A threat to endangered species? Dr Sheikh Raisuddin flags dangerous gaps in India's proposed lab testing rules

Dr Sheikh Raisuddin, founding member of Society of Alternative to Animal Experiments, has flagged concerns over India's proposed laboratory animal testing rules, warning that provisions allowing the capture of wild animals for experiments could threaten endangered species.

The government has released draft rules concerning laboratory experiments on animals. The deadline for submitting objections and suggestions is November 5. India TV spoke to Dr Sheikh Raisuddin, Head of Department at Jamia Hamdard and Vice President of the Society for Alternatives to Animal Experiments, to discuss the proposed rules and their implications.

Animal testing is linked to research as well as the economy: Dr Sheikh Raisuddin

Dr Sheikh Raisuddin spoke exclusively to India TV about the government's draft rules concerning animals. He said, "First of all, I would like to congratulate India TV for organising this kind of discussion, which is connected to both human welfare and animal welfare. Animal testing is not just about research. It is also related to our economy. Drug development takes place through animal testing. Medicines are also developed through this process. You must be aware that the pharmaceutical industry makes a significant contribution to our GDP. We export medicines to African countries, the United States, Europe and Japan."

What happens to animals in laboratories during testing?

Dr Sheikh Raisuddin said, "Most testing is conducted on animals because we cannot directly test everything on humans. These include mice, rats and other animals. There is a difference between mice and rats. Most testing is conducted on rats. These species are bred in laboratories. They are specifically bred for this purpose. They are not simply brought in from somewhere."

Dr Sheikh Raisuddin explained that every human being has different genetics. Similarly, mice, rats and rabbits also have different genetic makeups. According to him, animals may experience pain and serious illnesses during laboratory testing. If an animal is given a high dose of a substance, it can even die.

Dr Sheikh Raisuddin said animals do experience pain. However, if experiments are conducted properly, such adverse effects on animals can also be prevented.

Rats cannot vomit

Dr Sheikh Raisuddin explained that rats do not have the ability to vomit. They cannot throw up anything they consume. Humans, on the other hand, can vomit if something tastes bitter or unpleasant. Rats cannot do that. This is one of the differences between humans and animals. However, many experiments are conducted repeatedly, sometimes several times.

To some extent, if medicines are found to be safe in these animals, researchers can consider whether they may also be safe for humans. Rabbits are also used in testing. They are very sensitive animals, which is why they are fed carrots.

Dr Sheikh said, "We are different from one another. For instance, Europeans do not have melanin in their skin. That is why skin cancer is more common among them. People living in warmer regions, such as India and Africa, have melanin in their skin."

How different can the effects of chemicals be on animals and humans?

Dr Sheikh said, "To a large extent, the effects are similar and there is not a huge difference. However, they can also be different. As I just explained, the doses we take will be different for mice and humans. So, sometimes, this can make a difference. Cats, cows and buffaloes do not have many of the enzymes that are found in other animals. Medicines can have different effects, but the difference is not always very significant. I would also like to point that out."

Have medicines that appeared safe during animal testing ever proved harmful to humans?

Dr Sheikh said, "Yes, this has happened. Gentamicin antibiotics were introduced earlier and were found to be safe in animals. However, it was later discovered that they could cause kidney diseases. Age can also make a difference. The dosage for children will be different from that for adults and elderly people."

Dr Sheikh added, "Men do not menstruate, but women do. The same happens in animals. Different hormones are produced during that period, which can lead to differences. Developing medicines involves billions of dollars and costs thousands of crores of rupees because all kinds of testing are conducted. The objective of all this is to ensure that human health remains protected."

Does science now have alternatives that can replace animals in testing?

Dr Sheikh said, "To a large extent, this is possible. It is gradually happening because progress in science is bringing about changes. Work is being done on chips. Human-on-a-chip and organ-on-a-chip technologies can be used for organs such as the liver and kidneys. However, when it comes to behavioural studies, there is no doubt that we will still have to conduct them on animals. If an animal is already suffering from an illness, has not received proper food or does not have a proper diet, the effects can be different."

Dr Sheikh said, "New Approach Methodologies are emerging, particularly organ-on-a-chip and human-on-a-chip technologies. We believe that after about a decade, research on animals may be required only in a limited number of situations. Even then, it may not be possible to eliminate it 100 per cent."

Which animal experiments have been successfully replaced?

Dr Sheikh said many animal experiments have already been successfully replaced. If a cosmetic or product is exported to Europe, it has to be certified that it has not been tested on animals.

For instance, a skin model has been developed in laboratories. It is called reconstructed human epithelium. Several tests for skin irritation can now be conducted using this model.

Earlier, a toxicity test was conducted on rabbits' eyes. It was known as the Draize test. Dr Sheikh described the procedure as extremely inhumane because substances were put into the rabbits' eyes to observe their reactions. This test has now been completely replaced and banned. Rabbits can no longer be subjected to the Draize test in any country, including India.

Are the draft rules on animals aimed at gradually replacing animal testing?

Dr Sheikh said, "I am the Vice President of a society whose purpose is to promote alternatives to animal experiments. It was established in 2017. As you mentioned at the beginning, it is called the Society for Alternatives to Animal Experiments."

He said the organisation and its members have been working in this area. It organises an annual conference and workshops. The society is also associated with the Asian Federation, whose headquarters are in Japan.

He said the government also appears to have a positive intention behind the new regulations in India, as it has invited public opinion and suggestions until November 5. Any ordinary citizen, professor, teacher, scientist, social media user or media professional can submit their views. He described this as a good step.

What did Dr Sheikh say about the government's draft rules?

Dr Sheikh said, "I do not want to name any organisation. There is a provision in the draft that gives the impression that animals can be taken or captured from forests or other places for certain experiments. This perception is emerging among us and within the scientific community. Some people are not comfortable with it. I am a scientist and also a teacher of this subject, toxicology and alternatives to animal testing. My view is that any experiment we conduct should have global acceptance."

Dr Sheikh said, "It should not happen that we use a dog or another animal for such work in exchange for money, only for another country to say that it does not approve of it. They may stop accepting our medicines or importing our products. As I mentioned earlier, if cosmetics are tested on animals, we have to certify that they were not developed through animal testing. Therefore, these practices must have acceptance at the international level."

Threat to endangered species

Dr Sheikh said wild animals should not be permitted for experiments under any circumstances. He said, "We are Indians. There are certain commercial interests, and some species live in forests. If we start capturing animals and handing them over for experiments, several endangered species could also come under threat. I believe two things are important. The data we generate and the results obtained from it must be acceptable. The other important aspect in science is traceability."

What did he say about giving institutional committees the authority to approve mild and moderate experiments under the draft?

Dr Sheikh said there would be no problem if institutional committees performed their duties honestly and ethically. However, he pointed out that emotional considerations can sometimes influence decisions.

He said, "Sometimes, we collect biomaterials. Some people become emotional because their PhD is about to be completed and their time is running out. They ask us to approve their work quickly. In such situations, we may end up taking an emotional decision. So, institutional committees are fine, provided the existing system functions properly and meetings are held regularly. In our institution, meetings take place every two to three months, so nobody's time is wasted. To some extent, this is debatable. We should also see what other people and stakeholders have to say. There should be institutional oversight, but having an external member is also a good thing. It makes the oversight process stronger."

What suggestions would he make to amend or add to the draft rules?

Dr Sheikh said wild animals should be kept out of such experiments and that their use could be avoided. He also stressed the need for data traceability. While the draft provides for tracking animals and recording how many have been used, he said there should also be clarity on how the research and data generated through these experiments can be monitored.

Dr Sheikh added that another important aspect was the environment in which animals are kept and bred. He said, "Where animals are kept and bred, where one animal is used to produce another, the surroundings and environment must be properly maintained. Hygiene and other conditions should be good. Data reliability is an important factor, and it must be ensured."

What would he recommend to the government to make India a global leader in animal-free research? Dr Sheikh said, "My only recommendation is that if we want to become a global leader, we must follow global standards that are acceptable everywhere. We have developed global leadership in several areas. Medicines are a major example, and India also has a leading role in information technology products. In the same way, our research, including the work carried out by contract research organisations, must follow global standards. Indians are considered very capable, and we should maintain those standards."

Dr Sheikh added that while human life would always have greater value, the welfare of animals should not be ignored.

He said, "Human life will definitely have greater value. However, we cannot disregard animals either. In India, there is a tradition of believing that we are human beings in this birth, but who knows what we may become in the next one? We may become rats, jackals or even mosquitoes. That is why animal welfare matters. We must treat animals properly. This is also part of our culture. We Indians love animals. We consider the cow a mother, and many animals are associated with our gods and goddesses. I believe these two things are not separate. They complement each other."

Can animal testing be completely eliminated?

Responding to whether animal testing can be completely stopped, Dr Sheikh said it is not possible at present and that no country has achieved this. He said AI may partially replace animal testing in the future. He added that instead of completely withdrawing the government's draft rules on animals, they need to be amended.

Earlier, Ambika Shukla had raised concerns over the new rules for animal laboratory testing.

Note: Suggestions and objections to the proposed rules can be sent via email to cpcsea-mef@gov.in. The deadline is November 5.