FDA Ghana Confirms Pharmaceutical Imports from Aveo and Westfin; Orders Immediate Halt
The Food and Drugs Authority (FDA) of Ghana has issued an official statement confirming that Samospharma Limited has imported pharmaceutical products from Aveo Pharmaceuticals Pvt. Ltd. and Westfin International Pvt. Ltd., two Indian exporters recently implicated in the illicit opioid trade in West Africa. The statement follows an investigative report by BBC Africa Eye, which exposed how unregulated opioids were being smuggled into Ghana and Nigeria.
FDA Findings Confirm Business Ties
In a letter dated February 21, 2025, and addressed to Samospharma’s Head of Regulatory Affairs, the FDA confirmed that its official records from 2022 and 2023 indicate that both Aveo Pharmaceuticals Pvt. Ltd. and Westfin International Pvt. Ltd. were exporters for Samospharma. The products imported include:
- 2022: Timonidin Eye Drops (Westfin International Pvt. Ltd.)
- 2023: Samocef 750mg Injection (Westfin International Pvt. Ltd.)
- 2023: Prolatan Eye Drop (5ml) and Timonidin Eye Drops (Aveo Pharmaceuticals Pvt. Ltd.)
Despite Samospharma’s previous public denial of any business relationship with these companies, the FDA records establish direct import transactions.
Regulatory Crackdown: FDA Orders Import Ban
The FDA has now directed Samospharma to immediately cease all imports from both Aveo Pharmaceuticals Pvt. Ltd. and Westfin International Pvt. Ltd., citing the revelations in the BBC Africa Eye investigation that linked Aveo to illegal opioid production and distribution.
Additionally, the FDA has taken the following actions:
- Suspended the processing of an application by Masters Pharmaceutical Limited, which had used Aveo as a contract manufacturer.
- Announced stricter importation controls for pharmaceutical products from India.
- Warned that any further imports from these companies will not be processed by the FDA Ghana.
“In light of the BBC Africa Eye findings on Aveo Pharmaceuticals’ involvement in the illegal manufacturing and distribution of opioid products, the FDA has directed Samospharma to immediately cease using Westfin International Private Limited and Aveo Pharmaceuticals as exporters.” — FDA Ghana Statement
FDA’s Stance on the Opioid Crisis in Ghana
The FDA reaffirmed that tapentadol and carisoprodol—two highly addictive opioids—are unregistered and illegal in Ghana, and that no pharmaceutical company has been authorized to import them.
The regulatory body also emphasized that it has been actively enforcing drug safety measures, including:
- Seizing illegal opioid shipments at ports and entry points.
- Prosecuting six pharmaceutical retailers for selling unauthorized drugs.
- Collaborating with Ghana’s National Security, Customs, and the Narcotics Control Commission to enhance drug enforcement efforts.
Contradictions in Samospharma’s Response
The FDA’s findings now contradict Samospharma’s earlier public statements, in which the company categorically denied ever doing business with Aveo Pharmaceuticals Pvt. Ltd. and Westfin International Pvt. Ltd. The company had previously stated:
“Samospharma or any of its affiliates have no business relationships, past or present, with Aveo Pharmaceuticals, PRG Pharma, or Westfin.”
This revelation raises significant transparency concerns, particularly as Samospharma has threatened legal action against BBC Africa Eye for defamation. The confirmation from the FDA now adds weight to the original BBC investigation, potentially exposing misrepresentations made by the company.
What This Means for Ghana’s Pharmaceutical Industry
The FDA’s latest directive signals a stronger crackdown on unregulated pharmaceutical imports and highlights loopholes in Ghana’s drug enforcement policies. Moving forward, industry analysts predict:
- Increased scrutiny on all pharmaceutical imports, especially those from India.
- A possible expansion of FDA investigations into other importers linked to illicit drug trade.
- Potential legal consequences for Samospharma if further regulatory violations are uncovered.
- More cooperation between international regulatory agencies to prevent the spread of illicit pharmaceuticals in West Africa.
Next Steps & Unanswered Questions
With the FDA’s confirmation of these business ties, several critical questions remain unanswered:
- Will Samospharma acknowledge its business relationships with these exporters following the FDA’s directive?
- Will Samospharma withdraw its legal threats against BBC Africa Eye?
- What further regulatory actions will Ghana’s FDA take against other pharmaceutical companies implicated in illicit imports?
- How will Ghana’s government strengthen its pharmaceutical import regulations?
For now, Samospharma is under mounting pressure to provide clear answers, while FDA Ghana moves to reinforce regulatory oversight in the country’s pharmaceutical sector.
