GUWAHATI: The Ministry of Health and Family Welfare has taken swift action against M/s Aveo Pharmaceuticals, Mumbai, following concerns about the export of an unapproved drug combination containing Tapentadol and Carisoprodol to West African countries. On February 23, the Central Drugs Standard Control Organisation (CDSCO), in collaboration with the Maharashtra State Regulatory Authority, announced a series of decisive measures after a thorough audit of the company.
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A joint inspection team visited the manufacturing site between February 21 and 22, resulting in an immediate Stop Activity Order, halting all operations at the company’s premises. The Maharashtra FDA also issued a Stop Production Order on February 22, ceasing the production of the concerned drug combinations. A Stop Testing Order was also implemented.
Authorities seized 1.3 crore tablets/capsules and 26 batches of active pharmaceutical ingredients (APIs) of Tapentadol and Carisoprodol. These materials have been detained to prevent further distribution.
Since December 2022, CDSCO has conducted risk-based inspections of 905 drug manufacturing and testing units, leading to 694 actions, including Stop Production Orders, Stop Testing Orders, license suspensions/cancellations, warning letters, and showcase notices.
Effective immediately, CDSCO has withdrawn Export No Objection Certificates (NOCs) and Manufacturing Licenses for any combination of Tapentadol and Carisoprodol. Notifications have been sent to all State Drugs Control Authorities, Zonal Offices, and Customs offices at notified ports to ensure all consignments of these products are routed through CDSCO Port offices.
A shipment of Tapentadol 125 mg + Carisoprodol 100 mg destined for Ghana has been seized and is currently on hold at Mumbai Air Cargo.
To further enhance control over drug exports, CDSCO is updating its Export NOC checklist. The updated checklist will mandate either a Product Registration Certificate from the importing country’s National Regulatory Agency (NRA) or approval from CDSCO for all medicines being exported from India.
