Last Updated on August 29, 2024 by The Health Master
Ban
India’s Ministry of Health and Family Welfare has taken a decisive step to protect public health by banning the manufacture, sale, and distribution of the pain relief drug combination S(+)etodolac + paracetamol.
This immediate ban was implemented following a strong recommendation from the Drugs Technical Advisory Board (DTAB), which raised serious concerns about the drug’s safety and lack of therapeutic benefits.
Drug Found to Pose Unnecessary Risks
The DTAB’s decision to prohibit this drug combination was not taken lightly.
After a thorough evaluation, including a detailed sub-committee report, the board concluded that the drug posed potential risks to human health and lacked any justifiable therapeutic advantages.
This is not the first time the DTAB has raised red flags about this particular drug combination.
In fact, the board had previously recommended its ban, but the drug’s manufacturer, Emcure Pharmaceuticals, successfully challenged the decision in the Delhi High Court.
Legal Battles and Sub-Committee Formation
Following the court’s ruling, the DTAB established a sub-committee of experts to re-evaluate the drug.
This committee, chaired by Dr. Lalit Kumar Gupta, director of the Department of Pharmacology at LCMH Hospital in New Delhi, included specialists in clinical pharmacology, orthopaedics, and medicine.
The sub-committee conducted a rigorous analysis of the drug, considering data and information provided by the Central Drugs Standard Control Organization (CDSCO).
While the specific findings of the sub-committee have not been publicly disclosed, the DTAB ultimately agreed with the recommendation to ban the drug.
A History of Controversy
It’s important to note that this is not the first time the government has taken action against the etodolac + paracetamol combination.
In 2018, a similar ban was imposed on various formulations of this drug, including Emcure’s S(+)etodolac + paracetamol.
This earlier decision was also based on safety concerns and a lack of therapeutic justification.
Several pharmaceutical companies, including Emcure, challenged the 2018 ban in the Delhi High Court.
While the court upheld the ban for most companies, it sent the case involving Emcure back to the DTAB for further consideration.
The Core of the Dispute
The central issue in the case revolves around the potential differences between etodolac and its isomer, S(+)etodolac.
Emcure argued that S(+)etodolac is a superior form of the drug with enhanced benefits.
However, the DTAB and the sub-committee found no evidence to support this claim.
The Delhi High Court ultimately sided with the DTAB, emphasizing that the sub-committee’s failure to consider a clinical trial conducted by Emcure weakened its report and left it open to challenge.
A Necessary Step for Public Safety
The government’s decision to ban the S(+)etodolac + paracetamol drug combination is a crucial step in protecting public health.
By removing this potentially harmful drug from the market, the authorities have demonstrated their commitment to ensuring the safety and well-being of Indian citizens.
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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