Abstract
Patient and public involvement (PPI) is increasingly mandated in clinical research globally, reflected in recent updates to the CONSORT 2025 and SPIRIT 2025 guidelines, which now require structured reporting of PPI activities. These developments signal a shift toward inclusive, accountable, and co-produced research, recognizing the value of experiential knowledge in improving trial relevance and impact. However, Indian mental health clinical trials have yet to meaningfully adopt PPI, despite growing evidence of its feasibility and value in low- and middle-income countries. This commentary critically examines the current state of PPI in Indian mental health trials, drawing insights from two prominent studies-the MANAS and ARTEMIS trials. While both incorporate some elements of stakeholder engagement, they stop short of full co-production and lack formal integration of persons with lived experience (PWLE) in governance, evaluation, or authorship. We identify systemic, cultural, and operational barriers to authentic PPI and propose strategic pathways to embed it in Indian mental health research. These include mandating PPI in funding requirements, integrating it into ethical oversight, building capacity among researchers and PWLE, and adapting reporting tools like GRIPP2 for Indian contexts. Embedding PPI is both an ethical imperative and a scientific opportunity to strengthen mental health trials and their implementation.