Health Ministry Halts Export of Unapproved Tapentadol-Carisoprodol Drugs, Shuts Down Manufacturer

The Union Health Ministry has taken immediate action following some news reports highlighting concerns regarding the export of unapproved combination drugs containing tapentadol and carisoprodol. The action came following the new reports that a Mumbai-based Indian pharmaceutical manufacturer exported these drugs to certain countries in West Africa.

The Health Ministry, in a statement, said that a joint team of the Central Drugs Standard Control Organisation (CDSCO) and the Maharashtra State Regulatory Authority conducted a thorough audit of the drug manufacturing site. The findings from the audit led to the issuance of a Stop Activity Order, halting all operations at the company’s premises. A stop production order was also issued to the pharmaceutical company to halt the manufacturing of the concerned drug combinations.

CDSCO also moved for the immediate withdrawal of Export NOCs and



Manufacturing Licenses for Tapentadol-Carisoprodol combinations. The Ministry added that India, as a leading global supplier of pharmaceuticals, is dedicated to maintaining the highest standards of drug safety and regulatory compliance. The Union Health Ministry has assured the public and global community that the government will continue to monitor and regulate pharmaceutical exports to safeguard against any misuse of Indian-made medicines.

Regarding the specific issue at hand, 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.