The government is planning to place the opioid painkiller Tapentadol under the Narcotic Drugs and Psychotropic Substances (NDPS) Act to regulate its abuse, especially after reports of unregulated exports to West African countries where it has been fueling an opioid epidemic.

Key Highlights

Proposal for Regulatory Reclassification

• The health ministry can request the Department of Revenue to schedule Tapentadol as a psychotropic drug under the NDPS Act.

• Tapentadol is presently not scheduled under the Act but is included in Schedule H1 of the Drugs and Cosmetics Rules, 1945.

Export Ban to West Africa

• In February, the Drugs Controller General of India (DCGI) banned the manufacture and export of all Tapentadol combinations to West African nations.

• This came after claims of rampant abuse causing addiction problems in the area.

Previous Consideration of Schedule X Listing

• An earlier proposal to add Tapentadol to Schedule X of the Drugs and Cosmetics Act was rejected because of fears that it would limit access to a highly used pain killer drug.

• Special licenses for manufacture, distribution, and sale are needed for Schedule X drugs.

Sub-Committee Review

• A special sub-committee comprising a representative of DCGI, state regulator, psychiatrist, and pharmacologist examined the case.

• The committee suggested keeping Tapentadol in Schedule H1 but suggested that the Department of Revenue think about regulating it under the NDPS Act, as is the case with Tramadol.

Consequences of NDPS Scheduling

• If scheduled, the movement of Tapentadol will be strictly monitored by the Narcotics Control Bureau and law enforcement agencies.

• The step will prevent access but with essential availability to patients with scarce treatment choices.

The prospective recategorization of Tapentadol under the NDPS Act signifies increased anxiety over its domestic as well as overseas abuse. With regulators working toward achieving balance between control and medicinal necessity, Indian pharma companies and traders are likely to find compliance rules tightening on opioids soon.