NAFDAC Blacklists Aveo Pharmaceuticals and Bans of Tapentadol and Carisoprodol Combination – Tafrodol or Royal 225
The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted the general public that a company named Aveo Pharmaceuticals, based in the outskirts of Mumbai and managed by Vinod Sharma is involved in the production, sale and exportation of a range of addiction pills containing a harmful mix of Tapentadol (a powerful opioid), and Carisoprodol, a banned muscle relaxant with addictive properties that can cause overdose, or death. The mix comes as Tafrodol or Royal 225.
NAFDAC is relying on the investigation carried out BBC World Service which revealed that packets of these brands, branded with the Aveo logo, have been on sale on the streets of Ghana, Nigeria, and Cote D’Ivoire towns and cities. Aveo Pharmaceuticals, India, is also implicated in the manufacture of high dose tramadol for export to countries in West Africa, including Nigeria.
It is on this basis that NAFDAC is informing the public that NAFDAC has never registered Tafrodol or Royal 225 or a strength of tramadol greater than 100 mg (the prescription strength), or any product manufactured by Aveo Pharmaceuticals Pvt Limited. Therefore, drawing from the NAFDAC Act Cap N.1 LFN 2004 and the Counterfeit and Fake Drugs and unwholesome Processed Foods (Miscellaneous Provisions) Act Cap C.34 LFN 2004, NAFDAC has decided to BLACKLIST AVEO Pharmaceuticals Pvt Limited. We have also put in place measures to prevent future registration of any product manufactured by this company.
In order to validate the BBC’s investigation, NAFDAC also sent an undercover operative to the factory, posing as an African businessman looking to supply opioids to Nigeria. With a hidden camera, the operative recorded his interaction with Vinod Sharma who confessed to the exportation of large consignments of these combination of drugs across West Africa and their distribution for abuse as street drugs and opioids.
Key findings
- Aveo Pharmaceuticals, India, managed by Vinod Sharma is involved in the production and illegal exportation of Tapentadol to countries in West Africa, including Nigeria.
- Aveo Pharmaceuticals is implicated in the manufacture and illegal exportation of Tramadol doses above 100mg, particularly 250mg.
- The illegal opioid brands come in different brand names such as Tafrodol, Royal-225 etc.
- The illegal brands carry the logo of Aveo pharmaceuticals.
- The illegal opioids are street drugs causing opioid dependence in Nigeria, Ghana and other West African countries.
This combination of drugs is not licensed for use anywhere in the world, neither is it registered by NAFDAC and can cause breathing difficulties and seizures. An overdose can kill. Despite the risks, these opioids are popular as street drugs in many West African countries, because they are so cheap and widely available.
In a statement released and signe by its DG, Professor Mojisola Christianah Adeyeye FAS, “NAFDAC has intensified its enforcement activities against the sale of illicit and counterfeit pharmaceuticals across major distribution channels and hubs across the country and this will continue to happen to make Nigeria an uncomfortable place to engage in such unethical and unapproved distribution of fake, substandard and falsified pharmaceutical products. We are also working with other regulatory authorities and security agencies to curb the entry into Nigeria through our borders and thereby prevent the distribution and circulation of these dangerous products.”
The organisation therefore advises the public to support its fight against fake, substandard and falsified pharmaceutical products. Nigerians are also advised to avoid the use of unregistered products and consumption of medicines without prescription from trained medical practitioners. This is to assure the public that NAFDAC will continue to deploy various methods to ensure that only quality, safe and efficacious medicines are available for distribution, sale and use within Nigeria.
The organisation reminds everyone that it has consistently worked to ensure that public health is protected through the entrenchment of International best practices during product registration, which include dossier reviews, Good Manufacturing Practice (GMP) inspections and laboratory analysis of products intended for registration. It also has Post Marketing Surveillance activities and Pre-shipment Inspection Scheme also called the Clean Report of Inspection and Analysis (CRIA) Scheme for high-risk countries like India.
These measures are there to support NAFDAC’s efforts at prevention of import and distribution of substandard, fake, and falsified pharmaceutical products in Nigeria.
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