CPCSEA Guidelines

CPCSEA GUIDELINES TO CONDUCT
EXPERIMENTS ON ANIMALS
Presented by:- Lingaraj .V. Anawal
M.Pharm
Department of Pharmacology
H.S.K College of Pharmacy bgk
1

CONTENTS
• COMMAN LABORATARY ANIMALS
• WHAT IS CPCSEA?
• FUNCTION OF CPCSEA
• IAEC
• COMPOSITION AND FUNCTION OF IAEC
• GLP
• GOAL
• GUIDELINES
• CONCLUSION
• REFERENCE
2

COMMAN LABORATORY ANIMALS
• MICE (Mus musculus)
 Life span:- 1-3 years
 Weight :- male=20-30 gms
female=18-35gms
 Birth weight:- 1-2 gms
 Heart rate:- 310-840 beats/min
 Respiratory rate:- 80-230breaths/min
 Body temperature:- 36.5-38⁰C
 Blood volume:- 1.5-2.5ml(58.5ml/kg)
 Allergens:- Dander, Urinary Protein
3

• RABBIT
(0ryctolgaus cuniculus)
 Life span:- 8-12 years
 Weight :- 1.2-2 kg
 Respiratory rate:- 30-60 breaths/min
 Body temperature:- 38.5-40⁰C
 Blood volume:- 57-65ml/kg
4

• RAT (Rattus norvegicus)
 Life span:- 2.5-3.5 years
 Weight :- male=300-500 gms
female=250-300gms
 Respiratory rate:- 85 breaths/min
 Body temperature:- 35.9-37.5⁰C
 Blood volume:- 50-70ml/kg
5

CPCSEA
• CPCSEA:- Committee for the Purpose of Control and
Supervision of Experiments on Animals.
• CPCSEA is a statutory committee/body which is
established under chapter 4, section(1) of the act of
the Prevention of cruelty of animal act 1960.
• Which is formed in 1964
• It was revived in 1998 under the chairpersonship of
maneka gandhi.
• The current committee was constituted on 30th
August 2012 with 17 members under the
chairmanship of Shri Hema Pande, (additional
secretary) MoEF&CC. 6

• The Board consists of 28 members, & serve for
3 years.
• Its headquarters was in chennai, Now it has
been moved to Ballabhgarh of Faridabad district
in Haryana state in 2018.
7

• IAEC:- institutional animal ethical committee.
• IBSC/IBC:-institutional biosafety ethical
committee 8
GOVERNMENT OF INDIA
MINISTERY OF ENVIRONMENT FOREST, AND CLIMATIC
CHANGE
CPCSEA
IAEC IBSC/IBC

 MINISTER OF ENVIRONMENT, FOREST AND
CLIMATE CHANGE(MoEF&CC)
- PRAKESH JAVADEKAR(CABINATE MINISTER)
FROM-31 MAY 2019
 MINISTER OF ENVIRONMENT, FOREST AND
CLIMATE CHANGE(MoEF&CC)
- BABUL SUPRIYO(MINISTER OF STATE)
9

WORLD LABORATORY ANIMAL DAY – 24TH APRIL
 CPCSEA Web site has been launched by
MoEF&CC - PRAKESH JAVADEKAR ON 24TH APRIL
2015 0N THE WORLD LABORATORY ANIMAL DAY.
10

CPCSEA MEMBERS
 Shri HEMA PANDE
Additional secretary MoEFCC &
chairman (CPCSEA)
 MANJU PANDEY
Vice chairperson (CPCSEA)
 S.GOWRI SHANKAR
Deputy secretory
Member secretory(CPCSEA)
& DIRECTOR (NIAW)National Institute of Animal Welfare
11

Function of CPCSEA
The main functions of CPCSEA are:-
• Registration of establishments/institution for conducting
animal experimentation or breeding of animals for this
purpose.
• Selection and appointment of nominees in the
Institutional Animal Ethics Committees of 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 violation of any
legal norm/stipulation. 12

IAEC
‘INSTITUTIONAL ANIMAL ETHICS COMMITTEE’
• "Institutional Animals Ethics Committee" means
a local body/committee comprising of a group of
persons recognized and registered by the
Committee for the purpose of control and
supervision of experiments on animals
performed in an establishment.
• Which is constituted and operated in accordance
with procedures specified for the purpose by the
Committee.
13

IAEC
 Composition of IAEC
• Institutional Animals Ethics committee shall include
eight members as follows:-
1. Chairman
2. A biological scientist,
3. Two scientists from different biological disciplines,
4. A veterinarian involved in the care of animal,
5. Scientist in charge of animals facility of the
establishment concerned,
6. A scientist from, outside the institute,
7. A non-scientific socially aware member and
8. A nominee of CPCSEA(important link between CPCSEA
and IAEC)
14

IAEC
 Function of IAEC:-
• Review and approve all types of research
proposals involving small animal experimentation
before the start of the study.
• Monitor the research throughout the study and
after completion of study through periodic
reports and visit to animal house and laboratory
where the experiments are conducted.
• Visit to animal house and laboratory where the
experiments are conducted.
15

GLP
 Good Laboratory Practices (GLP) for animal facilities is
intended to assure quality maintenance and welfare of
animals used in laboratory studies while conducting
biomedical and behavioural research and testing of
products.
 GLP is an essential requirements of all modern testing
facilities.
 It embodies a set of principles that provides a frame work
within which laboratory studies are planned, performed,
monitored, recorded, reported, and archived.
 In order to promote such principles International
Conference on Harmonization(ICH), Organization for
Economic Co-operation and Development(OECD) have
developed certain guidelines and principles of GLP.
16

GOAL
 To Promote the Human Care of Animals used in
Biomedical and Behavioral Research and Testing.
17

GUIDELINES
• Adequate veterinary care must be provided
and is the responsibility of a veterinarian or a
person who has training or experience in
laboratory animal science and medicine.
• Daily observation of animals for sign of illness,
injury, or abnormal behaviour.
Veterinary
care
18

Animal procurement
• All animals must be acquired lawfully as per the
CPCSEA Guidelines.
• A health surveillance
program for incoming animals
should be carried out to
assess animal quality.
• Each consignment of animal should be
inspected for compliance with procurement
specification.
• Method has of transportation has been
provided in Annexure-4
19

Mouse Rat Hamster G. pig Rabbit Cat Dog Primate
Maximum
No. of
Animals per
cage
25 25 25 12 2 1 or 2 1 or 2 1
Material
Used in
Transport
box
Metal
Cardboard,
Synthetic
material
Metal
Cardboard,
Synthetic
material
Metal
Cardboard,
Synthetic
material
Metal
Cardboard,
Synthetic
material
Metal
Cardboard,
Synthetic
material
Metal Metal Bamboo /
wood /
metal
Space per
Animal (Cm.
Sq.) 20 - 25 80 - 100 80 - 100 160 - 180 1000 - 1200 1400 - 1500 3000 2000 -4000
Minimum
height of box
(cm) 12 14 12 15 30 40 50 48
ANNEXURE – 4
SPECIFICATIONS FOR TRANSPORT OF LABORATORY ANIMALS BY
ROAD, RAIL AND AIR
20

QUARANTINE
• Quarantine is the separation of
newly received animals form
those already in the facility until
the health and possibly the
microbial status of newly received
animals have been determined.
• An quarantine will reduce/minimize the chance of
introduction/spreading of pathogens into newly
established colony.
• A minimum duration of quarantine is:-
small animals(mice, rat, rabbit etc..) - 1 week
Large animals(cat ,dog, monkey etc..) - 6week
21

STABLIZATION AND SEPARATION
• Newly received animals should be a period for physiologic,
psychologic and nutritional stabilization before their use.
• Duration for stabilization
will depend on the type of
animal, duration of transportation
and intended to use of animal.
• Physical separation of animals by species is recommended,
Because
1) To prevent interspecies diseases transmission.
2)To eliminate anxiety.
3)The possible physiological and behavioural
changes due to interspecies conflict.
22

SUREILLANCE, DIAGNOSIS,
TREATMENT AND CONTROL OF DISEASE
• Observe for sign of illness, injury, or abnormal
behavior of animals by the animal house staff.
• Unexpected deaths and sign of illness, distress, or
other deviations from normal health condition in
animals should be reported.
• When the entire room of animals is known to be
exposed to an infectious agent (Mycobacterium
tuberculosis) the group should be kept intact and
isolated during the process of diagnosis,
treatment, and control.
• Diagnostic clinical laboratory may be made
available.
23

Annexure – 1
HAEMATOLOGICAL DATA OF COMMON LABORATORY ANIMALS
Mouse Rat Hamster G.pig Rabbit Cat Dog
(Beagle)
Primate
(Rhesus)
RBC(x10⁶/mm³) 7 – 12.5 7 -10 6 - 10 4.5 - 7 4 - 7 5 - 10 5.5 – 8.5 3.56- 6.96
PCV(%) 39 - 49 36 - 48 36 - 55 37 - 48 36 - 48 30 - 45 37 - 55 26 - 48
Hb (g/dl) 10.2 - 16.6 11 - 18 10 - 16 11 - 15 10 – 15.5 8 - 15 12 - 18 8.8 -16.5
WBC(X10³/mm³) 6 - 15 6 - 17 3 - 11 7 - 18 9 - 11 5 – 19.5 6 - 17 2.5 – 26.7
Neutrophlis (%) 10 - 40 9 - 34 10 - 42 28 - 44 20 - 75 35 - 75 60 - 70 5 - 88
Lymphocytes(%) 55 - 95 65 - 85 50 - 95 39 - 72 30 - 85 20 - 55 12 - 30 8 - 92
Eosinophils (%) 0 - 4 0 - 6 0 – 4.5 1 - 5 0 - 4 2 - 12 2 - 10 0 - 14
Monocytes(%) 0.1 – 3.5 0 - 5 0 - 3 3 - 12 1 - 4 1 - 4 3 - 10 0 - 11
Basophils(%) 0 – 0.3 0 -1.5 0 - 1 0 - 3 2 – 7 rare rare 0 - 6
Platelets
(X10³/mm³)
160 - 410 500 - 1300 200 - 500 250 - 850 250 - 656 300 -700 200 - 900 109 - 597
24

Annexure – 2
BIOCHEMICAL DATA OF COMMON LABORATORY ANIMALS
Mouse Rat Hamster G. Ppig Rabbit Cat Dog
(Beagle)
Monkey
Protein
(g/dl) 3.5-7.2 5.6-7.6 4.5-7.5 4.6-6.2 5.4-7.5 6-7.5 6-7.5 4.9-9.3
Albumin
(g/dl) 2.5-4.8 2.8-4.8 2.6-4.1 2.1-3.9 2.7-4.6 2.5-4.0 3-4 2.8-5.2
Globulin
(g/dl) 0.6 1.8-3.2 7-4.2 1.7-2.6 1.5-2.8 2.5-3.8 2.4-3.7 1.2-5.8
Glucose
(mg/dl) 62-175 50-135 60-150 60-125 75-150 81-108 54-99 46-178
Urea
nitrogen
(mg/dl)
12-28 15-21 12-25 9-31.5 17-23.5 3.5-8.0 3.5-7.5 8-40
Creatinine
(mg/dl) 0.3-1 0.2-0.8 0.91-0.99
0.6-2.2
0.8-1.8
<180
(n mol/l)
<120
(n mol/l) 0.1-2.8
Bilirubin
(mg/dl) 0.1-0.9 0.2-0.55 0.25-0.6 0.3-0.9 0.25-0.74
<4.0
(m mol/l)
<5.0
(n mol/l) 0.1-2
Cholesterol
(mg/dl) 26-82 40-130 25-135 20-43 35-53
2-4
(m mol/l)
4-7
(m mol/l) 108- 263
25

ANIMAL CARE AND TECHNICAL PERSONNEL
• Animal care programs require technical and
husbandry support.
• Institutions should employ people trained in
laboratory and animal science.
• They should provide for
both formal and on the job
training to ensure effective
implementation of program(Annexure-7)
26

Annexure - 7
QUALIFICATIONS & KNOWLEDGE REQUIRED FOR LABORATORY
ATTENDANT
• Certificate of animal handling and welfare from any recognized institution
• Introduction - Definition of plants and animals - types of animals – animals without
back bones (invertebrates)and those with back bones (chordates/vertebrates) - animals
that live in water (aquatic), air (aenar), land (terrestrial) - wild animals and
domesticated animals - poisonous and non-poisonous animals - laboratory bred and
non-laboratory bred animals - diurnal and nocturnal animals (suitable and relevant
Indian examples to be given).
• Animals rooms - animals chambers/cages - sizes of animal chambers general dimensions
for monkey and rat cages stocking density - need for light (LD cycles), air water and feed
- cleaning animal chambers, animal runs, aquana and animal rooms - frequency of
feeding - frequency of cleaning.
• Handling of animals - precautions while handling animals - common injuries and
ailments in animals - liters - weaning - maintenance - record keeping.
• Personal hygiene - need to use apron, gloves, mask handling of detergents and other
cleaning substances - zoonoses - need of safety handling - antidotes for specific poisons
if handling poisonous animals like venomous snakes - first aid.
• Emergency situations: escaping animals - use of fire extinguishers - emergency lamps -
sirens. 27

PERSONAL HYGIENE
• It is essential that the animal
care staff maintain a high
standard of personal cleanliness.
• Clothing suitable for the use in the
animal facility should be supplied
and laundered by institution.
• Institutional facilities should be used to decontaminate
clothing exposed to potentially hazardous microbial
agents or toxic substance.
• Use of disposable Wear such as gloves, masks, head
covers, coats, and shoe covers.
• No permission to eat, drink, smoke or apply cosmetics in
animal rooms.(separate area or room should be made
available for these purposes) 28

ANIMAL EXPERIMENTS INVOLVING
HAZARDOUS AGENTS
• Institution should have policies governing
experimentation with hazardous agents.
• Institutional Biosafety Committee.
• Use of animals in such studies requires a special
consideration, Such as procedures and the
facilities to be used must be reviewed by both the
Institutional Biosafety Committee and
Institutional Ethical Committee (IAEC).
29

Annexure – 8
Institutional Biosafety Committee (IBSC)
• Institutional Biosafety Committee (IBSC) is to be constituted in all centres engaged
in genetic engineering research and production activities. The Committee will
constitute the following.
(i) Head of the institution or his nominee
(ii) 3 or more scientists engaged in DNA work or molecular biology with an outside
expert in the relevant discipline.
(iii) A member with medical qualification-Biosafety officer (in case of work with
pathogenic agents/large scale used.)
(iv) One member nominated by DBT
• The Institutional Biosafety Committee shall be the point for interaction within
institution for implementation of the guidelines. Any research project which is
likely to have biohazard potential (as envisaged by the guidelines) during the
execution stage or which involve the production of either micro-organisms or
biologically active molecules that might cause biohazard should be notified to IBSC.
IBSC will allow genetic engineering activity on classified organisms only at places
where such work should be performed as per guidelines. Provision of suitable safe
storage facility of donor, vectors, recipients and other materials involved in
experimental work should be made and may be subjected to inspection on
accountability.
30

• The biosafety functions and activity include the following:
(a). Registration of Biosafety Committee membership composition with RCGM (Review
committee on genetic modification) and submission of report. IBSC will provide half yearly
reports on the ongoing projects to RCGM regarding the observance of the safety guidelines
on accidents, risks and on deviations if any.
• (b). Review and clearance of project proposals falling under restricted category that meets
the requirements under the guidelines. IBSC would make efforts to issue clearance
certificates quickly on receiving the research proposals from investigators.
• (c). Training of personnel on bio safety.
• (d). Instituting health monitoring program for laboratory personnel Complete medical check
up of personnel working in projects involving work with potentially dangerous
microorganism should be done prior to starting such projects. Follow up medical check ups
including pathological test should be done periodically, at annually for scientific workers
involved in such projects. Their medical record should be accessible to the RCGM. It will
provide half yearly reports on the ongoing projects to RCGM regarding the observance of the
safety guidelines on accidents, risks and on deviations if any.
• (e). Adopting emergency plans.
31

MULTIPLE SURGICAL PROCEDURE ON
SINGAL ANIMAL
• Multiple surgical procedure on single animal
should not be practiced unless specified in a
protocol only approve by the IAEC.
DURATION OF EXPERIMENT
• No animal is used for experimentation for more than 3
years unless adequate justification is provided.
32

PHYSICAL PLANT
• The physical condition and design of animal
facility should be well planned, properly
maintained facility is an important element in
good animal care.
33

PHYSICAL RELATIONSHIP OF ANIMAL
FACILITIES TO LABORATORY
• Good animal husbandry and human comfort and health
protection require separation of animal facilities from personnel
areas(such as office, conference room, and other laboratories).
• Laboratory animals are very sensitive to their living conditions so
animals should be away from human habitations and not exposed
to dust, smoke, noise, wild rodents, insects, and birds, and etc..
• The space should be well divided for various activities(such as
stores, washing, office, staff, machine room, quarantine and
corridors)
• The animal rooms should occupy about 50-60% of total
constructed area and remaining area is used for various activities.
• Animal housing area should be adjacent to laboratories or near
laboratories but separated.
• Recommended space requirement for animal rooms, for different
species are given in Annexure-3
34

Annexure – 3A
Minimum floor area recommended for laboratory animals (based on their
weight /size and behavioural activity)
Animal Weight in grams Floor area/animal (cm²) Cage height (cm²)
Mouse <10
upto15
upto25
>25
38.7
46
74
96.7
12
Rat <100
upto200
upto300
upto400
upto500
>500
109.6
148.3
187.0
258.0
387.0
>=451.5
14
Hamster/Gerbil/
Mastomy/Cotton
rat
>60
Upto80
Upto100
>100
64.5
83.8
103.2
122.5
12
Guinea pig <350
>350
387.0
>=651.4 18 35

Cont…..
Floor area Height
Weight in grams (sq.ft) (sq.meter) (inches)
<2000 1.5 0.135 14
upto 4000 3.0 0.27 14
Rabbit upto 5400 4.0 0.36 14
>5400 5.0 0.45 14
mother with 4.5 0.40 14
pubs
36

Annexure – 3B
Example for calculating the number of Mice to be kept per cage, based on floor
area recommended for animal according to their weight (size) and size of the cage
• Recommended floor 38.7 51.6 77.4 96.7
Area per animal
(cm²)
• Weight of animals <10 upto15 upto25 >25
(grams)
• Example 1
Cage size
24x14 cm
i.E floor area of 9 7 4 3
336cm²
Maximum number
of animals
37

Annexure – 3C
Example for calculating the number of rats to be kept per cage, based on floor
area recommended per animal according to their weight (size) and size of the
cage
• Recommanded floor 109.6 148.3 187 258 387 >451.5
area per animal
(cm²)
• Weight of animal <100 upto upto upto upto >500
(grams) 200 300 400 500
• Example
cage size
32.5x21cm
i.E floor area of 6 5 4 3 2 1
685.5cm²
Maximum number
of animals
38

Annexure – 3D
Example for calculating the number of Hamster/ Gerbils/ Mastomys/Cotton rats
to be kept per cage, based on floor area recommended per animal according to
their weight (size) and size of the cage
• Recommanded
Floor area per animal 64.5 83.8 103.2 122.5
(Cm²)
• Weight of animal <60 upto80 upto100 >100
(grams)
• Example
Cage size
32.5x21cm 11 8 7 6
i.E floor area of
685.5cm²
Maximum number
of animals 39

Annexure - 3E
Minimum floor area and height recommended for monkeys (rhesus and bonnet)
based on their weight (size) and behavioral activity (for langurs, the
recommended space is in the foot note below)
Weight floor area Height
(in kg) (cm) (cm)
Ft² cm²
Upto-1 1.6 1440 50
Upto-3 3.0 2700 72
Upto10-12 4.3 3870 72
Upto12-15 6.0 5400 72
Upto15-25 8.0 7200 90
40

Annexure - 3F
Recommended Space for Cats, Dogs and Birds
Animals weight, kg floor area/anmal,ft² Height
in inches
Cat <4 3.0 24
<4 >4.0 24
Dog <15 8.0 -
upto 30 12.0 -
>30 >24.0 -
Pigeon - 0.8 -
Chicken <0.25 0.25 -
upto0.5 0.50 -
upto1.5 1.00 -
upto3.0 2.00 -
>3.0 >3.00 - 41

FUNCTIONAL AREAS
• Sufficient animal area required to:
1)Ensure separation of species or isolation of
individual projects when necessary;
2)Receive, quarantine, and isolate animals; and
3)Provide for animal housing.
42

PHYSICAL FACILITIES
a) Building material:- Durable, moisture proof, fire resistant, and also including
vermin & pest resistance.
b) corridor:- wide enough, kept clean.
c) Animal room doors:- rust, vermin, dust proof. Fit properly, provided with door
closures, rodent barriers.
d) Exterior windows:- not recommended for small animals. In primate rooms,
windows can be provided.
e) Floors:- smooth, moisture proof, non adsorbent, skid proof, resistant to wear,
acid, solvents, and adverse effects of detergents, disinfectants.
f) Drains:- not essential in all rooms, but where floor drains are used the floor
should be sloped and drain taps filled with corrosion free mesh.
g) Walls & ceiling:- free of cracks, unsealed utility penetration, and free of
imperfect junctions with doors, ceiling, floors, and corners. Surface should
with stand scrubbing with detergent, disinfectant.
h) Storage area:- separate area for food, bedding, cages, refrigerated storage, cold
storage, and material not in use.
i) Facilities for sanitizing equipment and supplies:- adequate water supply for
sanitizing cages, and ancillary equipment is essential.
j) Experimental area:- It is separate area away from animal house. Which includes
surgical support area, preparation area, operating area, & area for intensive
care.
43

ENVIROMENT
a) Temperature and humidity control:- For common
laboratory animals temperature ranges from 18 to
29⁰C (64.4 to 84.2⁰F). The relative humidity should
be within 30% to 70% throughout year. For larger
animals it should be of (18 to 37⁰C) should be
maintained.
b) Ventilation:- Designed with 12-15 air cycles per
hour.
c) Power and lighting:- System should be safe and
provide a appropriate lighting. fluorescent lights are
efficient. emergency power should be available in
the event of power failure.
d) Noise control:- Noise free environment. concrete
walls are more effective.
44

ANIMAL HUSBANDRY
• Caging and housing system
 Provide adequate space(freedom of movement)
 Comfortable environment
 Escape proof enclosure that confines
animal safety.
 Easy access to food and water
 Provide adequate ventilation
 Meet biological needs of animals
 (temperature, urination, defecation, and reproduction)
 Keep the animal clean
• Sheltered or outdoor housing
 Accessible to all animals, sufficient ventilation, and prevent build up waste
material and excessive moisture.
• Social environment
 Should includes all interaction among individual of a groups
45

ACTIVITY
• Provision should be made for animals with specialized locomotor pattern
to express their natural habitat, especially when the animals are held for
long periods.
e.g., artificial trees, ropes, bars, and perches are appropriate for non-
human primates
FOOD
• Animals should be palatable,
non-contaminated and
nutritional adequate food daily.
• Food should be sufficiently available
to ensure normal growth in immature
animals and to maintain normal body weight,
reproduction, and lactation in adults.
• Diets should be free from heavy metals(lead, arsenic, cadmium, lead,
nickel, mercury) and naturally occurring toxins and other contaminants.
• The animal feed should contain moisture, crude fibre, crude protein,
essential vitamins, minerals, and crude fat and carbohydrate for
providing appropriate nutrition. 46

BEDDING
• Should be absorbent, free of
toxic chemicals or other substance
that could injury animals or personnel.
• Bedding should be removed and
replaced with fresh material to
clean the animal clean and dry. HUSK BED
• Materials used for bedding are a
piece of paper, tissue paper, cotton,
dry grass, crushed corn cobs etc..
generally paddy husk and saw
dust used for bedding.
• All the bedding material should
be sterialized before using.
PAPER BED 47

WATER
• Should have continous access to fresh, potable,
uncontaminated drinking water.
• Should contain all ions & minerals.
• Drinking tubes should be examined routinely for any
contamination & proper operation.
48

SANITATION AND CLEANLINESS
• SANITATION:- means healthy & clean room with drainage
&sewage disposal & also known for measures for the promotion
of health.
• CLEANLINESS:- means attentive to cleanness & having clean
habit like free from dirt, microbes, and diseases.
Both are essential in an animal facility.
 Animal rooms, corridors, storage space, and other areas should be
cleaned with appropriate detergents and disinfectants.
 Animal waste is removed by hosting or by flushing.
 Cages should be cleaned each time before animals are placed in
them.
 Animal cage racks feeders and watery devices should be washed
&cleaned.
49

ASSESSING THE EFFECTIVENESS OF
SANITATION
• Sanitation practice should be monitored by the visual
inspection of the materials, monitoring of
temperatures.
WASTE DISPOSAL
• Wastes should be removed regularly and frequently. All
the wastes should be collected and disposed of in a
sanitary manner.
• Preferred method for waste disposal is incineration.
• Incinerators should be compliance with all central,
state, and local regulations.
50

EMERGENCY, WEEKEND, AND
HOLIDAY CARE
• Animals should be cared for by qualified personnel every day,
including weekends and holidays to safe guard their well being
including emergency veterinary care.
RECORD KEEPING
• The animal house should maintain following records:-
 Animal house plans(typical floor plan, all fixtures etc..)
 Animal house staff record(both technical &non- technical)
 All SOPs for animals(standard operating procedure)
 Breeding, stock, purchase, and sales record.
 Minutes of institutional animal ethics committee meeting.
 Record of experiment conducted with number of animals.
 Death record
 Clinical record
 Water analysis report
51

STANDARD OPERATING
PROCEDURS(SOPs)/GUIDELINES
• The institute shall maintain SOPs describing procedures/methods
adapted with regard to animal husbandry, maintenance, breeding,
microbial analysis, and experimentation record.
• A SOP should contain the following items:-
 Name of author:-
 Title of SOP:-
 Date of preparation:-
 Reference of previous SOP on the same subjects and date(issue number
& date):-
 Location and distributIon of SOPs with sign of each recipient:-
 Objectives:-
 Detailed information about instrument (model no. serial no, etc..):-
 Name of manufacturer of reagents:-
 Normal value of each parameters:-
 Hazard identification and risk management:-
52

PERSONNEL AND TRAINING
• The animal facility staff must be provide with a all
required clothing (masks, afrons, gloves, other
footwear etc..) while working in animal rooms.
• It is important that regular medical check up is
required for staff.
• Animal house in-charge should look after the persons
working in animal house don’t eat, drink, smoke and
etc..
• A few weeks must be spent on the training of the
newly recruited staff, teaching them the animal
handling, technique, cleaning of cages, and important
of hygiene,
• Disinfection and sterilization. 53

TRANSPORT OF LABORATORY
ANIMALS
• The main consideration for transport of animals
are:-
 Mode of transport(depends on distance, seasonal, and
climatic condition, species of animal)
 Containers(comfortable ,free movement, and protection
from injury)
 Animal density in cages(permissible number and avoid
over crowding)
 Food and water during transit(adequate)
54

Mouse Rat Hamster G. pig Rabbit Cat Dog Primate
Maximum
No. of
Animals per
cage
25 25 25 12 2 1 or 2 1 or 2 1
Material
Used in
Transport
box
Metal
Cardboard,
Synthetic
material
Metal
Cardboard,
Synthetic
material
Metal
Cardboard,
Synthetic
material
Metal
Cardboard,
Synthetic
material
Metal
Cardboard,
Synthetic
material
Metal Metal
Bamboo /
wood /
metal
Space per
Animal
(Cm.Sq.) 20 - 25 80 - 100 80 - 100 160 - 180 1000 - 1200 1400 - 1500 3000 2000 - 4000
Minimum
height of box
(cm) 12 14 12 15 30 40 50 48
ANNEXURE – 4 (ANIMAL PROCUREMENT)
SPECIFICATIONS FOR TRANSPORT OF LABORATORY ANIMALS BY ROAD, RAIL AND AIR
55

ANAESTHESIA AND EUTHANASIA
• ANESTHESIA:-
DEFINITION:-These are which compound having a sedative
properties and its used before any experiments and they give reversible
unconsciousness during any experiment.
i. Sedative, analgesic and anesthetics should be used to control pain or
distress under experiment.
ii. Anesthetic agents will affect cardiovascular, respiratory, thermoregulatory
mechanism and also CNS system.
iii. Local or general anesthetics may be used depending on type of surgical
procedure.
iv. Local anaesthetics are used in minor and rapid procedure to block the nerve
supply to a limited area.
v. Various general anaesthetic agents are used in form of inhalants,
intravenous or intramuscular injection.
vi. While using an anaesthetics various side effects such as excessive
salivation, convulsion, excitement, and dis-orentation should be prevented
and controlled.
56

AS PER 2015 CPCSEA ANNEXURE – 5
COMMONLY USED ANAESTHETIC AGENTS FOR LABORATORY ANIMALS
Drugs
(mg/kg)
Mouse Rat Hamster Guinea
pig
Rabbit Cat Dog Primates
KTEAMINE
Hcl
87 IP
With
Xylazine
87 IP
With
xylazine
200 IP
With
Xylazine
40 im
60 Ipwith
Xylazine
24-35 IM 22-33 IM 11-22 IM 5-15
PENTOBAR
-BITONE
SODIUM
35 i/v
40-70 i/p
30-40 IV
40-60 IP
70-90 IP
_
30 i/v
40 i/p
30 i/v
40 i/p
25 -35 i/v
_
10 -33 i/v
_
20-30 i/v
_
THIOPENT-
ONE
SODIUM
25 i/v
50 i/p
20 -40 i/v
40 i/p
20 i/v
40 i/p
20 i/v
55 i/p
20 i/v 13.2-26.4
i/v
13.2-29
i/v
15-20 i/v
URETHANE 1000 IP* 1000 i/p* 1500 IP* 1500 i/p* 1000 i/p* 750 IV*
1500 IP*
100 IP* _
57

*(prolonged anaesthesia: terminal procedures only)
ATROPINE: Dose 0.02 – 0.05 mg/kg for all species by s/c or i/m or i/v routes used
to reduce salivary and bronchial secretions and protect heart from vagal inhibition,
given prior to anaesthesia.
58
Anesthesia for Laboratory Animals:
For mice ketamine is used alone intramuscularly. Usually IM is not recommended in Mice due
small muscle mass, and may cause lameness in mice. Also Injection may cause discomfort and
local tissue irritation. Ketamine is rarely administered alone due to its poor muscle relaxation.
Ketamine has been used in combination with various other anesthetic drugs, but it is most
commonly combined with Xylazine or Meditomidine.
The Drugs/dose and route of administration is as follows:-
Drug
mg/kg
Mouse Rat Rabbit Hamster G.Pig Cat Dog Primates
Ketamine
+
Xylazine
80+10
IP
75+10
IP
35-40+
5-10 IM
200+10
IP
40+5 IP 20+1 IM 5+1.5
IM
10+0.5
IM

EUTHANSIA
Euthanasia(derived from Greek word known as
“good death” where ‘eu’ means ‘well or good’ and
‘thanatos’ means ‘death’
Definition:- Procedure should be carried out quickly and
painlessly in an atmosphere free from fear or anxiety.
Method should meet the following requirements:-
i. Death, without causing anxiety, pain or distress with
minimum time lag phase.
ii. Minimum physiological & psychological disturbances.
iii. Compatibility with the purpose of study and minimum
emotional effect on the operator.
iv. Location should be separate from animal rooms and
free from environmental contaminates.
59

Species Mouse rat Hamste
r
Guinea
pig
Rabbit Cat Dog primate
a) PHYSICAL METHODS
Electrocution
Exsanguination
Decapitation
(for analysis of stress)
Cervical dislocation
NR
NR
A
A
NR
A
A
A
NR
A
A
A
NR
A
NR
NR
NR
A
NR
NR
NR
A
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
b) INHALATION OF
GASES
Carbon Monoxide
Carbon Dioxide
Carbon Dioxide plus
Chloroform
Halothane
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
NR
NR
A
A
NR
NR
A
c) DRUG
ADMINISTRATION
Barbiturate Overdose
(route)
Chloral hydrate
Overdose (route)
Ketamine Overdose
(route)
Sodium Pentothol
[ Overdose (route) ]
A(IP)
NR
A(IM/IP)
IP
A(IP)
NR
A(IM/IP)
IP
A(IP)
NR
A(IM/IP)
IP
A(IP)
NR
A(IM/IV)
IP
A(IV,IP)
A(IV)
A(IM/IV)
IV
A(IV,IP)
A(IV)
A(IM/IV)
IV
A(IV,IP)
A(IV)
A(IM/IV)
IV
A(IV,IP)
A(IV)
A(IM/IV)
IV
ANNEXURE – 6
EUTHANASIA OF LABORATORY ANIMALS (A – Methods Acceptable)
(NR – Not Recommended)
60

EUTHANASIA METHODS NOT ACCEPTABLE
FOR ANY SPECIES OF ANIMALS
• Physical methods
Decompression (super saturation of tissue with
nitrogen and present with limb pains, skin irritation,
respiratory decompression)
stunning
• Inhalation methods
Nitrogen flushing, Argon flushing
• Drug administration
Curariform drugs, nicotinic sulphate, magnesium
sulphate, potassium chloride, strychnine, paraquat,
dichlorvos, air embolisim
61

LABORATORY ANIMAL ETHICS
• All scientists working with laboratory animals must have
a deep ethical consideration for the animal they are
dealing with.(individual level, institutional level, national
level)
TRANSGENIC ANIMALS
• These are the animals whose germ line foreign gene(s) have
been engineered, Where as knockout animals are those whose
specific gene(s) have been disrupted leading to loss of function.
• These animals are breed to establish transegnic animal strains.
Transgenic animals are used to study:-
 Biological function of specific genes.
 To develop animal model for disease of humans or animals.
 To produce therapeutic products , and vaccines.
 Biological screening etc..
62

MAINTANANCE
• Special care has to be taken with transgenic/gene
knockout animals.
• Prevent cross breeding with other animals.
• Knockout animals should be maintained in clean
room environment or in animal isolator.
DISPOSAL
• The transgenic and knockout animals should be
first euthanized and then disposed off as
prescribed in the guidelines.
63

BREEDING AND GENETICS
• For initiating a colony, the breeding stock must
be procured from CPCSEA registered breeders or
suppliers.
• If it is a inbred the characters of the strain, gene
distribution, number of inbred generation must
be known for further propagation.
• Health status should indicate (conventional,
pathogen free or transgenic, ganotobiotic or
knockout stock.
64

CONCLUSION
• Animals should be handled with extreme care at
every step of experiment.
• Unnecessary animal killing should not be practiced.
• Laboratory animals should be used only for learning
and research objective.
• Euthanasia shall be preferred if the animal is
suffering from uncontrollable paining sensation &
severe organ failures.
• Always perform experiments in presence of
expertise of animal handling, with the use an
anesthetic agents to reduce the paining sensation.65

WE DON’T SMOKE, WE DON’T DRIVE.
WE DON’T WEAR MAKE-UP OR PERFUME.
WE DON’T DRINK. WE DON’T DROP BOMBS.
WE DON’T TAKE DRUGS
JUST BECAUSE HUMAN DO IT,
WHY SHOULD WE SUFFER THROUGH EXPERIMENTATION?
66

REFERENCE
• cpcsea.nic.in
• Screening methods in pharmacology, Shiva Prakash NS
Parmar.
• Ministry of environment, forest and climatic change
government of india (CPCSEA) COMPENDIUM OF
CPCSEA-2018
67

CPCSEA Guidelines

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