The production and export of drugs containing tapentadol and carisoprodol banned by the government

The production and export of drugs containing tapentadol and carisoprodol banned by the government.
Immediate and decisive action has been taken by the Indian government to control the export of unapproved combination drugs containing Tapentadol and Carisoprodol, manufactured by Aveo Pharmaceuticals, Mumbai, to certain countries in West Africa.
As a part of this exercise, a joint team of CDSCO and state regulatory authorities conducted a comprehensive audit of Aveo Pharmaceuticals between February 21 and 22, 2025.
The findings of the audit led to the issuance of a Stop Activity Order, halting all operations at the company’s premises.
Following the audit, the investigation team seized 1.3 crore tablets/capsules of tapentadol and carisoprodol and all related materials, including 26 API batches, to prevent further distribution.
In January, the Central Drugs Standard Control Organisation (CDSCO), in collaboration with state regulators, had focused on auditing firms manufacturing and exporting drugs covered under the Narcotic Drugs and Psychotropic Substances Act, 1985.
Based on the analysis of the observations received from the audit, important decisions were taken to strengthen regulatory monitoring on the export of NDPS drugs from India.
In December 2022, the government launched risk-based inspections of drug manufacturing and testing firms to ensure regulatory compliance in the pharmaceutical sector.
So far, 905 units have been inspected, resulting in action in 694 cases.