This article is written by Gunjan Rohit.

Introduction

Animal testing is a controversial topic. Animal activists are against it because they believe that it is cruelty on animals. They argue that animal testing is not effective and it should be banned whereas supporters of animal testing argue that animal is necessary for the development and discovery of new drugs. 

Different countries have various perspectives on animal testing. European Union, Brazil, Canada, Taiwan are some of the countries which are against animal testing and have banned or are planning to ban animal testing. Animal testing is legal in China. Animal testing is not banned in the United States. Our concern is whether animal testing for drugs should be banned in India. India is already behind when it comes to providing poor people with adequate healthcare and medicines. Therefore, if we compare India and the U.S. pharmaceutical industry, we can clearly infer that the reason the U.S. pharmaceutical industry is booming is the legality of animal testing. India being a developing country cannot ban animal testing.

Animal testing cannot exist without modern regulations. Regulations on animal testing are needed to ensure that animals do not suffer unnecessary pain, harm and suffering. As people become more aware of animal rights and safety in modern times, we cannot adhere to the old rules and regulations. The reason for the three Rs ‘ failure was because they were inappropriate for the present. The way forward in any civilized society should be to legalize anything under regulations. India can legalize animal testing but only with new regulations to properly regulate experimentation and avoid unnecessary testing of animals. Example of U.S. can be considered here, in U.S. the testing on animals is regulated by the Animal Welfare Act of 1966. We need restrictions in order to treat animals better.

We cannot ban animal testing only because it is cruel. We know well that animal testing has benefited us. Different life-saving medications could not have been identified without animal testing. In order to legalize animal testing in India, we need modern regulations.

What is Animal Testing?

Animal testing is the experimentation on animals. Animal testing is used to determine the effectiveness of drugs, products and medicines. These products and medicines are tested in animals to verify the safety levels and toxicity before these are tested on humans. It is also known as animal experimentation or animal research. The medicines, cosmetics, drugs and other products can only be tested on humans after going through a series of tests on animals. We rely on animal testing to find out if our food is safe, our household products, our drugs and the things we put in the environment. Animal experimentation is also used in biomedical research and education. Results of toxicological testing in laboratory animals predict reasonably well the effects of chemical exposure in humans. Researchers believe that drugs react differently on various types of animals. 

Therefore, all reputable researchers in industry, government and academia use more than one species to test a substance to control species differences.

Animal activists against animal testing argue that animal experiments are unreliable, cruel, ineffective and dangerous. According to them these experiments rarely work in humans as humans are different from animals. For example: raisins, grapes, chocolates, nuts, avocados, macadamia and nuts are harmless in people but toxic to dogs. These animal activists have started various campaigns around the world to ban animal testing. The main purpose of their campaign is to save animals from cruelty and unnecessary hurt and also to protect the rights of animals. 

In the case of A. Nagaraja, which mentions about ‘Jallikattu’ a bull-taming sport. This sport is a centuries-old tradition but it cannot be justified as it is cruelty on animals. In this case, it was held that animals have a fundamental right against infliction of pain. Bulls should not be used in any kind of competition including races or bullfights. It also added animal welfare board and government must protect freedoms of animals: freedom from distress and fear and freedom to expression of normal behaviour, freedom from thirst and hunger, freedom from discomfort, freedom from disease, pain and injury, freedom from discomfort. This case shows that if there is any cruelty towards animals or if any of their fundamental rights are violated, animal activists and animal welfare boards are always willing to stand up for them.

On the other hand, supporters of animal testing argue that animal experimentation is the need of the hour and we cannot ban it completely.

Background

Research on living animals has been practiced since at least 500 BC. Then testing on animals was started in the U.S. in the early 1900s, also it is important and useful to know why we started experimentation on animals. Lash Lure, a cosmetic, caused the death of a woman because of the ingredients of the cosmetic. Women were going blind because of this cosmetic. People were harmed and it led to an outcry. The marketing of these kinds of product is harmful and unsafe. Beauty is not really worth the risk of death, right? This led to an origin of animal experimentation. The notion behind experimentation on animals was that humans and animals are biologically similar and testing these products on animals will ensure safety.

Regulatory agencies and biomedical research advocates around the world have continued to overvalue the importance of animal testing in public safety assessment and to undervalue the potential of the new technology. Overvalued animal experimentation around the world resulted in various campaigns around animal testing in the United States and Europe. 

In order to find the alternatives of animal testing, both Europe and the United States spent millions of dollars on research. The researchers and advocates were not against animal experimentation but they were looking for a new approach which would be free from animal testing. Animal testing is necessary to determine whether a product is toxic for human or not. In order to find out the effectiveness of these products on animals, animal experimentation is significant.

There are various campaigns on animal testing around the world. Around 1975, animal activists began campaigns in Europe and the United States against the testing of cosmetics and toiletries on animals. Forever Against Animal Testing (FAAT) is one of them. This campaign was started by “The Body Shop” in 1989. The main aim of this campaign is to ban animal testing worldwide. According to Cruelty Free International, over 500,000 animals may be used in cosmetic animal testing worldwide every single year, even though alternative testing options exist that would allow neither animals or consumers to suffer.  

Preclinical and clinical trials

A study to test a procedure, a drug, or medical treatments in animals is known as a preclinical trial. Pre-clinical studies play a major role in drug development and acts as an eye-opener for the further advancement of the potential molecule. Preclinical studies are now necessary and require strict regulations. Pre-clinical trials are needed before clinical trials. A pre-clinical trial requires a number of steps: 

1. Approval file as a new investigative drug;
2. Establish toxic and effective doses;
3. Screen the drug in the assay;
4. Build a bioassay;
5. Identify the target of the drug. 

Clinical trials test how well people work with new medical approaches. Clinical and pre-clinical trials are used to test drugs to check efficacy. If a drug is not tested on animals then it cannot be tested on humans. The whole purpose of a pre-clinical trial is to ensure safety for humans. 

Why Animal Testing should be legal in India?

History of pharma industry in India

Production of modern medicine by indigenous units started with the setting up of  Bengal chemical and Pharmaceutical in 1892. Pharmaceutical discovery is an important part of  lives of people. In 1947 India became absolutely dependent on foreign drug companies. Indian drug prices were quite high. Due to the weak patent law in India, Indian pharmaceutical companies started copying existing foreign pharmaceuticals cheaply without the expenditures of money and time that the other foreign pharmaceutical companies spent on development and research of drugs. In contrast, Indian pharmaceutical companies did not fear any legal infringement by drug developers or the related litigation costs. As of the 1990s, “Indian companies control[led] seventy percent of the domestic formulations market and eighty-five percent of the bulk drugs market.” This made India free from foreign pharmaceutical companies’ domination. India accounts for 8 per cent of world’s pharmaceutical production and is the fifth largest country in the world after the US, Japan, Europe and China in terms of volume of production. All because of the weak patent laws of India.

Contribution of animal testing to discovery of drugs

All the great discoveries in the past were possible due to animal testing. Over the last century, every Nobel Prize for medical research has been dependent on animal research. The first Nobel prize in 1901 in medicine was for serum therapy and research involving use of horses. In 1922, insulin was first isolated from dogs and revolutionized diabetes care. In the 1970s, armadillos were used to develop antibiotic therapy and leprosy vaccines. Alexander fleming used rats in 1941 to discover penicillin. Further, in 1945, Alexander fleming won Nobel Prize for the development and discovery of penicillin. Diphtheria/tetanus antitoxin, prontosil (first drug for bacterial infections), streptomycin are some other drugs that were discovered using animal experimentation.

Laws on animal testing around the world

In order to argue that why animal testing should be made legal in India it is necessary that we know about the laws on animal testing around the world. Below mentioned are the important laws around the world on animal testing, which makes animal testing illegal and legal:

In European Union, there is a testing ban and a marketing ban on animal testing. It bans products or cosmetics which were tested on animals, it also bans those products whose ingredients were tested on animals. The ban protects over 0.5 million consumers from using the products which were tested on animals.

In 2014, Brazil’s Sau Paulo banned the tests on animals and now Sau Paulo is passing a nationwide bill. The bill has some loopholes but it is considered as a good step by them.

New Zealand has made animal experimentation illegal. The country’s parliament voted unanimously to ban animal experimentation for cosmetics The ban is expected to pass its third and final reading and be signed into law.

Taiwan and Canada proposed legislation to ban these tests as well as the sale of products that include animal experimentation.

In the United States, animal testing is not illegal. In  U.S. animal experimentation is regulated by the Animal Welfare Act of 1966 (AWA). The Animal Welfare Act provides treatment and a standard of care for animals. It is mandatory in the U.S. to test pesticides on dogs. The Food and Drug Administration (FDA) requires companies marketing fluoride products to swab the teeth of 200 rats with the test substance for two weeks, at which time the animals are killed and their heads baked in an oven for an hour. The total number of animals used in the USA in 2010 was almost 1.37 million. These statistics do not include birds, mice, rats and fish as these are not covered by the Animal Welfare Act (AWA), USA. Some of these animals are used in India too, as frogs are listed as endangered species their use requires special permission from the chief wildlife warden.  An estimated 300 thousand laboratory animals die each day in the United States.

In China Animal Testing is Legal. China requires animal testing for all imported cosmetics. China is the only country that requires products, drugs and cosmetics to be tested on animals. China is the largest cosmetics market. It could be said that animal testing in China enhanced its cosmetics market. The reason why the cosmetics market is flourishing in China is its mandatory animal experimentation. 

In India, The Drugs and Cosmetics Act, 1940 regulates the distribution, manufacture and import of cosmetics and drugs in India. Its aim is to ensure that the cosmetics and drugs sold in India are effective, safe and meet standards of quality. Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) under the prevention of cruelty to Animals Act 1960 is for ensuring that animals are not subjected to unnecessary suffering and pain before, during or after experiments. These acts represent that India has laws in favour of animal protection. The use of animal experimentation for cosmetic products is banned in India but animal experimentation for drugs is not banned in India. The ban also applies to the ingredients of the product. India is the first country to ban animal testing in South Asia. This shows that India is against animal testing and it has very strict laws against animal testing. The animals used for drug testing are rabbit, sheep, mice, guinea pig, albino rats, monkeys, frogs, primates etc. Also there is a belief that pharmacology cannot be learned without experimentation on animals. Therefore, these animals are important for new developments in the field of medicine and pharma.

India is one of the most backward and notorious for its poor healthcare system in the world, over 1.6 million Indians die due to the lack of access to good healthcare facilities. India has shortage of an estimated 6 lakh doctors and 2 million nurses. Poor people are often unable to afford life-saving antibiotic drugs. High out of pocket medical costs to the patient are compounded but limited government spending on health services. In India, 65 percent of health expenditure is out of pocket, and such expenditures push some 57 million people into poverty each year. India has not developed a single novel drug that has made it to market. Developing countries like India, which are already suffering from a lack of good and efficient health services need a good lab pharmaceutical research which can provide new vaccines and cost effective drugs for the vulnerable section of the society which really has nowhere to go. But animal testing cannot be an excuse and justification for any kind of animal cruelty which has occurred and is a real concern to worry in countries like china. Judicious use of the animals for animal testing is the need of the hour for developing countries like India, in the process animal rights should not be compromised and should remain the top priority. Advanced economies like US, has not banned animal testing completely and it contributes a lot to their pharmaceutical researches which has resulted in novel vaccines and cost effective medicines, it truly reflects on their world class health services. 

Due to the poor patent laws of India in the past, pharmaceutical firms of India copied foreign pharmaceuticals and Indian pharmaceutical firms. The demand for medicine and cheap drugs is steadily increasing in the modern age, and it can be said that complacency is not the right path to be taken by developing countries like India. Because Indian Pharmaceutical companies are unable to discover drugs and medications, drug prices are steadily rising. Drugs and medicines are inaccessible to the country’s poor. As India is already plagued by such issues, drug testing cannot be prohibited.

Why Animal Testing should have new restrictions?

Three Rs of animal experimentation

In order to alleviate the pain and sufferings of animals used in animal testing three Rs i.e. reduce, refine and replace were proposed by scientists Rex Burch and William Rusell in their 1959 book “The Principles of Humane Experimental Technique”.

Reduce refers to lessen the total number of animals used in animal testing. Russell and Burch called for animal use to be minimized by regulating variability and improving the design and evaluation of experiments. This method will be immensely helpful in contributing towards the reduction of animals in these experiments. Bare minimum use of animals should be the primary focus of all the pharma researchers. Better consultation and highly goal-oriented researches are required to get better and highly effective results. Their aim was to reduce the number of animals for the same experiment. Their methods were quite result-oriented and talked about the judicious use of animals. Inflicting pain upon animals for the same kind of experiment and using same kind of animals was to be avoided according to them.

Refine as defined by Russell and Burch talked about the improvements needed to lessen the sufferings of animals. Russell and Burch described the general refinement of anaesthesia as “the supreme refinement procedure.” The purpose of refine is to make sure animals suffer less.

Replace refers to other alternatives which can be used to avoid the use of animals in animal testing. The prominent idea behind replacement is that we replace animals with new approaches and technologies.

Many researchers and animal welfare organizations supported these three Rs. They were accepted by humane organizations, policymakers and public. Despite their acceptance, they fail to fulfil their purpose. 

The three R’s in recent time has come under a lot of scrutiny for undermining the sufferings of animals and the pain inflicting upon them. People in recent times are lot aware about the rights of the animals and have shown their concerns towards animal safety. The three R’s has also faced a lot of flack for their insensitive ways of treatments of animals and using them in scientific experiments. There has been a lot of contradictory statements found in three Rs regarding the safety of animals and the pain which have been inflicted upon them abd little has been done to weed out the real concern. Reduce has talked about using the lesser number of animals for the scientific experiments on the other hand refine have talked about their and shown their concern towards their sufferings. This is the conflict of ideas between these two methods which cannot be ignored away in today’s time.

The committee for the purpose of control and supervision of experiments on animals (CPCSEA) draws its powers from the Prevention of Cruelty to Animals (PCA) Act of 1960 which states that the duty of the committee is “to take all such measures as may be necessary to ensure that animals are not subject to unnecessary pain or suffering before, during or after the performance of experiments on them“. The CPCSEA most notably put forward the fourth R term, “rehabilitation” of the laboratory animals used.

The three R’s in recent time has come under a lot of scrutiny for undermining the sufferings of animals and the pain inflicting upon them. People in recent times are lot aware about the rights of the animals and have shown their concerns towards animal safety. The three R’s has also faced a lot of flack for their insensitive ways of treatments of animals and using them in scientific experiments. There has been a lot of contradictory statements found in three Rs regarding the safety of animals and the pain which have been inflicted upon them abd little has been done to weed out the real concern. Reduce has talked about using the lesser number of animals for the scientific experiments on the other hand refine have talked about their and shown their concern towards their sufferings. This is the conflict of ideas between these two methods which cannot be ignored away in today’s time.

In the fourth century BC, Aristotle’s theory highlighted that man is superior to animals. Whereas Thomas Aquinas, who believed that animals could and did experience pain, promoted better treatment of animals by discouraging unnecessary cruelty. They had contrasting beliefs. Considering the beliefs of Aquinas, in order to avoid unnecessary pain and hurt, society must adopt modern regulations for the welfare of animals.

Legalising anything under the set of regulations should be the way forward in any civilized society. If to protect the rights and dignity of the vulnerable section of society, certain restrictions are required to be brought in, state should impose those restrictions under some kind of observation authority. Animal testing also needs some kind of restrictions while we think of legalising it in India. We know from our past experiences that our general behaviour towards animals is not so gentle and kind enough. We need restrictions so animals can be treated better. There is an ethical imperative to replace unreliable animal-based safety tests, not only for animals, but also for the protection of humans. Unreliable animal tests should have regulations.

Animal testing is required in developing country like India where the health services are not so good, but that cannot be justified with inflicting pain upon animals. Government should launch several initiatives and programs regarding the awareness towards animals and their sufferings.

People should be taught about how animals should not be subjected towards any kind of cruelty and pain. More programs and campaigns should be launched. 

Restrictions on animal testing can only be brought in by strong laws, state should consider this matter utmost concern. In this modern era development of new alternatives is the need of the hour and we cannot deny the need of new regulations and also we cannot follow the old regulations.

Conclusion

Legalization of animal testing is necessary for a developing country like India. India needs good laboratory pharmaceutical research capable of providing new vaccines and cost-effective drugs for the vulnerable sections of the society.

Due to the fact that Indian Pharmaceutical companies can not discover medicines and drugs, drug prices continue to increase. Animal testing should be legalized in India to prevent rising prices in medicine. It should be kept in mind that only because it is barbaric, we cannot ban animal testing. We know well that animal testing has benefited us. Different life-saving medications could not have been identified without animal testing. If we argue to legalize animal testing in India, we need modern regulations. 

Strong laws can only impose restrictions on animal testing, the State will take the greatest issue into consideration. Indian animal testing can only be allowed by means of new legislation to properly regulate the study and prevent unnecessary animal testing.

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