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Animal Experimentation Regulations: A Review

Scope of Animals in Experiments

  • Fundamental biological, medical research
  • Development of new treatment for diseases
  • Safety testing
  • Breeding of laboratory animals
  • Development of new methods of diagnosis

Why Animals Used in Research

  • Anatomy and physiology similar to humans and other animals
  • Susceptible to the same diseases that affects humans
  • Short life span allows animals to be studied throughout their entire life
  • Environment easily controllable to keep experimental variables to minimum

Area of Concern in Scientific Research involving Animal

  • Extremist Animal  Experimenters
  • Extremist Animal Supporters
  • Polarisation of views between animal welfare activists and research scientists

Animal Experimentation: Ethical Issues

  • Why animals?
  • Any alternative?

Cell Culture SystemHuman Volunteers

Computers

New Imaging Techniques

In Vitro Models

  • How they are housed, handled and used?

Animal Experimentation: The Concept of 4 R’s

[Russell and Burch (1959)]

  1. Refinement: Use of methods to enhance animal welfare and minimising animal pain and suffering
  2. Replacement: Use of non-animals methods
  3. Reduction: Use methods enabling

Obtaining comparable data from fewer animals

More data from same number of animals

Animals genetically engineered to be susceptible to human conditions

4.   Rehabilitation: Aftercare and/or rehabilitation of animals post-experimentation

Pre-requisite for all animal Experiments

  • Strong scientific need.
  • Adequate animal care.
  • Compliance to Government regulation.

Government Regulation

  • Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) is the apex body in India.
  • Each animal house has to be registered with CPCSEA.
  • Institutional Animal Ethics Committee (IAEC) approval is mandatory for conducting animal experiments.
  • All Animals need to be maintained as per the guidelines of CPCSEA.
  • Import/Export of animals need license.

Guidelines on the regulation of scientific experiments on animals

Ministry of Environment & Forests

(Animal Welfare Division)

Government of India

June 2007

Aim:

To ensure humane and ethical treatment of animals, while facilitating legitimate scientific research involving experiments on animals

Evolution of Guidelines

  • CPCSEA stands for Committee for the Purpose of Control and Supervision of Experiments on Animals.
  • CPCSEA is a statutory body under the Prevention of Cruelty to Animal Act, 1960, in the Ministry of Environment and Forests.
  • Based on the report of a consultative Group set up by Government, CPCSEA in its meeting held on 20 December 2004 formed the basis of the Breeding of and Experiments on Animals (control and supervision) Amendment rules, 2006.

Statutory provisions

Scientific experiments on animals must conform to the Prevention of Cruelty to Animal Act, 1960, and the Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998, as amended. Laboratory animal facility should also comply with CPCSEA Guidelines.

Ethical Principles adopted by CPCSEA

Principle 1

Purpose

New discovery of knowledge useful

  • For saving or prolonging human life
  • Combating disease of human being, animals or plants

Principle 2

Choice of Animal

  • Animals lowest on the phylogenetic scale should be used
  • Design with the minimum number of animals to give statistically valid results at 95% level of confidence
  • Alternatives not involving animal testing should be given due and full consideration

Principle 3

Proper use of animals

  • Avoidance or minimization of pain and suffering inflicted on experimental animals should be an issue of priority for research personnel
  • Procedures that may cause more than momentary or slight pain and/or suffering should be performed with appropriate sedation, analgesia or anesthesia.

Principle 4

Aftercare and/or Rehabilitation

Investigators responsible for the aftercare and/or rehabilitation.

Euthanize

  • If paralyzed and is not able to perform its natural functions
  • Experimental procedure leave the animal with a severe recurring pain
  • In situations where nontermination of the animal experimented upon would be life threatening to human beings or other animals
  • Cost of aftercare and/or rehabilitation of animals are to be part of research costs

Principle 5

Facility for Animals

  • The living condition of animals should be appropriate for their species
  • The housing, feeding and care of all animals must be directed by a veterinarian or other specialist in a relevant discipline.

Powers of Animal Ethics Committee (AEC)

IAEC is not empowered to clear research project proposals that involve experiments on animals higher on the phylogenetic scale than rodents.

Inspection of animal house facility

  • Both announced and unannounced visits by duly authorized person (only) to inspect the animal house facilities may be carried out.
  • The personnel undertaking inspection may not impose any penalty, but must report their findings to the CPCSEA for further action.

Procedures for approval of scientific experiments on animals

  • “Experiments” mean any programme or project involving-animal(s) for the acquisition of knowledge the use of animal(s) in the production of reagents and products such as antigens and antibodies, routine diagnostics, testing activity and establishment of transgenic stocks.
  • The relative sentience of different species of animals subject to regulation are as follows:

Invertebrate < Birds <Rodents <Canines / Felines < Bovine / Equine < Primates (e.g.Rhesus Macaque) < More evolved Primates (e.g. Chimpanzee)

Anything higher than invertebrates in terms of level of sentience requires regulation.

Functions of CPCSEA

  • Registration of establishments.
  • Selection and appointment of nominees in the IAEC
  • Approval of Animal House Facilities
  • Permission for conducting experiments
  • Recommendation for import of animals
  • Action against establishments in case of violation of any legal norm/stipulation.

Contact address:

Member Secretary, CPCSEA,

Ministry of Environment & Forests,

8th floor, Jeevan Prakash Building,

25, Kasturba Gandhi Marg,

New Delhi-110 001

Tel: 011-2331-8553,

Fax :011-2331-8137

E-mail: cpcsea@rediffmail.com

Website: www.envfor.nic.in

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