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The clinical research industry is poised for big growth. From a negligible share in the late nineties, the market grew to $70 million in 2002 and is now valued at $100-150 million. The industry is set to garner $1-1.5 billion in revenues by 2010, says a McKinsey report. Amidst the euphoria over explosive growth, the sector is reporting a massive dearth of experienced clinical research employees. In other words, scaling up is a challenge. A vast, unwieldy population, a plethora of diseases, and rampant poverty: this was the picture India presented to the outside world till a while ago. But these days the fact that India has the largest pool of patients suffering from cancer, diabetes and other maladies is leading the country to an altogether different destination: the global hub of outsourcing of clinical trials. Almost all the top names in the pharmaceutical world have zeroed-in on India, setting up clinical trail facilities in major cities, especially Hydearbad and Ahmedabad. Global consultancy McKinsey & Co estimates that by 2010, global pharma majors would spend around $1-1.5 billion just for drug trials in the country. The world is simply attracted by the facilities that India offers for pharma companies, their product developments and trials. The biggest advantages many look at are, of course, India's huge population of more than one billion, and cheaper costs. Ironically, it's a combination of the best and worst the country has to offer, that is driving growth in the sector. For one, the Indian population is diverse, with a high incidence of lifestyle related diseases in urban areas and infectious diseases and malnutrition plaguing rural locals. This, coupled with a skilled and educated physician workforce, is proving to be a big driver for the industry. A study by Rabo India Finance, a subsidiary of the Netherlands-based Rabo Bank, emphasises that India is the ideal destination for clinical trials. The report says that India has the largest pool of patients with many diseases, including cancer and diabetes. Pharma giants are also magnetised by India due to the fact that the country offers nearly 700,000 speciality hospital beds, 221 medical colleges and skilled English-speaking medical personnel. The Rabo study, however, pinpoints that the biggest advantage is the low cost. For instance, trials for a standard drug in the US can cost about $150 million. A similar drug could be tested in India at a 60 per cent reduction of that whopping cost. According to a Confederation of Indian Industry study, clinical trials in India in 2002 generated $70 million in revenues. It predicts that it would grow to $200 million by 2007 and anywhere between $500 million and $1 billion by 2010. So today all big global pharma names like Novo Nordisk, Aventis, Novartis, GlaxoSmithKline, Eli Lilly and Pfizer have begun clinical drug trials across various Indian cities. The pace for drug trials in the country is so fast that the Clinical Data Interchange Standards Consortium (CDISC), US, a non-profit organisation committed to the development of clinical research organisations' standards the world over, is looking at setting up its chapter in India. Clinical research is still in its nascent stage in India. The universities have still not realised the importance of the industry and its underlying potential to create trained manpower for the industry. There is also a lack of communication between the educational bodies and industry personnel. The rapid acceleration of market will create huge challenges for medical manpower and healthcare infrastructure. The training focus of sponsors and CROs is on the investigators involved in their trials and their own monitors and other professionals. With the result, a small number of the trained investigators and monitors are retrained and large numbers of untrained physicians and students seeking a career in clinical research remain unexposed to research training. Unless there are research training institutes which can churn out trained professionals, this huge gap in the demand and supply of trained personnel cannot be bridged.
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