52 Perspectives: “India’s increasingly important role in clinical research”

This contribution to ’52 Perspectives’ comes to us from Sanjay Gupta, Director of Clinical Operations at Catalyst Clinical Services Pvt. Ltd.  Mr. Gupta  having more than 11 years of experience in clinical research and has conducted and supervised over 80 clinical trials across a wide range of therapeutic areas.  He has presented his research work in various International Journals and Conferences including ASCO and has authored 6 books on clinical research.

India: an emerging location for the conduct of global clinical trials

A nation with more than 1000 million people, India has the second largest population in the world. It is a sovereign, secular, democratic republic consisting of 28 states, 7 union territories and 593 districts. It has the world’s twelfth largest economy at market exchange rates and the fourth largest economy in purchasing power. With an average annual GDP growth rate of 5.8% for the past two decades, its economy is among then fastest growing economies in the world.

Internationally, India became a member of the World Trade Organization (WTO) in 1995 and agreed to adhere to the product patent regime from 2005. Being a signatory to the WTO agreements, India is being looked upon as a favorable destination for the conduct of global clinical trials. India clearly provides an opportunity in terms of availability of large patient populations, highly educated talent, a wide spectrum of disease, lower costs of operations, English speaking population and a favorable economic and intellectual property environment.

India’s performance in Clinical trials

Data suggests a 50-60% cost saving associated with conducting clinical trials in India compared to the same clinical trials being conducted in US or Western Europe. This is evident by the steadily increasing number of global studies in India over the past few years. With major pharmaceutical/biotech companies and CROs establishing their presence in India, the country is projected to conduct nearly 5% of the global clinical trials in next 5 years. An estimate of the total market for conducting clinical trials either directly or through Contract Research Organizations (CROs) in India till 2010 is projected at US$ 2 billion by major pharmaceutical companies.

Data from the site ClinicalTrials.gov enlists a total number of 1035 clinical studies for India (till July 2009) with 413 studies in the enrollment phase. Of the 1035, studies, 53% are Phase-III trials, 24% are phase-II trials and 6% are phase-I trials.

India is estimated to have more than 3000 GCP compliant investigator sites and 20,000+ GCP trained clinical research professionals. Recent amendment in clinical trial regulation has abolished the phase lag, allowing global clinical trials (phase-II, phase-III) to be conducted at parallel phase in India. A two-tier approval process is followed in India requiring the trial proposals to be approved by the IRBs at the institutional level in addition to the approval by the Drug’s Controller General of India at the country level.

Conclusion

The foundation of knowledge-based industries in India was laid down by the Information Technology industry and clinical research is fast following the footsteps to become the next sunrise industry. Indian Investigators and clinical research professionals have already demonstrated their medical and scientific competence by participating in several global registration trials as well as by publishing their research work in peer-reviewed scientific medical Journals of repute. Soon, Indian clinical research capabilities will become part of clinical development programs across the globe.

About Catalyst Clinical Services Pvt. Ltd.:

Catalyst Clinical Services Pvt. Ltd. is a Contract Research Organization based at India that acts as a strategic partner to the organizations in healthcare and biotechnology, making them winner by building on their core competence and empowering them to counter threats. The primary focus area in healthcare is Clinical Trial Management and Execution, Medical Writing, Training and Development and Independent Auditing. Catalyst’s mission is to meet the ever growing knowledge, compliance and execution needs of clinical research profession thereby making Indian clinical research industry, a benchmark for global clinical research.

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