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New drugs arrive on the block

AMR: An Escalating Global Health Threat

  • Definition: AMR (Antimicrobial Resistance) occurs when microorganisms resist effects of antimicrobial drugs.
  • Global Impact: Contributed to 1.27 million deaths in 2019; projected to directly cause 1.91 million deaths by 2050.
  • India’s Burden: 2.97 lakh deaths due to AMR in 2019; India has one of the highest bacterial infection rates globally.

Relevance : GS 2(Health ,Governance)

Key Causes of AMR

  • Misuse/Overuse of Antibiotics:
    • Only ~30% of antibiotics are used for humans; majority in livestock, aquaculture, and agriculture.
    • Widespread over-the-counter (OTC) sales without prescriptions.
    • Use of antibiotics like colistin as growth promoters in poultry (recently banned).
  • Self-medication and lack of public awareness.
  • Inadequate diagnostics: Delays in antibiogram reports lead to delayed/inappropriate treatments.
  • Hospital-related challenges:
    • Equipment quality issues, high patient load, understaffing, poor infection control.
    • Lack of accountability and stewardship in healthcare systems.

Scientific Breakthrough: Nafithromycin

  • Developed by: Wockhardt (India) with support from BIRAC.
  • Significance: First antibiotic developed globally in 30 years.
  • Features: 3-day once-a-day oral treatment for Community-Acquired Bacterial Pneumonia (CABP); 97% success rate.
  • Indias Milestone: First indigenously developed antibiotic in its class.

Innovation Gaps and Market Challenges

  • Antibiotic Innovation Gap:
    • Post-1960s “golden era” saw decline in new antibiotics.
    • Big pharma exited due to low ROI; chronic diseases more profitable.
  • Drug Development Barriers:
    • High cost, long timelines, stringent regulatory hurdles.
    • Small companies like Wockhardt, Bugworks, Orchid Pharma taking the lead.
  • Affordability Strategy: Tiered pricing based on country income level (e.g., India price 80% lower than US).

Challenges in Stewardship and Regulation

  • Emerging Resistance to New Drugs:
    • E.g., Ceftazidime-avibactam losing efficacy due to irrational use.
  • Regulatory Gaps:
    • Despite being prescription-only, antibiotics are freely available OTC in India.
    • Weak enforcement and lack of pharmacy-level control.
  • Public Awareness Deficit:
    • Antibiotics taken for viral infections.
    • Patient pressure on doctors contributes to overprescription.

Government and Institutional Action

  • National Action Plan (2017): Aligns India with global AMR strategy.
  • Surveillance Networks & Public Campaigns: Still in nascent stages.
  • Need for Holistic Reforms:
    • Better diagnostics and equipment quality.
    • Healthcare professional training on AMR stewardship.
    • Stronger policy and enforcement framework.

Way Forward: Multifaceted, Shared Responsibility

  • 3-Pronged Approach:
    • Education: For public and practitioners on responsible antibiotic use.
    • Innovation: Continued R&D investment in novel antibiotics.
    • Regulation: Strict control on antibiotic sales, improved hospital protocols.
  • Expert Consensus: Without immediate, cross-sectoral action, AMR will spiral into a larger public health crisis.

May 2025
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