FDA suspends Aveo Pharmaceuticals’ certification over opioid smuggling

The Food and Drugs Authority (FDA) has suspended the Good Manufacturing Practices (GMP) certification of Aveo Pharmaceuticals, an Indian drug manufacturer, following revelations of its involvement in the illegal distribution of opioid-based medications to West Africa.

The decision follows a BBC Africa Eye investigation, which exposed how Aveo Pharmaceuticals, through Westfin International, allegedly exported unapproved drugs containing tapentadol and carisoprodol to countries including Ghana, Nigeria, and Côte d’Ivoire.

These substances, classified as highly addictive opioids, pose serious health risks, including respiratory failure and death when abused.

In response to the exposé, the FDA has instructed Samos Pharma, a Ghana-based importer, to cease all dealings with Aveo Pharmaceuticals and Westfin International.

Furthermore, the registration process for six products from Masters Pharmaceutical Limited, which planned to use Aveo Pharmaceuticals as a contract manufacturer, has been put on hold.

The FDA reaffirmed its commitment to combating opioid abuse, highlighting ongoing enforcement efforts, including seizures, fines, and prosecutions of unauthorized drug distributors. It assured the public that it will continue to collaborate with law enforcement agencies to prevent the influx of dangerous pharmaceuticals into the country.

This latest action reinforces Ghana’s regulatory stance on illicit drug trafficking and strengthens ongoing measures to safeguard public health.