NEW DELHI, Feb 23: The apex drug regulatory authority has prohibited the production and export of all combinations of pain relief medicines tapentadol and carisoprodol, over news reports that unapproved combinations of the drugs exported to West African countries are driving an opioid crisis there.
In a communication, the Drugs Controller General of India (DCGI) has asked the drug control authorities of states and Union territories to withdraw all export NOCs and permission to manufacture all combinations of the two drugs.
Tapentadol is an opioid medication that is used to treat moderate to severe pain. Carisoprodol is a muscle relaxant which works on the centres in the brain and spinal cord to relieve pain.
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Both Tapentadol and Carisoprodol are approved individually by Central Drugs Standard Control Organisation (CDSCO) but not approved as a combination in the country. Also, they are not part of NDPS drugs 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 DCGI on Friday said.
Looking into the potential to have a harmful impact on people, DCGI requested an immediate withdrawal of all export NOCs and permission to manufacture, issued for all combinations of tapentadol and carisoprodol. (PTI)
