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India, best place for clinical trials

Source: PTI
Last updated on: September 29, 2005 21:00 IST
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India is increasingly becoming an attractive destination for clinical research for pharma groups looking for faster and more efficient ways to test drugs for western countries, United Nations Conference on Trade and Development said on Thursday.

It has been estimated that firms can reduce costs by 20-30 per cent by moving their R&D activities to India, UNCTAD's World Investment Report 2005, said.

However, the new patent regime in the country has eroded the power of domestic pharma companies to absorb knowledge spillover through reverse engineering, Nagesh Kumar director-general of Research and Information System for Developing Countries said while releasing the report.

So while the patent regime has reduced the power of domestic companies for absorption of knowledge dissemination on the other hand it has made India an attractive country for clinical trials, said Kumar.

The UNCTAD report said savings for firms going for clinical trials in India come from hiring researchers, nurses and IT staff at less than a third of wages in the West, in addition to differences in the costs associated with the patients.

However, there are some factors holding back the development of clinical research in India such as relatively slow approval process, the report said.

"Another one is India's reverence for animals, which makes it difficult to use certain animals (like monkeys)," the report added.

India, which is well-endowed with skilled R&D personnel, also has a substantial number of people with diseases that exist in developed countries, making it a favoured destination for clinical trials, according to the report.

India has up to 30 million people with heart disease, 25 million people with type-II diabetes and 10 million with psychiatric disorders, the report said.

The country also has a large pool of "treatment naive" patients who have not yet been exposed to other drugs in the market, UNCTAD said.

"In addition, Indian recruits are more likely to comply fully with the trial process, unlike in developed countries where a significant proportion of subjects drop out in order to seek second opinions," the report said.

It is estimated that the number of clinical research organisations based in India increased fourfold between 2001 and 2003, UNCTAD said adding Indian firms, too, are participating in this new industrial activity.

One factor apparently underpinning the shift has been India's newly adopted guidelines on good clinical practices, including the issue of consent by the patients in line with global norms, the report said.

However, other commentators have questioned what consent can mean in a drug trial when patients are illiterate and might not adequately understand the experiment's true risks.

"By definition, the drugs being tested have unknown beneficial effects on the patient's illness or disease, and negative side effects are also unknown," the report pointed out.

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