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NAFITHROMYCIN- FIRST INDIGENOUS ANTIBIOTIC OF INDIA

➔ It has developed by Wockhardt with support from the Biotechnology Industry Research
Assistance Council (BIRAC).
➔ Marketed name of this antibiotic is “ miqnaf”
Why development of ‘miqnaf’ is crucial?
1) Burgeoning problem of AMR( anti microbial
resistance). AMR is a situation when bacteria, fungi,
virus etc. develops tolerance to antibiotics. This
leads to ineffectiveness of antibiotics.
2) Around 6 lakh lives lost in India each year due to
AMR.
3) Be it pneumonia or TB, India shares the disease
burden close to1/4th w.r.t entire world.
4) Miqnaf," seeks to target Community-Acquired
Bacterial Pneumonia (CABP) caused by drug-
resistant bacteria.
5) Generally, AMR affects marginalized people more
severely as it leads to increase their “ out of pocket
expenditure” significantly. “miqnaf” will combat this
situation.
6) “Miqnaf," targets Community-Acquired Bacterial
Pneumonia (CABP) caused by drug-resistant
bacteria.
7) It is 10 times potent than “ Azithromycin”.
8) It has less side effects.

Why the situation of AMR prevails?

1. Antibiotics overuse.
2. Sometimes, microbes do mutates.
3. Poor regulation of antibiotic regimen.

Government Initiatives to Combat AMR

1) Surveillance and Reporting:
a) National networks and annual AMR reports submitted to the Global AMR
Surveillance System (GLASS).
b) Enhanced data collection on antimicrobial use in healthcare facilities.
2) Awareness and Training:
a) Development of educational materials on judicious use of antimicrobials, hand
hygiene, and infection prevention.

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b) National "train-the-trainer" programs for cascading knowledge across states and UTs.
3) Judicious Use of Antibiotics:
a) National Action Plan on AMR (NAP-AMR) launched in 2017, aligned with the Global
Action Plan.
b) Red Line Awareness Campaign: Encourages the public to avoid using antibiotics
without prescriptions.
c) ICMR Guidelines: Regulate antibiotic use for common conditions to prevent
unnecessary usage.
4) Regulation and Oversight:
a) Antibiotics listed under Schedule H and H1 of the Drugs Rules, 1945, ensuring
prescription-based availability.
b) High-end antimicrobials included under Schedule H1 for stricter regulation

Global Collaboration on AMR

1) India-US CDC Partnership: Focused on AMR surveillance and healthcare-associated
infection prevention.
2) Indo-Netherlands Collaboration: Pilot project integrating AMR surveillance with a One
Health approach in Andhra Pradesh.
3) Fleming Fund (UK): Supports infection control training and AMR network strengthening.
4) India-Denmark Collaboration: Technical collaboration to address AMR

Socio-Economic and Public Health Dimensions

1) Public-Private Collaboration: Nafithromycin development exemplifies successful
partnerships between government and industry.
2) Economic Impact:
a) Reduces healthcare costs by providing effective, shorter-duration treatment.
b) Promotes pharmaceutical innovation in India, boosting the biotech sector.
3) Public Health Benefits:
a) Protects vulnerable populations such as children, elderly, and immunocompromised
individuals.
b) Reduces the global pneumonia burden, especially in high-risk areas.

Way Forward for Tackling AMR

1) Enhanced R&D Investment:
a) Increase funding for indigenous antibiotic development.
b) Explore biotechnological solutions for AMR containment.

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2) Strengthened Regulation:
a) Expand antibiotic regulation frameworks to ensure responsible usage.
b) Promote rational prescription practices through healthcare reforms.
3) Integrated Global Approach:
a) Build stronger partnerships with international organizations to combat AMR
collaboratively.
b) Focus on the One Health approach, integrating human, animal, and environmental
health strategies.
4) Awareness Campaigns:
a) Scale up public education initiatives on antibiotic misuse and resistance.
b) Leverage digital platforms to spread awareness about AMR.

Conclusion: Miqnaf," targets Community-Acquired Bacterial Pneumonia (CABP) caused

by drug-resistant bacteria, Hence it will improve India’s out of expenditure scenario (now
48%) and ultimately shield people falling in “ poverty Trap”.

Alternate Conclusion: The development of Nafithromycin and India’s AMR initiatives

mark significant progress in addressing a global health crisis. By integrating innovation,
regulation, and global partnerships, India is setting a benchmark for combating AMR
while strengthening its public health infrastructure and pharmaceutical sector. Continued
efforts in these areas will play a pivotal role in ensuring sustainable and effective
healthcare solutions.

Antimicrobial Resistance (AMR): A Comprehensive Analysis

INTRODUCTION
Antimicrobial resistance (AMR) is a growing global health crisis that occurs when
microorganisms like bacteria, fungi, viruses, and parasites evolve and become resistant to
antimicrobial drugs, making infections harder to treat. This results in increased mortality,
prolonged illnesses, and rising healthcare costs.
With indiscriminate antibiotic use, lack of regulatory measures, and environmental factors,
AMR poses a significant threat to public health, food security, and economic stability.

Understanding Antimicrobial Resistance (AMR)

1. What is AMR?
• AMR occurs when microbes develop resistance to drugs that were once effective in
treating infections.

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• It renders standard treatments ineffective, requiring stronger and often more toxic
alternatives.
2. Causes of AMR
✔ Overuse and misuse of antibiotics – Unnecessary prescriptions, self-medication, and
over-the-counter sales.
✔ Agricultural use of antibiotics – Extensive antibiotic use in livestock, poultry, and
aquaculture leads to resistant bacteria entering the food chain.
✔ Poor infection control practices – Inadequate hospital hygiene and non-compliance with
infection prevention measures.
✔ Environmental contamination – Pharmaceutical, hospital, and industrial effluents pollute
water bodies with antibiotic residues.
✔ Lack of new antibiotics – Slow innovation in antibiotic development has created a
shortage of new treatment options.

Global & Indian Scenario of AMR

1. AMR in India
• India is one of the largest consumers of antibiotics globally, leading to high rates of
resistance.
• Widespread over-the-counter sales and limited enforcement of drug regulations have
accelerated AMR.
• High prevalence of drug-resistant tuberculosis (TB), typhoid, pneumonia, and urinary
tract infections (UTIs).
2. Global AMR Trends
• The WHO warns that AMR could lead to 10 million deaths annually by 2050.
• Emerging superbugs resistant to multiple antibiotics are increasing treatment failures.
• Developing nations face the greatest burden due to lack of healthcare infrastructure and
sanitation.

Key Findings from the First Multicentric Point Prevalence Survey (India)

✔ 94% of patients received antibiotics before any medical diagnosis.

✔ 71.9% of patients were prescribed antibiotics, reflecting high antibiotic consumption.
✔ 55% of antibiotics were used for preventive purposes, raising concerns over unnecessary
prescriptions.
✔ 38% of prescriptions were from the Access group, 57% from the Watch group, and 2%
from the Reserve group under the WHO AWaRe classification.
✔ Only 8 out of 20 medical institutes surveyed had an antibiotic policy in place.

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Concerns:
• Excessive use of Watch group antibiotics raises the risk of resistance.
• Lack of regulation in prescribing patterns highlights the need for stricter control.

Implications of AMR

1. Healthcare Impact
✔ Increased mortality and morbidity due to ineffective treatments.
✔ Prolonged hospital stays and higher risk of secondary infections.
2. Economic Consequences
✔ Higher medical costs due to second-line and third-line antibiotics.
✔ Loss of productivity due to prolonged illness and hospitalizations.
✔ AMR-related GDP losses estimated between $1 trillion to $3.4 trillion by 2030 (World
Bank).
3. Public Health Challenges
✔ Greater risk of outbreaks as infections become harder to control.
✔ Limited treatment options due to the slow pipeline of new antibiotics.

Measures Taken to Address AMR

1. National Initiatives
✔ National Programme on AMR Containment (2012-17) – Launched to monitor
antimicrobial usage and resistance patterns.
✔ Red Line Campaign – Urges people to avoid over-the-counter use of antibiotics marked
with a red line.
✔ Drugs and Cosmetics Rules, 1945 (Schedule H1) – Mandates that antibiotics be sold only
with a prescription.
✔ Ban on inappropriate Fixed Dose Combinations (FDCs) to curb irrational use of antibiotics.
✔ Operation AMRITH (Kerala Initiative) – Targets illegal antibiotic sales and strengthens
regulations.
✔ Kerala AMR Strategic Action Plan (KARSAP, 2018) – India’s first state-specific AMR action
plan aligned with the national strategy.

2. Global Measures
✔ Global Antimicrobial Resistance and Use Surveillance System (GLASS) (2015) – Tracks AMR
trends worldwide.

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✔ World Antimicrobial Awareness Week (WAAW) – Annual campaign to educate people on

responsible antibiotic use.
✔ WHO Global Action Plan on AMR – Encourages nations to adopt national AMR strategies.
✔ Global Antibiotic Research & Development Partnership (GARDP) – Focuses on developing
new antibiotics and alternatives.

Way Forward: Strategies to Combat AMR

1. Promote Judicious Use of Antibiotics

✔ Mandatory prescription guidelines – Doctors should specify indication and reason for
prescribing antibiotics.
✔ Stronger implementation of drug regulations (Schedule H1 Rules) – Ensuring pharmacies
sell antibiotics only with valid prescriptions.
2. Strengthen Surveillance & Monitoring
✔ Early detection of resistant strains through pathogen monitoring systems.
✔ Expanded AMR surveillance networks in hospitals, veterinary clinics, and food industries.
3. Infection Control & Hospital Hygiene
✔ Adherence to standard infection control protocols in hospitals.
✔ Stronger hygiene measures, handwashing campaigns, and sterilization techniques.
4. Public Awareness & Educational Campaigns
✔ Community engagement programs to promote responsible antibiotic use.
✔ One Health Approach – Training healthcare professionals, veterinarians, and farmers on
AMR risks.

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5. Promote Research & Development of New Antibiotics

✔ Government funding for new drug research to counteract resistant pathogens.
✔ Incentivizing pharmaceutical companies to develop new classes of antimicrobials.
6. Reduce Antibiotic Use in Agriculture & Environment
✔ Regulation of antibiotic use in livestock and poultry.
✔ Alternatives like probiotics, herbal medicine, and vaccines for disease prevention in
animals.
✔ Stricter wastewater treatment laws to prevent antibiotic residues from entering water
sources.

Conclusion
Antimicrobial resistance is a silent pandemic that threatens global health security and
economic stability. Addressing AMR requires a multi-sectoral approach, involving
governments, healthcare systems, industries, and the public.
By strengthening surveillance, enforcing regulations, promoting responsible antibiotic use,
and investing in research, India and the world can prevent AMR from becoming the next
major public health catastrophe.

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