The recent Palamur Biosciences Pvt. Ltd. case (2025) in Telangana highlights issues of animal experimentation and testing, revealing alleged cruelty and regulatory violations.

• PETA India filed a petition against Palamur Biosciences Pvt. Ltd., alleging cruel treatment and neglect of animals at its facility, a preclinical contract research organization and Beagle dog breeder.
• Delhi High Court banned the lab from procuring or housing new animals, based on allegations of animal cruelty and violations of regulations, following an inspection report by CCSEA.

What is Animal Testing? 

• Animal testing refers to the use of non-human animals in scientific experiments to study biological processes, test products, and evaluate the safety and efficacy of substances such as drugs, chemicals, cosmetics, and vaccines.
• Purpose of Animal Testing
  • To study disease mechanisms and test potential therapies.
  • To evaluate the safety of products before human trials.
  • To provide reliable models for human biological processes that cannot be easily replicated through other means.
• Common Animals Used in Testing
  • Rodents (rats, mice): The most common species, used due to their genetic similarity to humans.
  • Monkeys and dogs: Used in medical and drug research due to their biological similarities to humans.
  • Rabbits and guinea pigs: Used for safety testing in cosmetics and chemicals.

Historical Context of Animal Testing

• Modern Era: In the 19th century, with the rise of scientific curiosity, physicians and alchemists began using animals for more systematic experimentation to understand diseases, medications, and bodily functions.
• Shift from Human to Animal Testing: Initially, humans were used in experiments to assess toxicity and the effects of substances, as seen in the 1902-1904 U.S. government-sponsored study on food preservatives like benzoate and formaldehyde.
  • The shift to animal testing occurred because human subjects were found to be unpredictable—they didn’t always react as expected (e.g., not dying when anticipated or recovering unexpectedly). 
    • This unpredictability made animals more reliable as test subjects for creating controlled experimental conditions.
• Rise of Animal Testing for Medical Research
  • Early 20th Century: As medicine advanced, animals like guinea pigs, rabbits, and dogs were increasingly used in laboratories to test the safety and efficacy of new drugs, vaccines, and medical procedures.
  • 1940s-50s: Major medical breakthroughs, such as insulin for diabetes and polio vaccines, were developed through animal testing, particularly using monkeys and dogs for clinical trials.

Policy and Legal Reforms for Animal Experimentation in India 

Legal Framework

• Prevention of Cruelty to Animals Act, 1960 (PCA Act): 
  • The Prevention of Cruelty to Animals Act (1960) mandates the welfare of animals in research, including specific guidelines for humane treatment and the prohibition of unnecessary suffering.
  • Chapter IV of the Act allows animal experimentation but emphasizes the need to avoid experimentation when alternatives are available.
• Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA): Established under the PCA Act, the CPCSEA oversees animal experimentation, ensuring compliance with ethical standards. 
  • It mandates Institutional Animal Ethics Committees (IAECs) to approve experiments and enforce the 3Rs (Replacement, Reduction, Refinement) and a fourth R (Rehabilitation).

Recent Policy and Legal Reforms

• Ban on Animal Testing for Cosmetics:
  • 2014: India became the first Asian country to ban animal testing for cosmetics and the import of cosmetics tested on animals (Drugs and Cosmetics Rules, 2014, Rules 148C and 135B). 
  • 2016: The ban extended to soap and detergent industries, further reducing animal use in non-essential testing.
• Ban on Live Animal Experiments in Medical Education:
  • 2013: An amendment to the PCA Act banned live animal experiments in medical education, replacing them with simulations and virtual models. 
    • This reform tackled ethical concerns about animal suffering and psychological toll by eliminating unnecessary experiments in educational settings.
• Medical Council of India (MCI) Directives: Medical colleges in India are no longer required to maintain animal facilities and can use non-animal training methods such as computer-aided education.
  • Executive Committee of MCI (2003) recommended that sophisticated non-animal models replace live animal use in medical education.
• University Grants Commission (UGC, 2011) directed Indian institutions to phase out dissection and live animal experiments in life science courses, pushing for alternatives like 2D/3D visual models.
• Pharmacy Council of India (PCI) Guidelines: The PCI’s 2003 directive emphasized replacing animal testing in pharmacy schools with computer-aided learning (CAL) software.
• New Drugs and Clinical Trials Rules, 2019 (Amended 2023):
  • Key Provisions:
    • Encourages replacement, reduction, and refinement (3Rs) in drug testing.
    • Mandates justification for animal use and stricter welfare guidelines when animals are used.
    • Aligns with global standards (e.g., U.S. FDA Modernization Act 2.0, 2022; EU’s 2021 resolution), promoting human-relevant methods to address species disparities and failed predictions.
• Animal Welfare Board of India (AWBI): The AWBI, established under the PCA Act, advises on policy reforms, promotes alternatives, and supports public awareness.
  • It has pushed for stricter enforcement of CPCSEA guidelines and funding for non-animal technologies.

Arguments in Favor of Animal Testing

• Life-Saving Cures and Treatments: Animal testing has contributed to the development of life-saving treatments for humans and animals.
  • Without animal research, breakthroughs such as insulin for diabetes, polio vaccines, and treatments for neurodegenerative diseases would not have been possible.
• No Viable Alternatives in Some Cases: Despite the existence of alternatives, some research still requires animal models due to the complexity of biological systems that cannot be replicated with current technology (e.g., brain and organ functions, genetic mutations).
  • Shorter lifecycles of animals, like rodents, provide researchers the opportunity to study multiple generations in a shorter period of time.
• Unethical for Human Testing: Some experimental procedures, such as toxicology and genetic modifications, are unethical to perform directly on human subjects due to safety concerns.
  • Animal models help identify potential hazards before human exposure, making the process safer for human volunteers in clinical trials.
• Regulatory Requirements: Regulatory bodies like the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) require animal testing data before allowing drugs to proceed to human trials to ensure the safety and efficacy of new medicines.
  • Animal testing remains a regulatory necessity for approval of vaccines, treatments, and chemicals.
• Scientific Similarity Between Animals and Humans: Some species (like chimpanzees and mice) are genetically similar to humans (e.g., 99% similarity to humans in chimpanzees), making them suitable models for studying human diseases and therapies.
• Time Efficiency and Cost-Effectiveness: Animal testing provides faster results compared to human clinical trials, enabling quick screening of a large number of drug candidates.
  • The shorter lifespan of animals, particularly rodents, allows researchers to observe long-term effects over generations in a reduced time period.

Ethical Concerns in Animal Testing

• Severe Physical and Psychological Suffering: Animals are subjected to painful procedures: burns, shocks, poisoning, drug addiction, brain damage, and eventual death.
  • Even routine handling (e.g., blood collection, isolation) causes marked stress—elevated pulse, blood pressure, and hormone levels.
• Lack of Consent and Sentience Ignored: Animals are sentient beings capable of pain, fear, and distress.
  • They are forcibly restrained, imprisoned, and experimented upon without any consent, violating basic moral principles of autonomy and compassion.
• Unreliable Scientific Outcomes: Profound biological differences between animals and humans make extrapolation invalid.
  • Many drugs tested safe on animals fail in human trials (e.g., 92% failure rate as per FDA), making the practice both unethical and scientifically flawed.
• Inhumane Laboratory Conditions: Animals are kept in confined, unnatural cages, often alone—denied social interaction, grooming, or nesting.
  • Studies show such deprivation causes brain impairment, anxiety, and stereotypic behaviors even before experimentation begins.
• Moral Contradiction and Speciesism: Ethical justification based on animals’ perceived inferiority is deeply flawed.
  • If inability to reason justified harm, then harming infants or the intellectually disabled would also be permissible—something society rejects.

Alternatives to Animal Experimentation

• In Vitro Methods (Cell-Based Research): Human cell cultures and tissues are used to simulate human biological responses, providing more accurate data.
  • Organs-on-a-chip: Microfluidic devices containing living human cells mimic the structure and function of organs (e.g., liver, lungs, heart). 
  • These models are valuable for testing drug effects, toxicity, and disease progression.
• Tissue Engineering and Regenerative Medicine:
  • Lab-grown anatomical parts: Artificial muscle, pancreas, bladders, cartilage, heart, blood vessels, skin, bone marrow, bone, trachea.
  • Benefits: Ethical, reduces animal suffering, advances tissue-engineering field.
• Ex-Corpus Models: Bioartificial models replicate biological systems outside the body, suitable for experimentation and safety testing.
• In Silico Methods (Computer Modeling): Advanced computational simulations and AI-based models replicate human biological processes and predict how drugs, chemicals, or treatments will affect the human body.
  • These models are faster, more cost-effective, and do not suffer from species-specific variations that undermine animal testing.
• Human-Based Clinical Trials:
  • Microdosing: Small, sub-therapeutic doses of drugs are given to humans to study absorption, metabolism, and safety without significant risks.
  • Human volunteer studies provide direct, relevant data for drug safety and efficacy in human populations, overcoming animal model limitations.
• Organ-on-a-Chip and 3D Bioprinting
  • Organ-on-a-chip: 3D models of human organs created using human cells allow for real-time testing of drug effects and disease modeling.
  • 3D bioprinting: Uses human cells to create living tissues and organs layer-by-layer, enabling more realistic testing of chemical and drug responses.
• Personalized Medicine
  • Human-induced pluripotent stem cells (iPSCs): Stem cells derived from a patient’s own cells can be used to create specific models for studying diseases and testing drug effects, reducing the need for animal models.

Challenges in Animal Testing

• Inconsistent Policy Enforcement: Despite existing laws (e.g., the Prevention of Cruelty to Animals Act), inconsistent enforcement and self-regulation by institutions mean that animals are still subjected to inhumane treatment and unnecessary testing in some research facilities.
• Lack of Comprehensive Regulations: Though the PCA Act and guidelines from bodies like CPCSEA are in place, the lack of effective oversight often results in violations, including poor housing conditions, malnutrition, and lack of proper veterinary care.
• Archaic Educational Practices Despite Alternatives: Indian medical colleges still use live animals in classroom experiments despite global trends and Indian regulatory permissions for non-animal alternatives.
  • Continuation of such practices reflects institutional inertia rather than necessity.
• Cost and Infrastructure: Alternatives like organs-on-chip and 3D bioprinting require high initial investment. India’s biotech sector needs public-private funding (e.g., via ICMR, DBT).
• Inconsistent Global Standards: While the EU and other regions have progressively phased out animal testing, many developing countries, including India, still face challenges in adopting humane and scientifically sound alternatives.
• International Trade: Countries that fail to adopt animal-free testing practices face trade barriers and may be excluded from global markets, especially in industries like cosmetics, pharmaceuticals, and chemicals.

Way forward for addressing the ethical, scientific, and practical issues of animal testing:

• Stronger Legal Reforms and Enforcement: Amend the Prevention of Cruelty to Animals Act (1960) to mandate the use of non-animal alternatives wherever possible.
  • Strict enforcement of existing regulations and greater accountability for institutions that violate animal welfare guidelines, ensuring compliance with ethical standards.
• Increased Funding for Non-Animal Alternatives: Governments and private sectors should allocate more funding for the development and validation of alternative testing methods like 3D organ models, human-based simulations, and computational models.
  • Support for research grants in this area will help make these alternatives more accessible, reliable, and affordable.
• International Harmonization of Standards: Countries should align with international norms like the EU ban on animal testing for cosmetics and FDA’s modernization efforts to create a global standard that reduces the use of animals across industries.
  • Countries can work together to share best practices and promote the use of ethical, human-relevant models in testing.
• Integration of Human-Centered Models: Incorporate human-centric models such as human-induced pluripotent stem cells (iPSCs), microdosing, and organs-on-chips to study disease mechanisms, drug efficacy, and toxicity with more precision.
  • These advanced technologies can replace animals in clinical trials and preclinical research.
• Public Awareness Campaigns: Launch awareness campaigns to inform the public about the ethical implications and scientific drawbacks of animal testing. 
  • Encourage consumers to demand cruelty-free products, especially in sectors like cosmetics and pharmaceuticals.
• Collaboration Across Stakeholders: Government bodies, academia, NGOs, and industries should collaborate to promote the development of ethical alternatives and establish global standards for animal welfare.
  • Partnerships between academic institutions, tech companies, and regulatory bodies can drive the innovation and widespread adoption of alternative research methods.

Conclusion

The shift away from animal testing towards more humane and scientifically reliable alternatives is crucial. With stronger legal frameworks, global collaborations, and increased public awareness, the future of scientific research can be more ethical and precise, without the need for animal experimentation.

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