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.