NEW DELHI: As India’s pharmaceutical industry moves towards becoming a 500 billion dollars global powerhouse by 2047, a new report highlighted the growing role of non-animal, science-driven testing methods in strengthening drug development, improving translational science, and accelerating innovation.
According to Alokparna Sengupta, Managing Director, Humane World for Animals India, “For decades, there have been conversations around the use of animals and bringing 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 situation for all, and this report will play a pivotal role in bringing that change,” said Sengupta.
Traditionally, animal models have been central to preclinical testing. However, species-specific differences in physiology and genetics limit their ability to predict human outcomes.
Only around 10 per cent of drugs entering Phase I trials ultimately receive regulatory approval, leading to higher costs, longer timelines, and the loss of potentially beneficial therapies.
The report, jointly developed by Humane World for Animals India, DBT-InSTEM, Animal Law and Policy Network and Dr Reddy’s Laboratories Limited, also highlighted that Non-Animal Methods (NAMs) can support India’s ambition to expand into innovative drug discovery while improving efficiency, predictability, and patient outcomes.
It also maps emerging NAMs and identifies opportunities for their adoption across India’s pharmaceutical and MedTech ecosystem.
Globally, regulators and researchers are increasingly turning to NAMs such as organ-on-chip models, organoids, and computational simulations.
The momentum has been further strengthened by the US FDA Modernisation Act 2.0 (2022) and New Drugs and Clinical Trials (Amendment) Rules, 2023 in India, which authorise the use of non-animal approaches for evaluating drug safety and efficacy, marking a pivotal moment for broader global adoption, including in India.
“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," Dr Arvind Ramanathan, Scientist, DBT BRiC – Institute for Stem Cell Science and Regenerative Medicine (InStem) said.
"Initiatives such as these, coupled with policy support and strategic investments, can position India as a global leader in advanced, patient-centred drug development,” he added.
Prof. Sarfaraz K. Niazi, Adjunct Professor, University of Illinois, Chancellor, Chicago University, Chicago, Illinois, US, 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,” Sarfaraz added.
“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," said Deepak Sapra, Chief Executive Officer- API and Services, Dr Reddy’s Laboratories Ltd.
"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,” Sapra added.
The report said there is a need to establish an industry-led consortium to advocate for the adoption of the 3Rs - Replace, Reduce and Refine, raise awareness of global best practices, and enable structured engagement with regulators.
Also, presses to create a central agency for Non-Animal Methods (NAMs) to support validation, standardisation, and integration of NAMs into regulatory review and submissions.
They also suggested accelerating replacement of animal-based pyrogen testing by promoting validated alternatives such as the Monocyte Activation Test (MAT) and recombinant Factor C (rFC) assay, supported by training, standardisation, and improved reagent availability.
“With continued investment in infrastructure, workforce training, and regulatory support, human-relevant, non-animal methods can become a scalable and practical part of India’s drug development process. Their adoption promises to improve research efficiency, generate more predictive preclinical data, and help India build its position as a global hub for pharmaceutical innovation, delivering safer and more effective therapies to patients,” the report added.
