FDA issues show cause notice to pharma firm in Palghar for illegal export of opioids

Palghar: 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.

As per an official release of 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.

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 release stated.

Authorities seized all existing stock, prohibited further production, and initiated stringent legal action against the company, 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.

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.