Through the New Drugs and Clinical Trials Rules, 2019 (2019 Rules), India has developed the rules governing post-trial access (PTA) to new drugs or investigational new drugs. However, inconsistencies and interpretational challenges exist in the application of the 2019 Rules and the Indian Council of Medical Research Guidelines 2017. This conflation poses a real harm to the trial participants, specifically the ones with limited access to healthcare facilities. Since drug laws in India do not expressly deal with other forms of access like the ‘Compassionate Use’ or ‘Expanded Access’ mechanism, demarcating the scope and describing the strategies for PTA are the need of the hour. We propose possible strategies to address inadequacies in the regulatory regime and establish ‘win–win’ situations among all stakeholders. We further argue that India is well positioned to provide leadership by developing detailed PTA provisions and may set a potential path for the other clinical trial host countries.

中文翻译：

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印度试验药物的试验后获取：应对监管框架中的挑战

通过《2019 年新药和临床试验规则》（2019 Rules），印度制定了新药或研究性新药试验后准入（PTA）的规则。然而，2019 年规则和 2017 年印度医学研究指南理事会的应用存在不一致和解释挑战。这种混淆对试验参与者造成了真正的伤害，特别是那些无法进入医疗机构的参与者。由于印度的毒品法没有明确涉及其他形式的获取，如“同情使用”或“扩大获取”机制，因此划定 PTA 的范围并描述策略是当前的需要。我们提出可能的策略来解决监管制度的不足，并在所有利益相关者之间建立“双赢”的局面。我们进一步认为，印度完全有能力通过制定详细的 PTA 条款来发挥领导作用，并可能为其他临床试验东道国开辟一条潜在的道路。