution of unapproved and potentially dangerous pharmaceuticals within Ghana.
Source: myjoyonline.com