New rules on animal testing must take India forward, not backwards: Maneka Gandhi Officials maintain the changes seek to simplify approvals for research institutions, pharmaceutical and biomedical industries. Updated on: Oct 26, 2026, 14:54:47 IST By Jasjeev Gandhiok Prefer HTPrefer HT Prefer HT on Google Share The Centre’s draft rules governing animal experimentation have triggered concerns among animal rights groups, which say the changes could weaken independent oversight and make it easier for laboratories to conduct experiments on animals. However, officials maintain the changes seek to simplify approvals for research institutions, pharmaceutical and biomedical industries. Former Union minister Maneka Gandhi. Former Union minister Maneka Gandhi. HT speaks to animal rights activist and former Union minister Maneka Gandhi, a long-time campaigner against animal experimentation. Edited excerpts: A major change to animal experimentation, proposed in the draft, is that mild and moderate experiments could be approved by an institution’s own ethics committee rather than going to the central regulator. In practical terms, what does this change mean for an animal inside a laboratory? Does it make it easier for more animals to be experimented on? It means the animal loses the one independent pair of eyes that was looking at its fate. Today, experiments on animals larger than a rat go to the central regulator, and there is at least someone outside the building asking whether this experiment is necessary at all. Under the draft, the people who want to do the experiment, their colleagues and their department heads will be the ones approving it. And it is the institution itself, through its own veterinarian, that decides whether the experiment is mild or moderate in the first place. No institution has ever turned down its own funding. So yes, it will make it easier, and it will make it faster, and that means more animals. Mild and moderate are also the bulk of experiments, so we are effectively handing over most of animal experimentation in India to self regulation. The draft classifies experiments as mild, moderate, severe and non-recovery. Is there a concern that the institution conducting the research will effectively decide how severe the experiment is. Does this leave a grey area? It isn’t grey, it is completely black. Under this draft, the institution that wants to do the experiment is also the one that decides which category it falls into. That decision matters enormously, because if the experiment is classified as mild or moderate, the institution’s own committee approves it and it never goes to the central regulator. Only severe and non-recovery experiments on larger animals go outside. So the same people who want the experiment approved are deciding whether anyone independent will ever examine it. That is a clear conflict of interest, and it will push experiments towards the lower categories. Starving a rat for a day is called mild. Keeping a social animal alone in a cage is mild. Starving it for two days, or putting it through distress it cannot escape, is moderate. So is testing herbal products, testing established drugs, and anything described as having “known and reversible effects,” which could mean almost anything. This is not a scientific list. It is the most common commercial work. The draft also creates exceptions and allows laboratories to use animals from open markets, unregistered sources, and in certain circumstances, stray, feral, wild and protected animals. What is the biggest risk that this may create for animals in practice? Could community dogs, lost pets or animals taken from the wild find their way into laboratories? The biggest risk is that nobody will know where an animal came from. The whole point of registered breeders was traceability. Once you allow open markets and unregistered sources for cattle, goats, birds and fish, you create a demand, and in this country demand is met very quickly by people who will pick up anything. Strays and wild animals can be used if a “competent authority” permits it, and the draft never says who that is. Community dogs, someone’s lost pet, birds from illegal markets, all of it can find its way into a laboratory. These exceptions should be removed completely. If a lab cannot get an animal from a registered source, it should not be doing that experiment. The draft formally incorporates the principles of replacement, reduction and refinement, but critics say these safeguards become weaker if institutions themselves are approving experiments. Do you believe India should now be moving towards replacing animal experiments altogether, particularly when the health ministry has already allowed certain drug testing through non-animal methods? What should the rules do differently? Yes, and we are not starting from zero. The health ministry has already amended the drug rules to accept non-animal methods. The world is moving this way because these methods are often more predictive for humans than a mouse ever was. Writing replacement, reduction and refinement into the rules means nothing if the person checking compliance is the institution itself. The rules should make it mandatory to show that no validated alternative exists before an animal is used, set up a national body to validate and promote alternatives, put money into them, and set timelines to phase out animal use in areas where alternatives are already available. A rule that only mentions replacement as a principle is decoration. You have worked on animal experimentation regulation for decades. What specific changes would you want the government to make to this draft? I don’t think this draft can be fixed. There is hardly a provision in it that doesn’t need changing, and when everything needs to change, it is better to start again. So the draft should be put aside and written afresh, this time with independent scientists, animal welfare organisations and legal experts at the table. The new rules must take India forward, not backwards. Animals already have certain protections under the law which cannot be taken away. New should be building on them.

India’s proposed changes to animal experimentation rules have sparked concerns among animal rights advocates, with former Union minister and animal welfare activist Maneka Gandhi warning that the draft could weaken independent oversight and increase the risk of animals being subjected to laboratory experiments.

The Centre has maintained that the proposed changes aim to simplify approval procedures for research institutions, pharmaceutical companies and the biomedical industry. However, critics argue that transferring approval powers to institutional ethics committees could create conflicts of interest and reduce scrutiny of experiments conducted on animals.

In an interview with Hindustan Times, Gandhi, a long-time campaigner against animal experimentation, questioned whether institutions seeking permission to conduct research should also be responsible for deciding whether their experiments are ethically acceptable.

Maneka Gandhi Questions Institutional Self-Regulation

One of the most significant proposed changes would allow institutional ethics committees to approve experiments classified as mild or moderate, rather than requiring approval from the central regulator.

Gandhi argued that this could remove an important layer of independent scrutiny, particularly when experiments involve animals larger than rats. Under the proposed framework, institutions conducting the research would have greater authority to assess experiments and determine their severity.

She warned that researchers, colleagues and department heads could end up approving experiments within their own institutions, raising concerns about impartiality.

According to Gandhi, mild and moderate experiments account for a substantial proportion of animal testing. She argued that allowing institutions to approve these experiments internally could accelerate approvals while potentially increasing the number of animals used in research.

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Concerns Over Classification of Experiments

The draft categorises experiments as mild, moderate, severe and non-recovery. Gandhi questioned whether institutions conducting experiments should also be responsible for determining which category their research falls under.

She argued that the classification is particularly important because experiments considered mild or moderate could receive institutional approval without being referred to the central regulator.

Gandhi cited examples such as food deprivation, social isolation of animals and testing established drugs or herbal products to question the breadth of the proposed classifications. She also raised concerns about experiments described as having “known and reversible effects”, arguing that such terminology could be interpreted broadly.

In her view, the arrangement could create a conflict of interest, as the same institution would determine both the nature of an experiment and whether it requires independent scrutiny.

Animal Sourcing Rules Raise Further Questions

Another major concern relates to provisions that could allow laboratories, under specified exceptions, to obtain animals from open markets and unregistered sources. The draft also provides for the use of certain stray, feral, wild and protected animals under particular circumstances.

Gandhi warned that relaxing sourcing requirements could undermine traceability and create opportunities for animals to be obtained through unregulated channels.

She argued that registered breeders help establish where laboratory animals originate, making it easier to monitor their movement and ensure accountability. If animals can be sourced from unregistered suppliers or open markets, she cautioned, the system could become more vulnerable to misuse.

Gandhi also raised the possibility that community dogs, lost pets and birds obtained through illegal markets could find their way into laboratories if the proposed exceptions are not sufficiently restricted.

She questioned the draft’s reference to permission from a “competent authority”, arguing that the provisions should clearly identify the authority responsible and establish strict safeguards. Gandhi called for the removal of these exceptions, maintaining that experiments should not proceed if animals cannot be obtained through registered sources.

Call for Greater Investment in Non-Animal Testing

The proposed rules formally recognise the principles of replacement, reduction and refinement, commonly known as the three Rs. These principles seek to replace animal experiments with alternatives wherever possible, reduce the number of animals used and minimise the suffering of those involved in research.

However, Gandhi argued that these safeguards would have limited effectiveness if institutions were primarily responsible for monitoring their own compliance.

She pointed to changes already made by the health ministry to accept certain non-animal testing methods under drug regulations. According to her, advances in alternative testing technologies offer India an opportunity to reduce its dependence on animal experimentation.

Gandhi called for mandatory evidence that no validated alternative exists before an animal is used in an experiment. She also advocated establishing a national body to validate and promote alternative testing methods, increasing funding for their development and introducing timelines to phase out animal use in areas where reliable alternatives are available.

She maintained that merely including the principles of replacement, reduction and refinement in the rules would not be sufficient without enforceable requirements and independent monitoring.

Gandhi Calls for Draft to Be Rewritten

Questioning the overall framework, Gandhi said she did not believe the proposed draft could be adequately addressed through limited amendments. She called for the government to set aside the draft and prepare a new version after consulting independent scientists, animal welfare organisations and legal experts.

She also emphasised that existing legal protections for animals should not be diluted through new regulations. Instead, she argued, any revised framework should strengthen existing safeguards while encouraging scientific progress through alternative testing methods.

The government’s stated objective is to simplify approvals for research institutions and industries involved in pharmaceutical and biomedical research. The debate, however, centres on how to balance those administrative goals with independent ethical oversight, animal welfare and the development of alternatives to animal testing.

As concerns continue over the proposed changes, the final rules will be closely watched by animal welfare advocates and the scientific community, particularly over the extent of institutional autonomy, the monitoring of animal sourcing and the safeguards governing laboratory experiments.

Gandhi’s central demand is that India’s regulatory framework should build on existing protections rather than weaken them, ensuring that scientific research progresses without compromising animal welfare.