Ghana and Nigeria Set an Important Precedent on What Should be the African Approach to Responding to Manufacturers of Illicit, Substandard Medicines
Dr Delese Mimi Darko, CEO Ghana FDA and Prof. Mojisola C. Adeyeye: Director General of National Agency for Food and Drug Administration and Control

Ghana and Nigeria Set an Important Precedent on What Should be the African Approach to Responding to Manufacturers of Illicit, Substandard Medicines


Ghana and Nigeria have set an important precedence that raises the bar on the African response to manufacturers making illicit, counterfeit and substandard medicines for export to African markets. It is a response that African nations should adopt as a norm and n a coordinated manner to protect patient safety. In response to the BBC Africa Eye investigation exposing Aveo Pharmaceuticals' illegal exportation of harmful opioid products, the Food and Drugs Authority,Ghana (FDA) suspended the company's certificate to export products to the country. The BBC investigation revealed that Aveo Pharmaceuticals, based in India, had been manufacturing and distributing dangerous opioids, including a mixture of Tapentadol and Carisoprodol, under brands like Tafrodol and Royal 225. These drugs, which have addictive properties and pose serious health risks, were found on the streets of several West African nations, including Ghana and Nigeria. Two days later the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) (NAFDAC) followed suit and took action to protect public health by blacklisting Aveo Pharmaceuticals, the same Indian company implicated in the production and illegal exportation of harmful drugs to West Africa.

The move by the two countries follow a BBC World Service investigation that uncovered Aveo's involvement in manufacturing dangerous opioid combinations, including a cocktail of Tapentadol and Carisoprodol, sold under brands such as Tafrodol and Royal 225. These drugs, often used as street narcotics, have become a major public health concern in Nigeria and neighboring countries like Ghana and C?te d'Ivoire. The company's suspension is a critical measure to prevent the entry of illicit, unregistered, and dangerous pharmaceuticals into Ghana and Nigeria's markets, safeguarding public health. The action demonstrates a zero tolerance to exporters of illicit, substandard and counterfeited products into these countries.

Aveo Pharmaceuticals, managed by Vinod Sharma, has been found to produce illicit opioid products that have contributed to the growing opioid crisis in West Africa. These drugs are not only addictive but also pose severe health risks such as overdose, respiratory failure, and death. NAFDAC confirmed that none of these products, including any combination of Tapentadol or tramadol exceeding 100mg, have been registered for use in Nigeria. The company is now officially blacklisted under Nigerian law, specifically the Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous Provisions) Act, with measures in place to prevent future registration of its products. African countries should have a harmonized legal provision for similar bans in their markets as well.

This crackdown is a vital step in the broader effort to combat the rising tide of counterfeit and substandard medicines flooding African markets. The illegal sale of these opioids is particularly concerning, given their widespread abuse in West African countries. The availability of cheap and easily accessible drugs like Tafrodol and Royal 225 has exacerbated the opioid dependency crisis in the region, where these substances are often sold as street drugs. The prevalence of these counterfeit drugs poses a direct threat to public health, making urgent coordinated and harmonized regulatory action under the African Medicines Agency essential.

The issue of counterfeit medicines is not confined to Nigeria or Ghana alone. With the rising influx of substandard pharmaceuticals into Africa, it is super critical for other African nations to adopt similar measures to safeguard public health. Countries should continue to strengthen their regulations and working together, because when they do that, they can curb the distribution of these harmful substances, ensuring that only safe and effective medications reach the hands of their citizens.

These actions set an important precedence that we call on all African nations to adopt as a norm in circumstances where a manufacturer's has been shown to deliberately and consistently make counterfeit, substandard or illicit targeting African markets. Such actions would be taken in an Africa-wide coordinated manner that bans companies like Aveo from being able to export any of their products to any African market. Adoption of such a norm would signal strong collaboration towards a zero tolerance approach between African regulatory bodies to tackle the high burden of counterfeit and substandard medicines in the region. For instance in this specific case, the product should not be banned only by Ghana and Nigeria, but the entire West African community of nations (ECOWAS) because here is the thing. If the products can still be exported to Burkina Faso for instance, they can still easily enter Nigerian and Ghanian markets through cross-border trade. A regional approach would be more effective at addressing the opioid crisis.

The commitment of African nations to tackling fake, substandard, and counterfeited medicines is crucial in protecting people in Africa from the devastating impact of illicit medical products. medicines for africa (mfa) ca and regulators continues to call on the public to remain vigilant, avoid using unregistered products, and report suspicious activities to support the fight against counterfeit medicines. With sustained efforts, African nations can reduce the prevalence of dangerous medical products in the market and promote a healthier future for African populations.


These actions set an important precedence that we call on all African nations to adopt as a norm in circumstances where a manufacturer's has been shown to deliberately and consistently make counterfeit, substandard or illicit targeting African markets. Such actions would be taken in an Africa-wide coordinated manner that bans companies like Aveo from being able to export any of their products to any African market. Adoption of such a norm would signal strong collaboration towards a zero tolerance approach between African regulatory bodies to tackle the high burden of counterfeit and substandard medicines in the region. For instance in this specific case, the product should not be banned only by Ghana and Nigeria, but the entire West African community of nations (ECOWAS) because here is the thing. If the products can still be exported to Burkina Faso for instance, they can still easily enter Nigerian and Ghanian markets through cross-border trade. A regional approach would be more effective at addressing the opioid crisis. In Nigeria, the company is now officially blacklisted under Nigerian law, specifically the Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous Provisions) Act, with measures in place to prevent future registration of its products. Similar harmonized legal provisions for similar bans in tin all African markets could be a powerful deterrent for for manufacturers targeting the continent with harmful substances.

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Debisi Aboyade-Cole, MSEM, PMP

Pharmaceutical Engineering Consultant

1 小时前

This sustained precedence will go a long way in creating stability and consumer confidence in society. Let us know how we can help this course. Congratulations.

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Paul A. Lartey, Ph.D.

Independent Consultant | Pharmaceutical Industry Best Practice Advisor at National Coordination Center

2 小时前

This reflects strong leadership and commitment to regulatory excellence. The example by the CEO of Ghana FDA and the Director General of NAFDAC should be emulated across Africa. ??

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Greg Perry

“The secret of change is to focus all of your energy, not on fighting the old, but building on the new.” – Socrates All comments and posts represent my own personal views and interests .

2 小时前

Very significant move by Ghana and Nigeria . Reflects the strong leadership and vision of both regulatory authorities.

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KINGSLEY EZEA

Biochemists/pharmaceutics industry at Emzor Pharmaceutical Industries Ltd

7 小时前

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KINGSLEY EZEA

Biochemists/pharmaceutics industry at Emzor Pharmaceutical Industries Ltd

7 小时前

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