The National Agency for Food and Drug Administration and Control (NAFDAC) has banned Tafrodol also called Royal 225 and blacklisted the manufacturer; Aveo Pharmaceuticals.
Director General of NAFDAC, Prof. Mojisola Adeyeye announced the development in a press briefing in Abuja on Friday.
Adeyeye disclosed that 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.
She informed that the BBC World Service investigation revealed that packets of these brands, branded with the Aveo logo, had 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.
The DG stated that, “this press briefing is to inform the public that NAFDAC has never registered Tafrodol or Royal 225 or a strength of tramadol greater that 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”.
She advised the public to support NAFDAC’s fight against fake, substandard and falsified pharmaceutical products. They were also advised to avoid the use of unregistered products and consumption of medicines without prescription from trained medical practitioners.
Prof. Adeyeye further assured Nigerians of the Agency’s effort to ensure the circulation of only authentic medicines in the country:
“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.
“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”, she said.
In addition, the DG stated that NAFDAC had consistently worked to ensure that public health was 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”, she said.
