SPEECH OF MANEKA GANDHI AT THE SEMINAR ON 'THE STATE OF ANIMAL HOUSES IN INDIA'

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The Minister of State for Statistics & Programme Implementation, Smt. Maneka Gandhi address at the first ever Seminar on ‘The State of Animal Houses in India’ here today. This is the text of her address:-

" Senior officers of the Government of India, State Governments, Vice Chairman of the Animal Welfare Board, members of the CPCSEA, and distinguished scientists, it gives me great pleasure to extend a warm welcome to all of you to this first ever National Seminar to deliberate on the state of Animal Houses in our Research Laboratories, Medical Colleges and Universities, and Production Units in public and private sectors.

The subject for discussion in today's Seminar is of great national importance, and has been a matter of both national and global concern, more so in the recent years.  Contrary to the common perception, the issue at debate does not have only ethical dimensions, but also hardcore scientific, human, ecological, and trade and commerce-driven ramifications.

I am sure that there is complete unanimity amongst the fraternity of scientists that the results of scientific research impinge closely on the state of health and hygiene of animals on which experiments are conducted.  A scientifically- well-managed Animal House/Facility holds the key to research findings capable of validation, and subsequently culminating into drugs, formulations and vaccines that assure effective human health protection.  The importance and relevance of the norms contained in the Manual `Good Laboratory Practices' (GLP), which has been prepared by eminent scientists drawn from prestigious national institutions of science, need hardly be over-emphasized. 

Medicine and scientific research cannot exist in isolation. Therefore we must look at developments on the global scenario, which though known to a large number of us present here, merit reiteration.  All over the world the official government and scientific view is that stress should be put on observance of the three Rs viz. Replacement, Reduction and Refinement in animal experimentation.  On the Replacement front we must think and act more and more in terms of  `relative replacement' i.e. cell or tissue based and in vitro techniques till such time as we can move towards absolute replacement.  The scientists in the developed countries are also striving to reduce the number of animals for experimentation.  With careful experimental design and sophisticated statistical techniques, it is possible to use far fewer animals, and still get valid results.  The EEC Directive 86/609/EEC regarding the animals' use for experiments for scientific purposes does not permit the use of animals if alternative methods are available, and enjoins adoption of methodology that causes least pain and distress.  In England, cosmetic testing on animals has been banned and recently because of the cry that arose from the badly managed animal houses of Huntingdon, the government has closed those down as well. This was the largest animal house in England with millions sunk into its development.

Among other notable global developments which are of great relevance to us in this field are the switchover to LAL testing in the U.S. and British Pharmacopoeia in increasingly large number of drugs and formulations, and OECD's moving in the direction of deleting OECD Test Guideline 401, also known as the Lethal Dose 50 which has been the mainstay of the cosmetic, pesticide and drug industry will now be banned by the EEC in Europe. Similarly the enormously stressful Draize Test invented in 1944 is also out.   U.K., Germany and USA have taken the lead in developing more humane tests.  Instead of dosing at least 20 animals with a test substance, which might be expected to kill 50 per cent of them within 14 days, there are new tests, which drastically reduce not only the number of animals used but also the quantum of suffering they endure, and the death rate.  The WHO has also initiated the process of hazard classification in the light of the changed OECD guidelines.

As against the above scenario we are still at a stage where we have yet to replace the obsolete cholera, typhoid vaccines with newer and safer vaccines, and move over from in-vivo to in-vitro methodology for the potency test of Hepatitis-B vaccines.  The alternative methods of production available both for the Japanese Encephalitis (J.E.) and rabies vaccines are yet to be introduced even though it is well know that the current vaccines of rabies cause paralyses in thousands of cases. The only two countries using this outdated method are India and Tunisia. Even Bangladesh has shifted! The efficacy of alternative methods is acknowledged by the fraternity of scientists.  It is a recorded fact that monoclonal antibodies generated by ascites methods show reduced immunoreactivity of 60-70% when compared to an immunoreactivity of 90-95% for antibodies produced by in-vitro methods. Similarly syringes are still being tested on rabbits, which can even pass on serious disease to the user.      

The new terms of global trade in drugs and pharmaceuticals also enjoin adherence to ISO specifications.  If not for altruism, then for hardcore trade and commerce, we need to raise the standards of our laboratories to the standards of globally accepted good laboratory practices so that the toxicological data on the pharmaceutical products would be mutually acceptable among the trading countries without repetitive toxicological studies.

Some of our institutes are striving to move along with the times and keep up with the global trends.  The two cases that I would like to cite are those of Pasteur Institute of India (PII), Coonoor and the Vittal Mallya Scientific Research Foundation (VMSRF), Bangalore.  The PII took up the challenge of developing new tissue culture vaccine for rabies, and thus save the lives of excessively large number of sheep used for producing sheep brain-based anti-rabies vaccines.  The Institute can be credited with introduction of good practices in breeding, and maintenance of animal premises. I understand that under its R&D projects, new scientific studies have been taken up to develop Monoclonal Antibody against Tetanus Toxoid and Diphtheria Toxoid which will eliminate the usage of large animals like horses.  Studies are also reportedly underway for cell-derived J.E. vaccine. As for VMSRF it is engaged in its efforts for production of snake venom vaccines from chicken egg.  Production of diagnostic and therapeutic products in chicken represents a refinement and reduction in animal use, and the collection of blood is replaced by extraction of antibody from egg yolk.  As chickens produce larger amounts of antibodies, there is a reduction in the number of animals.  Theoretically, 25-50 eggs could yield venom-specific antibody equivalent to that obtained from 1 litre of horse serum, and one bird yields at least 250 eggs.  I am told that VMSRF have successfully developed methods to produce anti-snake venom (ASV) in chicken egg for the four common poisonous snakes viz. cobra, krait, saw-scaled, and Russell's Vipers.  These antibodies are stated to be six times more potent than the ASV produced in horses. For the first time, CPCSEA has commissioned expert scientists to do a study done on alternative testing for any drug available anywhere in the world. This should have been done many years ago and updated every year by the Drug Controller.

I take this opportunity to share with the august gathering the very positive judicial endorsements by the Hon'ble Supreme Court, and several Hon'ble High Courts of the country in matters raised before the judiciary under the provisions of The Prevention of Cruelty to Animals Act, 1960, and various Rules framed thereunder.  It reinforces our resolve to ensure effective implementation of the legal provisions.

The Committee for the Purpose of Control & Supervision of Experiments on Animals is a statutory body under the Provisions of the PCA Act, 1960, and is statutorily expected to take all such measures as may be necessary to ensure that the animals are not subjected to unnecessary pain or suffering. In response to a large number of public complaints against the state of animal based laboratories and cruelty, the Government set up the first CPCSEA in 1963 under the Chairmanship of Shri Kamal Nayan Bajaj. .

The present CPCSEA is the largest in size, and the most broad-based one since its beginning in 1960.  It has 28 members, with representatives of Ministries of Health & Family Welfare, Biotechnology, Animal Husbandry, ICAR, and DRDO.  The eminent institutes and organizations of science represented on CPCSEA are ICMR, CDRI, VCI, AIIMS, Drug Controller General, Zoo Authority of India, Zoological Survey of India, Indian Institute of Sciences, National Institute of Immunology, and Infrastructure Development Finance.  The Institutional Animal Ethics Committees (IAECs) that have been formed under the Breeding of & Experiments on Animals (Control & Supervision) Rules, 1998 as amended in 2001 consist of five Scientists, one trained activist member, and one nominee of CPCSEA. The endeavour of this Committee has always been to improve and facilitate the research.  In order to achieve this, the Committee brought out the first Rules on animal experimentation in 1968.  It has also notified rules for Breeding and Experiments on Animals in the years 1998 and 2001.  The Committee has also made guidelines for laboratory practices (GLP) as well as protocol for production of anti-snake venom serum from equines. This is not the first time that the rules have been made for laboratories. In fact, much before CPCSEA made the rules and started enforcing them in India, guidelines for care and use of animals in scientific research were first brought out by Indian National Science Academy (INSA) in 1992. Unfortunately these were not taken at all seriously by laboratories. The guidelines prepared by CPCSEA have also taken into account the guidelines published by INSA as well as practical field experience.  Even in the committee that drafted the Guidelines for Laboratory Animal Facility, most of the members were scientists. It is painful to know that scientists had even failed to adopt the guidelines prepared by the scientists themselves. In fact, guidelines and rules applicable to India are far more relaxed as compared to the rules available elsewhere in the world.  For example in UK, even the person working on animals is required to register with the ministry before conducting research on animals. . 
 
Over the last two years, the Committee has conducted more than 350 inspections of various institutions/laboratories throughout the country.  In many Institutions/Laboratories, the condition of animals was frightening.  Monkeys were found to be suffering from skin diseases, missing limbs and paralysis. Many of them had been in cages for even 15 years.  In one case the researchers had cut off their hands so that they would not be scratched while taking them out of their cages. Cages of rats and mice were found to be filthy and overcrowded. Feed was mixed up with fecal matter. Cannibalism was rampant because of the lack of food.  The rooms were filthy, airless, without electricity, unhygienic. Animals were inbred, many had gaping wounds on them. Proper quarantine facilities were also missing in many institutions. Even the record keeping in the animal houses of various institutions, which costs no money was extremely poor.  There was compartmentalization between various departments of the institutions with no sharing of information.  The department experimenting on animals did not know whether the animals have been procured from registered breeders or not.  This would have even rendered their research meaningless. However, as a result of these inspections and feedback given by the nominees of the Committee, about 100 institutions/laboratories have carried out improvements as per the guidelines and the Rules. . 

Many institutions complain that they are facing delays in having their projects passed. The reasons for the delay are not due to Rules or Guidelines but due to lack of willingness on the part of Institutions to repair themselves.  Most of the Institutions undermine the authority of the nominees of the Committee who are deputed for checking the facilities.  It should be made very clear that these persons are not animal activists but they authorized representatives of CPCSEA. If we have to ensure that delays are minimized, there has to be total transparency on both sides.    During inspection, one of the institutes expressed helplessness in carrying out the required improvements in the animal house due to paucity of funds.  The same institute was inspected again jointly with one renowned scientist of ICMR (Dr. S.D.Seth) and when the scientist told them that these were basic requirements to be fulfilled for proper research, the required improvements were carried out immediately.  The projects of the institute were cleared by the IAEC in the very next meeting.  This shows that improvements can be made easily if there is a will to do so. Similarly number of institutions carried out the required modifications or improvements only when directed by the Hon'ble Supreme Court.  These institutions were given approval on the same day when the compliance report was received. That shows that CPCSEA is aimed at expeditious approval of the projects. . 

In the Committee, there is a well laid down procedure for clearance of all the projects.  All the projects involving small animals are normally cleared by the Institutional Animal Ethics Committee, in which only one nominee of CPCSEA is present.  All the others are scientists/other officials of the organization.  Similarly, all the proposals involving large animals are cleared by a sub-committee, which consists of nationally and internationally known experts and is headed by Prof. Ranjeet Roy Chowdhry.  Some of the Members of this Committee include Dr. Sriramachari, Dr. Vasantha Muthusamy, Dr. A.J.Rao and Prof. R.P.Das, all from the Ministry of Health.  This sub-Committee also invites experts belonging to special areas, which are being assessed by the Committee.  All the proposals are reviewed transparently and objectively with the criteria developed and are being constantly reviewed.

I may mention here that these mechanisms are not unique to our country. The Animal Welfare Act of the US provides for Institutional Animal Committees in each Research Facility, and the latter is statutorily expected to provide for training of scientists and technicians with particular focus on humane practices of animal maintenance and experimentation. Likewise Animals (Scientific Procedures) Act,1986, of the U.K. provides for setting up of Animal Procedures’ Committee and its sub-committees and calls upon them to protect animals against avoidable suffering, and discourage their unnecessary use in scientific procedure. To give you an example of the seriousness with which this is taken, a lab that does not hold ethics committee meeting is shut down. Recently I read in an Indian paper that one lab in America was shut down because the ethics inspector saw that one box was overcrowded by one mouse too many. It is because of this insistence on animal care that America has so many patents in medicine. How many more would we have got if we have taken as much care? It is not money that is needed in keeping animal houses: crores of rupees have been given during the last fifty years. Pt. Jawahar Lal Nehru was very particular in establishing the best possible surroundings and conveniences for the development of science and this is a tradition that has been carried on: it is a proper and serious usage of the money that is lacking. What is needed is an attitudinal change and understanding that the core of scientific experimentation lies in the health and well being of the animal that is being used. A monkey with tuberculosis - as most of them in Indian laboratories- cannot give Indian any results for any other medicine. .

One of the main constraints raised by various institutes is lack of resources. I would like to point out that there is no shortage of resources, but there is a need to ensure optimum use of resources. You are all aware that if the animals are under stress or are sick due to any reason the research conducted on them is going to be meaningless. Similarly, experiments conducted on stray animals with unknown health and genetic background will give results, which cannot be validated. If that is so, it is better to support a small number of more relevant experiments rather than funding a large number of experiments. What is required is proper planning of the projects. No provision is made for rehabilitation of the animals, which have rendered valuable contributions to the research. In fact some of the institutions want to kill healthy animals on the ground that they have no funds for rehabilitation. Since the breeding is careless in most animal houses, there is over breeding and many animals born through caretaker’s carelessness are condemned to death. This cannot be accepted on any ethical ground. .

The CPCSEA believes in transparency and dissemination of information. As a part of this philosophy, we have started the publication of a newsletter and have launched CPCSEA’s website (www.cpcsea.org). Over the last two years, the nominees of the CPCSEA have conducted more than 350 inspections of various institutions and laboratories. While in the beginning there was stiff resistance, I am happy to say that a large number of institutions showed remarkable attitudinal change and effected the desired improvements in their animal houses. All of them report that their vaccines are more effectively made, that working is easier and more efficient for the scientists. And this is how the Members of Parliament envisage this was going to be when they passed the act unanimously in 1960. However, there are still a very large number of institutions, including some of the better known National Institutions which are expected to be role models but which are yet to take ameliorative steps. I call upon Heads and members of the faculty of all this institutions to chalk out an action plan and fit it within a specific time frame for implementation so that the chasm between the normative and the actual is eliminated.

But for the work of the CPCSEA and its panel of experts, which stepped in to recommend a more sophisticated, safer and kinder process, nothing would have changed. Too many researchers are content to carry on as they have always done, without concern for whether or not their work produces anything useful. I could give you many examples of such waste and unnecessary suffering. I know of laboratories that have taken money to build new, better cages for animals – but no cages were ever built. Where has that money gone? I know of researchers who have spent precious research funds for travel, expensive lunches and other trivial items. CAG has pointed out one laboratory that has spent 8 crores on Diwali gifts for VIPs instead of spending the money on animal house. Finally, we must look with a critical eye at the kind of research being proposed. International medical journals have repeatedly criticized the fact that much research that is being conducted with heavy government financing has never even been written up. This means that if something valuable has been produced, it has all been for naught, as no one will ever know about it. One premier institution alone has not written its research documents for 139 of the 338 experiments conducted in the 1980’s! I have also seen research for AIDS that was being done using a strain of SIV already rejected by researchers elsewhere in the world. I know of experiments that have already been done repeatedly in other laboratories and other experiments on animals when better, less-expensive non-animal models are available..

We should together strive to move towards a situation where we stop treating our animal houses as the junkyard of our laboratories and institutions. Many government scientific laboratories have complained to me that their animal houses are in a mess because the class IV employees are unionized, do not come to work and often the worst among them are given to the animal house. The scientists say that they cannot be removed. There are so many solutions to this. I would like you all to suggest some. There are very few trained lab attendants and in fifty years we had held no training programme for them. What can you expect from an untrained class IV employee? A scientifically maintained animal house is the very substratum of scientific research. If not for ethics, not for compassion and not for equity, at least for sound science, we must have better managed animal houses. In fact, we should move towards a system of accreditation of animal facilities along the lines worked out by the American Association for Accreditation of Laboratory Care (AAALAC). This seminar is not only historical, as it has taken 40 years for us to come together. It will be a success if we could build bridges, and clearly delineate the contours on the road map.

We cannot compromise on the Health of the Indian people. We cannot compromise on quality. Do we compromise on defence equipment? No, we endevour to get the best to protect our country. Why should our science be shoddy? If we are to reach an international level and actually achieve breakthroughs in scientific knowledge we cannot compromise on quality or make excuses for ourselves. When it comes to scientific research we have the same goals: to use our limited resources to conduct meaningful research that produces internationally recognized data. We do not have the funds to through away the experiments that have already been done a thousand times, which are poorly designed or tainted by carelessness. Study after study has shown that a failure to adhere to minimal animal welfare standards increases the unreliability of animal tests. Stress, such as that caused by overcrowding, inadequate or inappropriate food and unsanitary caging can have a powerful effect on the outcome of the studies. Stress can depress the immune system to such an extent that the treatments being studied – pharmaceuticals drugs for example – may appear inadequate or ineffective, when the reverse may be true. It is essential that animals at laboratories be provided with an environment as close as possible to their homes in nature. Cleanliness, proper food and water, veterinary care and other basic needs are the reason why the CPCSEA is needed - not only to ensure humane treatment, but also to ensure India’s contribution to science.

Johns Hopkins University, the leading research institution in the US, has spent $ 30 million to build a state-of-the-art laboratory for the rats used in experiments. This amount of money was deemed necessary to produce reliable data, which in the end, is what researchers strive for. The money will be returned 10-fold when experiments that cannot be questioned on the basis of technique yield results that can be written up in scientific journals and ultimately of use to mankind. It is only good science and good economics to employ the most sophisticated techniques and research procedures available. For example, Physiome Sciences in England uses mathematically base computer models to show the biophysical properties of normal and diseases mammalian cells. Using these single-cell models, the company builds anatomically precise and three dimensional organ models. These virtual organs can accurately predict the effects of drug therapies for a variety of diseases. As another example the UK has banned the use of live animals for medical training purposes and over half the medical schools in the US, including Stanford, Columbia, Duke, Harvard and Yale have also adopted more humane and superior methods. Harvard Medical School brings students directly into the human operating room to learn alongside the surgeons, perfusionist, and anesthesiologist during actual cardiac bypass surgery instead of using live animals. CD ROMS, such as "Physiology Labs" by SimBioSys, let students navigate through respiratory, cardiovascular and renal physiology and experiment with many different parameters in a truly interactive programme.

There are also simple, inexpensive policies that could be implemented immediately that will save funds and spare lives. In the area of product testing, for example, 100’s of European and US Companies have committed to using known-safe ingredients from what is called the Generally Recognized As Safe, or GRAS list, rather than test on animals. Many companies also use non-animal tests that are available through mail order, including cloned human skin, human corneas from eye banks, computer assays and in-vitro tests using human cells.

Implementing these non-animal methods will benefit India both monetarily and in terms of human health by freeing up funds for programmes so desperately needed to save lives. Countless people in India die of preventable diseases; more children succumb to diarrhoeal disease from contaminated water than to any other cause. In some parts of India, children are still crippled by polio, which can be prevented by a simple vaccine. Funds are desperately needed for simple programmes that we know will save lives. It is immoral to throw money away on poorly planned experiments when it could be used for these life-saving measures.

The CPCSEA can call on dozens of scientists from India and around the world who have the expertise to review research proposals and make recommendations about the validity of the protocols. It would be a terrible waste to ignore the immense intellectual brain trust at our disposal. Progress made in the US can be applied in India - we do not have to stay mired in outdated techniques and substandard procedures. India can be the world leader in scientific research, but only if we draw on the best the rest of the world has to offer.

This means that researchers must not be allowed to operate in a vacuum, accountable to no one. We must face the task of bringing our laboratories, our animal care guidelines and our research review process up to the highest standards possible if we are to make progress. It is not acceptable to say, "it can’t be done". We must say, "it will be done". We have the best minds in the world: sophisticated, innovative and above all eager to learn. Let us use these minds that India so desperately needs.

I shall be happy if during the course of their presentations, the distinguished speakers touch upon the norms as laid down in Good Laboratory Practices (GLP); areas of augmentation; action plan for observance of GLP; strategy for moving over to the adoption of the 3 Rs; importance of compliance with ISO specifications; accreditation of laboratories; and identification of constraints in terms of resources of funds and manpower.

At the end of this seminar I expect a draft resolution for the next step forward. I thank you all for coming and I look forward to listening to all the speakers.

Thank You."