India’s First Indigenous Antibiotic to Combat Drug Resistance
In a groundbreaking development for India’s biotechnology sector, Union Minister Dr. Jitendra Singh has officially launched the first indigenous antibiotic called “Nafithromycin” to combat resistant infections. This achievement is a result of the right kind of support provided to researchers since 2014, when Prime Minister Narendra Modi took office. Dr. Jitendra Singh emphasizes that Modi’s personal intervention has made the task much easier.
The antibiotic “Nafithromycin” has been developed with the support of the Biotechnology Industry Research Assistance Council (BIRAC), a unit of the Department of Biotechnology. It is being brought to market under the trade name “Miqnaf” by the pharmaceutical company “Wolkardt”. This antibiotic is the first indigenously developed antibiotic in India aimed at tackling Antimicrobial Resistance (AMR).
Nafithromycin is specifically designed to treat Community-Acquired Bacterial Pneumonia (CABP), a severe illness caused by drug-resistant bacteria. This condition disproportionately affects vulnerable populations, including children, the elderly, and individuals with compromised immune systems such as patients with diabetes or cancer.
Dr. Jitendra Singh describes the three-day treatment regimen of Nafithromycin as a game-changer in addressing drug-resistant pneumonia, which is responsible for over two million deaths globally each year. India bears 23% of the world’s community pneumonia burden and faces challenges with existing treatments due to widespread resistance to drugs like azithromycin. The new antibiotic, developed by Wolkardt with support from BIRAC, is ten times more effective than current options and offers a safer, faster, and more tolerable solution for patients.
Nafithromycin stands out for its efficacy in targeting both typical and atypical pathogens, providing a potent solution where no new antibiotic in this class has been developed worldwide for over three decades. It is ten times more effective than azithromycin and achieves comparable outcomes with just a three-day regimen, as validated by clinical trials. Additionally, Nafithromycin has superior safety and tolerability, with minimal gastrointestinal side effects, no significant drug interactions, and no interference from food, making it a versatile option for patients.
This milestone marks the first new antibiotic in its class to be developed globally in over 30 years. This is significant considering the growing global health crisis of antimicrobial resistance (AMR) and the limited number of new drugs entering the pipeline. The development of Nafithromycin showcases India’s scientific advancement, offering a much-needed solution to combat multi-drug-resistant pathogens. Its innovative design, targeting both typical and atypical organisms and overcoming existing resistance mechanisms, positions it as a beacon of hope in the fight against AMR, with the potential to save countless lives worldwide.
The development of Nafithromycin is the result of 14 years of dedicated research and an investment of ₹500 crores. Clinical trials have been conducted in the U.S., Europe, and India. The initiative is supported by BIRAC under its Biotechnology Industry Partnership Program (BIPP), highlighting the power of public-private collaboration in advancing healthcare innovation. The drug is currently awaiting final approval from the Central Drugs Standard Control Organization (CDSCO) for manufacturing and public use, marking a major leap forward in India’s fight against AMR.
Dr. Jitendra Singh emphasizes the importance of addressing AMR as a global crisis that prolongs illnesses and raises healthcare costs. He recognizes the critical role of innovation and collaboration in tackling this issue, particularly noting the increased public awareness of biotechnology and its potential due to the COVID-19 pandemic. He urges the scientific community to leverage this momentum to drive further advancements in diagnostics, AMR surveillance, and new antibiotic research.
As World AMR Awareness Week sheds light on the global challenge of antimicrobial resistance, Dr. Jitendra Singh calls upon stakeholders from the government, pharmaceutical industry, and research institutions to work collectively in combating this threat. He sees the achievement of Nafithromycin as a reaffirmation of India’s commitment to addressing AMR and improving public health, while establishing India as a global leader in biotechnology innovation.
Dr. Jitendra Singh praises the collaborative efforts between the public and private sectors that made the development of Nafithromycin possible. He highlights the partnership model, combining government support with private sector innovation, as key to driving India’s leadership in biotechnology and pharmaceuticals. The success of Nafithromycin demonstrates India’s growing capability to develop homegrown solutions for pressing healthcare challenges.
The Minister emphasizes the importance of sustained investment in research and development, particularly in the field of AMR. He underlines the government’s proactive approach to fostering innovation and strengthening the healthcare infrastructure, which will play a crucial role in addressing the global AMR crisis. Dr. Jitendra Singh stresses the need for continued collaboration between research institutions, the pharmaceutical industry, and government bodies to ensure that India remains at the forefront of global efforts to combat drug-resistant infections.
In conclusion, Dr. Jitendra Singh expresses optimism about India’s future in the battle against AMR. He sees this achievement as not only a significant milestone in the fight against antimicrobial resistance but also a stepping stone for future breakthroughs in the development of life-saving medicines. India is committed to improving lives and building a healthier, more resilient future for all. The soft launch of Nafithromycin serves as a powerful reminder of India’s potential to lead the world in tackling one of the most pressing health threats of our time.
The event was attended by prominent leaders in the scientific community, including Dr. Rajesh S. Gokhale, Secretary, DBT and Chairman, BIRAC; Dr. Habil Khorakiwala, Chairman, Wockhardt; Dr. Jitendra Kumar, MD, BIRAC; and Dr. Y.K. Gupta, President, AIIMS, Jammu. The launch of Nafithromycin signifies India’s determination to combat AMR and contribute meaningfully to global health.
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