India’s regulatory science is at an inflection point. The Landscape Analysis on Alternatives to Animal Testing for Drug Development in India lays out where animal testing is scientifically redundant, and sets a phased, evidence-driven roadmap for New Approach Methodologies and Non-Animal Methods (NAMs). It carries a foreword by the Drugs Controller General of India (DCGI), Dr. Rajeev Raghuvanshi, and a foreword note by Dr. Reddy’s Chairman, Satish Reddy.
Technically, the report is clear on what ‘ready’ looks like: organ-on-chip and 3D human tissue systems, advanced cellular assays, and in silico methodologies integrated under defined context-of-use and reproducibility expectations. This is backed by acceptance criteria, accreditation and Centers of Excellence, pilot NAM-led dossiers to build precedent, and interoperable data standards. It aligns with India’s direction of travel and the report’s citations to globally harmonized, model-informed principles (ICH M15).
By working across regulators, research institutes, and industry, the ecosystem can move faster by adopting validated best practices rather than reinventing evaluation pathways. InSilicoMinds contributed as part of the stakeholder consultations for this landscape.
For teams building or reviewing NAM and in silico packages (PBPK, IVIVE, AI toxicology) and looking to define regulatory acceptance criteria, validation plans, and submission-ready evidence frameworks, InSilicoMinds can help.
Read the Report Here: https://drive.google.com/file/d/19hmruGafWlHd3e23_Mckd4tolsPU6ynl/view
