DCGI bans production, export of all combinations of tapentadol, carisoprodol

New Delhi: Acting on recent reports regarding the export of unapproved combination drugs containing Tapentadol and Carisoprodol, the Drugs Controller General of India (DCGI) has imposed a ban on their production and export.

"The Ministry of Health and Family Welfare has taken immediate and decisive action following some news reports highlighting concerns regarding the export of unapproved combination drugs containing Tapentadol and Carisoprodol by Indian Pharmaceutical Manufacturer M/s Aveo Pharmaceuticals, Mumbai to certain countries in West Africa," the release stated.

DCGI has asked 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.

Tapentadol is an opioid medication used to treat moderate to severe pain. Carisoprodol is a muscle relaxant that works on the centre of the brain and spinal cord to relieve pain.

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.

"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 the DCGI on Friday said.

A joint team from the CDSCO and Maharashtra's Regulatory Authority conducted a comprehensive audit of M/s. Aveo Pharmaceuticals between 21st and 22nd February 2025, according to a statement. The findings from the audit led to the issuance of a Stop Activity Order, halting all operations at the company's premises.

The Maharashtra FDA issued a Stop Production Order to M/s. Aveo Pharmaceuticals on 22nd February 2025, effectively halting the manufacturing of the concerned drug combinations.

Aveo Pharmaceuticals, however, has denied the allegations and said it is fully cooperating with government authorities in the probe.

According to a statement issued by the FDA, the action was taken after the BBC's investigative report highlighted that tapentadol and carisoprodol manufactured in India were illegally exported to African countries, where those were misused for recreational purposes.

As per a PTI report, the FDA further said authorities have seized all existing stock in the company, prohibited further production and initiated stringent legal action against the firm, 

The company has been served a show-cause notice under the Drugs and Cosmetics Act, 1940 and officials have said all necessary legal measures will be taken, without any delay, fear or favour.

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.

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.

Going forward, CDSCO is updating 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 (CDSCO) is required for all medicines being exported from India.

This updation of the checklist will address the root cause of the problem and settle the issue once for all.

A spokesperson for Aveo Pharmaceuticals said the company has always adhered to the rules and regulations set by various regulatory authorities to manufacture and export its products.

"Tafrodol is our registered trademark, which contains both Tapentadol and Carisoprodol. This combination is licensed by the relevant state food and drug administration and exported under the necessary no-objection certificate (NOC) from the assistant drug controllers (ADCs) and with an export licence issued by the Central Drugs Standard Control Organisation (CDSCO)," he said.

He further said Aveo Pharmaceuticals is not the only company in India manufacturing a similar combination product.

"Several companies are unlawfully using our brand name and logo. We have already filed multiple legal cases against such companies and the matter is currently being heard in the high court," the spokesperson said.

He added that the company is fully cooperating with the relevant government authorities, providing all required support and granting access to the necessary documentation for their investigation.

"The Union Government will ensure smooth export operation for legitimate medicines to be used to support healthcare globally and strongly control these aberrations through swift and strong action as demonstrated through recent decisions and actions," the statement said.

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.