Addressing Antimicrobial Resistance (AMR) Through Collaborative Efforts

In an exclusive interview with India Pharma Outlook, Jaideep Gogtay, Global Chief Medical Officer at Cipla, discusses how pharmaceutical companies in India are adjusting their R&D strategies to address antimicrobial resistance (AMR). The discussion highlights collaborations between big pharma, academic institutions, and small-to-mid-sized firms, and the importance of government incentivization and global funding programs in advancing antibiotic development. Dr. Gogtay, a medical professional with nearly three decades of experience in pharmaceutical development and clinical trials, particularly in HIV/AIDS, infectious diseases, and respiratory diseases, has introduced several antiretroviral drugs and led clinical trials in asthma and COPD. He has authored 50 publications and presented at over 50 conferences.

India is among the highest consumers of antibiotics globally, driving concerns about AMR. How are pharmaceutical companies adjusting their R&D strategies to combat AMR and develop next-generation antibiotics?

The development of new antibiotics is a complex and extensive process. Globally, large pharmaceutical companies have had an overall slowdown in research and development, given the high risk of failure and low returns. It is important to collect surveillance data from various regions of the world to enable prioritizing the pathogens against which antibiotics need to be developed. The World Health Organisation (WHO) and the Indian Council of Medical Research (ICMR) have an existing list of such regions. However, new models are being explored to make it commercially viable for all stakeholders involved.

One such solution is for large pharmaceutical players to back academic institutions and small & mid-sized pharmaceutical firms that undertake early and mid-stage R&D of new antimicrobials. For instance, Cipla recently announced its partnership with Orchid Pharma to launch the new drug Cefepime-Enmetazobactam, which has been approved for the treatment of complicated Urinary Tract infections (cUTI). This collaboration leverages the extensive distribution muscle of Cipla to support this breakthrough antibiotic combination.

In addition to this, government incentivization schemes will be a key driver for innovation in the country as will global and national funding programs that pool in industry-wide resources and bring together big players and financers to fund and advance research in priority areas. Collaborative efforts like the Biomedical Advanced Research and Development Authority (BARDA), AMR Action Fund, and more recently, Global Antibiotic Research and Development Partnership (GARDP) exemplify how joining forces between pharma companies, philanthropies, development banks, and multilateral organizations needed to accelerate antibiotic development and reduce the financial risks associated with it.

AMR-related deaths are rising in India, with multidrug-resistant infections becoming common. How can pharmaceutical manufacturers enhance early detection and surveillance efforts to address this growing crisis?

A robust preventive care ecosystem is the first line of defense to reduce the risk of infections. It is estimated that approximately 50% of antibiotic treatments prescribed are incorrect because of improper diagnosis of the pathogen. Therefore, access to rapid and accurate antimicrobial susceptibility testing is essential to determine the appropriate line of treatment. Additionally, the collection and analysis of this data using AI can help identify infection patterns and resistance trends, in turn providing vital indications for the Government and healthcare players to customize the line of defense against AMR accordingly.

The ICMR has an AMR surveillance network in place to monitor resistance patterns across the country. This network can further be widened to include a large number of testing labs and hospitals that can be tasked with generating data to inform policies and interventions. In this context, studies have highlighted patterns of certain bacterial strains showing alarming resistance. ICMR, in their AMR 2023 report, has already identified concerning resistance trends, such as the ongoing rise in resistance against antimicrobials used to treat urinary tract infections, pneumonia, and bloodstream infections.

There is an opportunity for pharmaceutical companies to go beyond the pill and play a role across the AMR care continuum. First, pharma companies can enable access to point-of-care diagnostic tools for outpatient general practitioners to make more informed treatment decisions. Second, running extensive awareness programs and introducing adherence platforms for patients can help curb the unnecessary use of antibiotics as well as encourage responsible consumption among the larger population.

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India’s antibiotic pipeline remains limited despite rising AMR cases. How are Indian pharmaceutical companies collaborating with organizations like WHO or GARDP to accelerate the development of new antimicrobial treatments and address this crisis?

The paradox is that the prevalence of drug resistance is notably higher in Southeast Asia. However, drug discovery for AMR primarily takes place in the West, leading to delays in bringing new treatments to countries like India. Today, Indian pharmaceutical companies are working on a new class of antibiotics for serious drug-resistant infections as well as manufacturing drugs to combat certain gram-negative infections, in collaboration with GARDP. Companies like ours are cascading WHO’s stewardship practices in India. There are also efforts that are gaining steam in India, with the industry working with the India AMR Innovation Hub, the Indian Council of Medical Research (ICMR), and the Government’s National Action Plan (NAP) on AMR to solve for drug-resistant pathogens prevalent in India. India could potentially be the place where new antibiotics are first tested, and it could also play a significant role in the early development of these antibiotics.

Regulatory bottlenecks, including lengthy approval timelines and complex trial requirements, are delaying AMR drug approvals in India. How can the pharmaceutical industry collaborate with regulators to streamline and expedite this process?

India's high burden of AMR necessitates self-reliance in developing antibiotics. However, antibiotic development is resource-intensive and has limited commercial viability, which is why a conducive and collaborative environment is essential to combat AMR. Some of the policy interventions to incentivize R&D could include tax breaks, subsidies for clinical trials, and public-private partnerships. Additionally, setting up dedicated funding programs to support AMR research can further boost sustainable innovation. Regulatory bottlenecks in India often include complex clinical trial requirements and extended approval timelines. Additionally, the lack of clarity on regulations also poses barriers to conducting clinical trials in India. The first step in solving this could be to create a category for antimicrobials targeting serious or life-threatening infections within the existing regulatory framework, formally making antibiotics eligible for the expedited processes allowed under the 2019 NDCT Rules.

Faster approval timelines can also be achieved by adopting international best practices in clinical trial design for AMR-specific drugs. Creating a committee of regulatory experts focusing on AMR-related issues can also ease the introduction of innovative drugs into the Indian market. It would also prove beneficial to put in place a special clinical trial network to promote collaboration with national and international stakeholders and support the execution of complex clinical trials. India is actively encouraging the faster introduction of novel antibiotics to the market, with a strong sense of understanding shared among all stakeholders.

Overuse of antibiotics in agriculture contributes significantly to AMR in India. What collaborative strategies can the pharmaceutical and agricultural sectors adopt to reduce antibiotic usage and curb resistance?

The fight against AMR cannot be one-sided. A ‘One Health’ approach is the key to breaking the chain. The health of humans, animals, and the environment are intertwined, thereby an integrated approach is crucial. The National Action Plan on AMR involves coordination across sectors, including pharmaceuticals, healthcare, and agriculture.

In the pharmaceutical industry, all players need to follow robust regulatory frameworks to ensure responsible manufacturing practices and appropriate waste handling and disposal mechanisms to prevent breeding grounds for resistant bacteria. Additionally, pharmaceutical companies can play a key role in awareness programs that can cascade responsible use practices among healthcare practitioners, chemists, and consumers. Setting stringent rules for antibiotic use, awareness campaigns, and managing stewardship programs are important ways to keep resistance at bay. The agriculture sector should focus on building awareness of its role in reducing India’s AMR burden right from the grassroots in order to bring about change. Phasing out the use of pesticides and antibiotics for the purpose of higher yield and adopting integrated pest management and organic farming practices that promote natural pest control and soil health is the first action point to be considered. Using natural fertilizers and biopesticides can help maintain productivity while ensuring that residue limits in food products are strictly followed.

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With the growing threat of AMR, what innovative approaches and future technologies do you foresee will transform the pharmaceutical sector’s ability to develop effective antibiotics in India over the next decade?

AI can play a key role in the fight against AMR by enhancing the detection of antibiotic-resistant genes and identifying antibiotic targets and antagonistic bactericidal and bacteriostatic molecules that can be developed as antibiotics. This intelligence can help inform research and drug development efforts of the pharmaceutical industry. Additionally, innovations like genetic engineering and enzyme-based treatments can also offer new ways to combat resistant bacteria. Phage therapy, which uses bacteriophage viruses to combat bacteria, is also promising in the AMR context as an alternative or supplement to antibiotic treatments. The development of and access to rapid and accurate diagnostic tools can help with the right and timely treatment. These tools can quickly identify specific pathogens causing an infection and determine its susceptibility to antibiotics. It can also identify drug-resistant pathogens in real-time and provide valuable data on infection patterns and resistance trends, which can inform public health policies and monitor resistance evolution.