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Special Symposium “Animal Alternatives and Sustainable Development” within the “International Conference on Ecosystem Conservation and Sustainable Development” Ambo, ethiopia, February 10-12, 2011

Ambo (also known as Hagere Hiwot) is a small town in the West Shewa region of the State of Oromia in Central ethiopia, 112 km west of Addis Ababa. Ambo University, established in 1939, is a pioneering institution in the advance of scientific thought and practice in the fields of agriculture and rural development. The university now is making its impact felt in various other fields as well, including engineering and the health sectors. With its sprawling campus (8 colleges with 27 academic departments), more than 8000 students, large library, and modern laboratory equipment, Ambo is one of the prominent institutes of higher education in ethiopia.

the International Conference on “ecosystem Conservation and Sustainable Development” (eCOCASD 2011) was organ-ized by the Department of Biology of Ambo University and was held on February 10-12, 2011. More than 300 scientists from Africa, Asia, Australia, North-America, and europe attended. the Conference was organized primarily by Prof. Pavanasam Natarajan, Director-CAteR, Department of Biology, but the President and Vice-Presidents of the University also contrib-uted significantly to its success. The program was supported by tWAS-UNeSCO (Italy), MGDC (India), DZF (Switzerland), I-CARe (Italy), IlRI, IWMI, HoA-ReC/N, eFASA (ethiopia), CtA (Netherlands), SABS (India), and IOBB (Uganda).

The importance of this international conference is reflected in the list of illustrious attendees at the inaugural function. In addition to the organizer, Prof. Natarajan, and the President of Ambo University, Dr. Mitiku tesso, the audience included the President of the Federal Democratic Republic of ethiopia, Mr. Girma Wolde-Giorgis, as well as three ministers, Mr. tesgenu (Minister for Water and energy), Mr. Mekonen (Minister of education) and Dr. Urgessa (State Minister of education). the presence also of the Second Secretary of the Indian embassy, Mr. Subhash Chand, demonstrated the significance of the meet-ing to the country and to international relations.

the Special Symposium on “Animal Alternatives and Sus-tainable Development” took place on February 11 in the audito-rium of the university, with no parallel sessions.

Prof. Mohammad A. Akbarsha, Director of the Mahatma Gandhi Doerenkamp Center (MGDC) and Gandhi-Gruber-Doerenkamp Chair (India), opened the symposium with an in-troduction about the Gandhian philosophy of non-violence in teaching and research in the life sciences. Prof. Akbarsha traced the history and present status of animal use in education, re-search, and testing. Outlining the contexts of animal use, he discussed the implications of animal use in education from the perspectives of curricular, pedagogic, environmental, legal, and ethical issues. He emphasized not only that digital alternatives, models, charts, mannequins, self-experimentation, field studies, etc. can replace animal use in education, but also that these al-ternatives offer a much better learning opportunity than does the dissection of animals.

With respect to animal use in pharmacology, toxicology, and cosmetics testing, Prof. Akbarsha quoted surveys that revealed the use of several million animals for these purposes each year. Providing a long list of prescription drugs that were accepted in animal testing during the preclinical stage but later were with-drawn from the market due to life-threatening side effects, he highlighted the difference between animals and humans with respect to drug and toxic chemical metabolism. He then intro-duced Russell & Burch’s 3Rs concept and listed various alterna-tives in this context.

elaborating upon the laws of the european Union and the USA that require the reduction/replacement of animals in testing, Prof. Akbarsha briefly touched upon the evolution and role of the regulatory and validating authorities and organizations (i.e. FDA, OeCD, eCVAM, ICCVAM, JacVAM, ReACH, ZeBet, etc.) in the introduction of alternatives. He lauded the roles and contributions of CAAt, CAAt-europe, the transatlantic think tank for toxicology (t4), DZF, FRAMe, etc., as well as the scope and aims of tox21c, AxlR8, and the Human toxicology Project Consortium. He went on to introduce the journals publishing articles on animal alternatives: Altex, AAtex, AtlA, toxi-cology In Vitro, etc. Then he briefly introduced the World Con-gresses and other international meetings that discuss alternative

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of the ecosystems on the one hand and, on the other hand, the over-exploitation of amphibians in laboratories for experiments and for teaching purposes. Prof. Sharma introduced alternative non-invasive methods for phylogenic relationship and taxono-my using marker genes and sonographic techniques. He also demonstrated e-learning programs that can replace the dissec-tion of amphibians for educational purposes. the encouraging results viewed digitally on-screen raised a lengthy discussion about the features and future of the digital alternatives to in vivo hands-on education in classical biological education.

Dr. Surendra Ghaskadbi (Agharkar Research Institute, Pune, India) proposed “Hydra as a simple alternative model for studying diverse biological phenomena and their evolution.” He described the phylogeny of Hydra as an early, thus simple, metazoan with an organized nervous system, and he presented ongoing research data and new findings on the molecular fea-tures of Hydra. the focus of the research consortium around Prof. Ghaskadbi lies in functional similarities between Hydra and vertebrates, particularly with respect to pattern formation in vertebrate embryonic development. In this regard, the Noggin-Protein is of central importance in vertebrates. As Dr. Ghaskad-bi’s research revealed, the Hydra noggin-like gene shows func-tional conservation in vertebrates. He also described findings regarding the similarities between Hydra DNA repair abilities (Nucleotide excision Repair) and those of higher vertebrates. Dr. Ghaskadbi’s research anticipates that Hydra could be de-veloped as an alternative model system to in vivo as well as to in vitro testing of agents interfering with Noggin-related path-ways, DNA repair capacity, and similar molecular correlations that could be expounded.

Dr. Mardas Daneshian from the Center for Alternatives to Animal testing in europe (CAAt-europe) at the University of Konstanz, Germany presented the success story of the in vitro pyrogen test (IPt) as an alternative method for replacement of the rabbit pyrogen test. He explained the nature of pyrogens – fever-inducing agents – and their interaction with the human immune system. He pointed to the necessity of testing the pyro-genic burden in injectable drugs, and a critical discussion of the in vivo rabbit pyrogen test and the in vitro limulus amebocyte lysate test (lAl) followed, which focused especially on ethi-cal problems and methodological shortcomings. Dr. Daneshian introduced the in vitro pyrogen test principles of the second generation, which are based on measuring pro-inflammatory cytokine release from relevant human cell types and organs, i.e. monocytes and whole blood.

As the IPt involving human whole blood is a robust and sen-sitive pyrogen reporter system quantifying interleukin-1β (IL-1β) as a functional readout, it was validated and included in the european Pharmacopoeia. this “fever in a test tube” approach could save the lives of millions of rabbits, since the pharma-ceutical industry uses 400,000 rabbits per year for pyrogenicity safety testing. Furthermore, this method could be advanced by development and validation of cryopreserved human blood, thus standardizing the immune reactivity as a robust reference sys-tem. As the IPt system reveals a high degree of transferability, it could be successfully adapted to evaluate pyrogenic contami-nation on medical devices and materials and to an air-collecting

methods. He elaborated on the trends in in vitro toxicology and traced developments in the field that led to Integrated discrete Multiple Organ Co-Culture (IdMOC), Human Whole Blood Py-rogen test (fever in the test tube), the 3D skin and cornea recon-struction models, hepatocyte spheroid culture, etc.

Dr. Mukkura C. Sathyanarayana, Adjunct Professor, MGDC, India, in his talk on “Animal protection laws, alterna-tives, and sustainable development,” underscored for the audi-ence the very high numbers of frogs and lizards sacrificed for dissection and experiments in education: in India alone, three million frogs are utilized every year for teaching purposes. Prof. Sathyanarayana explained the absolutely essential role animal species play in the stability of an established ecosystem and the need for legal assurance of their rights: “the biodiversity conservationists must make it their mission to promote sustain-able ecosystems and conservation of biodiversity by advancing the understanding, development, and implementation of animal protection laws.” He then addressed the status of animal protec-tion regulations in different countries, focusing, in particular, on the “Prevention of Cruelty to Animals” Act (1960) of India. the statutory provisions associated with this Act are enforced in India by an independent Committee for the Purpose of Control and Supervision of experiments on Animals (CPCSeA). Due to the binding guidelines of CPCSeA, investigators using animals in their research must provide ethical and scientific justification in their applications to the Institutional Animal ethics Commit-tees (IAeC) prior to undertaking screening and/or pre-clinical studies on animals.

Dr. Sathyanarayana then gave an overview of the legal efforts aimed at strengthening animal and wildlife protection worldwide – a clear indication that the protection of animal rights and the protection of wildlife are of significant concern in modern socie-ties, as is the ethical evaluation of society’s actions with regard to animals and wildlife. He laid special emphasis on the animal protection law of Germany, enacted as early as 1930s, which re-flected grave concern for the wellbeing of animals. During the lively discussion that ensued, Dr. Sathyanarayana concluded that use of the alternative methods in education can obviate the re-moval of animals from their natural habitats and thereby contrib-ute to biodiversity conservation and sustainable development.

Next, Prof. Krishna K. Sharma from the Amphibian Bio-diversity Research laboratory, MDS University, Ajmer, Ra-jasthan, India, gave a lecture on the role of amphibians in the ecosystem and on current threats and conservation strategies. Prof. Sharma elucidated the role of amphibians in the ecosystem and their significant impact as secondary consumers in many food chains. Amphibians, as insectivores, also play an impor-tant role in containing insect-transmitted viral infections to man and plants (crops). Owing to their sensitivity in the larval stage and the usefulness of their decoded genomes, amphibians in early developmental stages are exploited, both as experimen-tal material and as sensors for gathering information about the stress status of ecological sites. the amphibian population has declined notably over the past two decades; currently 30% of frog strains worldwide are threatened. Prof. Sharma explained that in addition to natural stressors such as infections and radia-tion, the human threat to the amphibians includes destruction

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system for evaluation of air-borne pyrogens. In addition, the combination with albumin-coated beads opens the possibility of detecting pyrogens in immunomodulatory or interfering drugs and also detection of pyrogens in the femtomolar range. Dur-ing the subsequent discussion, Dr. Daneshian explained the rea-sons for the establishment of the lipopolysaccharide of E. coli strain O113 as the international standard reference system and described the complexity of the human immune system and the role of the cytokine network in it.

Dr. Hossein Hosseinkhani of the School of Biomedical en-gineering at the National Yang Ming University, taipei, taiwan, thrilled the audience by introducing new developments in the biomedical area involving the most recent knowledge on three-dimensional (3D) in vitro cell culture applications in microflu-idic chips. Dr. Hosseinkhani described the goal of his research as the integration of biology, nanotechnology, and material sci-ence to mimic organs and tissues as 3D cell cultures in vitro in a manner that simulates conditions, with the goal of reducing ani-mal testing and providing human-relevant functional systems for research and testing. His system involves a novel type of collagen-based hydrogels that provide a scaffold for cell growth comparable to the conditions in human organs. the cell-laden hydrogels can be infused with molecules of the extracellular matrix, and distinct concentrations of second messengers har-monize the cells in their differentiation and aggregation. this very promising technology provides cell clusters that mirror the physical, chemical, and biological properties of organs in vivo. the enthusiastic discussion that followed gave Dr. Hosseinkha-ni the opportunity to point out the importance and urgency of further adaptation and development of the technology he and

his team are working on. Such constructs have the potential to replace both present in vivo and in vitro tests, delivering a more physiological and functional approach for basic research as well for safety testing and quality assurance.

the audience were mesmerized by the on-screen demonstra-tion of the digital alternatives, ProFrog Dissector, Dissection Works, PhysioEX, etc., by Prof. Krishna K. Sharma and Dr. Mukkura C. Sathyanarayana.

the Chairperson, Prof. Rallapalli Ramamurthi, Former Vice-Chancellor, Sri Venkateswara University, tirupathy, India, and General President of the Indian Science Congress Association 2007-08, in his concluding remarks threaded all the talks to-gether into a cohesive story and elaborated upon the promising future for alternatives in the scientific scenario.

this special symposium covered many aspects of alternative methods and held the attention of the audience. The scientific exchange opportunities, the very inspiring and constructive at-mosphere of the conference, the cordiality of ethiopians, and the inviting features of the country all combined to make this event a fruitful, valuable, and unforgettable experience for all participants. Special mention should be made of the fact that most participants, including those from countries other than in Africa, were exposed to the concepts and practices of animal alternatives for the first time. To that extent, the special sym-posium was a novel venture of finding a link between animal alternatives and sustainable development, and of offering an au-dience its first “taste” of animal alternatives.

Mardas Daneshian, CAAt-europe, GermanyMohammad A. Akbarsha, MGDC, India

Fig. 1: Dr. Mardas Daneshian, Prof. Mohammad A. Akbarsha, Prof. Rallapalli Ramamurthi, Prof. Krishna K. Sharma, Dr. Surendra Ghaskadbi (f.l.t.r.).

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the newly organized evidence-based toxicology Collabora-tion (eBtC) held its inaugural conference on March 10, 2011 in Washington DC as a satellite to the 50th Annual Society of toxi-cology meeting. the eBtC is a volunteer group of individuals with ties to US governmental agencies, chemical and pharmaceu-tical companies, academia, and animal protection organizations. the group’s purpose is to foster the development of a process, based on the Cochrane Collaboration in evidence-based Medi-cine (eBM), for quality assurance of new toxicity tests for the assessment of safety in humans and the environment. (A list of the members of the Steering Committee with their respective or-ganizations appears below.)

At the kick-off meeting, speakers introduced the audience of about 130 attendees to the concept of evidence-based Medicine and how it might be applied to validating toxicity tests developed under a new paradigm, i.e., the one described in the NRC report Toxicity Testing in the 21st Century: A Vision and a Strategy (tox 21c). Dr. Milo Puhan, a member of the Cochrane Collaboration, made the first presentation, describing the concept of Evidence-based Medicine and the methodologies used to conduct systematic reviews of the literature to produce reference documents for clini-cians. the Cochrane Collaboration is housed at the Johns Hopkins Bloomberg School of Public Health.

Dr. Thomas Hartung, Director of the Johns Hopkins Center for Alternatives to Animal testing (CAAt), then provided a history of the evidence-based toxicology idea and how such an approach might be well suited to evaluating the quality of new tests for safety assessment. Dr. Kim Boekelheide, a member of the NRC committee that wrote the tox 21c report, gave a case study using carcinogenicity and genotoxicity testing in animals as an example of how inappropriate the current animal tests are for predicting human carcinogens; in fact, the animal tests have not been vali-dated against known human carcinogens. these presentations es-tablished the basis for developing new validation methods for new

toxicological tools that are based on mechanistic toxicology and on discovering pathways of toxicity in humans.

two representatives of US regulatory agencies and two repre-sentatives from regulated industries gave the final set of presenta-tions in the session. Dr. Suzanne Fitzpatrick from the Food and Drug Administration and Dr. Jack Fowle from the environmental Protection Agency spoke about the willingness of their respective agencies to work with the industries and academic scientists to help incorporate the new testing strategies into the regulatory proc-ess. two representatives from regulated industries, Dr. Robert Chapin from Pfizer and Dr. Fran Kruszewski from the American Cleaning Institute, speaking for the chemical industry, addressed the needs of their respective industries vis-à-vis the types of tests that would be useful and necessary for the evaluation of new drugs and chemicals, respectively.

the meeting closed with a discussion session in which audi-ence members asked the panel questions about the presentations and about how to move forward in the process. Dr. Hartung in-dicated that the Center for Alternatives to Animals testing will serve as secretariat for the eBtC and will work with the Steer-ing Committee to develop the next steps. The first of these steps is to identify individuals interested in playing a role in writing the procedural guidelines for the entire eBt enterprise. Until such guidelines are established, the Steering Committee will assume the role of appointing experts to working groups that will address methods development, guidelines for conducting systematic reviews, etc.

A full conference/workshop will be planned for the fall of 2011.Joanne ZurloCAAtJohns Hopkins UniversityBloomberg School of Public HealthBaltimore, MD, USAe-mail: JZurlo@jhsph.edu

Evidence-based Toxicology Collaboration Kick-off Meeting1 Washington DC, USA, March 10, 2011

1 Sponsors of the meeting included CAAT, the Society of Toxicology, the American Chemistry Council, the American Cleaning Institute, and CropLife America.2 N.B. Organizations are listed for identification purposes only and should not be construed as their endorsement of this activity.

Melvin Andersen, The Hamner InstituteRichard Becker, American Chemical CouncilKim Boekelheide, Brown UniversityJames Bus, Dow Chemical CompanyRobert Chapin, Pfizer

Rodger Curren, Institute for In Vitro SciencesSuzanne Fitzpatrick, US FDAJack Fowle, US EPAAlan Goldberg, JHU CAATThomas Hartung, JHU CAAT

Michael Holsapple, ILSI/HESIWendolyn Jones, CropLife AmericaRichard Judson, US EPAFran Kruszewski, American Cleaning InstituteMartin Stephens, Humane Society of the US

William Stokes, NIEHS, NIHRaymond Tice, National Toxicology ProgramMark Vossenar, Agilent Corp.Neil Wilcox, US FDAJoanne Zurlo, JHU CAAT

The EBTC Steering Committee (and their organizations2)

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CPCSEA National Conference, India Chennai, India, March 1-2, 2011

voiceless and work for the improvement and well-being of all animals.”

Mr. Anjani Kumar, Director (Animal Welfare) and Mem-ber Secretary of CPCSeA, outlined the role of CPCSeA. each institution or establishment dealing with experimental animals should have a CPCSeA-approved animal housing fa-cility. Maintenance should follow CPCSeA norms, and ani-mal care should be in accordance with the Breeding of and experimentation on Animals (Control and Supervision) Rules (1998). All experiments and the well-being of the experimen-tal animals should be monitored by Institutional Animal eth-ics Committees (IAeC), which shall have eight members, one of whom shall be a CPCSeA nominee. the Committee will scrutinize each research proposal carefully and approve it only if the experiment is absolutely necessary. the number of animals approved shall be the bare minimum required to satisfy the statistical analysis. Wherever called for, the ani-mal should be subjected to anesthesia/analgesia. effort must be put into rehabilitating animals after an experiment, and if the health condition of the animal does not allow this, the animal must be euthanized as permitted in CPCSeA norms. the CPCSeA nominee in the IAeC is empowered to visit the animal house facility at any time, even without giving prior notice, and inspect the facility with special reference to the well-being of the animals. Institutions that fail to fulfill these requirements will be severely dealt with, he said, and the ap-proval for animal experiments will be cancelled.

Speaking about “evolution of breeding and rules for ani-mal experimentation in India,” Dr. Vasantha Muthuswamy (Former Deputy Director General of Indian Council for Med-ical Research, New Delhi), Member of CPCSeA, referred to the “Prevention of Cruelty to Animals Act” of 1960, amended in 1982, which provides for the prevention of cruelty to ani-mals in general. Chapter 4 deals with experiments on animals. The CPCSEA, which was constituted to fulfill a requirement in this Act, issued the “Breeding of and experiments on Ani-mals (Control and Supervision) Rules, 1998,” and has updat-ed the rules regularly to safeguard the experimental animals, she said.

Dr. P. Balakrishna Murthy (Director, International Insti-tute for Biotechnology and toxicology), Member of CPC-SeA, emphasized good laboratory practice in animal research relevant for drug, chemical, and biotech product testing. Ac-cording to him, “adoption of GlP will reduce the role of the confounding factors that influence the validity of preclinical toxicity studies and, thus, provide ethically and humanely meaningful data to regulators to make candid decisions on risk assessment.”

Dr. Shiranee Pereira (Scientist, ICAR), Member of CPC-SeA, outlined the validated alternatives in regulatory test-

the third National Conference of the Committee for the Purpose of Control and Supervision of experiments on Ani-mals (CPCSeA) was held on March 1-2, 2011 at the Breeze Hotel, Chennai. CPCSeA is the statutory body that oversees the welfare of laboratory animals under the Animal Welfare Division of the Ministry of environment and Forests, Gov-ernment of India. the aim of the conference was to focus on the recent norms and guidelines of CPCSeA and to pro-vide a platform for CPCSeA representatives in institutions, universities and other members of the Institutional Animal ethics Committees (IAeC) to interact and share their views with CPCSeA national committee members. the conference was organized by Mr. Anjani Kumar (Member Secretary, CPCSeA), Dr. P. Balakrishna Murthy (Director, Interna-tional Institute of Biotechnology and toxicology, Padappai), Dr. Shiranee Pereira (Scientist, Indian Council of Agricultural Research (ICAR)), and Dr. K. Nachimuthu (expert Consult-ant, CPCSeA, Chennai).

Mr. M. F. Farooqui IAS, Additional Secretary and Chair-man of CPCSeA, introduced the objectives of the conference in his inaugural address, voicing his optimism that India will be one of the world’s major economies by 2050. towards this goal, India should invest in science and technology, including pharmacology, microbiology, and information technology. to match the other big economies of the world, India should endeavor to match the concern these countries exhibit – for animals in general and for experimental animals in particu-lar. Invoking the love for animals in the culture, ethos, and religious practices of India, and the sentiments expressed by Mahatma Gandhi about animals, Mr. Farooqui said India should be a leader in protecting experimental animals. While our ultimate goal should be to fully replace animal use in ex-periments, he stressed the need to be sensitive to the pain and suffering of experimental animals and to avoid this wherever possible. He also emphasized the need to end the use of ani-mals in education.

Dr. R. Prabakaran, Vice-Chancellor, tamil Nadu Veteri-nary and Animal Sciences University (tANUVAS), Chennai, spoke about the healing power of animals and the role pet ani-mals play in clinical therapies. He observed that loving and caring for animals relieves stress and tension. the tANU-VAS, he said, tries to motivate this love and care for animals by way of an online course on animal welfare.

At the inaugural session, all conference participants took the CPCSeA pledge, which reads as follows: “I pledge to pro-tect and improve the natural environment, including plants, lakes, rivers, and wild life and have compassion for all living creatures. I pledge to make a difference to the stray animals on the streets and work towards giving them the love and care they deserve. I refuse to abuse and I will be the voice of the

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animals in education, research, and testing in his talk on “Al-ternatives in education and in vitro toxicology.” He said “it is important that animal dissection be dropped from the cur-riculum and be replaced with exercises more relevant to the recent trends in the respective subjects – especially exercises that also provide prospective employment opportunities to the learners. In particular, ICt-based, user-friendly teaching de-vices with which one can learn anatomy, physiology, ecology, evolution, etc. more effectively should be prescribed in the curriculum to replace animal dissections,” he said. Adoption of the Up-and-Down method of the OeCD by India could greatly reduce the number of animals and the number of tests, he contends. In vitro and in silico approaches to chemical, pharmacological, and/or cosmetics testing and vaccinology not only would greatly reduce the use of animals but would supply more reliable and relevant information. In his opinion, “It is time for India to wake up in this respect and catch up with the international trend.

the real problem in India is that the regulatory authorities are varied and do not see eye to eye. For example, while the Wild life Protection Act prohibits capture of frogs of Rana species from the wild, the use of frogs in medical, veteri-nary, pharmacy, and science education is still enforced. It is time that a coordinated committee consisting of representa-tion from MCI, PCI, VCI, ICMR, CSIR, DBt, DSt, Central Drugs Standard Control Organization, CPCSeA, and similar regulatory authorities be formed. this subject must be seri-ously deliberated so as to evolve a comprehensive national policy. Development of new alternatives, particularly digital, in vitro, and in silico, should be encouraged and supported. India needs to organize a national authority to validate alter-native methods, in the manner of ICCVAM, eCVAM, JaC-VAM, and KoCVAM.”

According to Dr. Sashi Motilal (Associate Professor, Phi-losophy Department, Delhi University, Delhi), Member of CPCSeA, “the Object Model, which treats animals as mere objects of use and does not consider inhumane treatment as ethically wrong because the human species is considered a superior species, is to be rejected. the Rights Model, which ascribes rights to animals also is flawed, since it requires an-imals to be given the same moral status as humans, which is conceptually difficult to ascribe to them. The Respect for Nature Model, based on biocentrism, is the ethically correct model. this model relies on the principle of equal considera-tion of relevant interests of all concerned, according to which animals and humans have similar interests, such as avoidance of pain and suffering. This third model is a true reflection of the 3Rs concept.”

Dr. S. R. Srinivasan, Dean, Faculty of Science, Madras Veterinary College, Chennai, emphasized the need to integrate animal welfare into veterinary education. Dr. R. Raveen-dran, Professor of Pharmacology, Jawaharlal Institute of Post Graduate Medical education and Research, Pondicherry, in his address on “Alternatives to animals in pharmacological edu-cation,” supported the replacement of animal experiments in

ing. explaining the basic tenets of the 3R’s concept and the various practicable components of each R, she emphasized the need for validation of the various alternatives by compe-tent organizations and agencies such as eCVAM, ICCVAM, JacVAM, etc., prior to acceptance by regulatory authorities such as OeCD, ePA, european Pharmacopoeia, etc. She list-ed the various validated alternatives, most of which are full replacements, as well as others that replace vertebrates with less sentient animals. She emphasized that these alternatives must be practiced in laboratories in India engaged in contract testing for companies in the USA, the eU, and other parts of the world if they are to comply with the relevant laws. Using these alternatives in basic biomedical research as well could help save millions of animals.

Dr. Pereira gave a talk on “the concept of the 4th R – Reha-bilitation – Principles of the CPCSeA in the rehabilitation of large animals following experimentation.” She said this con-cept arose from the Gandhian philosophy of “Ahimsa” and, in spirit, is a continuation of the three R’s concept of Russell and Burch (1959). According to the CPCSeA guideline, “persons using experimental animals have a moral responsibility to the animals after their use, and investigators are responsible for the after-care and/or rehabilitation of animals post-experi-mentation.” thus, rehabilitation of experimental animals is a legal requirement in India today.

Addressing the topic “Role and responsibility of IAeCs,” Ms. Norma Alvarez, (Practicing Senior Counsel, High Court of Mumbai), Member of CPCSeA, elaborated upon the ra-tionale for having a CPCSeA nominee, a veterinarian, a so-cially aware person, and a scientist from outside the institute, in addition to four local members in an IAeC. this Commit-tee examines proposals for performing experiments on small animals and provides an independent, competent, and timely review of the ethics before commencement of a study. In ad-dition, it regularly monitors ongoing studies. experiments on larger animals are monitored directly by the CPCSeA. the respective committees consider i) purpose of the experiment and relevance; ii) use of animals of lesser sentience; iii) mini-mizing pain; iv) proper care of animals; and v) post-experi-mental care, with rehabilitation or euthanasia.

Dr. A. Jagannatha Rao (Ramanna Fellow, Indian Insti-tute of Science, Bangalore), Member of CPCSeA, spoke on the need for experiments with large animals and the need for welfare measures. the use of large animals such as monkeys, dogs, sheep, and cats is inevitable, he said, considering the regulatory requirements to be met before a drug is approved for human application. this makes it all the more important to insure strict adherence to welfare measures. Dr. K. Venkai-ah (Scientist, National Institute of Nutrition, Hyderabad), an-other member of CPCSeA, noted that proper design of the experiment and the most appropriate statistical treatment can greatly reduce animal use in regulatory and toxicity testing.

Prof. Mohammad A. Akbarsha, Gandhi-Gruber-Doer-enkamp Chair and Director Mahatma Gandhi Doerenkamp Center (MGDC), summarized issues arising from the use of

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the CPCSeA nominees of the IAeCs held a free session to discuss their experiences IAeC members. Most of the is-sues raised involved non-adherence or misinterpretation of the CPCSeA guidelines. It was emphasized that the CPCSeA nominees in IAeCs should be vigilant and strict but at the same time motivate the other members of the IAeCs to ad-here to the CPCeSeA guidelines, which require implementa-tion of the 4R’s (Reduce, Refine, Replace, and Rehabilitate).

the MGDC distributed complimentary copies of the abridged version of Russell and Burch’s “the Principles of Humane experimental techniques” (printed in India with kind courtesy of FRAMe, UK), a Pro Dissector Frog CD, and a copy of a recent issue of ALTEX to the CPCSEA officials, members, and the participants.

Mohammad A. Akbarsha, Mohammad Zeeshan (MGDC, India) and Shiranee Pereira (ICAR, India)

the pharmacology under-graduate curriculum with alternatives such as digital alternatives, simulation experiments, manne-quins, etc. He was apprehensive, however, about the introduc-tion of alternatives into the post-graduate pharmacology cur-riculum, since the candidates qualifying in this program may enter the pharmaceutical industry, where animal experiments are necessary for regulatory approval. He insisted that the al-ternatives for pharmacology education should be made afford-able and relevant to the special context of India.

According to Dr. S. Thilagar, Professor, Surgery, tANU-VAS, Chennai, while several countries have started using al-ternatives to animals for training and experiments, there is resistance to this in India, particularly from teachers – even though published reports show that the use of alternatives rather than animals results in better learning outcomes. He spoke of opportunities to replace animal use in surgical train-ing and veterinary studies. He suggested avoiding duplica-tion of animal experiments by establishing an open source research bank.

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