The document summarizes guidelines from the Committee for the Purpose of Control and Supervision on Experiments on Animals (CPCSEA) regarding the care and use of animals for research purposes. It outlines provisions for veterinary care, quarantine, food/water/bedding, sanitation, facilities, transportation, anesthesia, euthanasia, record keeping, and standard operating procedures. The guidelines aim to promote the humane treatment of laboratory animals used for biomedical and behavioral research experiments.
The document is all about the SOP for handling and caring for animal house. the sop is prepared by considering rat and mice housing for pharmacological experiments.
This presentation include the guidelines related to the pre-clinical trial on animals. animal ethics committee , act and rules , animal care requirements .
Pharmaceutical Jurisprudence. Based on the PCI Syllabus. Ethics to be considered for handling the animals in experiments. Reference from Pharmaceutical Jurisprudence by B. M. Mithal.
The document is all about the SOP for handling and caring for animal house. the sop is prepared by considering rat and mice housing for pharmacological experiments.
This presentation include the guidelines related to the pre-clinical trial on animals. animal ethics committee , act and rules , animal care requirements .
Pharmaceutical Jurisprudence. Based on the PCI Syllabus. Ethics to be considered for handling the animals in experiments. Reference from Pharmaceutical Jurisprudence by B. M. Mithal.
Animal Testing: Rationale for conducting studies, CPCSEA Guidelines
The use of animals in research is currently an essential component of the drug discovery process.
Animals help us advance our scientific understanding, serve as models to study disease, help us develop and test potential new medicines and therapies.
Animal testing has benefited researchers in understanding how to treat and prevent various conditions such as high blood pressure, diabetes, tuberculosis, polio, muscular dystrophy, and Parkinson's disease.
Education:
Undergraduate teaching to demonstrate effects of various drugs although this has been phased out in most institutes.
Postgraduate teaching to demonstrate the effects of various drugs, to determine the nature of an unknown drug for bioassay, screening methods and to learn skills e.g. administering drugs.
Research:
A larger number and a greater variety of animals are used in pure research than in applied research. This usually involves studies on embryogenesis, developmental biology, behaviour and breeding in Fruit flies, nematodes, mice and rats.
INTRODUCTION
The motto of Prevention of Cruelty to Animals (PCA) Act 1960 as amended in 1982 is to prevent infliction of unnecessary pain or suffering on animals.
The Central Government has constituted a Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), which is duty bound to take all such measures as may be necessary to ensure that animals are not subjected to unnecessary pain or suffering before, during or after the performance of experiments on them.
The goal of these guidelines is to promote the human care of animal used in biomedical and behavioural research and testing.
To avoid/minimize pain and suffering inflicted on experimental animals
Inspection of animal house facilities
It provides guidelines for -
Proper care, housing, breeding, maintenance, handling and use of experimental animals.
Source of experimental animals
Acceptable experimental procedures for anaesthesia and euthanasia.
Registration of establishments conducting animal experimentation or breeding of animals for this purpose.
Selection and assignment of nominees for the Institutional Animal Ethics Committees (IAEC) 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.
To assure quality maintenance and safety of animals used in laboratory studies while conducting biomedical and behavioural research and testing of products.
Quarantine
2. Personal hygiene
3. Environment
4. Physical facility
5. Animal husbandry
6. Animal disposal
7. Documentation
• The Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) is a statutory Committee of Department of Animal Husbandry and Dairying (DAHD), Ministry of Fisheries, Animal Husbandry and Dairying (MoFAH&D) constituted under the Prevention of Cruelty to Animals (PCA) Act, 1960.
• CPCSEA is duty bound to take all such measures as may be necessary to ensure that animals are not subjected to unnecessary pain or suffering before, during or after performance of experiments on them.
INTRODUCTION
• For this purpose, the Committee formulated the Breeding of and Experiments on Animals (Control & Supervision) Rules, 1998 (amended in 2001 & 2006) to regulate the experimentation on animals.
• Under the provisions of the above rules, establishments who are engaged in Bio-medical research, breeding and trading of laboratory animals are required to get themselves registered with CPCSEA.
• There are 19 members in the present CPCSEA wherein Dr. O. P. Chaudhary, Joint Secretary (Animal Welfare) is the Chairman of CPCSEA and Dr. S. K. Dutta, Joint Commissioner (Animal Welfare) is the Member Secretary of CPCSEA.
Need of cpcsea
FUNCTIONS
Institutional Animals Ethics Committee (IAEC)
(a) Every experiment shall be performed by or under the supervision of a person duly qualified.
(b) That experiments are performed with due care and humanity and as far as possible experiments involving operations are performed under the influence of some anaesthetic of sufficient power to prevent the animals from feeling pain;
(c) That animals who, in the course of experiments under the influence of anaesthetics, are so injured that their recovery would involve serious suffering, are ordinarily medically allowed to death while still under influence of anaesthetic;
(d) That experiments on animals are avoided wherever it is possible to do so.
(e) That experiments on larger animals are avoided when it is possible to achieve the same results by experiments on small laboratory animals like guinea-pigs, rabbits, mice, rats etc;
(f) That, as far as possible, experiments are not performed merely for the purpose of acquiring manual skill;
(g) That animals intended for the performance of experiments are properly looked after before, during and after experiments;
(h) That suitable records are maintained with respect to experiments performed on animals
Members of iaec
• A. IAEC members from the establishment (05 members):
• i. One biological scientist
• ii. Two scientists from different biological disciplines
• iii. One veterinarian involved in the care of animal
• iv. One scientist in charge of animal facility of the establishment concerned
• B. Nominees from the CPCSEA:
• i. Main Nominee (01)
• ii. Link Nominee *
• iii. Scientist from outside the Institute (01)
• iv. Socially Aware Nominee (01)
Institutional Biosafety Committee (IBSC)
• Institutional Biosafety Committee (IBSC) is to be constituted in all centers engaged in genetic engineering researc
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CPCSEA Guidelines
1. Presented by:
ABIN JOY
1st M-PHARM
Dept. of
Pharmacology
CPCSEA GUIDELINES
Committee for the Purpose of Control and Supervision
on Experiments on Animals
1
3. The goal of these Guidelines is to promote the
humane care of animals used in biomedical and
behavioral research.
These guidelines provide the basic provisions for
animal care in using animals for teaching or
research purposes. 3
4. VETERINARY CARE
Adequate veterinary care must be
provided and is the responsibility of a
veterinarian or a person who has training or
experience in laboratory animal sciences
and medicine.
QUARANTINE, STABILIZATION AND
SEPARATION
Quarantine is the separation of newly received
animals from those already in the facility until the
health and possibly the microbial status of the
newly received animals have been determined. 4
5. 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. 5
6. SANITATION AND CLEANLINESS
Animal rooms, corridors, storage spaces
and other areas should be cleaned with
appropriate detergents and disinfectants.
ANIMAL CARE AND TECHNICAL PERSONNEL
Animal care programs require technical and husbandry
support. Institutions should employ people trained in
laboratory animal science to ensure effective
implementation of the program.
6
7. 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.
DURATIONS OF EXPERIMENTS
No animal should be used for experimentation for
more than 3 years unless adequate justification is
provided.
7
8. 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 of
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. 8
9. PHYSICAL FACILITIES
Building materials should be selected to facilitate efficient
and hygienic operation of animal facilities. Durable,
moisture-proof, fire-resistant, seamless materials 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.
9
10. 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. 10
11. 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.
11
12. 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 of withstanding scrubbing
with detergents and disinfectants.
STORAGE AREAS
Separate storage areas should be designed for
feed, bedding, cages and materials not in use.
12
13. 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.
The Animal House should maintain following records:
13
RECORD KEEPING
14. Name of the Author
Title of the SOP
Date of preparation
Reference of previous SOP on the same subject and
date (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.)
STANDARD OPERATING PROCEDURES
(SOPs) / Guidelines
A SOP should contain the following items:
14
15. 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.
15
16. ANAESTHESIA AND EUTHANASIA
The scientists should ensure that the procedures, which
are considered painful, are conducted under appropriate
anaesthesia as recommended for each species of animals.
It must also be ensured that the anaesthesia 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. 16
17. 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. 17
19. 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.
19
20. 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.
20