CPCSEA RULES » Institutions wanting to conduct experiment on animals must get themselves registered with the CPCSEA. » No experiment can be conducted on animals without the permission of the CPCSEA. » Institutions wishing to experiment on animals should form Institutional Animals Ethics Committees (IAEC) that includes a permanent representative of the CPCSEA. » Permission of the CPCSEA or the IAEC is mandatory for breeding, storage and import of animals. » The CPCSEA may revoke the registration of an establishment, breeder or IAEC found violating the rules. » No organisation can undertake contract research on behalf of another institution. NEW SUGGESTIONS » CPCSEA should devolve power to allow the use of animals to animal ethics committees of respective institutions. » Decision of IAEC should be taken by a majority vote. » Healthcare institutions must have the power to hold emergency meetings of IAEC. In an urgency, experiments should be allowed to be performed. » One-time permission be given for routine experiments which need to be performed on a regular basis. » Contract research to be allowed with the permission of the IAEC. » Till breeding facilities become functional, teaching and research institutions should be allowed to acquire animals from registered suppliers.

It could well be termed a battle between the custodians of the health of humans and animals. The debate has assumed more than academic significance with Minister of Animal Care Maneka Gandhi ordering a ban on all animal experiments at the Pune-based National Institute of Virology, a key research centre working on an aids vaccine. The decision was taken on May 11 after a team from her ministry found monkeys lodged in NIV's animal house in a bad condition. With product patents slated to replace process patents by March 2005, pharmaceutical companies that extensively conduct experiments on animals to develop drugs for human beings, fear that they will lag far behind in developing drugs at the international level.

The problem started in 1998 when Maneka Gandhi, after taking charge of the Social Justice and Welfare Ministry, got animal welfare included in her jurisdiction. Almost immediately, she whipped up a controversy by strengthening the existing Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) by formulating a set of rules for the breeding of animals and conducting experiments on them under the Prevention of Cruelty to Animals Act, 1960.

Animal studies, the scientific community, it argues, are mandatory for testing the safety of new drugs, to examine their efficacy and to determine safe dosages for human beings. Failing to get any concessions, some of the major pharma companies have already decided to relocate research laboratories out of India. "Continuing research in India is just not possible. We are planning to shift our research laboratory to the US," says Dr J.M. Khanna, president of research and analysis department of Ranbaxy. At another pharma major, Nicholas Piramal, similar sentiments are echoed, despite the fact that such relocation of labs is an expensive proposition. The cost-up to $300 million or Rs 1,470 crore-is still economical compared to the steep price of contract research abroad.

Pharmaceutical companies feel they are left with little option. They need genetically engineered animals for specific scientific studies but the procedures laid down by the CPCSEA for the import of animals are cumbersome and time-consuming. It took Nicholas Piramal 18 months to get approval to import genetically-engineered mice for trials of a drug it was developing for diabetes, a problem disease in both urban and rural India. In a competitive drug research industry, such delays may prove costly if a foreign company were to develop the same drug and get it patented. Says Dr C.K. Katiyar of Dabur: "The company can then dictate the prices of the drug in a country which does not have an alternative to the developed drug."

The rules have since been slightly relaxed to facilitate experiments on small animals like rats and mice-not for larger animals like dogs and primates. But they are still stringent enough to scare away the pharma industry. Take drugs for cardiovascular diseases: research requires the import of beagle dogs for conducting non-terminal cardiovascular experiments. Dr Reddy's Laboratory has been unable to import the Watanabe rabbit that is known to be the best rodent model for evaluating hypolipidemic drugs. Similarly, blood pressure drugs can be tested most suitably on dogs because their cardio-vascular system is similar to that of humans.

CREATURE DISCOMFORT: Maneka (top right); a medical student conducts test on a dog

"Experiments for medical research are not banned under the Prevention of Cruelty to Animals Act. We must have an amicable solution." Dr C.P. Thakur, Union Health Minister

Use of animals for medical research is not banned under the Prevention of Cruelty to Animals Act and there should be an "amicable solution", says Union Minister for Health and Family Welfare Dr C.P. Thakur, who himself was a victim of Maneka's pro-animal stand. An expert on the dreaded kala azar disease, Thakur required four white rats to conduct certain experiments. It took six months and several personal requests to Maneka to get his experiment going.

In May last year, Thakur appointed a committee of eminent scientists headed by Dr N.K. Ganguly, director, the Indian Council of Medical Research, to study the impact of CPCSEA rules on biomedical research. Predictably, the panel termed the CPCSEA rules unrealistic. It felt that since there were no breeders of large animals in the country, they have to be imported or bred in the animal houses of research institutes-practices prohibited by CPCSEA. The committee also asked the CPCSEA to furnish the credentials of its Chennai-based expert consultant to promote transparency.

Scientists feel that CPCSEA rules should be eased, with institutions needing to seek only a one-time permission from CPCSEA to carry out their studies instead of having to approach it every time they needed to use animals for scientific study. But with Maneka refusing to even take cognisance of the Ganguly Committee report, the scientific community has almost given up hope. Worse, when Maneka was recently shifted to the Ministry of Culture, she ensured the Department of Animal Care-which oversees the dreaded CPCSEA-stayed with her.

The medical and scientific community feels that if rules aren't eased, the Indian pharma industry's backbone could break with the coming into force of the product patent regime in three years. "Only multinational companies with well-established research labs will reign after March 2005," says Thakur.

So far, Indian medicines have been able to compete in the world market purely due to their pricing-which also explains why exports of Indian drugs, Rs 600 crore in 1990, grew to Rs 7,000 crore last year. The industry believes that with the massive demand for Indian medicines in Africa, east Asia and south America, exports could go up to Rs 20,000 crore over the next few years.

But there remains a hitch: Maneka. Refusing to relax laws on animal testing, there has been no dialogue between the pharma industry and her. She refused even to speak to India Today. But CPCSEA Member Secretary A.K. Joshi defends Maneka, saying she is only enforcing rules that have been in existence since 1965. "The regulations were necessitated because few institutes maintain proper facilities for housing animals. Lots of experiments on animals are still being conducted despite the existence of alternative methods," says Joshi.

Thakur appears fed up. "We are all against cruelty on animals," he says. "But in an era of economic liberalisation, laws should facilitate, not obstruct industrial growth." About time too the debate on the desired balance between concern for animals and that for scientific research was settled.