Ahimsa and Alternatives - the Concept of the 4Th R

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Ahimsa and Alternatives - the Concept of the 4th R. The CPCSEAin India Shiranee Pereira' and Massimo Tettamanii? ICommittee fos the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), IN-Chennai 2International Centre for Alternatives in Research and Education (I-CARE), IN-Chennai

Summary Zusammenfassung: Ahimsa und Alternativen - das Konzept The Committee for the Purpose of Control and Supervision of des vierten R. Das CPCSEA in Indien Experiments on Animals (CPCSEA) in India is one of a kind in Das Komitee zur Kontrolle und Aufsicht über Tierversuche the world. It is a statutory body of the government of India (CPCSEA) in Indien ist weltweit einzigartig. Es ist eine Ein- formed by an act of the Indian parliament. This body consists richtung der indischen Regierung, geschaffen durch einen of nominated members and representatives from national Beschluss des indischen Parlaments. Das Gremium besteht aus regulatory agencies, Ministry of Health and Family Welfare, ernannten Mitgliedern und Vertretern von nationalen Aufsichts- Ministry of Environment and Forests, national academic and behörden, des Ministeriums für Gesundheit und Familie und research councils, premier research institutes, eminent seien- des Ministeriums für Umwelt und Wälder. Im Weiteren gehören tists and animal welfare organisations. The CPCSEA draws ihm nationale Berater aus Akademie- und Forschungskreisen, its powers from the Prevention of Cruelty to Animals (PCA) Act bekannte Wissenschaftler sowie Vertreter von führenden of 1960 which states that the duty ofthe committee is "to take Forschungseinrichtungen und Tierschutzorganisationen an. all such measures as may be necessary to ensure that animals Das CPCSEA leitet seine Befugnisse aus dem Gesetz zur are not subject to unnecessary pain or suffering before, during Vermeidung von Grausamkeit gegen Tiere von 1960 ab, in dem or after the performance of experiments on them ". festgelegt ist, dass das Komitee "alle nötigen Massnahmen With the power to promulgate its own laws to ensure the ergreifen muss, um sicherzustellen, dass Tiere vor, während humane and ethical use of animals in research and education, und nach Versuchen keinen unnötigen Schmerzen oder Leiden the CPCSEA in 1998 notified in the gazette of India the ausgesetzt werden ". "Breeding of and Experiments on Animals (Control and Mit der Befugnis eigene Gesetze zu erlassen, um die humane Supervision) Rules 1998". und ethische Nutzung von Tieren in Forschung und Lehre The CPCSEA is unique in that the law in itself has enabled the sicherzustellen, hat das CPCSEA 1998 in der Gazette of India creation of a common platform of discussion for scientists "Richtlinien zur Zucht und Nutzung von Tierenfür Experimente and animal activists for humane and progressive solutions for (Kontrolle und Aufsicht) 1998" publiziert. the use of animals in experimentation. In a country that is Das CPCSEA ist einzigartig, weil hier ein Gesetz unmittelbar caught in a paradox of violence and rich cultural and religious eine Plattform geschaffen hat, auf der Wissenschaftler und Tier- traditions, India still draws a lot of its power from the concept schützet Diskussionen im Sinne humaner und fortschrittlicher of "Ahimsa" (the philosophy of non-violence). This concept is Lösungen bei Tierversuchen führen. In einem Land, das sich also pertinent to the use of animals in laboratories. Unethical, in einem Paradoxon von Gewalt und reicher kultureller und inhumane and unscientific practices, and ignorance of the religiöser Traditionen verfangen hat, schöpft Indien immer use of alternatives were the way of science until 1999 when noch viel seiner Kraft aus dem Konzept der "Ahimsa ", der CPCSEA became functional. For four years CPCSEA has Philosophie der Gewaltlosigkeit. Dieses Prinzip findet nun auch waged a battle, rescued thousands of animals from laborato- in Tierversuchsanlagen Anwendung. Unethische, inhumane ries, fought legal battles to victory, enforced for the first time und unwissenschaftliche Praktiken und Unkenntnis gegenüber in the country good laboratory practice, designed guidelines dem Einsatz von Alternativmethoden waren vor 1999, als das for the use of animals in the production of immunobiologicals, CPCSEA seine Arbeit aufnahm, gängige Methoden in der introduced the credo of 3R principles, trained and taught Wissenschaft. Vier Jahre führte das Komitee einen regelrechten scientific personnel the credibility of humane science and Feldzug, rettete tausende Tiere aus Laboratorien, führte most importantly brought forward the concept of the fourth R, siegreiche Prozesse, setzte erstmals im Land die "gute Labor- "rehabilitation" of used laboratory animals. Today CPCSEA praxis " in Kraft sowie Richtlinien für die Verwendung von has made it anational policy that personnel using experimen- Tieren bei der Herstellung von Immunbiologika, führte das tal animals have amoral responsibility towards these animals Credo der 3R ein, brachte wissenschaftlichem Personal die

Received 18 November 2004; received in final form and accepted for publication 3 January 2005

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after their use. Costs of after-care/rehabilitation of animals Grundsätze humaner Wissenschaft näher und, am allerwich- post experimentation are to be apart of research costs and tigsten, es verhalf dem Konzept des vierten Rs, der Rehabilitation should be scaled in positive correlation with the level of verwendeter Labortiere, zur Geltung. Das Komitee hat dieses sentience of the animals. Konzept zu einem nationalen Grundsatz erhoben, nach dem This paper is about the Indian law on anima I experimentation Personen, die Tiere verwenden, auch nach dem Experiment eine and the success story of the CPCSEA in India in inculcating moralische Verpflichtung gegenüber diesen Tieren haben. Die the credo of 4Rs - Replacement, Reduction, Refinement, and Kosten der Nachsorge und Rehabilitation der Tiere nach den Rehabilittuion of animals used in experimentation. Experimenten bilden Teil der Forschungskosten; sie sind positiv korreliert mit der Empfindungsfähigkeit der Tiere. In diesem Beitrag geht es um die indische Rechtsprechung zu Tierversuchen und die Erfolgsgeschichte des CPCSEA bei der Festlegung des Bekenntnisses zu den 4Rs - Replacement, Reduction, Refinement und Rehabilitation von Versuchstieren.

Keywords: anima I experimentation, rehabilitation, ahimsa, animal welfare in India, control and supervision

1 Introduction Animal Welfare Board of India, by an act the following changes were brought of parliament, with the sole purpose of about: Ahimsa is a Sanskrit word meaning "not controlling and supervising experiments • Over 850 laboratories registered with to kill". In a broader sense it refers to the on animals. The PCA lays down the duty the CPCSEA concept of "non-violence", It is derived of the CPCSEA as "to take all such mea- • IAEC's (Institution al Animal Ethics from the word "himsa" which means "to sures as may be necessary to ensure that Committees) were founded in all regis- kill". Ahimsa is an enduring Indian tradi- animals are not subject to unnecessary tered institutes tion signifying the sacredness of life. pain or suffering before, during or after • Over 300 CPCSEA nominees were ap- Hindus, Buddhists and Jains view all the performance of experiments on pointed in these institutes living things as incarnations of a single them". • An expert committee was appointed to life force. When a creature dies it could With the power to promulgate its own scrutinise and approve large animal be re-incarnated into another form and laws to ensure the humane and ethical use hence be vitalised by a soul of an ances- use of animals in research and education, • Good Laboratory Practice was intro- tor or friend. In a country that is caught the CPCSEA in 1998 notified the duced in a paradox of violence and rich cultur- "Breeding of and Experiments on Ani- • A protocol for the care and use of al and religious traditions, India still mals (Control & Supervision) Rules equines in the production of immuno- draws a lot of its power from the concept 1998" (Anon, 1998) which was amended biologieals was introduced of Ahimsa. Like India's struggle to in 2001. The CPCSEA is unique in that • The 3R credo was introduced freedom from British occupation, the the law itself has enabled the creation • Alternatives validated by ECVAM progress towards laws that govern the of a comrnon platform for recourse and (European Commission for the Valida- care and use of animals in experimenta- discussion between scientists, policy tion of Alternative Methods) and ICC- tion has been guided and propelled by makers and animal activists by way of VAM (Interagency Coordination Com- Ahimsa. which the CPCSEA works for humane mittee for the Validation of Alternative and progressive solutions in the use of Methods) were recommended to regu- animals in experimentation. latory authorities 2 Indian law and animal From 1964 to 1998 little was done to • A national ban on the SempIe vaccine experimentation alleviate the suffering of laboratory ani- was urged mals in India. The CPCSEA committees • Two year phase-out of the ascites The law that governs the use and care of failed to irnpose the laws and lacked ef- method of monoclonal antibody pro- animals in experimentation is the Preven- fective methods for implementation and duction tion of Cruelty to Animals Act (PCA) of a dismal scenario continued in laborato- • Hundreds of laboratory animals were 1960. Sections 15 to 20 of the Act regu- ries across the country (Pereira et al., rescued and rehabilitated late the power, position and duties of the 2003). A pro-active secretariat was only The animals rehabilitated were ap- Committee for the Purpose of Control created in 1999 under the comrnitted proximately 300 beagles, 50 mixed- and Supervision of Experiments on chairpersonship of Maneka Gandhi. breed dogs, 220 primates, 170 equines, Animals (CPCSEA). The CPCSEA is From 1999 the CPCSEA enforced the 30 sheep, 250 birds, 110 rabbits and thus a statutory body of the government law of the land tirelessly, and for the first others, which included frogs, mice and of India, constituted on the advice of the time in the history of independent India cobras.

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With this was born the concept of the nology), IVRI (Indian Veterinary Re- scientific procedures adopted with ani- 4th R,"Rehabilitation" of laboratory ani- search Institute), NIl (National Institute mals that may cause more than momen- mals, borne out of an urgent need to of Immunology), Ministry of Health, tary or slight pain and/or distress should provide relief and succour to the ailing philosophers and animal activists. be performed with appropriate sedation, animals in laboratories. Rehabilitation The consultative group held six brain- analgesia or anaesthesia. was undertaken when the need arose storming sessions to elucidate the under- with the sole intention of alleviating any lying principles for animal experimenta- 4.4 Principle No. 4 form of suffering or pain and/or to save tion and their philosophical foundations, Personne1 using experimental animals the life of the animal. The concept of 4th to provide the conceptual framework to have a moral responsibility for the ani- R "Rehabilitation" is defined as "the review prevailing norms and promulgate mals after their use. Investigators are after-care rendered to animal/s that new ones. Five major guiding principles responsible for the after-care and/or re- has/have been (i) bred for the purpose of for the utilisation and care of animals habilitation of animals, post-experimen- experimentation (ii) subject to any form used in testing, research, training and ed- tation, and may be permitted to euthanise of experimentation (iii) retained in labo- ucation were elucidated in a consensus animals only in the following situations: ratory animal houses or breeding houses (Anon, 2004). • When the animal is paralysed and is for the purpose of experimentation, both not able to perform its natural func- for education and research, with the tions, it becomes incapable of indepen- sole purpose of alleviating any/all pain or 4 The Principles dent locomotion and/or can no longer suffering due to the physicallphysiologi- perceive the environment in an intelli- cal/psychological trauma that the ani- 4.1 Principle No. 1 gible manner. malls has/have been exposed to and to "Experiments on animals" (including ex- • During the course of the experimental prolong the life of the animalls until the periments involving operations on ani- procedure the animal has been left point of natural death." During the period mals) may be carried out for the purpos- with a severe recurring pain wherein of rehabilitation the animal/s should es of advancement by new discovery of the animal exhibits obvious signs of not be subjected or exposed to any kind physiological knowledge, or of knowl- long-term extreme pain and distress. of activity/work that is unnaturallalien edge which will be useful for saving • In situations where non-termination of to their natural behaviour or needs (Tet- or for prolonging life or alleviating suf- the animal experimented upon would tarnanti et al., 2004). fering or for significant gains in well- be life-threatening to human beings or being for the people of the country or other animals. 3 The year 2004 for combating any disease, whether of Investigators are responsible for ani- human beings, animals or plants. mals even after termination of the exper- The proactive work of CPCSEA over the iment and they have a moral obligation to last 5 years has helped to create a great 4.2 Principle No. 2 ensure that experimental animals should degree of awareness among research! Animals lowest on the phylogenetic be rehabilitated at the end of the experi- educational establishments and has in- scale and with the least degree of sen- ment, or only where that is not possible, culcated sensitivity towards understand- tience which may give scientifically valid in situations as referred to above, should ing the pain and suffering experienced results should be used for any experi- be humanely euthanised. by animals during experiments. It has mental procedure. Experiments should Costs of after-care and/or rehabilita- gradually helped to raise awareness be designed with the minimum number tion of animals post-experimentation are about the need for observance of norms of animals to give statistically valid re- to be part of research costs and should of humane treatment of animals. sults at 95% level of confidence. Alterna- be scaled per animal in positive correla- In March 2004, in response to a com- tives not involving animal testing should tion with the level of sentience of the plaint received from the scientific com- be given due and full consideration and animals. munity that CPCSEA regulations were sound justification provided if alterna- posing unnecessary hurdles to the smooth tives, when available, are not used. 4.5 Principle No. 5 conduct of medical research, a consulta- The living conditions of animals should tive group was constituted under the 4.3 Principle No. 3 be appropriate for their species and chairpersonship of the Secretary of the Proper use of animals in experiments and contribute to their health and comfort. Ministry of Environment and Forest, the avoidance and/or minimisation of dis- Normally, the housing, feeding and care ministry to which the CPCSEA belongs. tress and pain infiicted on experimental of all animals used for biomedical pur- Members of the group included represen- animals should be an issue of priority poses must be directed by a veterinarian tatives from the ICAR (Indian Council of for research personne1 and unless the or other scientist trained and experienced Agricultural Research), CSIR (Council contrary is scientifically established, in- in the proper care, handling and use of for Scientific and Industrial Research), vestigators should proceed on the basis the species being maintained or studied. ICMR (Indian Council for Medical Re- that procedures that cause pain or dis- In any case, veterinary care shall be pro- search), CDRI (Central Drug Research tress in human beings will also cause vided as necessary. Institute), DBT (Department of Biotech- similar pain or distress in animals. All

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5 Implementation 6 Conclusion experience has taught us that immediate and dramatic changes could even kill the With this, the concept of the 4th R has The recognition of the concept of the 4th animal (Tettamanti et al., 2004). In our been officially recognised and adopted as Rand the official status rendered to it as experience of rehabilitating laboratory a policy decision of the government of anational policy is indeed acelebration animals like rats, mice, rabbits, horses, India. Given this official status it will of the Indian philosophy of Ahimsa and mules, dogs, cats and primates we have be imposed as a legal and mandatory our belief in the sacredness of life. We observed that the rehabilitation does at requiremeat by the amendment of the believe the 4th R - "Rehabilitation" of times present problems which, however, "Breeding of and Experiments on Animals laboratory animals - is a befitting moral are resolvable with patience and care and (Control & Supervision) Rules 1998". continuum of the 3R credo of Russell the animals' survival is areminder that Principle NoA relating to the period of and Burch (1959). So far rehabilitation in every form of life the strongest and rehabilitation of animals after experi- has been performed by India's largest deepest psychologie al need is to live. ments, rehabilitation costs and agencies animal welfare organisation, People for to undertake rehabilitation of such Animals (PFA). Animal refuges and shel- animals, is to be incorporated by amend- ters run by the PFA and other animal References ment of the "Breeding of and Experi- welfare organisations across the country Anon. (2004). Report of the consultative ments on Animals (Control and Supervi- have come forward to rehabilitate the group on review of the norms and sion) Rules 1998" by inserting a new laboratory animals. In the case of dogs, practices for regulation of animal ex- provision which will read as follows: most have been rehabilitated in individu- perimentation. Ministry of Environ- "Personnel using experimental ani- al hornes. The shelters received a small ment and Forests, Animal Welfare mals have amoral responsibility for the degree of financial support from the Division, Government of India. animals after their use. Investigators are CPCSEA. However, now with CPCSEA Anon. (1998). Breeding of and Experi- responsible for the after-care and re- having officially recognised this as a ments on Animals (Control and Super- habilitation of animals post-experimen- moral and legal need, the funds received vision) Rules 1998. Gazette of India tation, and may be permitted to euthanise from scientific institutes will go a long No.809, 15th December 1998. animals only in situations as defined at way to establish independent laboratory Pereira, S., Veeraraghavan, P., Ghosh, S. Rule 9 (ff). animal rehabilitation centres in associa- and Gandhi, M. (2004). Animal Costs of after-care and rehabilitation tion with animal welfare organisations Experimentation and Ethics in India: of animals post-experimentation are to and help organise and implement the The CPCSEA Makes a Difference. be part of research costs and should be concept of the 4th R with more vigour ATLA 32, Supplement I, 411-415. scaled in positive correlation with the and ease. Russell, W. M. S. and Bureh, R. L. level of sentience of the animals. In areal world where we are faced (1959). The Principles of Humane A lump-sum amount needs to be pro- with the reality, where millions of ani- Experimental Technique. London: vided for, as rehabilitation costs for each mals are and will continue to be used Methuen. animal's entire statistically expected life in experimentation, the concept of reha- Tettamanti, M., Pereira, S. and Veer- span. Either the establishment undertak- bilitation should become a reality and be araghavan, P. (2004). The 4th R - ing experiments or a duly licensed and recognised as a moral and ethical conse- "Rehabilitation" of laboratory animals. authorised animal welfare organisation quence of the use of animals in experi- The ethos of I-CARE. Journal of Ani- (AWO) under the regulatory control of mentation. Hopefully, the initiative of the mal Welfare (communicated). the CPCSEA on payment of a lump-sum, Indian govemment will become a prece- may undertake rehabilitation of animals," dence for other nations to emulate. For adoption of norms for euthanasia, The concept and act of rehabilitation Correspondence to Rule 9 of the "Breeding of and Experi- is beautiful, but we must understand that Dr. Shiranee Pereira ments on Animals (Control and Supervi- it is not a romantic vision of an animal CIBA,75 sion) Rules 1998" is to be amended by released from a stable/cage in a laborato- Santhome Hg. Road inserting a new provision which will ry running onto a lawn, free and happy. R.A. Puram incorporate the permissible situations in An idyllic situation like this does not IN-Chennai-600 0028 which euthanasia can be performed as always correspond to the rehabilitated India elaborated in Principle NoA. laboratory animal's demands and our e-mail: [email protected]

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