A new multi-stakeholder report led by Dr. Reddy’s Laboratories, Humane World for Animals India, and DBT BRiC – Institute for Stem Cell Science and Regenerative Medicine (InStem) highlights how science-driven, non-animal testing methods could reshape drug development in India. The report, titled Landscape Analysis on Alternatives to Animal Testing for Drug Development in India, outlines the growing role of Non-Animal Methods (NAMs) in improving translational science, strengthening research efficiency, and accelerating innovation across the pharmaceutical and MedTech ecosystem.

Developed in collaboration with the Animal Law and Policy Network, the study maps emerging human-relevant testing technologies and identifies opportunities to integrate them into India’s research framework. The findings align with the government’s broader push to catalyse pharmaceutical and MedTech innovation, positioning NAMs as tools to enhance predictability, reduce development timelines, and improve patient outcomes.

Animal models have traditionally been central to preclinical drug testing, yet biological differences between species often limit their ability to predict human responses. Industry estimates suggest that only a small fraction of drug candidates entering early clinical trials ultimately receive approval, contributing to high costs and delays. The report argues that NAMs — including organ-on-chip platforms, organoids, and advanced computational simulations — offer more human-relevant insights that could reduce late-stage failures.

Global regulatory momentum is also supporting this transition. Recent policy updates in India and legislative changes abroad have opened the door for non-animal approaches to be used in safety and efficacy evaluations. The report was formally unveiled by Dr. Reddy’s chairman Satish Reddy, signalling industry interest in expanding adoption.

Experts involved in the initiative emphasised that NAMs can simultaneously improve scientific accuracy and ethical standards while lowering development risks. The report notes that earlier identification of ineffective or unsafe compounds could streamline research pipelines and make therapies more affordable.

A detailed sector analysis covering generics, new chemical and biological entities, and advanced therapies highlights opportunities to replace outdated animal testing practices. Recommendations include establishing an industry-led consortium, creating a central coordination agency for NAM adoption, and accelerating the transition to validated alternatives for pyrogen testing through training and standardisation.

Stakeholders say broader implementation of human-relevant testing methods could strengthen India’s pharmaceutical R&D ecosystem while supporting faster, safer, and more patient-centric innovation.