Nafithromycin: India’s First Indigenous Antibiotic

November 22, 2024

GS Paper III Science and Technology

Nafithromycin: India’s First Indigenous Antibiotic

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

About Antimicrobial Resistance (AMR)

It 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 of drug resistance, antibiotics and other antimicrobial medicines become ineffective and infections become increasingly difficult or impossible to treat.

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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