Roadblock for research

S K Basu, director of the National Institute of Immunology NII, New Delhi, the premierinstitute carrying out vaccine research, says: 8220;We just might need to close shop as a consequence of these new guidelines.8221;

Indian biomedical scientists are extremely agitated over the month-old regulations for carrying out experiments on animals. They fear these rules will hamstring all animal experimentation-based research in India. On the other side of the table, of course, are the protagonists of these new guidelines. They say the rules haven8217;t come a day too soon, with Indian scientists having literally had a free run on animal experiments so far.

While the scientists insist they are great disciplinarians, this self-regulation has just not worked, say the guideline-makers. Predictably, the brain behind these fresh guidelines is animal rights activist Maneka Gandhi, Minister of State in the Ministry of Social Justice and Empowerment, and also chair of the 17-member Committee for the Purpose of Control and Supervision of Experiments on Animals CPCSEA.

Framed as part of the Prevention of Crueltyto Animals Act, 1960, the proposed new guidelines are called the Breeding of and Experiments on Animals Control and Supervision Rules 19988242;. Gandhi describes her new rulebook as 8220;one of the most progressive in the world conforming to well established norms adhered to in the West.8221; However, V. Ramalingaswami former chief of the Indian Council of Medical Research ICMR, New Delhi says the rules are 8220;fraught with serious consequences to the progress of biomedical research in India for research into new vaccines and new drugs will not advance in Indian laboratories.8217;

The main idea behind the new rules is that all labs doing animal experimentation register with the CPCSEA. Once the guidelines are enforced no experiment should be done without the written approval of the committee. The guidelines clearly ban all contract research on behalf of unregistered institutions, effectively ruling out all overseas contract based animal-testing that is undertaken in India on behalf of multi-national corporations. Oncethe guidelines are enforced 8212; which incidentally may happen as soon as the middle of November 8212; scientific institutions can neither transfer nor acquire animals without the permission of the all-powerful committee.

But just a minute, it isn8217;t as though the scientists didn8217;t think of all this earlier. Back in 1992, the Indian National Science Academy, New Delhi widely circulated a set of guidelines for care and use of animals in scientific research. The guidelines were expected to become a self-regulatory mandate of the scientific community. They had the good laboratory practice mantra: animal ethics committees which would 8220;examine all projects where animals are used and ensure that ethical guidelines are strictly adhered to.8221;

But the truth is this self-discipline did not happen totally. Issues of animal rights are still a taboo subject in Indian labs. A recent sample survey of 30 labs carried out for the CPCSEA found that out only 50 per cent of the surveyed labs had any form of animal ethicscommittee and of these only two had any outsiders as members of the ethics committee.

So the charges and counter charges are flying thick and fast. But what does an actual working scientist make of these new guidelines? 8220;Time overruns will be the order of the day and these guidelines will only increase the paperwork manifold and how can you expect me to get permission for each and every experiment that I carry out? Is sticking every injection considered an independent experiment or will only protocols be whetted by the expert committee?8221; says Satyajit Rath, an immunologist at NII who annually conducts experiments on about 2,000 mice. He adds: 8220;The rules are fine in intent but are un-workable by way of procedures it lays down.8221;

The rats are only the tip of the iceberg. It is estimated that in India over 5 million animals from frogs, rats, snakes, horses, cats, dogs, monkeys to buffaloes are experimented upon in over 5,000 laboratories. Add to this the fact that India has traditionally been a majorsource for wild Rhesus and Bonnet monkeys, considered prize animals for biomedical testing.

All this was till India banned all export of monkeys in 1978. This ban forced overseas pharmaceutical companies to relocate their drug testing base into India, now it costs ten times less to conduct these tests in India, say experts. 8220;Today labs are paying hardly anything for procuring animals, a wild caught Rhesus monkey is procured for a few hundred rupees! The cost advantage will be totally wiped out once these labs are made to conform to some sort of regulations,8221; says Gandhi. She adds: 8220;Why should my animals be subjected to cruel tests for the sake of western companies?8221;

She says: 8220;I am very happy that there will be more paper work for the scientists, these are the same rules that exist all over the world and nobody else has found them restrictive. But, here because they scientists are so spoilt they are so used to doing what ever they feel like8230; now they will have to fall in line.8221;

There areothers who worry that finding effective drugs and new vaccines for typically Indian diseases like kalazar, malaria and tuberculosis might get hampered since overseas companies are just not interested in investing money in these poor man8217;s diseases. Experts say research on developing new contraceptives is also likely to delayed. R.A. Mashelkar, director-general of the Council of Scientific and Industrial Research CSIR, New Delhi admits: 8220;We may not have done well in the past on animal rights issues and this is a good opportunity to set our house in order for there is an urgent need to have a pragmatic animal testing policy. But at the same time over-regulation does not help anybody.8221;

The boffins have certainly not given up 8212; over 50 representations seeking amendments to the new regulations have already been sent. A committee headed by Dr. P.K. Dave, director of the All India Institute of Medical Sciences, New Delhi is likely to give in their report on the fate of these new guidelines in another twoweeks. For once, they are pitched against somebody who means real business, the minister seems determined to get the guidelines in place 8220;very soon8221; and has recently even brought the Animal Welfare Board AWB under the umbrella of her own ministry. The scientists can get prepared for a stiff climb ahead.

Pallava Bagla is India Correspondent for SCIENCE magazine