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European Pharmaceutical Contractor

A Passage to India

With India fast becoming a new pharmaceutical frontier, Ed J Brennan at IndiPharm explains why outsourcing here makes sense in order to achieve lower cost clinical trials

Western pharmaceutical and biotech companies need to increase productivity, decrease costs and shorten the time-tomarket for new drugs. The costs of clinical trials needed to gain regulatory approval represent roughly two-thirds of the typical billion-dollar cost of developing a single new chemical entity (NCE). There is, therefore, a critical need for conducting clinical trials that provide lower cost and faster recruitment without compromising the quality of the research.

WHY INDIA?

India provides a number of significant advantages as a destination for clinical trials. It offers a large patient population, low per-patient trial costs, and a highly qualified professional medical community (many of them Western-trained), as well as global quality hospitals and clinical research facilities. Furthermore, with a highly developed IT and data collection capability and no language barrier, India has become an increasingly attractive destination for clinical trials.

THE BACKGROUND

Until recently, there were few clinical trials conducted in India by Western pharmaceutical and biotech companies, primarily because of regulatory hurdles. Recognising the significant advantages that India offers to multinational companies and the potential benefits of conducting clinical trials in India, the Government made major changes in 1999 with the amendments to Schedule Y of the Drugs and Cosmetics Act. These changes formalised the definition and conduct of clinical trials; specified the responsibilities of the sponsor, the investigators, and the Ethics Committees; developed guidelines and procedures for importing drugs for clinical trials; instituted required compliance with GCP; specified the requirements for informed consent; and defined the structure, content and formats of clinical study reports. In addition, the Indian Government provided increased protection for intellectual property (IP).


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Dr Edward J Brennan is President and CEO of IndiPharm. Prior to joining IndiPharm in 2007, he was Director of Clinical Pharmacology and Discovery Medicine at GlaxoSmithKline, where he was responsible for coordinating all clinical activities. Before joining GSK, Ed held clinical development positions of increasing responsibility at both Wyeth and Johnson & Johnson. He has extensive experience across all phases of clinical development and across multiple therapeutic areas, including oncology, infectious disease, immunology, and critical care. Ed received his undergraduate Bachelor of Science Degree in Pharmacy from The Philadelphia College of Pharmacy and Science, and went on to study Medicine at The Royal College of Surgeons in Ireland, receiving his Medical Degree from Temple University. Ed has published more than 30 articles in scientific journals and spoken at numerous international medical conferences.
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Dr Edward J Brennan
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