DCGI halts production, export of all pain relief medicines tapentadol and carisoprodol

Amid the reports of exporting unapproved combinations of the drugs to West African countries leading to an opioid crisis there, the apex drug regulatory authority Drugs Controller General of India has prohibited the production and export of all combinations of pain relief medicines – tapentadol and carisoprodol.

The DCGI in an official communication has asked the state and UTs drug control authorities to withdraw all export NOCs and permission to manufacture all combinations of the two drugs.

Meanwhile, 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.

While Tapentadol is an opioid medication that is used to treat moderate to severe pain, Carisoprodol is a muscle relaxant which works on the centres in the brain and spinal cord to relieve pain.

In a statement, the union health ministry said, “both – Tapentadol and Carisoprodol – are individually approved by CDSCO in India. Tapentadol is approved in 50, 75, and 100 mg tablet forms, as well as 100, 150, and 200 mg extended-release tablets. However, the combination of Tapentadol and Carisoprodol is not approved in India. Neither of these drugs is included in the NDPS (Narcotic Drugs and Psychotropic Substances) list in India.”

“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”, said the health ministry.

“This is in connection with a recent article from BBC whereby, it has been written that the combination drug Tapentadol and Carisoprodol has significant abuse potential and this combination is being exported to West African countries from India,” the communication sent by DCGI on Friday said.
Looking into the potential to have a harmful impact on people, DCGI requested an immediate withdrawal of all export NOCs and permission to manufacture, issued for all combinations of tapentadol and carisoprodol

The ministry said that during end Jan’25, CDSCO in collaboration with State Regulators had done focused audit of firms manufacturing and exporting NDPS drugs. Based on analysis of observations from the audit, important decisions were taken to strengthen regulatory oversight on export of NDPS drugs from India.

A joint team from the CDSCO and the State Regulatory Authority conducted a comprehensive audit of M/s. Aveo Pharmaceuticals between 21st and 22nd February 2025. The findings from 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 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, said the health ministry.