Mumbai: This isn’t the first time that Aveo Pharmaceuticals is under scrutiny. In Oct 2024, acting on a tipoff about large-scale production of tafrodol in Aveo’s factory, the FDA issued a 14-day stop-work notice for discrepancies in its manufacturing and distribution records.
There is more. The company lists a Borivli address as its HQ with its warehouse in Boisar, Palghar. But on Sunday, TOI found that the building with the company’s registered head office was demolished over a year ago. At the redevelopment site, there is no board mentioning the developer or any advisory about shifted offices; Aveo representatives insisted their HQ had been relocated within Borivli, but refused to share the location.
Officials from the company as well as the state maintained Aveo had all approvals for production and export. Until Saturday, the country’s export regulations allowed pharma manufacturers to produce and ship medicines containing a combination of tapentadol and carisoprodol — banned in India and other countries. FDA officials told TOI India lacks a system to verify whether a product is prohibited in the importing country. “Permissions are granted, and an NoC is issued as long as the manufacturer furnishes a purchase order from a country,” said a state FDA official. (Following the BBC report, Central Drugs Standard Control Organisation, or CDSCO, asked states to withdraw export NoCs and manufacturing permissions for all combinations of tapentadol and carisoprodol. It also mandates the cancellation of approvals for any combinations that are not authorised by the importing country.)
One key requirement for both exporting and importing countries is a good manufacturing practice (GMP) certificate as per WHO norms. In India, it is issued after inspections by state and central drug regulators. Aveo is among over 500 manufacturers with this certification in Maharashtra; theirs is valid until 2026, as per FDA records.
FDA officials said it’s the responsibility of importing countries to regulate the products they receive. “If a banned product is making its way in, then it is a failure on the part of their regulatory authorities,” the official said. A similar case emerged in 2018 when the opioid painkiller tramadol was widely abused in West African nations, prompting India to tweak its export regulations. However, West African authorities told BBC that opioid exporters have since turned to combination pills such as Tafrodol as a substitute to evade the rules.
Aveo Pharmaceuticals has denied the allegations made in the BBC report. “We have always adhered to the rules and regulations set by various regulatory authorities for manufacturing and export,” a company spokesperson said. “Tafrodol is our registered trademark containing both tapentadol and carisoprodol. This combination is licensed by the relevant state food and drug administration and exported with the necessary no-objection certificate (NoC) from the assistant drug controllers (ADC) and an export licence issued by the CDSCO.”