Factories, call centres — and now clinical trials
outsourced to India

The West reaps the benefits, but the ethical implications have watchdogs worried

By Tony Craig

India's own pharmaceutical market is expanding at breakneck speed, yet even its phenomenal rate of growth, 9% annually, can't explain the research boom. That's because most of that research is being conducted for us, here in the West. The Indian population is fast becoming our guinea pigs.

This is not necessarily a bad thing. Indians enrolled in clinical trials can expect far better treatment than they would likely receive otherwise. In particular, the many oncology studies carried out in India have brought unprecedented opportunities to India's cancer patients and oncologists.

Traditionally, Indian drug companies have manufactured generic copies, reverse engineered from existing drugs. But India's 1995 adherence to the World Trade Organization came with a price: they promised to respect pharmaceutical patents. As a developing country, it was granted a ten-year grace period, but that expires next year. After that, Indian drug giants like Ranbaxy will be faced with the same massive R and D challenges as Western companies — but not the same massive costs.

RICH PICKINGS
"There's an Indian advantage in doing clinical trials," says Chetan Tamhankar, general manager of Bombay-based research firm SIRO Clinpharm, a partner of the US-based clinical trials giant Covance. "It costs less. And, unfortunately, in India we have every possible disease you can think of. Anything from tropical diseases, like malaria or tuberculosis, to lifestyle diseases, like diabetes or cardiovascular diseases. And we've got great doctors. It makes sense." India also has the largest English-speaking educated workforce of any country outside the United States, along with a high number of teaching hospitals and FDA-approved pharmaceutical facilities.

Then there are the potential subjects — hundreds of millions of them. When SIRO Clinpharm was approached by the German firm Mucos Pharma to find patients for a head and neck cancer trial, it took them 18 months to find 750 patients in five hospitals. In the European trial centres, it took three years to find 100 patients in 22 hospitals.

Another advantage is that, unlike Africans or Chinese, there are no racial differences between Indians and typical Westerners that might confound results. And Indians are increasingly burdened by the same chronic diseases as Westerners. Mr Tamhankar estimates that India has about 40 million diabetes sufferers.

ETHICAL QUAGMIRE?
Is there an ethics problem in the transfer of research to India? Few would suggest that global research firms are exploiting local companies. The real wealth gap lies not between Chicago and Bangalore, but between Bangalore and the Indian countryside where many of the trials take place.

Indian patients are prized because they are 'treatment-naive,' with conditions that have often not yet been diagnosed, never mind treated. But it's widely admitted that their valuable naivety goes beyond that. They are less likely to question doctors or refuse consent. There have also been dark rumours of too many trials being stopped halfway, and of drugs being tested that couldn't get ethics committee approval for trials in the West.

Dr Vasantha Muthuswamy, senior deputy director general at the Indian Council of Medical Research (ICMR), which oversees medical research, admits that researchers target the poor. "The government hospitals don't have a good supply of medicines. So the pharma companies usually target the government hospitals for trials, except maybe for cancer patients," she says. "And many times, when dealing with patients from lower socioeconomic groups, there have been doubts about informed consent."

But government and industry alike claim that India is putting its house in order. "All doctors conducting trials are trained in good clinical practice norms according to international standards," says Mr Tamhankar. "Each hospital has an ethics committee, which we must go through. Simultaneously, we must also apply to the Indian drugs controller. Everything is carefully documented."

Dr Muthuswamy agrees. "The situation is now changing. We already have some laws in place, and are working on passing more legislation," she says. "Pharma companies know that to meet with Indian and international standards, they need to be more stringent. Otherwise their studies won't be accepted."