NAFDAC blacklists AVEO Pharma over importation of unregistered highly-addictive opioids

The National Agency for Food and Drugs Administration and Control (NAFDAC) has blacklisted AVEO Pharmaceuticals Pvt Limited for its involvement in the production and illegal exportation of tapentadol to countries in West Africa, including Nigeria.

The pharmaceutical firm was also implicated in the manufacture and illegal exportation of tramadol doses above 100mg, particularly 250mg.

Consequently, NAFDAC also banned the importation and sale of tapentadol and carisoprodol combination- tafrodol or Royal 225 in the country.

The Director General of NAFDAC, Prof Mojisola Adeyeye, who announced this, on Friday, said that Aveo Pharmaceuticals, based in the outskirts of Mumbai,India, managed by Vinod Sharma, is involved in the production, sale and exportation of a range of addictive 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.

Adeyeye noted that the sanction followed an investigation, which revealed that packets of these brands, branded with the Aveo logo, have been on sale on the streets of Nigeria, Ghana and Cote D’Ivoire.

She observed that Aveo Pharmaceuticals is also implicated in the manufacture of high dose tramadol for export to countries in West Africa, including Nigeria, adding that the mix comes as Tafrodol or Royal 225.

According to her, 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 this combination of drugs across West Africa and their distribution for abuse as street drugs and opioids.

She explained that this combination of drugs is not licenced for use anywhere in the world, neither is it registered by NAFDAC as it can cause breathing difficulties and seizures. An overdose, she said, can kill; adding that despite the risks, these opioids are popular as street drugs in many West African countries because they are so cheap and widely available.

Adeyeye stated that NAFDAC has never registered tafrodol or Royal 225; or tramadol greater than 100 mg strength, the prescription strength, or any product manufactured by Aveo Pharmaceuticals Pvt Limited.

She said: “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 blacklisted AVEO Pharmaceuticals Pvt Limited. 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.”

Adeyeye, who observed that NAFDAC has also put in place measures to prevent future registration of any product manufactured by this company, noted that the agency has intensified enforcement activities against the sale of illicit and counterfeit pharmaceuticals across major distribution channels and hubs across the country.

She said that the enforcement 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.

“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. These measures are there to support NAFDAC’s efforts at prevention of import and distribution of substandard, fake, and falsified pharmaceutical products in Nigeria.”

The NAFDAC boss urged Nigerians to support the agency’s fight against fake, substandard and falsified pharmaceutical products and avoid the use of unregistered products and consumption of medicines without prescription from trained medical practitioners.

She assured Nigerians 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.