CPCSEA GUIDELINES
Presented By :
Prabakaran A.
B.Pharm Final Year
C.L.Baid Metha college of Pharmacy
CONTENTS
Introduction
Objectives
Veterinary care
Animal procurement
Quarantine , Stabilization ,Separation
Surveilance ,Diagnosis, Treatment and Control of Disease
Laboratory animal husbandry and Management
Anaesthesia and Euthanasia
CPCSEA
• COMMITTEE FOR THE PURPOSE OF CONTROL AND SUPERVISION OF
EXPERIMENTS ON ANIMALS
• Statutory body formed by the Act of the Indian Parliament under the
prevention of cruelty to animals act ,1960
• Formed in 1964.
• Revived in 1998, under the committed chairmanship of Meneka Gandhi
• Headquarters at Chennai
• Includes various Guidelines and Subcommittees
• ALL ESTABLISHMENTS ENGAGED IN RESEARCH AND
EDUCATION INVOLVING ANIMALS ARE REQUIRED TO
COMPLY WITH THE VARIOUS GUIDELINES BY CPCSEA.
• Experimentation on animals has great importance in the advancement of
medical and pharmaceutical sciences.
• Therefore ,to control and supervise the experiments performed on animals
,the central govt constituted this committee.
FUNCTIONS OF CPCSEA
• The main functions of CPCSEA are:
• Registration of establishments conducting animal experimentation or breeding of
animals for this purpose.
• Selection and assignment of nominees for the Institutional Animal Ethics Committees
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.
• Conduct of Training Programmes for the Nominees of CPCSEA.
• Conduct / Support of Conference / workshop on Animal Ethics.
OBJECTIVES
• The objective of CPCSEA is to ensure that animals are not subjected to unnecessary
pains or suffering before, during or after performance of experiments on them. For this
purpose, under the delegated powers, the Committee formulated the ‘Breeding of and
Experiments on Animals (Control and Supervision) Rules, 1998’ which were amended in
2001 and then in 2006, to regulate the experimentation on animals.
•The main objectives of CPCSEA
includes:
i. To promote the human care of animals
used in research
ii.To provide specifications that will
enhance animals well being and quality
of research
VETERINARY CARE:
Adequate veterinary care must be provided by a Veterinarian .
Daily observation of the animals , direct and frequent communication
should be adopted so that timely information on problems in animal health
,behavior and well being is conveyed.
QUARANTINE ,STABILIZATION AND
SEPARATION:
Quarantine is the separation of newly received animals from those already in
their facility until the health and microbial status of the newly received
animals have been determined.
The duration of quarantine in small lab animals is one week to one month
and large animals allowed up to 6 weeks ( cats, dogs and monkeys)
Newly received animls should be given a period for physiologic
,psychological and nutritional stabilization before their use The length of
stabilization will depend on the type and duration off animal transportation
,animal species.
Physical separation of animals by species is recommended to prevent
interspecies disease transmission ,to eliminate anxiety and behavioral
changes due to interspecies conflict .Such separation is usdually
accomplished by housing different species in separate rooms .
• FOOD AND WATER
• Animals should be fed palatable,
• non-contaminated and nutritionally adequate food.
•BEDDING
 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.
SURVEILLANCE ,DIAGNOSIS, TREATMENT
AND CONTROL OF DISEASE
• All animals should be observed by the animal house staff for signs of
1. Illness
2. Injury
3.Abnormal behavior
• Animals that show signs off contagious disease should be isolated from
healthy animals in colony ,the groups should be intact and isolated
during the process off diagnosis , Treatment and control
PERSONAL 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.
It is acceptable to use disposable gloves, masks, head covers, coats and
shoe covers .
Personnel should not be permitted to eat , drink or smoke or apply
cosmetics in animal rooms.
•DURATIONS OF EXPERIMENTS
No animal should be used for experimentation for more than 3 years unless
adequate justification is provided.
•RESTRAINT
Devices required for holding animals for examination and collection of
samples should be made available to minimize stress.
•TRANSPORT OF LABORATORY ANIMALS
The main considerations for transport off 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.
PHYSICAL FACILITIES
• Building materials should be selected to facilitate efficient and hygienic
operation of animal facilities.
• Durable, moisture-proof, fire-resistant, seamlessmaterials are most
desirable for interior surfaces including vermin and pest resistance.
• Corridors should be wide enough to facilitate the movement of personnel
as well as equipment's and should be kept clean.
• Utilities such as water lines, drain pipes, and electrical connections
should preferably be accessible through service panels in corridors outside
the animal rooms
• ANIMAL ROOM DOORS
Doors should be non-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
PHYSICAL FACILITIES
EXTERIOR 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.
FLOORS
• Floors should be smooth, moisture proof, nonabsorbent, skid-proof,
resistant to acid solvents, adverse effects of detergents and disinfectants.
WALLS & CEILINGS
• Walls should be free of cracks, unsealed utility penetrations, or
imperfect junctions with doors, ceilings, floors and corners.
• Surface materials should be capable off withstanding scrubbing with
detergents and disinfectants.
STORAGE AREAS
• Separate storage areas should be designed for feed, bedding, cages and
materials not in use.
RECORD KEEPING
The Animal House should maintain following records:
• Animal House plans, which includes typical floor plan.
• Animal House staff record – both technical and non – technical
• Health record of staff/ animals
• All SOPs relevant to the animals
• Breeding, stock, purchase and sales records
• Records of experiments conducted with the number of
animals used
• Death Record
• Clinical record of sick animals.
STANDARD OPERATING PROCEDURES (SOPs) /
Guidelines
A SOP should contain the following items:
• Name of the Author
• Title of the SOP
• Date of preparation
• Reference of previous SOP on the same subject anddate (Issue no and
Date)
• Objectives
• Detailed information of the instruments used in relation with animals
with methodology (Model no.,
• Serial no., Date of commissioning, etc.)
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
ANAESTHESIA AND EUTHANASIA
The scientists should ensure that the procedures, which are considered
painful, are conducted under appropriate anesthesia as recommended for
each species of animals.
 It must also be ensured that the anesthesia is given for the full duration of
experiment and at no stage the animal is conscious to perceive pain during
the experiment.
 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.
ANAESTHESIA
Local anaesthetics are used to block the nerve supply to a limited area
and are used only for minor and rapid procedures.
A number of General anaesthetic agents are used in the form of
inhalants.
 General anaesthetics are also used in the form of intravenous or
intramuscular injections such as barbiturates.
The animal should remain under veterinary care till it completely recovers
from anaesthesia.
EUTHANASIA
Euthanasia is resorted to events where an animal is required to be
sacrificed on termination of an experiment or otherwise for ethical
reasons.
The procedure should be carried out quickly and painlessly in an
atmosphere free from fear or anxiety
EUTHANASIA
• The method should in all cases meet the following requirements:
(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.
ICMR Guidelines
• ICMR – Indian council of Medical Research
• The most commonly used animals in Colleges/ research institutions are:
Frog , Mouse, Rat, Hamster ,G.Pig , Rabbit ,Cat Dog Monkey Sheep
• The guidelines same as that of in CPCSEA:
1. Procurement of animals
2. Food and water
3. Sanitation and cleanliness
4. Veterinary care( as per cpcsea guidelines)
a. Personnel hygiene
b. Records keeping
INSA GUIDELINES
• INSA -INDIAN NATIONAL SCIENCE ACADEMY .The Indian National Science
Academy (INSA) in New Delhi is the apex body of Indian scientists
representing all branches of science and technology.
• In India, the need to develop guidelines for the use of animals in research
has been discussed at various forums. Unfortunately no standard
document was available for reference till 1992 when the
• Indian National Science Academy developed the guidelines for use of
animals in scientific research.
• Considering the knowledge generated internationally over the years and
the guidelines of WHO,
• NIH associated NRC, USA and European Union, the INSA guidelines have
been updated.
OBJECTIVES
To provide guidelines for
1. housing, care, breeding and maintenance of experimental animals to keep
them in physical comfort and good health and to permit them to grow,
reproduce and behave normally;
2. sources of experimental animals of known genetic, health and nutritional
status;
3. development of training facilities for scientists, technicians and other
supportive staff for the care of animals and their use in experiments;
4. acceptable experimental techniques and procedures for anesthesia and
euthanasia;
5. developing alternate in-vitro systems to replace animal experiments;
6. the constitution of institutional ethics committees, their functions and
the legal and ethical obligations to ensure minimal and ethical use of
animals.
References:
• CPCSEA ,ICMR , and Helsinki guidelines
• cpcsea.nic.in
• icmr.nic.in/bioethics/final
• INDIAN NATIONAL SCIENCE ACADEMY, Published by S. K. Sahni,
Executive Secretary, Indian National Science Academy,
Cpcsea guidelines

Cpcsea guidelines

  • 1.
    CPCSEA GUIDELINES Presented By: Prabakaran A. B.Pharm Final Year C.L.Baid Metha college of Pharmacy
  • 2.
    CONTENTS Introduction Objectives Veterinary care Animal procurement Quarantine, Stabilization ,Separation Surveilance ,Diagnosis, Treatment and Control of Disease Laboratory animal husbandry and Management Anaesthesia and Euthanasia
  • 3.
    CPCSEA • COMMITTEE FORTHE PURPOSE OF CONTROL AND SUPERVISION OF EXPERIMENTS ON ANIMALS • Statutory body formed by the Act of the Indian Parliament under the prevention of cruelty to animals act ,1960 • Formed in 1964. • Revived in 1998, under the committed chairmanship of Meneka Gandhi • Headquarters at Chennai • Includes various Guidelines and Subcommittees • ALL ESTABLISHMENTS ENGAGED IN RESEARCH AND EDUCATION INVOLVING ANIMALS ARE REQUIRED TO COMPLY WITH THE VARIOUS GUIDELINES BY CPCSEA. • Experimentation on animals has great importance in the advancement of medical and pharmaceutical sciences. • Therefore ,to control and supervise the experiments performed on animals ,the central govt constituted this committee.
  • 4.
    FUNCTIONS OF CPCSEA •The main functions of CPCSEA are: • Registration of establishments conducting animal experimentation or breeding of animals for this purpose. • Selection and assignment of nominees for the Institutional Animal Ethics Committees 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. • Conduct of Training Programmes for the Nominees of CPCSEA. • Conduct / Support of Conference / workshop on Animal Ethics.
  • 5.
    OBJECTIVES • The objectiveof CPCSEA is to ensure that animals are not subjected to unnecessary pains or suffering before, during or after performance of experiments on them. For this purpose, under the delegated powers, the Committee formulated the ‘Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998’ which were amended in 2001 and then in 2006, to regulate the experimentation on animals. •The main objectives of CPCSEA includes: i. To promote the human care of animals used in research ii.To provide specifications that will enhance animals well being and quality of research
  • 6.
    VETERINARY CARE: Adequate veterinarycare must be provided by a Veterinarian . Daily observation of the animals , direct and frequent communication should be adopted so that timely information on problems in animal health ,behavior and well being is conveyed.
  • 7.
    QUARANTINE ,STABILIZATION AND SEPARATION: Quarantineis the separation of newly received animals from those already in their facility until the health and microbial status of the newly received animals have been determined. The duration of quarantine in small lab animals is one week to one month and large animals allowed up to 6 weeks ( cats, dogs and monkeys) Newly received animls should be given a period for physiologic ,psychological and nutritional stabilization before their use The length of stabilization will depend on the type and duration off animal transportation ,animal species. Physical separation of animals by species is recommended to prevent interspecies disease transmission ,to eliminate anxiety and behavioral changes due to interspecies conflict .Such separation is usdually accomplished by housing different species in separate rooms .
  • 8.
    • FOOD ANDWATER • Animals should be fed palatable, • non-contaminated and nutritionally adequate food. •BEDDING  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.
  • 9.
    SURVEILLANCE ,DIAGNOSIS, TREATMENT ANDCONTROL OF DISEASE • All animals should be observed by the animal house staff for signs of 1. Illness 2. Injury 3.Abnormal behavior • Animals that show signs off contagious disease should be isolated from healthy animals in colony ,the groups should be intact and isolated during the process off diagnosis , Treatment and control
  • 10.
    PERSONAL HYGIENE It isessential 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. It is acceptable to use disposable gloves, masks, head covers, coats and shoe covers . Personnel should not be permitted to eat , drink or smoke or apply cosmetics in animal rooms.
  • 11.
    •DURATIONS OF EXPERIMENTS Noanimal should be used for experimentation for more than 3 years unless adequate justification is provided. •RESTRAINT Devices required for holding animals for examination and collection of samples should be made available to minimize stress. •TRANSPORT OF LABORATORY ANIMALS The main considerations for transport off 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.
  • 12.
    PHYSICAL FACILITIES • Buildingmaterials should be selected to facilitate efficient and hygienic operation of animal facilities. • Durable, moisture-proof, fire-resistant, seamlessmaterials are most desirable for interior surfaces including vermin and pest resistance. • Corridors should be wide enough to facilitate the movement of personnel as well as equipment's and should be kept clean. • Utilities such as water lines, drain pipes, and electrical connections should preferably be accessible through service panels in corridors outside the animal rooms • ANIMAL ROOM DOORS Doors should be non-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
  • 13.
    PHYSICAL FACILITIES EXTERIOR 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. FLOORS • Floors should be smooth, moisture proof, nonabsorbent, skid-proof, resistant to acid solvents, adverse effects of detergents and disinfectants. WALLS & CEILINGS • Walls should be free of cracks, unsealed utility penetrations, or imperfect junctions with doors, ceilings, floors and corners. • Surface materials should be capable off withstanding scrubbing with detergents and disinfectants. STORAGE AREAS • Separate storage areas should be designed for feed, bedding, cages and materials not in use.
  • 14.
    RECORD KEEPING The AnimalHouse should maintain following records: • Animal House plans, which includes typical floor plan. • Animal House staff record – both technical and non – technical • Health record of staff/ animals • All SOPs relevant to the animals • Breeding, stock, purchase and sales records • Records of experiments conducted with the number of animals used • Death Record • Clinical record of sick animals.
  • 15.
    STANDARD OPERATING PROCEDURES(SOPs) / Guidelines A SOP should contain the following items: • Name of the Author • Title of the SOP • Date of preparation • Reference of previous SOP on the same subject anddate (Issue no and Date) • Objectives • Detailed information of the instruments used in relation with animals with methodology (Model no., • Serial no., Date of commissioning, etc.)
  • 16.
    DISPOSAL The transgenic andknockout 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
  • 17.
    ANAESTHESIA AND EUTHANASIA Thescientists should ensure that the procedures, which are considered painful, are conducted under appropriate anesthesia as recommended for each species of animals.  It must also be ensured that the anesthesia is given for the full duration of experiment and at no stage the animal is conscious to perceive pain during the experiment.  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.
  • 18.
    ANAESTHESIA Local anaesthetics areused to block the nerve supply to a limited area and are used only for minor and rapid procedures. A number of General anaesthetic agents are used in the form of inhalants.  General anaesthetics are also used in the form of intravenous or intramuscular injections such as barbiturates. The animal should remain under veterinary care till it completely recovers from anaesthesia.
  • 19.
    EUTHANASIA Euthanasia is resortedto events where an animal is required to be sacrificed on termination of an experiment or otherwise for ethical reasons. The procedure should be carried out quickly and painlessly in an atmosphere free from fear or anxiety
  • 20.
    EUTHANASIA • The methodshould in all cases meet the following requirements: (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.
  • 21.
    ICMR Guidelines • ICMR– Indian council of Medical Research • The most commonly used animals in Colleges/ research institutions are: Frog , Mouse, Rat, Hamster ,G.Pig , Rabbit ,Cat Dog Monkey Sheep • The guidelines same as that of in CPCSEA: 1. Procurement of animals 2. Food and water 3. Sanitation and cleanliness 4. Veterinary care( as per cpcsea guidelines) a. Personnel hygiene b. Records keeping
  • 22.
    INSA GUIDELINES • INSA-INDIAN NATIONAL SCIENCE ACADEMY .The Indian National Science Academy (INSA) in New Delhi is the apex body of Indian scientists representing all branches of science and technology. • In India, the need to develop guidelines for the use of animals in research has been discussed at various forums. Unfortunately no standard document was available for reference till 1992 when the • Indian National Science Academy developed the guidelines for use of animals in scientific research. • Considering the knowledge generated internationally over the years and the guidelines of WHO, • NIH associated NRC, USA and European Union, the INSA guidelines have been updated.
  • 23.
    OBJECTIVES To provide guidelinesfor 1. housing, care, breeding and maintenance of experimental animals to keep them in physical comfort and good health and to permit them to grow, reproduce and behave normally; 2. sources of experimental animals of known genetic, health and nutritional status; 3. development of training facilities for scientists, technicians and other supportive staff for the care of animals and their use in experiments; 4. acceptable experimental techniques and procedures for anesthesia and euthanasia; 5. developing alternate in-vitro systems to replace animal experiments; 6. the constitution of institutional ethics committees, their functions and the legal and ethical obligations to ensure minimal and ethical use of animals.
  • 24.
    References: • CPCSEA ,ICMR, and Helsinki guidelines • cpcsea.nic.in • icmr.nic.in/bioethics/final • INDIAN NATIONAL SCIENCE ACADEMY, Published by S. K. Sahni, Executive Secretary, Indian National Science Academy,