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.
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.
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.
Publications
Kotwani A
(2022)
Marketing and Distribution System Foster Misuse of Antibiotics in the Community: Insights from Drugs Wholesalers in India
in Antibiotics
Kotwani A
(2021)
Over-the-Counter Sale of Antibiotics in India: A Qualitative Study of Providers' Perspectives across Two States
in Antibiotics
Gautham M
(2022)
Availability, Prices and Affordability of Antibiotics Stocked by Informal Providers in Rural India: A Cross-Sectional Survey.
in Antibiotics (Basel, Switzerland)
Porter G
(2020)
Using 'smart regulation' to tackle antimicrobial resistance in low-income and middle-income countries.
in BMJ global health
Kotwani A
(2021)
Pharmaceutical effluent: a critical link in the interconnected ecosystem promoting antimicrobial resistance.
in Environmental science and pollution research international
Kotwani A
(2021)
Over-the-counter sale of antibiotics - Using Net-Map to identify and segment stakeholders as the first step towards the development of smart regulation.
in Indian journal of medical microbiology
Kotwani A
(2023)
Treatment and disposal practices of pharmaceutical effluent containing potential antibiotic residues in two states in India and perceptions of various stakeholders on contribution of pharmaceutical effluent to antimicrobial resistance: a qualitative study.
in Journal of pharmaceutical policy and practice
Porter G
(2021)
Over-the-counter sales of antibiotics for human use in India: The challenges and opportunities for regulation
in Medical Law International
Kotwani A
(2021)
Knowledge and behavior of consumers towards the non-prescription purchase of antibiotics: An insight from a qualitative study from New Delhi, India.
in Pharmacy practice
Description | To date, the award has resulted in contributions to the academic literature in two main ways. First, the project publications have raised the profile of the approach known as 'smart regulation' within the context of regulating the sale and use of antibiotics in India as a necessary step to deal with the problem of antimicrobial resistance. This represents a fresh and useful approach to dealing with the considerable practical challenges faced by the Indian government. Second, the research has examined specific sectors in India and contributed to our understanding of the various Indian stakeholders, their relationships as well their interests and concerns. This has led to the formulation of suggestions for approaching regulation that cohere with a 'smart regulation' approach to tackling the problem of the overuse and misuse of antibiotics in India. |
Exploitation Route | The outcomes delivered so far in the form of the project publications can be built on through further research into the formulation of viable regulatory approaches for tackling the overuse and misuse of antibiotics in India, particularly through the codesign of options with relevant stakeholders. This can be taken up by academic researchers, and approaches can also be piloted or implemented by Indian state governments and at the national level. The general approach that we advocate for using smart regulation to tackle antimicrobial resistance can also be taken up and used by stakeholders in other LMICs. |
Sectors | Agriculture Food and Drink Communities and Social Services/Policy Education Environment Healthcare Manufacturing including Industrial Biotechology Pharmaceuticals and Medical Biotechnology Retail |
Description | Co-design of a Code of Conduct for Evidence Based Marketing of Antibiotics by the Pharmaceutical Industry |
Geographic Reach | National |
Policy Influence Type | Participation in a guidance/advisory committee |
Impact | Through our work we have gathered substantial evidence on inappropriate marketing of antibiotics through pharmaceutical supply chains. There is no legal regulation of pharmaceutical marketing practices in India. Although a general code of conduct for marketing exists (Uniform Code of Pharmaceutical Marketing Practices or UCPMP), this is a voluntary one and the industry is opposed to legalising it. Through our Task Force we are working on a code of conduct for antibiotics that can be implemented more effectively by the pharmaceutical industry and that can be integrated with the UCPMP. We have developed a new strategy of co-opting the industry into regulatory design, using modern regulatory thinking that includes the perspectives of both the regulators and the regulatees. The process has already influenced and impacted industry leaders as several big and small companies and pharma associations have stepped forward to think together and find collective solutions to this challenge. |
URL | https://oasisamr.com/intervention-guidelines/ |
Description | Member, Centre for Science and Policy (CSaP), University of Cambridge |
Organisation | University of Cambridge |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | CSaP is a network of academics and decision-makers to improve the use of evidence and expertise in public policy. I engage with policy makers and programme implementers through the network to address critical questions on health systems and AMR policies. |
Collaborator Contribution | My last meeting was with Myung Soo Chu, Head of the Programme Planning, Monitoring, & Strategic Partnership Unit in the HIV/AIDS Section in Health Programme Group, United Nations Children's Fund (UNICEF). We discussed realist evaluations of policy formulation and implementation using a variety of analytical frameworks. Chu observed that this platform 'could be very useful for UN systems and through them to national governments whom they assist with policy development.' |
Impact | I am part of a network of academics at the Centre for Science and Policy pooling their expertise and evidence for improving public policy. The network is likely to lead to future collaborations. |
Start Year | 2020 |
Description | Invited talk on One Health and the Drivers of Antibiotic Use in India, Uganda and Colombia, for the Society for One Health, University of Cambridge |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Postgraduate students |
Results and Impact | I delivered an invited one-hour lecture on One Health and the drivers of antibiotic use in India, Uganda and Colombia at the ANTIMICROBIAL RESISTANCE: ONE HEALTH CONFERENCE 2023. This was organised by the CAMBRIDGE UNIVERSITY ONE HEALTH SOCIETY AND ONE HEALTH BRISTOL, comprising mainly post graduate students of One Health. The lecture was very well received and I was asked several questions by the audience ranging from policy challenges to provider attitudinal barriers. I also received good feedback via linked in from one of the students who was pursuing a PhD at Cambridge. |
Year(s) Of Engagement Activity | 2023 |
Description | Pilot workshop - OTC sales of antibiotics case-study VP Chest Institute, New Delhi, 29 February 2019 |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Policymakers/politicians |
Results and Impact | There were 20 participants including representatives from the Central Drugs Standard Control Organisation, pharmacists' association, cinsomers and project team members. The project's co-design methodology was tested during the workshop, and is being modified based on the findings in the workshop report. |
Year(s) Of Engagement Activity | 2019 |
Description | Stakeholder Network Mapping workshop for OTC sales of antibiotics case-study, VP Chest Institute, New Delhi, 17 January 2019 |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Policymakers/politicians |
Results and Impact | There were 12 participants including representatives from the Central Drugs Standard Control Organisation, Haryana State Drug Regulatory Authority, the pharmaceutical industry and a non-governmental organisation, as well as retail pharmacists. The workshop was based on a systems approach and net-mapping and led to a stakeholder mapping report. |
Year(s) Of Engagement Activity | 2019 |
Description | Stakeholder consultations with groups of medical, veterinary, pharmaceutical and policy/regulatory stakeholders. These were conducted as part of our intervention co-design process to develop antibiotic stewardship for community settings in India. |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | Aim of the workshops: To co-design, with diverse stakeholders, a One Health antibiotic stewardship intervention for community settings in India. Objectives of the workshops: Present evidence to stimulate reflection and dialogue amongst stakeholders regarding their roles within the healthcare system in the context of AMR. Enable a deeper understanding of the alignments and misalignments between antibiotic stewardship practices and the realities of the health and antibiotic systems (private and public), supply chain incentives and business models, and community needs. Engage stakeholders in the co-design of an intervention for antibiotic stewardship in primary care and community settings. Develop and evaluate a strategy for multi-stakeholder engagement to influence policy. We organised four workshops with groups of medical and veterinary practitioners, pharmaceutical industry leaders and senior managers, and policymakers. Workshop participants (approximately 50 in total) agreed with our study findings and participated in animated discussions. Several common recommendations that emerged across the four groups. These included: -Development of tier-wise guidelines for antibiotic use in human and livestock health, starting at the level of the para healthcare providers (as these do not exist at present). -Continuing training and orientation about antibiotics for all supply chain actors and communities -Antimicrobial resistance surveillance at different tiers of the health system to understand patterns of resistance -Prescription audits for health professionals - Development of an evidence based code of conduct/marketing for the pharmaceutical stakeholders to align the promotion and marketing of antibiotics with guidelines. - Strengthening mentorship and referral links between formal and informal providers in human and veterinary sectors, to create stepped care models for less accessible rural areas. As a next step, we have established two task groups to work on antibiotic use guidelines for para health providers for human and for animal health, and a third one will develop a pharmaceutical code of conduct with industry stakeholders. |
Year(s) Of Engagement Activity | 2021,2022 |
URL | https://oasisamr.com/key-stakeholder-consultations/ |
Description | UKRI AMR Event Series - AMR and One Health after COVID-19 |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Other audiences |
Results and Impact | The aim of this series of workshops was to consolidate learning from across UKRI-funded Antimicrobial Resistance (AMR) projects to synthesise and highlight high-level findings of global relevance from these research investments. Workshops also considered research findings and future priorities in relation to COVID-19 and the global implications for AMR and antimicrobial stewardship. To achieve this, the event series aimed to: (i) enable grant holders to consider and compare key findings from UKRI investments in global AMR research and engage high-level stakeholders, in order to maximise impact for policy and practice; (ii) showcase research excellence across the UKRI portfolio of AMR research; and (iii) initiate dialogue between AMR researchers, funders, and other stakeholders regarding the consequences of the COVID-19 pandemic for AMR and implications for future One Health AMR strategies. |
Year(s) Of Engagement Activity | 2021 |
Description | Workshop - 'Involving participants in developing Smart Regulation' V.P. Chest Institute Delhi, 21-23 August 2019 |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Policymakers/politicians |
Results and Impact | This workshop tested the project's proposed co-design approach, through workshops and activities that took place at the V.P. Chest Institute in Delhi between 21st - 23rd August 2019. The workshops focused on the project case sector study of OTC sales of antibiotics with the main goal to review the co-design methodology before adapting and deploying it to the other three sectors. |
Year(s) Of Engagement Activity | 2019 |