Jan. 22, 2008 | As a place to conduct clinical trials, India has become strategic to the growth of biopharmaceutical companies and large clinical research organizations (CROs) contending for patients on a global scale.
All the major industry players are doing trials here with the help of in-country partners, and some of them have established an on-the-ground research presence. “India’s participation is reducing time to complete trials and helping bring drugs to market sooner,” says Ferzaan Engineer, CEO for Quintiles India. “India is also a large and growing market for pharmaceuticals.”
Companies conducting trials here include GSK, Pfizer, Novartis, Eli Lilly, Roche, and Eisai, as well as international CROs Quintiles, Covance, PPD, Parexel, Icon, Omnicare, and Clintec. A number of Indian CROs, such as SIRO and iGate, have also been growing in stature, according to Utkarsh Palnitkar, a leader in the policy and investment advisory services of Ernst & Young Private Limited in Hyderabad. “The quantum of outsourcing to India has also seen a steady increase year on year.”
Mid-size multinationals and even some smaller biopharmaceutical companies are now starting to arrive and some of them are outsourcing all of their clinical work. Forecasters say that, by 2011, India will be conducting more than 15 percent of total global clinical trials (to order the full report, Booming Clinical Trials Market in India, go to http://www.bharatbook.com/general/Clinical-Trial.asp).
India currently participates in about 1 percent of worldwide biopharmaceutical clinical trials, involving 757 sites, according to a recently published article in Nature Reviews Drug Discovery. But its average relative annual growth rate is nearly 20 percent.
The country itself has one of the world’s strongest emerging economies, growing at a 9 percent annual clip, says Engineer. It is also heavily populated (estimated 1.136 billion people), with both the need for and potential to do clinical trials. It doesn’t hurt that English is the spoken language in the medical community as well as the language of instruction at most colleges.
Among India’s notable advantages is that its ethnically diverse, largely treatment-naïve populace can be recruited about three times faster than in the United States. It graduates thousands of information technology graduates every year who are “easy to integrate into Western-style business,” says Steve Powell, senior vice president of worldwide sales for leading electronic data capture firm Phase Forward. Investigators in India have also proven themselves capable of delivering clean data.
Over the last several years, Quintiles has sailed through all five audits of its clinical work by the FDA, says Engineer, adding that many drugs have been approved in Europe and the U.S. with significant data from India. “The number of investigative sites that can work in any given therapeutic area has also gone up, he adds. “Ten years ago we had [fewer] than 10 clinical sites. Now we have 1,704.”
Staffing costs are economically attractive in India, says Powell. Intellectual property protections have tightened up in the last couple of years, and there is strong government support for turning India into a global hub for clinical trials. Infrastructural improvements have been made by both the government and the private sector in terms of “new campuses, highways, telecommunications, and housing.”
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Part 2 of this article will appear in the Jan. 28, 2008, issue of eCliniqua.