The tussle over animals

What will happen to the debate on animal testing in scientific laboratories in India, with the exit of Maneka Gandhi and C.P. Thakur from the Vajpayee government?

THE exit of Maneka Gandhi, who was in charge of the Animal Welfare Department, and C.P. Thakur, who handled the Health portfolio, from the Union Council of Ministers has somewhat abated the debate over the use of animals in scientific research. However, questions such as those on the need to exercise prudence in expecting international animal welfare standards from Indian scientific laboratories which face a cash crunch, and delineation of the role of bodies like the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) remain unresolved.

The CPCSEA was set up 40 years ago under the provisions of the Prevention of Cruelty to Animals Act, 1960. It was meant to ensure that animals are not subjected to unnecessary pain or suffering before, during and after the performance of experiments on them; that they are procured from registered breeders; that there is no duplication of research and consequently unnecessary sacrifice of animals for the sake of research; and that experiments on large animals are avoided when the same result can be obtained by experimenting on small laboratory animals. For the implementation of these rules in institutions conducting experiments on animals, the Institutional Animal Ethics Committee (IAEC) was constituted. The IAEC has members nominated by the head of the institution concerned; one member is a nominee of the CPCSEA.

But pharmaceutical companies and scientists have always complained that the guidelines of the CPCSEA interfere with research; they have been demanding an easing of CPCSEA rules. In May 2001, the Indian Council of Medical Research (ICMR), under its Director N.K. Ganguly, studied the impact of CPCSEA rules on biomedical research and described them as unrealistic. What is found as particularly troublesome is the stipulation that institutions wanting to conduct experiments on animals should get themselves registered with the CPCSEA. Scientists say that it is unfair to expect them to approach the CPCSEA each time they want to conduct experiments using animals. They want a one-time clearance for animal tests.

Scientists say that the use of animals for biomedical research is unavoidable. They charge the CPCSEA with doublespeak. Even as animal rights activists profess that experiments on animals are fine as long as they are conducted within the framework of guidelines, in reality they expect standards that are unachievable, scientists say.

The CPCSEA, on the other hand, says that the standards expected in India are less rigorous than, say, in the United Kingdom. It says that the debate over the use of animals for testing is being misrepresented as a choice between the welfare of people and the welfare of animals. The CPCSEA says that it is only asking for decent cages and food for the animals, which, in turn, would result in better scientific results. Scientists, however, fault the confrontationist attitude of the CPCSEA, especially in the matter of inspection of laboratories; they suggest that such inspections be treated as occasions to make a mutual effort to improve the conditions of experimental animals rather than use them as fault-finding processes.

Reacting to the charge that the CPCSEA does not make thoughtful and discriminating judgment, animal rights activists say that they cannot help reacting emotively to the issue. They argue that applying the results of experiments on mice to human beings is unreliable. The CPCSEA says that if the animals used for experimentation are kept in hygienic conditions and are looked after well, the results of the experiments would be accurate and would benefit scientific research. The Johns Hopkins University, which spent $30 million to build a state-of-the-art laboratory for maintaining experimental rats, is a case in point. According to Anuradha Sawhney, the chief functionary of the People for the Ethical Treatment of Animals (PETA) in India, such investment was deemed necessary to produce reliable data. "The money will be returned ten-fold when experiments that cannot be questioned on the basis of technique yield results that can be written in scientific journals and be of use to mankind," she said. Other cases cited include that of drug companies such as Physiome Sciences of the U.K. which do not use any animals at all in the development of new drugs and have developed three-dimensional computer models that can predict a chemical's effect on all organs of the human body.

The scientific community replies that the question of results does not arise in India as the CPCSEA guidelines have seen to it that animal-based research is next to impossible. The pharma companies are at the receiving end now, especially in the face of an inevitable escalation in costs. At a time when every minute is precious in globally competitive science, the CPCSEA is pushing the country backward by disheartening scientists, they feel. With product patents slated to replace process patents by March 2005, pharmaceutical companies that use animals extensively in experiments fear that they will lag far behind at the international level in developing drugs. Pushpa Bhargava, former Director of the Centre for Cellular and Molecular Biology, feels that CPCSEA cannot be the judge of scientific activity in India since its members generally do not have a background in science. They delay or stop research which they do not understand, he says.

Questions have also been raised on where the CPCSEA would draw the line. Pushpa Bhargava argues that the CPCSEA, which pleads the case of animals in scientific institutes, should ban the use of pesticides since they kill insects, which are also animals. It should also ban agriculture, which requires the killing of plants, which are also living and which share, by and large, the same chemistry and biochemistry as animals, including human beings.

The debate has spilled over to alternatives to animal testing and practices in medical schools. Groups opposing animal testing swear by international standards, such as those followed in the Harvard Medical school - instead of practising on live animals students here are brought straight to the human operating room to watch and learn as surgeons perform cardiac bypass surgery. In the area of product testing, they cite the examples of European and American companies that have committed themselves to the use of ingredients from the Generally Recognised as Safe (GRAS) list rather than tests on animals. (But scientists here say that though alternatives like cell culture and tissue culture can be used in some studies, they cannot replace animal testing.) According to the Physicians Committee for Responsible Medicine (PCRM), a non-governmental organisation, leading universities in the U.S. train medical students in hospitals under the close supervision of experienced doctors.

The present debate on animal testing goes back to mid-1999 when about 50 monkeys and other animals at the National Institute of Nutrition (NIV) in Hyderabad were forcibly released on the grounds that the institute's facilities fell short of CPCSEA rules. On March 8 this year, three members of CPCSEA officials visited the Institute once again and found that it still flouted the rules. They sent a report to Maneka Gandhi, drawing her attention particularly to the state of 37 monkeys, which were found to be suffering from mange, had missing fingers and were arthritic owing to the lack of exercise. The report said that some monkeys exhibited symptoms like zoochosis - that is, circling their cages without stopping. Two monkeys were deformed and one other was paralysed. Most of them were very aggressive. The drinking water in some monkey cages had larvae floating in it, the report said. The report prompted Maneka Gandhi to write a letter to Prime Minister Atal Behari Vajpayee in May, seeking a Central Bureau of Investigation (CBI) inquiry into the functioning of the NIV.

In response to the letter, Health Minister C.P. Thakur told the Prime Minister that the CPCSEA's guidelines were too strict to follow. He wrote that resource constraint made it impossible for research to be undertaken in India in accordance with the CPCSEA norms, which were formulated in keeping with international standards. The letter also pointed out that the Prevention of Cruelty to Animals Act specifically excluded experiments using animals if they were meant for the advancement of medical research. It further noted that several provisions under the Act affected drug development and other biomedical research. These included a ban on contract research and the import of animals. The researchers were required to procure their animals only from registered breeders even in cases where there were no indigenous breeders for many categories of animals, the letter pointed out.

C.P. Thakur's stand found favour with scientists and pharmaceutical companies. Maneka Gandhi found an emotive audience in international animal welfare organisations and some former movie stars. A letter from former French actress Brigitte Bardot, now an animal rights activist, to Thakur was widely circulated by PETA. Bardot made a sentimental plea on behalf of the monkeys at the NIV: "My heart goes out to these suffering beings, who are so very much like people in their capacity to feel. I can only imagine, with great heaviness of heart, what led to their terrible state. How many weeks or months or years were they neglected to have become encrusted with the painful sores of mange? How many years in undersized cages did it take to cripple their tiny bodies with arthritis? How many nights did they spend lying awake, their organs ravaged by infection that went untreated?"

Matters came to a head when the Prime Minister intervened in the ministerial row in June and asked Murli Manohar Joshi, the Minister for Science and Technology, to resolve the issue. Joshi was brought into the picture because the National Accredition Board of Laboratories (NABL), which comes under the Science and Technology Ministry, is in charge of matters relating to the regulations concerning experimentation using animals. The pharma companies and Thakur had been pushing for strengthening the NABL. Leading pharma companies have recommended that the IAEC be asked to monitor tests on animals and that it report directly to the NABL and not to the CPCSEA.

With the Cabinet reshuffle, both Maneka Gandhi and C.P. Thakur have been shunted out. It is not clear yet who would look after the Animal Welfare portfolio in the revised scheme of things. Whether the new Health Minister, Shatrughan Sinha, will continue with Thakur's line of argument regarding animal testing remains to be seen.