Plarmacy Law and Ethics D. pharm -2nd year

1. Presented by: Ms. Nilima G. Sakharkar
Lecturer
Nagpur College Of Pharmacy ,
Wanadongri, Hingna Road, Nagpur -441110

2. 1. This government imposed penalties for causing unnecessary cruelty and suffering to
animals.
2. Animals and their various varieties are defined by this Act.
3. This Act codifies provisions pertaining to the organization of an animal welfare
board, as well as to its structure, authority, and duties.
4. This Act defined various types of cruelty, exceptions, and the killing of an animal in
pain in the occasion that cruelty has been done to it in order to end its suffering.
5. This Act outlines rules for using animals in experiments for research purposes.
6. This Act specifies that no punishment may be brought for any of the Act's offences
after a 3-month limitation period.
7. This Act codifies regulations governing the display of performing animals and
offences committed against them.
Objectives

3. Animal: It refers to any living thing that is not a human.
Captive animal: Any animal (that is not a domestic animal) that is restrained, is injured or
appearing to be harmed, is in captivity or imprisonment of any kind, whether it is
permanent or temporary, or that is subjected to any device or device intended to prevent
it from leaving from captivity or confinement.
Domestic animal: Any animal that has been or is being sufficiently educated to fulfill a
purpose for human use, or that, despite never having been or being meant to be so
trained, is or has become fully or partially dependent on humans.
Owner: This term refers to both the animal's actual owner and any other person
temporarily in charge of the animal, with or without the owner's permission.
Phooka or doom dev: Any procedure that involves injecting air or other materials into a
milking animal's reproductive organ with the goal of attracting the animal's milk secretion
away.
Street: Any public access way, road, lane, square, court, alley, passageway, or open area is
included, whether or not it is a highway.
Definitions

4. Institutional Animal Ethics Committee (IAEC)
IAEC is a Committee that has a group of people registered by the committee for
the control and supervision of animal experimentation ( CPCSEA).
Objectives :
1. To examine and approve research proposals.
2. Experimentation by people who are sufficiently qualified and skilled.
3. To protect animals used in research from unnecessary pain and suffering.
4. Disposing of animals by humans following experimentation.
5. Wherever possible, minimize from using animals in experiments.
6. To prevent using large animals in studies.
7. To keep an accurate record of animal experimentation.
8. To properly care for animals before, during, and after research.
9. Simply to improve one's physical ability, not to prevent experimentation.

5. Composition of IAEC
Institutional Animal Ethics Committee (IAEC) includes 8 members are as follows:
A) Institutional members :
I. Two scientists from different biological discipline
II. One biological scientist
III. One veterinarian involved in the care of animals
IV. One scientist in charge of animal facility of establishment concerned.
B) CPCSEA nominated members :
I. A main nominee & link nominee
II. Scientist from outside the institute
III. A socially aware Scientist.
On receipt of names of institutional members, CPCSEA nominates the members &
constitutes IAEC . The chairman of committee is preferably head of institution/
department. The member secretary is nominated by establishment from among
institutional members. As per guidelines of CPCSEA, the committee must be
reconstituted every 5 Years.

6. Functions of IAEC
I. To put up effort toward IAEC's goals being fulfilled.
II. Ensuring that animals are handled professionally and systematically both during
and after tests in order to minimise their suffering.
III. Before the start of the study, all forms of protocols for research involving small
animal experiments should be examined and approved.
IV. Recommend and submit large animal experiments ideas to CPCSEA for approval in
the appropriate manner.
V. Should keep an eye on the research both throughout and after the study is over.
VI. To acquire monthly reports on research and to visit the institution housing the
animals used for tests.
VII. To make sure that all legal criteria, rules, regulations, and guidelines are being
followed.

7. Breeding of Animals
1. Without being registered, no organization or institution may engage in the
trade or business of breeding animals for experimentation.
2. Every breeder engaged in the business of breeding animals or trading in
animals for scientific purposes must submit an application for registration
within sixty days of the date of issuance of these rules, and must cease
breeding if the committee later rejects their application.

8. The breeder or producer and facility are required to stock the animals in the following way.
1. Animal cages for small animals and stables for large animals must be designed so that
animals can live in comfort and overcrowding is avoided.
2. The cages and stables should, whenever possible, conform to the standards of the
Indian Standards Institution. Animal houses must be situated in a quiet area free from
traffic, and the premises must be kept clean, hygienic, and free from waste. Animals
must also be protected from extreme weather and lack of rain.
3. Animals House staff members must have the necessary training and experience to
handle the animals both during and after the research.
4. An experienced and qualified attendant will take care of the animals both before and
after the studies.
5. There must be a suitable arrangement for caring for animals on weekends and during
holidays.
6. The breeder and organization must follow the guidelines of the Indian National Science
Academy.
Stocking of Animals

9. Performance of Experiments
The following conditions should be considered when conducting animal research;
 Experiments must be carried out under the supervision of a person who is appropriately
qualified in that regard, i.e., a degree- or diploma-holder in veterinary science, medicine,
or laboratory animal science from a university or institution recognised by the
government for the purpose, and under the authority of the experiments.
 Experiments must be carried out with sufficient caution and humanity.
 Investigators adequately care for the animals used in tests both before and after the
experiments.
 In order to prevent suffering and discomfort for the animals throughout the studies,
experiments involving surgical procedures must be performed while they are under the
necessary anaesthesia, delivered by a veterinary surgeon or a skilled scientist or
technician.
 Animals who suffer severe injuries during tests while being anaesthetized and whose
recovery would result in pain or suffering must be properly placed to death while still
being anaesthetized.

10.  The tests must not be carried out to develop or maintain technical skill.
 It is prohibited to perform experiments using examples or sample.
 Experiments must not be conducted in front of the public.
 No experiments may employ or give a paralysing substance unless it is done so
in conjunction with anaesthesia.
 If the result of an experiment is known, it must not be repeated.
 For the aim of absorption through the conjunctional membrane, no chemical
compounds should be introduced to an animal's eye.
 Dogs kept for research purposes must not be produced by users.
 Animal care, whether within or outside the facility where animal studies are
conducted, is the responsibility of the institutions or organisation.

11. Transfer and Acquisition of Animals for Experiment
1. A breeder is not allowed to give an animal to an unregistered institution via sale
or any other means.
2. A facility must only purchase animals for testing from registered breeders.
3. After purchasing animals, no organization may transfer those animals by sale or
any other means to any other organization or person than a registered breeder or
organization.
4. The breeder institution may distribute the animals utilised for experiments in a
production/breed improvement project for domestic use.
5. Genetically characterised animals may be imported with the consent of the
Directorate General of Foreign Trade in the event that they are not available
through a licenced breeder or other lawful sources nationally or internally.
6. Breeders and organizations are required to follow CPCSEA instructions.

12. Records
1. Every organization/Institutional Animals Ethics Committee is required to
keep a record of the animals in its care and custody in the format
specified.
2. Every establishment must provide the information requested by the
Institutional Animals Ethics Committee in the format prescribed by the
Committee.
3. All laboratories must provide the Member secretary or another officer
appointed by the Committee in this regard with the exact number and
species of animals using the format provided.

13. Power to Suspend OR Revolve Registration
1. If the committee believes that only an establishment or breeder has at least to
an extent failed to comply with the provisions of these regulations, it may
suspend the registration of that institution or breeder while waiting for the
outcome of the investigation.
2. In the case that an establishment's or breeder's registration is revoked or
suspended, the committee may provide any instructions for the care and
protection of animals that are in the custody or supervision of that facility or
breeder that it deems reasonable.
3. That in the event of a licence suspension or revocation, the breeding facility or
breeder shall stop immediately doing any animal studies, purchasing or
transferring any animals, and notifying the order.
4. If the committee determines that any organisation, breeder, or Institutional
Animals Ethics Committee is not following the regulations made by it after
receiving a report from the Member-Secretary of the authorised officer of the
Committee or other information, the committee may, after giving the
organisation, breeder, or Institutional Animals Ethics Committee a reasonable
opportunity to be heard in the matter, revoke its authority to conduct an
inspection.

14. CPCSEA (Committee for the Purpose of Control and
Supervision of Experiments on Animals )
1. The Ministry of Agriculture officially founded regulations for animal experiments
in 1968, and a represents approximately under the Prevention of Cruelty to
Animals Act of 1960 carried out their administration.
2. The group was ultimately terminated in 1977, unfortunately. Following a 13-year
long break, the Animal Welfare Board of India (AWBI) recommended that the
"Committee for the Purpose of Control & Supervision of Experiments on Animals
(CPCSEA)" be re - established. Acting on the board's recommendation, the central
government established the CPCSEA in 1991, with as many official and non-
official members as it considered appropriate. After that, the Committee was
reformed as required.

15.  One of the Committee's members must be nominated by the central government to
serve as its chairman.
 The current committee was established on November 2, 2021, with 19 members, and
is handled over by the joint secretary for animal welfare in the ministry of fisheries,
animal husbandry, and dairying.
 A statutory committee established by the prevention of Cruelty to Animals (PCA) Act of
1960, the Committee for the Purpose of Control & Supervision of Experiments on
Animals (CPCSEA) is part of the Ministry of Fisheries, Animal Husbandry & Dairying
(MoFAH&D).
The CPCSEA's goals are to prevent unnecessary pain and suffering or discomfort for
the animals before, during, or after the performance of the tests on them. The
"Breeding of & Experiments on Animals (Control and Supervision) Rules, 1998" were
created for this reason under the delegated powers and then changed to regulate
animal experimentation.

16. Functions Of CPCSEA
1. Registration of a facility using animals for research or breeding them
specifically for such purposes.
2. Nominees are selected and assigned to the Institutional Animal Ethics
Committees (IAEC) at the registered establishments.
3. Animal House Facilities' approval is based on reports from CPCSEA
inspections.
4. Permission to perform animal-using experimentation.
5. Importing animals to be used in experiments is permitted.
6. When any legal requirements are broken, take action against the
establishment.
7. Conducting training programmes for CPCSEA nominees
8. Conducting or supporting a workshop or conference on animal ethics.

17. SR. NO OFFENCES PENALTIES
1. Treating animals cruelly I. Imprisonment + fine Rs. 10
to 50 on first conviction.
II. Punishment 1 years + fine
Rs. 25 to 100 on subsequent
conviction.
There may be time to time revision in fine
& punishment
Recent revision :
I. Imprisonment up to 2 years +
fine Rs. 25000 on first
conviction.
II. Imprisonment up to 3 years
+ fine 1 lakh on subsequent
conviction.
2. Performing the operation like phooka or
doom dev : any cow or other milch animal
or any other operation to improve lactation
which is injurious to the health of the
animal
I. Imprisonment up to 2 years +
fine up to Rs. 1000 or both
Offences and Penalties

18. SR. NO OFFENCES PENALTIES
4. Not complying the rules made by
CPCSEA by or institution carrying on
experiments on animals
Punishable with prohibiting
person or institution carrying
on any such experiments
either for a specified period
5. Contravention of any order made by
Committee or breach of any condition
imposed by the Committee
Punishable with fine up to Rs.
200