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Clinical Precision

Sudhir Chowdhary, BV Mahalakshmi

Posted: 2008-05-05 19:50:20+05:30 IST
Updated: May 05, 2008 at 1950 hrs IST

A gradual shift is taking place in the Asian clinical trials landscape. India is becoming the major beneficiary of the offshoring strategies of an increasing number of pharmaceutical and biotech companies deciding to move their clinical trials, which can account for two-thirds of the cost of developing a new drug.

Does it mean that India is leaving behind China, widely touted as the ‘other’ destination in Asia? After all, China is fiercely contesting with India to grab a leading position in the fast-growing $45 billion clinical trials and data management market. The short answer is yes and the numbers speak for themselves.

At first glance, it is a neck-to-neck battle when it comes to the total number of trials conducted in the two countries last year. China conducted 496 trials and India was just one short with 495 trials. Significantly, the share of multinationals conducting their trials in India is far greater compared to China. Majority of the top 10 pharmaceutical companies such as Astra Zeneca, Eli Lilly, GSK, Merck, Novartis and Pfizer conduct higher number of trials in India than China. Encompassing India, China, Japan, Taiwan, Korea, Singapore and Philippines, Asia conducts about 40% of the global trials.

“Since the mindset of big pharma is to move East, a conducive atmosphere by having favourable government policies and regulations, along with tech manpower will bring significant business,” says Venkat Jasti, CEO, Suven Life Sciences Ltd. With 98 trials, China clearly lags India which had a total number of 139 trials in its basket last year. Phase III trials constitute about 60% of the total trials in India compared to only 45% in China. India has the highest number of diabetic patients in the world and has a very large number of patients with cardiac disorders and cancer. Thus, not only does India lead China in cardiology, diabetes and oncology trials, it will be a sought after destination for clinical trials in these three ‘hot’ therapeutic areas in years to come.

Nonetheless, far from being belligerent on its new-found success, industry is advocating a cautious approach and talking of a multi-pronged strategy to keep the momentum going. Its prescription: strengthen the regulatory mechanism by making it fast and efficient, permit phase I trials and raise a substantial manpower to undertake clinical trials.

Last year’s Novartis case, in which the company lost the patent case over its cancer drug Gleevec, is foremost in its mind and...

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