Rule-Breaking and Rulemaking: Governance of the Antibiotic Value Chain in Rural and Peri-Urban India.

Background/Objectives: Antimicrobial resistance (AMR) is a growing global health challenge, driven in part by how antibiotics are accessed, distributed, and used within complex value chains. In peri-urban India, these supply chains involve a range of formal and informal actors and practices, making them a critical yet underexamined focus for antimicrobial stewardship efforts. While much research has focused on the manufacturing and regulatory end, less is known about how antibiotics reach consumers in rural and peri-urban settings. This study aimed to map the human antibiotic value chain in West Bengal, India, and to analyse how formal and informal governance structures influence antibiotic use and stewardship. Methods: This qualitative study was conducted in two Gram Panchayats in South 24 Parganas district, West Bengal, India. Semi-structured interviews were carried out with 31 key informants, including informal providers, medical representatives, wholesalers, pharmacists, and regulators. Interviews explored the structure of the antibiotic value chain, actor relationships, and regulatory mechanisms. Data were analysed thematically using a value chain governance framework and NVivo 12 for coding. Results: The antibiotic value chain in rural West Bengal is highly fragmented and governed by overlapping formal and informal rules. Multiple actors-many holding dual or unofficial roles-operate across four to five tiers of distribution. Informal providers play a central role in both prescription and dispensing, often without legal licences but with strong community trust. Informal norms, credit systems, and market incentives shape prescribing behaviour, while formal regulatory enforcement is inconsistent or absent. Conclusions: Efforts to promote antibiotic stewardship must move beyond binary formal-informal distinctions and target governance structures across the entire value chain. Greater attention should be paid to actors higher up the chain, including wholesalers and pharmaceutical marketing networks, to improve stewardship and access simultaneously. This study highlights how fragmented governance structures, overlapping actor roles, and uneven regulation within antibiotic value chains create critical gaps that must be addressed to design effective antimicrobial stewardship strategies.