DCC Explores Measures to Address Potential Misuse of Tapentadol and Pregabalin: Regulatory Insights and Recommendations

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The Drugs Consultative Committee (DCC) has recently undertaken a comprehensive examination into the potential misuse of opioid pain-relief medicine tapentadol and the anticonvulsant and analgesic drug pregabalin. This blog post delves into the committee’s decisions and considerations, shedding light on the recommendations for potential control measures on the sales of these drugs in the market.


Sub-Committee Formation for In-Depth Analysis:
In its 62nd meeting under the chairmanship of Drugs Controller General (India) Dr Rajeev Singh Raghuvanshi, the DCC recommended the formation of a sub-committee. Comprising regulators, clinicians, and a pharmacologist, this sub-committee is tasked with examining the aspects related to both pregabalin and tapentadol, ultimately providing recommendations based on their findings.

Tapentadol’s Potential Listing to Schedule X:
The DCC’s decision was prompted by a proposal for listing tapentadol to Schedule X of the Drugs Rules, 1945. The committee, however, expressed concerns about potential restrictions on the availability of tapentadol, considering its widespread use. Further deliberation on this matter is deemed necessary, as highlighted in the minutes of the DCC meeting.

Pregabalin’s Misuse and Proposal by Punjab:
The State of Punjab has proposed the inclusion of pregabalin and its drug formulations under Schedule H1 of the Drugs Rules, 1945, citing concerns about the drug’s misuse and intoxication. The drug regulatory authority from Punjab highlighted instances of pregabalin formulations being seized due to violations, urging a re-evaluation of DCGI approvals for dosage forms containing pregabalin 150 mg and 300 mg.

International and National Context:
Tapentadol, categorized as Schedule II in the USA, has not been scheduled under the Narcotic Drugs and Psychotropic Substances Act in India or any international conventions. The WHO expert committee on Drug Dependence recommended surveillance due to insufficient data on dependence, abuse, and public health risks. The Department of Revenue has requested analysis for scheduling tapentadol under the NDPS Act, 1985.

The DCC’s proactive approach to address the potential misuse of tapentadol and pregabalin reflects the evolving landscape of drug regulation. As the sub-committee begins its in-depth examination, further insights and recommendations are expected, shaping the regulatory framework for these drugs in the Indian market. Stay tuned for updates on this critical issue.

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