Human-based technologies are reshaping the pharmaceutical sector, and India has the opportunity to lead
In December 2025, the European Union (EU) introduced the Biotech Act that prioritises the use of non-animal methods (NAMs) in the development and production of medicinal products and medical technologies. Similarly, in November 2025, the United Kingdom (UK) released a roadmap to phase out animal testing in science and usher in a new era in research and development, one that is led by innovative and human-relevant approaches.
These global regulatory and policy shifts have been driven by the growing realisation that while animals have been conventionally used to test the safety and efficacy of new drugs, they are often poor predictors of human health and disease. Over 85 percent of drugs that appear safe and effective in animals fail during human clinical trials, and failure to predict human toxicity in animals has been attributed as one of the major reasons for this. This translational gap becomes more prominent in diseases, such as cancer, neurodegenerative disorders, or inflammatory conditions—the average rate of successful translation from animal models to clinical cancer trials is less than 8 percent. Conversely, some widely used medications, such as aspirin, which are deemed safe in humans, cause acute toxic effects in animals, indicating that animals can be unreliable predictors of both false positives (flagging safe drugs as unsafe) and false negatives (failing to detect human toxicity). On the other hand, rapid advances in technology, including 3D cellular systems, -omics (genomics, proteomics, and metabolomics, etc.), and AI, now allow us to start probing human biology and diseases in a precise and patient-specific manner. Thus, policymakers are enabling and accelerating this shift from traditionally used animal-based models to emerging human cell-based technologies via strong policy and funding initiatives.
Thus, policymakers are enabling and accelerating this shift from traditionally used animal-based models to emerging human cell-based technologies via strong policy and funding initiatives.
The UK initiative comes on the heels of a similar roadmap by the United States (US) Food and Drug Administration (FDA) that outlines a stepwise approach to replace animal testing with scientifically validated human-relevant and non-animal methods (NAMs). In another landmark decision, the US National Institutes of Health (NIH) recently announced that it will no longer fund research proposals that are exclusively based on animal models to study human diseases. The World Health Organization (WHO) has also recently come up with guidelines to replace or remove animal tests for the quality control of biological products. In 2024, the Brazilian Senate approved a new chemical management bill that restricts animal testing to a "last resort" and mandates the development of a strategic plan to fully transition toward animal-free methods. The National Council for the Control of Animal Experimentation (CONCEA), under the Ministry of Science, Technology and Innovation, Brazil, has also issued specific Normative Resolutions that recognise, regulate and progressively require the use of non-animal methods.
In India, in a similar vein, the New Drugs and Clinical Trials (Amendment) Rules, 2023, now explicitly allow the use of organ-on-chip and other human biology-based methods in drug safety and efficacy studies. Recently, several funding calls have been released by public funding bodies to accelerate the development and commercialisation of indigenous human-relevant technologies.
Many countries have set up a structured strategy to replace the use of animals, dividing the replacement opportunity areas into “three baskets”. The first basket includes animal tests where non-animal technologies are mature and can be immediately applied to the goal of phasing out animal testing, except in exceptional cases. The second basket includes animal tests for which non-animal methods are of high technology-readiness levels and could be adopted in the medium term. The last category includes animal tests, which involve complex biological endpoints and will require research and development for replacement in the long term.
In India, in a similar vein, the New Drugs and Clinical Trials (Amendment) Rules, 2023, now explicitly allow the use of organ-on-chip and other human biology-based methods in drug safety and efficacy studies.
One of the priority tests in “basket 1” is one designed to detect the presence of pyrogens or fever-causing contaminants in medicines administered by injection, medical devices, or raw materials used in biomanufacturing. This is an essential quality control step, which typically involves injecting a small amount of the product into rabbits; the subsequent presence of fever indicates the presence of pyrogens in the product. However, the accuracy of this test has been questioned due to its poor relevance to humans, high degree of variability, and inability to predict exact pyrogen levels. A human blood cell-based assay has now been developed and validated to detect and quantify pyrogen levels. The US, UK, and EU pharmacopoeias have prioritised the replacement of the rabbit-based pyrogen test with a more precise and human blood cell-based assay to detect pyrogens.
Another area prioritised within both the US and the UK is the testing of lab-made proteins called monoclonal antibodies that can target and attack specific molecules associated with diseased cells or other targets in the body. These therapeutic molecules are being used to treat cancer and autoimmune diseases, amongst others. However, as these molecules are very specific to human targets (for example, human cell surface receptors, growth factors, etc), testing these in animal models is often not relevant. In 2006, a clinical trial of a monoclonal antibody deemed safe in studies on monkeys caused organ failure in six patients, exposing these risks. The UK government has announced that by the end of 2026, it will apply guidance that can permit first-in-human clinical trials for such therapies which lack relevant animal models.
It will take sustained, strategic efforts for widespread adoption of these technologies. Model development, qualification, validation, and manufacturing of these methods at scale will all require dedicated and intensive investment. Globally, pharma companies are now submitting data using these methods for regulatory submission–access to such case studies and protocols where these technologies have been successfully adopted can support cross-sector learning. Many countries are establishing dedicated funding programmes, such as the NIH’s US$500 million Complement ARIE programme that aims to develop NAMs technology development centres, regulatory frameworks, and establish data sharing structures. Similarly, the EU has also made significant investments in this sector, including the €60 million ASPIS (Animal-free Safety Assessment of chemicals) cluster, and the €400 million PARC (Partnership for the Assessment of Risks from Chemicals) programme to create human-relevant methods and next-generation approaches for risk assessment of chemicals, including pharmaceuticals, to protect human health and the environment.
Developing “made-in-India” human-relevant technologies can not only accelerate drug development in India but also position it as a global supplier of these cutting-edge technologies and contribute to global standards and regulations.
As global regulatory frameworks increasingly align with calls for innovation in regulatory science, this field has also been rapidly expanding in India, with more than 80 labs now developing human-relevant models. Under the Global Regulatory Knowledge Exchange Forum for Emerging Technologies, a multi-party consultation was organised by the Biotechnology Industry Research Assistance Council (BIRAC) with the Department of Biotechnology (Ministry of Science and Technology, Government of India), the Committee for Control And Supervision of Experiments on Animals, and the Bureau of Indian Standards along with the Central Drugs Standard Control Organisation (CDSCO). This exchange addressed the regulatory challenges for developing emerging human-relevant technologies in India. BIRAC is also actively supporting the transition from animal models to newer systems, including organoids and microphysiological systems. Developing “made-in-India” human-relevant technologies can not only accelerate drug development in India but also position it as a global supplier of these cutting-edge technologies and contribute to global standards and regulations. With many Indian pharma companies catering to both domestic and global markets, technological advancements in this space can be pivotal for the pharma sector.
Human-based technologies represent the next frontier for the biopharma industry, and a means to ensure more efficient, faster-to-market, and predictive drug pipelines. With a structured funding programme to develop the technology and capacity in India, regulatory transformation and harmonisation with global policies, and multi-stakeholder collaboration, India can play a key role in shaping the next generation of globally accepted standards in drug development and safety assessment. We stand at a critical inflexion point where there is an opportunity for regulators, academia, industry, and contract research organisations in India to work together to position India as a global leader in this space.
Surat Parvatam is a Program Director (Research and Regulatory Sciences) at Humane World.
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Surat Parvatam is a Program Director (Research and Regulatory Sciences) at Humane World. She works across biomedical research, chemical and agrochemical safety testing, vaccine batch ...
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