The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Aveo Pharmaceuticals Pvt Limited, an Indian pharmaceutical company, for its role in the illegal production and exportation of dangerous opioid combinations into West Africa, including Nigeria.
The agency announced the decision in a press release, revealing that investigations traced the company’s activities.
NAFDAC stated that the company was responsible for manufacturing and distributing Tafrodol and Royal 225—drugs containing a mix of Tapentadol, a powerful opioid, and Carisoprodol, a banned muscle relaxant.
“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,” they stated.
According to the agency, these substances pose severe health risks, including respiratory failure, seizures, overdose, and death.
BBC investigation exposes illegal distribution
According to the agency, a BBC World Service investigation uncovered how packets of these drugs, branded with the Aveo Pharmaceuticals logo, were found on the streets of Nigeria, Ghana, and Côte d’Ivoire.
The report also confirmed that Aveo Pharmaceuticals was involved in the illegal exportation of high-dose Tramadol above 100mg, a strength that is neither registered nor approved by NAFDAC.
“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,” they noted.
NAFDAC cited undercover footage in which Vinod Sharma admitted to the mass distribution of these opioids as street drugs across West Africa. The footage was captured by an undercover operative posing as an African businessman seeking to supply opioids to Nigeria.
Given these findings, NAFDAC has decided to blacklist Aveo Pharmaceuticals and block any future registration of its products in Nigeria.
Commitment to public safety
NAFDAC reaffirmed its commitment to protecting Nigerians by enforcing international best practices in pharmaceutical regulation.
The agency stated that it implements strict Good Manufacturing Practice (GMP) inspections, post-marketing surveillance, and pre-shipment inspections for high-risk imports.
Additionally, NAFDAC stated that it has intensified enforcement operations against illicit pharmaceuticals in major drug distribution hubs nationwide. The agency urged Nigerians to avoid unregistered medicines and only use prescription drugs dispensed by licensed healthcare professionals.
