India's Union Health Ministry has taken decisive action against the export of unapproved drug combinations involving Tapentadol and Carisoprodol, following alarming reports of the illegal distribution of these medications by Aveo Pharmaceuticals, based in Mumbai. The ministry’s announcement, made on Sunday, includes the immediate withdrawal of export no-objection certificates (NOCs) and manufacturing licences for these specific drug combinations.
Tapentadol, known for its strong opioid properties, serves as a potent pain reliever, whereas Carisoprodol is classified as a muscle relaxant, often used to treat painful bone conditions. Recent investigations, prompted by a report from the BBC, revealed the distribution of this unlicensed combination to various West African countries, namely Nigeria, Ghana, and Côte d’Ivoire.
Following the investigation, the health ministry confirmed it had issued a Stop Activity Order against Aveo Pharmaceuticals, halting all operations at the company after comprehensive audits were conducted by a joint team from the Central Drug Standards Control Organisation (CDSCO) and the Maharashtra state regulatory authority.
“Approximately 1.3 crore tablets/capsules and 26 batches of Active Pharmaceutical Ingredients (APIs) of Tapentadol and Carisoprodol were detained to prevent the distribution of these potentially dangerous drugs,” the ministry stated, underscoring the urgency of safeguarding public health.
Yet, Aveo Pharmaceuticals has firmly denied all allegations described in the BBC report, claiming the assertions are baseless. A spokesperson for the company stated, “Tafrodol is our registered trademark, which contains both Tapentadol and Carisoprodol. This combination is licenced by the relevant State Food and Drug Administration (FDA) and is exported under the necessary NOC from the Assistant Drug Controllers (ADC) and with an export licence issued by the CDSCO.”
The company argues it has already filed legal cases against several entities accused of misusing its brand name, which is currently being deliberated in the high court. The spokesperson also emphasized, “The manufacturing code of Tafrodol blister shown in the BBC article does not bear the manufacturing code of our factory depicting it as having been manufactured by some other company.”
Despite Aveo's protestations, regulatory bodies assert the combination of Tapentadol and Carisoprodol is not approved for distribution within India even though both drugs are individually approved by the CDSCO. “Neither of these drugs is included in the Narcotic Drugs and Psychotropic Substances (NDPS) list in India,” the health ministry added.
On February 22, the Maharashtra FDA simultaneously halted production at Aveo Pharmaceuticals, citing the investigation’s findings. This included a comprehensive review of the company, which was solidified with audit actions highlighting safety and compliance issues. “We are committed to ensuring the safety and well-being of citizens both domestically and internationally,” the health ministry stated, echoing their zero-tolerance policy toward illegal pharmaceutical exports.
Future actions to strengthen regulatory compliance have also been initiated. The health ministry, along with the CDSCO, is updating the export NOC checklist to require explicit product registration certification from the importing country's National Regulatory Agency (NRA) for all medicines exported from India. This is aimed at preventing any future breaches of export regulations.
All customs offices at notified ports have received directives to route consignments of these prohibited products through CDSCO port offices. Earlier this month, the export of Tapentadol 125 mg and Carisoprodol 100 mg destined for Ghana was also placed on hold at Mumbai Air Cargo as the audit and investigation continued.
The Indian health ministry's actions mark a significant step toward safeguarding the integrity of pharmaceutical exports from the country, with repeated reassurances aimed at maintaining high standards of drug safety and regulatory compliance globally. Clearly, the government's emphasis on vigilance sends ripples of accountability through the pharmaceutical industry, ensuring public safety takes precedence over corporate interests.