Indian Government bans the production, and export of drugs containing tapentadol and carisoprodol | 24 February, 2025

The Indian government has taken immediate and decisive action to control the export of unapproved combination drugs containing Tapentadol and Carisoprodol manufactured by Aveo Pharmaceuticals, Mumbai, to certain countries in West Africa, the Ministry of Health and Family Welfare said in a statement.

The ministry said that in January, the Central Drugs Standard Control Organisation (CDSCO), in collaboration with state regulators, had focused on auditing firms manufacturing and exporting drugs covered by the Narcotic Drugs and Psychotropic Substances Act 1985. "Based on analysis of observations from the audit, important decisions were taken to strengthen regulatory oversight on the export of NDPS drugs from India,” the health ministry said in its statement.

As part of the exercise, a joint team from the CDSCO and the state regulatory authorities conducted a comprehensive audit of Aveo Pharmaceuticals between 21 and 22 February 2025. The audit's findings 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, according to the health ministry. Approximately 1.3 crore tablets/capsules and 26 batches of APIs (Active Pharmaceutical Ingredients) of Tapentadol and Carisoprodol were confiscated to prevent further distribution of these potentially dangerous drugs.

Meanwhile, the Maharashtra Food & Drugs Administration issued a Stop Production Order to Aveo Pharmaceuticals on Saturday, effectively halting the manufacturing of the drug combinations in question, 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.”

The government has further seized export consignments related to these two drugs. "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,” the ministry said.

“Regarding the specific issue at hand, 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, and neither of these drugs is included in the NDPS list," the health ministry stated.

(Source: Mint)