Govt cracks down on Aveo Pharma over unapproved tapentadol-carisoprodol exports, seizes 13 mn pills

The Union health ministry has cracked down on Mumbai-based Aveo Pharmaceuticals following reports that the company exported unapproved drug combinations containing Tapentadol and Carisoprodol to West African countries, the government said on Friday.

The Central Drugs Standard Control Organization (CDSCO) and state regulators conducted an inspection of Aveo Pharmaceuticals’ facilities on February 21-22, leading to a ‘Stop Activity Order’ that halted all operations, the health ministry said in a statement.

Authorities seized approximately 13 million tablets and capsules, along with 26 batches of active pharmaceutical ingredients (APIs) of Tapentadol and Carisoprodol, to prevent further distribution of the unapproved drug combinations, the statement added.

Tapentadol and Carisoprodol are individually approved by India’s drug regulator, but their combination has not been cleared for use in the country. While neither drug is classified under India’s Narcotic Drugs and Psychotropic Substances (NDPS) list, concerns over regulatory violations prompted intervention from the regulators.

Maharashtra’s Food and Drug Administration (FDA) issued a Stop Production Order to Aveo Pharmaceuticals on February 22, while authorities withdrew all Export No-Objection Certificates (NOCs) and manufacturing licenses for the Tapentadol-Carisoprodol combination.

An export consignment of the drugs bound for Ghana has been put on hold at Mumbai Air Cargo pending further investigation.

In December 2022, CDSCO and state authorities launched risk-based inspections of drug manufacturing and testing firms, according to the ministry. Since then, 905 units have been inspected, resulting in 694 regulatory actions, including production suspensions, license cancellations, and warning letters.

As part of its response, CDSCO is updating its Export NOC checklist to mandate either a Product Registration Certificate from the importing country’s regulator or approval from India’s CDSCO before medicines can be exported.

“India as a leading global supplier of pharmaceuticals, is dedicated to maintaining the highest standards of drug safety and regulatory compliance,” the health ministry said, assuring the public and global community that the government will continue to monitor and regulate pharmaceutical exports to safeguard against any misuse of Indian-made medicines.