By Anna Claudia Duker
The Food and Drugs Authourity (FDA) following the BBC Africa Eye Investigative report exposing the alleged exportation of unapproved drugs Expose has directed Samos Pharma to immediately cease using Westfin International Private limited and Aveo Pharmaceuticals as exporters.
The Authourity has also 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 Chief Executive Officer (CEO) of FDA, Mrs Delese Darko stated, the Food and Drugs Authourity (FDA) has taken note of the recent BBC Africa Eye Investigative report exposing the alleged exportation of unapproved drugs containing tapentadol, a powerful opoid and Carisoprodol by Indian pharmaceutical company Aveo Pharmaceuticals, through Westfin International, to west Africa, particularly Cote d’Ivoire, Nigeria and Ghana.
Mrs Darko stated, Samos Pharma, mentioned in the BBC report is a registered importer of injections and eye drops manufactured by FDA-inspected Indian companies, none of which is Aveo pharmaceuticals.
She disclosed the FDA 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 CEO added the FDA Center for Import and export Control (CEIC) has not received or processed an import permit application for Tafradol or similar brands as such products are unauthorised for use in Ghana.
According to her, during the BBC Investigation, the FDA was contacted and unequivocally confirmed that these drugs are unapproved and illegal for importation.
She indicated, the expose reinforces the Authourity’s longstanding enforcement efforts against the illegal importation of unregistered drugs and susbstances of abuse, including Tramadol, Trafanol, Tarapamol and Tramaking.
Mrs Darko noted, through rigorous surveillance, the FDA has imposed fines, seized illicit drugs and ensured their safe disposal.
The CEO explained Tapentadol is an opioid with a high potential for addiction, leading to psychological dependence. Abuse can cause drowsiness, lethargy, respiratory collapse, and even death while, Carisoprodol, used in some countries for musculoskeletal pain management, also carries addiction risks and can cause drowsiness, concentration difficulties and confusion.
However, records from 2022 and 2023 indicate that Westfin International Private limited and Aveo pharmaceuticals were exporters of these products to Samos Pharma.
Aveo Pharmaceuticals Private Limited was granted a Good Manufacturing Practices (GMP) certificate in September 2024 following an inspection in April 2024. The company was in the process of contract manufacturing for masters Pharmaceutical Limited, based in Kumasi, which had applied for the registration of six products.
The CEO assured the public that is actively working with key stakeholders to investigate the issues raised in the BBC AFfrica Eye report and remains resolute in its mission to protect public health and ensure the safety of all regulated products in Ghana.
