Bio-India

BioIndia™

India has been providing the developing world comprise of 2/3 of the world’s population with the necessary medicines from common cold to HIV, from antibiotics to anti-diabetics for the past several decades. Over these periods India has developed a well-developed drug manufacturing industry that now poised to compete with multinational pharmaceuticals companies such as, Pfizer, Roche, Merck and GSK globally. Initial model of the Bio-industry was to provide medicine to the bottom of the pyramids emerging as the model to provide cost saving options to the top of the pyramid (CK Prahalad).

Indian pharma and biotech corporations have obtained clearance from FDA to launch several generics drug in USA and many are in the pipelines. More and more biotech and pharma companies in India are partnering with their counter parts in USA for pre-clinical and clinical studies – an emerging bio-outsourcing economy.

India has developed a solid infrastructure for pre-clinical and clinical studies that is approved and recognized by FDA. Recently FDA expressed its intend to house inspectors and agents in India to assist Indian and USA bio-companies in their drug development, manufacturing and regulatory processes and compliance protocols – A step forward for BioIndia.

v Clinical trials in India is growing at a 60% AAGR
v Crossed USD 100 million in 2004.
v By 2010, the industry will spend USD 300M+ on clinical trials in India.
v 240 international studies recruiting subjects = 1.2% of the total studies worldwide
v 66% of international clinical trials are Phase III
v 207 sites FDA registered
v 40,000 subjects participated in clinical trials to date (<0.02%>

India companies have approximate share of 35% in DMFs and 25% in ANDAs filing globally
Second and third tier companies have aggressively scaled up ANDA/DMF filing in the US market over the last 2-3 years
www.biopreneur.org

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Ryan Baidya
California Takshila University