Aveo Pharma suspects misuse of its drug in some countries

Firm received 'stop production' order and show cause notice from CDSCO on Feb 24

- SOHINI DAS

Mumbai-based Aveo Pharmaceuticals, which has been under scrutiny for exporting drug combinations of Tapentadol and Carisoprodol, used as painkillers, under the brand Tafrodol, said on Monday that it suspects "possible misuse" of this medicine by local entities in the importing countries.

The company also clarified that the "stop production" order of February 24 was due to compliance issues under the Schedule M of the Drugs and Cosmetics Rules, 1945, and not due to the combination product.

Arvind Sharma, managing director, Aveo Pharmaceuticals, said it is crucial to clarify that the "stop production" order is not because of the combination product of Tapentadol and Carisoprodol but due to some compliance issues under Schedule M of the Drugs and Cosmetics Rules, 1945 that specifies Good Manufacturing Practices (GMP) related to premises & equipment, sanitation & hygiene, manufacturing practices, documentation, etc. "We have already taken corrective and preventive measures suggested by the regulatory authorities and submitted our reply to them," he said.