Indian Regulators Crack Down on Unapproved Antibiotics to Fight Misuse

When antibiotics are used inappropriately, bacteria develop mechanisms to evade their effects, rendering them ineffective for future infections.

The Health Master

May 21, 2024

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Last Updated on October 9, 2024 by The Health Master

Antibiotics

The Indian healthcare system is taking a crucial step towards tackling the concerning issue of misuse of antibiotics.

The Drugs Controller General of India (DCGI) has initiated a nationwide crackdown on unapproved antibiotic combinations, aiming to curb the irrational use of these life-saving medications.

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Why is This Important?

Antibiotics are a cornerstone of modern medicine, effectively treating bacterial infections.

However, their overuse and misuse can lead to antibiotic resistance, a growing public health threat.

When antibiotics are used inappropriately, bacteria develop mechanisms to evade their effects, rendering them ineffective for future infections.

Unapproved antibiotic combinations further exacerbate this issue.

These combinations, often lacking proper scientific evaluation, can be less effective or even harmful.

Additionally, they might contain unnecessary ingredients, increasing the risk of side effects and contributing to the development of resistance.

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Taking Action: A Multi-Step Approach

The DCGI’s initiative follows a series of critical steps taken by various Indian health agencies:

ICMR Recommendations (April 25, 2023):

A meeting at the Indian Council of Medical Research (ICMR) recognized the urgency of addressing irrational antibiotic use.

They recommended an immediate ban on inappropriate combinations and stricter regulations to prevent their future availability.

DGHS Meeting (October 16, 2023):

A high-level meeting chaired by the Director General of Health Services (DGHS) focused on strategies to regulate antibiotic overuse.

The CDSCO was tasked with conducting six-monthly reviews of antibiotic combinations marketed across the country.

DTAB Sub-Committee (January 25, 2024):

The Drugs Technical Advisory Board (DTAB) established a sub-committee led by Dr. D.S. Arya to investigate the issue and recommend necessary actions.

The committee included experts in pharmacology, medicine, and microbiology, ensuring a comprehensive approach.

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DCGI’s Call to Action

Following these discussions, the DCGI has issued a communication to State Licensing Authorities (SLAs) outlining two key actions:

Inventory of Approved Combinations (Within Two Weeks):

SLAs have been written to provide the DCGI with a complete list of antibiotic combinations licensed for manufacturing and marketing within their respective states.

This will establish a national database of authorized combinations.

Monitoring for Unapproved Combinations (Ongoing):

The SLAs are tasked with actively monitoring their jurisdictions for the presence of unapproved antibiotic combinations.

Any such instances must be addressed under the provisions of the Drugs and Cosmetics Act & Rules, with prompt notification to the CDSCO.

These actions demonstrate the Indian government’s commitment to promoting responsible antibiotic use.

By identifying and eliminating unapproved combinations, this initiative aims to safeguard public health and preserve the efficacy of these crucial medications for future generations.

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