FDA responds to BBC Africa Eye’s documentary on illegal importation of unapproved opioids into Ghana

The Food and Drugs Authority (FDA) has responded to a recent BBC Africa Eye investigation that exposed the export of unapproved drugs containing tapentadol, a powerful opioid and carisoprodol by India’s Aveo Pharmaceuticals to West African countries, including Ghana.

The investigative report uncovered that these drugs were exported through Westfin International to West Africa, particularly Côte d’Ivoire, Nigeria, and Ghana.

The FDA in its statement released on February 26 asserted 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.

According to the FDA, its Centre for Import and Export Control (CIEC) has not received or processed any import permit application for products containing these substances or similar brands, as they are unauthorized for use in Ghana.

“During the BBC investigation, the FDA was contacted and unequivocally confirmed that these drugs are unapproved and illegal for importation,” the FDA’s statement said.

In December 2023, FDA said 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 on February 21, 2025 following a court order in January 2025.

According to the statement, in May 2024, a joint operation involving the FDA, National Security, Narcotics Control Commission, Ghana Revenue Authority (Customs Division), Bureau of National Investigations, and other agencies intercepted 376 cartons of Tramadol Hydrochloride 225mg (Tramaking 225mg) concealed among 50 cartons of laboratory coverall suits.

They were safely disposed of in October 2024.

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.

“Similarly, the Authority has suspended the processing of Masters Pharmaceutical Limited’s application using Aveo Pharmaceuticals as a contract manufacturer with immediate effect and has also suspended Aveo Pharmaceuticals’ GMP certificate,” the statement added.

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.

The post FDA responds to BBC Africa Eye’s documentary on illegal importation of unapproved opioids into Ghana first appeared on 3News.

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