Value Chain Analysis Case Study

‘Clinical Trials’:Outsourcing to India

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Abstract:

With escalating operational costs, patent expiries and high research and development (R&D) expenditure, global pharmaceutical companies have been looking to outsource their manufacturing and R&D development to 'low cost' countries such as India and China. The Tufts Center for Drug Development established that the cost of bringing a new drug into the market was between $802 and $880 million and took about 15 to 17 years. Clinical trials (CTs) are a major part of these costs. Many global companies outsource this job to Contract Research Organisations (CROs). Analysts estimated that the CRO market would be worth $20 billion by 2010. India, with its nimble chemistry skills, vast population, ethnic diversity, uninformed patients, ease of patient registration and low cost advantages both in research and manufacturing, caught the attention of global companies to conduct CTs.

Pedagogical Objectives:

• To discuss the numerous opportunities available to the global companies to outsource and conduct CTs in the booming CTs market in India.

Keywords : Clinical trials (CTs) outsourcing, Indian pharmaceutical industry, Government and Business Environment Case Study, Contract Research Organisation (CRO) market, Good clinical practices, Research and development (R&,D), Contract manufacturing,Business Environment Case Study, Quintiles Transnational, Ethics committee, Independent Institutional Review Boards, Phase I, Phase II, Phase III trials, Drug Controller General of India, Indian Clinical Research Laboratories, Post 2005 product patent regime, United States Food and Drug Administration, Clinigene Clinpharm Siro Lotus Labs

Contents:

• Introduction
• India – a favored destination
• Clinical trials market
• Regulations
• Challenges