The BBC Eye investigation uncovered Aveo-branded packets of these opioids being sold on the streets of Nigeria and Ghana. To confirm the company’s involvement, an undercover BBC reporter posed as a businessman looking to supply opioids to Nigeria and secretly filmed Aveo’s managing director, Vinod Sharma, admitting that the drug combination was ‘very harmful’ but still referring to it as ‘business’. The footage showed Mr Sharma acknowledging that users could get high on the pills and that taking multiple doses would lead to a state of relaxation.
Additionally, the BBC report highlighted the severe health consequences of these drugs, including breathing difficulties, seizures and fatal overdoses. Tapentadol is a potent opioid, while Carisoprodol, a muscle relaxant, is banned in Europe due to its addictive properties. Despite these risks, the combination remains a popular street drug in West Africa due to its low cost and easy availability.
Following the BBC report,
the Indian ministry of health and family welfare took immediate action against Aveo. A joint audit by the central drugs standard control organisation (CDSCO) and the Maharashtra food and drug administration (FDA) between 21st February and 22 February 2025 resulted in a stop-activity order (SPO), bringing all operations at Aveo’s facility to a halt. Officials seized 13mn (million) tablets and capsules, along with 26 batches of active pharmaceutical ingredients (APIs), to prevent further distribution.
Additionally, the Maharashtra FDA issued an SPO on 22 February 2025, effectively suspending the manufacture of the concerned drug combinations. Authorities also intercepted an export consignment of Tapentadol (125 mg) and Carisoprodol (100 mg), destined for Ghana, at Mumbai air cargo, pending further investigation.
The Union health ministry clarified that, while Tapentadol and Carisoprodol are individually approved by CDSCO, their combination is not authorised anywhere in the world. Furthermore, the ministry has directed all state drugs control authorities and customs offices to revoke all export no-objection certificates (NOCs) and manufacturing licences for the drug combination.
To prevent similar incidents in the future, the government is updating the export NOC checklist, making it mandatory for exporters to obtain either a product registration certificate from the importing country’s regulatory body or approval from CDSCO.
This latest move aligns with India's zero-tolerance policy against the illegal and unethical export of unapproved drugs. Since December 2022, risk-based inspections of pharmaceuticals companies have led to 700 enforcement actions, including licence suspensions and SPOs, strengthening India's regulatory oversight.
In response to the BBC allegations and government crackdown, Aveo denied any wrongdoing and called the accusations "baseless and without merit."
A company spokesperson stated: "We categorically deny all claims. The allegations against us are entirely baseless. We have always adhered to the rules and regulations set by various regulatory authorities to manufacture and export our products."
Aveo defended its product, Tafrodol, a trademarked combination of Tapentadol and Carisoprodol, claiming it is licensed by the state food and drug administration and exported with the necessary NOC from the assistant drug controllers (ADC) and an export licence from CDSCO.
The company also suggested that other Indian companies manufacture similar products and that several entities may be misusing its brand name and logo. Multiple legal cases regarding brand misuse are currently pending in the High Court.
Additionally, Aveo claimed that the Tafrodol blister pack shown in the BBC documentary does not match its actual manufacturing code, suggesting it may have been produced by another company. The company assured that it is fully cooperating with government authorities and providing all necessary documentation for their investigation.
The Union health ministry reiterated India's commitment to ensuring high drug safety standards, while supporting the legitimate export of medicines to global markets. Officials stressed that the government will continue to monitor pharmaceutical exports closely to prevent misuse and maintain India’s reputation as a responsible pharmaceuticals supplier.
With new export regulations and stricter oversight, the crackdown on Aveo serves as a warning to companies engaged in unethical pharmaceutical practices.
ZERO tolerance on such addictive opoid drugs is must by FDA & GOI under Criminal Laws!