The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted an Indian company, Aveo Pharmaceuticals Pvt Limited for its involvement in the illegal production, sale and exportation of addiction pills into West Africa, including Nigeria.
The Director-General (DG) of NAFDAC, Prof. Mojisola Adeyeye made this known in a statement on Friday, noting that the company is managed by Vinod Sharma.
Mrs. Adeyeye disclosed that the range of addiction pills contain a harmful mix of Tapentadol (a powerful opioid), and Carisoprodol (a banned muscle relaxant with addictive properties that can cause overdose, or death, while the mix comes as Tafrodol or Royal 225.
“The BBC World Service investigation 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,” she stated.
According to her, the regulatory body has never registered Tafrodol or Royal 225 or a strength of tramadol greater than 100mg (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,” the DG said.
She called on the public to support the agency’s fight against fake, substandard and falsified pharmaceutical products – and advised them to avoid the use of unregistered products and consumption of medicines without prescription from trained medical practitioners.
Adeyeye assured 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.
She stressed: “An undercover operative sent inside the factory, posing as an African businessman looking to supply opioids to Nigeria with a hidden camera recorded his interaction with Vinod Sharma who confessed to exportation of large consignments of these combination of drugs across West Africa and their distribution for abuse as street drugs and opioids.
“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.
“NAFDAC 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. We also have 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.”
DG Adeyeye explained that these measures are there to support the agency’s efforts at prevention of import and distribution of substandard, fake, and falsified pharmaceutical products in Nigeria.
She highlighted the key findings including Aveo Pharmaceuticals, India, being managed by Vinod Sharma, and involved in the production and illegal exportation of Tapentadol to countries in West Africa, including Nigeria.
Others are: “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.”
The CEO emphasised that the regulatory body has intensified its enforcement activities against the sale of illicit and counterfeit pharmaceuticals across major distribution channels and hubs in the country.
This, she said, 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 DG noted.
She further assured that with the support of the public, the agency will continue to carry out the major mandate of safeguarding the health of Nigerians.
