Last Updated on April 18, 2024 by The Health Master
DTAB
This article explores the ongoing saga surrounding the pain relief drug combination S(+) etodolac + paracetamol. The Drugs Technical Advisory Board (DTAB) of India has once again recommended prohibiting its manufacture, sale, and distribution.
Previous Ban and Legal Challenge
In 2018, the Indian government prohibited the sale of several fixed-dose combination (FDC) drugs, including S(+) etodolac + paracetamol.
This decision stemmed from concerns about potential safety risks. However, Emcure Pharmaceuticals, the manufacturer of this specific combination, challenged the ban in the Delhi High Court.
High Court Order and Sub-Committee Formation
The High Court, while upholding the ban on other FDCs, directed the DTAB to form a sub-committee to re-evaluate the case of S(+) etodolac + paracetamol.
This sub-committee, led by Dr. Lalit Kumar Gupta, was tasked with analyzing the safety and efficacy data submitted by Emcure.
Latest DTAB Recommendation
On January 25, 2024, the DTAB, after reviewing the sub-committee’s report, recommended once again prohibiting S(+) etodolac + paracetamol. The specific details of the sub-committee’s findings were not disclosed.
Emcure’s Argument: S(+) Etodolac vs. Etodolac
Emcure argued that their version of the drug contains the “S(+) enantiomer” of etodolac, a purer and potentially more effective form compared to the standard racemic etodolac.
They claim this S(+) form offers advantages like targeted COX-2 enzyme inhibition for better pain relief.
High Court’s Observation and Remaining Questions
The High Court acknowledged its limitations in evaluating such technical arguments.
It also pointed out that the sub-committee might not have considered Emcure’s clinical trial data, potentially impacting their decision.
Uncertain Future for S(+) Etodolac + Paracetamol
The latest DTAB recommendation reignites the debate around the safety and efficacy of S(+) etodolac + paracetamol.
Whether the ban is implemented or Emcure successfully challenges it again remains to be seen.
Key Takeaways
- DTAB recommends prohibiting the pain relief drug combination S(+) etodolac + paracetamol.
- This follows a previous ban and legal challenge by Emcure Pharmaceuticals.
- The debate centers on the safety and potential advantages of the S(+) enantiomer form.
- The final decision on the drug’s fate awaits further developments.
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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