Investigation into Tapentadol and Pregabalin: DCC recommendation

DCC recommendation: The DCC, in its 62nd meeting under the chairmanship of Drugs Controller General (India) [DCGI], recommended the formation of a sub-committee.

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Drug Consultative Committee DCC
DCC

DCC recommendation

DCC recommendation: In a recent development, the Drugs Consultative Committee (DCC) has taken a significant step to address concerns about the potential misuse of opioid pain-relief medicine tapentadol and the anticonvulsant and analgesic drug pregabalin.

This move signals a growing awareness of the need to regulate these medications to prevent misuse and protect public health.

DCC’s Decision-Making Process

1. Committee Formation

The DCC, in its 62nd meeting under the chairmanship of Drugs Controller General (India) [DCGI] Dr. Rajeev Singh Raghuvanshi, recommended the formation of a sub-committee.

This sub-committee, comprising regulators, clinicians, and pharmacologists, will delve into the various aspects of both pregabalin and tapentadol.

2. Tapentadol’s Schedule X Proposal

The committee deliberated on a proposal to list tapentadol under Schedule X of the Drugs Rules, 1945.

This decision, while aiming to control the drug’s sales, raised concerns about restricting its availability, considering tapentadol’s widespread use as a medicine.

3. Pregabalin’s Schedule H1 Proposal

Simultaneously, the State of Punjab proposed including pregabalin and its formulations under Schedule H1 of the Drugs Rules, 1945.

This proposal stemmed from the increasing misuse and intoxication associated with the drug.

Global Context and WHO Recommendations

4. Tapentadol’s International Status

Tapentadol, categorized as Schedule II in the USA and a controlled drug in several other countries, presents a complex regulatory challenge.

Interestingly, the drug is not scheduled under the Narcotic Drugs and Psychotropic Substances Act (NDPS Act) in India or any international conventions.

5. WHO’s Perspective on Tapentadol

The WHO expert committee on Drug Dependence (ECDD), in its 36th report (2014), recommended keeping tapentadol under surveillance due to insufficient data on dependence, abuse, and public health risks.

The Department of Revenue, under the Ministry of Finance, has requested further analysis for scheduling tapentadol under the NDPS Act, 1985.

Pregabalin’s Growing Concerns

6. Pregabalin’s Misuse in Punjab

The State of Punjab reported widespread misuse of pregabalin formulations, particularly those containing 150mg/300mg.

Drugs Control Officers seized these formulations due to violations of the Drugs & Cosmetics Act/Rules, prompting a call for inclusion in Schedule H1.

7. Re-evaluating DCGI Approvals

Given the limited therapeutic usage of pregabalin and its increasing misuse, the state drug regulator urged the re-evaluation of DCGI approvals for dosage forms containing pregabalin 150mg and 300mg.

Understanding Pregabalin’s Therapeutic Use

8. Various Strengths in the Market

Pregabalin formulations are available in strengths ranging from 75mg to 300mg per unit dosage form, highlighting the drug’s versatility.

9. Prescribed Usage for Neuropathic Pain

Doctors typically prescribe pregabalin for managing neuropathic pain and treating fibromyalgia.

The drug is also used alongside other medications to address certain types of seizures in both adults and children.

DCC’s Comprehensive Approach

10. Sub-committee’s Mandate

Emphasizing the importance of a thorough examination, the DCC recommended the formation of a sub-committee comprising regulators, clinicians, and pharmacologists.

This sub-committee will play a pivotal role in providing recommendations for both pregabalin and tapentadol.

11. Balancing Availability and Regulation

The DCC faces the challenge of balancing the need for regulation with ensuring the continued availability of these widely used medications.

FAQs

1. Are tapentadol and pregabalin banned in India?

No, as of now, tapentadol and pregabalin are not banned in India. The DCC is exploring regulatory measures to address potential misuse.

2. How does the WHO view tapentadol?

The WHO recommends surveillance for tapentadol due to insufficient data on dependence, abuse, and public health risks.

3. What is the therapeutic use of pregabalin?

Pregabalin is prescribed for managing neuropathic pain, treating fibromyalgia, and addressing certain types of seizures.

4. Why is pregabalin being considered for Schedule H1 inclusion?

Pregabalin’s increasing misuse has prompted the State of Punjab to propose its inclusion in Schedule H1 for tighter regulation.

5. How will the sub-committee influence regulatory decisions?

The sub-committee, comprising regulators, clinicians, and pharmacologists, will provide recommendations based on a comprehensive examination of tapentadol and pregabalin.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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