The Ministry of Chemicals and Fertilisers highlights the significance of nafithromycin, India’s inaugural native macrolide antibiotic, which is currently pending final authorization from the Central Drugs Standard Control Organization (CDSCO). This breakthrough represents a monumental moment in tackling antimicrobial resistance, underlining India’s advancing pharmaceutical innovation.
On November 20, 2024, Union Minister Dr. Jitendra Singh unveiled the drug, which was developed with Rs. 8 crore funding through the Biotechnology Industry Research Assistance Council (BIRAC) Biotech Industry Programme during its phase 3 clinical trials.
Created by Wockhardt with BIRAC’s backing, the antibiotic will be sold as “Miqnaf”. It focuses on treating community-acquired bacterial pneumonia (CABP) caused by drug-resistant organisms that largely impact vulnerable groups such as children, the elderly, and immunocompromised individuals.
The ministry declared that “this revolutionary antibiotic surpasses existing treatments like azithromycin with tenfold effectiveness and offers a shorter, three-day treatment course, thereby enhancing patient recovery and outcomes.” Nafithromycin targets both typical and atypical drug-resistant bacteria, making it a crucial asset in tackling the global health challenge of antimicrobial resistance. It has been praised for its excellent safety profile, minimal adverse effects, and lack of significant drug interactions, the ministry stated.
Nafithromycin’s creation represents a groundbreaking achievement as the world’s first new antibiotic in its class introduced in over 30 years. Developed with a substantial Rs. 500 crore investment and subjected to rigorous clinical trials in the US, Europe, and India, it is awaiting CDSCO approval, added the ministry.
Amidst the escalating worldwide concern over antimicrobial resistance, pharmaceutical innovators globally have been grappling to unveil new treatments. After three decades of dedicated research, India has played a pivotal role in this breakthrough.
Since India shoulders a significant portion of the global pneumonia burden, the introduction of nafithromycin is particularly critical, as no new antibiotics have been developed in recent years. It enhances patient compliance and is crucial in the ongoing battle against AMR.
Additionally, the government expressed its commitment to various initiatives aiming to combat antimicrobial resistance.