PHARMA
Trial & Error
Systemic disconnects in the drug testing process could undermine India’s ability to emerge as a key destination for clinical trials.
GINA S. KRISHNAN AND GAURI KAMATH
Seated in his spanking new office, with tall windows and plenty of natural light, Vasudeo Ginde, 42, has the air of a man who has overcome many odds. In the short span of a decade, this doctor has western drug manufacturers trusting him with their bread and butter —new drugs. DiagnoSearch (now renamed iGate Clinical Research), the company that Ginde created and then sold off to a US company, iGate Corp., manages clinical tests of experimental drugs on humans in India. At the time Ginde started his outfit in 1996, India’s drug patenting regime was lax, and a track record in human testing or clinical trials was absent. Not any more.
In 2005 the government passed the Patents (Amendment) Act, which gave new protections to patents held by foreign companies and, thus, emboldened them to invest in India. By 2006, global pharmaceutical companies had already begun discovering the advantages of India as a destination for clinical testing of drugs under development. The same year A.T. Kearney listed India second, just after China, in a study that rated 15 countries for their attractiveness as clinical trials centres on parameters such as availability of patient population and cost efficiency. “I don’t have to sell India these days to customers, I just sell my company,” says Ginde, whose company recently moved into facilities three times larger in Mumbai. Frost & Sullivan, a US consultancy firm, says that the value of clinical trial activity in India is set to more than double to $281 million by 2010, not including the trials that companies do themselves without using clinical research organisations (CROs) such as iGate.
And there is the potential size of the Indian pharmaceutical market itself. Consumer spending on healthcare went up from 4 per cent of GDP in 1995 to 7 per cent in 2005. That number is expected to go up to as high as 13 per cent of GDP by 2015. According to a recent McKinsey report, that will turn India into a $20-billion pharmaceutical market. Global pharmaceutical companies keen on selling in India are likely to test their products more widely in the country, which will further accelerate the number of domestic clinical trials.
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