India’s Indigenous Antibiotic
Source: Indian Express
GS III: Science and Technology – Developments and their applications and their effects in everyday life.
Overview
- News in brief
- Significance of the development
- What is Anti-Microbial Resistance (AMR)?
- Way Ahead
Why in the News?
Recently, the US FDA has approved Zaynich (Nafithromycin), an indigenously developed antibiotic in India.
News in Brief
- The United States Food and Drug Administration approval for Zaynich marks a milestone for the Indian innovation ecosystem.
- Zaynich (Brand name), Nafithromycin (Scientific name of the antibiotic): developed for Community – Acquired Bacterial Pneumonia (CABP).
- This development helps to treat the global threat of Anti-Microbial Resistance (AMR).
Significance of the development
- The first indigenously developed antibiotic in India.
- It is regarded as India’s first major breakthrough in nearly three decades.
- Addresses the fight against the toughest Anti-Microbial Resistance (AMR) challenges in the world.
- Demonstrates India’s transition from producer of affordable medicines and vaccines to an innovator in antibiotics that meet the most demanding global standards.
- Showcases Indian drug innovators’ capability in discovering and developing new therapeutics with global relevance on the global stage.
- Ensured that Indian innovation can address global health challenges at the highest level.
- Symbolises the maturation of the Indian life-Science ecosystem.
What is Anti-Microbial Resistance (AMR)?
- Occurs when germs that cause infections resist the effectiveness of treatments and become harder to cure.
- Driven by misuse and overuse of antibiotics.
- The World Health Organisation considers AMR as one of the most serious threats to global health.
Way Ahead
- Ensure the regulatory framework aligns with India’s innovation ambitions.
- The Indian regulator, Central Drugs Standard Control Organisation (CDSCO) should accelerate approval for innovative antibiotics that address unmet medical needs.
- Ensure no compromise is made in scientific rigour.
- Strengthen antimicrobial stewardship.
- Promote appropriate use of antimicrobial medicines to preserve their effectiveness and reduce the emergence of AMR.
- Accelerated approval should thus be linked to appropriate stewardship measures, surveillance and post-marketing monitoring.
- Ensure rapid, responsible and affordable access.
- Collaborate with international organisations on AMR research for data sharing and the development of new antimicrobial agents.
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