India Tightens Tapentadol Control, Exporters Face Risk

India's finance ministry has started a process to classify Tapentadol as a psychotropic substance under the NDPS Act. Two government officials confirmed the move to Mint. The reclassification would bring the painkiller's production and distribution under India's toughest drug law, with criminal penalties including imprisonment and fines. The department of revenue has sought feedback from four industry bodies – IDMA, Pharmexcil, the Indian Chemical Council and Chemexcil.

Tapentadol is currently a Schedule H1 drug, requiring a prescription and three years of purchase records. It is not a controlled substance under NDPS in India. In the US, it falls under Schedule II of the Controlled Substances Act. The review asks companies for five-year data on manufacturing, imports, exports, trade flows and seizure records.

A government sub-committee formed in January 2024 flagged high consumption levels, linking abuse to increased risk of Hepatitis C infection and citing easy availability and low cost. Enforcement has already begun: 1,720 Tapentadol tablets were seized in Bengaluru. The Drugs Controller General of India earlier banned export of unapproved Tapentadol–Carisoprodol combinations to West African countries amid concerns over an opioid crisis.

Dr. Atul Ambekar, professor of psychiatry at the National Drug Dependence Treatment Centre, AIIMS, said India's move mirrors earlier action on Tramadol and is correct. He stressed the need to balance regulation.