Nafithromycin has been developed by the Wockhardt group. It is a novel macrolide specifically designed for the treatment of Community Acquired Bacterial Pneumonia (CABP). The phase III clinical study of Nafithromycin in India was supported in-part by Biotechnology Industry Research Assistance council (BIRAC), a not-for-profit, Section 8, Public Sector Enterprise of the Department of Biotechnology (DBT). Central Drugs Standard Control Organisation (CDSCO) has issued marketing authorization permission for sale and distribution of Nafithromycin Tablets 400 mg, for the treatment of adults (≥18 years) with CABP, to M/s Wockhardt Limited.

The Government is supporting research &development and innovation to promote indigenous discovery and development of antibiotics through structured funding and ecosystem support. The Government support spans the research and development continuum from early-stage research& development, initial validation andcommercialization of products. Specific efforts are as follows:

• The Department of Biotechnology in collaboration with World Health Organization country office has developed an Indian Priority Pathogen list to guide research, discovery and development of new antibiotics in India.
• The Department of Biotechnology through its ‘Biotechnology Research Innovation and Entrepreneurship Development (Bio- RIDE)’ scheme is supportingR&D projects for advancement of anti-microbial therapeutics, antibiotic combinations, efficacy studies as well as drug repurposing studies for pathogens such as Mycobacterium tuberculosis, Staphylococcus aureus, Escherichia coli.
• The Department of Pharmaceuticals through its ‘Promotion of Research and Innovation in Pharma-MedTech Sector (PRIP)’ scheme is supporting the development and validation of new medicines.
• Department of Science & Technology has taken an initiative for the development of small chemical molecules naturally or synthetically for combating Anti Microbial Resistance (AMR).
• Council of Scientific & Industrial Research -Central Drug Research Institute (CSIR-CDRI), Lucknow is implementing various projects for antibiotic discovery.

Development of indigenous antibiotics will strengthen national capacity to combat AMR by improving the ability to treat hard to treat/ drug resistant infections, improve access to effective and affordable treatments, enhance self reliance and improve public health outcomes. This will also reinforce domestic research and manufacturing.

This information was given by Union Minister of State (Independent Charge) for Science & Technology and Earth Sciences, and Minister of State in the Prime Minister’s Office, Personnel, Public Grievances and Pensions, Atomic Energy and Space, Dr. Jitendra Singh, in a written reply in the Lok Sabha on Wednesday.

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AK/SK