The health ministry has taken strict action against Aveo Pharmaceuticals, Mumbai, following reports of the company exporting unapproved drug combinations containing Tapentadol and Carisoprodol to West African countries. The ministry issued a stop-activity order and revoked the company’s export no-objection certificate (NoC) and manufacturing licenses for these combinations.
Tapentadol and Carisoprodol Approved Separately, but Not in Combination
According to the Health Ministry, Tapentadol and Carisoprodol each have individual approvals from the Central Drugs Standard Control Organisation (CDSCO) in India. Tapentadol is available in 50 mg, 75 mg, and 100 mg tablet forms, along with extended-release versions of 100 mg, 150 mg, and 200 mg. However, the combination of these two drugs has not received approval in India. The ministry also clarified that neither drug is classified under India’s Narcotic Drugs and Psychotropic Substances (NDPS) list.
Regulatory Crackdown on Pharmaceutical Non-Compliance
To ensure compliance across the pharmaceutical industry, the CDSCO, in collaboration with State regulators, launched risk-based inspections of drug manufacturing and testing firms in December 2022. So far, officials have inspected 905 units, leading to 694 enforcement actions. These include stop-production and stop-testing orders, license suspensions and cancellations, warning letters, and show-cause notices based on the severity of non-compliance.
Inspection and Seizure at Aveo Pharmaceuticals
Between February 21 and 22, a joint team from CDSCO and the State Regulatory Authority conducted a thorough audit of Aveo Pharmaceuticals. Based on the findings, authorities issued a stop-activity order, halting all operations at the company’s facility.
During the investigation, officials seized all raw materials, in-process substances, and finished products. They confiscated approximately 1.3 crore (13 million) tablets and capsules, along with 26 batches of Active Pharmaceutical Ingredients (APIs) of Tapentadol and Carisoprodol. To prevent further distribution, the Maharashtra FDA issued a stop-production order on February 22 and directed all State Drug Control Authorities and Zonal Offices to immediately revoke export NoCs and manufacturing licenses for any combination of these drugs.
Stricter Export Controls Implemented
The health ministry has also instructed all Customs offices at designated ports to reroute consignments of these drugs through CDSCO port offices for inspection. As part of this enforcement, officials placed an export consignment of Tapentadol 125 mg + Carisoprodol 100 mg, bound for Ghana, on hold at Mumbai Air Cargo pending further investigation.
To prevent similar violations in the future, the CDSCO is revising the export NoC checklist. Under the new regulations, exporters must provide either a Product Registration Certificate from the importing country’s National Regulatory Agency (NRA) or approval from India’s CDSCO.
As reported by thehindu.com, the measure aims to address the root cause of unauthorized drug exports, ensuring stricter oversight of pharmaceutical shipments from India.
