FDA finds 9 more companies previously permitted to produce now-banned drug

MUMBAI: Food and Drug Administration (FDA) officials have identified nine more companies in and around Palghar that were previously permitted to manufacture and export a lethal medicine combination banned worldwide. The drug gained attention after a media exposé held Aveo Pharmaceuticals responsible for its role in fuelling the opioid crisis in West African countries.
Of the nine companies, seven never produced the drug. However, two firms based in Boisar—the same area where Aveo operates—National Pharmaceuticals and Maxwell Life Science Private Ltd— had reportedly exported it to West African countries in the past, much like Aveo.
Representatives from National Pharmaceuticals could not be reached for comment. Sanjay Surana, managing director at Maxwell Life Science, stated that while they had explored the market, they had never proceeded with manufacturing or exporting the drug. "There was no buyer. It is now out of the question to manufacture these drugs as the product permission has been revoked," Surana said.
Aveo held a Good Manufacturing Practice (GMP) certificate in accordance with World Health Organization (WHO) norms, a requirement in most West African importing countries. FDA officials noted Maxwell Life Science had recently re-applied for GMP certification, while National Pharmaceuticals had never obtained one. "India does not make WHO-GMP mandatory for pharmaceutical exports," an FDA official said.
Meanwhile, officials have seized five consignments of Aveo's Tafrodol, the drug in question—a dangerous combination of tapentadol, a potent opioid painkiller, and carisoprodol, a muscle relaxant with sedative properties. A total of 90 lakh tablets, worth Rs 1.5 crore, were confiscated, including 26 batches of raw materials classified as active pharmaceutical ingredients (API). "We are still investigating where the other seven companies intended to export these medicines," an FDA official said.
The Central Drugs Standard Control Organisation (CDSCO) only last week instructed all states to withdraw export NoCs and manufacturing permissions for all combinations of tapentadol and carisoprodol. It mandated cancellation of approvals for any combinations not authorised by the importing country.
This was following an investigation by BBC where Aveo Pharmaceuticals managing director Vinod Kumar Sharma was recorded acknowledging the harmful effects of the exported Tafrodol in Ghana, Nigeria, and the Ivory Coast. Aveo has denied the allegations and said in a statement they were not "the only company in India manufacturing a similar combination product". They said the exports were done after obtaining a license from the FDA, NoC from the assistant drug controllers and export licence from CDSCO.
TOI had earlier reported the company lists a Borivli address as its headquarters, but the building where its registered head office was located was demolished over a year ago. When TOI visited the redevelopment site on Sunday, there was no board displaying the developer's name or any advisory about the office relocation.
Aveo representatives on Monday said a banner was previously placed at the site but was torn down by miscreants, after which the company did not put it up again. "We have now put it back at the site," a company representative said.