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Published on: July 24, 2021
A strategic approach to regulating new antimicrobials
Shilpi Malhotra1, Nitin Bansal1, V Ramasubramanian2
1Division of Descriptive Research, Indian Council of Medical Research, New Delhi, India.
Abstract:
Antimicrobial resistance (AMR) is a significant threat to healthcare in India, which is experiencing increasing resistance to critical antibiotics, including last-resort treatments. Emerging data indicate that resistance to last resort life-saving drugs continues to rise, limiting treatment options for drug-resistant infections. While the introduction of new antimicrobials offers hope, historical patterns suggest that resistance may develop rapidly. Enforcement challenges of regulatory initiatives, such as Schedule H1 restrictions in India, underscore the need for a national-level strategic approach when introducing new antimicrobials in the future. We propose a regulatory and access framework designed to preserve and increase the longevity of new antimicrobials in India. Key recommendations include restricting their availability to formularies of hospitals implementing antimicrobial stewardship and infection prevention and control standards, and mandating AMR surveillance reporting. We also examine stakeholders' perspectives on policy measures necessary for the responsible introduction of these drugs.
Insights
Antimicrobial resistance (AMR) in India is rising, threatening critical antibiotics. A new framework is proposed to preserve new drugs by restricting access and mandating surveillance.
Area of Science:
- Public Health
- Infectious Diseases
- Pharmacology
Background:
- Antimicrobial resistance (AMR) poses a significant threat to healthcare in India, with increasing resistance to critical and last-resort antibiotics.
- Rising resistance limits treatment options for drug-resistant infections, necessitating urgent strategies for antimicrobial preservation.
Purpose of the Study:
- To propose a regulatory and access framework to preserve and extend the longevity of new antimicrobials in India.
- To address the challenges in enforcing existing regulatory initiatives and inform future national-level strategies.
Main Methods:
- Review of emerging data on antimicrobial resistance trends in India.
- Analysis of historical patterns of antimicrobial resistance development.
- Examination of stakeholder perspectives on policy measures for responsible antimicrobial introduction.
Main Results:
- Resistance to last-resort antibiotics is increasing, limiting therapeutic options.
- Challenges exist in enforcing regulatory initiatives like Schedule H1 restrictions.
- A strategic national-level approach is needed for introducing new antimicrobials.
Conclusions:
- A proposed framework recommends restricting new antimicrobial access to hospitals with established antimicrobial stewardship and infection control programs.
- Mandatory antimicrobial resistance surveillance reporting is a key recommendation.
- Stakeholder engagement is crucial for developing effective policies for responsible antimicrobial introduction to combat rising AMR.
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