BBC opioid exposé: FDA suspends Aveo Pharmaceuticals’ GMP certificate

The Food and Drugs Authority (FDA) has suspended Aveo Pharmaceuticals' Good Manufacturing Practices (GMP) certificate with immediate effect following a BBC exposé on the illegal manufacturing and export of highly addictive opioids to West Africa.

According to the investigation, Aveo Pharmaceuticals, based in Mumbai, India, has been producing unlicensed, highly addictive pills and illegally exporting them to countries such as Ghana, Nigeria, and Côte d'Ivoire.

ALSO READ: NSS Scandal: NIB releases former deputy NSA director after days in detention

These pills, marketed under various brand names, are designed to resemble legitimate medicines but contain the same dangerous combination of tapentadol, a powerful opioid, and carisoprodol.

In its official statement dated 26 February, the FDA clarified that it had neither received nor processed an import permit application for Tafradol or any similar brands, as such products are unauthorised for use in Ghana.

FDA Clarifies Its Relationship with Aveo Pharmaceuticals

The FDA provided further details regarding its dealings with Aveo Pharmaceuticals, stating:

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. However, records from 2022 and 2023 indicate that Westfin International Private Limited and Aveo Pharmaceuticals were exporters of these products to Samos Pharma.

ALSO READ: Deputy minister-designate embarrassed as he fails to name NDC’s manifesto policy

Aveo Pharmaceuticals Pvt. Ltd. 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.

Sanctions Imposed

In response to the BBC Africa Eye findings, the FDA has taken the following actions:

• Directed Samos Pharma to immediately cease sourcing products from Westfin International Private Limited and Aveo Pharmaceuticals.

• Suspended the processing of Masters Pharmaceutical Limited’s application to register six products that were to be manufactured by Aveo Pharmaceuticals.

• Revoked Aveo Pharmaceuticals’ GMP certificate with immediate effect.

The FDA reaffirmed its commitment to safeguarding public health by enforcing strict regulatory controls and preventing the infiltration of harmful and unapproved medicines into the Ghanaian market.