Authorities Propose Stricter Control of Tapentadol under Narcotics Act

Tapentadlol is used for patients who have limited substitute treatment options and for pain. The government of India is planning to bring up the controversial opioid Tapentadol under the Narcotic Drugs and Psychotropic Substances Act following claims of uncontrolled exports of the drug to West Africa, causing an opioid addiction crisis there. This is expected to considerably reduce Tapentadol’s availability through tight regulation.

The proposal was placed before the Drugs Consultative Committee, an advisory body on drugs, to put Tapentadol under Schedule X of the Drugs and Cosmetics Act.

The drugs' controller General of India prohibited the production and export of all combinations of Tapentadol to West African nations by the month of February. According to ET, the Ministry of Health is expected to take up with the Department of Revenue to plan Tapentadol as a psychotropic substance under the NDPS act in the light of misuse and intoxication.

The Ministry of Finance regulates certain sections of the Act, like the categorization of pharma drugs as narcotics. Currently, Tapentadol is not scheduled under the Act, and Schedule X lists habit-forming narcotic and psychotropic substances, requiring licenses for their import, manufacture and sale.

This change to place Tapentadol in Schedule X might restrict its availability as a widely used medicine. A sub-committee, including a regulator from the drug regulatory authority, to examine the matter with respect to the controversial drug was formed by the state regulators of a clinician and a pharmacologist.

The drug to be retained in Schedule H1 will be placed in Schedule X and could restrict its availability. The category comes under the Drugs and Cosmetics Rules of 1945 and this specific list of drugs are primarily antibiotics, anti-TB drugs and certain psychotropic medications.