Sun Feb 23 16:10:43 UTC 2025: **Indian Health Ministry Halts Export of Unapproved Combination Drug**
**NEW DELHI, February 23, 2025** – The Indian Health Ministry has taken swift action against Aveo Pharmaceuticals, Mumbai, following reports of the company exporting unapproved combination drugs containing Tapentadol and Carisoprodol to West African countries. A stop-activity order has been issued, along with the immediate withdrawal of export no-objection certificates (NoCs) and manufacturing licenses.
The ministry stated that while Tapentadol and Carisoprodol are individually approved in India, their combination is not. A joint team from the Central Drugs Standard Control Organisation (CDSCO) and the Maharashtra FDA conducted an audit of Aveo Pharmaceuticals, resulting in the seizure of approximately 1.3 crore tablets/capsules and 26 batches of active pharmaceutical ingredients (APIs). A stop production order was issued on February 22nd, and communications were sent to all state drug control authorities and customs offices to prevent further distribution. An export consignment bound for Ghana has been halted pending investigation.
This action is part of a larger initiative launched in December 2022, involving risk-based inspections of 905 drug manufacturing and testing units. This resulted in 694 actions, including production and testing halts, license suspensions, and warning letters.
The ministry is updating the export NoC checklist to require either a product registration certificate from the importing country’s regulatory agency or approval from the CDSCO for all exported medicines, addressing the root cause of this issue.
First Piper 