Smart regulation of antibiotic use in India: Understanding, innovating and improving compliance

Lead Research Organisation: University of Edinburgh
Department Name: Sch of Law

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.

Planned Impact

Regulation is a key tool to tackle the problem of antimicrobial resistance (AMR). In India for many of the sectors impacted by AMR, the law seems fragmented/disconnected or lacking- e.g., in poultry, aquaculture, livestock and environmental protection, clear regulations with respect to AMR are lacking. Compliance is often poor and enforcement is patchy, even when the existing regulations are fairly clear. For better compliance of regulation and improvement in use of antibiotics we need to move beyond traditional approaches (legal threats/penalties) and to use innovative softer approaches. For the work proposed we will engage sector-specific regulators and their regulatory targets right from the beginning of our work and understand their perspective and co-design implementable options for regulators.

Our research involves an innovative methodology of co-designing smart and soft regulations by an interactive process between various regulators and the stakeholders affected by these regulations. We have chosen four case studies which involve one-health approach for containment of antimicrobial resistance, namely human, animal and environment. The four case studies are: (i) OTC antibiotic sales at pharmacies without valid prescription; (ii) Poultry farmers using antibiotics (including as a growth factor); (iii) Hospital AMR containment and (iv) Pharma industry effluents and AMR.

The choice of regulatory approaches which the study may propose for the four case studies following the research has potential to impact the regulatory environment. With the innovative regulations designed with regulators and stakeholders with the facilitation of multi-disciplinary Indian and UK team, we hope to achieve better compliance of regulation which will decrease overuse of antibiotics in the community for both human and poultry and better regulation for effluent of antibiotics from pharmaceutical industry.

By including influential members in the advisory panel and with in-depth interviews with key holders and involving them in the interactive workshops and dissemination meeting, we are likely to have regulations implemented in the two study states. We will also involve the media in our dissemination meeting and are sure there will be coverage in print media about AMR and our innovative approach of co-designing smart regulations for containment of AMR. Our research and work will raise awareness in the community and amongst policy makers and regulators about AMR, the containment of AMR and the appropriate use of antibiotics, which is the need of the hour.

The two states will be strengthened in their policy environment and through stakeholder engagement. The Indian research team will be strengthened in research, writing and policy engagement skills. Their international counterparts will gain greater understanding of local realities and challenges.

We are sure that in the near future the other states of India will also work towards creating such a regulatory environment combined with awareness programmes which will decrease the burden of antibiotic in the environment and selection pressure on microbes for the containment of antimicrobial resistance. Thus, our study will have great impact on containment of AMR which will have impact on the health and development of the nation.

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