Health Ministry halts export of unapproved drug combinations

In response to concerns raised over the export of unapproved drug combinations containing Tapentadol and Carisoprodol by Aveo Pharmaceuticals, Mumbai, the Ministry of Health and Family Welfare has taken immediate regulatory actions. The company was found to be exporting these unapproved drugs to West African nations, prompting the Central Drugs Standard Control Organisation (CDSCO) to launch an audit.

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A joint team from CDSCO and the Maharashtra State Regulatory Authority conducted a comprehensive audit of the manufacturing site from February 21-22. The audit uncovered serious concerns, resulting in swift action. A Stop Activity Order was issued, halting all operations on the company’s premises, and a Stop Production Order was handed down by the Maharashtra FDA, effectively stopping the production of the concerned drug combinations.

To prevent further distribution, the regulatory team seized approximately 1.3 crore tablets and 26 batches of Active Pharmaceutical Ingredients (APIs) from the facility. These materials were seized to ensure no potentially harmful drugs reached consumers. Additionally, the CDSCO has ordered the immediate withdrawal of all Export No-Objection Certificates (NOCs) and manufacturing licences for Tapentadol-Carisoprodol combinations.

The CDSCO has also taken action on export consignments. A shipment of Tapentadol 125 mg + Carisoprodol 100 mg, destined for Ghana, was intercepted at Mumbai Air Cargo and put on hold for further investigation.