India Cracks Down on Export of Unapproved Drug Combinations

On 23rd February 2025, the Union Health Ministry took swift action after reports surfaced regarding the export of unapproved combination drugs containing Tapentadol and Carisoprodol by a Mumbai-based pharmaceutical manufacturer to certain West African nations.

Key Points

Regulatory Action: A joint team from the Central Drugs Standard Control Organisation (CDSCO) and the Maharashtra State Regulatory Authority conducted an audit of the company’s manufacturing site, leading to a Stop Activity Order halting all operations.
Export and Manufacturing Halted: The Health Ministry issued a Stop Production Order and revoked Export NOCs and Manufacturing Licenses for Tapentadol-Carisoprodol combinations.
Drug Approval Status: While both Tapentadol and Carisoprodol are individually approved by CDSCO in India, their combination is not approved for manufacturing or sale.
India’s Commitment to Drug Safety: The government reiterated its commitment to maintaining strict pharmaceutical regulations and ensuring Indian-made medicines are not misused internationally.
Legal Classification: Neither Tapentadol nor Carisoprodol is classified under the NDPS (Narcotic Drugs and Psychotropic Substances) Act in India.