Whereas certain draft rules to amend the Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998 were published, as required by sub-section (1) of section 17 of the Prevention of Cruelty to Animals Act, 1960 (59 of 1960)

REGD. NO. D. L.-33004/99 The Gazette of India

EXTRAORDINARY

PART II—Section 3—Sub-section (ii)

PUBLISHED BY AUTHORITY

No. 92] NEW DELHI, THURSDAY, FEBRUARY 15, 2001/MAGHA26,1922

458 GI/2001

(02 THE GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC. 3(ii)] 3 4 THE GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC, 3(ii)] 5 6 THE GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC. 3(ii)1

MINISTRY OF SOCIAL JUSTICE AND EMPOWERMENT

NOTIFICATION

New Delhi, the 15th February, 2001

s.o. 134(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-section (1) 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 Social Justice and Empowerment number S.O. 168(E) dated the 18th February, 2000 inviting objections and 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 24th February, 2000;

And whereas the objections/suggestions received in respect of the said draft rules, have been duly considered by the Committee for control and supervision of experiments on animals;

Now, therefore, 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), the Committee for control and supervision of experiments on animals hereby makes the following rules to amend 7 the Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998, namely:-

1.(1) These rules may be called the Breeding of and Experiments on Animals (Control and Supervision) Amendment Rules, 2001.

(2) They shall come into force on the date of their publication in the Official Gazette.

2. In the Breeding of and Experiments on Animals (Control and

Supeivision) Rules, 1998( hereinafter referred to as the said rules), In

rule 2, for the existing clause (e), the following clause shall be

substituted, namely:-

(e) "experiment" means any programme/project Involving ut9

of an animal/animals for the acquisition of knowledge of a biological,

psychological, ethologlcal, 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 for combating any disease

whether on human beings or animals.

3. In the said rules, in rule 5, for sub-rule (c ) , the following sub-rules shall be substituted, namely:-

"(c ) A breeder or the establishment on registration for the purpose of

performing experiments on animals shall comply with the conditions as

may be specified at the time of registration by the Committee.

(d) The Committee or any other officer authorized In this regard by the

Committee shall take decision on the registration within three months of

making the application.

(e) If any modification of facilities are required before registration, the

details needed shall be communicated by the Committee."

(4) In the said rules, for rule 6, the following rule shall be substituted, namely:-

"6. Details of the experiments conducted:- (a) Every registered

establishment shall maintain a register of particulars about the animals

used from day to day for conducting experiments, with the number of

animals, the species, the age, gender and other relevant particulars."

(b) "The Committee or any other officer authorized by the Committee

may examine the register so maintained and If the Committee Is not

satisfied even after opportunities given for Improvement, It may take

such action as may be appropriate under these rules".

(5) In the said rules, in rule 7, after the existing condition (f), the following conditions shall be inserted, namely:-

"(g) - detailed specifications for housing, feeding and maintenance of

various species to be used In animal experimentation as notified by the

Committee, shall be adhered to by the registered establishment,

(h) In the Interim period till such detailed specifications are notified, the

breeders and establishments shall comply with the standards specified

by the Indian National Science Academy Guidelines."

(6) In the said rules, in rule 9, - (i) for the existing condition (a), the following condition shall be substituted, namely:-

"(a) experiments shall be performed in every case by or under the supervision of a person duly qualified in that behalf, that is, Degree holders In Medicine or Veterinary Science, Post Graduate and above In Life Sciences/Pharmaceutical Sciences or any other natural sciences, Degree or Diploma holders In Pharmacy, Diploma or Certificate In Laboratory Animal Techniques Sciences from a recognized Institution as Identified by Committee for the Purpose of Control and Supervision9

of Experiments on Animals for the purpose and under the responsibility

of the person performing the experiment;";

(ii) for the existing condition (g), the following condition shall be substituted, namely:-

"(g) the experiments shall not be performed for the sole purpose of attaining or retaining manual skill except In schools, colleges and programmes duly scrutinized and permitted In registered establishments by the Committee;";

(iii) in the existing condition (j), for the words, "the substance known as urari or curare or any such paralysan shall not be used", the words "no paralyzing agent, Including but not limited to curare, shall be used" shall be substituted.

7. In the said rules, in rule 10, -

(i) for sub-rule (b), the following sub-rules shall be substituted, namely:-

"(b) A breeder or establishment shall not acquire any animal by sale or

otherwise except from a registered breeder or establishment.

(bb)For the acquisition of laboratory bred experimental rats and mice

species of genetically defined strains not available within the country,

the registered breeders or establishments shall apply for permission to

the Institutional Animal Ethics Committee recognized by the Committee

for the Purpose of Control and Supervision of Experiments on Animals."

(ii) for sub-rule (e), the following sub-rule shall be substituted, namely:-

"(e)No animal shall be Imported by a registered breeder or

establishment, except genetically defined or laboratory bred

experimental rats and mice of genetically defined strains, which Is

available In the country."

^g 10 THE GAZETTE OF INDIA: EXTRAORDINARY (PART II—SEC. 3(ii)]

8. In the said rules, for rule 12, the following rule shall be substituted, namely:-

"12. Contract animal experiments. - No establishment shall contract or undertake to perform contract research or

experiments on contract basis on behalf of any other establishment or

research or educational Institution, except with prior permission of the

Committee:

Provided that no such restriction shall apply to collaborative research

between academic Institutions."

[F. No. 7-5/98-AW (Vol. II)]

A. K. JOSHI, 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, Part II, Section 3, Sub-section (ii) vide SO. No. 809, dated 15th December, 1998.

Printed by the Manager, Oovt. of India Press, Ring Road, Mayapuri, New Dclhi-110064

and Published by the Controller of Publications, Pelhi-110054.