Malhotra Shilpi, Bansal Nitin, Ramasubramanian V, Balaji Veeraraghavan, Menghaney Leena, Walia Kamini
Division of Descriptive Research, Indian Council of Medical Research, New Delhi, India.
Department of Infectious Diseases, Apollo Hospitals, Chennai, India.
J Glob Health. 2025 Aug 18;15:03033. doi: 10.7189/jogh.15.03033.
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.
抗菌素耐药性（AMR）对印度的医疗保健构成重大威胁，印度对包括最后手段治疗药物在内的关键抗生素的耐药性正在不断增加。新出现的数据表明，对最后手段的救命药物的耐药性持续上升，限制了耐药感染的治疗选择。虽然新抗菌药物的推出带来了希望，但历史模式表明耐药性可能迅速产生。监管举措（如印度的H1附表限制）的执法挑战凸显了未来引入新抗菌药物时采取国家层面战略方法的必要性。我们提出了一个监管和获取框架，旨在维持并延长新抗菌药物在印度的使用寿命。主要建议包括将其供应限制在实施抗菌药物管理以及感染预防和控制标准的医院处方集范围内，并强制进行抗菌素耐药性监测报告。我们还研究了利益相关者对负责任引入这些药物所需政策措施的看法。
