painkillers: Two painkillers Tapentadol and Pregabalin may go off OTC over misuse

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The Drugs Controller General of India (DCGI) is considering banning over-the-counter (OTC) sales of pain relievers Tapentadol and Pregabalin, a move aimed at curbing their misuse, a person in the know said.

While drug formulations containing Pregabalin are prescribed mainly for the management of neuropathic pain, and to treat fibromyalgia, the Pregabalin capsules and tablets are used along with other medications to treat certain types of seizures.

Now, the drug regulator is considering putting Pregabalin and Tapentadol in the category of drugs that cannot be purchased without a valid prescription from a registered medical practitioner (RMP).

In this regard, the DCGI has constituted a sub-committee, including experts from the regulator’s office, clinicians and pharmacologists, who will review the matter. The sub-committee will give its recommendations soon, a person in the know said.

The matter was discussed during the Drug Consultative Committee (DCC) meeting held last month.

“DCC deliberated and opined that putting Tapentadol in Schedule X may restrict its availability, as it is a widely used medicine and, therefore, it needs further in-depth deliberation,” said the minutes of the meeting. ET has seen the minutes. “It was recommended to form a sub-committee comprising one regulator from CDSCO, one from the state, one or two clinicians (psychiatrist), and one pharmacologist for examining the matter in respect of both Pregabalin and Tapentadol and give its recommendation.”Tapentadol has often been misused by the young. Earlier, some boys were caught injecting diluted Tapentadol to get high.The sub-committee will examine putting Tapentadol under Schedule X, which has other narcotic drugs or controlled drug substances. They cannot be purchased without a valid prescription. Similarly, Schedule H1 comprises third and fourth generation antibiotics.

The DCC was informed that Tapentadol has been categorised in the US under Schedule II of the Control Substances Act. It is also a controlled drug in some other countries. In India, Tapentadol is not scheduled under the NDPS Act or any international convention.

Earlier, the Department of Revenue had called for an analysis of Tapentadol for its scheduling under the NDPS Act, 1985.

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