ICMR Addendum Exempts AYUSH-Approved Medicines from Extra Safety Trials

Integrative Medicine (IM) involves a multimodal approach, where Ayush systems are integrated alongside modern/conventional medicine to enhance patient care and improve health outcomes. With growing global interest in holistic and personalised medicine, it is observed that ethical and regulatory clarity is essential to ensure the credibility, safety, and efficacy of integrative approaches.

This addendum aims to guide researchers, institutions, Ethics Committees (ECs), and regulatory bodies involved in Integrative Medicine research, ensuring that scientific integrity and patient safety remain paramount.

The addendum introduces key measures to enhance the ethical and regulatory framework for Integrative Medicine research. Ethics Committees overseeing such research must now include two Ayush subject-matter experts, with at least one being external to the institution, ensuring well-rounded and informed deliberations. Informed consent standards have been strengthened, requiring that research participants receive clear, tailored information about Integrative Medicine interventions while adhering to India's standard ethical guidelines for biomedical and clinical research.

Additionally, Ayush-approved medicines used in integrative research will not require extra safety trials or preclinical studies. However, non-codified traditional medicines must undergo the entire regulatory approval process. To ensure compliance, all research must align with the Drugs & Cosmetics Act (1940), New Drugs & Clinical Trial Rules (2019), and Good Clinical Practice (GCP) guidelines specific to Ayush systems.

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