Clinical trials are an integral part of drug discovering method in India as well as worldwide. Clinical trials are set of processes that are needed to assure a drug product as safe and effective to the denizens. Global Clinical Trials are explored in India. Yet, it is not the people of west that introduced clinical research to India. Two antediluvian books, “Charaka Samhita (a textbook of medicine) and “Sushruta Samhita (a textbook of surgery), compiled as early as 200 B.C. and 200 A. D. respectively, show India's age-old proficiency in medical research”. There are so many laws governing the clinical trials in India such as “ Drug and cosmetics act, 1940” and “Medical Council of India act, 1956” which was later amended in the year 2002.
Animals form an essential part in conducting research that helps in finding out drugs and products to treat diseases. Researchers may develop some drugs and products by conducting research works that may not include animals. If the incipient therapy seems to be promising only then it is allowed to be tested in animals to visually perceive whether it seems to be safe. "Animal testing is justified for scientific advancement and study." Most of us heard this statement if someone tried to open up the issue of animal testing and abuse. Yes, it is justified that you know that out of 100, 92 of the experiments fail on humans, but it is not clear that what works on animals will not necessarily work on humans, to the point that any ethical and conscientious steps are taken to ensure the wellbeing of animals who are treated like laboratory rats. Unlike creatures who don't have mouths to voice their opposition, no reasonable human being will be able to become a helpless guinea pig. India has a culture that promotes tolerance and respect for all life forms. Article 51A (g) of the Constitution of India imposes a fundamental obligation on us to safeguard the wildlife and have commiseration for all living creatures. This means that a corresponding right vest in animals to be treated with empathy. Co-existence of all life forms is absolutely essential to avert an imbalance of our eco-system.
We should not ban the testing of animals simply because it is barbaric. We are well aware that we have learned from animal research. Without animal trials, multiple life-saving drugs may not have been detected. We need modern laws in order to legalize animal research in India. People for the Ethical Treatment of Animals (PETA) on a global scale has increased consciousness among people to come forward and actively condemn the 'compulsory need' for such painful animal experiments to be carried out in order to combat the cruelty and unfairness of the situation. Have the aims of such awareness campaigns, legislative initiatives, and petitions, therefore, better animal conditions, and what is the best solution to animal testing?
Most commonly, clinical tribulations are habituated to test the safety and efficacy of drugs and contrivances. Conventionally, they are sponsored by pharmaceutical companies and are conducted by research teams that include medicos and other medical professionals. They test safety and efficacy before it gets approval. Clinical tribulations show researchers what does and doesn’t work in people. Clinical tribulations additionally avail researchers and medicos decide if the side effects of an incipient treatment are acceptable when weighed against the benefits offered by the incipient treatment.
The report will assist the judiciary in taking their respected decisions in certain matters. The thesis will also assist researchers in their interpretation of laws and their importance. This analysis, therefore, is on this day, it is important to consider and behave accordingly on the aforementioned contemporary conflict of interest.
Present studies seek to examine the relevance of clinical trials and propose options for experiments with animals. When such an implication occurs, the study therefore seeks to propose an action plan. Nevertheless, the new thesis reflects mostly on the facts behind animal research. It also examines the landmark cases that protect animal welfare in India. It also discusses the reality that there are Indian rules against animal testing. It also studies what rights animals have and what abuses there are. Though it compares how the animal testing process is done in other countries but the scope of the analysis, however, is in an Indian context.
Understanding Animal testing:
Animal testing is animal experimentation. To assess the efficacy of medications, products and medicines, animal testing is used. In mammals, these goods and drugs are checked to ensure the level of protection and toxicity before they are tested on humans. It is also known as animal experiments or testing into animals. It is only after a number of experiments on animals that medications, cosmetics, narcotics and other products will be tested on humans. To figure out if our food is healthy, our household goods, our medicines and the stuff we bring into the world, we depend on animal testing.
Animal campaigners contend that animal tests are unreliable, barbaric, inefficient, and unsafe for animal experimentation. These tests hardly operate in humans, they claim since humans are separate from animals. For starters, in humans, raisins, strawberries, chocolates, almonds, avocados, macadamia, and nuts are harmless but poisonous to dogs. These animal campaigners have begun numerous efforts to ban animal experimentation around the world. The primary goal of their initiative is to save animals from cruelty and needless harm, as well as to protect animal rights. Not only is animal experimentation immoral, it has often proved to be very futile in the world of medicine and science, directed at equipping humanity with their cruel tests on weak and ignorant animals to combat the problems in the respective fields.
In the case of A. Nagaraja, which discusses the bull-taming competition of 'Jallikattu.' This sport is a centuries-old practice, but because it is animal cruelty, it should not be explained. In this case, animals were held to have a constitutional right against pain infliction. It also added that the animal welfare board and government would uphold animal freedoms: freedom from suffering and anxiety and freedom to communicate natural actions, freedom from thirst and starvation, freedom from discomfort, freedom from sickness, pain, and disability, freedom from discomfort. This case reveals that animal lovers are still able to speak up for them if there is any violence against animals. In the other side, animal research proponents contend that the need for the hour is animal experimentation and we should not fully prohibit it.
“The Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA)”.
It is important that we protect the interests of animals and consider making the most judicious and ethical use of them in science. The provisions of the Protection of Cruelty to Animals Act (PCA Act) 1960and the Laws of the revised Act of 1998 and 2001 officially cover animal studies in India. The application of this is "Through a group called the "Committee for the Purpose of Animal Experiment Management & Oversight (CPCSEA)". It is a statutory agency established in 1964 under the Ministry of Environment Forestry & Climate Change under Section 15(1) of Chapter 4 of the PCA Act. This was to stop needless pain and suffering being inflicted on animals.
The Committee's key goal is to ensure the judicious use of animals in science. The Committee stresses the application of the Substitution, Elimination, Refinement, and Restoration 4R concepts. Therefore, the committee is objectively evaluating and recommending wherever practical, complementary approaches and effective models. It helps to minimize and refine the number of animals by encouraging innovative strategies to relieve discomfort and discomfort during testing. It recommends that large animals (above rabbits) be rehabilitated after experiments with established criteria already published on the website.
Around the same time, there is a need for thought and everyone is responsible for developing more and more appropriate terminology and changing, if possible, the administrative policies to reinforce the conditions for substitution, elimination, refinement, and recovery of current 4Rs. In developing countries like India, animal testing is required where health systems are not so good, but that cannot be explained by causing suffering on animals. Several campaigns and services on animal awareness and suffering should be initiated by the government. It is important to educate people about animals cannot be exposed to any form of cruelty and suffering. There can be more projects and campaigns introduced.
State of U.P Vs. Mustakeem and Ors, In this case An FIR was filed against the owner in the state of Uttar Pradesh, in a case where goats were found to be transported for slaughter in a cruel way (they were closely tied to each other, which was contrary to the provisions of the Prohibition of Cruelty to Animals Act, 1960). However, when the case was under appeal, the UP High Court returned custody of the animals to the owner. The Hon'ble Supreme Court, on appeal, ruled that the animals had to be seized from the owner and kept in a gaushala, under the custody of the government of the state, who had been charged for the duration of the litigation.
Both these rules and regulations were adopted long ago, but only in recent years have they been applied with severe consequences, even after the 1999 PETA fiasco. It is an unfortunate occurrence that India continues to trade with countries and finance industries where such gross abuses continue to take place, long though such laws occur. While the number of cases of such violations declined after 2015, there is still a lack of accountability in the system since it was found in a report that 90% of the animals were not listed in the documents kept by laboratories for compiling data on animal subjects because they were unlawfully transported to the laboratories. In the scheme, there are still gaps that cause these numbers to appear.
“Indian Laws Against Animal Testing”:
On a hopeful note, India has shown an increase in the vigorous defense of animal welfare, though at the same time protecting the needs of the parties involved in the proceedings. But are they enough sustainable to keep the number of cases of violence down? The response is 'no' because just as the judges spoke of 'animal rights' in the 2018 Uttarakhand High Court judgment, but those rights were only conveyed to 'non-citizens' rights, which somehow deprives animals of some very crucial rights, exclusive to citizens only, in the same way some animal rights are secured, but the loopholes for preserving human rights have gone righteous.
Animal research, though we think of legalizing it in India, still requires some kind of restrictions. Through our previous experiences, we realize that our overall conduct towards animals is not sufficiently gentle and kind. Such that animals will be properly handled, we need controls. There is an ethical obligation, not just for animals but also for the sake of humans, to replace unreliable animal-based safety monitoring. Animal experiments that are ineffective should have rules.
For a developing world like India, the legalizing of animal testing is important. India wants strong clinical laboratory testing that is capable of supplying disadvantaged parts of the population with new vaccines and cost-effective medicines. Unfortunately, also though regulatory guarantees were made to safeguard the needs of animals and their welfare, but even today, officials have made use of the system's serious loopholes to perpetuate the malpractices of testing and exploiting animals used as objects of the examination. In order to get the standard work obtained from a "good quality experimental animal," modernizations of animal facilities are required.
While testing on animals for cosmetics and soaps have been banned in India, this does not indicate that imports of cruelty-free goods are strictly pursued. India also imports from China where, for cosmetic, medicinal and science research, animals continue to be experimented on, many resulting in their deaths. In addition, foreign corporations working within the Indian territories continue to experiment with wildlife, which applies to medical and scientific degrees from several universities. And there are still ways of animal cruelty taking place in villages, towns, and lesser-known areas.
It should be borne in mind that we should not ban animal experimentation simply because it is barbaric. We are well aware that we have learned from animal research. Without animal trials, multiple life-saving drugs may not have been detected. We need modern laws if we want to legalize animal research in India. Only limits on animal experimentation can be enforced by tough legislation, and the State can take the main problem into account. Only by means of new laws can Indian animal research be approved to better regulate the research and stop needless animal testing.
Now, the target of lawmakers should be not only Indian businesses, but also international companies operating in India, along with those who let the criminals get away with such mistreatment. The penalty will be awarded not only to one who commits the offence, but also to others who know about it but have not reported or objected to it. It is high time for the integration into society and the economy of a variety of serious and systemic legally binding steps.
Peter Singer, Animal Liberation, Harper Collins, 1975.
Herrmann, K., & Jayne, K., Animal Experimentation: Working Towards a Paradigm Change, 2019.
Sandhya Srinivasan, The Clinical Trials Scenario in India, Vol. 44, No. 35, Economic and Political Weekly, pp. 29-33, AUGUST 29-SEPTEMBER 4, 2009.
K.M. Seethi, Clinical Drug Trials: Bioethics under Siege, Vol. 36, No. 34, Economic and Political Weekly, Aug. 25-31, 2001.
The Drug and Cosmetics Act, 10 April 1940.
The Medical Council of India Act, 1956.
INDIA CONST. art 51, cl. A.
The Cruelty to Animals Act, 1960 by Rukmini Devi Arundale.
The Drug and Cosmetics Act, 1940.
Animal Welfare Board of India vs A. Nagaraja & Ors on 7 May, 2014.
Protection of Cruelty to Animals Act (PCA Act),1960.
State of U.P Vs. Mustakeem and Ors, 1 October, 2019.
Koiyur Raghavendran Keerthana,
Symbiosis Law School, Hyderabad.