In February, the Drugs Controller General of India prohibited the production and export of all combinations of Tapentadol to West African countries.
The ministry of health is likely to take it up with the Department of Revenue to schedule Tapentadol as a psychotropic substance under the NDPS Act in light of its misuse and intoxication, according to a document accessed by ET.
The finance ministry regulates certain sections of the Act like categorisation of pharma drugs as narcotics. At present, Tapentadol is not scheduled under the Act. A proposal was earlier placed before the Drugs Consultative Committee (DCC), an advisory body on drugs, to put Tapentadol under Schedule X of the Drugs and Cosmetics Act. Schedule X lists habit-forming narcotic and psychotropic substances, requiring licences for their import, manufacture, distribution and sale.
However, it was concluded that putting Tapentadol in Schedule X may restrict its availability as it is a widely used medicine, and therefore, the issue needed further deliberation.
A sub-committee comprising a regulator from the drug regulatory authority, one from state regulators, a clinician (psychiatrist) and a pharmacologist was formed for examining the matter in respect of the controversial drug.
The sub-committee concluded that the drug be retained in Schedule H1, as putting it in Schedule X will restrict its availability. Schedule H1 is a category under the Drugs and Cosmetics Rules of 1945 that lists specific drugs primarily antibiotics, anti TB drugs and certain psychotropic medications that require stringent control and monitoring due to the risk of misuse.
The sub-committee in its report also recommended that the Department of Revenue should be asked to schedule Tapentadol as a psychotropic substance under the NDPS Act, similar to Tramadol, another drug that was known to be abused.
