Effect of pharmaceutical manufacturing waste on the environmental resistome of a pharmaceutical manufacturing hub in India

Effect of pharmaceutical manufacturing waste on the environmental resistome of a pharmaceutical manufacturing hub in India | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Effect of pharmaceutical manufacturing waste on the environmental resistome of a pharmaceutical manufacturing hub in India Chiara Borsetto, Emma R. Travis, Arpita Bhatt, Chandradeo Narayan, and 11 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8833409/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Antimicrobial resistance (AMR) is one of the top global health threats estimated to cause over 10 million deaths by 2050. To tackle this crisis, a One Health approach acknowledging the interconnectedness across human, animal and environmental health is essential. Over the last few decades, evidence has accumulated that the environmental dimension of AMR has been exacerbated by increased pollutants (e.g. pharmaceuticals, heavy metals, etc) being released in the environment from different sources, driving selection of antimicrobial resistance genes (ARGs) in microbial communities and pathogens. Pharmaceutical manufacturing is a major source of release into the environment of high concentrations of active pharmaceutical ingredients (APIs) - including antimicrobials, representing an increased risk of selection of AMR and exposure to human health. This study investigated the effect of environmental pollution from pharmaceutical manufacturing waste on the selection of ARGs in Baddi, one of the largest pharmaceutical manufacturing hubs in India, located in the state of Himachal Pradesh. Comparative analyses were performed with samples collected in Kangra, an unindustrialised municipality in the same area. Results have shown that APIs were detected only in Baddi, particularly in the waste stream from manufacturing plants, across different seasons. These samples also showed higher levels of ARG and mobile genetic element (MGE) diversity and relative abundance compared to the surrounding areas, including clinically important genes associated with extended spectrum beta-lactamases and carbapenemases. At both locations, a background pollution from faecal sources was observed, contributing to the resistome (i.e., the collection of ARGs present in the sample) observed in these environments. However, the presence of manufacturing pollution has likely impacted the selection of specific ARGs in the industrialised hub. These results highlighted the potential increased risk of exposure to higher levels and more diverse ARGs in pharmaceutical manufacturing waste-impacted areas. This further demonstrates the need to implement more robust standards for pharmaceutical manufacturing waste as supported by the AMR Industry Alliance and the World Health Organisation to protect the environment and human health. Molecular Epidemiology antimicrobial resistance (AMR) environmental pollution pharmaceutical manufacturing API Full Text Additional Declarations The authors declare no competing interests. Supplementary Files MSEnvResPharmaWasteSupplementarypreprint.pdf Supplementary material Supplementarytablespreprint.xlsx Supplementary tables Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8833409","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":588509410,"identity":"857c8fe8-f8ce-4e11-b17e-dae666c6cbbd","order_by":0,"name":"Chiara Borsetto","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA70lEQVRIie2RvarCQBBGRwKxGd12gj7EBkERRV9FCHibe3srWRFis76OlcWGBSvTK1YiWFlYiRcD/luIrMHOYk81M3D4ZhgAi+UrwUfhqFt7H/A0hRDc1scK8qdYo8JELlp1knq3mZU7+h/rIpMqs92DLpkUUvnAj8M2IcYjT641UiwcT4IumxQOWPZ6QhPS32iGaoGcARQAdP2tIpLjWfldz5Ob4hzSFVddFHdxTckJ95JiXIz0+ZZeGHhyOqkciuqINI3CquQ/xvPZYBgtRdJg2UF/5W9Uu8lkoGf7Ts0XJsd5HWXE20daLBaLJZ0TaQZNYJVRMmQAAAAASUVORK5CYII=","orcid":"https://orcid.org/0000-0003-4848-9522","institution":"School of Life Science, University of Warwick, Coventry, UK","correspondingAuthor":true,"prefix":"","firstName":"Chiara","middleName":"","lastName":"Borsetto","suffix":""},{"id":588509411,"identity":"b3410f64-0b1f-46f6-a5b9-13a54dbd9ad5","order_by":1,"name":"Emma R. 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