[TO BE PUBLISHED IN THE
GAZETTE OF INDIA, EXTRAORDINARY, PART-II, SECTION-3, SUB-SECTION(ii) ]
____________________________________________________________________
New Delhi, the 23rd October, 2006.
S.O. 1818 (E). - Whereas certain draft rules to amend the
Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998
were published, as required by sub-sections(1), (1A) and (2) of section 17 of the
Prevention of Cruelty to Animals Act, 1960 (59 of 1960), under the notification
of the Government of India in the Ministry of Environment and Forests number
S.O.42(E) dated 10th January, 2006 inviting suggestions from all the
persons likely to be affected thereby, before the expiry of the period of
thirty days from the date on which copies of the Gazette containing the said
notification are made available to the public;
And whereas the said Gazette
was made available to the public on 10th January, 2006;
And whereas the
objections/suggestion received in respect of the said draft rules, have been
duly considered;
Now, therefore, in exercise
of the powers conferred by sub-section (1), (1A) and (2) of Section 17 of the
Prevention of Cruelty to Animals Act, 1960 (59 of 1960), the Committee for the
purpose of control and supervision of experiments on animals hereby makes the
following rules to amend the Breeding of and Experiments on Animals (Control
& Supervision) Rules, 1998, namely:-
1.
(1) These rules may be called
the Breeding of and Experiments on Animals (Control and Supervision) Amendment
Rules, 2006.
(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(s) for the acquisition of
knowledge of a biological, physiological, ethological, physical or chemical
nature; and includes 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, 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 animal(s) shall be responsible for the welfare of animal(s)
during their use in experiments;
(ii) investigators shall be
responsible for the aftercare and rehabilitation of animal(s) after
experimentation, and shall not euthanise animal(s) except in situations as
defined in clause (ff);
(iii) costs of aftercare and
rehabilitation of animal(s) 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 animal(s);
(iv) rehabilitation treatment of an animal 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(s) for experiments from
registered breeders only;
(ii) in case of non-availability of animal(s) from registered breeders,
the animal(s) 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 of 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 Secretary,
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.