Title: Smart regulation of antibiotic use in India: Understanding, innovating and improving compliance
Funder: Economic and Social Research Council

Abstract: The containment of AMR is a multi-faceted task that needs a one-health approach as suggested in the World Health Organization's (WHO) 2015 Global Action Plan (GAP) on AMR. Countries including India have aligned their National Action Plans (NAPs) on AMR with this international guidance. One of the important links for various activities for AMR containment is the appropriate use of antibiotics to reduce selection pressure on microbes. According to the GAP, effective regulation will be a key tool for ensuring that national standards aimed at optimising the use of antimicrobial medicines in human and animal health are followed in practice. The academic literature suggests, however, that the Indian government faces a number of challenges in the regulatory sphere. Regulations may be fragmented or incomplete in relation to AMR-relevant sectors, Furthermore, empirical studies demonstrate that effective state-level regulation can be impeded by a range of systemic problems, including human resource constraints, ambivalence in the roles of regulatory organisations, ineffective co-ordination between regulatory groups and the contestation of regulatory policies by private stakeholders. Fundamental questions therefore arise about whether a credible and enforceable AMR regulatory framework can be developed for India, and if so, how best to tackle this complex challenge. The core idea of this project is to apply the ideas and methods of 'smart regulation' to better understand the underlying problems and co-produce innovative regulations with regulators and regulatory subjects that will likely lead to mutually acceptable regulations and improved compliance. Three central design principles of smart regulation include: a) the use of a range of 'softer' regulatory options to shape behaviour in conjunction with 'traditional' regulatory measures of fines and legal penalties; b) effective stakeholder engagement and input into regulation; and c) an emphasis on identifying win-win outcomes in regulation. We will implement the 'smart regulation' approach through, inter alia, interactive workshops that bring regulators and other stakeholders in AMR-related sectors together to share perspectives and discuss viable regulatory options. We will focus on four particularly important sectors for AMR containment (antibiotic sales over-the counter at pharmacies, hospital AMR containment use of antibiotics in poultry farming and antibiotics in pharmaceutical industry effluent). Our project has been designed to have significant impact on the Indian regulatory environment. By engaging with regulators and subjects of regulation in the two selected Indian states and in central government right from the start, the project will encourage 'buy-in' and enable us to develop a rich understanding of the situated positions of the key actors in the field of AMR regulation in India. The regulatory options emerging from the collaborative spirit of the workshops will be acceptable to regulators and other stakeholders, and therefore likely to result in increased compliance. The project's key outputs will include a user-friendly guidance document to facilitate uptake of the 'smart regulation' approach for AMR containment in other Indian states and also internationally. We will also co-design a 'Statement of Intent' that we will encourage the regulators (and potentially other stakeholders) to adopt and sign.


Research activity codes: 8.3 POLICY, ETHICS AND RESEARCH GOVERNANCE
Health categories: INFECTION