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Use of Animals in Medical Research �

Medico - legal Aspects

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Dr. S.K. Roy Chaudhary�M.B.B.S (Hons); M.D. FIAFM

Prof. & Head,

Dept. of Forensic Medicine

RMC Bareilly

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Why Experiments on Animals

Animals as distant from humans as –mice, and rats share many physiological and genetic similarities with humans, as such animal experimentation has been tremendously helpful in scientific study of life since antiquity

Before use in humans; animal experiments are widely used to develop new medicines and to test the safety of other products.

Animals are also subjected to experimentation for gaining knowledge about human diseases by causing such diseases in them and then testing potential human remedies.

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Originators of Vivisection

Aristotle and Erasistratus were among the first to perform experiments on living animals 250- 350 BC

Galen, a physician (129-200 AD), of Rome, dissected pigs and goats to demonstrate that arteries contained blood and not air and is known as the "father of vivisection”.

Ibn Zuhr (Avenzoar), an Arabic Muslim physician of 12th-century (Syria) practiced dissection, introduced animal testing as an experimental method of testing surgical procedures before applying them to human patients

Aristotle travelled with Theophrastus to the island of Lesbos, where together they researched the botany and zoology of the island. Aristotle married Pythias, either Hermias's adoptive daughter or niece. She bore him a daughter, whom they also named Pythias. Soon after Hermias' death, Aristotle was invited by Philip II of Macedon to become the tutor to his son Alexander in 343 BC. Aristotle is properly recognized as the originator of the scientific study of life He dissected animals but not humans; his ideas on how the human body works have been almost entirely superseded. Erasistratus was a Greek anatomist and royal physician under Seleucus I Nicator of Syria (Seleucus' wars took him as far as India, where, after two years of war (305-303 BC), he made peace with the Indian Emperor Chandragupta Maurya, and exchanged his eastern satrapies in the Indus River Valley for a considerable force of 500 war elephants, which would play a decisive role against Antigonus at the Battle of Ipsus in 301 BC and against Lysimachus^[E] at the Battle of Corupedium in 281 BC.). Along with fellow physician Herophilus (He was the first to distinguish sensory from motor nerves and was a great teacher), he founded a school of anatomy in Alexandria, where they carried out anatomical research.Wikipedia

vivisection (vĭv'ĭ-sěk'shən,n.) The act or practice of cutting into or otherwise injuring living animals, especially for the purpose of scientific research. While Greek law prohibited the dissection of human bodies, physician and medical researcher Galen performed countless animal dissections (dogs, pigs, and macaques, cows & goat) and vivisections (circa 168 A.D.) and claimed that he dissected animals almost every day of his career—not only to enhance his surgical skills but also to learn more about the human body. Ibn Zuhr presented an accurate description of the esophageal and stomach cancers, as well as other lesions. He introduced animal testing as an experimental method of testing surgical procedures before applying them to human patients, he was the first to perform tracheostomy in a goat. Artists such as Leonardo da Vinci and Michelangelo, who wanted to learn to illustrate their subjects with better accuracy, also conducted dissections

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The Physician & Anatomist Andreas Vesalius 1514-1564

Dissection as a Research & Teaching tool

Born in Brussels, Belgium in a family of physicians and pharmacists, Andreas Vesalius’s father was court apothecary to Charles V of Spain, the Holy Roman Emperor. Vesalius learned medicine from the University of Louvain and the University of Paris. He later obtained his medical degree from the University of Padua in 1537. After his graduation, Vesalius became very interested in anatomy. Andreas Vesalius, considered to be the founder of modern human anatomy, felt strongly that dissection should be performed as a way to accurately teach students about anatomy instead of using illustrations or descriptions in books, as well as to gain new knowledge³⁷. Vesalius appears to have set the foundation for dissection as a teaching and research tool. Dissections were performed in theater settings with large numbers of students as the audience. Human cadavers were highly desired, which often led to grave robbing or the use of bodies of executed criminals³⁸. As legal and ethical concerns about the use of human cadavers led to a decrease in the availability of bodies to dissect, the use of animals, who most considered to be incapable of feeling pain, became increasingly common. ��In the early 1900s, the dissection of animals became more common in biology classes. Frog dissection was established in college level courses and eventually was taught in high schools³⁹. Between 1910 and 1920, dead frogs became commercially available for use in education, and by the 1920s, frog dissection became a routine activity in many high school classrooms^40,41. Animal dissection that included crayfish, grasshoppers, mollusks, starfish, sharks, frogs, fetal pigs, and cats in high school became widespread following the Biological Sciences Curriculum Study, a federally-funded initiative in the 1960s to create science curricula for elementary and secondary school students⁴². Also as a result, more high schools established advanced biology courses involving dissection of cats, minks, and fetal pigs, as well as an increased use of live animals. Previously, dissection of such animals was more common in college-level comparative anatomy courses⁴³. In 1988, it was estimated that animal dissection occurred in 75-80% of pre-college level biology classes⁴⁴.

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WilliamHarvey (1578 – 1657) Was an English physician who described completely and in detail the systemic circulation and properties of blood being pumped to the brain and body by the heart dissecting live and dead animals including , the eel and other fishes, snail, shrimp, the chick, pigeon & deers

(1 April 1578 – 3 June 1657) After his death the William Harvey Hospital was constructed in the town of Ashford, several miles from his birthplace of (Harvey)Folkestone. William was the eldest of nine children, seven sons and two daughters, of Thomas and his wife Joan Halke. Notable family connections include Heneage Finch, 1st Earl of Nottingham, who married William's niece Elizabeth Harvey, and the diplomat Sir Daniel Harvey. Thomas Harvey's portrait can still be seen in the central panel of a wall of the dining-room at Rolls Park

Harvey moves on to a fundamental premise to his treatise, stating that it was extremely important to study the heart when it was active in order to truly comprehend its true movement; a task which even he found of great difficulty, as he says:"...I found the task so truly arduous... that I was almost tempted to think... that the movement of the heart was only to be comprehended by God. For I could neither rightly perceive at first when the systole and when the diastole took place by reason of the rapidity of the movement..."^[22] Harvey went on to prove how the blood circulated in a circle by means of countless experiments initially done on serpents and fish: tying their veins and arteries in separate periods of time, Harvey noticed the modifications which occurred; indeed, as he tied the veins, the heart would become empty, while as he did the same to the arteries, the organ would swell up.

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Robert Boyle:- 25/01/1627 to 31/12/1691; Air Pump Expt

Robert Boyle FRS^[2] (25 January 1627 – 31 December 1691) was an Anglo-Irish^[3] natural philosopher, chemist, physicist and inventor born in Lismore, County Waterford, Ireland. He is best known for Boyle’s law,^[4] which describes the inversely proportional relationship between the absolute pressure and volume of a gas, if the temperature is kept constant within a closed system.An Experiment on a Bird in the Air Pump is a 1768 oil-on-canvas painting by Joseph Wright of Derby, one of a number of candlelit scenes that Wright painted during the 1760s.The painting is recreating one of Robert Boyle's air pump experiments, in which a bird is deprived of air, before a varied group of onlookers Robert Boyle was a 17th century natural philosopher and scientist whose work, especially in chemistry and physics, was influential in shaping the development of modern scientific methodology. He is famously remembered for his experiments in thermodynamics, and in particular for his Air Pump experiment concerning the relationship between the pressure and volume of gas within a closed system.In 1659, Robert Boyle commissioned the construction of an air pump, then described as a "pneumatic engine", which is known today as a vacuum pump. 43 experiments he conducted, on occasion assisted by Hooke, on the effect of air on various phenomena. Boyle tested the effects of "rarified" air on combustion, magnetism, sound, and barometers, and examined the effects of increased air pressure on various substances. He listed two experiments on living creatures: "Experiment 40," which tested the ability of insects to fly under reduced air pressure, and the dramatic "Experiment 41," which demonstrated the reliance of living creatures on air for their survival. In this attempt to discover something "about the account upon which Respiration is so necessary to the Animals, that Nature hath furnish'd with Lungs", Boyle conducted numerous trials during which he placed a large variety of different creatures, including birds, mice, eels, snails and flies, in the vessel of the pump and studied their reactions as the air was removed.^[3] Here, he describes an injured lark’…the Bird for a while appear'd lively enough; but upon a greater Exsuction of the Air, she began manifestly to droop and appear sick, and very soon after was taken with as violent and irregular Convulsions, as are wont to be observ'd in Poultry, when their heads are wrung off: For the Bird threw her self over and over two or three times, and dyed with her Breast upward, her Head downwards, and her Neck awry.^[4]

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1831

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Dr. Louis Pasteur- 1822 to 1895 He experimented widely on animals in his work on germs, pasteurization, vaccination against childhood cholera, tuberculosis, anthrax and rabies.

Pasteur developed the overall principle of vaccination and contributed to the foundation of immunology.

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One of Pavlov’s dogs with a saliva-catch container and tube surgically implanted in his muzzle, Pavlov Museum, 2005

The Instinct for Research

Ivan Pavlov: 14/09/1849 To 27/02/1936

In the 1890s, Ivan Pavlov famously used dogs to describe classical conditioning. Taxidermied remains Ivan Petrovich Pavlov 26 September [O.S. 14 September] 1849 – 27 February 1936) was a Russian physiologist known primarily for his work in classical conditioning. Coined the phrase-“The Instinct for Research“

Ivan Pavlov, the eldest of eleven children,^[8] was born in Ryazan (now the Central Federal District) of the Russian Empire. His father, Peter Dmitrievich Pavlov (1823–1899), was a village priest. As a child, Pavlov willingly participated in house duties such as doing the dishes and taking care of his siblings. He loved to garden, ride his bicycle, row, swim, and play gorodki; he devoted his summer vacations to these activities.^[9] Although able to read by the age of 7, Pavlov was seriously injured when he fell from a high wall onto stone pavement;^[10] he did not undergo formal schooling until he was 11 years old as a result of his injuries.^[8] However, in 1870, Pavlov left the seminary without graduating to attend the university at St. Petersburg where he enrolled in the physics and math department and took natural science courses. In his fourth year, his first research project on the physiology of the nerves of the pancreas^[11] won him a prestigious university award. In 1875, Pavlov completed his course with an outstanding record and received the degree of Candidate of Natural Sciences. However, impelled by his overwhelming interest in physiology, he decided to continue his studies and proceeded to the Imperial Academy of Medical Surgery. While at the Academy of Medical Surgery, Pavlov became an assistant to his former teacher, Tyson, but left the department when Tyson was replaced by another instructor. He was inspired to forsake his Orthodox Christian background and pursue a scientific career by D. I. Pisarev, a literary critique and natural science advocate of the time and I. M. Sechenov, a Russian physiologist, whom Pavlov described as 'The father of physiology'. After completing his doctorate, Pavlov went to Germany where he studied in Leipzig with Carl Ludwig in the Heidenhain laboratories in Breslau. n 1904, Pavlov was awarded the Nobel Prize "in recognition of his work on the physiology of digestion, Pavlov’s laboratory housed a full-scale kennel for the experimental animals. Pavlov was interested in observing their long-term physiological processes. This required keeping them alive and healthy in order to conduct chronic experiments, as he called them. These were experiments over time, designed to understand the normal functions of animals. This was a new kind of study, because previously experiments had been “acute,” meaning that the dog went through vivisection and was ultimately killed in the process.^[8]

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5/7/1996- 14/2/2003

National Museum of Scotland

Ian Wilmut

Taxidermied Remains. Dolly was born on 5 July 1996 and had three mothers (one provided the egg, another the DNA and a third carried the cloned embryo to term).^[8] She was created using the technique of somatic cell nuclear transfer, where the cell nucleus from an adult cell is transferred into an unfertilized oocyte (developing egg cell) that has had its cell nucleus removed. The hybrid cell is then stimulated to divide by an electric shock, and when it develops into a blastocyst it is implanted in a surrogate mother.^[9] Dolly was the first clone produced from a cell taken from an adult mammal. The production of Dolly showed that genes in the nucleus of such a mature differentiated somatic cell are still capable of reverting to an embryonic totipotent state, creating a cell that can then go on to develop into any part of an animal.^[10] Dolly's existence was announced to the public on 22 February 1997.^[2] It gained much attention in the media. A commercial with Scottish scientists playing with sheep was aired on TV, and a special report in TIME Magazine featured Dolly the sheep.^[5] Science featured Dolly as the breakthrough of the year. Even though Dolly was not the first animal to be cloned, she gained this attention in the media because she was the first to be cloned from an adult cell.^[11] She was cloned by Ian Wilmut, Keith Campbell and colleagues at the Roslin Institute, part of the University of Edinburgh, Scotland, and the biotechnology company PPL Therapeutics, based near Edinburgh. The funding for Dolly's cloning was provided by PPL Therapeutics and the Ministry of Agriculture.^[5] She was born on 5 July 1996 and died from a progressive lung disease 5 months before her seventh birthday.^[2] She has been called "the world's most famous sheep" by sources including BBC News and Scientific American

The cell used as the donor for the cloning of Dolly was taken from a mammary gland, and the production of a healthy clone therefore proved that a cell taken from a specific part of the body could recreate a whole individual. On Dolly's name, Wilmut stated "Dolly is derived from a mammary gland cell and we couldn't think of a more impressive pair of glands than ”Dolly Parton’s”

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Dr Charles Vacanti 1997 “ The Earmouse”

In 1997 Dr Jay Vacanti and his team grew an ear on the back of a mouse. The earmouse, as it became known, was created by Charles Vacanti and colleagues in the Department of Anesthesiology (University of Massachusetts Medical School) and their results were published in 1997. The mouse itself is called a nude mouse, a commonly used strain of immunocompromised mouse, preventing a transplant rejection.

The Vacanti mouse was a laboratory mouse that had what looked like a human ear grown on its back. The "ear" was actually an ear-shaped cartilage structure grown by seeding cow cartilage cells into a biodegradable ear-shaped mould and then implanted (the ear itself actually grew) under the skin of the mouse, then the cartilage naturally grew by itself.^[1] The photo of the mouse was passed around the internet, mainly via email, sometimes with little to no text accompanying it leading many people to speculate whether the photo was real. In the late 1990s, the picture prompted a wave of protests against genetic engineering—although in this specific experiment no genetic manipulation was preformed. Even the strain of mouse used is not genetically modified; it is the result of a spontaneous natural genetic mutation

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In Favour of Animals

Many of these experiments cause pain to the animals involved; or reduce their quality of life in other ways.
So some people argue that all animal experimentation should end because it is wrong to treat animals merely as tools for furthering knowledge.
An animal should have as much right as a human being to live out a full life, free of pain and suffering
Brain Damaged Human Vs Animals

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Scottish Island “Gruinard” Experiments on killing power of Anthrax was tested on sheep during 2^nd WW

Gruinard Island is a small, oval-shaped Scottish island approximately 1.2 miles (2 km) long by 0.62 miles (1 km) wide, located in Gruinard Bay, about halfway between Gairloch and Ullapool. At its closest point to the mainland it is just over 0.68 miles (1.1 km) offshore. The island was made dangerous for all mammals by experiments with the anthrax bacterium, until it was decontaminated in the late 20th century. Anthrax was the weapon of choice and between 1942 and 1943 [Dr Paul Fildes'] team from Porton Down took over the remote Scottish island of Gruinard, where they exploded a series of anthrax-laden bombs, testing their killing efficiency using sheep', 'Dr Fildes obtained this anthrax from Prof R L Vollum – Professor of Bacteriology at Oxford University',It seems that in 1881 six people lived on the island, and the ruins of cottages and field walls can be found on the land. There do not appear to be any records of when the last inhabitant left the island, but by the 1930s it was being used solely for sheep grazing, rough shooting, fishing, collecting birds eggs, and as a popular spot for local picnics. Other than the sheep, the island's population comprised of rabbits, and visiting birds.The uninhabited island became well known after World War II, having been chosen as the test site for lethal germ warfare tests, which led to it being quarantined for 48 years due to the resultant contamination.

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Animal Research for Benefit to Humans ?

Those in favour of animal experiments say that the good done to human beings outweighs the harm done to animals.
The benefits of animal research have been enormous and it would have severe consequences for public health and medical research if it were abandoned
Polls show that a high proportion—84% in 1999, 90% in 2002 and 89% in 2005 of people—are ready to accept the use of animals in medical research if the research is for serious medical purposes, suffering is minimized and/or alternatives are fully considered

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Pros & Cons

Animal lovers are for stopping use of animals completely
Less hardcore want that use of animals to be phased out in favour of “more accurate, reliable, human-relevant other methods”.
But sixteen Nobel laureates have supported the resolution of 149 science organizations defending use of animal based research

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Response of Govts on Animal Research

Prevention of Cruelty to Animal Act 1960/82
Draft of ‘THE ANIMAL WELFARE ACT, 2011’
Animals (Scientific Procedures) Act 1986- UK Revised from 1^st Jan. 2013
European Union's Directive 86/609/EEC on the protection of animals
EU Directive 2010/63/EU
Similar Acts in USA

NC3Rs; London, UK(May 2004)-National Centre for the Replacement, Refinement and Reduction of Animals in Research

Animal-rights groups also disagree with the 3Rs, since these principles still allow for the use of animals in research

The revised legislation came into force on 1 January 2013. This law safeguards laboratory animal welfare while allowing important medical research to continue. These controls are widely regarded as the strictest in the world. �Central to the Animals (Scientific Procedures) Act 1986 is a cost-benefit assessment which must be applied before any research project involving animals can go ahead. Thus the costs, in terms of potential animal suffering, must be weighed against the potential benefits of the research. Draft guidance on the operation of ASPA (Animals (Scientific Procedures) Act,)was published on 29 January 2013.

The final text of the Directive was finalised and signed on 22nd September 2010. It was formally published in the Official Journal of the European Union on the 20th October 2010 and was given its final name: 2010/63/EU. The directive then entered into force on the 9th November 2010, which put the deadline for Member States to transpose it into their own words at 10th November 2012. The Directive will be formally applied across Europe as of 1st January 2013.

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W. M. S. Russell and R. L. Burch

The Principles of Humane Experimental Technique- Published in 1959

3Rs -In the use of animals in research

Replacement-use of non-animal methods
Reduction: use of fewer animals.
Refinement: use of methods that

Alleviate or minimize potential pain, suffering or distress, to animals
And enhance animal welfare for the animals used.

The Principles of Humane Experimental Technique by W.M.S. Russell and R.L. Burch: Foreword to Special Edition

In October 1959, Major Charles Hume, Founder of the Universities Federation for Animal Welfare, presented a paper at the Tenth Annual Meeting of the Animal Care Panel ¹1 in Washington, DC. In this he reported UFAW's ( Universities Federation for Animal Welfare,)recent change of direction from laboratory animal husbandry to the far more controversial topic of experimental techniques.

He was referring to the appointment in 1954 of William Russell, whom he described as a brilliant young zoologist who happened to be also a psychologist and a classical scholar, and Rex Burch, a microbiologist, to inaugurate a systematic study of laboratory techniques in their ethical aspect. This led to publication in 1959 of The Principles of Humane Experimental Technique in which they classified humane techniques under the headings of replacement, reduction, and refinement--now commonly known as the three Rs.

The Three Rs (3Rs) in relation to science are guiding principles for more ethical use of animals in testing. They were first described by W. M. S. In 1990, the Humane Society of the United States announced its new annual Russell and Burch Award. This is to recognize researchers or educators who have made outstanding contributions towards the advancement of alternative methods in biomedical research, testing, or higher education. In this context alternative methods are considered in the broad sense of replacement, reduction, and refinement as first articulated by Russell and Burch. Russell and R. L. Burch in 1959.[1] The 3Rs are:

Replacement: preferred use of non-animal methods over animal methods whenever it is possible to achieve the same scientific aims.

Reduction: use of methods that enable researchers to obtain comparable levels of information from fewer animals, or to obtain more information from the same number of animals.

Refinement: use of methods that alleviate or minimize potential pain, suffering or distress, and enhance animal welfare for the animals used.

The 3Rs have a broader scope than simply encouraging alternatives to animal testing, but aim to improve animal welfare and scientific quality where the use of animals cannot be avoided. In many countries, these 3Rs are now explicit in legislation governing animal use.

Replacement- animal experimentation should be avoided whenever possible in favour of alternative research strategies.

Only animals of second or older generations be used, subject to transitional periods, to avoid taking animals from the wild and exhausting wild populations

Ban on the use of great apes - chimpanzees, bonobos, gorillas and orangutans - in scientific procedures, other than in very exceptional circumstances,

By invertebrate species and foetuses in their last trimester of development and also larvae

By cell culture,

Computer modelling,

epidemiological study,

And use of human volunteers etc

REDUCE, REUSE & Recycle- 3Rs for protection of environment

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The principles of the 3Rs (Replacement, Reduction and Refinement) were developed over 50 years ago as a framework for humane animal research. They have subsequently become embedded in national and international legislation regulating the use of animals in scientific procedures

Replacing experiments on animals with alternative techniques such as: Experimenting on cell cultures instead of whole animals Using computer models (in silico) Studying on human volunteers Ames test- uses strains of the bacterium Salmonella typhimurium to determine whether chemicals cause mutations in cellular DNA. This and other tests are already widely used as pre-screens to partly replace rodent testing for cancer-causing compounds Using epidemiological studies such as human studies, and in vitro and in silico (In silico is an expression used to mean "performed on computer or via computer simulation." The phrase was coined in 1989 as an analogy to the Latin phrases in vivo, in vitro, and in situ, which refer to experiments done in living organisms, outside of living organisms, and where they are found in nature ( In the original position. Confined to the site of origin), respectively). the technology to develop these alternatives is not available or does not yet exist

Unfortunately, the in vitro tests can produce false results, and tend to be used more to understand the processes of mutagenicity and carcinogenicity than to replace animal assays.

Reducing the number of animals used in experiments by: Improving experimental techniques Improving techniques of data analysis Sharing information with other researchers Despite the inherent limitations of some non-animal tests, they are still useful for pre-screening compounds before the animal-testing stage, which would therefore reduce rather than replace the number of animals used.

Refining the experiment

Using less invasive techniques

Refining the management of pain

Administration of appropriate anaesthetics and analgesics during the experiment

Replacing the standard mouse carcinogenicity assay with other animal-based tests that cause less suffering because they use fewer animals and do not take as long

The way the animals are cared for so as to reduce their suffering by:

The amount of handling and restraint required should all be considered.Better medical care Better living conditions

Although animals cannot yet be completely replaced, it is important that researchers maximize reduction and refinement. Sometimes this is achieved relatively easily by improving animal husbandry and housing, for example, by enriching their environment. These simple measures within the laboratory aim to satisfy the physiological and behavioural needs of the animals and therefore maintain their well-being

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Replacement

It's wrong to use animals if alternative testing methods would produce equally valid results.

Experimenting on cell cultures instead of whole animals.
uses strains of the bacterium
Using computer models
Studying on human volunteers
Using epidemiological studies

Animal research remains a small, but vital, part of biomedical research, about 10% of total spending

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Reduction:

Reducing the number of animals used in experiments by:

Improving experimental techniques
Improving techniques of data analysis
Sharing information with other researchers

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Refinement

Refining the experiment or the way the animals are cared for so as to reduce their suffering by:

Using less invasive techniques
Better medical care

Better living conditions

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Fixed Dose Procedure Replacing LD 50 Technique

Microdosing is an exciting new technique for measuring how very small doses of a compound move around the body. In principle, it should be possible to use this method in humans and therefore to reduce the number of animals needed to study new compounds; however, it too has limitations. By its very nature, it cannot predict toxicity or side effects that occur at higher therapeutic doses.

Unfortunately, the in vitro tests can produce false results, and tend to be used more to understand the processes of mutagenicity and carcinogenicity than to replace animal assays. However, there are moves to replace the standard mouse carcinogenicity assay with other animal-based tests that cause less suffering because they use fewer animals and do not take as long. This has already been achieved in tests for acute oral toxicity, where the LD50—the median lethal dose of a substance—has largely been replaced by the Fixed Dose Procedure, which was developed, validated and promoted between 1984 and 1989 by a worldwide collaboration, headed by scientists at the British Toxicological Society (Macclesfield, UK).

British Toxicological Society (Macclesfield, UK)-1984-89

Fixed Dose Procedure replacing LD 50 technique

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Ban on Use of Animals for Some Drugs

After 2004 amendment to the Cosmetics Directive, cosmetic products can not be tested on animals in EU
After March 2009 amendment even cosmetic ingredients can not be tested on animals in Europe
Ban on the use of great apes - chimpanzees, bonobos, gorillas and orangutans - in scientific procedures, other than in very exceptional circumstances, but there is no proposal to phase out the use of other non-human primates in the immediate foreseeable future.

“Moral worth as richness of life" model

This point of view suggests that more complicated organisms have richer, more fulfilling lives and that it is the richness of the life that actually correlates with moral worth.

This creates a hierarchy of moral standing with more complex animals at the top and microorganisms and plants at the bottom

Therefore preferential research use of less complex organisms whenever possible. For example bacteria, fruit flies, and plants would be preferred over mammals.

With a 2004 amendment to the Cosmetics Directive, the animal testing for cosmetic products is forbidden in the EU. Also animal testing for cosmetic ingredients is prohibited since March 2009. The amendment also prohibited, since 11 March 2009, to market cosmetic products containing ingredients which have been tested on animals

Scientists say that banning animal experiments would mean either

An end to testing new drugs or Using human beings for all safety tests

To make it compulsory to carry out ethical reviews and require that experiments where animals are used be subject to authorisation

To widen the scope of the directive to include specific invertebrate species and foetuses in their last trimester of development and also larvae and other animals used in basic research, education and training to set minimum housing and care requirements

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Prevention of Cruelty to Animal Act 1960/82

Nothing contained in this Act shall render unlawful the performance of experiments (including) experiments involving operations) on animals for the purpose of advancement by new discovery of physiological knowledge or of knowledge which will be useful for saving or for prolonging life or alleviating suffering or for combating any disease, whether of human beings, animals or plants.

India is one of the pioneering countries to institute Prevention of Cruelty to Animals Act in 1960 whereas such Act was instituted in France in 1963 and in USA in 1966. The detailed rules for experimentation on animals were first enacted by the Ministry of Agriculture in 1968 and were implemented by a Committee set up in pursuance of Section 15(1) of the PCA Act,1960. However, the Committee was later wound up in 1977. After a hiatus of 13 years, a recommendation to reconstitute Committee for the purpose of control and supervision of experiments on animals (CPCSEA) was received from Animal Welfare Board of India (AWBI). After due consideration of the recommendation of AWBI, CPCSEA was set up by this Ministry on 8th February, 1991. The Committee was, subsequently, reconstituted on 23rd February, 1996 with 15 Members and one Member Secretary. Since then, this Ministry has reconstituted the CPCSEA routinely. The present Committee was constituted on 30th August, 2012 under the chairmanship of Additional Secretary, MoEF with 17 Members. At present, Shri Hem Pande, Additional Secretary, MoEF&CC is the Chairman of the Committee.

The Animal Welfare Division is entrusted with the implementation of the provisions of the Prevention of Cruelty to Animals Act, 1960 (59 of 1960). Plan Schemes are in operation for implementation of the statutory obligations under this Act. Two statutory bodies viz, Animal Welfare Board of India (AWBI) and Committee for the Purpose of Supervision and Control of Experiments on Animals (CPCSEA) have also been set up under this Act. Apart from this there is a subordinate body namely, National Institute of Animal Welfare (NIAW), Ballabhgarh, Haryana for imparting training and education on diversified subjects in Animal Welfare including animal management, behavior and ethics.

Activities relating to Animal Welfare are looked after by the Animal Welfare Division of the Ministry of Environment & Forests with the mandate to prevent the infliction of unnecessary pain or suffering on animals

The Supreme Court has issued show-cause notices to the ministries of Defence and Social Welfare, Justice & Empowerment, and the Andhra Pradesh Governments asking them to explain why old horses of the Army were being handed over to serum vaccine firms, leading to a painful death of the animals. Firms which produce antibodies for making serums and vaccines by bleeding the horses use over-aged horses of the Army. Due to excessive administration of high doses of toxins (venoms, antigens), there have been several deaths of these horses in these firms and the State has failed (in its constitutional duty) to have compassion for living creatures. The state is not a breeder and under rules only a breeder can give away animals for such scientific experiments. So this is not only a violation of rules, but also the action is beyond the pale of imagination. The animal activists further argued that it was shockingly disturbing to find that the Army, after using the animals for 15 or more years, discards them like this. They can surely be allowed to graze in its many pastures.

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Indian Panorama

ANIMAL WELFARE BOARD OF INDIA,13/1, Third Seaward Road, Valmiki Nagar, Thiruvanmiyur, �Chennai-600041
Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA)(Animal Welfare Division)�Ministry of Environment, & Forest, New Delhi
The National Institute of Animal Welfare (NIAW) is a division of the Ministry of Environment and Forests in India. It is located in Ballabgarh, Haryana
LASA - Laboratory Animal Scientists' Association (India) ACTREC, Tata Memorial Centre, Kharghar, Navi Mumbai-410210,�

ANIMAL WELFARE BOARD OF INDIA, 13/1, Third Seaward Road, Valmiki Nagar, Thiruvanmiyur, Chennai- 600 041.

Phone : 044-24571024, 24571025 Fax: 044-24571016

E-mail : awbi@md3.vsnl.net.in, animalwelfareboard@gmail.com

Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA)

(Animal Welfare Division)�Ministry of Environment, Forest & Climate Change; 5th Floor, 'Vayu' Wing,�Indira Paryavaran Bhawan, Jor Bagh Road, New Delhi - 110 003 Tel- 011-24695231

Email- cpcsea.moef@gmail.com

E-mail : awbi@md3.vsnl.net.in, animalwelfareboard@gmail.com

The National Institute of Animal Welfare (NIAW) is a division of the Ministry of Environment and Forests inIndia. It is located in Ballabgarh, Haryana

The Committee for the Purpose of Control and Supervision of Experiments on Animals Chennai “CPCSEA Tamilnadu Veterinary and Animal Sciences University (popularly abbreviated asTANUVAS).

LASA - Laboratory Animal Scientists' Association (India)

The Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) is the state-of-the-art R&D satellite of the Tata Memorial Centre (TMC), which also includes under its umbrella the Tata Memorial Hospital (TMH), the largest cancer hospital in Asia. ACTREC has the mandate to function as a national centre for treatment, research and education in cancer. TMC is an autonomous grant-in-aid institution of the Department of Atomic Energy (DAE), Government of India. It is registered under the Societies Registration Act (1860) and the Bombay Public Trust Act (1950). Its Governing Council is headed by the Chairman, Atomic Energy Commission, Government of India.

ACTREC comprises of 2 arms - one for basic research and another for clinical research. The basic research building was inaugurated in March 2002 at the new site of ACTREC in Kharghar, Navi Mumbai. In August 2002, the Cancer Research Institute (CRI) shifted in toto from its Parel campus in Mumbai to serve as the basic research arm of ACTREC. The clinical research arm of ACTREC comprising of the Clinical Research Centre (CRC) became functional from March 2005. ACTREC also has a 100-bed hospital fully equipped with state-of-the-art diagnostic and therapeutic facilities. Research investigations at CRI currently focus on molecular mechanisms responsible for causation of major human cancers relevant to India. It is envisaged that in the future, ACTREC will play a greater role in drug development and emerging therapies for treatment and prevention of cancer

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Indian Panorama (Cont.)

The Committee for the Purpose of Control and Supervision of Experiments on Animals Chennai “CPCSEA Guidelines For Laboratory Animal Facility”
"Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998" as amended during 2001 and 2006,
Indian National Science Academy New Delhi “Guidelines for care and use of animals in scientific research -2000”
“Use of Animals in Scientific Research” Indian Council of Medical Research Ministry of Health & Family Welfare New Delhi- May 2000

The Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) is a statutory body formed by the Act of the Indian Parliament under the Prevention of Cruelty to Animals Act 1960. Formed in 1964, it was revived in 1998, under the committed chairpersonship of Maneka Gandhi. In the last two years, the CPCSEA has bettered the life of the animals in laboratories across India. This committee is composed of members of the scientific community, regulatory authorities and animal activists. The CPCSEA functions with a brilliant network of volunteers who liaise with the laboratories. For the first time in India: over 665 laboratories are registered with the CPCSEA; Institutional Animal Ethics Committees (IAECs) are constituted in every laboratory, which are only empowered to approve research project proposals that use rats, mice, guinea-pigs or rabbits; every project that uses canines, ovines, bovines or non-human primates can only be conducted if approved by the panel of scientific experts constituted for this purpose; guidelines on laboratory animal care and practice have been formulated and enforced; a protocol for the production of immunobiologicals from equines has been formulated and ratified by the Supreme Court of India; the CPCSEA has been deliberating on alternatives and working out modalities to introduce alternatives in basic/regulatory research and education, in keeping with the international arena; the CPCSEA, to date, has rehabilitated and homed over 300 dogs, 150 equines, 200 non-human primates and several cattle, cats, birds, rabbits and mice; the CPCSEA proactively trains and guides scientific and non-scientific personnel on issues of alternatives and laboratory animal welfare; and the CPCSEA has fought legal issues on laboratory animal care and use and have had verdicts that favoured alternatives and animal welfare.

Many film personalities recently signed a petition by People for the Ethical Treatment of Animals (PETA) demanding amendments to strengthen the Prevention of Cruelty to Animals Act. According to the petition, a new bill, which would amend the Act, was drafted two years ago but is currently languishing in parliament. “The current Act, passed four decades ago, has not been updated and imposes only minimal fines for even the most heinous cases of cruelty. The fine for any violation of the Act, committed any number of times, is merely Rs. 60. This is hardly a deterrent to those who commit acts of cruelty to the animals”. In 1999, PETA had exposed India’s cruel underground leather and meat trade. The investigations by PETA revealed the unholy nexus between corrupt traders and officials for smuggling the animals across State borders at night, and those animals that collapse during the march have their tailbones fractured just to keep them moving.��The Supreme Court has issued show-cause notices to the ministries of Defence and Social Welfare, Justice & Empowerment, and the Andhra Pradesh Governments asking them to explain why old horses of the Army were being handed over to serum vaccine firms, leading to a painful death of the animals. Firms which produce antibodies for making serums and vaccines by bleeding the horses use over-aged horses of the Army. Due to excessive administration of high doses of toxins (venoms, antigens), there have been several deaths of these horses in these firms and the State has failed (in its constitutional duty) to have compassion for living creatures. The state is not a breeder and under rules only a breeder can give away animals for such scientific experiments. So this is not only a violation of rules, but also the action is beyond the pale of imagination. The animal activists further argued that it was shockingly disturbing to find that the Army, after using the animals for 15 or more years, discards them like this. They can surely be allowed to graze in its many pastures. According to a notification published in Extraordinary Gazette of India (8th September, 1998), one should have prior permission from CPCSEA for carrying out every animal experiment. These rules prevent the use of animals for teaching, attaining the surgical skills and / or for repeating a known fact. ��This Committee, now headed by Ms. Maneka Gandhi, presently Minister of State for Welfare, has assumed the power to decide on all details of the animal based experiments in the country. In 1998, the Committee for Control and Experiments on Animals (CCEA) in the Ministry of Social Justice and Empowerment drafted the breeding of and conducting experiments (Control and Supervision Rules) on animals. Many animal facilities are closed down. All routine teaching at undergraduate and postgraduate levels at all the medical colleges including All India Institute of Medical Sciences, New Delhi; Institute of Medical Sciences, Banaras Hindu University and many other renowned institutes of learning, came to a halt. The use of live demonstrations on the animals and the research work requiring the use of laboratory and non-laboratory animals also came to a halt.[1] �A number of symposia on this subject were organised to raise the voice against the unilateral decision of the government. Prof. V. Ramlingaswami chaired a symposium organised by the Association of Physiologists and Phamacologists of India at All India Institute of Medical Sciences, New Delhi (11-11-1998). A panel discussion “Should animal experiments be stopped in India?” was held on 5th December 1998 at Banaras Hindu University during the 10th Annual Conference of the Physiological Society of India. The panel recommended that the experiments on animals are absolutely necessary for proper training of science students, especially the medical students. Though some experiments, especially for drug testing, could be done away by alternate methods, it is not possible to avoid animal experiments completely. There is difference between doing experiments scientifically in ethical conditions and abusing animals, and the CCEA should ensure that one does not suffer because of the other. email: cpcsea[dot]moef[at]gmail[dot]com: Telephonic enquiries strictly between 15:00 hrs to 16:00 hrs at 011-24695231.

The motto of Prevention of Cruelty to Animals (PCA) Act 1960 as amended in 1982, is to prevent infliction of unnecessary pain or suffering on animals. The Central Government has constituted a Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) which is duty bound to take all such measures as may be necessary to ensure that animals are not subjected to unnecessary pain or suffering before, during or after the performance of experiments on them. For this purpose, the Government has made "Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998" as amended during 2001 and 2006, to regulate the experimentation on animals.

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CPCSEA

All establishments engaged in research and education involving animals, are required to comply with the various guidelines, norms and stipulations set out by Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA).

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Functions

Registration of establishments conducting animal experimentation or breeding of animals for this purpose.
Selection and appointment of nominees in the Institutional Animal Ethics Committees of registered establishments.
Approval of Animal House Facilities on the basis of reports of inspections conducted by CPCSEA.
Mandatory actions, SOP & Recommendation for import of animals for use in experiments.
Action against establishments in case of violation of any legal norm / stipulation.

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Requisite Forms

Application for Registration of the Institution- Form A- Online: http://cpcsea.nic.in
Application for Permission for Animal Experiments- Form B
Record of Animals bred/ Acquired Form C
Record of Animal Used in Experiments D
Biodata Format for Members IAEC
Checklist for Protocol
Checklist for Inspection
Annual Statement of Large Animal Use

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For Further Information

Please contact:

Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA)
(Animal Welfare Division)�Ministry of Environment, Forest & Climate Change; 5th Floor, 'Vayu' Wing,�Indira Paryavaran Bhawan, Jor Bagh Road, New Delhi - 110 003 Tel- 011-24695231

Email- cpcsea.moef@gmail.com

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Activities

Observation of World Laboratory Animals Day by CPCSEA and Launching of website of CPCSEA for online services by Minister of Environment, Forests & Climate Change was held on 24^th April, 2015.
CPCSEA Nominees Training Programme was held on 18-22 May, 2015 at National Institute of Animal Welfare, Ballabhgarh, Haryana
53^rd Meeting of CPCSEA was held on 24^th June, 2015 under the Chairmanship of Shri Hem Pande, Additional Secretary.

"animal" means any living creature other than a human being, Today's small animal pets include more than 40 breeds of rabbit, 13 breeds of guinea pig, five species of hamster, plus ferrets, chinchillas,gerbils, hedgehogs, mice, rats and sugar gliders.

“captive animal" means any animal (not being a domestic animal) which is in capacity or confinement, whether permanent or temporary, or which is subjected to any appliance of contrivance for the purpose of hindering or preventing its escape from captivity or confinement or which is pinioned or which is or appears to be. maimed;

“domestic animal" means any animal which is tamed or which has been or is being sufficiently tamed to serve some purpose for the use of man or which, although it neither has been nor is intended to be so tamed, is or has become in fact wholly or partly tamed-,

The main large animal models used for biomedical research are domesticated livestock species, such as cows, sheep, goats, pigs, and occasionally horses. This section will not cover primate models, or companion animals such as dogs and cats, which although are “large animals” have their unique set of attributes and issues as animal models.

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CERTIFICATE COURSE IN LABORATORY ANIMAL SCIENCE 7-17 Dec.15 Chennai

The objective of this certificate course was to meet the quality standards prescribed by FELASA (Federation of European Laboratory Animal Science Associations) addressed to the scientists to be fully competent to undertake research work involving animals on their own responsibility.

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Pending Bill

Draft for THE ANIMAL WELFARE ACT, 2011

And ensure that experiments only to gain manual skills, or experiments whose results are known, or experiments that have non animal alternatives, or repetitive experiments, are Not performed

No person or institution shall perform an experiment on animals unless permitted by the Committee for the Purpose of Control and Supervision of Experiments on Animals, established under this Act.

It shall be the duty of the Committee to take all such measures as necessary to ensure that animals are not subjected to unnecessary trauma, pain or suffering before, during or after the performance of experiments on them,

Make such rules as it may think fit in relation to the conduct of such experiments.

And ensure that experiments only to gain manual skills, or experiments whose results are known, or experiments that have non animal alternatives, or repetitive experiments, are not performed

And to maintain records of various experiments performed by institutes registered with it,

And to maintain details of various available non animal alternatives ,

The responsibility for such experiments would be on the person in charge of the institution

Ensuring that the experiments are performed by qualified individuals

Operations are performed under the influence of an anesthetic of sufficient potency to prevent the animals feeling pain;

Due to experiment if so injured that recovery would involve serious suffering, then kill while still insensible

That experiments and dissections are avoided in hospitals, educational institutes including undergraduate medical colleges, pharmacy colleges, zoology and other degree and diploma colleges and universities;

That experiments on larger animals are avoided when it is possible to achieve the same results by experiments upon small laboratory animals

That the animals intended to be used or used for experiments are cared for during and after experiments and rehabilitated wherever feasible in rehabilitation centers, and not in such offending institutes

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THE ANIMAL WELFARE ACT, 2011

That experiments and dissections are avoided in hospitals, educational institutes including undergraduate medical colleges, pharmacy colleges, zoology and other degree and diploma colleges and universities;
That experiments on larger animals are avoided when it is possible to achieve the same results by experiments upon small laboratory animals
That the animals intended to be used or used for experiments are cared for during and after experiments and rehabilitated wherever feasible in rehabilitation centers, and not in such offending institutes

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THE ANIMAL WELFARE ACT, 2011

That suitable records are maintained with respect to experiments performed on animals
An inspector can visit at any time and seize records and animals and may order closure of experiment.
For violation of rules fine up to 50000/Rs for first offence and imprisonment up to 3 years
For second offence fine up to 1 lakh imprisonment up to 5 years
In charge of the institute will also be held jointly responsible

Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act, 1994-minimumAny person who contravenes the provisions of sub

-

section (1) or sub

-

section (2) shall be punishable with

imprisonment for a term which may extend to three years and with fine which may extend

to ten thousand rupees.

Explanation

:

-

For the purposes of this, “advertisement” includes any notice, circular, label wrapper or other document

and also includes any visible representation made by means of any light, sound, smoke or gas. The name of the registered medical practitioner shall be reported by the appropriate

Authority to the State Medical Council concerned for taking necessary action including suspension of the

registration if the charges are framed by the Court and till

the case is disposed of and on conviction for

removal of his name from the register of the Council for a period of five years for the first offence and

permanently for the subsequent offence.

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Will You Not Make the Effort?

108 Nobel Prizes were awarded in medicine up to 2015 out of them 92 scientists had worked on animals.
In fact, since 1979 every Nobel Prize in Medicine had involved experiments on animals except the award of 1983.
2015 awardees- Satoshi Ōmura & William C. Campbell discovered the antiparasitic property of Ivermectin working on cattle, sheep, dogs and chickens &
Professor Tu You you with her experiment on Monkey & Mouse identified artemisinin a first-line drug for malaria from an extract of the plant qinghao, scientific name Artemisia annua.

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The 2015 Nobel prize in medicine or physiology has been won by William C Campbell, Satoshi Ōmura and Youyou Tu.

Campbell and Ōmura discovered a new drug Avermectin, the derivatives of which have radically lowered the incidence of river blindness and lymphatic filariasis, caused by roundworm parasites.

Tu, the 12th woman to win the medicine prize, discovered Artemisinin, a drug that has significantly reduced the mortality rates for patients suffering from malaria.

Avermectin is used for and was tested on sheep, cattle and poultry: see this Satoshi Omura’s paper which used mice http://aac.asm.org/content/15/3/361.full.pdf and http://aac.asm.org/content/15/3/372.full.pdf for more details.

Artemisin was tested on monkey and mouse models of malaria, see http://www.tm.mahidol.ac.th/seameo/2004/35_2/02-3334.pdf for more.

Satoshi Ōmura had identified a series of bacterial cultures that produced a variety of antimicrobial agents, including the bacteria Streptomyces avermitilis which showed promise against parasitic roundworm infection in mice, in 1979 William C. Campbell and colleagues identified a particular component produced by S. avermitilis called Avermectin B1a which had a broad efficiency against roundworm infections in a wide range of domesticated animal species, including cattle, sheep, dogs and chickens. Following this the team developed a modified form of Avermectin B1a known as Ivermectin, which was entered into clinical trials following positive tests in animal models of parasitic infection, and has since gone on to become a key treatment for parasitic infections – particularly the nematode worm infections that cause River Blindness and Lymphatic Filariasis (the extreme manifestation of which is known as elephantitis) – and is on the World Health Organization’s list of Essential Medicines.