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World / Sat, 15 Jun 2024 Hindustan Times

4% of antibacterial agents under development globally in India: WHO

India has 4% of the total percentage of antibacterial agents in clinical development by location of research facilities, according to the report on antibacterial agents in clinical and preclinical development worldwide. The aim is to steer antibacterial research and development to better counter the ever-growing threat of antimicrobial resistance (AMR). AMR is driven largely by the misuse and overuse of antimicrobial agents, yet, at the same time, many people around the world do not have access to essential antimicrobial medicines. Antibacterial agents are simply not reaching the patients who desperately need them in countries of all income levels.”Not only are there too few antibacterial medicines being developed, given the time needed for R&D and the likelihood of failure, there is also not enough innovation. “Efforts to develop new antibacterial agents need to be accompanied by parallel efforts to ensure they can be equitably accessed, particularly in low- and middle-income countries,” the report said.

The number of antibacterial agents in the clinical pipeline, including antibiotics, increased globally from 80 in 2021 to 97 in 2023, according to the World Health Organization, which said in a report that there was still pressing need for new, innovative agents for serious infections and to replace those becoming ineffective due to widespread use. First released in 2017, this WHO annual report evaluates whether the current R&D pipeline properly addresses infections caused by drug-resistant bacteria most threatening to human health.

India has 4% of the total percentage of antibacterial agents in clinical development by location of research facilities, according to the report on antibacterial agents in clinical and preclinical development worldwide. Among the upper middle-income countries, China, Russia and South Africa comprised 7%, 3%, and 2% of the agents, respectively, and 84% put together from the pipeline was in the high-income countries.

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First released in 2017, this WHO annual report evaluates whether the current R&D pipeline properly addresses infections caused by drug-resistant bacteria most threatening to human health. The aim is to steer antibacterial research and development to better counter the ever-growing threat of antimicrobial resistance (AMR).

AMR occurs when bacteria, viruses, fungi and parasites no longer respond to medicines, making people sicker and increasing the risk of spread of infections that are difficult to treat, illness and deaths. AMR is driven largely by the misuse and overuse of antimicrobial agents, yet, at the same time, many people around the world do not have access to essential antimicrobial medicines.

“Antimicrobial resistance is only getting worse, yet we’re not developing new trailblazing products fast enough to combat the most dangerous and deadly bacteria,” Dr Yukiko Nakatani, WHO’s assistant director-general for antimicrobial resistance, said in a statement. “Innovation is badly lacking yet, even when new products are authorized, access is a serious challenge. Antibacterial agents are simply not reaching the patients who desperately need them in countries of all income levels.”

Not only are there too few antibacterial medicines being developed, given the time needed for R&D and the likelihood of failure, there is also not enough innovation. Of the 32 antibiotics under development to address bacterial priority pathogen list (BPPL) infections, only 12 can be considered innovative, said WHO. Further, just four of these 12 are active against at least 1 critical pathogen. There are gaps across the entire pipeline, including in products for children, oral formulations more convenient for outpatients, and agents to tackle rising drug resistance, it said.

Looking at newly approved antibacterial drugs, the report said that since July 1, 2017, 13 new antibiotics have obtained marketing authorization but only two represent a new chemical class and can be termed innovative, underscoring the scientific and technical challenge in discovering novel antibacterial agents that are both effective against bacteria and safe for humans.

The preclinical pipeline was active and innovative, with many non-traditional approaches, as part of a stable number of preclinical candidates over the last four years. Its focus remains gram-negative pathogens, which are resistant to last-resort antibiotics. Gram-negative bacteria have built-in abilities to find new ways to resist treatment and can pass along genetic material that allows other bacteria to become drug-resistant as well.

Greater transparency was required in the pipeline that would in the long run facilitate collaboration around potentially innovative but challenging projects, help scientists and drug developers and generate more interest and funding for drug development for novel antibacterial agents, the researchers said.

“Efforts to develop new antibacterial agents need to be accompanied by parallel efforts to ensure they can be equitably accessed, particularly in low- and middle-income countries,” the report said.

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