Aveo Pharmaceuticals Pvt Limited, an Indian company, has been placed on the National Agency for Food and Drug Administration and Control’s blacklist due to allegations that it produces and imports hazardous opioid combinations into West Africa, particularly Nigeria.
According to NAFDAC, there are serious health hazards associated with the chemicals, including respiratory failure, convulsions, overdose, and death.
NAFDAC accused the Indian company of manufacturing and selling Tafrodol and Royal 225, which are medications that contain a dangerous combination of the opioid tapentadol and the prohibited muscle relaxant carisoprodol, in a statement signed by its Director General, Prof. Mojisola Adeyeye, on Friday.
According to NAFDAC, there are serious health hazards associated with the chemicals, including respiratory failure, convulsions, overdose, and death.
“The National Agency for Food and Drug Administration and Control has officially blacklisted Aveo Pharmaceuticals Pvt Limited, an Indian company implicated in the illegal production and exportation of highly dangerous opioid combinations into West Africa, including Nigeria.
“Investigations have revealed that the company, managed by Vinod Sharma on the outskirts of Mumbai, is responsible for manufacturing and distributing Tafrodol and Royal 225—drugs containing a harmful mix of tapentadol, a powerful opioid, and carisoprodol, a banned muscle relaxant. These substances pose severe health risks, including respiratory failure, seizures, overdose, and death,” the statement read.
The agency noted that an investigation conducted by the British Broadcasting Corporation “exposed how packets of these drugs, branded with the Aveo Pharmaceuticals logo, have been found on the streets of Nigeria, Ghana, and Côte d’Ivoire.”
“Further evidence confirmed that Aveo Pharmaceuticals is also involved in the illegal exportation of high-dose Tramadol above 100mg, a strength not registered or approved by NAFDAC. Undercover footage captured Vinod Sharma admitting to the mass distribution of these opioids for abuse as street drugs across West Africa.
“Given the severity of these findings, NAFDAC has taken decisive action to blacklist Aveo Pharmaceuticals and block any future registration of its products in Nigeria,” the agency stated.
NAFDAC reaffirmed its commitment to “protecting public health by enforcing international best practices in pharmaceutical regulation, including stringent product registration, Good Manufacturing Practice inspections, post-marketing surveillance, and pre-shipment inspections for high-risk imports.”
