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

Representational pic

Maharashtra's Food and Drug Administration (FDA) has issued a show-cause notice to a pharmaceutical company in Palghar for the alleged illegal export of opioids, an official said on Sunday.

According to an official release from FDA, the action was prompted after a news report revealed that Tapentadol and Carisoprodol, both manufactured in India, were being illegally exported to African nations, where they are misused for recreational purposes.

The joint team of drug inspectors from both the Centre and Maharashtra government raided Aveo Pharmaceuticals, a company based in Palghar, on Friday following directives from the Central government, PTI reported. The raid was part of the investigation into the illegal export of these drugs, the release stated.

"Authorities seized all existing stock, prohibited further production, and initiated stringent legal action against the company," the FDA said in its statement. "The company has been served a show-cause notice under the Drugs and Cosmetics Act 1940, and we assure 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 NOCs (No Objection Certificates) for all unapproved combinations of Tapentadol and Carisoprodol, and to revoke manufacturing permissions for these drugs in order to prevent misuse, PTI reported. The FDA in Maharashtra has already begun implementing these directives to curb the illegal production and export of these opioid combinations.

The Drugs Controller General of India (DCGI) has prohibited the production and export of all combinations of pain relief medicines Tapentadol and Carisoprodol.

"Tapentadol is an opioid medication used to treat moderate to severe pain, and Carisoprodol is a muscle relaxant which works on the brain and spinal cord to relieve pain," a release by DCGI stated.

Both Tapentadol and Carisoprodol are individually approved by the Central Drugs Standard Control Organisation (CDSCO) but have not been approved for use as a combination in India. Moreover, they are not included in the NDPS (Narcotic Drugs and Psychotropic Substances) list in India.

Due to the harmful impact on people's health, the DCGI has ordered the immediate withdrawal of all export NOCs and manufacturing permissions for these drug combinations.

(With PTI inputs)