Text of the 1998 Rules (S.O. 1074, ), followed by the amendments of 2001 (S.O. 134(E)) and 2006 (S.O. 1818(E)), as published by CCSEA. The amendments change the rules they name; read them together.
Rules, 1998 (S.O. 1074, 15 Dec 1998)
MINISTRY OF SOCIAL JUSTICE & EMPOWERMENT NOTIFICATION New Delhi, the 15th December, 1998 S.O. 1074.—Whereas the draft 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, Ministry of environment and Forests number S.O. 789(E) dated, the e September, 1998 in the Gazette of India, Extraordinary , Part II, section 31 Sub-section (ii) inviting objections and suggestion 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 8th September, 1998. 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-section (1) (1A) and (2) of section 17 of the Prevention of Cruelty to Animals Act, 196 (59 of 1960), the Committee for control and supervision of experiments on animals hereby makes the following rules, namely:
1. Short Title and commencement
(1) These rules may be called the Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. Definitions
In these rules, unless the context otherwise requires –
(a) “Act” means the Prevention of Cruelty to Animals Act, 1960 (59 of 1960);
(b) “breeder” means a person including an institution, which breeds animals for the purpose of transfer to other authorised institution for performing experiments;
(c) “Committee” means the Committee under section 15 of the Act for control and supervision of experiments on animals;
(d) “establishment means any individual, company, firm, corporation, institution other than schools up to higher secondary level, which performs experiments on animals;
(e) “experiment” means any programme/project involving experiments on an animal /animals for the purpose of advancement by new discovery of physiological knowledge which will be useful for saving or prolonging life or alleviating suffering or for combating any disease whether on human beings or animals;
(f) “Institutional Animals Ethics Committee” means a body comprising of a group of persons recognised and registered by the Committee for the purpose of control and supervision of experiments on animal performed in an establishment which is constituted and operated in accordance with procedures specified for the purpose by the Committee;
(g) “contract Research” means any research undertaken by an individual, company, firm, corporation or institution on behalf of a foreign individual, company, firm, corporation or institution for any consideration;
(h) “collaborative research” means any research undertaken between two or more research institutions on an equal footing which does not involve any financial or monetary considerations and is undertaken solely for the purpose of advancement of scientific research and human welfare;
(i) “specified format” means the form specified for the purpose by the Committee from time to time.
3. Breading of animals
(a) No establishment shall carry on the business of breeding of animals or trade of animals for the purpose of experiments unless it is registered.
(b) Every breeder/establishment carrying on the business of breeding animals or trade of animals for the purpose of experiments, shall, apply for registration within sixty days from the date of commencement of these rules and, stop breeding of animals if registration is subsequently refused to it by the Committee.
4. Registration of establishments
(a) No establishment shall perform any experiment on animals unless it is registered.
(b) Every establishment performing experiments on animals, shall, apply for registration within sixty days from the date of commencement of these rules and, stop performing experiments on animals if registration is subsequently refused to it by the Committee.
5. Application for registration
(a) The application for registration by a breeder under sub-rule (b) of rule 3 and an establishment under sub-rule (b) of rule 4 shall be made in the specified format to the Member- Secretary or any other officer authorised in this regard by the Committee.
(b) The Member-Secretary or the authorised officer of the Committee, may for deciding the issue of registration, ask for information relating to premises where the experiments are to be conducted, animal housing facilities, details of breeding of animals and its trade, other infrastructure including availability of manpower trained in handling animals and for verification of facts mentioned in the application for registration, and if satisfied, shall register such establishment or the breeder.
(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 Member-Secretary of the Committee or any officer authorised in this regard by the Committee.
6. Details of the experiments conducted
(a) Every registered establishment shall maintain a register as per the specified format and keep complete particulars about the kind of animal to be used for conducting any experiment, the health of the animal, the nature of experiment to be performed, and the reasons necessitating the performance of such an experiment on particular species.
(b) The Member-Secretary or the officer authorised by the Committee in this behalf may examine the register so maintained, and if, he is not satisfied irrespective -of the -opportunity given for improvement, he may bring the same to the notice of the Committee seeking directions in this regard.
7. Stocking of animals
The animals shall be stocked by the breeder and the establishment in the following manner:-
(a) animal houses shall be located in a quiet atmosphere undisturbed by traffic, and the premises kept tidy, hygienic and the animals protected from drought and extremes of weather;
(b) animal cages for small animals and stables for large animals shall be such that animals can live in comfort and overcrowding is avoided;
(c) where standards have been laid down by the Indian Standards Institution, the cages, the stable, as the case may be, shall conform to those standards;
(d) animals attendants must be suitably trained and experienced in the duties allotted to them,
(e) animals shall be looked after, before and after the experiments by a trained and experienced attendant;
(f) there-shall be satisfactory arrangement for looking after the animals during off hours and on holidays,
8. Permission of the Committee required for conducting experiments
(a) Every registered establishment before acquiring an animal or conducting any experiment on an animal/animals shall apply for permission of the Committee or the Institutional Animals Ethics Committee recognised for the purpose by the Committee along with the details contained in the specified format to the Member Secretary of the Committee or the Institutional Animals Ethics Committee, as the case may be.
(b) The Member Secretary of the Committee or the Institutional Animals Ethics Committee, shall cause the application for permission to be brought before the Committee/Institutional Animals Ethics Committee as the case may be, and the Committee/ Institutional Animals Ethics Committee after scrutiny of the application, if satisfied, may grant permission to the establishment stating the name of the species and the number of animals that can be acquired for carrying out the experiments.
(c) The Committee or Institutional Animals Ethics Committee, as the case may be, may, while granting permission for conducting experiments on animals, put conditions as it may deem fit to ensure that animals are not subjected to unnecessary pain or suffering before, during or after the performance of experiments on them.
(d) The Committee may require the establishments and Institutional Animals Ethics Committees and persons carrying on experiments on animals to forward to the Committee such information as it may require, on completion of experiments for which the permission has been granted.
9. Performance of experiments
In conducting experiments on animals, regard shall be had to the following conditions, 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 or Diploma holders in Veterinary Science or Medicine or Laboratory Animal Science of a University or an Institution recognised by the Government for the purpose and under the responsibility of the person performing the experiment;
(b) experiments shall be performed with due care and humanity;
(c) animals intended for the performance of experiments are properly looked both before and after experiments;
(d) experiments involving operative procedure more severe than simple inoculation or superficial venesection shall be performed under the influence of anaesthetic to prevent the animal feeling pain and it shall remain so throughout the experiment. Anesthesia shall be administered by a Veterinary Surgeon trained in methods of anesthesia or a Scientist/technician so trained for this purpose and who shall remain present near the animal till the completion of the experiment;
(e) animals which in the course of experiments under the influence of anaesthetic are so injured that their recovery would involve pain or suffering shall be destroyed humanely while still under the influence of anesthesia;
(f) when there is reason to believe that an animal is suffering abnormal or severe pain at any stage of a continuing experiment, it shall be painlessly destroyed at that stage without proceeding with the experiment;
(g) the experiment shall not be performed for the purpose of attaining or retaining manual skill except in schools, colleges and recognised training institutions;
(h) experiments shall not be performed by way of an illustration;
(i) experiments shall not be performed as a public demonstration;
(j) the substance known as Urari or Curari or any such paralysan shall riot be used or administered for the purpose of any experiment except in conjuction with anaesthetic of sufficient depth to produce loss of consciousness;
(k) no experiment the result of which is already conclusively known, shall be repeated without previous justification;
(l) there shall not be applied to the eye of an animal by way of experiment any chemical substance for the purpose of absorption through the conjunctival membrane or through the cornea calculated to only give pain;
(m) dogs held for experimental purposes shall not be debarked.
(n) where experiments are performed in any institution, the responsibility therefor is placed on the person in charge of the institution and in cases where experiments are performed outside an institution by an individual qualified in that behalf, the-experiments, are performed on his responsibility.
10. Transfer and acquisition of animals for experiment
(a) A breeder shall not transfer any animal by sale or otherwise to an establishment which is not registered under these’ rules.
(b) An establishment shall not acquire any animal by sale or otherwise except from a registered breeder/establishment.
(c) Every establishment after acquisition of a animal or animals shall not transfer such animal or animals by sale or otherwise to any other establishment or person except to a registered breeder/establishment.
(d) The animals used for experimentation in a production/ breed improvement programme may be given out by the breeder’ institution for domestic use.
(e) No animal shall be imported by a breeder or an establishment which is available in the country.
(f) A breeder or establishment shall comply, with the directions given by the Committee for the purpose of controlling and supervising experiments on animals.
11. Records
(a) Every, establishment/Institutional Animals Ethics Committee shall maintain a record of the animals under its control and custody in the specified format.
(b) Every establishment/Institutional Animals Ethics Committee shall furnish such information, as the Committee may from time to time require in the specified format.
(c) All laboratories shall inform the exact number/ species of animals to the Member Secretary or any officer authorised in this regard by the Committee as per the specified format.
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, This shall not apply to collaborative research between academic institutions.
13. Composition of Institutional Animals Ethics Committee
Every Institutional Animals Ethics committee shall include a biological scientist, two scientists from different biological disciplines, a veterinarian involved in the care of animal, the scientist in charge of animals facility of the establishment concerned, a scientist from outside the institute, a non scientific socially aware member and a representative or nominee of the specialist may be co-opted while reviewing special project using hazardous agents such as radio-active substance and deadly micro organisms.
14. Power to suspend or revolve registration
(a) If the Committee is satisfied, on the report of the Member-Secretary of the authorised officer of the Committee made to it as a result of any inspection or information received otherwise that the rules made by it are not being complied with by any establishment or breeder or an Institutional Animals Ethics Committee, the Committee may, after giving a reasonable opportunity to the establishment or breeder or Institutional Animals Ethics Committee of being heard in the matter, revoke the registration of such establishment or breeder or Institutional Animals Ethics Committee either for a specified period or indefinitely, or may allow the establishment of- breeder or Institutional Animals Ethics Committee to carry on subject to such special conditions as the Committee may impose.
(b) The Committee may, pending the final determination, if, it is of the opinion that an establishment or breeder has prima facie failed to comply with the provisions of these Riles, suspend the registration of such establishment or the breeder.
(c) The Committee may in the event of revocation or suspension of registration of an establishment or breeder, issue such directions as it, deems fit for the care and protection of the animals which are under the custody or control of such establishment or the breeder.
(d) That in the event of suspension or revocation of a license, such establishment or breeder shall forthwith on the communication of the order cease to perform any experiment on, any animal or acquire or transfer any animal. {F. No. 7-5/98-AW] ASHOK PAL SINGH, Member Secretary Committee for the Purpose of Control & Supervision of Experiments on Animals
Amendment Rules, 2001 (S.O. 134(E), 15 Feb 2001)
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 th number S.O. 168(E) dated the 18 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 the Gazette containing the said notification are made available to the public; th And whereas the said Gazette was made available to the public on 24 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 am supervision of experiments on animals hereby makes the following rules to amend 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 Supervision) Rules, 1998 (hereinafter referred to as the sold rules), In rule 2, for the existing clause (e), the following clause shall be substituted, namely:
(e) “experiment” means any programme/project Involving use of an animal/animals for the acquisition of knowledge of a biological, psychological, 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 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. Detail; 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 fill such detailed specifications are notified, the breeders and establishments shall comply with 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 Supervision 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 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 an! d mice of genetically defined strains, which is available in the country.”
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 S.O. No. 809, dated l5th December, 1998.
Amendment Rules, 2006 (S.O. 1818(E), 23 Oct 2006)
NOTIFICATION
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 th Government of India in the Ministry of Environment and Forests number S.O.42(E) dated 10 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;
th And whereas the said Gazette was made available to the public on 10 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;’
3. In rule 9 of the said rules, –
(1) after clause (b), the following clause shall be inserted, namely:-
“(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;” ;
(2) after clause (c), the following clause shall be inserted, namely:
“(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;” ;
(2) for clause (e), the following clause shall be substituted, namely:-
“(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.
