India gets its first indigenous antibiotic ‘Nafithromycin’ to combat drug resistance

New Delhi: India’s first indigenous antibiotic, “Nafithromycin” developed with the support of Biotechnology Industry Research Assistance Council (BIRAC), a unit of the Department of Biotechnology, has been brought to market under the trade name “Miqnaf” by Wockhardt Limited. It is the country’s first indigenously developed antibiotic aimed at tackling Antimicrobial Resistance (AMR).

This innovation is designed to treat Community-Acquired Bacterial Pneumonia (CABP), a severe illness caused by drug-resistant bacteria, which disproportionately affects vulnerable populations, including children and the elderly as well as immune compromised hosts like Patients with Diabetes, Cancers etc.

The drug was formally launched by the Union Minister for Science and Technology, Dr Jitendra Singh in New Delhi on November 20, 2024.

Dr Singh described the three-day treatment regimen of Nafithromycin as a game-changer in addressing drug-resistant pneumonia, a condition responsible for over two million deaths globally each year. India, which bears 23% of the world’s community pneumonia burden, faces challenges with existing treatments, including widespread resistance to drugs like azithromycin. The new antibiotic, developed by Wockhardt with support from the Biotechnology Industry Research Assistance Council (BIRAC), is ten times more effective than current options and offers a safer, faster, and more tolerable solution for patients.

Nafithromycin’s efficacy stands out as it targets both typical and atypical pathogens, offering a potent solution where no new antibiotic in this class has been developed worldwide for over three decades. Remarkably, it is ten times more effective than azithromycin and achieves comparable outcomes with just a three-day regimen, as validated by clinical trials. Beyond its efficacy, Nafithromycin boasts superior safety and tolerability. The antibiotic has minimal gastrointestinal side effects, no significant drug interactions, and remains unaffected by food, making it a versatile option for patients.

Nafithromycin marks a historic breakthrough as the first new antibiotic in its class to be developed globally in over 30 years. This significant milestone comes at a time when antimicrobial resistance (AMR) is a growing global health crisis, with few new drugs entering the pipeline. The development of Nafithromycin is a testament to 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 its ability to overcome 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 represents 14 years of dedicated research and an investment of ₹500 crores, with clinical trials spanning the U.S., Europe, and India. Supported by BIRAC under its Biotechnology Industry Partnership Program (BIPP), the initiative showcases the power of public-private collaboration in advancing healthcare innovation. Dr. Jitendra Singh highlighted that the drug is now 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.

The Minister underscored the importance of addressing AMR, calling it a global crisis that prolongs illnesses and raises healthcare costs. He pointed to the critical role of innovation and collaboration in tackling this issue, emphasizing that the COVID-19 pandemic had significantly increased public awareness of biotechnology and it’s potential. Dr. Jitendra Singh also urged the scientific community to leverage this momentum to drive further advancements in diagnostics, AMR surveillance, and new antibiotic research.

As World AMR Awareness Week shines a spotlight on the global challenge of antimicrobial resistance, Dr. Jitendra Singh rallied stakeholders from the government, pharmaceutical industry, and research institutions to work collectively in combating this threat. “Today’s achievement reaffirms our commitment to addressing AMR and improving public health, while positioning India as a global leader in biotechnology innovation,” he said.

Dr Jitendra Singh also praised the collaborative efforts between the public and private sectors that made the development of Nafithromycin possible. He noted that this partnership model, which combines government support with private sector innovation, is key to driving India’s leadership in biotechnology and pharmaceuticals. “The success of Nafithromycin is a testament to India’s growing capability to develop homegrown solutions for pressing healthcare challenges,” he stated.

The Minister highlighted the importance of sustained investment in research and development, particularly in the field of AMR. He emphasized that the government’s proactive approach to fostering innovation, alongside its focus on strengthening the healthcare infrastructure, will play a crucial role in addressing the global AMR crisis. Dr. Jitendra Singh stressed 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 expressed optimism about India’s future in the battle against AMR. “This achievement not only marks a significant milestone in our fight against antimicrobial resistance but also paves the way for future breakthroughs in the development of life-saving medicines. We are committed to improving lives and building a healthier, more resilient future for all,” he said. 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 signals India’s determination to combat AMR and contribute meaningfully to global health.