THE FOOD and Drugs Authority (FDA) has announced the initiation of an investigation into a recent report by BBC Africa Eye, which revealed that India’s Aveo Pharmaceuticals has been exporting unapproved drugs containing tapentadol and carisoprodol to West African countries, including Ghana.
The FDA has clarified that it has not registered tapentadol or carisoprodol as single-ingredient products, nor has it approved Tafradol, a fixed-dose combination of both substances, for any medical condition.
The Authority has assured the public that it is actively collaborating with key stakeholders to investigate the concerns raised in the BBC Africa Eye report, adding, “The FDA remains committed to protecting public health and ensuring the safety of all regulated products in Ghana.”
In response to these findings, the FDA has directed Samos Pharma to immediately cease using Westfin International Private Limited and Aveo Pharmaceuticals as exporters. Additionally, the Authority has suspended the processing of Masters Pharmaceutical Limited’s application that involves Aveo Pharmaceuticals as a contract manufacturer, effective immediately.
This action comes in light of the BBC Africa Eye findings regarding Aveo Pharmaceuticals’ involvement in the illegal manufacturing and distribution of opioid products.
BBC Report
An Indian pharmaceutical company is manufacturing unlicensed, highly addictive opioids and exporting them illegally to West Africa where they are driving a major public health crisis in countries including Ghana, Nigeria, and Cote d’Ivoire, a BBC Eye investigation has revealed.
Aveo Pharmaceuticals, based in Mumbai, makes a range of pills that go under different brand names and are packaged to look like legitimate medicines. But all contain the same harmful mix of ingredients: tapentadol, a powerful opioid, and carisoprodol, a muscle relaxant so addictive it’s banned in Europe.
This combination of drugs are not licensed for use anywhere in the world, and can cause breathing difficulties and seizures. An overdose can kill. Despite the risks, these opioids are popular as street drugs in many West African countries, because they are so cheap and widely available.
In response to the above claims, the Authority indicated that the FDA Centre for Import and Export Control (CIEC) has not received or processed an import permit application for Tafradol or similar brands, as such products are unauthorised for use in Ghana.
A statement, signed by the CEO, Mrs. Delese Mimi Darko, revealed that during the BBC investigation, the Food and Drugs Authority was contacted and categorically confirmed that the drugs in question are unapproved and illegal for importation.
“This exposé reinforces the Authority’s longstanding enforcement efforts against the illegal importation of unregistered drugs and substances of abuse, including Tramadol, Trafanol, Tarapamol, and Tramaking. Through rigorous surveillance, the FDA has imposed fines, seized illicit drugs, and ensured their safe disposal,” part of the statement read.
Meanwhile, upon its strict ongoing enforcement, recent operations, according to the Authority, have identified the continued presence of various Tramadol brands, including Trafanol, Tarapamol, and Tramaking, in Tamale and other parts of the country.
The Authority revealed that on December 18, 2023, a container (MRKU 9648934) declared for transit to Nemin, Niger, was found to contain 181 cartons of Royal 225mg (Tapentadol and Carisoprodol), 51 cartons of Timaking 120mg (Tapentadol and Carisoprodol), and 90 cartons of Tafradol 120mg, stating that, “these were seized and disposed of following a court order dated January 16, 2025, with destruction completed on February 21, 2025.”
The FDA has also confiscated approximately 287,011 units of Tramadol in varying strengths from 50mg to 225mg, 8,576 units of Trafadol, and 2,053 units of Tramaking at different border posts, over-the-counter medicine sellers (OTCMS), and from hawkers. None of the confiscated products had manufacturer details indicated on them.
The Authority further added that in collaboration with state agencies, including the Ghana Revenue Authority (Customs Division), Narcotics Control Commission, National Intelligence Bureau, Port Health, Ghana Standards Authority, Ghana Police Service, National Security, Pharmacy Council, Local Government, Environmental Protection Agency, and the media, has conducted multiple safe disposals of confiscated Tramadol and other opioids. Perpetrators of these illegal activities face strict regulatory sanctions, including administrative fines and prosecution.
BY Prince Fiifi Yorke