Aveo also claimed it is not the only company in India manufacturing a similar combination product.
A recent BBC investigation report alleged that the “unlicensed addictive” combination was being illegally exported to African nations such as Ghana and Nigeria, leading to a serious public health crisis of opioid addiction.
Denying the claims, Aveo told ET that the allegations are “entirely baseless” and “without merit.”
“We have always adhered to the rules and regulations set by various regulatory authorities to manufacture and export our products,” it said in a statement.Tafrodol is Aveo’s 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 Organisation (CDSCO),” the company said.
“It is important to note that Aveo Pharmaceuticals is not the only company in India manufacturing a similar combination product. In fact, 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,” it added.
“Furthermore, the manufacturing code of the Tafrodol blister shown in the BBC article does not bear the manufacturing code of our factory… It has been manufactured by some other company,” Aveo claimed.
The health ministry, on the other hand, said it has taken an immediate action, halting all operations at the company’s premises, following news reports highlighting concerns regarding the export of unapproved combination drugs containing tapentadol and carisoprodol by Aveo Pharmaceuticals.
The ministry said both tapentadol and carisoprodol are individually approved by CDSCO. However, their combination is not approved in India, it said. Neither of these drugs is included in the NDPS (Narcotic Drugs and Psychotropic Substances) list in India.
The regulator conducted an audit at Aveo’s premises and seized all raw materials, in-process materials and finished products.
Approximately 13 million tablets/capsules and 26 batches of APIs of tapentadol and carisoprodol were “detained to prevent further distribution of these potentially dangerous drugs,” the ministry said. It said the Maharashtra FDA has issued a stop production order to Aveo Pharma on Saturday effectively halting the manufacturing of the concerned drug combinations.
It ordered withdrawal of export NOCs and manufacturing licenses granted for any combination of tapentadol and carisoprodol, and alerted customs offices 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, it said.
The CDSCO will update the Export NOC checklist to ensure that either product registration certificate from the importing country’s national regulatory agency (NRA) or approval from the Indian regulatory authority (CDSCO) is mandatory for all medicines being exported.
