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Emerging Clinical Trial Locations – India

 

Executive Summary

Introduction

• A number of key issues confronting the pharmaceutical and biotechnology industry have been identified. These are generic competition, intellectual property protection, managing regulatory compliance, cost containment and government funding restrictions, obtaining and maintaining competitive advantage, recruitment and retention of a skilled workforce, improvement to research and development productivity, reducing time to market for next generation drugs and high risks and costs associated with drug development.
• Issues concerning the costs associated with drug development have been identified as: escalating costs associated with clinical trials, global increase in the number of clinical trials conducted, longer R&D development times and increased attrition rates during R&D.
• By the end of 2008 an estimated 50,600 clinical trials were being carried out globally. This represented a 1.7% increase of the total number of clinical trials that were conducted in 2006/2007.

Conducting clinical trials in emerging markets

• Key business, scientific and clinical needs to conduct more clinical trials in emerging geographic regions include: the need to reduce the time taken to conduct clinical trials, opportunity to obtain favored drug status amongst prescribers and end users in new markets and gain access to new markets through exclusive access to new patient populations.
• The major advantages conducting clinical trials in the emerging markets are rapid recruitment of treatment naïve patients from large patient pools, cost benefits associated with lower labor and service fees, improved transparency and compliance with international regulations, expansion of CROs, improved hospital and facilities infrastructure and huge future commercial value in emerging trial markets.
• Major issues and challenges of conducting clinical trials in emerging markets include the continued concerns over the clinical trial transparency, availability of accurate demographic and epidemiology data, assimilation of individual national regulations and guidelines, compliance with recognized and approved international regulations, issues of translation of clinical trial documents, assimilation of local culture and traditions, ethical issues, intellectual property protection, issues concerning import licenses, customs regulations and clinical trials supplies distribution, efficient and effective clinical trial patient recruitment, compliance and retention and the assimilation of new technologies into clinical trial protocols.

India

• According to official reports in 2005 about 100 clinical trials had been approved by the Drug Controller of India (DCI). In 2006, it increased to around 150 and to 240 in 2007. By the end of May 2009, 895 clinical trials were registered in India.
• The value of the clinical trials market outsourced to India in 2009 has been estimated at around $400m. It is predicted to reach about $800m by 2014.
• The outsourcing of Phase I trials to India may be allowed by 2009-10 after the Central Drugs Standard Control Organization (CDSCO) said it is considering changing its stance.
• India has a booming population of over 1.15bn India not only has a genetically diverse population compared with western countries but it also has a treatment naïve population with a very large pool of different acute and chronic disease conditions.
• India is able to offer significant cost saving compared with conducting clinical trials in western countries. According Dr. S K Gupta, Dean & Director General, Institute Of Clinical Research, India the cost of Phase I trial is 50% cheaper in India and for Phase II and Phase III it is 60% less.
• Accession to the Patent Laws and WTO Trade-Related Intellectual Property Rights (TRIPS) and to Schedule Y Drugs and Cosmetics Act and Rules 1940 during 2005 has given added confidence amongst multinational corporations to conduct clinical trials in India.
• Changes to the regulatory and administrative structure within the office of the Drugs Controller General India (DCGI) has significantly altered the ease and efficiency of conducting clinical trials in India.

INTRODUCTION

Summary

• A number of key issues confronting the pharmaceutical and biotechnology industry have been identified. These are generic competition, intellectual property protection, managing regulatory compliance, cost containment and government funding restrictions, obtaining and maintaining competitive advantage, recruitment and retention of a skilled workforce, improvement to research and development productivity, reducing time to market for next generation drugs and high risks and costs associated with drug development.
• Issues concerning the costs associated with drug development have been identified as: escalating costs associated with clinical trials, global increase in the number of clinical trials conducted, longer R&D development times and increased attrition rates during R&D.
• By the end of 2008 an estimated 50,600 clinical trials were being carried out globally. This represented a 1.7% increase of the total number of clinical trials that were conducted in 2006/2007.
• The chapter also examines the role of the clinical trial sponsor and Contract Research Organization.
• Contact Mahasagar Publications for Dissertation Writing Help.  Also Read Key Issues Facing Pharma and Biotech Companies in India