A multi-stakeholder report has outlined the role of non-animal, science driven testing methods in drug development in India, as the pharmaceutical sector works towards the target of USD 500 billion by 2047 under the Viksit Bharat vision. The report, titled Landscape Analysis on Alternatives to Animal Testing for Drug Development in India, has been developed by Humane World for Animals India, DBT-InSTEM, Animal Law and Policy Network and Dr. Reddy’s Laboratories Limited.
The report maps Non-Animal Methods and identifies opportunities for their use across the pharmaceutical and MedTech ecosystem in India. It aligns with the Government of India’s policy to support research and innovation in the Pharma MedTech sector and outlines how these methods can be applied in drug discovery.
Animal models have traditionally been used in preclinical testing. Differences in physiology and genetics across species limit their ability to predict human outcomes. Around 10 per cent of drugs entering Phase I trials receive regulatory approval, contributing to cost increases, longer timelines and discontinuation of therapies.
Regulators and researchers in several regions are using Non-Animal Methods such as organ-on-chip models, organoids and computational simulations. The US FDA Modernization Act 2.0 of 2022 and the New Drugs and Clinical Trials (Amendment) Rules, 2023 in India authorise the use of non-animal approaches for assessing drug safety and efficacy.
The report was released by Satish Reddy, Chairman, Dr. Reddy’s Laboratories, at an event attended by participants from animal welfare organisations, government and academic institutions.
Alokparna Sengupta, Managing Director, Humane World for Animals India, said, “We are proud to be part of this project. For decades, there have conversations around the use of animals and bring in alternatives. The time has come now for these conversations to move to action. In this modern age, we have human cell-based and computational models that can reflect human biology far more accurately, reducing the risk of drug failures. These emerging technologies can save the lives of animals, revolutionise public health, and aid in quicker and cost-effective drug development. Attention, funding and developing this sector will be a win-win-win situation for all, and this report will play a pivotal role in bringing that change.”
Dr Arvind Ramanathan, Scientist, DBT BRiC – Institute for Stem Cell Science and Regenerative Medicine, said, “We are committed to supporting scientific innovation that accelerates drug development while ensuring safety and ethical research practices. Human-relevant, non-animal testing methods provide an important pathway to strengthen India’s pharmaceutical R&D ecosystem, reduce reliance on animal models, and improve the predictability and efficiency of preclinical research. Initiatives such as these, coupled with policy support and strategic investments, can position India as a global leader in advanced, patient-centered drug development.”
Prof. Sarfaraz K. Niazi, Adjunct Professor, University of Illinois, Chancellor, Chicago University, Chicago, Illinois, USA, said, “Globally, drug regulators and research institutions are rethinking long-standing preclinical paradigms, with increasing openness to evidence generated through human-relevant, non-animal approaches. This shift reflects a broader move towards science-led regulatory decision-making that prioritises clinical relevance and real-world predictability. As these frameworks mature globally, countries that proactively align their scientific and regulatory systems with such approaches will be better positioned to participate in collaborative research, global trials, and cross-border regulatory convergence.”
Deepak Sapra, Chief Executive Officer – API and Services, Dr. Reddy’s Laboratories Ltd., said, “Science driven, non-animal testing methods present a valuable opportunity for India’s pharmaceutical industry to strengthen early-stage research, improve scientific relevance, lower development costs, and accelerate drug development timelines. When combined with existing approaches, these methods can support the creation of therapies that meet both domestic and international standards. With coordinated action and targeted investment, India can be at the forefront of the global transition towards NAMs, strengthening its innovation ecosystem while advancing patient safety, ethical research practices, and long-term competitiveness.”
The report notes that adoption of human-relevant testing methods supports early-stage decision-making, shorter research timelines, lower development costs, and screening of unsafe or ineffective drugs before clinical trials. It also outlines reduced use of animal models in line with accepted practices.
An assessment across generics, new chemical and biological entities, and cell and gene therapies identifies areas where animal tests can be removed and replaced with patient-specific technologies.
The report outlines opportunities including the formation of an industry consortium to support the 3Rs framework, creation of a central agency for Non-Animal Methods, replacement of animal-based pyrogen testing with validated alternatives, investment in domestic infrastructure, establishment of Centres of Excellence, training programmes, and engagement with regulators. It also notes alignment with the New Drugs and Clinical Trials Rules and inclusion of validated Non-Animal Methods in regulatory submissions.