The Food and Drugs Authority (FDA) has refuted claims of approving tapentadol and carisoprodol as single-ingredient products in Ghana, following a recent BBC Africa Eye investigative report.
The report exposed the illegal exportation of unapproved opioid-containing drugs by Indian pharmaceutical company Aveo Pharmaceuticals through Westfin International to West African countries, including Ghana.
Dr. Delese A. A. Mimi Darko, Chief Executive Officer of the FDA, emphasized that the regulatory body has never approved or registered tapentadol or carisoprodol as standalone medications.
Furthermore, Tafradol, a fixed-dose combination of both substances, remains unregistered and unauthorized for any medical use in the country.
“The FDA categorically states that we have not registered tapentadol or carisoprodol as single-ingredient products, nor have we approved Tafradol for any medical condition. Our Centre for Import and Export Control (CIEC) has not processed any import permits for Tafradol or similar products, as these are unauthorized for use in Ghana,” Dr. Darko stated.
She reaffirmed that the FDA has maintained a strong stance against the illegal importation of unregistered and potentially harmful drugs, including Tramadol and its variants such as Trafanol, Tarapamol, and Tramaking.
Enforcement measures have led to the seizure and safe disposal of large quantities of these drugs over the years.
As part of its enforcement measures, the FDA recently intercepted and destroyed multiple shipments of unauthorized drugs.
A significant seizure occurred on December 18, 2023, when a container bound for Niger was found carrying 181 cartons of Royal 225mg, 51 cartons of Timaking 120mg, and 90 cartons of Tafradol 120mg.
Following a court order, these drugs were disposed of on February 21, 2025.
Additionally, in May 2024, a joint operation involving the FDA, National Security, Narcotics Control Commission, Ghana Revenue Authority (Customs Division), and other agencies led to the interception of 376 cartons of Tramadol Hydrochloride 225mg, which were disguised as laboratory coverall suits. These were safely destroyed in October 2024.
Dr. Darko highlighted that, through sustained surveillance, the FDA has confiscated approximately 287,011 units of Tramadol in strengths ranging from 50mg to 225mg, along with thousands of units of other unapproved opioid drugs.
She warned that unregulated opioids pose significant health risks, including addiction, respiratory collapse, and death.
The FDA has taken decisive action against Aveo Pharmaceuticals, which was implicated in the BBC Africa Eye exposé.
Although Aveo Pharmaceuticals had received a Good Manufacturing Practices (GMP) certificate in September 2024, the recent findings prompted the FDA to suspend the certificate and halt all pending regulatory processes involving the company.
“Samos Pharma, which was mentioned in the BBC report, is a registered importer of injections and eye drops from FDA-inspected Indian companies, none of which is Aveo Pharmaceuticals. However, we have directed Samos Pharma to cease all dealings with Aveo Pharmaceuticals and Westfin International Private Limited immediately,” Dr. Darko stated.
Furthermore, the FDA has suspended the processing of six drug registration applications submitted by Masters Pharmaceutical Limited, which had intended to use Aveo Pharmaceuticals as a contract manufacturer.
Dr. Darko reaffirmed the FDA’s commitment to curbing opioid abuse through stringent regulatory measures. In 2018, the FDA played a key role in the enactment of Executive Instruments (E.I.) 167 and 168, which banned the manufacture and sale of codeine-containing cough syrups and reclassified Tramadol as a controlled substance, respectively.
These measures have significantly tightened the importation, manufacture, and distribution of these drugs in Ghana.
“The FDA remains vigilant and will continue working with law enforcement agencies to ensure the safety and well-being of the public. We urge all stakeholders, including healthcare professionals and the general public, to report any suspicious drug activities to the Authority,” Dr. Darko concluded.
The FDA assures Ghanaians that it will leave no stone unturned in its fight against illegal and unregulated pharmaceutical products, reinforcing its mission to safeguard public health and safety.
Story by: Joshua Kwabena Smith
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