Days after reports emerged about the export of unapproved combination drugs containing Tapentadol and Carisoprodol by Indian pharmaceutical manufacturer Aveo Pharmaceuticals to certain West African countries, the Health Ministry stated that this combination is not approved in India.
“Neither of these drugs is included in the NDPS (Narcotic Drugs and Psychotropic Substances) list in India,” the Ministry said in its statement.
“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,” it stated.
The Ministry also revealed that a joint team from the CDSCO and the State Regulatory Authority conducted a comprehensive audit of 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,” it revealed.
Moreover, the Maharashtra FDA issued a Stop Production Order to Aveo Pharmaceuticals on 22 February 2025, effectively halting the manufacturing of the concerned drug combinations.
“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. 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,” it added.
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, the Ministry maintained.
This updation of the checklist will address the root cause of the problem and settle the issue once for all. 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, it stated.
The steps taken in response to this issue reflect the Government’s zero-tolerance policy towards illegal or unethical export of unapproved and potentially harmful drugs, it added.
The Health Ministry also revealed that to ensure regulatory compliance across the pharmaceutical sector, the Central Drugs Standard Control Organization (CDSCO), in collaboration with state regulators, initiated risk-based inspections of drug manufacturing and testing firms in December 2022.
“As of now, 905 units have been inspected, resulting in 694 actions being taken. 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 relevant corrective actions, resulting in noticeable improvements in the regulatory framework. 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,” it added.
Reportedly, 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.
An investigative report done by BBC revealed that found packets of these combination medicines, branded with the Aveo logo, for sale on the streets of Ghanaian, Nigerian, and Ivoirian towns and cities.
According to the BBC Eye investigative report, this combination of drugs is not licensed for use anywhere in the world and can cause breathing difficulties and seizures and overdose can kill. However, these opioids are popular as street drugs in many West African countries, because they are so cheap and widely available. The BBC report also revealed that Aveo Pharmaceuticals, along with a sister company called Westfin International, is shipping millions of these tablets to Ghana and other West African countries.
It is noteworthy in 2018, following a BBC Africa Eye investigation into the sale of opioids as street drugs, Nigerian authorities took cognizance of the widely abused opioid painkiller called tramadol. Moreover, the government banned the sale of tramadol without prescription, imposed strict limits on the maximum dose, and cracked down on imports of illegal pills. Meanwhile, Indian authorities tightened export regulations on tramadol. However, Aveo Pharmaceuticals began to export a new pill based on tapentadol, an even stronger opioid, mixed with the muscle-relaxant carisoprodol.
As Carisoprodol is highly addictive, it has been banned in Europe. It is approved for use in the US but only for short periods of up to three weeks. Withdrawal symptoms include anxiety, insomnia, and hallucinations. The BBC report also revealed that Aveo is not the only Indian company making and exporting unlicensed opioids. Publicly available export data suggest other pharma companies manufacture similar products and they are available across West Africa.
Meanwhile, Aveo Pharmaceuticals has denied the allegations and said it is fully cooperating with the government authorities in the probe. A spokesperson of 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 is exported under the necessary No Objection Certificate (NOC) from the Assistant Drug Controllers (ADC) and with an export licence issued by the Central Drugs Standard Control Organization (CDSCO),” he said as quoted by Business Standard.
On Friday, the Ministry issued an advisory on Friday directing all state governments to withdraw export NOC (no objection certificate) for all unapproved combinations of Tapentadol and Carisoprodol and revoke manufacturing permissions for these drugs to prevent their misuse.