<p>Animal testing can be traced back to ancient Greece, with references as early as 400 BCE. Aristotle and Erasistratus have documented experiments on live animals, and over the centuries, the practice became accepted for evaluating surgical procedures, studying anatomy, and testing the safety and efficacy of vaccines, drugs and chemicals -- including those used in warfare.</p>.<p>The use of animals in research peaked in the 1970s but has since declined, largely due to a shift in pharmaceutical research from animal screening to mechanistic-based approaches. A downward trend was first evident in countries such as Great Britain, the Netherlands, Switzerland, and Germany, where increased research funding and advances in biomedical techniques provided more accurate and reliable alternatives. Crucially, 90% of drugs that pass animal testing still fail in human clinical trials. Differences in metabolism, absorption, and physiology make animal models poor predictors of human outcomes. Yet, despite these flaws, the practice persists.</p>.<p><strong>Global trends</strong></p>.<p>In April 2025, the US Food and Drug Administration (FDA), in a landmark move, announced that animal testing will be phased out in favour of more “effective and human-relevant methods”. Similarly, the EU Council has endorsed the European Research Area (ERA) Policy Agenda 2025-27, encouraging animal-free innovation and the adoption of New Approach Methodologies (NAMs). </p>.<p>These developments align with the principles of the 3Rs -- replacement, reduction, and refinement -- which promote humane and science-based research. NAMs include <em>in-vitro</em> methods such as human cell and tissue cultures, 3D bioprinting, and organ-on-chip (OoC) technologies. OoCs are microphysiological systems that simulate human organ tissues like the heart, brain, or liver using microfluidics in a controlled physiological and mechanical environment. The other category is <em>in-silico</em> models, which rely on large datasets along with mathematical modelling, AI, and machine learning to predict toxicity and pharmacokinetics. Complementary categories include <em>in-chemic</em>o methods and high-throughput screening.</p>.<p class="bodytext">With progress in artificial intelligence, advanced technologies, and the declining cost of computational power, these options are more accurate, ethical, and significantly faster. However, they demand high upfront costs, and herein lies the challenge for countries like India. </p>.<p class="bodytext">Post-independence, India enacted broadly progressive animal laws, though implementation remains patchy. The Prevention of Cruelty to Animals Act (PCA 1960) was the first comprehensive national law, followed by the creation of the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) in 1964 to regulate research and education. From 1998, only registered research institutions and breeders were permitted to use animals for experimentation.</p>.<p class="bodytext">Despite this framework, outdated clauses -- largely related to penalties -- remain its Achilles’ heel. Though attempts at reform have largely failed, progress has been made: animal dissection in education was banned in 2012; in 2013, India became the first country in South Asia to ban the testing of animals for cosmetics; and in 2014, the ban on the import of animal-tested cosmetics was introduced. More recently, the New Drugs and Clinical Trial Rules (2023) took a decisive step by promoting non-animal methods for drug and vaccine research. However, overlapping regulations governing animal testing continue to create complexity and confusion. This inconsistency was reflected in the 2020 Global Animal Protection Index, where India received a “C” rating, highlighting how its laws risk becoming a paper tiger: strong on paper, but weak in enforcement.</p>.<p class="bodytext">India faces real-world challenges. Live animals (like rodents, rabbits, dogs, monkeys, fish, birds, and invertebrates like fruit flies) remain easy to source. Many large pharmaceutical firms and Contract Research Organisations (CROs) have invested millions of dollars in animal-based research, built extensive infrastructure over the decades, designed supply chains and trained personnel around conventional animal studies. Replacing them with NAMs requires a concerted and globally coordinated effort, as major CROs in India cater to foreign clients, whose regulations still mandate animal testing.</p>.<p class="bodytext">A path forward will require a multi-pronged approach:</p>.<p class="BulletPoint">A National Action Plan: India should draft a roadmap for animal-free research and integrate it into flagship missions such as Make in India and Atmanirbhar Bharat, ensuring support from all stakeholders.</p>.<p class="BulletPoint">Boost R&D investment: Incentivise innovation, increase funding, and strengthen academia-industry-government partnerships to reduce reliance on costly foreign infrastructure and imported technologies.</p>.<p class="BulletPoint">Forge global collaboration: Encourage knowledge exchange, training and the building of resilient supply chains.</p>.<p class="bodytext">India’s pharmaceutical sector is currently valued at $50 billion (2023-24) and is projected to grow to $130 billion by 2030 and $450 billion by 2047. A clear government stance on human-based testing could bridge knowledge gaps, attract private investment, and align societal values with scientific progress. After all, a policy without effective implementation is like a caged bird: full of promise, but unable to fly.</p>.<p class="bodytext">As the world's fourth-largest economy, India must lead from the front.</p>.<p class="bodytext">(The writer is the head of Policy School, Takshashila Institution)</p>
<p>Animal testing can be traced back to ancient Greece, with references as early as 400 BCE. Aristotle and Erasistratus have documented experiments on live animals, and over the centuries, the practice became accepted for evaluating surgical procedures, studying anatomy, and testing the safety and efficacy of vaccines, drugs and chemicals -- including those used in warfare.</p>.<p>The use of animals in research peaked in the 1970s but has since declined, largely due to a shift in pharmaceutical research from animal screening to mechanistic-based approaches. A downward trend was first evident in countries such as Great Britain, the Netherlands, Switzerland, and Germany, where increased research funding and advances in biomedical techniques provided more accurate and reliable alternatives. Crucially, 90% of drugs that pass animal testing still fail in human clinical trials. Differences in metabolism, absorption, and physiology make animal models poor predictors of human outcomes. Yet, despite these flaws, the practice persists.</p>.<p><strong>Global trends</strong></p>.<p>In April 2025, the US Food and Drug Administration (FDA), in a landmark move, announced that animal testing will be phased out in favour of more “effective and human-relevant methods”. Similarly, the EU Council has endorsed the European Research Area (ERA) Policy Agenda 2025-27, encouraging animal-free innovation and the adoption of New Approach Methodologies (NAMs). </p>.<p>These developments align with the principles of the 3Rs -- replacement, reduction, and refinement -- which promote humane and science-based research. NAMs include <em>in-vitro</em> methods such as human cell and tissue cultures, 3D bioprinting, and organ-on-chip (OoC) technologies. OoCs are microphysiological systems that simulate human organ tissues like the heart, brain, or liver using microfluidics in a controlled physiological and mechanical environment. The other category is <em>in-silico</em> models, which rely on large datasets along with mathematical modelling, AI, and machine learning to predict toxicity and pharmacokinetics. Complementary categories include <em>in-chemic</em>o methods and high-throughput screening.</p>.<p class="bodytext">With progress in artificial intelligence, advanced technologies, and the declining cost of computational power, these options are more accurate, ethical, and significantly faster. However, they demand high upfront costs, and herein lies the challenge for countries like India. </p>.<p class="bodytext">Post-independence, India enacted broadly progressive animal laws, though implementation remains patchy. The Prevention of Cruelty to Animals Act (PCA 1960) was the first comprehensive national law, followed by the creation of the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) in 1964 to regulate research and education. From 1998, only registered research institutions and breeders were permitted to use animals for experimentation.</p>.<p class="bodytext">Despite this framework, outdated clauses -- largely related to penalties -- remain its Achilles’ heel. Though attempts at reform have largely failed, progress has been made: animal dissection in education was banned in 2012; in 2013, India became the first country in South Asia to ban the testing of animals for cosmetics; and in 2014, the ban on the import of animal-tested cosmetics was introduced. More recently, the New Drugs and Clinical Trial Rules (2023) took a decisive step by promoting non-animal methods for drug and vaccine research. However, overlapping regulations governing animal testing continue to create complexity and confusion. This inconsistency was reflected in the 2020 Global Animal Protection Index, where India received a “C” rating, highlighting how its laws risk becoming a paper tiger: strong on paper, but weak in enforcement.</p>.<p class="bodytext">India faces real-world challenges. Live animals (like rodents, rabbits, dogs, monkeys, fish, birds, and invertebrates like fruit flies) remain easy to source. Many large pharmaceutical firms and Contract Research Organisations (CROs) have invested millions of dollars in animal-based research, built extensive infrastructure over the decades, designed supply chains and trained personnel around conventional animal studies. Replacing them with NAMs requires a concerted and globally coordinated effort, as major CROs in India cater to foreign clients, whose regulations still mandate animal testing.</p>.<p class="bodytext">A path forward will require a multi-pronged approach:</p>.<p class="BulletPoint">A National Action Plan: India should draft a roadmap for animal-free research and integrate it into flagship missions such as Make in India and Atmanirbhar Bharat, ensuring support from all stakeholders.</p>.<p class="BulletPoint">Boost R&D investment: Incentivise innovation, increase funding, and strengthen academia-industry-government partnerships to reduce reliance on costly foreign infrastructure and imported technologies.</p>.<p class="BulletPoint">Forge global collaboration: Encourage knowledge exchange, training and the building of resilient supply chains.</p>.<p class="bodytext">India’s pharmaceutical sector is currently valued at $50 billion (2023-24) and is projected to grow to $130 billion by 2030 and $450 billion by 2047. A clear government stance on human-based testing could bridge knowledge gaps, attract private investment, and align societal values with scientific progress. After all, a policy without effective implementation is like a caged bird: full of promise, but unable to fly.</p>.<p class="bodytext">As the world's fourth-largest economy, India must lead from the front.</p>.<p class="bodytext">(The writer is the head of Policy School, Takshashila Institution)</p>