New drugs arrive on the block, but AMR threats continue, Pg22

Key Highlights

• Nafithromycin, developed by Indian biotech firm Wockhardt, is the first antibiotic in over 30 years for community-acquired bacterial pneumonia.
• Despite new drugs, Antimicrobial Resistance (AMR) remains a critical threat.
• AMR led to 4.95 million deaths globally in 2019, with 1.27 million directly attributed to it.
• India is among the top contributors to AMR due to overuse/misuse of antibiotics and weak regulation.
• OTC sale of antibiotics continues despite being prescription drugs.
• Health experts urge multi-sectoral action involving human, animal, and agricultural sectors.
• Global and national efforts are focused on AMR surveillance, new drug R&D, and regulatory reforms.

Detailed Insights

1. What is AMR and Why Is It Alarming?

• AMR occurs when microorganisms evolve to resist the effects of antibiotics.
• Caused primarily due to overuse in humans and livestock, poor infection control, and unregulated access to antibiotics.
• Results in longer hospital stays, higher treatment costs, and increased mortality.

2. India's Burden

• India had the highest bacterial AMR burden in 2019.
• AMR is rampant in Indian ICUs, particularly for Gram-negative bacteria like Klebsiella pneumoniae and Acinetobacter baumannii.
• AMR surveillance is conducted via the Indian Council of Medical Research (ICMR) and AMR Surveillance Network.

3. Drug Development & Nafithromycin

• Nafithromycin targets community-acquired bacterial pneumonia (CABP).
• Developed indigenously and supported by CARB-X, a global AMR initiative.
• India’s contribution is crucial due to low drug discovery over decades and high AMR burden.

4. Challenges Beyond Drug Discovery

• OTC sale of antibiotics in India is rampant despite prescription-only regulation.
• Low regulatory capacity, poor public awareness, and weak hospital infection control amplify resistance.
• In low-income countries, lack of proper antibiotic stewardship exacerbates the issue.

5. Policy & Governance Efforts

• WHO’s Global Action Plan on AMR mandates national strategies.
• India has adopted a National Action Plan on AMR, but implementation remains weak.
• The pharma industry is urged to engage in R&D for "access and stewardship".

Scientific/Technical Concepts Involved

• Antimicrobial Resistance (AMR): Ability of microbes to resist drugs meant to kill them.
• Antibiotic Stewardship: Systematic effort to prescribe antibiotics responsibly.
• Prescription-only Drugs (Schedule H): Drugs that legally require a prescription in India.

Significance

• India stands at a critical juncture in the fight against AMR.
• The launch of new drugs like Nafithromycin is encouraging, but regulatory, behavioural, and systemic reforms are necessary.
• Without coordinated global and national actions, AMR threatens to reverse decades of medical progress.

Mains Mock Question:

“The launch of new antibiotics is a welcome step, but without coordinated stewardship, AMR will continue to threaten global health.” Discuss with reference to India's preparedness and policy response.