Representative image. Photo: Olga/Pexels.
Many drug and cosmetics manufacturers across the world currently test the safety and potency of their products on animals. As a result, thousands of animals like rabbits, rats, mice, monkeys and dogs are frequently kept in subpar conditions in laboratories, and suffer physical and psychological trauma. Sustained campaigns by the global animal rights movement have resulted in corporations and governments considering alternatives.
India was the first South Asian country to ban animal testing for cosmetics, and was lauded by commentators across the world. However, animal testing becomes murkier when it comes to testing for drugs, particularly life-saving drugs.
No country in the world has completely banned animal testing for drugs. In India, the legal position on experimentation on animals is captured under the Prevention of Cruelty to Animals (PCA) Act 1960 and its regulations.
Under the PCA, a statutory body to control and supervise experiments on animals has been set up. Its main objective is to ensure judicious use of animals in research. It also makes sure persons and establishments that experiment on animals are properly registered, and oversees housing and feeding provisions. This body can also direct persons and institutions to not perform certain experiments.
However, contravening any decision by this body invites a fine of only Rs 200. Similarly, a person violating the PCA is liable to be punished but the extent of punishment hasn’t been specified. So the PCA is effectively impotent.
At the same time, India has taken a few steps to reduce animal testing for drugs. A 2016 amendment to the Drugs and Cosmetics Rules allows animal toxicity tests for a drug conducted in other countries to simply be resubmitted in India when registering the same drug.
The Indian Pharmacopoeia Commission also has guidelines on drug tests by Indian manufacturers, enforced by regulatory authorities. In 2018, the commission approved two animal-free tests for drugmakers: the pyrogen test to confirm the impurity of a drug or potential side-effects, and the abnormal toxicity test to confirm vaccines are free of biological contamination.
So the Indian animal rights movement towards securing the rights of animals used in labs has achieved some victories. Even if animal testing hasn’t been eliminated altogether, the activism has helped erode the importance of animal-testing for drugs.
We have much to learn from moral philosophy to understand the way forward, particularly the work of Peter Singer and Tom Regan. Philosophers have over the years sought to understand the moral status of animals. While some have argued that animals are inferior beings, devoid of value except in relation to their usefulness to humans, there is today a robust body of literature that argues otherwise.
Singer argues that as animals have the ability to suffer and seek to avoid pain, a moral framework must take animals into consideration. As a consequentialist, he is opposed to animal experimentation except in limited circumstances, and hinges his opposition to animal-testing on the inability of such tests to produce sufficiently effective results. He concludes that, currently, there is no sufficient reason to conduct animal tests given the magnitude of pain it causes relative to the benefits for humans, although he concedes experiments on animals could be justified if it leads to greater collective good, for example of a drug that can treat a currently incurable disease.
Regan (1938-2017) took a different, rights-based view, and argued that similarities between humans and animals must guide our understanding of animal rights. Animals have the ability to experience pain and hunger, express emotions, and form intimate social ties. They may also have strong problem-solving abilities.
Many regard these attributes as being unique to humans, but they’re really not. Ultimately, it is our ability to experience life as conscious creatures that matters, so we’re inherently valuable and worthy irrespective of whether we are useful to others. This is also a response to skeptics who have argued that animals don’t possess the same intellectual capabilities as humans, so they’re not deserving of the same rights.
Regan’s moral philosophy determined his views on how we could free animals from oppression. He adopted an abolitionist approach and believed we had to immediately dismantle all systems that oppressed animals. For example, improving the living conditions of animals already destined for slaughter wouldn’t be enough; instead, Regan would have pushed to dissolve animal agriculture altogether. Notably, he didn’t weaken this abolitionist stance when it came to the use of animals in labs, including to test drugs.
A way forward
Most people have accepted research on animals to improve medical or scientific knowledge. However, within the scientific community itself, some have said the importance of animals to medical or scientific knowledge has been overstated. There have also been instances where animal testing has in fact had a detrimental impact on humans.
An analysis by Michael Balls, Jarrod Bailey and Michelle Thew, on the use of animals in drug testing, is pertinent here. They found that the absence of toxicity in animals, including monkeys, provides no significant or additional insight into whether a new drug will also be safe for humans. And although many animals are psychologically similar to humans in the way they experience pain and fear, the results of tests conducted on animals can be misleading due genetic, physiological and biochemical differences.
As Bailey, a geneticist and senior research scientist at an NGO named Cruelty Free International, has said, “Mice aren’t rats, cats aren’t dogs, and monkeys aren’t humans.” He has also said that the importance of animal testing to breakthroughs in medicine have been exaggerated and that the inter-species variability is too high to draw sensible parallels.
There is no evidence to categorically prove that testing drugs on animals, i.e. in animal trials, is predictive of how humans would respond to such drugs. But there appear to be numerous reports that outline failures in predicting how humans might respond to a drug based on how an animal did.
Finally, the manner in which animals are kept captive in labs often leaves them bereft of fresh air, natural light, free movement and company. This may cause animals to exhibit abnormal or unnatural behaviour, and potentially exposes them to lab-generated diseases and distresses. Animals have also been known to experience contagious anxiety, stress and high blood pressure if they can see, hear or in any way sense that their kin are hurt.
For example, clinical trials of a monoclonal antibody conducted in London in 2006 caused systemic organ failure in six healthy participants, despite producing no harmful results on a wide range of animals on which it had been tested. The US Food and Drug Administration has also recorded that 92% of all drugs – closer to 96% as of 2015 – that successfully complete animal tests subsequently fail in human trials.
Convincing lawmakers to do away with animal testing for cosmetics was easier. Within the Indian animal rights movement, there are different opinions about the best way to do eliminate animal testing for drugs. However, when negotiating with the government, the movement has been more cautious with its demands, favouring an incremental approach over asking for a complete ban – as Regan might have.
Indeed, the high moral standard of Regan’s absolutism may be impossible to achieve for lawmakers, especially those who have not been previously exposed to animal rights. And even if they are sensitised about animal suffering, they may still find it hard to believe that animals have inherent worth.
At the same time, Singer’s requirement of equitable consideration is difficult to achieve as well, even if it is more within reach than Regan’s view. However, Singer’s approach to animal testing – on the grounds that it produces insufficient results of value – is relevant. Policymakers also largely adopt a similar consequentialist approach, designing laws that have the maximum positive consequences.
So the strategy of approaching lawmakers with proof of the ineffectiveness of tests and the potential harm to humans as a result is more likely to succeed.
Some scientists are developing sophisticated non-animal testing techniques that have proven to be more effective, faster, more accurate, more economical and, most of all, more empathetic. Many organisations, such as the UK’s National Centre for the Replacement, Refinement and Reduction of Animals in Research, funds research into alternative technologies. Some related technologies include stem cell platforms, 3D tissue and organ cultures and ‘organs on a chip‘. Some experiments performed with the last item have proved to be more accurate than those performed on animals.
In a society that currently doesn’t recognise the inherent worth of all animals, lobbying for laws to protect animal rights warrants a piecemeal rather than absolutist approach. Indian laws on animal testing are relative more progressive than those in other countries (but the PCA specifically also has no teeth), thanks in part to the Indian animal rights movement’s cautious approach. Let’s hope that they continue with similar success until the endgame: to replace animal testing with more sustainable, empathetic and fool-proof solutions.
Malavika Parthasarathy and Stuti Shah are lawyers based in Bengaluru. Malavika is an incoming LLM candidate at the University of Chicago Law School and Stuti is an associate at a leading Indian law firm.