Health Ministry halts export of unapproved drug combo by Aveo Pharmaceuticals, seizes 1.3 cr tabs. Report highlights export of drugs, containing Tapentadol and Carisoprodol, by Indian pharmaceutical manufacturer, Aveo. The findings from the audit led to the issuance of a Stop Activity Order, halting all operations at the company’s premises. An export consignment of Tapentdol 125 mg + Carisobrodol 100 mg, destined for Ghana, has been put on hold at Mumbai Air Cargo pending further investigation. The CDSCO is updating the Export NOC checklist, to ensure that either the Product Registration Certificate from the importing country’s National Regulatory Agency (NRA) or approval from the Indian regulatory authority (CDSCO) is required for all medicines being exported from India. A total of 905 units have been inspected, resulting in 694 actions being taken. These actions include Stop Production Orders (SPO), Stop Testing Orders (STO), license suspensions/cancellations, warning letters, and showcase notices, depending on the severity of non-compliance.
