Recently, the Union ​​Minister of Science & Technology Dr. Jitendra Singh formally launched the first indigenous antibiotic “Nafithromycin” for resistant infections.

Nafithromycin: India’s First Indigenous Antibiotic

• About:  Nafithromycin is the first indigenously developed antibiotic in India, brought to market under the trade name Miqnaf by Wockhardt Pharmaceuticals. 
• Developed by:  Biotechnology Industry Research Assistance Council (BIRAC), a division of the Department of Biotechnology, 
• Aim: To address critical health challenges like Antimicrobial Resistance (AMR).
• Purpose and Application
  • Nafithromycin specifically targets Community-Acquired Bacterial Pneumonia (CABP), a severe condition caused by drug-resistant bacteria. 
• Efficacy and Benefits
  • Nafithromycin targets both typical and atypical pathogens, making it highly effective against drug-resistant bacteria.
  • It is ten times more effective than azithromycin, with minimal side effects and no food interaction.
  • The recommended dosage is a three-day regimen, validated by clinical trials for ease of use and effectiveness.
• Regulatory and Approval Status
  • The drug is currently awaiting final approval from the Central Drugs Standard Control Organization (CDSCO) for manufacturing and public use.
• Significance:
  • Nafithromycin is a landmark in India’s pharmaceutical innovation, showcasing the nation’s ability to address global health crises like antimicrobial resistance through indigenous research and development.

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About Central Drugs Standard Control Organisation (CDSCO)

• CDSCO is India’s National Regulatory Authority (NRA) under the Directorate General of Health Services, Ministry of Health & Family Welfare.
• Headquarters: New Delhi.
• Headed by: Drugs Controller General of India (DCGI) 
• Mandates: Under the Drugs and Cosmetics Act, CDSCO is responsible for:
  • Approval of New Drugs
  • Conduct of Clinical Trials
  • Laying down the standards for Drugs
  • Control over the quality of imported Drugs in the country
  • Coordination of the activities of State Drug Control Organizations

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