New Delhi, Feb 23: The Drugs Controller General of India (DCGI) has prohibited the production and export of all combinations of pain-relief medicines tapentadol and carisoprodol over news reports that unapproved combinations of these drugs were exported to West African countries by a Mumbai-based pharma firm, causing an opioid crisis there.
In a communication, the DCGI has asked the drug control authorities of the states and Union territories to immediately withdraw all export NOCs (no-objection certificates) and manufacturing licences granted for any combination of these two drugs. Tapentadol is an opioid medication used to treat moderate to severe pain. Carisoprodol is a muscle relaxant that works on the centre of the brain and spinal cord to relieve pain. In a statement, the Union health ministry said it has taken immediate and decisive action following news reports highlighting concerns regarding the export of unapproved combination drugs containing tapentadol and carisoprodol by Indian pharmaceutical manufacturer Aveo Pharmaceuticals to certain countries in West Africa. It said both tapentadol and carisoprodol are individually approved by the Central Drugs Standard Control Organisation (CDSCO) in India. Tapentadol is approved in 50, 75 and 100-mg tablet forms as well as 100, 150 and 200-mg extended-release tablets. However, a combination of tapentadol and carisoprodol is not approved in India.
Neither of these drugs is included in the NDPS (Narcotic Drugs and Psychotropic Substances) list in India.
“This is in connection with a recent article from BBC whereby, it has been written that the combination drug Tapentadol and Carisoprodol has significant abuse potential and this combination is being exported to West African countries from India,” the communication sent by the DCGI on Friday said. Looking at the potential to have a harmful impact on people, the DCGI requested for an immediate withdrawal of all export NOCs and permissions to manufacture all combinations of tapentadol and carisoprodol. According to the ministry’s statement, a joint team from the CDSCO and Maharashtra’s state regulatory authority conducted a comprehensive audit of Aveo Pharmaceuticals between February 21 and February 22. (PTI)
