LEGAL ASPECTS OF ANIMAL TESTING UNDER CLINICAL TRIALS BY - AISHWARYA PRABHU
LEGAL ASPECTS OF ANIMAL TESTING UNDER
CLINICAL TRIALS
AUTHORED BY - AISHWARYA PRABHU
LLM II, Semester III.
(2022-2023)
Progressive Education Society’s
Modern Law College, Pune.
Savitribai Phule Pune Univeristy.
Abstract:
Clinical trials are a series of
procedures necessary to guarantee that a medicinal product is both safe and
effective for the populace. Drugs must initially be tested on animals for this
reason to confirm that they are safe for human use. But by causing physical
pain, psychological discomfort, and suffering to a huge number of sentient
beings, this was cruel to animals and violated their rights. So new laws were
passed to protect animals and enhance their welfare during research. In this
article, we will examine the historical context of animal research in clinical
trials, current legal protections for animals, and whether new rules have had
any impact.
Keywords: Clinical Trials, Animal testing,
Animal protection rights and laws.
Introduction:
Clinical trials are research studies
that are carried out on individuals (healthy volunteers or patients with a
particular health concern) or animals to explore and evaluate novel medical
treatments, such as medications, vaccines, medical devices (like spinal cord
stimulators), medical procedures (like surgeries), and diagnostic tests.
Clinical trials may also be carried out to compare treatments, investigate
novel therapy combinations, or investigate an already available medicine for a
novel use.[1]
The term "animal testing"
refers to procedures carried out on living animals for research into basic
biology and diseases, evaluating the efficacy of new pharmaceuticals, and
testing the safety of consumer and industry products for human health and/or
the environment. The operations frequently lead to a lot of pain. Most animals
are killed at the conclusion of an experiment, although some might be used
again.[2]
However, doing so put the rights of
animals in jeopardy. For the benefit of humanity, they had to suffer intense
pain and psychological trauma. Prior to Independence, there were few
regulations pertaining to animal safety and little knowledge. Later, as public
awareness grew, laws were passed that favored animals to safeguard their rights
and spare them from suffering. These rules and regulations have now been put
into effect. As in the present situation, prior authorization from the law is
required to begin the procedure to test and experiment on animals.
Objectives:
1. To study animal testing and its types
in clinical trial
2. To study the historical context of
clinical trials.
3. To study the animal protection laws
and rights.
4. To assess whether the situation of
animals in trials has improved as a result of the new regulations.
Animal testing under clinical trials:
The pharmacological and clinical
profile of a novel drug in humans, including its pharmacodynamic and
pharmacokinetic effects, are studied methodically in clinical trials. It
precedes animal trials in which the effectiveness and side effects of the
medicine are demonstrated in animals and an estimated drug dose is established.
This is the only way to determine a medication's efficacy and safety before it
is sold for use by humans.[3]
Some treatments and goods may be
developed by researchers through non-animal research projects. Animal testing
is permitted to determine whether the experimental therapy appears to be safe
only if it appears to be a promising treatment.[4]
It is crucial to understand why
animal testing
began in the first place.
A permanent mascara known as Lash
Lure caused the blindness of more than a dozen people and the death of one
other in 1933. P-phenylenediamine, an unproven substance, was in Lash Lure.
There were no rules in place to guarantee product safety at the time. The
p-phenylenediamine rendered some Lash Lure users completely blind and produced
horrifying boils, abscesses, and ulcers on their faces, eyelids, and eyes. In
one instance, the ulcers were so bad that a woman died from a bacterial
infection.[5]
It has always been common practice to
conduct scientific research using animals as models. Animals were initially
used in scientific experiments around 500 B.C. in ancient Greece. Vivisection
of animals were common during that time to learn more about the workings of
living things.[6]
Following are some examples of tests
conducted on animals:
·
The Draize
Test
A substance's toxicity can be
evaluated using the Draize test. The substance to be evaluated is applied to
the skin or eye of a restrained animal.
·
Acute toxicity
Animals are made to undergo repeated
chemical exposure for up to three months while testing for acute toxicity. This
can be done to examine how the chemical affects various organs, including the
heart, lungs, liver, and neurological system.
·
Skin corrosion
and irritation
In tests, rabbits are used to
determine how corrosive or irritative compounds are.
·
Skin
sensitization
To determine whether a substance has
the potential to trigger an allergic reaction, skin sensitization studies are
conducted. 5 The substance may be injected beneath the skin or used topically.
·
Toxicokinetic
These tests are performed to find out
how quickly harmful compounds pass through the body. As the body breaks down
some compounds, their toxicity increases. Force feeding, inhaling, or injecting
an animal with a chemical dose are three possible methods.
·
Carcinogenicity
Carcinogens are substances that
either promote the growth of cancerous cells or raise the risk of it happening.
These experiments employ drugs that cause test animals' tumors to grow.
·
Reproductive
& developmental toxicity
These experiments, which frequently
include rats, mice, and rabbits, are intended to look at how a substance
impacts an animal's reproductive system and capacity for reproduction.[7]
Current animal protection laws and
committees against clinical trials (CPCSEA):
Today's scenario is vastly superior
than that during the time of British Indian control. It has been accepted that
employing animals in research is vital because India has not yet created an
artificial human simulator as a substitute; However, the Committee for the
Purpose of Control and Supervision of Experiments on Animals has established
specific guidelines (CPCSEA).
1. Prevention of Cruelty to Animals Act,
1960
The Prevention of Cruelty Act, 1960
was created with the intention of severely punishing individuals who harm
animals. Additionally, it created an animal welfare board and specified the
actions that meet the criteria.[8]
Now a new amendment draft is prepared
to amend the Prevention of Cruelty to Animals Act, 1960.
In order to alter the
six-decade-old Prevention of Cruelty to Animal Act, 1960, the government has
created a draught bill titled Prevention of Cruelty to Animal (Amendment)
Bill-2022. The Ministry of Fisheries, Animal Husbandry, and Dairy has drafted
the draught.[9]
2. The Committee for the Purpose of
Control and Supervision of Experiments on Animals (CPCSEA) formed in 1964:
As a statutory committee, CPCSEA is
obligated to take any and all steps required to prevent undue pain or suffering
for animals before, during, or after performing research on them. In order to
control animal experiments, the Committee created the "Breeding of and
Experiments on Animals (Control & Supervision) Rules, 1998" (amended
in 2001 & 2006).
3. PETA:
Since its founding in 1980, ‘People
for the Ethical Treatment of Animals (PETA)’ has worked to uphold and protect
the rights of all animals. PETA educates the public about animal mistreatment
and promotes for the humane treatment of animals. Regardless of whether they
are helpful to humans, PETA believes that animals have rights and should have
their best interests considered. They have the same capacity for pain as you
do, and they want to live their own lives.[10]
4. No cosmetics shall be tested on
animals:
The Ministry of Health & Family
Welfare has now published the cosmetic testing ban, which adds the new rule
"148-C. prohibition of testing of cosmetics on animals - No person shall
use any animal for testing of cosmetics" to the existing Drugs and
Cosmetics Rules, 1945. This follows the removal of animal tests from the
cosmetics testing standards by the PCD 19 Cosmetics Sectional Committee of the
Bureau of Indian Standards (BIS) last year.
The Drugs and Cosmetics Rules, 1945
have recently been amended, and the Ministry of Health & Family Welfare
recently released a cosmetic testing ban that, if approved, will prohibit the
import of cosmetics from any country that have undergone animal testing. The revised
regulation, if it is adopted, may read "135-B. Import of cosmetics barred
from animal testing. - No cosmetic tested on animals shall be imported."[11]
5. Breeding of and Experiments on
Animals (Control and Supervision) Rules, 1998 (as amended in 2001 and 2006)
These regulations, which were first
published on November 15, 1998, and were later updated in 2001 and 2006, place
a strong emphasis on registering businesses before conducting experimentation
and breeding, inspecting animal house facilities, maintaining informational
registers there, providing home for animals there, obtaining authorization from
the IAECS and CPCSEA to perform experiments, and setting up breeding facilities
under the right conditions.
6. Institutional Animal Ethics Committee
(IAEC)
The Standard Operating Procedures for
Institutional Animal Ethics Committees were published by the CPCSEA in January
2010 and are known as SOP for IAECS. The Institutional Animal Ethics Committee
(IAEC) of the establishments is permitted to approve experiments on small
animals under the Rules for Breeding of Animals and Experiments on Animals
(Control & Supervision).[12]
The situation of animals in trials
has improved as a result of the new regulations.
Over the last decade, there have also
been significant landmarks in the legal protection of animals. Based on these
achievements, it is obvious that, while the animal rights movement still has a
long way to go, it is far past its infancy and well into adolescence. However,
in order for the movement to truly fulfil its objectives, systematic
institution development and the passage of tougher protection laws are
required.
While these rules may seem extensive
there is a major issue with implementation. And the reasons for this range from
public apathy to a vested or commercial interest in exploiting animals. Despite
rules being passed in 2001 for each district to have an SPCA, hardly any states
have them. The state of Maharashtra, for instance, only began issuing notices
to set up SPCAs in 2018—seven years after the mandate was issued. Similarly,
rules regulating shops that sell animals for pets and breeders have not been
implemented in any state completely. Even if one is able to push for better
implementation, there is still the issue of penalties, which are often not
commensurate with the offense.[13]
Some of the most horrific animal
experiments in history:
1. Charles River employees force animals
to breathe harmful gases
Millions of animals, including mice,
rats, gerbils, rabbits, and monkeys, are bred and sold by Charles River
Laboratories to research facilities all over the world. Additionally, it
performs animal testing for businesses that make medications, insecticides,
food additives, and industrial chemicals. In addition to being forced to
breathe harmful chemicals, employees also smear experimental chemicals onto
animals' shaved skin. Before they eventually die or are murdered, they
experience excruciating abdominal pain, diarrhea, convulsions, seizures,
paralysis, and bleeding from the nose, mouth, and genitalia.
2. For experiments involving Huggies
baby products, researchers covered mice in faeces and urine.
Huggies baby product manufacturer
Kimberly-Clark paid researchers at the University of Iowa to cover mouse skin
with human baby urine and excrement. For up to 48 hours, the feces were
attached to the animals. After the mice were killed, their skin was removed for
analysis to examine diaper dermatitis.
3. Coca-Cola forced-fed chemicals to
rodents while slicing the faces of chimps.
The Coca-Cola business forced-fed
rodents chemicals to test "caramel color" and performed "taste
experiments" in which chimpanzees had their faces sliced open. In 2007,
the company stopped using animals in its testing.
4. Puppy blindness experiments and acid
drips through injured eyes
Six beagle puppies from the
University of Missouri were divided into two groups after having their left eye
blinded. To investigate if topical hyaluronic acid had any therapeutic effects,
researchers dripped it into the injured eyes of the puppies in one group. The
six beagles were murdered once the experiment was over since none of them were
able to regain their vision.[14]
Case Laws:
1. Kennel Club of India (KCI) v. Union
of India (2013)[15]
The petitioner informed the Indian
Veterinary Council that the Animal Welfare Association Board of India had
informed them that puppies of breeds of dogs such as Doberman, Cocker Spaniel,
Great Dane, Boxer, etc. were all subjected to avoidable and unneeded cosmetic
procedures. As a result, they performed procedures like docking tails.
According to Section 11 of the 1960 Prevention of Cruelty to Animals Act, the
owners' sole discretion does not apply when a dog's ears are cropped or its
tail is docked; rather, the court made this ruling.[16]
According to Article 21, everyone has the
right to life and personal liberty, neither of which may be taken away from
them without a court order. The Supreme Court explicitly ruled in favour of
animals in the 2014 case of Animal Welfare Board of India v. Nagaraja and
Others.[18]
In this case, the Petitioner filed a writ
petition asking the respondents to protect the rights of those who are strongly
opposed to the use of animals and animal products by requiring manufacturers to
print a list of the contents that go into manufacturing a product on their
packaging, as 60% of Indians are vegetarians. As a result, the Delhi High
Court's decision in this case enabled citizens to make educated decisions about
the things they buy or consume.
Suggestions:
1. Proper Facilities under which trials are
conducted should be developed to provide better facilities for animals.
2. Everyone should feel the responsibility
towards wellbeing of animals.
3. Which laws are created should be implemented
properly in practical way.
4. Law makers should work on loopholes through
which illegal animal testing is still carried out.
Conclusion:
Sadly,
despite the existence of laws protecting animals' rights and interests,
authorities continue to abuse and mistreat the animals used as test subjects.
This is done by taking advantage of severe flaws in the legal system. Despite
India's ban on animal testing for cosmetics and soaps, import regulations for
cruelty-free goods are not strictly enforced in that country. And animals
are still harmed for the sake of experimentations.
Bibliography:
1. www.indiankanoon.com
2. www.peta.org
3. www.pci.nic.in
4. www.animalethics.org
5. The free press journal
6. www.hsi.org
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What are they? What Happens? Who is Involved?
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last seen on 02/12/2022.
[3] Pikee Saxena and Rohit Saxena,
Clinical trials: Changing Regulations in India, National
Library of Medicine, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4215498/,
last seen on 02/12/2022.
[4] S. Bhambri & Associates,
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[5] Safety Testing, Science, Medicine,
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[6]By Beonchip, Animal-free testig,
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[7] Experimentation of cosmetics and
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https://www.animal-ethics.org/experimentation-cosmetics-household-products/,
last seen on 03/12/2022.
[8] Draft Prevention of Cruelty to
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2022#:~:text=Recently%2C%20the%20Government%20has%20introduced,Fisheries%2C%20Animal%20Husbandry%20and%20Dairying.
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[9] Draft for amendment to Prevention
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gruesome cruelty, 5 for killing, Updated on November 24, 2022, The Free Press
Journal,
https://www.freepressjournal.in/india/draft-for-amendment-to-prevention-of-cruelty-to-animal-act-ready-public-comments-sought-3-year-jail-for-gruesome-cruelty-5-for-killing
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[10]Animals are not ours, Peta,
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[11] Cosmetics Testing Ban on Animals
Now Permanent, May 24,2014, Peta,
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[12] Regarding CPCSEA Guidelines,
Chapter on Animal Welfare, https://www.pci.nic.in/pdf/15.pdf.
[13]Ambika Hiranandani, Animal rights: Legislation is not enough,
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https://idronline.org/animal-rights-legislation-is-not-enough/.
[14] History
of Animal Testing in new PETA Exhibit, ‘Without Consent’, PETA,
https://withoutconsent.peta.org/, last seen on 03/12/2022.
[16] Kakoli8 Nath, Landmark Cases and
Laws, Finology Blog, https://blog.finology.in/Legal-news/animal-rights-india,
last seen on 03/12/2022.
[18] Jis John Sebastian, Protection of
Animals: Important Laws in India, last updated on September 24, 2022, ClearIAS,
https://www.clearias.com/protection-of-animals/.