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Dr. Santosh B Dighe
Pravara Rural College of Pharmacy, Loni
CCSEA Guidelines
Three Rs
Refinement
Replacement
Reduction
4
LAWS FOR EXPERIMENTAL
ANIMALS IN INDIA
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.
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
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
PRINCIPLES
Principle No.1
“Experiments on animals”
• may be carried out for the purposes of advancement
by newdiscovery.
OR
• Knowledge which is expected to be useful for saving or
prolonging human life or alleviating suffering
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)
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.

54

Principle No.4
• Persons engaged in animal
experimentation have a moral responsibility
for the welfare of the animals after their use
in experiments.
.
Principle No.5
• The living conditions of animals should be
appropriate for their species and contribute to their
health and comfort
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 ofAnimal House Facilities:
4. Permission for Conducting Experiments involving
use of Animals.
5. Recommendation for import.
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.
GUIDELINES
4
VETERINARY CARE

• Adequate veterinary care must be provided and is
the responsibility of a veterinarian.
• Daily observation.
5
• All animals must be acquired lawfully as per the
CPCSEA guidelines.
• A health surveillance program for incoming
animalsshould be carried out to assess animal
quality.
• Methods of transportation should be taken into
account.
ANIMAL PROCUREMENT
6
QUARANTINE, STABILIZATION AND SEPARATION
• An 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.
• 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
9
• Employ people who are trained in laboratory
animal science.
• They should be provide for both formal andon-the- job
training.
ANIMAL CARE AND TECHNICAL PERSONNEL
PERSONAL HYGIENE
• PPE – e.g. change of uniforms, footwears.
• Use disposablegear.
• N o permission to eat, drink, smoke or apply
cosmetics in animal rooms.
• Institutional BiosafetyCommittee.
• The procedures must be reviewed by both theInstitutional
Biosafety committee and Institutional Animal Ethics
Committee (IAEC).
ANIMAL EXPERIMENTATION INVOLVING HAZARDOUS AGENTS
The following are important points for the use of
restraint equipments
• Not 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.
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.
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
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
21
(c) POWER AND LIGHTING
• A time-controlled lighting system
• Emergency power should be available in case of
power failure
(d) NOISE CONTROL
(a
) CAGING OF HOUSING SYSTEM:

Provide adequate space
Comfortable environment


Easy access to food and water;


Provide adequate ventilation

ANIMAL HUSBANDRY
WATER
• Continuous access of fresh, potable, uncontaminated drinking
water.
• Periodic monitoring of microbial contamination.
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
82.20C (180 F) or higher.

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.
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
TRANSPORT OF LABORATORYANIMALS
The main considerations for transport of animals are:
• Mode oftransport
• Containers
• Food and water duringtransit
• Protection from transit infections
• Injuries and stress
ANAESTHESIA AND EUTHANASIA
32
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
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.
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) PHYSICALMETHODS
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
SodiumPentothol
(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
3I5V
CPCSEA Guidelines Dr Santosh B Dighe.pdf

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CPCSEA Guidelines Dr Santosh B Dighe.pdf

  • 1. Dr. Santosh B Dighe Pravara Rural College of Pharmacy, Loni CCSEA Guidelines
  • 2.
  • 3.
  • 6.
  • 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.
  • 8.
  • 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 the purposes of advancement by newdiscovery. 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 • The 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 ofAnimal 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.
  • 18.
  • 20. 4 VETERINARY CARE  • Adequate veterinary care must be provided and is the responsibility of a veterinarian. • Daily observation.
  • 21. 5 • All animals must be acquired lawfully as per the CPCSEA guidelines. • A health surveillance program for incoming animalsshould be carried out to assess animal quality. • Methods of transportation should be taken into account. ANIMAL PROCUREMENT
  • 22.
  • 23. 6 QUARANTINE, STABILIZATION AND SEPARATION • An 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
  • 25.
  • 26.
  • 27. 9 • Employ people who are trained in laboratory animal science. • They should be provide for both formal andon-the- job training. ANIMAL CARE AND TECHNICAL PERSONNEL
  • 28. PERSONAL HYGIENE • PPE – e.g. change of uniforms, footwears. • Use disposablegear. • N o permission to eat, drink, smoke or apply cosmetics in animal rooms.
  • 29. • Institutional BiosafetyCommittee. • The procedures must be reviewed by both theInstitutional 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 • Not 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.
  • 31.
  • 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
  • 37.
  • 38.
  • 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 82.20C (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 LABORATORYANIMALS The main considerations for transport of animals are: • Mode oftransport • Containers • Food and water duringtransit • Protection from transit infections • Injuries and stress
  • 44.
  • 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) PHYSICALMETHODS 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 SodiumPentothol (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 3I5V