In a major achievement, after three decades of research and hard work, India has led the way with the creation of Nafithromycin, the country’s first indigenous Macrolide antibiotic.
Antimicrobial resistance has long been a growing global concern, with pharmaceutical companies striving to develop new medicines to combat it worldwide. Despite years of challenges and relentless effort, a breakthrough has finally emerged.
It is noted that India has achieved the goal after three decades of research and hard work. India has led the way with the creation of Nafithromycin, the country’s first indigenous Macrolide antibiotic. This remarkable achievement marks a pivotal moment in the fight against antimicrobial resistance, showcasing India’s growing capabilities in pharmaceutical innovation.
India's Fight Against Antimicrobial Resistance
Antimicrobial Resistance (AMR) occurs when bacteria, viruses, fungi and parasites no longer respond to antimicrobial medicines. As a result of drug resistance, antibiotics and other antimicrobial medicines become ineffective and infections become difficult or impossible to treat, increasing the risk of disease spread, severe illness, disability and death. While AMR is a natural process driven by genetic changes in pathogens over time, its spread is significantly accelerated by human activities, particularly the overuse and misuse of antimicrobial drugs in humans, animals, and plants. Antimicrobial resistance (AMR) has become a major global health issue, with around 6 lakh lives lost in India each year due to resistant infections. However, India is making significant strides in addressing AMR, particularly through the development of new drugs. Nafithromycin, developed with ₹8 crore in funding under the Biotechnology Industry Research Assistance Council (BIRAC) Biotech Industry Program for Phase 3 clinical trials, is a key milestone in this effort. Since India carries a large share of the global pneumonia burden, introducing Nafithromycin is especially important, as there have been no new antibiotics in recent years. Nafithromycin offers improved patient compliance and is a vital step in combating AMR.
Nafithromycin: Milestone for Public Health
Nafithromycin, was officially launched on November 20, 2024, by Union Minister Dr. Jitendra Singh. Developed by Wockhardt with support from the Biotechnology Industry Research Assistance Council (BIRAC), Nafithromycin, marketed as "Miqnaf," targets Community-Acquired Bacterial Pneumonia (CABP) caused by drug-resistant bacteria, which disproportionately affects vulnerable populations such as children, the elderly, and those with compromised immune systems.
Nafithromycin’s development marks a historic milestone as the first new antibiotic in its class to be introduced globally in over 30 years. The drug, which has undergone extensive clinical trials across the U.S., Europe, and India, has been developed with an investment of ₹500 crores and is now awaiting final approval from the Central Drugs Standard Control Organization (CDSCO).
This innovation exemplifies the power of public-private collaboration and underscores India’s growing capabilities in biotechnology. Nafithromycin’s successful introduction represents a major leap in the fight against AMR, offering hope for treating multi-drug-resistant infections and saving lives worldwide.
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