CPCSEA Guidelines Dr Santosh B Dighe.pdf

CPCSEA Guidelines Dr Santosh B Dighe.pdf

1. Dr. Santosh B Dighe
Pravara Rural College of Pharmacy, Loni
CCSEA Guidelines

4. Three Rs
Refinement
Replacement
Reduction
4

5. LAWS FOR EXPERIMENTAL
ANIMALS IN INDIA

7. CCSEA
• The Committee for the Purpose of Control
and Supervision of Experiments on Animals
( CPCSEA )

• Statutory committee, established under Chapter
4, Section 15(1) of the Prevention of cruelty to
Animals Act 1960.

• National level expert committee to scrutinize and
approve the research projects conducted using
animals.

9. CCSEA AND IAEC
•Role of CPCSEA is to monitor animal experiments through
ethics committee set up in institution ( IAEC )

•CPCSEA nominee – important link between CPCSEA and
IAEC.

•IAEC scrutinize all the projects proposals for experiment on
animals
--For small animals – gives the final approval
--For large animals – makes its recommendation to

10. AIM OF CCSEA
•To promote the humane care of animals use in
biomedical and behavioral research and
testing.
•To provide quality in gaining advanced biological
knowledge that is relevant to humans and
animals

11. PRINCIPLES
Principle No.1

“Experiments on animals”


• may be carried out for t he purposes of advancement
by new discovery.

OR

•Knowledge which is expected to be useful for saving or
prolonging human life or alleviating suffering

12. 52
Principle No.2.
•Animals lowest on the phylogenetic scale
should be used for any experimental
procedure.

• Cockroach (Invertebrates) < Birds < Rodents
< Canines < Bovine/Equines <Primates (e.g.
Rhesus macaque)< More evolved Primates
(e.g. chimpanzee)

13. 53
Principle No.3
Proper use of animals in experiments and
avoidance of pain and suffering inflicted on
experimental animals
By using appropriate sedation, analgesia or
anaesthesia.


14. 54

Principle No.4
•Persons engaged in animal
experimentation have a moral responsibility
for the welfare of the animals after their use
in experiments.
.

15. Principle No.5
•T h e living conditions of animals should be
appropriate for their species and contribute to their
health and comfort

16. FUNCTIONS OF CPCSEA
40
Main activities

1.Registration of establishments conducting animal
experiments or breeding of animals.

2.Selection and appointment of Nominees in the IAEC.

3.Approval of Animal House Facilities:

4.Permission for Conducting Experiments involving
use of Animals.

5.Recommendation for import.

17. GROUND RULES
•The Member – Secretary would take a decision on
any application for registration within two months
of receipt

•Application for permission for conducting
experiments are brought before CPCSEA by MS.

•IAEC of an establishment is constituted by CPCSEA at
the time of registration for a period of 5 years.

19. GUIDELINES

20. 4
VETERINARY CARE

•Adequate veterinary care must be provided and is
the responsibility of a veterinarian.
•Daily observation.

21. 5
•A l l 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.

•Methods of transportation should be taken into
account.
ANIMAL PROCUREMENT

23. 6
QUARANTINE, STABILIZATION AND SEPARATION
•A n effective quarantine minimizes the chance for introduction of
pathogens into an established colony.

•Minimum duration of quarantine
- Small lab animals - 1 week and
- Larger animals - 6 weeks

•Newly received animals should be given a period of
physiologic, psychologic and nutritional stabilization before
their use.

•Physical separation of animals by species is
recommended.

24. •Observe for signs of illness, injury, or abnormal behavior.
•Unexpected deaths and signs of illness should be
reported.
•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 must be available.
SURVEILLANCE, DIAGNOSIS, TREATMENT AND CONTROL
OF DISEASE

27. 9
•Employ people who are trained in laboratory
animal science.

•They should be provide for both formal and on-the- job
training.
ANIMAL CARE AND TECHNICAL PERSONNEL

28. PERSONAL HYGIENE
• PPE – e.g. change of uniforms, footwears.

•U s e disposable gear.

•N o permission to eat, drink, smoke or apply
cosmetics in animal rooms.

29. •Institutional Biosafety Committee.
•The procedures must be reviewed by both the Institutional
Biosafety committee and Institutional Animal Ethics
Committee (IAEC).
ANIMAL EXPERIMENTATION INVOLVING HAZARDOUS AGENTS

30. The following are important points for the use of
restraint equipments
•N o t be used simply as a convenience in handling
/ managing animals

•Minimum time.

•Should be given training to adapt to the equipment.

•Observe the animal at appropriate intervals.

•Veterinary care should be provided if lesions or
ilness associated with restraint are observed.

32. 18
FUNCTIONAL AREAS
Sufficient animal area is required to -

•Ensure separation of species or isolation of
individual projects when necessary;

•Receive, quarantine, and isolate animals;

•Provide for animal housing.

33. PHYSICAL FACILITIES
19
(7)Corridor

(8)Exterior windows
(1)Building material
(2)Animal room doors
(3)Floors
(4)Drains
(5)Storage areas
(6)Experimental area

34. 20
 (a) TEMPERATURE AND HUMIDITY CONTROL

•18 to 29°C temperature range
•30% to70% relative humidity
(b) VENTILATION

Heating, ventilation and air conditioning
system should be designed with 12-15 air
cycles per hour
ENVIRONMENT

35. 21
(c) POWER AND LIGHTING
•A time-controlled lighting system

•Emergency power should be available in case of
power failure

(d) NOISE CONTROL

36. (a

) CAGING OF HOUSING SYSTEM:


Provide adequate space
Comfortable environment


Easy access to food and water;


Provide adequate ventilation

ANIMAL HUSBANDRY

39. WATER
•Continuous access of fresh, potable, uncontaminated drinking
water.

•Periodic monitoring of microbial contamination.

40. SANITATION and CLEANLINESS
Cleaning with detergents and disinfectants with Sodium
hypercholrite to destroy pathogenic organism.

□ Bottom cages other than rodent cages should be washed at least
every 2 weeks.

Cages can be disinfected by rinsing at a temperature of
82.2
0C (180 F) or higher.

41. 
WASTE DISPOSAL
•Remove regularly and frequently.

•The most preferred method of waste disposal is
Incineration.

•• Animal tissues, carcasses, and hazardous wastes should be
lined with leak – proof, disposable liners.

42. RECORD KEEPING
28
The Animal House should maintain following records:

• Animal House plans, which includes typical floor plan,
fixtures.
•Animal House staff record and there health record
•All SOPs related to experiments, care and management of
animals.
•Breeding, stock, purchase and sales records

43. TRANSPORT OF LABORATORY ANIMALS
The main considerations for transport of animals are:

•Mode of transport
•Containers
•Food and water during transit
•Protection from transit infections
•Injuries and stress

45. ANAESTHESIA AND EUTHANASIA
32

46. COMMONLY USED ANAESTHETIC DRUGS FOR
LABORATORY ANIMALS
Mouse Rat Hamster Rabbit Cat Dog Monkey Guinea pig

22-24
i/m

22-24
i/m

-

22-24 i/m

30 i/m

30 i/m

15-40 i/m

22-24 i/m
Drugs
(mg/kg)

KETAMI
-NE
PENTO-
BARBIT
ONE
35 i/v
50 i/p
25 i/v
50 i/p
35 i/v
-
30 i/v
40 i/p
25 i/v
-
20-30 i/v
-
35 i/v
-
30 i/v
40 i/p
THIOPE
NTONE
SODIUM
25 i/v 20 i/v 20 i/v 20 i/v 25 i/v 25 i/v 25 i/v 20 i/v
50 i/p 40 i/p 40 i/p - - 60 i/p 55 i/p
URETHA
NE -
0.75 i/p
-
0.75 % 1.25 i/v
1.50 i/p
1.0 i/v 1.0 i/v 1.5 i/p
33

47. EUTHANASIA
34
(a)Death, without causing anxiety, pain or distress with
minimum time lag phase.

(b)Minimum physiological and psychological disturbances.

(c)Compatibility with the purpose of study and minimum
emotional effect on the operator.

(d)Location should be separate from animal rooms and free
from environmental contaminants.

48. EUTHANASIA OF LABORATORY ANIMALS
(A – Methods Acceptable for species of animals indicated NR – Not
Recommended)
Species
pig
Mouse Rat Hamster Guinea Rabbit Cat Dog Monkey
a) PHYSICAL METHODS
Electrocution
Exsanguination
Decapitation
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 mono oxide
Carbon di oxide
CO2+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
Chloral hydrate overdose
Ketamine overdose
Sodium Pentothol
(IP)
NR
IM/IP
IP
(IP)
NR
IM/IP
IP
(IP)
NR
(IM/IP)
IP
(IP)
NR
IM/IP
IP
IV,IP
IV
IM/IV
IV IV
IV,IP IV,IP
IV IV
IM IM
IV,IP
IV
IM/IV
IV
3
I
5
V