 "Arvind Sharma, managing director, Aveo Pharmaceuticals")
Mumbai-based Aveo Pharmaceuticals, which has been under scrutiny for exporting drug combinations of Tapentadol and Carisoprodol (used as painkillers) under brand Tafrodol, says that it suspects “possible misuse” of this medicine by the locals in the importing countries.
The company also clarified that the “stop production” order of February 24 was due to compliance issues under the Schedule M of the Drugs and Cosmetics Rules, 1945, and not due to the combination product.
Arvind Sharma, managing director, Aveo Pharmaceuticals, said that it is crucial to clarify that the stop production is not because of the combination product of Tapentadol and Carisoprodol but due to some compliance issues under Schedule M of the Drugs and Cosmetics Rules, 1945 that specifies Good Manufacturing Practices (GMP) related to premises & equipment, sanitation & hygiene, manufacturing practices, documentation, etc. “We have already taken corrective and preventive measures suggested by the regulatory authorities and submitted our reply to them,” he said.
Sharma went on to add that they have valid product permissions from the State FDA for Tafrodol. “These permissions align with established market precedents and approvals granted to other manufacturers in Maharashtra and other states of India,” he added.
On February 24, Aveo Pharmaceuticals received a “stop production” order and a show-cause notice from the CDSCO (Central Drugs Standard Control Organization) and State FDA. “As a result, our factory is closed, and all pharmaceutical production has been stopped. We have submitted a detailed Corrective and Preventive Action (CAPA) plan to both authorities, showing our commitment to all compliances and regulatory norms. We are waiting for further instructions and hope to resume production soon,” Sharma said.
The Union health ministry had said in February that Aveo Pharmaceuticals has been issued a “Stop Activity Order”, halting all operations on the company’s premises after a comprehensive audit by a joint team of the CDSCO and the Maharashtra state regulatory authority. Following the audit, the investigation team seized all raw materials, in-process materials, and finished products. “Approximately 13 million tablets/capsules and 26 batches of Active Pharmaceutical Ingredients (APIs) of Tapentadol and Carisoprodol were detained to prevent further distribution of these potentially dangerous drugs,” the ministry had stated.
Meanwhile, the pharma company also suspects “misuse” of Tafrodol in the importing countries by locals. Sharma said: “Based on the BBC documentary, we suspect possible misuse of Tafrodol in the importing countries by the locals. There may also be fake brands illegally using our brand name and design. These counterfeit products could be distributed in countries where we have not exported Tafrodol. To control the misuse of any drugs and check the counterfeits, it’s the responsibility of regulatory authorities of respective importing countries.”
Sharma added that they are working with their legal team to address the misinformation and inaccuracies propagated by BBC. He clarified that their agreement with the buyer is for contract manufacturing and Cost, Insurance, and Freight (CIF) export to the destination port.
“It is important to note that distribution, marketing, and pharmacovigilance of the product are the buyer's responsibilities in their respective countries. So far, we have not officially received any reports of adverse events during post-marketing surveillance from our buyer,” he claimed.
Aveo has also filed legal cases against several companies that are unlawfully using its brand name, product design and logo in India. “The matter against various companies like Amico Pharma, K S Pharmachem, Towa Pharma, and others is currently sub-judice in the high court,” Sharma informed.
Aveo has a portfolio of 400 products sold in India as well as overseas.
Case History
> Firm says “stop production” order due to compliance issues under the Schedule M and not due to the combination product
> Authorities seized approximately 13 million tablets/capsules of Tapentadol and Carisoprodol to prevent further distribution
> The firm claims that they have not officially received any reports of adverse events during post-marketing surveillance from the buyer
