The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted AVEO Pharmaceuticals Pvt Limited, reasons tied to production and spread of harmful drugs that can cause death.
The decision was contained in a press briefing issued by the Director General of NAFDAC, Mojisola Christianah Adeyeye.
She explained that the India based pharmaceutical company, managed by Vinod Shama is involved in the production, sale and exportation of some addiction pills containing “Tapentadol” and “Carisoprodol”, an addictive property that can cause overdose, or death.
Adeyeye also revealed investigations from the BBC World service confirming the sale of these branded products in Ghana, Nigeria, Cote D’Ivoire towns and cities, with the India branch manufacturing high dose tramadol for export to countries in West Africa including Nigeria.
According to Adeyeye, “A company named Aveo Pharmaceuticals, based in the outskirts of Mumbai, 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”.
“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”.
The key findings from the company’s statement reveal significant concerns regarding the activities of Aveo Pharmaceuticals, India, which is managed by Vinod Sharma. The company is actively involved in the production and illegal exportation of Tapentadol to various countries in West Africa, including Nigeria.
Furthermore, Aveo Pharmaceuticals has been implicated in the manufacture and unauthorized distribution of Tramadol doses exceeding 100mg, particularly the 250mg variant. These illicit opioids are distributed under different brand names such as Tafrodol and Royal-225. Notably, these illegal brands bear the logo of Aveo Pharmaceuticals, further linking the company to their production.
Moreover, these unregulated opioids have found their way into the streets, contributing to opioid dependence in Nigeria, Ghana, and other West African nations. The widespread circulation of these drugs poses a serious public health challenge, as they are being misused and abused without proper medical oversight.
Adeyeye said the briefing is issued to notify the publics that NAFDAC does not register any products coming from the company and in accordance to 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 has blacklisted the company.
She also noted that measures have been put into place to prevent future registration of any products manufactured by the company.
“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 stated.
Furthermore, Adeyeye urged the public to support NAFDAC’s fight against fake drugs, avoiding the use of unregistered products and consuming only prescribed medicine from medical practitioners.
She assured the publics of NAFDAC’S continuous effort to ensure the distribution and sale of only quality and safe medicine.
“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. 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.” She stated.
Moreso, An undercover investigation from the agency has revealed confession from the manager of Ayeo Pharmaceutical Company, Vinod Sharma, who confirmed the exportation and distribution of the illegal drugs in large quantity across West Africa.
“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.” Adeyeye noted.
She further explained that NAFDAC has ensure public health protection through registration practices involving dossier reviews, Good manufacturing Practice (GMP) inspections, and laboratory analysis of products intended for registration with 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.
She noted that the measures are there to support NAFDAC’s efforts at preventing import and distribution of substandard, fake, and falsified pharmaceutical products in Nigeria.
“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.” She noted.
Moreso, NAFDAC claimed intensifying enforcement activities against the sale of fake pharmaceuticals across major distribution channels and hubs across the country as well as working with other regulatory authorities and security agencies to curb border entry for these drugs.
“We have intensified our 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.”
“With the partnership of the public, NAFDAC will continue to carry out the major mandate of safeguarding the health of Nigerians”.
