A strategic approach to regulating new antimicrobials

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.