Updated: Feb 24, 2025 01:31:11pm
India Bans Export Of Tapentadol-Carisoprodol Combinations Amid West Africa Opioid Crisis
New Delhi, Feb 24 (KNN) Indian drug regulators have imposed an immediate prohibition on the manufacture and export of pharmaceutical combinations containing tapentadol and carisoprodol, following reports of these unapproved drug combinations contributing to an opioid crisis in West Africa.
The decision comes after a Mumbai-based company, Aveo Pharmaceuticals, was found exporting these unauthorised combinations to several West African nations.
The Drugs Controller General of India (DCGI) has directed state and Union territory drug authorities to revoke all export NOCs and manufacturing licenses for products combining these medications.
The regulatory action follows a BBC report highlighting the significant abuse potential of these combination drugs in West African markets.
While both medications are individually approved by India’s Central Drugs Standard Control Organisation (CDSCO) – tapentadol as a pain medication in various dosage forms and carisoprodol as a muscle relaxant – their combination has never received regulatory approval in India.
Tapentadol is approved in 50, 75, and 100-mg tablet forms, as well as extended-release versions in 100, 150, and 200-mg strengths. Neither drug is currently listed under India’s Narcotic Drugs and Psychotropic Substances (NDPS) Act.
The Union health ministry emphasised its swift response to the situation, stating it has taken ‘immediate and decisive action’ following the emergence of these concerning reports.
The incident highlights growing international scrutiny of pharmaceutical exports and their potential impact on global public health, particularly in developing regions.
(KNN Bureau)