Small antibiotic developers face huge challenges, need handholding: Experts

Antibiotic developers who spoke at CSE webinar highlighted their challenges related to scientific, financial and regulatory aspects of drug development

By DTE Staff
Published: Friday 25 August 2023
Representative photo: iStock__

Indian small and medium companies stepping into antibiotic development are hindered by enormous challenges. But they can play an important role in rejuvenating the global pipeline if their concerns are addressed, experts said at a global webinar organised by Delhi-based think tank Centre for Science and Environment (CSE) on August 24, 2023.

“While the big pharmaceutical companies are no longer keen, it’s the small and medium-scale companies that have taken up the responsibility. They have a huge task at hand and a lot depends on how they are supported,” CSE Director-General Sunita Narain said in her opening speech.

Antibiotic resistance is a silent pandemic impacting health, livelihoods and economies. Antibiotics are becoming ineffective and treatment options are reducing. In 2019, about five million deaths were associated with it.

“We need to conserve the antibiotics that we have, but we also need new antibiotics to treat deadly resistant infections,” said Narain, who is also a member of the Global Leader’s Group on Antimicrobial Resistance.

The webinar Small and Medium Scale Antibiotic Developers: Challenges they face and the way forward, the second of a series, brought together key stakeholders and experts from across the country. The series was based on a CSE assessment, A Developing Crisis, published in Down To Earth (July 16-31).

The assessment showed how the global antibiotic pipeline is weak across the pre-clinical and clinical development stages. Analysis of the clinical pipeline of 15 big pharmaceutical companies to understand their research and development (R&D) focus showed that most big companies have quit the R&D of new antibiotics. 

The antibiotic developers who spoke at the webinar highlighted their challenges related to scientific, financial and regulatory aspects of drug development.

In addition to the big funding for antibiotic innovators, there is a need for regulatory harmonisation at the global level so that the innovators can use the data generated, said Vasan Sambandamurthy from Bugworks Research India Pvt Ltd, a biopharmaceutical company engaged in developing two traditional antibacterial agents.

“We need to open up clinical trial testing for innovator drugs in India. We also need accelerated approval pathways so that it is clear how a life-saving antibiotics can qualify. It will spur alot of innovation and help companies across the discovery space,” he added.

The experts also highlighted difficulties in sourcing funds.

“The level of resistance in pathogens may vary in India and the western world; western interests would not be keen to fund if it is not a major problem there. This makes us completely dependent on Indian sources or sources from neighbouring countries,” said TS Balganesh of GangaGen, a company focusing on non-traditional therapies such as protein antibacterials and bacteriophages for treating serious bacterial infections. 

CSE researchers, in their assessment, had called for critical reforms to stimulate the antibiotic R&D ecosystem for sustainable and equitable antibiotic access. There is a need for greater public financing, a coordinated response from national governments and striking the right balance in public-private partnerships for antibiotic development. They highlighted antibiotics have attributes of a ‘global public good’ despite not fitting into the strictest definition.

“We need to see how public funding is used not just for innovation but also to make sure to get these drugs out on the table. This is where we will need to look at our priorities, target what we need and see if we are able to use it for the rest of the world,” said Narain.

“But it is not just a debate of push and pull incentives. It is a question of what more can be done. It is very clear that there is an agenda beyond just talking about funding,” she said, while concluding the webinar. 

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