India's large pool of treatment-naive patients was hailed as the most major benefit of running trials in India in a recent interview with Dr Vasudeo Ginde, president of Indian-based CRO iGATE clinical research.

"This effectively allows patient recruitment to be completed in India much faster than in most places. For example, in the US it may take one year to recruit 500 diabetes patients, whereas in India it would take seven months," he said.

"Speed equals money," he added, giving the example of Prozac, which was generating $4bn (€2.8bn) a year in revenue before it went off patent , so if it had been brought to market even three months earlier, its developers would have reaped in an extra $1bn.

According to Ginde, the second most beneficial aspect of conducting clinical research in India is related to the first, being the variety of patients on offer in the country, who are sporting such a large range of illnesses that affect those in both the developed and non-developed world, at all different stages of progression.

"This again leads back to a faster recruitment time and also provides sponsors access to certain patients that they would not be able to find in the 'developed' world."

Thirdly Ginde pointed to India's good command of the English language as a major draw card for international companies operating there.

"All documents, with the exception of most of the clinical consent forms, are in English and this means that no burdensome translations are required and everything is more straightforward and transparent for all involved, including the regulators," he said.

On the flipside, Ginde also discussed the main challenges of operating in this growing business area in India.

By far the biggest problem is staff recruitment and retention and the situation is only getting worse, he said.

"More and more pharmaceutical companies and CROs are doing business here and there are only a number of trained and experienced clinical research staff to spread between them."

In 2003 there were between 60 and 80 trials being conducted in the country and now this has jumped to around 260.

The economics of this supply and demand problem is that the price of clinical research is being pushed up, via higher salaries.

"In the last two years the cost of clinical research staff has doubled," said Ginde.

On a related note, the second biggest industry challenge highlighted by Ginde is staff poaching. Experienced staff are constantly being lured to rival firms through the opportunity of promotion and career progression, along with more money.

"The average attrition rate in clinical research staff is 45 per cent. Pfizer, for example has seen a turnover of 75 per cent of staff in its clinical research group in India over the last 18 months," he said.

"This scenario is very destabilising for the industry and more must be done to curb it."

Ginde added that his firm has a low attrition rate, at 10 per cent, "because we try to incentivise staff through offering them the opportunity to develop multidisciplinary and interdisciplinary skill sets and career progression, and rotating the jobs they are working on roughly every two years."

Meanwhile, the third greatest challenge is also of a similar vein, being that there are not enough clinical investigators and sites to cater for all the clinical work that is being done.

This is resulting in a growing bottleneck, with investigators working on competing and sometimes conflicting trials; being lured to work on the trials that pay the most, which is also driving up price. Eventually this scenario could begin to affect quality, he explained.