Tapentadol is a strong opioid and is used to relieve severe pain, while carisoprodol is a muscle relaxant in acute cases or painful bone conditions.
The BBC probe found Mumbai-based Aveo Pharmaceuticals making a combination of the two drugs but those are not approved for use anywhere in the world. BBC’s sting operation showed an Aveo Pharma official admitting he planned to sell the drugs to teenagers in Nigeria as part of the business. The drugs sold in Nigeria, Ghana, and Cote D’Ivoire under different brands were traced to Aveo Pharma’s factory in India.
A February 21 note from the Central Drugs Standard Control Organization said the combination of tapentadol and carisoprodol had significant abuse potential.
It said the combination was being exported to West African countries from India.
“Looking into the potential of drug abuse and its harmful impact on population, it is requested to immediately withdraw all export NOCs (no objection certificate) and permission to manufacture issued for combination of tapentadol and carisoprodol,” the CDSCO note added. The export NOCs will be withdrawn for all combinations of the two drugs which are not approved by the importing countries.
Under the Lens
Senior government sources told ET as part of the action, the central drug regulatory officials, along with the Maharashtra Food and Drug Administration, launched a investigation into Aveo and the two drugs that are exported as a combination. “We will get more details on the manufacturers and the brands,” a Maharashtra government official said.
The combination of the two drugs is not sold in India, he categorically said, but added all state agencies are directed to find if illegal opioid combinations are being produced in any facilities. Industry sources say Aveo may have managed to escape scrutiny since none of the two drugs is included in the list of Narcotic Drugs and Psychotropic Substance (NDPS). “The company may have mixed the two ingredients to come up with a potent addictive drug,” the source added.
Aveo Pharma could not be reached for a comment. Its website shows its manufacturing site is based in Boisar, Palghar industrial zone near Mumbai. Besides West Africa, the company exports medicines to Russia, Kazakhstan, Ukraine, Poland and Türkiye.
Sources said the Indian government is taking steps to inform regulatory agencies in Africa to keep a closer vigil on imports of unapproved and addictive opioid drug combinations.
