FDA issues showcause notice to Aveo for illegal export of opioids

Aveo Pharmaceuticals has denied the allegations and said it is fully cooperating with the government authorities in the probe

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Maharashtra's Food and Drug Administration has issued a show cause notice to a pharmaceutical company here for alleged illegal export of opioids, an official said on Sunday.

Following the Central government's directives on Friday, a joint team of drug inspectors from the Centre and state government raided Aveo Pharmaceuticals, a Palghar-based company allegedly involved in exporting these drugs, the FDA stated in a release.

Aveo Pharmaceuticals, however, has denied the allegations and said it is fully cooperating with the government authorities in the probe.

As per a statement issued by the FDA, the action was taken after the BBC's investigative report highlighted that Tapentadol and Carisoprodol manufactured in India were illegally exported to African countries, where they are misused for recreational purposes.

Authorities have seized all existing stock in the company, prohibited further production, and initiated stringent legal action against the company in Palghar, the FDA said.

The company has been served a show cause notice under the Drugs and Cosmetics Act 1940, and officials have assured that all necessary legal measures will be taken without any delay, fear, or favour.

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.

He further said that Aveo Pharmaceuticals is not the only company in India manufacturing a similar combination product.

"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," the spokesperson said.

He added that the company is fully cooperating with the relevant government authorities, providing all required support and granting access to the necessary documentation for their investigation.

The Union government 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.

The release said the FDA Maharashtra has already begun implementing these directives to curb the illegal production and export of these opioid combinations.