THE GAZETTE OF INDIA :
EXTRAORDINARY
[PART II - SEC.3 (ii) ]
New Delhi, the 10th January,
2006.
S.O. 42(E)._____The
following draft of the Breeding of and Experiments on Animals (Control and
Supervision) Amendment Rules, 2005, which the Committee for the Purpose of
Control and Supervision of Experiments on Animals proposes to make, in exercise
of the powers conferred by sub-sections(1), (1A) and (2) of section 17 of the
Prevention of Cruelty to Animals Act, 1960 (59 of 1960), are hereby published
for information of all persons likely to be affected thereby, and notice is
hereby given that the said draft rules shall be taken into consideration after
the expiry of a period of thirty days from the date on which copies of the
Gazette of India containing this notification are made available to the public;
Any person desirous of making any suggestion or objection
in respect of the said draft rules may, within the period so specified, forward
the same for consideration of the said Committee, addressed to the Member
Secretary, Committee for the Purpose of Control and Supervision of Experiments
on Animals, Animal Welfare Division, Ministry of Environment and Forests, 8th
Floor, Jeevan Prakash Building, 25, Kasturba Gandhi Marg, New Delhi-110001.
1.
(1) These rules may be called
the Breeding of and Experiments on Animals (Control and Supervision) Amendment
Rules, 2005.
(2) They shall come
into force on the date of their final publication in the Official Gazette.
2.
In
the Breeding of and Experiments on Animals (Control and Supervision) Rules,
1998 (hereinafter referred to as the said rules), in rule 2, for clause (e),
the following clause shall be substituted, namely:-
‘(e) “Experiment” means any
programme or project involving use of animal for the acquisition of knowledge
of a biological, physiological, ethological, physical or chemical nature; and
includes the use of animal in the production of reagents and products such as antigens
and antibodies, routine diagnostics, testing activity and establishment of
transgenic stocks, for the purpose of saving or prolonging life or alleviating
suffering or significant gains in well being for people of the country or for
combating any disease whether of human beings or animals ;'
"(bb) animals lowest on the phylogenetic
scale which may give scientifically valid results should be first considered
for any experimental procedure and the experiment should be designed using
minimum number of animals to give statistically valid results at 95% degree of
confidence:
Provided that replacement
alternatives not involving experiments on animals should be given due and full
consideration and sound justification must be provided in case alternatives,
though available, are not used;” ;
"(cc) (i) personnel using experimental animals shall be
responsible for the welfare of animal during their use in experiments;
(ii) investigators shall be responsible for the
aftercare and rehabilitation of animal after experimentation, and shall not
euthanise animals except in situations as defined in clause (ff);
(iii) costs of aftercare and rehabilitation of
animal after experimentation shall be made part of research costs and shall be
scaled in positive correlation with the level of costs involved in such
aftercare and rehabilitation of the animals;
(iv) rehabilitation
treatment of animals after experimentation shall extend till the point the
animal is able to resume a normal existence by providing a lump-sum amount as
costs for rehabilitation and care of such animal to cover its entire
statistical expected life span; and
(v) the establishment undertaking experiments or
duly licensed and authorised animal welfare organization under the control of
the Committee may, on payment of lump-sum amount, undertake rehabilitation of animals;”;
(3) after
clause (f), the following clause shall be inserted, namely:-
"(ff) the
following parameters shall be adopted for application of euthanasia, namely:-
(i) when the
animal is paralyzed and is not able to perform its natural functions or it
becomes incapable of independent locomotion or it can no longer perceive the
environment in an intelligible manner; or
(ii) if during the
course of experimental procedure the animal has been left with a recurring pain
wherein the animal exhibits obvious signs of pain and suffering; or
(iii) where the
non-termination of the life of the experimental animal will be life threatening
to human beings or other animals;”.
4. In rule 10 of the said rules, -
(1) for clause (b), the following clause shall
be substituted, namely:-
“(b) (i) an establishment
shall acquire animal for experiments from registered breeders only;
(ii) in case of
non-availability of animal from registered breeders, the animal may be procured
from alternate legal sources;
(iii) in case the animal is procured from the alternate legal sources,
the same shall be procured after taking written permission from the authority
competent under the law for the time being in force, to give such permission;
and
(iv) the establishment
procuring such animal shall maintain a record in this regard and shall produce
the same before the Committee,
whenever required;” ;
“(e) In case an
animal is not available from a registered breeder or from alternate legal
sources within the country, genetically defined animals may be imported with
permission of Directorate General of Foreign Trade:
Provided that the condition of non-availability within the
country shall not apply for laboratory bred rats and mice of genetically
defined strains;”.
5. For rule 12 of the said rules, the following rule shall be substituted, namely:-
“12. Contract animal experiments. - Registered establishments may undertake
contract research on behalf of any
other agency in accordance with the Prevention of Cruelty to Animals Act, 1960
(59 of 1960) and the rules made thereunder.”.
6. In
rule 14 of the said rules, for clause (a), the following clause shall be
substituted, namely:-
“(a) The Committee, if it is satisfied with the
report of the Member-Secretary or the authorized officer of the Committee (made
to it as a result of any inspection or information received or otherwise) that
-
(i) the rules made by it are not being complied with
by an establishment or breeder; or
(ii) a violation of the directions of the Committee
has been committed by any establishment or breeder and the Committee’s
directions to rectify such violation have not been complied within the period
so specified,
the Committee may, by order in writing, suspend or
revoke the registration of the establishment or breeder and/or direct closure
of the animal house facility for such a period as may be specified in the
order:
Provided that no order under this clause shall be
made without giving the establishment or breeder any opportunity of being heard
in the matter:
Provided further that no order for suspension or
revocation of registration, or closure or animal house facility shall be issued
in a case of minor violation.
Explanation:- for the purposes of this clause, “minor violation” means an act of commission
or omission which does not have direct bearing on the health of an animal which
may not lead to adverse health effect or pain or suffering or death of an
animal.”.
[F.No.25/04/2005-AWD]
SOMYA T. DAVE,
Member-Secy.
(Committee
for the Purpose of Control
and
Supervision of Experiments on Animals)
Note:-
The principal rules were published in the Gazette of India, Extraordinary, vide
number S.O. 1074 dated
15th December, 1998 and subsequently amended vide
number S.O.134(E) dated 15th February, 2001.