Animal Testing: Rationale for conducting studies, CPCSEA Guidelines

Animal Testing: Rationale for conducting studies, CPCSEA Guidelines

The use of animals in research is currently an essential component of the drug discovery process.

Animals help us advance our scientific understanding, serve as models to study disease, help us develop and test potential new medicines and therapies.

Animal testing has benefited researchers in understanding how to treat and prevent various conditions such as high blood pressure, diabetes, tuberculosis, polio, muscular dystrophy, and Parkinson's disease.

Education:
Undergraduate teaching to demonstrate effects of various drugs although this has been phased out in most institutes.
Postgraduate teaching to demonstrate the effects of various drugs, to determine the nature of an unknown drug for bioassay, screening methods and to learn skills e.g. administering drugs. 

Research:
A larger number and a greater variety of animals are used in pure research than in applied research. This usually involves studies on embryogenesis, developmental biology, behaviour and breeding in Fruit flies, nematodes, mice and rats.

INTRODUCTION
The motto of Prevention of Cruelty to Animals (PCA) Act 1960 as amended in 1982 is to prevent infliction of unnecessary pain or suffering on animals.
The Central Government has constituted a Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), which is duty bound to take all such measures as may be necessary to ensure that animals are not subjected to unnecessary pain or suffering before, during or after the performance of experiments on them.

The goal of these guidelines is to promote the human care of animal used in biomedical and behavioural research and testing.
To avoid/minimize pain and suffering inflicted on experimental animals
Inspection of animal house facilities

It provides guidelines for -
Proper care, housing, breeding, maintenance, handling and use of experimental animals.
Source of experimental animals
Acceptable experimental procedures for anaesthesia and euthanasia.

Registration of establishments conducting animal experimentation or breeding of animals for this purpose.
Selection and assignment of nominees for the Institutional Animal Ethics Committees (IAEC) of the registered establishments.
Approval of Animal House Facilities on the basis of reports of inspections conducted by CPCSEA.

Permission for conducting experiments involving use of animals.
Recommendation for import of animals for use in experiments.
Action against establishments in case of established violation of any legal norm/stipulation.
Conduct of Training Programmes for the Nominees of CPCSEA.
Conduct/Support of Conference/Workshop on Animal Ethics.

To assure quality maintenance and safety of animals used in laboratory studies while conducting biomedical and behavioural research and testing of products.
Quarantine
2. Personal hygiene
3. Environment
4. Physical facility
5. Animal husbandry
6. Animal disposal
7. Documentation

1. Animal Testing: Rationale for conducting studies, CPCSEA Guidelines Presented by: Vanshika G upta 1 st sem M.Pharm (RA ) MRA104T Parul Institute Of Pharmacy Parul University 1

2. Content Animal testing Advantages & Disadvantages of Animal Testing Animal Welfare Initiatives In Selected Countries In Asia Rationale for conducting studies CPCSEA Guideline Maintenance of laboratory animals as per CPCSEA guidelines 2

3. Animal Testing Animal testing is use to help us understand diseases , for assessing the safety of a wide range of substances, including medications, vaccines, food additives, household items, workplace chemicals, cosmetics, water and air pollutants. About 10 million animals around the world are being tested every year . 84 % are Rodents 12 % are Fish, Amphibians, & Reptiles 2.1 % are Large Mammals 1.4 % are Small Mammals 0.3 % are Dogs & Cats and 0.1% are Primates 3

4. Cont... Animal experimentation is conducted all over the world. Universities and Medical Schools Pharmaceutical & Biotechnology companies Military Defence Establishments ( nuclear trials, military sonars ) The reason for animal experimentation is to tests substances and procedures to see if they are harmful or it would be safe for human use . Many of these experiments cause pain to the animals involved or reduce their quality of life in other ways. 4

5. Advantages of Animal Testing Can help to save many lives by curing the diseases. Understanding certain bacteria and viruses. Useful to treat future pandemics. Invention of new medicines, New vaccines. Can increase our overall life expectancy. Safety improvements for customers. 5

6. Disadvantages of Animal Experimentation Animals have to scarify for our research. May be considered to be cruel. Animal testing may not be acceptable regarding religious aspects. Animal testing can be expensive. May not be suitable to determine long-term effects. 6

7. Animal Welfare Initiatives In Selected Countries In Asia Country Animal Welfare Initiatives India Prevention of Cruelty to Animals Act, 1960 Institutional Animal Ethic Committee (IAEC) -Animal Welfare Board of India (AWBI) Committee for the Purpose of Supervision and Control of Experiments on Animals (CPCSEA) China The Animal Husbandry Law of People Republic of China (2006)  Farm Animal welfare requiremen t for pigs Indonesia Animal welfare legislation, 1967. 7

8. Cont... Philippines -Animal Welfare Act, 1998 South Korea -Korean Animal Welfare Advisory Committee Malaysia -The Malaysian Animal Welfare Act, 2016 -Prevention of Cruelty to Animals, 1910. Singapore -National Advisory Committee for Laboratory Animal Research (NACLAR)  Thailand -National Research Council of Thailand -Ethical Principles and Guidelines for the Use of Animals for Scientific Purposes 1999  8

9. Rationale for conducting studies The use of animals in research is currently an essential component of the drug discovery process . Animals help us advance our scientific understanding , serve as models to study disease , help us develop and test potential new medicines and therapies. Animal testing has benefited researchers in understanding how to treat and prevent various conditions such as high blood pressure, diabetes, tuberculosis, polio, muscular dystrophy, and Parkinson's disease. 9

10. Cont... Humans are 98% genetically similar to mice.  Animals are susceptible to many of the same health problems as humans – cancer, diabetes, heart disease , etc. Research on animal models has advanced the understanding and development of clinical and medical sciences.  For example, guinea pigs and frogs were heroes in the process of inventing asthma inhalers. Meningitis C cases are now rare, going down to 700 cases per year through the last decade. 10

11. Cont... Education: Undergraduate teaching to demonstrate effects of various drugs although this has been phased out in most institutes. Postgraduate teaching to demonstrate the effects of various drugs, to determine the nature of an unknown drug for bioassay, screening methods and to learn skills e.g. administering drugs.  11

12. Cont... Research: A larger number and a greater variety of animals are used in pure research than in applied research. This usually involves studies on embryogenesis, developmental biology , behaviour and breeding in Fruit flies, nematodes, mice and rats. i. Cosmetic testing ii. Toxicology testing 12

13. CPCSEA INTRODUCTION The motto of Prevention of Cruelty to Animals (PCA) Act 1960 as amended in 1982 is to prevent infliction of unnecessary pain or suffering on animals . The Central Government has constituted a Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), which is duty bound to take all such measures as may be necessary to ensure that animals are not subjected to unnecessary pain or suffering before, during or after the performance of experiments on them . 13

14. Goals The goal of these guidelines is to promote the human care of animal used in biomedical and behavioural research and testing. To avoid/minimize pain and suffering inflicted on experimental animals Inspection of animal house facilities It provides guidelines for - Proper care, housing, breeding, maintenance, handling and use of experimental animals. Source of experimental animals Acceptable experimental procedures for anaesthesia and euthanasia. 14

15. Functions of CPCSEA Registration of establishments conducting animal experimentation or breeding of animals for this purpose. Selection and assignment of nominees for the Institutional Animal Ethics Committees (IAEC) of the registered establishments. Approval of Animal House Facilities on the basis of reports of inspections conducted by CPCSEA. Permission for conducting experiments involving use of animals. Recommendation for import of animals for use in experiments. Action against establishments in case of established violation of any legal norm/stipulation. 15

16. Cont... Conduct of Training Programmes for the Nominees of CPCSEA. Conduct/Support of Conference/Workshop on Animal Ethics. Requirement of form in CPCSEA supervision 16 Application for registration of breeder/ establishment/ educational institution (Form A). Application for permission for animal experiments (Form B). Record of animals bred/acquired and record of animals acquired and experiments performed (Form C and D). Record of animals sold to the establishment by the traders (Form-E).

17. Maintenance of laboratory animals as per CPCSEA guidelines To assure quality maintenance and safety of animals used in laboratory studies while conducting biomedical and behavioural research and testing of products. Goal: To provide the specification that will enhance animal wellbeing, quality in the advancement of biological knowledge that is relevant to humans and animals. 1. Quarantine 2. Personal hygiene 3. Environment 4. Physical facility 5. Animal husbandry 6. Animal disposal 7. Documentation 17

18. Cont... 1. Veterinary Care: A mechanism of direct and frequent communication should be adopted so that timely and accurate information on problems in animal health, behaviour, and well being is conveyed to the attending veterinarian. Observed regularly for sign of illness, injury, or abnormal behaviour. Contagious disease - isolated from healthy animal. 18

19. Cont... 2. Animal Procurement: All must be acquired lawfully as per the CPCSEA guidelines.  Rodents can be imported from abroad after necessary licence from Director General of Foreign trade (DGFT) is obtained for import. A health surveillance program for screening incoming animals should be carried out before purchase to assess animal quality.  Each consignment of animals should be inspected for compliance with procurement specifications Animals  should  be   quarantined  and  stabilized  according  to procedures 19

20. Cont... 3. Quarantine, Stabilization And Separation: Quarantine is the separation of newly received animals from those already in the facility Duration at quarantine in small lab animals is from one week to one month and large animals allowed up to 6 weeks. Physical separation of animals by species is recommended to prevent interspecies disease transmission  20

21. Cont... 4. Surveillance, Diagnosis, Treatment and Control of Disease: All animals should be observed for signs of illness, injury, or abnormal behaviour by animal house staff.  Post-mortem examination and signs of illness, distress, or other deviations from normal health condition should be reported promptly. Laboratory services should include necropsy, histopathology, microbiology, clinical pathology, serology, and parasitological as well as other routine or specialized laboratory procedures 21

22. Cont... 5. Animal Care and Technical Personnel: Animal care programs require technical and husbandry support.  People trained in laboratory animal science or provide for both formal and on-the- job training  6. Personal Hygiene: Clothing suitable for use in the animal facility  Personnel should not be permitted to eat , drink, smoke or apply cosmetics and perfumes in animal rooms.  It is acceptable to use disposable gloves, masks, head covers, coats, coveralls and shoe covers 22

23. Cont... 7. Animal Experimentation Involving Hazardous Agents: Institutions should have policies governing experimentation with hazardous agents. Since the use of animals in such studies requires special considerations, the procedures and the facilities to be used must be reviewed by both the Institutional Bio-safety committee and Institutional Animal Ethics Committee (IAEC).   8. Multiple Surgical Procedures On Single Animal: Multiple surgical procedures on a single animal for any testing or experiment are not to be practiced. Individual animals should not be used in more than one experiment. 23

24. Cont... 9. Durations of Experiments: No animal should be used for experimentation for more than 3 years unless adequate justification is provided. 10. Physical Restraint: Prolonged restraint of any animal, including the chairing of non-human primates, should be avoided unless essential to the research objectives. Animals should be handled by competent individuals trained in methods that cause minimal distress and injury Restraint devices cannot be used simply as a convenience in handling or managing animals Provision should be made for observation of the animal at appropriate intervals. 24

25. Cont... 11. Location Of Animal Facilities To Laboratories: Physical separation of animal facilities from personnel areas such as offices, break room, training and education room. It is important that they shall be housed in an isolated building located as far away from human habitations as possible and not exposed to dust, smoke, noise, wild rodents, insects and birds. 12. Functional Areas: Animal housing facilities that are small, maintain few animals or maintain animals under special conditions. Equipment, if hazardous biological, physical, or chemical agents are to be used Receiving and storage areas for food, bedding 25

26. Cont... 13. Physical Facilities The design and size of an animal facility depend on the scope of institutional research activities, animals to be housed, physical relationship to the rest of the institution, and geographic location. Housing facility should be: Designed and operated to facilitate control of environmental factors Kept clean and tidy and operated to achieve maximum possible hygiene. Pest control programme to monitor and control vermin. Adequate and appropriate storage areas for food, bedding and equipment . 26

27. References National Research Council (US) Committee to Update Science, Medicine, and Animals. Science, Medicine, and Animals. Washington (DC): National Academies Press (US); 2004. Safety Testing. Available from: https:// www.ncbi.nlm.nih.gov/books/NBK24645 Guidelines for Research Ethics in Science and Technology.  Jahrbuch für Wissenschaft und Ethik . 2017;22(1): 439-456.  Nizamuddin Q, Rahman SA. Animal Welfare in Asia: Specific Flaws and Strengths, Future Trends and Objectives CPCSEA guidelines for laboratory animal facility, Indian Journal of Pharmacology 2003;35:257-274. https://www.cvsccauaizawl.edu.in/sites/default/files/files/iaec/cpcsea_laboratory.pdf 27

28. Cont... https://www.fondation-droit-animal.org/proceedings-aw/animal-welfare-in-asia/ https://www.bbc.co.uk/ethics/animals/using/experiments_1.shtml https://environmental-conscience.com/animal-testing-pros-cons / https://doi.org/10.1515/jwiet-2017-0021 https://www.slideshare.net/sau214/standard-operating-procedure-for-animal-house https://blog.biobide.com/benefits-of-animal-testing-how-ethical-testing-aids-research 28

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