The Union Health Ministry has taken immediate actionagainst a Mumbai-based pharmaceutical manufacturerfollowing reports of unapproved drug combinations containing Tapentadol and Carisoprodol being exported to certain West African countries.
Although Tapentadol and Carisoprodol are individually approved by Central Drugs Standard Control Organization (CDSCO) in India, their combination has not yet received approval.
Neither of these drugs is included in the NDPS (Narcotic Drugs and Psychotropic Substances) list in India, but their misuse may pose significant health risks.
A joint team comprising officials from CDSCO and Maharashtra State Regulatory Authority conducted a comprehensive audit of Aveo Pharmaceuticals between 21 and 22 February 2025.
Following the audit, authorities issued a Stop Activity Order, halting all operations at the company's premises.
Additionally, a Stop Production Order was issued on February 22, 2025, stopping further manufacturing of the drug combination.
To prevent further distribution of these potentially dangerous drugs, the investigation team seized approximately 13 million tablets/capsules and 26 batches of Active Pharmaceutical Ingredients (APIs) of Tapentadol and Carisoprodol.
Authorities have also put an export consignment of Tapentadol 125 mg + Carisoprodol 100 mg, destined for Ghana, on hold at Mumbai Air Cargo for further investigation.
The CDSCO has directed all State Drug Control Authorities and Zonal Offices to immediately withdraw Export No Objection Certificates (NOCs) and Manufacturing Licenses for any Tapentadol-Carisoprodol combinations.
A similar communication has been sent to Customs offices at notified ports, ensuring that all consignments of these drugs undergo rigorous checks through CDSCO Port offices.
To prevent future regulatory violations, CDSCO is updating the Export NOC checklist.
Moving forward, all medicines being exported from India must have either the Product Registration Certificate from the importing country's National Regulatory Agency (NRA) or approval from the Indian Regulatory Authority (CDSCO).
“This updation of the checklist will address the root cause of the problem and settle the issue once for all,” the Health Ministry said in a statement.
The government reaffirmed its zero-tolerance policy towards illegal or unethical export of unapproved and potentially harmful drugs.
“India, as a leading global supplier of pharmaceuticals, is dedicated to maintaining the highest standards of drug safety and regulatory compliance,” the Union Health Ministry said in its release.
The Ministry assures the public and global community that the government will continue to monitor and regulate pharmaceutical exports to safeguard against any misuse of Indian-made medicines.
To ensure regulatory compliance across the pharmaceutical sector, the CDSCO, in collaboration with state regulators, launched risk-based inspections of drug manufacturing and testing firms in December 2022.
So far, 905 units have been inspected, leading to 694 enforcement actions. These measures include Stop Production Orders (SPO), Stop Testing Orders (STO), license suspensions or cancellations, warning letters, and showcause notices, depending on the severity of non-compliance.
“This initiative has provided valuable insights into the ground reality of manufacturing practices and has led to relevant corrective actions, resulting in noticeable improvements in the regulatory framework,” the ministry noted.
In late January 2025, the CDSCO, along with state regulators, conducted a focused audit of firms manufacturing and exporting NDPS drugs. Based on the audit findings, key decisions were made to strengthen regulatory oversight of NDPS drug exports from India.
