Nafithromycin: India’s First Indigenous Antibiotic Launched

Why in the news?

 Union Minister launched Nafithromycin, India’s first indigenously developed antibiotic, addressing Antimicrobial Resistance and Community-Acquired Bacterial Pneumonia with high efficacy and safety, supported by BIRAC.

Nafithromycin: India's First Indigenous Antibiotic Launched

Introduction of India’s First Indigenous Antibiotic:

  • The Union Minister launched Nafithromycin, India’s first indigenously developed antibiotic, under the trade name “Miqnaf”.
  • This breakthrough innovation marks a significant achievement for India’s biotechnology sector.
  • Developed with support from the Biotechnology Industry Research Assistance Council (BIRAC), Nafithromycin addresses critical healthcare challenges.

Key Features and Benefits:

  • Primarily designed to combat Antimicrobial Resistance (AMR) and treat Community-Acquired Bacterial Pneumonia (CABP).
  • Demonstrates 10x efficacy compared to existing antibiotics, requiring only three doses for treatment.
  • Effective against both typical and atypical bacterial pathogens.
  • Offers a safe profile with minimal side effects, no drug interactions, and compatibility with food consumption.

About Nafithromycin: Key Highlights

  • Developed with Biotechnology Industry Research Assistance Council (BIRAC) support.
  • Marketed under the trade name “Miqnaf”, India’s first indigenously developed antibiotic.
  • Targets Antimicrobial Resistance (AMR) and treats Community-Acquired Bacterial Pneumonia (CABP).
  • Effective against typical and atypical pathogens; first in its class in over 30 years globally.
  • Minimal side effects, no drug interactions, and food-compatibility.
  • Delivers 10x efficacy with just three doses.
  • Developed over 14 years with a ₹500 crore investment; trials held in India, the U.S., and Europe.

Key Facts about Community-Acquired Bacterial Pneumonia (CABP):

  • A common infectious disease contributing significantly to global mortality and morbidity.
  • Caused by typical bacterial pathogens like Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis.

About Antimicrobial Resistance (AMR):

  • Occurs when microorganisms like bacteria, viruses, fungi, and parasites adapt, making medicines ineffective.
  • Leads to infections being harder to treat, raising risks of severe illness, disease spread, and mortality.
  • Antibiotics and antimicrobials become ineffective, complicating treatment.

About Central Drugs Standard Control Organisation (CDSCO):

  • India’s National Regulatory Authority (NRA) under the Ministry of Health & Family Welfare.
  • Headquarters: New Delhi; headed by the Drugs Controller General of India (DCGI).
  • Mandates under the Drugs and Cosmetics Act:
  • Approving new drugs.
  • Overseeing clinical trials.
  • Setting drug standards.
  • Ensuring quality of imported drugs.
  • Coordinating State Drug Control Organizations.

Sources Referred:

PIB, The Hindu, Indian Express, Hindustan Times