The Union Ministry of Health and Family Welfare has taken action following some news reports highlighting concerns regarding the export of unapproved combination drugs containing Tapentadol and Carisoprodol by Indian Pharmaceutical Manufacturer Aveo Pharmaceuticals, Mumbai to certain countries in West Africa.
- To ensure regulatory compliance across the pharmaceutical sector, the Central Drugs Standard Control Organization (CDSCO), in collaboration with state regulators, initiated risk-based inspections of drug manufacturing and testing firms in December 2022.
- Both Tapentadol and Carisoprodol are individually approved by 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, the 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.
