GS Paper III

News Excerpt:

Innovation in antibiotics research and development is urgently needed.

About Antimicrobial Resistance (AMR):

• AMR occurs when bacteria, viruses, fungi and parasites change over time and no longer respond to medicines making infections harder to treat and increasing the risk of disease spread, severe illness and death.
• As a result, the medicines become ineffective and infections persist in the body, increasing the risk of spread to others.
• AMR threatens the effective prevention and treatment of an ever-increasing range of infections.
• Antimicrobials - including antibiotics, antivirals, antifungals and antiparasitics - are medicines used to prevent and treat infections in humans, animals and plants. Microorganisms that develop AMR are sometimes referred to as “superbugs”.

AMR as a Global Health Crisis:

• There is an urgent need for innovation in antibiotics research and development to address the growing threat of AMR.
• The lack of innovation in the field of AMR is identified as a key issue, with a stagnant antibiotic pipeline since the 1970s.
• AMR is highlighted as a global health crisis, ranking among the top 10 threats to humanity.
• The historical significance of antibiotics, particularly the discovery of penicillin, is acknowledged, but overuse and misuse of antibiotics have contributed to the emergence of drug-resistant infections or "superbugs."

Status of AMR in India:

•  India has one of the highest age-standardised infectious disease mortalities in South Asia, and the rates of antibiotic resistance are alarming.
•  India leads the world in human antibiotic use, a prime driver of antimicrobial resistance, at 10·7 units per person.
• About 1 lakh culture reports were prepared between January 1 and December 31, 2021, from 20-odd hospitals in the country.
  • It found E-coli is the most common resistant bug, followed by Klebsiella pneumoniae and Acinetobacter baumannii.

Hurdles Faced in Antibiotic Innovation:

• Lack of Innovation: Limited exploration of alternative pathways and mechanisms hampers the emergence of groundbreaking antibiotic solutions.
• Challenges in Identifying New Druggable Targets: Unraveling suitable bacterial targets for antibiotics is a complex puzzle, often compounded by evolving resistance mechanisms.
• Regulatory Difficulties: Approval hurdles arise due to safety concerns linked to the necessity for high antibiotic dosages within short treatment durations.
• Limited Funding Options: Inadequate financial support impedes the progression of antibiotic research, stalling potential breakthroughs in the field.
• Exit of Major Pharmaceutical Companies: Withdrawal of prominent pharmaceutical players from antibiotic development diminishes collective expertise and resources dedicated to combating bacterial infections.
• For example- Between 2016 and 2018, four big companies – AstraZeneca, Sanofi, Novartis, and Allergan exited from antibiotic R&D.
• Less Attractive Profit Margin: The comparatively lower profitability of antibiotics discourages investment, diverting attention and resources toward more lucrative therapeutic areas like cancer or chronic diseases.

Way Forward:

• Recognition: Combined effort is required from major regulatory bodies to treat AMR as a global/national challenge, akin to climate change. E.g.- Call for integrated action on AMR by World Federation of Public Health Associations. 
• Harmonized approach: The need for a harmonized approach, support for clinical trials, minimizing duplication, and reducing the burden on developers is required. 
• Encourage innovation: Treat AMR as a national issue and require policies and funding to encourage innovation. 
• The Global Antibiotic Research and Development Partnership (GARDP), proposes to focus on public health-driven, non-profit antibiotic development.
• Use of PPP:  Public-Private Partnerships, labelled as ‘push incentives’ are acknowledged but are suggested to be complemented with 'pull incentives’ to guarantee revenue for antibiotic developers.
• Government support: There is a need of the Government’s push for R&D, infrastructure, and clinical development along with organized market forces and incentives for novel antimicrobial discovery. E.g.- India's National Action Plan (NAP) for AMR 2017 by the Union Ministry of Health and Family Welfare. 
• One Health approach: As AMR affects human, animal, plant, and environmental health, a One Health approach is required to tackle its complexities.
• It is a comprehensive solution, encompassing regulated antibiotic usage, surveillance, infection control, and incentivizing innovation for both human and non-human use. E.g.- Food Safety and Standards Authority of India (FSSAI) released “Antibiotic Residues limits” in food from animal origin.

Mains PYQ

Q. Can overuse and free availability of antibiotics without Doctor’s prescription, be contributors to the emergence of drug-resistant diseases in India? What are the available mechanisms for monitoring and control? Critically discuss the various issues involved. (UPSC 2014)