CCSEA
CCSEA
COMMITTEE FOR CONTROL AND SUPERVISION OF EXPERIMENTS ON ANIMALS
CCSEA
MAHATHI COLLEGE OF PHARMACY (AUTONOMOUS)
Madanapalle, Andhra Pradesh
ABOUT CCSEA
The Committee for Control and Supervision of Experiments on Animals (CCSEA) is a statutory committee functioning under the Department of Animal Husbandry and Dairying (DAHD), Ministry of Fisheries, Animal Husbandry and Dairying, Government of India.
CCSEA has been constituted under the Prevention of Cruelty to Animals Act, 1960.
Its fundamental objective is to ensure that animals used for scientific purposes are not subjected to unnecessary pain or suffering before, during or after experimentation.
CCSEA & PHARMACEUTICAL RESEARCH
Animal experimentation, wherever scientifically justified and legally permitted, plays a role in certain areas of biomedical and pharmaceutical research.
CCSEA regulates establishments involved in animal experimentation and has responsibilities relating to:
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Registration and renewal of establishments
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Constitution and reconstitution of Institutional Animal Ethics Committees
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Approval of animal-house facilities
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Review of applicable research protocols
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Inspection of animal facilities
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Monitoring compliance with animal-welfare requirements
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Promotion of ethical laboratory-animal care
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Promotion of alternatives to animal experimentation
INSTITUTIONAL ANIMAL ETHICS COMMITTEE – IAEC
Institutional Animal Ethics Committee
The Institutional Animal Ethics Committee (IAEC) provides institutional-level ethical oversight of research involving laboratory animals in accordance with applicable CCSEA rules and guidelines.
The IAEC plays an important role in ensuring that proposed animal experiments are scientifically justified and that animal welfare and ethical requirements are appropriately considered.
OBJECTIVES OF IAEC
The Institutional Animal Ethics Committee aims to:
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Ensure ethical use of laboratory animals.
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Review research protocols involving animal experimentation.
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Ensure compliance with applicable CCSEA rules and guidelines.
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Minimize unnecessary use of experimental animals.
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Promote humane handling of laboratory animals.
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Ensure appropriate housing and animal-care practices.
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Minimize pain, distress and suffering.
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Encourage alternatives to animal experimentation wherever appropriate.
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Monitor approved animal research.
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Promote responsible and scientifically justified research.
THE PRINCIPLE OF 3Rs
An important foundation of ethical animal research is the internationally recognized principle of the 3Rs.
REPLACEMENT
Replace animals wherever possible.
Researchers should consider suitable alternative methods that avoid or replace the use of animals whenever scientifically appropriate.
Examples may include:
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In-vitro techniques
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Cell and tissue culture
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Computer-based methods
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Validated non-animal models
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Other appropriate alternative research methods
REDUCTION
Reduce the number of animals used.
The number of animals should be limited to the minimum scientifically necessary to obtain reliable and meaningful research results.
Appropriate experimental design and statistical planning are important components of Reduction.
REFINEMENT
Refine experimental procedures.
Experimental and animal-care procedures should be designed and performed to minimize:
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Pain
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Suffering
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Stress
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Distress
Appropriate housing, handling, veterinary care and humane experimental procedures should be followed.
ROLE OF THE IAEC
The Institutional Animal Ethics Committee reviews applicable research proposals involving laboratory animals before commencement of the study.
Its responsibilities include consideration of:
Scientific Justification
Whether the proposed use of animals is scientifically justified.
Number of Animals
Whether the number proposed is appropriate for achieving the scientific objectives.
Alternatives
Whether appropriate non-animal alternatives have been considered.
Animal Welfare
Whether adequate measures are proposed to protect the welfare of experimental animals.
Experimental Procedures
Whether procedures are planned according to applicable ethical and scientific requirements.
Monitoring
Monitoring of approved research involving animals according to applicable requirements.
IAEC COMPOSITION
The Institutional Animal Ethics Committee is constituted/reconstituted in accordance with the applicable CCSEA guidelines.
The committee incorporates scientific, veterinary and external/CCSEA representation as prescribed under the prevailing requirements.
The composition and tenure of the IAEC shall follow the latest constitution/reconstitution approval and applicable CCSEA guidelines.
IAEC MEETINGS
IAEC meetings are conducted according to applicable CCSEA requirements and the institution's approved Standard Operating Procedures.
Research proposals involving animal experimentation are placed before the committee for appropriate ethical review.
Important aspects considered during review may include:
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Scientific rationale
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Research objectives
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Experimental methodology
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Species proposed
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Number of animals
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Source of animals
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Animal housing
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Experimental procedures
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Pain and distress management
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Humane endpoints
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Alternatives to animal use
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3Rs compliance
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Post-experimental care, where applicable
LABORATORY ANIMAL FACILITY
The institutional laboratory-animal facility, where applicable, is maintained in accordance with relevant CCSEA requirements and approved institutional procedures.
Attention is given to:
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Appropriate animal housing
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Environmental conditions
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Hygiene and sanitation
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Feeding and drinking-water arrangements
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Veterinary care
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Quarantine requirements
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Animal health monitoring
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Record maintenance
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Experimental areas
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Waste disposal
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Personnel safety
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Animal welfare
RESEARCH ACTIVITIES
Subject to ethical approval and applicable regulations, research involving experimental models may contribute to areas such as:
Pharmacological Research
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Anti-inflammatory studies
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Analgesic studies
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Antidiabetic research
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Hepatoprotective research
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Neuropharmacology
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Cardiovascular pharmacology
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Gastroprotective studies
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Toxicological investigations
Natural Product Research
Scientific evaluation of pharmacological properties of medicinal plants, extracts and other research materials.
Preclinical Research
Research designed to generate scientific information regarding potential pharmacological activity and safety, where animal studies are scientifically justified and approved.
ANIMAL WELFARE & RESEARCH ETHICS
OUR COMMITMENT
Mahathi College of Pharmacy (Autonomous) is committed to promoting responsible scientific research with due consideration to:
Animal Welfare
Respectful and humane treatment of laboratory animals.
Scientific Integrity
Scientifically valid and appropriately designed research.
Research Ethics
Compliance with applicable ethical principles and regulatory requirements.
3Rs PRINCIPLE
Replacement • Reduction • Refinement
Regulatory Compliance
Adherence to applicable CCSEA rules, guidelines and approved institutional procedures.
REGULATORY FRAMEWORK
Animal experimentation in India is governed by the applicable legal and regulatory framework, including:
Prevention of Cruelty to Animals Act, 1960
Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998
and subsequent amendments, rules, notifications, orders and guidelines issued by the Government of India and CCSEA from time to time.
CCSEA
Committee for Control and Supervision of Experiments on Animals
Department of Animal Husbandry and Dairying
Ministry of Fisheries, Animal Husbandry and Dairying
Government of India