New Delhi, Feb 23 The Health Ministry on Sunday said it has taken decisive action following reports highlighting the export of unapproved combination drugs, containing Tapentadol and Carisoprodol, by Indian pharmaceutical manufacturer, Aveo Pharmaceuticals in Mumbai to certain west African countries.
A joint team from the Central Drugs Standard Control Organisation (CDSCO) and the State Regulatory Authority conducted a comprehensive audit of Aveo Pharmaceuticals between February 21-22.
The findings from the audit led to the issuance of a Stop Activity Order, halting all operations at the company's premises, according to a Health Ministry statement.
The investigation team seized all raw materials, in-process materials, and finished products. Approximately 1.3 crore tablets/capsules and 26 batches of APIs (active pharmaceutical ingredients) of Tapentadol and Carisoprodol were detained to prevent further distribution of these potentially dangerous drugs.
"The Maharashtra FDA issued a Stop Production Order to Aveo Pharmaceuticals on February 22, 2025, effectively halting the manufacturing of the concerned drug combinations," the ministry said.
"Communications have been sent to all State Drugs Control Authorities and Zonal Offices to immediately withdraw Export NOCs and Manufacturing Licenses granted for any combination of Tapentadol and Carisoprodol. The same communication has also been sent to all Customs offices at notified ports to route all consignments of referred products through CDSCO Port offices," it highlighted.
An export consignment of Tapentadol 125 mg + Carisoprodol 100 mg, destined for Ghana, has been put on hold at Mumbai Air Cargo pending further investigation.
Going forward, 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.
The CDSCO, in collaboration with state regulators, initiated risk-based inspections of drug manufacturing and testing firms in December 2022.
As of now, 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.
This initiative has provided valuable insights into the ground reality of manufacturing practices and has led to relevant corrective actions, resulting in noticeable improvements in the regulatory framework.
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