UNIT IV: PREVENTION OF CRUELTY TO ANIMALS ACT-1960

Introduction
 The Prevention of Cruelty to Animals Act, 1960 (which repeals the Act of 1890) has been enacted.
 As recognition of the general awareness about animal welfare, the Breeding of and Experiments on Animals
(Control and Supervision) Rules 1998 have been recently incorporated.
 It extends to the whole of India except the State of Jammu and Kashmir.

Objectives
 To prevent the infliction of unnecessary pain or suffering on animals.
 This act provides information on the provisions of pharmaceutical interest which are related to Animal
Experimentations.

Definitions:
Animal- Any leaving creature other than human being
Board – Animal welfare board established under sec- 4 of the act.
Breeder – Breeds animals for the purpose of transfer to the authorized institution for performing experiments.
Committee – Control and supervision on animals under section 15 of the act.
Establishment – Any individual, company, firm, corporation, institution except college (upto PG label) performing
experiments on animals.
Experiment – Use of an animal for the purpose of acquiring knowledge of a biological, psychological, ethological, physical
or chemical nature.
Institutional Animals Ethics Committee- A body/committee comprising a group of persons to control and supervision on
experimented animals.
Contract Research – Any research undertaken by an individual, company, firm, corporation or institution on behalf of a
foreign individual, corporation or institution.
Collaborative Research – Any research undertaken between two or more research institution without any financial
consideration and is meant for advancement of scientific research and human welfare.

Institutional Animal Ethics Committee (IAEC):

The primary duty of IAEC is to work for the achievement of the objectives as mentioned below.
a) Experiments shall be performed 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.
b) Experiments are performed with care and humanity and that as far as possible experiments involving operations are
performed under the influence of some anesthetic of sufficient power to prevent the animals feeling pain.
c) Animals which,in the course of experiments under the influence of anesthetics, are so injured that their recovery would
involve serious suffering, are ordinarily destroyed while still insensible.
d) Experiments on animals are avoided wherever it is possible to do so; as for example; in medical schools, hospitals,
colleges etc.
e) Experiments on larger animals are avoided when it is possible to achieve the same results by experiments upon small
laboratory animals like guinea-pigs, rabbits, mice, rats, etc.
f) As far as possible, experiments are not performed merely for the purpose of acquiring manual skill.
g) Animals intended for the performance of experiments are properly looked after both before and after experiments.
h) Suitable records are maintained with respect to experiments performed on animals.

IAEC will review and approve all types of research proposals involving small animal experimentation before the start of
the study. For experimentation on large animals, the case is required to be forwarded to CPCSEA in prescribed manner with
the recommendation of IAEC

IAEC consist of
a) A biological scientist
b) Two scientists from different biological dept.
c) A veterinarian physician
d) A scientist from animal facility of the establishment concern
e) A scientist from outside of the institution
f) A social person
g) A representative of the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA)
h) A specialist (radioactive substance or deadly microorganisms) may be co-opted.

 An eight-member IAEC is constituted in every registered institute. All research project proposals using small
animals, such as rats, mice, rabbits or guinea-pigs, have to be approved by the IAEC before initiation.
 Every member of the IAEC has the right to question/reject of a project; unapproved proposals are referred to a
subcommittee of experts for scrutiny and possible approval. The IAEC cannot approve research projects on large
animals, such as dogs, cats, nonhuman primates, cattle, goats and sheep.

BREEDING AND STOCKING OF ANIMALS

 Only registered establishments can carry on business of breeding of animals for the purpose of experiments.
 Apply for registration within 60 days from the date of commencement of breeding and experiments on animals and
stop breeding should be stopped if the committee refuses registration.
 The application should be made in specified format to the member secretary by the committee in this regard.
 For registration of establishments/breeders the Govt. of India has setup the "committee for the purpose control and
supervision of experiments on animals" under the ministry of social justice and empowerment, shastri Bhavan, New
Delhi.
 The secretary of the committee ask for the information relating to the premises where the experiments conducted,
animal house 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 breeder. Every registered shall maintain a register of particulars about the animal
to be used for conducting experiment, the species, the age, gender, and other particulars.\
 The Committee or any other authorized officer may examine the register maintained and if he is not satisfied even
after opportunities given for improvement, it may take appropriate action.
 The animals shall be stocked by the breeder and the establishment in a prescribed manner.
 Animal houses shall be located in a quiet atmosphere undisturbed by traffic and the premises kept tidy, hygienic
and protected from drought and extremes of weather. Animal cages and stables for largeanimals so it may live in
comfort and overcrowding is avoided.
 The registered breeder shall adhere to the detailed specifications notified by the Committee for housing, feeding,
and maintenance of various species used in animal experimentation.
 Standards have been laid down by the Indian Standards Institution (ISI), the cages or the stable Animal's attendants
must betrained and experienced in the duties.

Performance of Experiments:
Purpose:
 Discovery of new knowledge or chemical (or biological) active compound
 Useful for saving or establish prolonging life
 Less sever suffering of any disorder or disease
 Combating any disease in human, plant and animals.
Guidelines for performing the experiment as follows
1. The experiment shall not have performed in public demonstration except in school, college and recognized
training institution for attaining purpose of manual skills.
2. Person-in-charge of the institution should take responsibility to perform on animal experiment. In case outside
of the institution, the experiment should be carried out by qualified person.
3. All experiment shall be performed by or under the supervision of a duly qualified person (Diploma/Degree/PG
in Pharmacy/ Medicine/ Veterinary/ Life Sciences or certificate in Laboratory animal techniques sciences).
4. Experiment performed with due care and humanity.
5. During or after experiment, the animals are not suffering unnecessary pain.
6. Before and after experiment, the animals should be under proper care or looked properly.
7. During operational procedure, anesthetic should be administered to animal by a trained person, so that, animals
are not suffer pain or feeling of pain throughout the experiment.
8. Under influence of anesthesia, if animals are recovered abnormal or sever pain at any stage of continuing experiment, it
shall be painlessly destroyed and discontinued the experiment.
9. Experiment with animals shall not be repeated, if experiment is already established or justified or conclusively known.
10. Pain on eye of animal by any chemical agent that should not be applied.
11. Dogs shall not have debarked (This is a surgical procedure to reduce tissue in the vocal chords) during experiment
purpose.

Transfer and acquisition of animals for experiment:

Acquiring animal for conducting any experiment:

1. Every breeder has a register and shall apply for experimental activity permission directly to the Secretary or authorized
person of Committee/ Institutional Animal Ethics Committee by stating name of the species and the number of animals
acquired.
2. The committee shall scrutiny the application, if satisfied, may grant the permission for conducting experiments.
3. While granting permission, a condition is applied that animals are not suffering unnecessary pain during or after
experiments on them.
4. Person carrying on experiments on animals should inform authority about completion of experiment for which the
permission has been granted.

Contract animal experiments:

1. Contract animal experiment or research shall not permit to any establishments or educational institutional except with
prior permission of the committee.
2. Collaborative research between two academic institutions may be permitted for such purpose.

Transfer of animals for experiment:

1. Transfer of any animal for sale purpose to an unregistered breeder is not permitted.
2. A breeder can’t acquire any animal by sale except from a registered breeder.
3. Acquired animal can’t be sale except from registered breeder.
4. Experiment in production/breed improvement programme, animals may be given out by breeder institution for domestic
use.
5. Genetic experiment on rat and mice not available in India, if such, the breeder shall take the permission from Institutional
Animal Ethics Committee (IAEC).
6. Import of any animal available in the country is also not allowed.

Records:
1. Every registered breeder\IAEC should maintain record of the animals and furnish them to the committee from time to
time.
2. All laboratory shall inform exact number of animals used in a specified format to the Secretary or authorized person.
Power to suspend or revoke registration:

1. Rules made by the committee are not followed or not satisfied by the committee.
2. The Committee giving a reasonable opportunity for rectification, after that the registration may revoke for a specific
period or indefinitely or grant the license on a special condition.
3. Failure of compliance of rule and regulation, the committee may impose pending or suspend the registration.12
4. During suspension period, the breeder shall take care of animals, cease to perform any experiment or acquire or transfer
of any animal is prohibited.
Offences and Penalties
If any person-
1. Breaks any order made by the Committee under section 19; or commits a break of any condition imposed by the
Committee under that section: he shall be punishable with fine which may extend to two hundred rupees
2. The person in-charge of the institution has breached the condition imposed by the Committee under that section: he shall
be deemed to be guilty of the offence and shall be punishable accordingly.
3. The penalty under this Act is, the offender (in the case of a first offence) will have to pay fine which shall extend to fifty
rupees and if it is the case of second offence or subsequent offence committed within three years of the previous offence,
he will be fined with not less than twenty-five rupees but which may extend to one hundred rupees or with the imprisonment
for a term which may extend to three months or with both. Also, in the case of second offence, the offender’s vehicle is
seized, and he will never be allowed to keep an animal again.

Reference:
1. Text book of Forensic Pharmacy by B.M. Mithal
2. A text book of Forensic Pharmacy by N.K. Jain
3. Pereira S, Veeraraghavan P, Ghosh S, Gandhi M. Animal experimentation and ethics in India: the CPCSEA makes a
difference. Altern Lab Anim. 2004;32 Suppl 1B:411-415. doi:10.1177/026119290403201s67
4. The Prevention of Cruelty Animals Act,1960 by Govt. of India publications