**Executive Summary**
This report, answering Unstarred Question No. 1938 in Lok Sabha on 11/02/2026, addresses the development of indigenous antibiotics in India. It confirms the development of Nafithromycin by the Wockhardt group and outlines government initiatives supporting antibiotic research, development, and innovation to combat antimicrobial resistance (AMR). The development of indigenous antibiotics is expected to improve national capacity to combat AMR.
**Key Points / Main Content**
* **Nafithromycin Development:**
* Nafithromycin, a novel macrolide, has been developed by the Wockhardt group.
* It is designed for the treatment of Community Acquired Bacterial Pneumonia (CABP).
* Phase III clinical studies were supported in part by BIRAC.
* CDSCO has issued marketing authorization to M/s Wockhardt Limited for Nafithromycin Tablets 400 mg for adults (≥18 years) with CABP.
* **Government Support for Antibiotic Development:**
* The government supports research, development, and innovation to promote indigenous discovery and development of antibiotics through structured funding and ecosystem support.
* Support spans from early stage research to commercialization.
* **Specific Initiatives:**
* The Department of Biotechnology has developed an Indian Priority Pathogen list with WHO to guide antibiotic research.
* The Department of Biotechnology supports R&D projects through the 'Biotechnology Research Innovation and Entrepreneurship Development (Bio- RIDE)' scheme for anti-microbial therapeutics targeting pathogens like *Mycobacterium tuberculosis*, *Staphylococcus aureus*, and *Escherichia coli.*
* The Department of Pharmaceuticals supports the development and validation of new medicines through the ‘Promotion of Research and Innovation in Pharma-MedTech Sector (PRIP)' scheme.
* The Department of Science & Technology has taken an initiative for developing small chemical molecules to combat Anti-Microbial Resistance (AMR).
* Council of Scientific & Industrial Research -Central Drug Research Institute (CSIR-CDRI), Lucknow is implementing projects for antibiotic discovery.
* **Benefits of Indigenous Antibiotics:**
* Strengthened national capacity to combat AMR.
* Improved treatment of drug-resistant infections.
* Enhanced access to effective and affordable treatments.
* Increased self-reliance and improved public health outcomes.
* Reinforced domestic research and manufacturing.
**Impact Analysis**
**Stakeholder: Wockhardt Group**
* **Impact:** Receives marketing authorization permission from CDSCO for Nafithromycin Tablets 400 mg for sale and distribution for the treatment of adults (≥18 years) with Community Acquired Bacterial Pneumonia (CABP)
* **Action Required:** Proceed with the sale and distribution of Nafithromycin Tablets 400 mg, according to marketing authorization.
**Stakeholder: Biotechnology Industry Research Assistance council (BIRAC)**
* **Impact:** BIRAC supported the phase III clinical study of Nafithromycin
* **Action Required:** Continue supporting similar studies in the future.
**Stakeholder: Department of Biotechnology**
* **Impact:** The Department of Biotechnology is responsible for developing an Indian Priority Pathogen List.
* **Action Required:** Guide research, discovery, and development of new antibiotics in India.
**Stakeholder: Department of Science & Technology**
* **Impact:** Department of Science & Technology has taken an initiative for the development of small chemical molecules naturally or synthetically for combating Anti Microbial Resistance (AMR).
* **Action Required:** Continue supporting the development of these chemical molecules.
**Stakeholder: Department of Pharmaceuticals**
* **Impact:** Department of Pharmaceuticals supports the development and validation of new medicines through the ‘Promotion of Research and Innovation in Pharma-MedTech Sector (PRIP)' scheme
* **Action Required:** Continue supporting the development and validation of new medicines
**Stakeholder: Council of Scientific & Industrial Research (CSIR-CDRI), Lucknow**
* **Impact:** The institute is implementing projects for antibiotic discovery.
* **Action Required:** Continue implementing projects for antibiotic discovery.
**Stakeholder: Indian Population**
* **Impact:** Improved access to effective and affordable treatments for drug-resistant infections, leading to improved public health outcomes.
* **Action Required:** Benefit from new treatments for CABP using Nafithromycin.
Key Entities Referenced
Department of Biotechnology (DBT): A department involved in supporting the development and commercialization of indigenous antibiotics.
Ministry of Science & Technology: The primary ministry overseeing the development of indigenous antibiotics.
Biotechnology Industry Research Assistance Council (BIRAC): Council supporting clinical studies of indigenous antibiotics.
Central Drugs Standard Control Organisation (CDSCO): Regulator that issued marketing authorization for an indigenous antibiotic.
Promotion of Research and Innovation in Pharma-MedTech Sector (PRIP): Scheme by the Department of Pharmaceuticals supporting development and validation of new medicines.
GOVERNMENT OF INDIA
MINISTRY OF SCIENCE & TECHNOLOGY
DEPARTMENT OF BIOTECHNOLOGY
LOK SABHA
UNSTARRED QUESTION NO. 1938
ANSWERED on 11/02/2026
DEVELOPMENT OF INDIGENOUS ANTIBIOTICS
1938. Dr. Raj Kumar Chabbewal:
Will the Minister of SCIENCE AND TECHNOLOGY be pleased to state:-:
(a) whether it is a fact that country has developed the first indigenously discovered antibiotic and if
so, the details thereof;
(b) whether the Government is taking any other measures towards the development of more such
indigenous antibiotics in the country and if so, the details thereof and if not, the reasons
therefor; and
(c) the details of the benefits likely to accrue to the people of the country due to the development of
these indigenous antibiotics?
ANSWER
MINISTER OF STATE (INDEPENDENT CHARGE) FOR THE
MINISTRY OF SCIENCE AND TECHNOLOGY & EARTH SCIENCES
(DR. JITENDRA SINGH)
(a) Yes, 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.
(b) 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.
(c) 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.
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