COMMITTEE FOR THE PURPOSE OF CONTROL AND

SUPERVISION OF EXPERIMENTS ON ANIMALS

(CPCSEA)

Presented By :
Dr. Nisha H. Khobragade
 Established under
chapter 4, Section
15(1) of prevention of
cruelty to animal act
1960

It is Statutory Committee
of Department Of Animal
Husbandry and Dairying,
Ministry Of Fisheries,
Animal Husbandry And
https://cpcsea.nic.in/
Dairying, Government Of
India.
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 GOAL

• The goal of these Guidelines is to promote the humane care of animals.

• Testing with the basic objective of providing specifications that will enhance animal
well being.

• Quality in the pursuit of advancement of biological knowledge that is relevant to

humans and animals.

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 VETERINARY CARE

◦ Daily observation of animals health, behavior, and well being.

◦ The veterinarian can also help the establishment in designing appropriate policies and
procedures.
◦ The use of appropriate methods to prevent and control diseases operative and post-
operative care, diagnosis and treatment of diseases as well as injuries.
◦ Reviewing protocols and proposals, animal husbandry and animal welfare.
◦ Monitoring occupational health hazards containment, and zoonosis control programs.
◦ Supervising animal nutrition and sanitation.

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 ANIMAL PROCUREMENT
◦ All animals (like cattle, buffalo, sheep, goat, pigs, equine
etc.) must be acquired lawfully as per the CPCSEA
guidelines.
◦ Small animals and dogs can be procured from registered
breeders. Large animals can be procured from farm,
farmers or as per guidance of wild life department.
◦ Cats can be bred for their use.
◦ Rodents can be imported from abroad after necessary
license from Director General of Foreign trade (DGFT)
is obtained for import.
◦ A health surveillance program for screening incoming
animals should be carried out before purchase to assess
animal quality.
◦ Methods of transportation should also be taken into
account.

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 QUARANTINE, STABILIZATION AND SEPARATION

QUARANTINE STABILIZATION

✓ Separation of newly received animals. ✓ Physiologic, psychologic and

✓ Minimizes the chance for introduction nutritional stabilization before their
of pathogens. use.
✓ Small lab animals is from one week to ✓ Depend on the type and duration of
one month. animal transportation, the species
✓ Large animals allowed up to 6 weeks involved and the intended use of the
(cat, dog, monkey, etc.) animals.

SEPARATION

✓ Prevent interspecies disease transmission.

✓ Eliminate anxiety and possible physiological and behavioral changes.
✓ Housing different species in separate rooms.
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 SURVEILLANCE, DIAGNOSIS, TREATMENT AND CONTROL OF DISEASE
All animals should be observed for signs of illness, injury, or abnormal behavior by animal house staff.
It is imperative that appropriate methods be in place for disease surveillance and diagnosis.

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 ◦ Post-mortem examination and signs of illness, distress, or other deviations from
normal health condition in animals should be reported promptly.
◦ Animals that show signs of a contagious disease should be isolated from healthy
animals in the colony to ensure appropriate and timely delivery of
veterinary medical care.
◦ Animals suffering from contagious diseases like Tuberculosis etc. must be
euthanized as is practiced internationally to prevent its spread to other animals and
often animal handlers.
◦ Preventive medication programs should be initiated.
◦ Disease surveillance is a major responsibility of the veterinarian and should include
routine monitoring of colony animals for the presence of parasitic and
microbiological agents that may cause overt or unapparent disease.
◦ Diagnostic laboratory services must be available and used as appropriate

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 ANIMAL CARE AND TECHNICAL PERSONNEL
◦ Animal care programs require technical and husbandry support.
◦ Institutions should employ people trained in laboratory animal science.
◦ Qualifications & knowledge required for laboratory Attendant. (Annexure - 7)

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 PERSONAL HYGIENE
◦ Appropriate Personnel Protective Equipment (PPE)
e.g. showers, change of uniforms, footwear etc.
◦ Clothing suitable for use in the animal facility
should be supplied and laundered by the
institution.
◦ It is acceptable to use disposable gloves, masks,
head covers, coats, coveralls and shoe covers.
◦ Personnel should change clothing as often as is
necessary to maintain personal hygiene.
◦ Washing and showering facilities appropriate to the
program should be available.
◦ Personnel should not be permitted to eat, drink,
smoke or apply cosmetics and perfumes in animal
rooms.

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 ANIMAL EXPERIMENTATION INVOLVING HAZARDOUS
AGENTS

Institutional Bio-safety Committee whose

members are knowledgeable about
hazardous agents are in place in most of the
higher-level education, research institutes
and in many pharmaceutical industries for
taking care of safety issues.

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 MULTIPLE SURGICAL PROCEDURES ON SINGLE ANIMAL
◦ Multiple surgical procedures on a single animal for any testing or experiment are not to be
practiced unless specified in a protocol only approved by the IAEC.
◦ Individual animals should not be used in more than one experiment.
◦ Animal permitted to recover fully from the first experiment before the subsequent experiment
is performed.

DURATIONS OF EXPERIMENTS

No animal should be used for experimentation for more than 3 years unless adequate justification
is provided.

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 PHYSICAL RESTRAINT
o Manually or with devices be suitable in size and design for the animal being held and operated properly to
minimize stress and avoid injury to the animal.
o Prolonged restraint of any animal, should be avoided unless essential to the research objectives.
o Less restrictive systems, such as the tether system or the pole and collar system should be used when
compatible with research objectives.

Following points should be considered during handling and

restraining animals:-
✓Handled by competent individuals trained in methods that cause
minimal distress and injury.
✓Restraint device should be use minimum.
✓Extent, for the minimum period required to accomplish the
purpose of the experiments and the appropriate of the animals.
✓Tranquilizers or anesthetics may initially be used to aid restraint
but they may prolong recovery from the procedure. When these
agents have been used, recovery of the animals should be closely
monitored.
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 LOCATION OF ANIMAL FACILITIES TO LABORATORIES

◦ Good animal husbandry and human comfort and health protection require physical separation
of animal facilities from personnel areas such as offices, break room, training and education room.
◦ It should not exposed to dust, smoke, noise, wild rodents, insects and birds.
◦ The building, cages and environment of animal rooms are the major factors, which affect the
quality of animals.
◦ The animal rooms should occupy about 50-60% of the total constructed area and the remaining
area should be utilized for services such as stores, washing, office and staff, machine rooms,
quarantine and corridors.
◦ The environment of animal room (Macro-Environment) and animal cage (Microenvironment) are
factors on which the production and experimental efficiency of the animal depends.
◦ Since animals are very sensitive to environmental changes, sharp fluctuations in temperature,
humidity, light, sound and ventilation should be avoided.

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 FUNCTIONAL AREAS
◦ Ensure separation of species or isolation of individual projects when necessary.
◦ Receive, quarantine, and isolate animals; and Provide for animal housing.
◦ 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 or Equipment,
if hazardous biological, physical, or chemical agents are to be used.
◦ Receiving and storage areas for food, bedding.
◦ Pharmaceuticals and biologics, and supplies. Space for administration, supervision, and direction of
the facility. Showers, sinks, lockers and toilets for personnel. An area for washing and sterilization
equipment and supplies, An autoclave for equipment Food, and bedding; and separate areas.
◦ For holding soiled and cleaned equipment. An area for repairing cages and equipment.
◦ An area to store wastes prior to incineration or removal.

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 PHYSICAL FACILITIES
◦ Housing facility should be compatible with the needs of the species to be housed.
◦ Housing Facilities should be designed and operated to facilitate control of environmental factors to exclude vermin and
limit contamination associated with the housing of animals, delivery of food, water, bedding, and the entry of people
and other animals.
◦ Walls and floors should be constructed of durable materials with surfaces that can be cleaned and disinfected readily.
◦ Clean and tidy and operated to achieve maximum possible hygiene.
◦ There should be a pest control programme to monitor and control vermin.
◦ There should be adequate and appropriate storage areas for food, bedding and equipment.
◦ Deodorants designed to mask animal odours should not be used in Housing Facilities as they may expose animals to
volatile compounds which can alter metabolic processes.
◦ There should be proper water supply and drainage.
◦ Cleaning practices should be monitored on a regular basis to ensure effective hygiene and
sanitation.
◦ There should be adequate contingency plans to cover such emergencies as flooding and fire, or
the breakdown of lighting, heating, cooling or ventilation.
◦ Unauthorized persons should be restricted
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 ENVIRONMENT

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 ANIMAL HUSBANDRY
The housing system should
✓Provide space that is adequate, permit freedom of movement and normal
postural adjustments, and have a resting place appropriate to the species;
Provide a comfortable environment.
✓Provide an escape proof enclosure that confines animal safety.
✓Provide easy access to food and water.
✓ Provide adequate ventilation.
✓Meet the biological needs of the animals, e.g., maintenance of body
temperature, urination, defecation, and reproduction.
✓Keep the animals dry and clean, consistent with species requirements.
✓ Facilitate research while maintaining good health of the animals.
✓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.

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 SOCIAL ENVIRONMENT

◦ Includes all interactions among individuals of a group or among those able to communicate.
◦ Animals are naturally territorial or communal and accordingly they should be housed single or
in groups.
◦ In grouping animals, it is important to take into account population density and ability to
disperse; initial familiarity among animals; and age, sex, and social rank.
◦ Population density can affect reproduction, metabolism, immune responses, and behavior.

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 ACTIVITY

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 FOOD
o Palatable, non contaminated, and nutritionally adequate food daily unless the experimental protocol
requires.
o Food should contain adequate nutrition, with proper formulation and preparation
o The animal feed should contain moisture, crude fiber, crude protein, essential vitamins, minerals, crude fat
and carbohydrate for providing appropriate nutrition.
o Areas in which diets are processed or stored should be kept clean and enclosed to prevent entry
of insects or other animals.
o Diet should ideally be free from heavy metals (e.g., Lead, Arsenic, Cadmium, Nickel, Mercury), naturally
occurring toxins and other contaminants
o Exposure to extremes of relative humidity, unsanitary conditions, light, oxygen, and insects hasten the
deterioration of food.

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 BEDDING
o Bedding should be absorbent, free from toxic chemicals or other substances that cause irritation,
injure animals or personnel, and of a type not readily eaten by animals.
o Bedding should be removed and replaced periodically with fresh materials
o In general it is ideal to change the bedding twice a week or whenever requires.

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 SANITATION AND CLEANLINESS

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 ASSESSING THE EFFECTIVENESS OF
SANITATION
◦ Sanitation practices should be monitored appropriately to ensure effectiveness of the process
and materials being cleaned; it can include visual inspection of the materials, monitoring of
water temperatures, or microbiologic monitoring.
◦ The intensity of animal odors particularly that of ammonia should not be used as the sole
means of assessing the effectiveness of the sanitation program.
◦ A decision to change the frequency of such bedding changes or cage washing should be based
on factors such as the concentration of ammonia, appearance of the cage, condition of the
bedding and number and size of the animals housed in the cage.
◦ Autoclaving : Chemical Indicator - batch wise assessment; Biological indicator – Periodical
assessment.

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 WASTE DISPOSAL AND PEST CONTROL

◦ Wastes should be removed regularly and frequently. All waste should be collected and disposed
off in a safe and sanitary manner. The most preferred method of waste disposal is incineration.
◦ Waste containers containing animal tissues, carcasses, and hazardous wastes should be lined
with leak - proof, disposable liners.
◦ The waste storage area should be separated from other storage facilities and free of flies,
cockroaches, rodents, and other vermin.
◦ Hazardous wastes should be rendered safe by disinfection, decontamination, or other
appropriate means before they are disposed off from an animal facility.
◦ Adaptation of Programs designed to prevent, control, or eliminate the presence of or
infestations by pests are essential in an animal home environment.

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 EMERGENCY, WEEKEND AND HOLIDAY CARE

◦ There should be an institutional policy to care animals by qualified personnel

every day, including weekends and holidays, to safeguards their well - being
including emergency veterinary care.
◦ In the event of an emergency, institutional security personnel and fire or police
officials should be able to reach responsible persons for the animals.
◦ A disaster plan that takes into account both personnel and animals should be
prepared as part of the overall safety plan for the animal facility.

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 RECORD KEEPING
It is essential that animal House should maintain following records:
✓Animal House plans, which includes typical floor plan, all fixtures etc.
✓Animal House staff record - both technical and non – technical.
✓Health record of staff and animals.
✓All SOPs relevant to experiments, care, breeding and management of animals.
✓Breeding, stock, purchase and sales records.
✓Minutes of institutional Animals Ethics Committee Meetings.
✓Records of experiments conducted with the number of animals used (copy of Form D).
✓Mortality, Post-mortem Record, wherever required.
✓Clinical record of sick animals.
✓Training record of staff involved in animal activities.
✓Water, feed and bedding materials analysis report.
✓Health monitoring Records.

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✓Rehabilitation Records, wherever required. 31
 STANDARD OPERATING PROCEDURES
The Institute should maintain SOPs describing procedures / methods adapted with regard to Animal
Husbandry, maintenance, breeding, animal house activities microbial testing and experimentation.
A SOP should contain the following items:
◦ Name of the Author
◦ Title of the SOP
◦ Date of approval
◦ Reference of previous SOP on the same subject and date (Issue number and Date).
◦ Location and distribution of SOP’s with sign of each recipient.
◦ Objectives
◦ Detailed information of the instruments used in relation with animals with methodology (Model no.,
Serial no., Date of commissioning, etc.)
◦ The name of the manufacturer of the reagents and the methodology of the analysis pertaining to animals.
◦ Normal value of all parameters.
◦ Hazard identification and risk assessment.
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 PERSONNEL AND TRAINING
◦ The selection of animal facility staff, particularly the staff working in animal rooms or involved in
transportation, is a critical component in the management of an animal facility.
◦ The staff must be provided with all required protective clothing (face masks, head covers, aprons, gloves,
gumboots, other footwear etc.) while working in animal rooms. Facilities should be provided for change over
with lockers, wash basin, toilets and bathrooms to maintain personal hygiene. It is also important a regular
medical check-up is arranged for the workers to ensure that they have not picked up any zoonotic infection and
also that they are not acting as a source of transmission of infection to the animals. The persons working in
animal house should not eat, drink, smoke in animal room and have all required vaccination, particularly
against Tetanus and other zoonotic diseases.
◦ Initial In-house training of staff at all levels is essential. A few weeks must be spent on the training of the
newly recruited staff, teaching them the animal handling techniques, cleaning of cages and importance of
hygiene, disinfection and sterilization. They should also be made familiar with the activities of normal healthy
and sick animals so that they are able to spot the sick animal during their daily routine check up of cages
(Annexure - 7)

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 TRANSPORT OF LABORATORY ANIMALS
◦ The transport of animals from one place to another is very important and must be undertaken with
care. The main considerations for transport of animals are, mode of transport, containers, animal
density in cages, food and water during transit, protection from transit infections, injuries and stress.
◦ The mode of transport of animals depends on the distance, seasonal and climatic conditions and the
species of animals. Animals can be transported by road, rail or air taking into consideration of above
factors. In any case the transport stress should be avoided and the containers should be of an
appropriate size so as to enable these animals to have a comfortable movement and protection from
possible injuries. Sometimes injuries can be avoided by reducing space but parallely decreasing time
of transportation.
◦ The food and water should be provided in suitable containers or in suitable form so as to ensure that
they get adequate food and more particularly fluid during transit. The transport containers (cages or
crates) should be of appropriate size and only a permissible number of animals should be
accommodated in each container to avoid overcrowding and infighting (Annexure - 4)

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 ANAESTHESIA AND EUTHANASIA
◦ The investigators 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 procedure. If at any stage during
the experiment the investigator feels that he has to abandon the experiment or he has inflicted
irrepairable injury, the animal should be humanely sacrificed. Neuromuscular blocking agents
must not be used without adequate general anesthesia (Annexure - 5).
◦ In the event of a decision to sacrifice an animal or termination of an experiment or otherwise
an approved method of euthanasia should be adopted (Annexure - 6) and 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.

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 ANAESTHESIA
◦ Unless contrary to the achievement of the results of study, sedatives, analgesics and anaesthetics should
be used to control pain or distress under experiment. Anaesthetic agents generally affect cardiovascular,
respiratory and thermo-regulatory mechanism in addition to central nervous system.
◦ Before using actual anaesthetics the animals are prepared for anaesthesia by overnight fasting and using
pre anaesthetics, which block parasympathetic stimulation of cardio-pulmonary system and reduce
salivary secretion. Atropine is most commonly used anti-cholinergic agent. Local or general anaesthesia
may be used, depending on the type of surgical procedure.
◦ Local anaesthetics are used to block the nerve supply to a limited area and are used only for minor and
rapid procedures. This should be carried out under an expert supervision for regional infiltration of
surgical site, nerve blocks and for epidural and spinal anaesthesia.
◦ A number of general anaesthetic agents are used in the form of inhalants. General anaesthetics are also
used in the form of intravenous or intra-muscular injections such as barbiturates. Species characteristics
and variation must be kept in mind while using an anaesthetic. Side - effects such as excess salivation,
convulsions, excitement and disorientation should be suitably prevented and controlled. The animal
should remain under veterinary care till it completely recovers from anaesthesia and postoperative stress.

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 EUTHANASIA
◦ Euthanasia should be resorted to events where an animal is required to be sacrificed to reduce suffering or to
limit spread of infections or for termination of an experiment or for other ethical reasons. The procedure should
be carried out quickly and painlessly in an atmosphere free from fear or anxiety. For accepting an euthanasia
method as humane it should have an initial depressive action on the central nervous system for immediate
insensitivity to pain. The choice of a method will depend on the nature of study, the species of animal to be killed
(Annexure - 6). The method should in all cases meet the following requirements:
1. Death, without causing anxiety, pain or distress with minimum time lag phase.
2. Minimum physiological and psychological disturbances.
3. Compatibility with the purpose of the study and minimum effect of the operator.
4. Location should be separated from the animal room and free from environmental contaminated.
Tranquilizers have to be administered to larger species such as monkeys, dogs and cats before a procedure of
euthanasia.

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 LABORATORY ANIMAL ETHICS

◦ All scientists working with laboratory animals must have a deep

ethical consideration for the animals they are dealing with. From
the ethical point of view, it is important that such considerations are
taken care at the individual level, at institutional level and finally at
the national level. Interaction amongst people working in animal
house should be organized once in a while to discuss ethical issues
favoring wellbeing of animals

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 TRANSGENIC ANIMALS
◦ Transgenic animals are those animals, into whose germ line foreign gene(s)
have been engineered, whereas knockout animals are those whose specific
gene(s) have been disrupted leading to loss of function. These animals can be
bred to establish transgenic animal strains. Transgenic animals are used to
study the biological functions of specific genes, to develop animal models for
diseases of humans or animals, to produce therapeutic products, vaccines and
for biological screening, etc. These can be either developed in the laboratory or
procured for R&D purpose from registered scientific/academic institutions or
commercial firms, generally from abroad with approval from appropriate
authorities.

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 MAINTENANCE
◦ Housing, feeding, ventilation, lighting, sanitation and routine management
practices for such animals are similar to those for the other animals of the
species as given in guidelines. However, special care has to be taken with
transgenic/gene knockout animals where the animals can become susceptible
to diseases where special conditions of maintenance are required due to the
altered metabolic activities. The transgenic and knockout animals carry
additional genes or lack genes compared to the wild population. To avoid the
spread of the genes in wild population, care should be taken to ensure that
these are not inadvertently released in the wild to prevent cross breeding with
other animals. The transgenic and knockout animals should be maintained in
clean room environment or in animal isolators.

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 DISPOSAL

◦ The transgenic and knockout animals should be first euthanized and then
disposed off as described elsewhere in the guidelines. A record of disposal and
the manner of disposal should be kept as a matter of routine.

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 BREEDING AND GENETICS

◦ For initiating a colony, the breeding stock must be procured from established
breeders or suppliers ensuring that genetic makeup and health status of animal
is known. In case of an inbred strain, the characters of the strain with their gene
distribution and the number of inbred generation must be known for further
propagation. The health status should indicate their origin, e.g. conventional,
specific pathogen free or transgenic, gnotobiotic or knockout stock.

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 REFERENCES
◦ https://cpcsea.nic.in/

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