Govt bans production, export of drugs containing tapentadol and carisoprodol

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 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.

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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.

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“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.

It has also been planned that going forward, CDSCO will update the Export NOC checklist, to ensure that either the Product Registration Certificate from the importing country’s national regulatory agency (NRA) or approval from the Indian regulatory authority or CDSCO is required for all medicines being exported from India.

The pharma industry welcomed the move, saying it was time the drugs were removed from the export list. Devesh Malladi, chairman of the NDPS Committee at the Indian Drugs Manufacturers Association (IDMA) said, “This particular combination of Tapentadol and Carisoprodol is irrational and odd. It is not approved anywhere in the world. It may be manufactured by small pharma companies, not the bigger ones. I don’t think there is any financial implication on the manufacturers over the ban on this combination. It is good that DCGI has banned the combination.”

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He added that it is a matter of investigation to determine how these drugs were exported and how the importing country allowed the import.

“This updation of the checklist will address the root cause of the problem and settle the issue once and for all. The government will ensure smooth export operation for legitimate medicines to support healthcare globally and strongly control these aberrations through swift and strong action as demonstrated through its recent decisions and actions,” the health ministry said.

The ministry added that the government has a zero-tolerance policy towards illegal or unethical export of unapproved and potentially harmful drugs.

In December 2022, the government initiated risk-based inspections of drug manufacturing and testing firms to ensure regulatory compliance across the pharmaceutical sector. As of now, 905 units have been inspected, resulting in action being taken in 694 cases. 

These actions include Stop Production Orders (SPO), Stop Testing Orders (STO), license suspensions/cancellations, warning letters, and showcase notices, depending on the severity of non-compliance. This initiative has provided valuable insights into the ground reality of manufacturing practices and has led to corrective actions, leading in noticeable improvements in the regulatory framework.

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India, as a leading global supplier of pharmaceuticals, is dedicated to maintaining the highest standards of drug safety and regulatory compliance. The government will continue to monitor and regulate pharmaceutical exports to safeguard against any misuse of Indian-made medicines, the ministry added.