Regulatory Update: India Bans Tapentadol-Carisoprodol Combination Export and Manufacturing
Content Editor: Dr M Kasif
May 19, 2025 at 7:04:44 AM
Export Ban, Drug Abuse, Combination drugs, Opioids

The Drugs Controller General of India (DCGI) has revoked manufacturing and export permissions for tapentadol (opioid painkiller) and carisoprodol (muscle relaxant) combinations.
While both drugs are individually approved by the Central Drugs Standard Control Organisation (CDSCO), their combination has never been authorised in India.
A BBC report highlighted their high abuse potential and widespread misuse in West Africa.
Though not listed under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, their unregulated export has fueled an opioid crisis.
To curb illegal supply and protect public health, India has banned their production and export, reinforcing stricter pharmaceutical regulations and preventing further misuse.
.png)