The Hindu Business Line : GSK doubles clinical trials

Snapshot
GSK conducts clinical trials in India for its parent company, GSK Plc, across oncology, neuropsychiatry, cardiovascular and metabolic and anti-infectives segments.
Clinical trials in India are estimated to touch about $1.5 billion by 2010, says McKinsey.

P.T. Jyothi Datta

Mumbai, Nov. 25 GlaxoSmithKline Pharmaceuticals has witnessed close to a two-fold increase in its clinical trials in India. The multinational drug maker clocked about 31 trials in the country this calendar year, up from 16 in 2006.

The company had undertaken only three trials in the country, in the pre-2005 period, a GSK official told Business Line. What has changed since is the product patent regime came into effect in India from 2005, he indicated.

Drug companies in the past have had misgivings about bringing new products or doing trials in the country, apprehending that generic companies would make similar products and sell it in the local market before the launch of the original product.

But the product patent regime has changed that, since it provides an innovator company protection for about 20 years, keeping at bay generic versions. Clinical trials in India are estimated to touch about $1.5 billion by 2010, according to McKinsey.

GSK’s clinical trials in the country are for its parent company, GSK Plc, across oncology, neuropsychiatry, cardiovascular and metabolic and anti-infectives segments. GSK’s local revenue from this service is about Rs 30 crore for 2007.

In 2005, GSK and the University of Oxford had forged a collaboration in cancer research to be conducted through clinical centres in India. And the plan was to spread the net to other therapeutic areas. But that has not happened as yet, said GSK’s Dr Hasit Joshipura, Vice-President (South-Asia) and Managing Director (India).

“We have our hands full with the GSK Plc’s portfolio. The number of trials that we do has been going up steadily. To that extent that has not moved to other therapeutic areas,” he told Business Line in a recent interview. In fact, India was one of the venues supporting trials of breast cancer drug Tykerb, set to be launched in India early next year.

Also, he pointed out that confidence has grown and the company is looking to bring in Phase II and Phase I trials into the country. In Phase I, a prospective drug molecule has its first exposure on a small number of human volunteers to evaluate the safety profile and safe dosage range of the drug. The sample size of humans gets bigger in Phase II, and the prospective drug is targeted on people who are affected by the illness it seeks cure. Regulatory clearances in India are stringent for Phase I trials, specially done by overseas companies.