Drugs Control Dept’s fight against Antimicrobial Resistance: Karnataka

Medicine Antibiotic
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Drugs Control

The Karnataka drugs control department has recently intensified its surveillance on pharmacy outlets and pharmaceutical companies, aiming to closely monitor the sale and manufacturing practices of antimicrobial medications.

This heightened focus begins with the monitoring of antibiotics, anti-viral, anti-fungal, and anti-parasitic medications. In this article, we delve into the significant steps taken by the department, emphasizing the need for collaboration across various stakeholders.

Monitoring Over-the-Counter Sales

In a bid to control the dispensing of antimicrobial medications, particularly over-the-counter sales, pharmacists are urged to exercise caution.

This move highlights the pivotal role of pharmacists in ensuring responsible dispensing practices, contributing to the broader effort to combat antimicrobial resistance.

Collaborative Efforts by Drugs control

Recognizing the complexity of the issue, the Karnataka drugs control department emphasizes the importance of a concerted effort involving pharmaceutical companies, pharmacies, regulatory authorities, and pharmacy colleges.

This collaborative approach is crucial in effectively addressing the challenges posed by antimicrobial resistance.

Drugs Control Dept’s Perspective

From a regulatory standpoint, the continuous process of implementing and enforcing regulations for drug control is underscored.

The directive to pharmacy outlets is clear – drugs falling under Schedule H and H1 categories, especially those for infectious diseases, must be dispensed with the latest prescription from a registered medical practitioner.

Record Keeping

To ensure transparency and accountability, pharmacy retail is advised to maintain systematic records of antibiotic stocks and sales.

This directive, articulated by Karnataka drugs controller BT Khanapure, aims to establish a robust tracking mechanism for these critical medications.

Enforcement Actions


The enforcement team has been proactive, filing 51 cases against pharmacy outlets over the last three years related to the sale of Schedule H and H1 drugs without a prescription.

This underscores the regulatory commitment to ensuring adherence to prescription requirements and the pivotal role of pharmacists in the dispensing process.

Advice to Pharmacists

Khanapure emphasizes a threefold approach for pharmacists – think thrice before dispensing an antibiotic. It should be the right prescription, the right antibiotic, and the right quantity.

This advice is pivotal in preventing the misuse and overuse of antibiotics, contributing to the fight against antimicrobial resistance.

World Antimicrobial Awareness Week (WAAW) 2023

As part of the global effort, the Karnataka drugs control department, in collaboration with the Royal Society of Chemistry and PATH, organized an event titled ‘Preventing AMR together’ during the World Antimicrobial Awareness Week 2023.

The event, attended by thousands, underscores the global commitment to addressing the challenges posed by antimicrobial resistance.

Global Impact of AMR

The potential fatality of antimicrobial resistance is projected to be a staggering 10 million annually by 2050, with a colossal cost of US$ 100 trillion to the global economy through the loss of productivity.

In 2019 alone, 4.95 million succumbed to AMR, with 2.7 million fatalities directly caused by bacterial antimicrobial resistance.

Challenges in Treating AMR

Amaresh Tumbagi, Karnataka additional drugs controller, expresses serious concerns about the lack of new medicines to treat AMR.

The pharmaceutical industry is identified as a critical reservoir for antibiotics.

The burden of infectious diseases is compounded by factors such as poor sanitation, inadequate implementation of infection control practices, close animal-human interface, and a lack of specific diagnostics.

ICMR Study


Insights from an ICMR study highlight the high incidence of AMR due to non-adherence to standard treatment guidelines, irrational self-administration, medicine purchase without prescription, and poor drug quality.

This underscores the urgent need for advancing antimicrobial stewardship within a time-bound framework.

Pharmaceutical Industry’s Role

The pharmaceutical industry plays a pivotal role in addressing AMR through responsible antibiotic marketing and research.

It serves as a reservoir for antibiotics, and the responsible marketing and research of these medications are crucial in the fight against antimicrobial resistance.

Pharmacy Colleges Engagement

Pharmacy colleges are called upon to engage with the community, creating awareness about antibiotic abuse.

Their role extends to contributing to research, innovation, and community engagement to collectively address the multifaceted challenges posed by antimicrobial resistance.

Responsibility of Pharmacies

Pharmacies hold a significant responsibility in dispensing antibiotics responsibly.

They are urged to educate patients on the proper usage of antibiotics and to implement safe disposal practices for unused and expired drugs. Dr. Tumbagi emphasizes the onus on pharmacies in contributing to the broader efforts to address antimicrobial resistance.


  1. Why is there a need for intensified surveillance on pharmacy outlets for antimicrobial medications?
  2. What is the significance of Schedule H and H1 drugs?
    • Schedule H and H1 drugs, especially those for infectious diseases, require a latest prescription for dispensing.
  3. How can pharmacies contribute to preventing antimicrobial resistance?
    • Pharmacies can play a crucial role by dispensing antibiotics responsibly, educating patients, and implementing safe disposal practices.
  4. What challenges does the lack of new medicines pose in treating antimicrobial resistance?
    • The lack of new medicines is a significant concern in treating antimicrobial resistance, as highlighted by Amaresh Tumbagi.
  5. How can pharmacy colleges contribute to addressing antibiotic abuse?
    • Pharmacy colleges can contribute by creating awareness about antibiotic abuse, engaging with the community, and actively participating in research and innovation.

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