2. Contents:
• INTRODUCTION
• OBJECTIVES
• CPCSEA GUIDELINES FOR LABORATORY ANIMAL FACILITY
1. VETERINARY CARE
2. ANIMAL PROCUREMENT
3. QURANTINE , STABILIZATION , SEPARATION
4. TRANSPORT OF ANIMAL
5. SURVEILLANCE, DIAGNOSIS, TREATMENT AND CONTROL OF DISEASE
6. LABORATORY ANIMAL HUSBANDARY & MANGE MENT
7. ANIMAL EXPERIMENTS INVOLVING HAZARDOUS AGENTSS
3. Contents:
8. LOCATION OF ANIMAL FACILITIES TO LABORATORIES
9. FUNCTIONAL AREA REQUIREMENTS OF ANIMAL FACILITY
10. RECORD KEEPING
11. STANDARD OPERATING PROCEDURE GUIDELINES
12. ANAESTHESIA
13. EUTHANASIA
14. DISPOSAL
4. WHY ANIMALS ARE USED IN
RESEARCH?
To understand the principles of anatomy and
physiology which are true for all mammals.
Certain strains or breeds of animals get the
same disease or conditions as humans.
It is possible to control environment
(temperature, humidity etc) of animals and
shield them from disease or condition not
related to the research (control their health).
We can scientifically study physiology and
diseases by using valid no of animals.
5. What is CPCSEA?
The Committee for the Purpose of
Control and Supervision of Experiments
on Animals (CPCSEA) is a statutory
body formed by the Act of the Indian
Parliament under the Prevention of
Cruelty to Animals Act 1960.
6. Objectives of CPCSEA
1. The goal of these guidelines is to promote the human care of animal used in
biomedical and behavioural research and testing.
2. To avoid unnecessary pain before ,during and after experiment .
3. To provide guidelines for
a. housing, care, breeding and maintenance
b. source of experimental animals
c. acceptable experimental procedures for anesthesia and euthanasia
7. Functions Of CPCSEA
1. Registration of establishments conducting animal experimentation or breeding of
animals for this purpose.
2. Selection and appointment of nominees in the Institutional Animal Ethics
Committees of registered establishments.
3. Approval of Animal House Facilities on the basis of reports of inspections
conducted by CPCSEA.
4. Permission for conducting experiments involving use of animals.
5. Recommendation for import of animals for use in experiments.
6. Action against establishments in case of violation of any legal norm/stipulation.
8. 1. Adequate veterinary care must be provided and is the responsibility of a
veterinarian or a person who has training or experience 'in laboratory animal
sciences and medicine.
2. Daily observation of animals can be accomplished by someone other than a
veterinarian
- Animal must be observed regularly for sign of illness, injury, or abnormal behaviour.
- Any anomalies must be reported to veterinarian.
- In case of Contagious disease –animal must be isolated from healthy animal.
1. The veterinarian can also contribute to reviewing protocols and proposals.
Veterinary Care
9. All animals must be acquired lawfully as per the CPCSEA guidelines.
A health surveillance program for screening incoming animals should be carried
out to assess animal quality.
Each consignment of animals should be inspected for compliance with
procurement specifications, and the animals should be quarantined and
stabilized according to procedures appropriate for the species and
circumstances.
Animal Procurement
10. Quarantine is the separation of newly received animals from those already in the
facility until the health and possibly the microbial status of the newly received
animals have been determined.
An effective quarantine minimizes the chance for introduction of pathogens into
an established colony.
The duration at quarantine in small lab animals from one week to one month and
large animals allowed up to 6 weeks (cat, dog, monkey, etc.)
For non-human primates the period varies from 2 to 3 months depending on the
reaction of TB testing.
Quarantine, Stabilization and
Separation
11. Physical separation of animals by species is recommended to prevent
interspecies disease transmission and to eliminate anxiety and possible
physiological and behavioral changes due to interspecies conflict.
Different species should ideally be housed in different rooms; however, cubicles,
laminar-flow units, cages that have filtered air or separate ventilation, and
isolators shall be suitable alternatives.
Exception: If two species have a similar pathogen status and are behaviorally
compatible, then they can be housed in same room.
Separate set of personnel are required for handling different species.
Quarantine, Stabilization and
Separation
12. The main considerations for transport of animals are, the mode of transport, the
containers, the animal density in cages, food and water during transit, protection
from transit infections, injuries and stress.
Methods of transportation has been provided in Annexure - 4.
Transport of Animals
13.
14. All animals should be observed for signs of illness, injury, or abnormal behaviour.
Unexpected deaths and signs of illness should be reported; Postmortem
examination should be reported for timely delivery of veterinary medical care.
If animals are known to be exposed to an infectious agent the group should be kept
intact and isolated during the process of diagnosis, treatment, and control.
Diagnostic clinical laboratory may be made available.
Appropriate methods for disease surveillance and diagnosis has been provided in
Annexure 1 & 2.
Surveillance, Diagnosis, Treatment and Control
of Disease
15.
16.
17. All animals should be observed for signs of illness, injury, or abnormal behaviour.
Unexpected deaths and signs of illness should be reported; Postmortem
examination should be reported for timely delivery of veterinary medical care.
If animals are known to be exposed to an infectious agent the group should be kept
intact and isolated during the process of diagnosis, treatment, and control.
Diagnostic clinical laboratory may be made available.
Appropriate methods for disease surveillance and diagnosis has been provided in
Annexure 1 & 2.
Laboratory Animal Husbandry and
Management
18. FOOD AND WATERFOOD AND WATER
Animals should be fed palatable, non-contaminated and nutritionally
adequate food.
Diet should be free from heavy metals (e.g., Lead, Arsenic, Cadmium,
Nickel, Mercury).
Ordinarily animals should have continuous access to fresh, potable,
uncontaminated drinking water, according to their particular requirements.
Water should be replaced everyday.
Laboratory Animal Husbandry and
Management
19. BEDDINGBEDDING
Bedding should be absorbent, free of toxic chemicals or other substances
that could injure animals or personnel, and of a type not readily eaten by
animals.
Bedding should be removed and replaced with fresh materials as often as
necessary to keep the animals clean and dry.
Laboratory Animal Husbandry and
Management
20. ANIMAL CARE AND TECHNICAL PERSONNELANIMAL CARE AND TECHNICAL PERSONNEL
Animal care programs require technical and husbandry support. Institutions should
employ people trained in laboratory animal science to ensure effective implementation of
the program.
Institutions should employ people trained in laboratory animal science or provide for
both formal and on-the-job training to ensure effective implementation of the program
( as in Annexure 7)
Laboratory Animal Husbandry and
Management
21.
22. SANITATION AND CLEANLINESSSANITATION AND CLEANLINESS
Animal rooms, corridors, storage spaces and other areas should be
cleaned with appropriate detergents and disinfectants.
Where animal waste is removed by hosing or flushing, this should
be done at least twice a day.
For larger animals, such as dogs, cats, and non - human primates,
soiled litter material should be removed twice daily.
Laboratory Animal Husbandry and
Management
23. SANITATION AND CLEANLINESSSANITATION AND CLEANLINESS
Wire - bottom cages other than rodent cages should be washed at least
every 2 weeks.
Cages can be disinfected by rinsing at a temperature of 82.2C (180oF)
or higher for a period long enough to ensure the destruction of
vegetative pathogenic organisms
Laboratory Animal Husbandry and
Management
24. SANITATION AND CLEANLINESSSANITATION AND CLEANLINESS
Water bottles, sipper nozzles stoppers, and other watering equipment should be washed and
then sanitized by rinsing with water of at least 82.2o
C (180o
F) or appropriated chemicals agents
(e.g. Sodium Hyperchlorite) to destroy pathogenic organisms.
If bottles are washed by hand, mechanized brushes at the washing sink are useful, and
provision should be made for dipping or soaking the water bottles in detergents and
disinfectant solutions: A two – compartment sink or tub is adequate for this purpose
Laboratory Animal Husbandry and
Management
25. SANITATION AND CLEANLINESSSANITATION AND CLEANLINESS
Some means for sterilizing equipments and supplies, such as an autoclave or gas sterilizer, is
essential when pathogenic organisms are present.
Routine sterilization of cages, feed and bedding is also essential besides care is taken to use
clean materials from reliable sources.
Deodoriants or chemical agents other than germicidal agents should not be used to mask
animal odors. Such products are not a substitute for good sanitation
Laboratory Animal Husbandry and
Management
26. DURATIONS OF EXPERIMENTSDURATIONS OF EXPERIMENTS
No animal should be used for
experimentation for more than 3 years unless
adequate justification is provided.
Laboratory Animal Husbandry and
Management
27. PERSONAL HYGIENEPERSONAL HYGIENE
It is essential for the animal care staff to maintain high standard of personal cleanliness.
Facilities and supplies for meeting this obligation should be provided e.g. showers, change of
uniforms, footwear etc.
Clothing suitable for use in the animal facility should be supplied and laundered by the
institution: A commercial laundering service is advised.
Use disposable gloves, masks, head covers, coats, coveralls and shoe covers is recommended.
Laboratory Animal Husbandry and
Management
28. PERSONAL HYGIENEPERSONAL HYGIENE
Personnel should not be permitted to eat, drink, smoke or apply cosmetics and perfumes in
animal rooms.
Personnel should be provided space to sit some where else out side and not in the animal
rooms / areas., once the work is finished.
Laboratory Animal Husbandry and
Management
29. Laboratory Animal Husbandry and
Management
CAGING & HOUSING SYSTEMCAGING & HOUSING SYSTEM
Adequate ventilation
Meet the biological need of animal
Keep the animal dry and clean
Cages made of steel or painted steel
Feeding and watering devices should be easily accessible for filing, changing,
cleaning and servicing.
Polypropylene, polycarbonate and stainless steel cages should be used to house
small lab animals
Monkeys should be housed in cages made of steel or painted mild steel
(Annexure 3)
30. Laboratory Animal Husbandry and
Management
CAGING & HOUSING SYSTEMCAGING & HOUSING SYSTEM
Cages should have smooth, impervious surfaces that neither attract
nor retain dirt and a minimum number of ledges, angles, and corners in
which dirt or water can accumulate.
The design should allow inspection of cage occupants without
disturbing them.
Cages, runs and pens must be kept in good condition to prevent
injuries to animals, promote physical comfort, and facilitate sanitation
and servicing. Particular attention must be given to eliminate sharp
edges and broken wires, keeping cage floors in good condition.
31. RESTRAINTRESTRAINT
Devices required for holding animals for examination and collection
of samples should be made available to minimize stress.
WASTE DISPOSALWASTE DISPOSAL
Wastes should be removed regularly and frequently. All waste should
be collected and disposed in a -safe and sanitary manner. The most
preferred method of waste disposal is incineration.
Cold storage might be necessary to prevent decomposition of
biological wastes
Laboratory Animal Husbandry and
Management
32. EMERGENCY, WEEKEND AND HOLIDAY CAREEMERGENCY, WEEKEND AND HOLIDAY CARE
Animal should be cared for by qualified personnel every day, including
weekends and holidays, to safeguards their well- being including
emergency veterinary care.
Laboratory Animal Husbandry and
Management
33. Institutions should have policies governing experimentation with hazardous agents.
A separate Institutional Bio-safety Committee has to be constituted for this purpose (as in
Annexure 8)
Such experiments will require approval from both Institutional Animal Ethics Committee
(IAEC) as well as Institutional Bio-safety committee.
Animal Experimentation Involving
Hazardous Agents
34.
35.
36. Animal house should be located in an isolated building far away from human habitations as
possible and not exposed to dust, smoke, noise, wild rodents, insects and birds.
However animal housing should be in areas adjacent to or near laboratories, but separated
from them by barriers such as entry locks, corridors, or floors.
The space of animal facility should be well divided for various activities.
1. The animal rooms should occupy about 50-60% of the total constructed area.
Location of Animal Facilities to
Laboratories
37. The space of animal facility should be well divided for various activities.
2. Remaining 40-50% area should be utilized for services such as stores, washing, office and
staff, machine rooms, quarantine and corridors.
3. Since animals are very sensitive to environmental changes, sharp fluctuations in temperature,
humidity, light, sound and ventilation should be avoided.
4. The recommended space requirements for animal rooms, for different species are given in
Annexure 3.
Location of Animal Facilities to
Laboratories
38.
39.
40. 1. Specialized laboratories or Individual areas contiguous with or near animal housing areas
for such activities as surgery, intensive care, necropsy, radiography, preparation of special
diets, experimental manipulation, treatment, and diagnostic laboratory procedures
containment facilities
2. Equipment, if hazardous biological, physical, or chemical agents are to be used
3. Receiving and storage areas for food, bedding
4. Pharmaceuticals and biologics, and supplies
Functional Area Requirements of
Animal Facility
41. 5. Space for administration, supervision, and direction of the facility
6. Showers, sinks, lockers and toilets for personnel
7. An area for washing and sterilization equipment and supplies
8. An autoclave for equipment
9. Food, and bedding; and separate areas
10. For holding soiled and cleaned equipment
Functional Area Requirements of
Animal Facility
42. 11. An area for repairing cages and equipment
12. An area to store wastes prior to incineration or removal
Functional Area Requirements of
Animal Facility
43. 1) Building material
2) Corridor
3) Utilities
4) Animal room doors
5) Exterior Windows
6) Floors
7) Drains
8) Walls and Ceilings
Functional Area Requirements of
Animal Facility
9) Storage areas
10)Facilities for Sanitizing equipment
and supplies
11)Experimental area
12)Environment
13)Animal Husbandry (discussed
previously)
44. Functional Area Requirements of
Animal Facility
BUILDING MATERIALBUILDING MATERIAL
Should be selected to facilitate efficient and hygienic operation of animal
facilities.
Durable, moisture-proof, fire-resistant, seamless materials are most
desirable for interior surfaces including vermin and pest resistance.
CORRIDORCORRIDOR
should be wide enough to facilitate the movement of personnel as well as
equipments and should be kept clean
45. Functional Area Requirements of
Animal Facility
UTILITIESUTILITIES
Such as water lines, drain pipes, and electrical connections should preferably be
accessible through service panels or shafts in corridors outside the animal rooms
ANIMAL ROOM DOORSANIMAL ROOM DOORS
Doors should not be rust, vermin and dust proof.
They should fit properly within their frames and provided with an observation
window.
Door closures may also be provided.
Rodent barriers can be provided in the doors of the small animal facilities.
46. Functional Area Requirements of
Animal Facility
EXTERIOR WINDOWSEXTERIOR WINDOWS
Windows are not recommended for small animal facilities.
However, where power failures are frequent and backup power is not
available, they may be necessary to provide alternate source of light and
ventilation.
In primate rooms, windows can be provided.
47. Functional Area Requirements of
Animal Facility
FLOORSFLOORS
Floors should be either monolithic or epoxy smooth, moisture proof,
nonabsorbent, skid-proof, resistant to wear, acid, solvents, adverse effects of
detergents and disinfectants.
They should be capable of supporting racks, equipment, and stored items
without becoming gouged, cracked, or pitted, with minimum number of
joints
A continuous moisture-proof membrane might be needed. If sills are
installed at the entrance to a room, they should be designed to allow for
convenient passage of equipment
48. Functional Area Requirements of
Animal Facility
DRAINSDRAINS
Floor drains are not essential in all rooms used exclusively for housing
rodents.
Floor should be vacuumed or mopped with appropriate disinfectants or
cleaning compounds.
In case floor drains are used, the floors should be sloped and drain taps
kept filled with water or corrosion free mesh.
At the inlet and outlets of the drains should be fitted with wire mesh guard
to prevent wild rodent entry
49. Functional Area Requirements of
Animal Facility
WALLS AND CEILINGSWALLS AND CEILINGS
Walls should be free of cracks, unsealed utility penetrations, or imperfect junctions
with doors, ceilings, floors and corners.
Surface materials should be capable of withstanding scrubbing with detergents,
disinfectants and the impact of water under high pressure.
STORAGE AREASSTORAGE AREAS
Separate storage areas should be designed for feed, bedding, cages and materials
not in use.
Refrigerated storage, separated from other cold storage, is essential for storage of
dead animals and animal tissue waste.
50. Functional Area Requirements of
Animal Facility
FACILITIES FOR SANITIZING EQUIPMENT AND SUPPLIESFACILITIES FOR SANITIZING EQUIPMENT AND SUPPLIES
Should be additionally provided.
EXPERIMENTAL AREAEXPERIMENTAL AREA
Should be away from the place where animals are housed.
Aseptic surgery for large animals should include: preparation area, the
operating theatre room or rooms, and an area for post operative & intensive
care and for treatment of animals.
51. Functional Area Requirements of
Animal Facility
ENVIRONMENTENVIRONMENT
a.Temperature and humidity control:
Temperature should be within or approximately between 18 to 29°C (64.4 to 84.2oF)
all times.
The relative humidity should be under control within the range of 30% to 70%
throughout the year.
For larger animals a comfortable zone (18 to 37°C) should be maintained.
During extreme summer appropriate methods e.g. sprinklers should be adopted for
cooling.
52. Functional Area Requirements of
Animal Facility
ENVIRONMENTENVIRONMENT
b.Ventillation:
Heating, ventilation, and air-conditioning systems should be designed with 12-15 air
cycles per hour so that operation can be continued with a standby system.
The animal facility and human occupancy areas should be ventilated separately.
c.Power and Lighting:
Fluorescent lights are efficient and less than 400 lux is preferable for rodent facilities.
A time-controlled lighting system should be used to ensure a regular diurnal lighting
cycle wherever required.
Emergency power should be available in the event of power failure
53. Functional Area Requirements of
Animal Facility
ENVIRONMENTENVIRONMENT
d.Noise Control:
Preferably less than 85 dB is desirable for rodents and non human primates.
54. Record Keeping
Following records must be maintained:Following records must be maintained:
1.Animal House plans, which includes typical floor plan, all fixtures etc.
2.Animal House staff record - both technical and non - technical
3.Health record of staff and animals
4.All SOPs relevant to experiments, care, breeding and management of animals
5.Breeding, stock, purchase and sales records
6.Minutes of institutional Animals Ethics Committee Meetings
7.Records of experiments conducted with the number of animals used (copy of
Form D)
55. Record Keeping
Following records must be maintained:Following records must be maintained:
8.Mortality, Postmortem Record
9.Clinical record of sick animals
10.Training record of staff involved in animal activities
11.Water, feed and bedding materials analysis report
12.Health monitoring Records
13.Rehabilitation Records.
56. Standard Operating Procedure
Guidelines
SOP’s should contain following items:SOP’s should contain following items:
1.Name of the Author
2.Title of the SOP
3.Date of approval
4.Reference of previous SOP on the same subject and date (Issue no and Date)
5.Location and distribution of SOP’s with sign of each recipient
6.Objectives
7.Detailed information of the instruments used in relation with animals with
methodology (Model no., Serial no., Date of commissioning, etc)
57. Standard Operating Procedure
Guidelines
SOP’s should contain following items:SOP’s should contain following items:
8.The name of the manufacturer of the reagents and the methodology of the
analysis pertaining to animals
9.Normal value of all parameters
10.Hazard identification and risk assessment
58. Anaesthesia
The scientists should ensure that the procedures, which are
considered painful, are conducted under appropriate
anaesthesia as recommended for each species of animals.
It must also be ensured that the anaesthesia is given for the
full duration of experiment and at no stage the animal is
conscious to perceive pain during the experiment.
Sedatives, analgesics and anaesthetics should be used to
control pain or distress under experiment (Annexure 5)
60. Anaesthesia
Before use of actual anaesthetics, the animal should be prepared for anaesthesia by over
night fasting and using pre-anaesthetics.
Local or general anaesthetics may be used depending on type of surgical procedure.
Local anaesthetics are used to block the nerve supply to a limited area and should be
used only for minor and rapid procedures.
For major surgical procedures, a number of General anaesthetic agents are used in the
form of inhalants, intravenous or intramuscular injections such as barbiturates.
The animal should remain under veterinary care till it completely recovers from
anaesthesia.
61.
62. Euthanasia
In the event of a decision to sacrifice an
animal on termination of an experiment or
otherwise, an approved method of
euthanasia should be adopted.
The procedure should be carried out
quickly and painlessly in an atmosphere
free from fear or anxiety.
63. Euthanasia
In the event of a decision to sacrifice an animal on termination of an
experiment or otherwise, an approved method of euthanasia should be
adopted (Annexure 6).
The investigator must ensure that the animal is clinically dead before it is
sent for disposal.
The data of all the animals, that have been euthanised, should be
maintained.
64. Euthanasia
Methods used for euthanasia should meet following requirements:
• Death, without causing anxiety, pain or distress with minimum time lag phase.
• Minimum physiological and psychological disturbances.
• Compatibility with the purpose of study and minimum emotional effect on the
operator.
• Location should be separate from animal rooms and free from environmental
contaminants.
65.
66. Disposal
The transgenic and knockout animals should be first euthanized and
then disposed off as prescribed elsewhere in the guidelines.
A record of disposal and the manner of disposal should be kept as a
matter of routine.
68. Main Activities of CPCSEA
1. Registration of establishments for Breeding of animals
2. Registration of establishments for experiments on animals
3. Approval of Animal House Facilities
4. Permission of Committee for Conducting Experiments
5. Recommendation for import
69. Regulatory Mechanism of
CPCSEA
2.1 Committee for the Purpose of Control and Supervision of
Experiments on Animals (CPCSEA)
To ensure that animals are not subjected to unnecessary pain or
suffering before, during or after performance of experiments on
them.
70. Regulatory Mechanism of
CPCSEA
2.2 Sub-Committees of the CPCSEA
1) Sub-Committee on Large Animals (SCLA).
2) Sub-Committee for selection of CPCSEA Nominees on
Institutional Animals Ethics Committees.
71. Regulatory Mechanism of
CPCSEA
2.3 Institutional Animal Ethics Committee (IAEC): made up of
1.A Biological Scientist
•Two Scientists from different biological disciplines
•A veterinarian involved in the care of animals
•A scientist in charge of animals facility of the establishment concerned
•A scientist from outside the institute
•A non-scientific socially aware member and
•A representative or nominee of the CPCSEA
•A specialist may be co-opted while reviewing special projects using hazardous
agents such as radio-active substance and deadly micro organisms
72. Key Role of IAEC
To assess whether:
1.The use of animals is justified.
2.The welfare of animal is protected.
3.The benefits from animal experiment outweigh the potential costs to the
animals.
4.To ensure the four R’s of animal use is justified
i. I R: Replacement: methods which avoid or replace the use of animals in research.
ii. II R: Reduction: use of methods that enable the researchers to obtain comparable levels of
information from fewer animals.
73. Key Role of IAEC
To assess whether:
4.To ensure the four R’s of animal use is justified
iii. IIIR: Refinement: use of methods that alleviate or minimize the potential pain, suffering or
distress, and enhance animal welfare for the animals used.
iv. IVR: Reuse and rehabilitation: is the aftercare rendered to animals that have been
Bred for the purpose of experimentation
Subject to any form of experimentation
Retained in the laboratory animal houses or breeding houses for he purpose of
experimentation, both for education and research, with the sole intention of alleviating
the pain/ distress or suffering due to physical, physiological or psychological trauma that
the animals have been exposed to and to provide the animal, a life distinctly different
from laboratory housing and care, until a point of natural death.
74. Regulatory Mechanism of
CPCSEA
2.4 Member Secretary (CPCSEA): made up of
Member Secretary, is responsible for registration of establishment engaged in
Breeding of Animals and also in Experimentation on Animals.
Application for permission for conducting experiments are brought before the
CPCSEA and SCLA by MS.
He has also been authorized to constitute the Inspection Teams for inspection
of Animal House Facilities.
75. Standing Time Tables of the
Regulator / Expert Body
Committees Days
CPCSEA Quarterly as on 20thDec, 20th March, 20th
June, 20th Sep
SCLA 10thof every alternate month
IAEC Varies as per need
Sub-Committee for selection of CPCSEA
Nominees on IAEC
Once in 6 months (Jan/July)
Member Secretary, CPCSEA No requirement of time table
Note: Special meetings of above regulatory bodies may be conducted in emergent
situations and to clear backlog, with approval of the Chair.
76. Nomination of Co-chair/Vice chair of the
regulator/expert body for presiding over the
meeting in the absence of the chair
1. CPCSEA:
JS or an equivalent in charge of Animal Welfare as Vice-Chair of the
Committee.
In the absence of JS or equivalent, the members present could nominate any
member from amongst themselves to preside over proceedings of a meeting.
2. SCLA:
The CPCSEA could make following provision in absence of the Chair:
The members present could nominate any member from amongst themselves
to preside over proceedings of a meeting.
77. Ground Rules
1. Registration of establishment for Breeding of animals & for experiments
of animals:
The Member-Secretary would take a decision on any application for Registration within two
months of its receipt.
In case the application can not be decided within two months, it will be brought to the notice of
CPCSEA at its ensuing meeting.
i.The application should be accompanied by a bank draft of Rs.1,000/- in favor of CPCSEA as
registration fee.
ii.The establishment should have constituted an IAEC before applying for registration.
iii.Before taking the decision regarding Registration, a spot inspection of the organization would
be necessary.
78. Ground Rules
2. Approval of Animal House Facilities:
Will involve detailed inspection by a Inspection team.
Structure of Inspection team is as follows:
i.CPCSEA’s Nominee
ii.Expert Consultant, CPCSEA
iii.Person in charge of another animal house in the same state, where the
institution carrying out experiment is located.
79. Ground Rules
3. Permission of Committee for Conducting Experiments:
1.No proposal for Animal Experimentation would be entertained, unless the
Animal House Facility of the concerned establishment has been approved by
competent authority.
2.The approval for experimentation on small animals will be accorded by IAEC.
3.Approval for experimentation on Large Animals will be considered by SCLA on
the recommendation of IAEC.
80. Ground Rules
3. Permission of Committee for Conducting Experiments:
4.The decision in the IAEC would normally be taken by consensus.
If divergent views are expressed by the members these may be recorded in the minutes and a
broad consensus be recorded as per understanding of the Chair.
However, in case of dissent by the CPCSEA nominee, the proposal with the report of IAEC
and the dissenting note of the CPCSEA nominee, would be submitted to SCLA for taking a
final decision
5.The decision in the SCLA would be taken by consensus. If divergent views are
expressed by the members, these may be recorded in the minutes and a broad
consensus be recorded as per understanding of the Chair.
81. Principles of Utilization and Care of Animals to
be Used in Testing, Research and Training
1. Principal No1: Experiments on animals” (including experiments
involving operations on animals) may be carried out for:
1.The purposes of advancement by new discovery
2.Knowledge which is expected to be useful for saving or for prolonging
human life or alleviating suffering
3.For combating any disease, whether of human beings, animals or
plants
82. Principles of Utilization and Care of Animals to
be Used in Testing, Research and Training
2. Principal No2:
1.Animals lowest on the phylogenetic scale which may give scientifically valid
results should be used for any experimental procedure.
2.Experiments should be designed with the minimum number of animals to give
statistically valid results at 95% level of confidence.
3.Alternatives not involving animal testing should be given due and full
consideration and sound justification provided if alternatives, when available, are
not used.
83. Principles of Utilization and Care of Animals to
be Used in Testing, Research and Training
2. Principal No2:
“Cockroach“ (Invertebrates) < Birds < Rodents < Canines <
Bovine/Equines <Primates (e.g. Rhesus macaque)< More evolved
Primates (e.g. chimpanzee)
84. Principles of Utilization and Care of Animals to
be Used in Testing, Research and Training
3. Principal No3:
1.Proper use of animals in experiments and avoidance or minimization of
pain and suffering inflicted on experimental animals should be an issue of
priority for research personnel.
2.All scientific procedures that may cause more than momentary or slight
pain and/or suffering should be performed with appropriate sedation,
analgesia or anesthesia
85. Principles of Utilization and Care of Animals to
be Used in Testing, Research and Training
4. Principal No4:
1.Persons engaged in animal experimentation have a moral responsibility
for the welfare of the animals after their use in experiments.
5. Principal No5:
1.The living conditions of animals should be appropriate for their species
and contribute to their health and comfort.
86. References
• http://icmr.nic.in/animal_ethics.htm
• cpcsea.nic.in
• http://www.elearnvet.net/moodle/file.php/79/PDF_Files/opg_CPCSEA.pdf
• http://www.pci.nic.in/CollegesCourses/AnimalWelfareAnnouncement.pdf
• www.aaalac.org/resources/SOP
• http://www.iisermohali.ac.in/AnimalHouse/CPCSEA.pdf
• Google.com: Operational Guidelines for Observance of Good Practices in
CPCSEA