The National Agency for Food and Drug Administration and Control (NAFDAC) says it has blacklisted an Indian company, Aveo Pharmaceuticals, for producing a range of harmful addictive pills capable of causing death.
The director-general of NAFDAC, Mojisola Adeyeye, said at a news conference in Abuja on Friday that the company is situated on the outskirts of Mumbai in India.
She said the company was involved in the production, sales, and exportation of addictive pills containing a harmful mix of Tapentadol (a powerful opioid) and Carisoprodol, a banned muscle relaxant with addictive properties that could result in overdosing or cause death.
According to the NAFDAC boss, the mix comes as Tafrodol or Royal 225.
The NAFDAC boss said that a BBC World Service investigation revealed that packets of these brands, branded with 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.
“This press briefing is to inform the public that NAFDAC has never registered Tafrodol or Royal 225 or 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 No. 1 Law of the Federation of Nigeria (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,” said Ms Adeyeye.
The NAFDAC DG also disclosed that the agency had put measures in place to prevent future registration of products by Aveo Pharmaceuticals.
“The public is, therefore, advised to support NAFDAC’s fight against fake, substandard, and falsified pharmaceutical products.
“They are also advised to avoid the use of unregistered products and consumption of medicines without prescription from trained medical practitioners,” Ms Adeyeye said.
She said an undercover operative sent into the factory with a hidden camera posing as an African businessman looking to supply opioids to Nigeria recorded his interaction with one of Aveo’s directors, Vinod Sharma, who confessed to the exportation of large consignments of this combination of drugs across West Africa and their distribution for abuse as street drugs and opioids.
Ms Adeyeye said this combination of drugs was not licensed for use anywhere in the world and was not registered by NAFDAC, noting that it could cause breathing difficulties and seizures.
The NAFDAC boss said an overdose of the drugs could kill, adding that despite the risks, the opioids were popular as street drugs in many West African countries because they were so cheap and widely available.
The DG assured the public that NAFDAC would continue to deploy various methods to ensure that only quality, safe, and efficacious medicines are available for distribution, sale, and use within Nigeria.
She said the agency also worked on post-marketing surveillance activities and the pre-shipment inspection scheme, also known as the Clean Report of Inspection and Analysis (CRIA) scheme, for high-risk countries like India.
Ms Adeyeye said NAFDAC had intensified its enforcement activities against the sale of illicit and counterfeit pharmaceuticals across major distribution channels and hubs nationwide.
The NAFDAC boss said the agency was also working with other regulatory authorities and security agencies to curb their entry into Nigeria through the borders.
(NAN)
