India emerges hot market for human drug development testing

Mumbai: What if India is not a key player in the global pharmaceutical business, the country is fast emerging a hot destination for human studies for new drug development.

For the last one year, clinical research activity in India has witnessed an exponential growth with a total market value of around $70-80 million during the period 1999-2001, suggest global consultancy firm Ernst & Young figures.

The market was around $25 million in 2001 itself. Analysts expect the market to grow at 50-60 per cent per annum. The Ernst & Young study covered nearly 100 centres in India, conducting different phases of clinical studies. Generally, human trials are done in three phases.

India offers tremendous scope for human studies with a vast reserve of patients and rich clinical expertise, the study observes. Large patient pools in most of the major therapeutic segments attract many multinational clinical research organisations to choose India. The ethnically diverse populace provides an admixture of samples, which are crucial in the flawless evaluation of new therapeutic agents.

Another advantage is the easy patient availability. Lifestyle-related diseases like cancer, diabetes and cardiovascular are high in the country. Globally over 70 per cent of the new drugs pipeline is split between these three major segments. Cost-effectiveness is also a compelling factor. Strong intellectual capital and improved medical infrastructure allow studies with complex protocols to be conducted as per international standards, Ernst & Young finds out.

The new Good Clinical Practice guidelines brought forth by the Drugs Controller is also seen further facilitating the growing market.