The Rules for animal experimentation and certain flaws...

Of all the gifts only one is supreme and that is freedom from fear

All scientists working with laboratory animals must have a deep ethical consideration for the animals they are dealing with.

These considerations are taken care of at the

individual level,

institutional level

and finally at the national level.

Experimentation

on animals in course of research and education

is covered by provisions of the

Prevention of Cruelty to Animals Act, 1960 and the Rules under the Act of 1998 and 2001.

Main Activities

(a) Registration of establishments for Breeding of animals

(b) Registration of establishments for experiments on animals

(c) Approval of Animal House Facilities

(d) Permission of Committee for Conducting Experiments:

(e) Recommendation for import under Rule 10 (e) of Breeding of

and Experiments on Animals (Control and Supervision) Rules

1998 as amended in 2001 :

Committee for the Purpose of Control and Supervision of Experiments on

Animals

(CPCSEA)

Statutory body under the Prevention of Cruelty to Animals Act, 1960

Under these provisions:

* the concerned establishments should get registered with CPCSEA,

* get Animal House Facilities inspected

* get specific projects for research cleared before commencing them.

All animals must be acquired lawfully as per the CPCSEA guidelines.

QUARANTINE, STABILIZATION AND SEPERATION

Physiologic, psychological and nutritional stabilization before their use.

Every establishment, constituted and operated in

accordance with the procedures specified by the

CPCSEA, is required to constitute an

Institutional Animal Ethics Committee.

To each IAEC, a CPCSEA Nominee would be allotted

by the Government of India and nominees presence is

mandatory for every meeting.

Permission of Committee for Conducting Experiments

(a)No proposal for Animal Experimentation would be

entertained, unless the Animal House Facility of the

concerned establishment has been approved by competent

authority.

(b) The approval for experimentation on small animals will be

accorded by IAEC.

(c) Approval for experimentation on Large Animals will be

considered by SCLA on the recommendation of IAEC.

PHYSICAL PLANT:

The physical condition and design of animal facility

determine, the efficiency and economy of their operation.

The design and size of an animal facility depend on the

scope of institutional research activities animals to be housed, physical

relationship to the rest of the institution, and geographic location.

RECORD KEEPING

The 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/ animals

All SOPs relevant to the animals

Breeding, stock, purchase and sales records

Minutes of institute Animals Ethics Committee Meetings

Records of experiments conducted with the number of animals used (copy

of Form D)

Death Record

Clinical record of sick animals

Training record of staff involved in animal activities

Water analysis report

STANDARD OPERATING PROCEDURES (SOPs) The Institute shall maintain SOPs describing procedures / methods employed with

regard to Animal Husbandry, maintenance, breeding, animal house microbial analysis and

experimentation records.

A SOP should contain the following items:

Name of the Author

Date of preparation

Reference of previous SOP on the same subject and date (Issue no and Date)

Location and distribution of Sops 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

Transgenic animals

are those animals, into whose germ line foreign gene(s) have been engineered.

Knockout animals

are those whose specific gene(s) have been disrupted leading to loss of function.

Institutional Biosafety Committee (IBSC)Institutional Biosafety Committee (IBSC) is to be constituted in all

centers engaged in genetic engineering research and production activities.