Introduction
The practice of experimenting on animals has long been a focal point of ethical and regulatory debates. Juxtaposed against the concerns for animal welfare, this complex landscape tries to strike a balance between the pursuit of scientific progress to advance human knowledge and safeguard the rights and well-being of fellow planet inhabitants. Notwithstanding the surge in global commitment to reduce the number of animals used in experimentation and research activities, reports indicate that more than 100 million animals are used globally for experimentation on an annual basis. Further, trend suggests that, currently, there is little to no decline in worldwide use of animals in research and lab work.
India’s Regulatory Regime
In 1959, William Russell and Rex Burch first introduced the concept of the three ‘Rs’, namely, Replacement, Reduction and Refinement in the context of animal experimentation through their book ‘The Principles of Humane Experimental Technique’. As per their observations, ‘Reduction’ signifies the need to lessen the number of animals used in experimentation by regulating variability and leaning towards judicious use of animals by relying on advancements in experimentation methodologies. ‘Refinement’ refers to the need for improvement to mitigate the suffering of animals (such as use of anesthesia), while ‘Replacement’ refers to the use of alternative methods and innovative technologies which may be used to avoid animal experimentation. These founding principles have influenced the regulatory regime in the context of animal experimentation across the globe. In India, experimentation on animals is regulated by the Prevention of Cruelty to Animals Act, 1960 (“PCA”). Section 14 thereto permits experiments on animals for the purposes of advancement by new discovery of physiological knowledge, knowledge which will be useful for saving or prolonging life or alleviating suffering and for combating any disease in animals, plants or humans.
Role of CPCSEA
In terms of the PCA, the Central Government has constituted a Committee for the Purpose of Control and Supervision of Experiments on Animals (“CPCSEA”). The CPCSEA is duty bound to take all such measures as may be necessary to ensure that animals are not subjected to unnecessary pain before, during or after the performance of experiments on them. The CPCSEA enforces the Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998 (as amended from time to time) (“1998 Rules”). Under these rules, the concerned establishments are required to get themselves registered with the CPCSEA and form Institutional Animal Ethics Committee (“IAEC”). The IAEC of establishments have been given powers to permit experiments on small animals and only proposals for conducting experiments on large animals are required to be sent to CPCSEA for approval. The 1998 Rules also require the establishments to get their Animal House Facilities inspected, and get specific projects for research cleared by the CPCSEA before commencing research on animals. Further, breeding and trading of animals for such experimentation are also regulated. The 1998 Rules also increase the scope of permissibility of experiments on animals for the purposes of ‘significant gains in wellbeing for people of the country’.
While the PCA, read with the 1998 Rules, permits experimentation on animals for inter alia drug discovery and disease mitigation, such experimentation may only be conducted within the boundaries and conditions prescribed under the 1998 Rules. These conditions ensure that the hallmarks and spirit of the three Rs are enshrined under the Indian regulatory regime. These conditions include:
- It is mandated that the experiments are to be performed with due care and humanity;
- Experiments which involve operative procedure more severe than simple inoculation or superficial venesection need to be performed under the influence of anesthetic;
- If there is reason to believe that an animal is suffering abnormal or severe pain at any stage of a continuing experiment, it shall be painlessly destroyed at that stage without proceeding with the experiment;
- Animals lowest on the phylogenetic scale, which may give scientifically valid results, should be first considered for any experimental procedure and the experiment should be designed using minimum number of animals to give statistically valid results at 95% degree of confidence;
- Replacement alternatives not involving experiments on animals should be given due and full consideration, and sound justification must be provided, in case, alternatives, though available, are not used; and
- Investigators shall be responsible for aftercare and rehabilitation of animal(s) after experimentation, and shall not euthanize them except in situations as prescribed.
The CPCSEA has also implemented ‘Guidelines for Laboratory Animal Facility’ (“Guidelines”) to assure quality maintenance and safety of animals used in laboratory studies while conducting biomedical and behavioral research and testing of products. These Guidelines must be adhered to by all laboratories and facilities engaged in experiments on animals for biomedical/ behavioral research and testing of products. The Guidelines lay down specifications on several aspects including hygiene, animal care, personnel, duration of experiments (not exceeding three years unless justified), experiments involving hazardous agents, multiple surgical procedures on a single animal, physical facilities, equipment, animal husbandry, etc.
Shifting Tides: Alternative Methods of Experimentation
Considering that awareness related to the shortcomings of the three Rs principles has increased worldwide, countries have now begun revaluating their animal experimentation regulatory regimes to accommodate alternative and non-animal experimentations. From an Indian policy perspective, the Indian Council of Medical Research (“ICMR”), in a bid to advance both human medical progress and facilitate a move away from reliance on animals such as monkeys and dogs as models of human disease, announced its plans to establish a new “ICMR Centre of Excellence in Human Pathway-Based Biomedicine and Risk Assessment” and introduced a draft “Indian Roadmap on Alternatives to Animals in Research” to serve as a foundation for developing future research in the area of alternatives to animals in experimentation.
Further, animal testing is no longer mandatory and alternative methods are now acceptable to assess and evaluate the safety and efficacy of new drugs and/ or investigational new drugs in terms of recent amendments made to the New Drugs and Clinical Trial Rules, 2019. The changes in the regulatory regime now enable non-animal testing methodologies, including technologies like organ chips and micro physiological systems, sophisticated computer modeling and other human biology-based test methods to test the safety and efficacy of new drugs. Additionally, the Cosmetics Rules, 2020, which govern the manufacturing, import, distribution and development of cosmetics in India, prohibit any person from using animals for testing cosmetics.
India’s approach to animal experimentation encapsulates a nuanced balance between scientific advancement and ethical responsibility. Gradual changes in policy outlook and amendments made to the applicable regulatory regime, along with the legal framework anchored by the PCA and CPCSEA underscores the country’s commitment to animal welfare. The journey towards a global switch to non-animal testing methodologies requires continued dialogues between all stakeholders, refinements and advancement in alternative technologies and a shared commitment to fostering a culture where scientific progress harmonizes seamlessly with the principles of compassion and respect for animals that contribute to our collective pursuit of knowledge.
For further information, please contact:
Biplab Lenin, Partner, Cyril Amarchand Mangaldas
biplab.lenin@cyrilshroff.com
