In a significant breakthrough for India’s biotechnology sector, Wockhardt Ltd, a pharmaceutical company based in Maharashtra, has developed the first indigenously discovered antibiotic, Nafithromycin (trade name: Miqnaf), to combat drug-resistant pneumonia. This novel antibiotic marks a milestone in the fight against community-acquired bacterial pneumonia (CABP) in adults.
Launch and Background
The drug was unveiled at an event organized by the Department of Biotechnology (DBT) and Biotechnology Industry Research Assistance Council (BIRAC) on November 20, 2024, in New Delhi. Dr. Jitendra Singh, Union Minister of State for Science and Technology, presided over the soft launch.
India bears 23% of the global burden of community pneumonia, with many cases exhibiting resistance to existing antibiotics like azithromycin. According to the Union Ministry of Science & Technology, drug-resistant pneumonia is responsible for over two million deaths annually worldwide.
Key Features of Nafithromycin
Nafithromycin offers groundbreaking advancements in pneumonia treatment:
- Potency: It is 10 times more potent than azithromycin.
- Enhanced Lung Exposure: Provides eight times higher lung concentration compared to existing drugs.
- Dosage and Duration: Requires a once-daily dose for just three days.
- Clinical Efficacy: Achieves a clinical cure rate of 96.7%.
- Safety: Demonstrates superior tolerability and safety profile.
Investment and Development
The development of Nafithromycin took 14 years of research and a financial investment of ₹500 crore. Clinical trials were conducted across India, the United States, and Europe. BIRAC supported the project with ₹8 crore funding for Phase 3 clinical trials and provided technical assistance through expert committees.
Addressing Antimicrobial Resistance (AMR)
This achievement is especially significant in the fight against antimicrobial resistance (AMR), a global health challenge where microorganisms become resistant to existing antimicrobial treatments. No new antibiotics for community respiratory infections have been introduced globally in the past 30 years, making Nafithromycin a crucial development.
Dr. Habil Khorakiwala, founder-chairman of Wockhardt, emphasized the importance of Miqnaf in tackling respiratory infections. He described this milestone as a testament to India’s potential to lead innovations in combating AMR and developing life-saving medicines.
Challenges in Antibiotic Development
Globally, the development of antibiotics has shifted from large pharmaceutical companies to smaller firms. A report by the Centre for Science and Environment (CSE) highlighted this shift, attributing it to the high costs and challenges associated with antibiotic research. In 2023, CSE researchers organized a webinar featuring developers like Wockhardt, Bugworks Research India, and BIRAC to discuss the obstacles and future opportunities in antibiotic development.
Conclusion
The introduction of Nafithromycin underscores India’s growing capability to tackle pressing global health issues. This breakthrough represents a significant step forward in addressing the AMR crisis and improving global health outcomes.
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