Nafithromycin, India’s first indigenously developed antibiotic for resistant infections, showcases innovation through public-private collaboration.
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India has been globally renowned as the “pharmacy of the world” for decades, as a supplier of low-cost generic drugs and vaccines. However, novel drug development in the country has remained largely unexplored. Nafithromycin, which is expected to be sold under the brand name Miqnaf in 2025, could be a tremendous shift. Developed indigenously by Wockhardt with critical support from the Biotechnology Industry Research Assistance Council (BIRAC), it is India's first indigenously developed novel antibiotic for resistant infections. It will help address the global health emergency of antimicrobial resistance (AMR). This antibiotic is targeted toward drug-resistant Community-Acquired Bacterial Pneumonia (CABP) and is a medical breakthrough that says much about India's potential in pharmaceutical innovation.
Developed indigenously by Wockhardt with critical support from the Biotechnology Industry Research Assistance Council (BIRAC), it is India's first indigenously developed novel antibiotic for resistant infections.
The timing of Nafithromycin’s emergence could not have been more critical. Pneumonia remains one of the leading causes of death in the world, and AMR makes this crisis worse by rendering many treatments ineffective. With no new class of antibiotics being developed in the world since the 1980s, this innovation from India could offer renewed hope for both national and global health.
AMR has been called the “silent pandemic” which threatens to reverse decades of progress in modern medicine. AMR is projected to kill as many as 10 million people per year by 2050. Pneumonia is among the major causes, disproportionately ravaging low- and middle-income countries. India alone accounts for 23 percent of all global pneumonia deaths with a reported incidence rate of 4 million CABP cases per year.
The pharmaceutical industry's step backwards from antibiotic development further aggravates this situation. A different economic model for antibiotics that includes short treatment cycles, restricted use to prevent resistance, and pricing pressure, has also deterred investments in their development. Research into antibiotics and venture capital investments have thus declined and innovation in the development of drugs in this focus area has largely ceased. Our health systems have been reliant on older, outdated medicines that are being outmanoeuvred by pathogens. Nafithromycin shows how targeted public-private collaboration can overcome market failures in critical areas.
Our health systems have been reliant on older, outdated medicines that are being outmanoeuvred by pathogens. Nafithromycin shows how targeted public-private collaboration can overcome market failures in critical areas.
This crisis is also compounded by a lack of prioritisation within global antibiotic development pipelines: while billions are invested yearly in research and development (R&D) for diseases like cancer and diabetes, antibiotics—which are less profit-driven due to shorter time frames for treatment and wider use restrictions—are an afterthought. The problem of market failure has shifted the burden onto smaller firms and academic institutions with inadequate resources; many of them can only advance promising discoveries up to the clinical trial stage. Moreover, even when novel antibiotics enter the market, most of them are derivations of existing classes, exhibiting limited efficacy against evolved “superbugs”. It has never been more urgent to develop drugs for critical pathogens such as Gram-negative bacteria due to their resistance to existing treatments and their role in causing life-threatening infections—pneumonia, sepsis, bloodstream infections, amongst others.
The clinical and practical superiority of Nafithromycin will make it more attractive to both practitioners and patients. The drug is tenfold superior to azithromycin in its ability and yields comparable results within the shortest regimen of just three days, improving patient compliance and outcomes considerably. Further, it can target both typical and atypical pathogens, including drug-resistant strains, which also shows its value as a first line of treatment against CABP.
The drug is tenfold superior to azithromycin in its ability and yields comparable results within the shortest regimen of just three days, improving patient compliance and outcomes considerably.
Safety is also quite apparent. Nafithromycin causes very few gastrointestinal side effects and has minor drug interactions, making it a safer bet for a large population pool. It was also found to be well-tolerated at all dosage levels with no serious or adverse events observed. This effectiveness and safety make Nafithromycin a global contender, especially considering that it is the first antibiotic of its class in over three decades. More than just clinical promise, it represents India's capability to produce world-class pharmaceutical ingenuity. Nafithromycin is an exception to the otherwise dismal trend of making derivative drugs of existing classes—calling attention to what is possible when public and private institutions collaborate to advance public interests.
Political action towards combating AMR has reached a critical point, with a high-level meeting on AMR at the United Nations General Assembly (UNGA) stating a need to “recognize the benefits of public-private partnerships” in addressing AMR. Taking note of the advancements made by Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and Global Antibiotic Research and Development Partnership (GARDP)—two global non-profit partnerships spearheading the production and sustainable access to antibacterial products, Public-Private Partnerships (PPP) represent a unique mechanism for the development and commercialisation of biopharma products. On the Indian front, PPP remains one of the central pathways of the country’s National Health Mission in attaining health resilience.
BIRAC’s mandate involves bridging the gap between academic research and industry by linking innovative research technologies with suitable industry partners to address different stages of product development, such as refining proof-of-concept ideas with the potential for commercialisation, providing incubation support for start-ups, aiding evaluation and validation, and identifying seed funding opportunities for start-ups.
Biotechnology Industry Research Assistance Council (BIRAC), a not-for-profit- public sector enterprise, under the Department of Biotechnology (DBT), invested INR 8 crore (~US$945,000) to support Phase III clinical trials from Nafithromycin. BIRAC endeavours to boost India’s bioeconomy, which is expected to reach US$300 billion in 2030, by catalysing the research and innovative development of high-quality products. India houses a thriving start-up environment, with over 8,000 devoted to biotech alone in 2023. BIRAC’s mandate involves bridging the gap between academic research and industry by linking innovative research technologies with suitable industry partners to address different stages of product development, such as refining proof-of-concept ideas with the potential for commercialisation, providing incubation support for start-ups, aiding evaluation and validation, and identifying seed funding opportunities for start-ups. Other notable breakthroughs include CERVAVAC—a Quadrivalent Human Papillomavirus (qHPV) vaccine—jointly developed by the Serum Institute of India, DBT, BIRAC, and the Bill and Melinda Gates Foundation; and ZyCoV-D—the world’s first DNA-based COVID-19 vaccine—developed by Zydus Cadila in partnership with DBT and BIRAC.
AMR represents a public health emergency that necessitates novel drug development. Antibiotic development and commercialisation take approximately 10-15 years; India’s Nafithromycin took about 14 years. Further, the impetus to work on new antibiotics has received a lukewarm response from global biopharmaceutical companies owing to its low return on investment (ROI). Challenges to transition from pre-clinical development to commercialisation, the relatively short duration of treatment regimens compared to chronic conditions, and their use as a ‘last resort’ treatment have left novel antibiotic development a lost cause. A considerable amount of interest in this space has been garnered by small- and medium-scale biopharmaceutical firms, with reports from the Biotechnology Innovation Organisation (the world’s largest biotech trade organisation) stating that 80 percent of new antibiotic discoveries were attributed to small firms, while large-scale companies represented only 12 percent. Small- and medium-scale firms still face the same hurdles—difficulties in acquiring profits and commercialisation In this lacunae, public-private partnerships can leverage the opportunity to accelerate the development of needed biopharma products and strengthen India’s healthcare ecosystem.
India’s BioE3 (Biotechnology for Economy, Environment, and Employment) and Bio-RIDE (Biotechnology – Research, Innovation, and Entrepreneurship Development) policies, which are set to attract INR 10,000 crore (~US$11.8 million) investments, will spearhead India’s biomanufacturing sector.
India’s BioE3 (Biotechnology for Economy, Environment, and Employment) and Bio-RIDE (Biotechnology – Research, Innovation, and Entrepreneurship Development) policies, which are set to attract INR 10,000 crore (~US$11.8 million) investments, will spearhead India’s biomanufacturing sector. Presently, India’s bioeconomy has grown significantly in the last decade from US$10 billion to US$151 billion by the end of 2023. India’s start-up sector is likely to expand and is set to harbour 10,000 biotech start-ups by next year. India boasts a substantially young demography—47 percent of the population is under 25—representing a skilled workforce that can contribute to the bioeconomy. With a burgeoning health emergency and a dry antibiotic pipeline, India is advancing its biopharma sector by tapping into PPPs that serve to leverage unique technologies for a population that is undergoing a health crisis. India’s Priority Pathogen List can also provide the biopharma industry with a roadmap to develop urgently needed antibiotics. Representing a huge global threat due to their high incidence and ability to resist currently available treatments, these pathogens necessitate the prioritisation of investments and a call for funding and incentives.
Lakshmy Ramakrishnan is an Associate Fellow within the Health Initiative at the Observer Research Foundation.
S. Uplabdh Gopalis an Associate Fellow within the Health Initiative at the Observer Research Foundation.
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Lakshmy is an Associate Fellow with ORF’s Centre for New Economic Diplomacy. Her work focuses on the intersection of biotechnology, health, and international relations, with a ...
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Dr. K. S. Uplabdh Gopal is an Associate Fellow within the Health Initiative at ORF. His focus lies in researching and advocating for policies that ...
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