CPCSEA a guideline to stop cruelty on animals being used for pharmaceutical research and better development of drugs for human use.

1. Animal testing: rationale for conducting studies,
CPCSEA Guideline
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2. Animal testing
 Animal testing is use to help us understand diseases, for assessing the safety of a wide range of substances,
including medications, vaccine, food additives, household item, 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
 0.1% are primates
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3.  Animal experiment conduct all over the world.
 Universities and medical school
 Pharmaceutical and 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.
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4. Advantage 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.
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Disadvantages of animal testing
 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.

5. 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 requirement for pigs
Indonesia • Animal welfare legislation, 1967
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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 guideline for the useof animal for scientific purpose 1999

6. 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.
 Humans are 98% genetically similar to mice.
 Animals are susceptible to many of the same health problems as humans- cancer, diabetes ,heart disease, etc..
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 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.

7. 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.
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Research :
 A large 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

8. CPCSEA
(committee for the purpose of control and supervision of experiments on animals)
 The motto of prevention of cruelty to animal (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 animal(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.
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9. Goals
 The goal of this 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
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10. 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.
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 Conduct of training programmes for the nominees of CPCSEA.
 Conduct/support of conference/ workshop on animal ethics.
Requirement of form in CPCSEA supervision :

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Application for registration of breeder/ establishment/education institution (Form A)
Application for permission for animal experiments (Form b)
Record of animal 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)

12. 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.Aniaml disposal
7.documentation
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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

13. 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.
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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.

14. 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.
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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

15. 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.
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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

16. 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 fer away from human habitation 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 animal 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
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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 :
1.control of environmental factor
2.clean and tidy
3.pest control program
4.appropriate storage areas for food ,bedding and equipment.