Small companies stepping into antibiotics development, face huge challenges

During a global webinar organized on August 24 by the Centre for Science and Environment (CSE), discussions revealed that small and medium-scale biopharmaceutical companies are stepping in to address the research and development gap in new antibiotics, while major pharmaceutical companies are showing reluctance.

These smaller companies are, however, encountering substantial challenges of their own. Unless these obstacles are tackled and surmounted, the availability of life-saving antibiotics may continue to decline, exacerbating a critical global situation.

Antibiotics development

The event marked the second installment in a series of webinars initiated by CSE to address the crisis in antibiotic research and development. Sunita Narain, Director General of CSE and a member of the Global Leader’s Group on Antimicrobial Resistance (AMR), emphasized the need for conserving existing antibiotics and developing new ones to combat deadly resistant infections. She noted that smaller pharmaceutical companies are now bearing this responsibility.

Antibiotic resistance, described as a silent pandemic, is causing antibiotics to lose their effectiveness, shrinking treatment options, and impacting health, livelihoods, and economies. In 2019 alone, around five million deaths worldwide were linked to antibiotic resistance.

The webinar, titled ‘Small and Medium Scale Antibiotic Developers: Challenges they face and the way forward,’ centered on developers based in India. Key stakeholders and experts participating included Vasan Sambandamurthy from Bugworks Research India Pvt Ltd, Jitendra Kumar from Biotechnology Industry Research Assistance Council (BIRAC), Sachin Bhagwat from Wockhardt Research Centre, T S Balganesh from GangaGen Biotechnologies Pvt Ltd, and Amit Khurana from the Sustainable Food Systems Programme at CSE. The session was moderated by Sunita Narain.

The webinar series was prompted by a CSE assessment titled ‘A Developing Crisis,’ published in Down To Earth (July 16-31). The assessment revealed the vulnerability of the global antibiotic pipeline at both pre-clinical and clinical development stages. Analysis of the clinical pipeline of 15 high-earning pharmaceutical companies indicated a lack of interest in new antibiotics research by major players. Smaller companies have taken up the mantle, but they face challenges.

Facing multiple challenges

Amit Khurana from CSE stressed, “Indian small and medium antibiotic developers are facing multiple challenges. They can play an important role in rejuvenating the global pipeline, if their concerns are addressed.”

Developers participating in the webinar highlighted challenges related to scientific, financial, and regulatory aspects of drug development. Vasan Sambandamurthy from Bugworks emphasized the need for global regulatory harmonization to facilitate the use of generated data. He also called for open clinical trial testing and accelerated approval pathways in India.

Balancing short-term needs and innovation

Sachin Bhagwat from Wockhardt, which is working on four traditional antibiotics, stated the importance of striking a balance between supporting viable products for short-term unmet needs and innovative drugs with higher long-term failure risks.

T S Balganesh from GangaGen noted the difficulty in sourcing funds due to variations in pathogen resistance levels between India and the western world. Jitendra Kumar from BIRAC assured support, highlighting ongoing initiatives to address the AMR crisis.

CSE researchers, in their assessment, called for critical reforms to stimulate sustainable and equitable antibiotic access. They emphasized the necessity for increased public financing, coordinated government responses, and balanced public-private partnerships for antibiotic development.

Narain concluded the webinar by discussing the use of public funding for innovation and drug availability, underscoring the broader agenda beyond funding incentives.

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