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Smart Regulation of Antibiotic Use in India

The aims of the 'Smart regulation of antibiotic use in India: Understanding, innovating and improving compliance' project are first, to better understand the various problems surrounding the regulation of antimicrobial resistance (AMR) containment in India, and second, to improve the situation by applying the concepts and methods of ‘smart regulation’.

Close up of pills

This is a Newton-Bhabha Fund project funded by the Economic & Social Research Council (ESRC) and the Government of India, Department of Biotechnology (DBT).

AMR logos

Principal Investigators

Mr Gerard Porter is a Lecturer in Medical Law & Ethics at the Edinburgh Law School.

Prof Anita Kotwani is an Associate Professor in the Department of Pharmacology at the Vallabhbhai Patel Chest Institute, University of Delhi.

Co-investigators

Dr Anjana Sankhil Lamkang is a Research Fellow at the Center for Disease Dynamics, Economics and Policy, New Delhi.

Prof Javier Guitian is Professor of Veterinary Public Health at the Royal Veterinary College, London.

Dr Jyoti Joshi is Head of South Asia at the Center for Disease Dynamics, Economics and Policy, New Delhi.

Prof Lucy Kimbell is Professor of Contemporary Design Practices at the University of the Arts London.

Dr Meenakshi Gautham is Research Fellow – Health Systems and Policy Analysis at the London School of Hygiene and Tropical Medicine.

Dr Nagendra R Hegde is based at the National Institute of Animal Biotechnology, Hyderabad.

Staff

Dr Ana-Despina Tudor is a Research Fellow at the University of the Arts London.

Dr Jyoti Saini is a Research Associate at the Amity Institute of Public Health, Noida.

Ms Kalpita Shubhankar is the Project Officer at the Vallabhbhai Patel Chest Institute, University of Delhi.

Dr Poulami Dasgupta is a Senior Research Fellow at the Vallabhbhai Patel Chest Institute, University of Delhi.

Dr Ranjana Bharti is a Junior Research Fellow at the Amity Institute of Public Health, Noida.

OTC antibiotics sales at pharmacies

Over the counter (OTC) sales of antibiotics without a prescription from a registered medical practitioner together with lack of knowledge about responsible use, among other factors, has led to the misuse and overuse of antibiotics and contributed to the development of antimicrobial resistance in India. This state-of-affairs exists despite the existence of a framework for the regulation of OTC sales of antibiotics, namely the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945.

In particular, from March 2014, the Central Drugs Standard Control Organization (CDSCO) started implementing Schedule H1, which covers specified drugs (including 24 antibiotics).

  • The container of a medicine that contains any of these drugs must be labeled with the symbol Rx in red, which is conspicuously displayed on the left top corner, as well as a printed warning in a box with a red border.
  • These drugs cannot be sold without the prescription of a registered medical practitioner.
  • The pharmacist must maintain a separate register with the patient’s name, contact details of the prescribing doctor, and the name and dispensed quantity of the drug.
  • This register has to be retained for at least three years and is subject to audit by the government.


AMR containment in hospitals

Hospital acquired infections (HAI) resulting from poor infection prevention or control, hygiene or sanitation practices in healthcare facilities can lead to the emergence and spread of AMR in India. The available data indicates a high burden of HAI in low- and middle-income countries like India. Hospital containment through infection prevention or control practices, maintenance of proper hygiene and sanitation, and the adoption of antimicrobial stewardship have a critical role to play in addressing this challenge.

  • The Indian Council of Medical Research (ICMR) as well as the National Centre for Disease Control (NCDC) have published guidelines on infection prevention and control in hospitals. Strong implementation plans are now required.
  • Antimicrobial stewardship programmes include initiatives to improve antibiotic use in hospitals. For instance, in 2013, the ICMR launched the Antimicrobial Stewardship, Prevention of Infection and Control Programme.
  • Standard treatment guidelines inform healthcare providers about appropriate treatment and prescribing practices for common infections. Both the ICMR and the NCDC have published treatment guidelines for antimicrobial use.


Use of antiobiotics in poultry farming

India is the world’s fifth largest egg producer and eighteenth largest producer of broilers. During the period 2017-18, Indian exported poultry products worth USD 77 million. The growth of the poultry sector is marked by an increase in the size of the poultry farm, although the structure of the poultry industry varies from one region to another.

Antibiotics are administered to poultry for three main reasons:

  • to cure illness;
  • to prevent illness;
  • as growth promoters to reduce the time it takes to rear poultry.

There is a link between use of antibiotics in poultry for infection prevention or control, or as growth hormones on the one hand, and the development of antimicrobial resistance (AMR) in human beings on the other. This includes the widespread use of colistin, which is an antibiotic of last resort for human beings. At least eight antibiotics deemed ‘highly’ or ‘critically’ important for human health that are banned for growth promotion purposes in the EU are used for such purposes in India.

The regulation of use of antibiotics in poultry farming can prevent or control AMR in human beings. Until recently, the government did not regulate such use. In fact, according to a news report published in December 2018, the government was likely to introduce some measures in the near future. On 19 July 2019, the Ministry of Health and Family Welfare notified the prohibition of sale, manufacture and distribution of colistin and its formulations in poultry, among other animals.

Useful resources

Chandra Bhushan, Amit Khurana, Rajeshwari Sinha and Mouna Nagaraju, Antibiotic Resistance in Poultry Environment: Spread of Resistance from Poultry Farm to Agricultural Field (Centre for Science and Environment 2017).

S Sivaraman, Antibiotic Use in Food Animals: India Overview (ReAct Asia-Pacific 2018).

Antimicrobial Resistance in Food-Animal Production: India Overview (ReAct Asia-Pacific 2018).

Pharma industry effluent and AMR

India has the world’s third largest pharmaceutical industry, accounting for 10 per cent of the global market by volume. The pharmaceutical industry comprises large companies as well as small and medium enterprises. In 2017, revenue is estimated to have grown by 7.4 per cent, making India one of the fastest growing pharmaceutical sectors globally; the market is projected to be worth USD 100 billion in revenue by 2025. India is also one of the largest exporters of pharmaceuticals, reaching USD 16.8 billion in pharmaceutical exports in 2016-17.

After China, India has a sizeable share of production of active pharmaceutical ingredients (API), besides processing of drugs. Pharmaceutical industries involved in the manufacture of API and formulations may discharge effluents that contain antibiotic residues into the environment. This leads to the contamination of surface water and groundwater, which is the source of drinking water supply among other uses.

At present, the effluent standards for ‘Pharmaceutical (Manufacturing and Formulation) Industry’ under domestic environmental laws do not include standards for the discharge of antibiotic residues. However, in 2018, the Central Pollution Control Board has proposed standards for antibiotic residue released by the pharmaceutical industry.

Useful resources

Changing Markets and Ecostorm, Superbugs in the Supply Chain: How pollution from antibiotics factories in India and China is fuelling the global rise of drug-resistant infections (Nordea Asset Management 2016).

Changing Markets and Ecostorm, Impacts of Pharmaceutical Pollution on Communities and Environment in India (Nordea Asset Management 2016).

Changing Markets and Profundo, Bad Medicine: How the pharmaceutical industry is contributing to the global rise of antibiotic-resistant superbugs (SumOfUs 2015).

 

The conventional “command and control” model of environmental regulation, which prevailed in the 1970s, came under increasing criticism by the early 1980s, and led to the introduction of deregulation. Neil Gunningham, Peter Grabosky and Darren Sinclair came up with the concept of “smart regulation” in the 1990s “to overcome the inefficiencies of traditional regulation on the one hand, and the pitfalls of deregulation on the other”. At its core, ‘smart regulation’ denotes a form of “regulatory pluralism” that embraces “flexible, imaginative and innovative forms of social control”. The proponents identified five core regulatory design principles:

  1. Incorporate a broad range of policy instruments and actors;
  2. Adopt least interventionist viable measures to achieve the desired outcome;
  3. Progressively serious penalties for non-compliance with regulatory measures;
  4. Empower a broad range of parties to act as surrogate regulators; and
  5. Optimise the opportunity for win-win outcomes.

Source: N Gunningham, P Grabosky and D Sinclair, Smart Regulation: Designing Environmental Policy (Oxford University Press 1998).

Our publications

Over-the-counter sales of antibiotics for human use in India: The challenges and opportunities for regulation. (2021) Medical Law International 21(2) 147-173.

Knowledge and behavior of consumers towards the non-prescription purchase of antibiotics: An insight from a qualitative study from New Delhi, India. (2021) 19(1) Pharmacy Practice 2206.

Pharmaceutical effluent: a critical link in the interconnected ecosystem promoting antimicrobial resistance. (2021) 28 Environmental Science and Pollution Research, 32111–32124.

Using ‘smart regulation’ to tackle antimicrobial resistance in low-income and middle-income countries.(2020) 5 BMJ Global Health e001864

International

General

Global Action Plan on Antimicrobial Resistance (World Health Organisation 2015)

Political Declaration of the high-level meeting of the General Assembly on antimicrobial resistance (United Nations 2016)

Berlin Declaration of the G20 Health Ministers (2017)

Monitoring and Evaluation of the Global Action Plan on Antimicrobial Resistance – Framework and recommended indicators (World Health Organisation, Food and Agriculture Organisation and OIE 2019)

No Time to Wait: Securing the Future from Drug-Resistant Infections, Report to the Secretary General of the United Nations (Interagency Coordination Group on Antimicrobial Resistance 2019)

On food animals

OIE Standards, Guidelines and Resolution on antimicrobial resistance and the use of antimicrobial agents (World Organisation for Animal Health (OIE) 2015)

WHO Guidelines on Use of Medically Important Antimicrobials in Food-Producing Animals (World Health Organisation 2017)

Regional level

Jaipur Declaration on Antimicrobial Resistance (Health Ministers of Member States of WHO South-East Asia Region 2011)

India

Laws

The Clinical Establishments (Registration and Regulation) Act, 2010

The Drugs and Cosmetics Act (1940) and Rules (1945)

The Environment (Protection) Act, 1986

The Water (Prevention and Control of Pollution) Act, 1974

Note: These text versions of the documents are for reference only. If you wish to rely on them for any other purpose, please refer to their official versions.

Policies

National level

National Action Plan on Antimicrobial Resistance (NAP-AMR) 2017-2021 (Government of India 2017)

National Policy for Containment of Antimicrobial Resistance (Directorate General of Health Services 2011)

Delhi Declaration on Antimicrobial Resistance (19 April 2017)

National Treatment Guidelines for Antimicrobial Use in Infectious Diseases (National Centre for Disease Control 2016)

Draft National Guidelines for Infection Prevention and Control in Healthcare Facilities (National Centre for Disease Control 2018)

Treatment Guidelines for Antimicrobial Use in Common Syndromes (Indian Council of Medical Research 2017)

Hospital Infection Control Guidelines (Indian Council of Medical Research)

Chennai Declaration (2013)

State level

Guidance for developing State Action Plans for Containment of Antimicrobial Resistance (SAPCAR) (National Centre for Disease Control 2018)

Kerala Antimicrobial Resistance Strategic Action Plan (Government of Kerala 2018)

Madhya Pradesh State Action Plan for Containment of Antimicrobial Resistance (MP – SAPCAR) (Government of Madhya Pradesh 2019)

State Action Plan to Combat Antimicrobial Resistance in Delhi (SAP-CARD) (Government of NCT of Delhi 2020)

Other documents

Sumanth Gandra, Jyoti Joshi, Anna Trett, Anjana Sankhil Lamkang and Ramanan Laxminarayanan, Scoping Report on Antimicrobial Resistance in India (Center for Disease Dynamics, Economics and Policy 2017).

For enquiries related to the project, please contact:

Mr Gerard Porter

Lecturer in Medical Law and Ethics

Edinburgh Law School

gerard.porter@ed.ac.uk