India offers the global biopharmaceutical industry an array of opportunities in the field of contract research. It has rapidly become one of the most preferred destinations for contract research due to its huge, heterogeneous patient population; English-speaking western educated investigators (physicians) and track record of sincerity in meeting regulatory and recruitment timelines; and most importantly well accepted good quality auditable data. Although most media attention has been on the increasing clinical trial investment by the major global pharmaceutical companies, there is growing interest in India from many other companies within the drug development sector. From a sponsor perspective, there has been a perceptible change from skepticism to acceptance in how India is viewed for clinical trials, with it being considered as a core region in initial plans. As a result, many global pharmaceutical players (Pfizer, Novartis, Astra Zeneca, Eli Lilly, GSK, Aventis, Novo Nordisk, Bristol Myers Squibb, Roche and Amgen - to name but a few) have expanded their existing clinical research investment and infrastructure in India. Analyses by market observers such as Ernst & Young, McKinsey and Strategic Associates have backed the view that the Indian contract research market has considerable potential. While global pharmaceutical companies and Contract Research Organizations (CROs) are opening up their branches/offices in the country, smaller companies are looking for preferred partners to conduct their research activities in India. There remain considerable opportunities for companies to expand clinical research activities in India because of the wide availability of well-qualified investigators and clinical research professionals. An important regulatory change has been the amendment of Schedule Y (2005) of the Drugs and Cosmetic Act 1945, which outlines the rules concerning the approval of new drugs and clinical trials in India. This development represents a major step towards harmonizing the Indian regulatory framework with international Good Clinical Practice (GCP) for all the stakeholders in clinical research including sponsors, CROs, Site Management Organizations (SMOs), Institutional Ethics Committees (IECs), Investigators and the subjects participating in clinical trials in India. This chapter analyzes the clinical trial environment and attempts to highlight the efforts of all stakeholders to meet the challenge of meeting the demand for trained and skilled manpower in India. Further, the need for the evolution of laboratories and their accreditation processes in supplementing the clinical trials business in India is outlined. Indiaís growth in pharmaceutical and biotech manufacturing, and contract research supported by IT skills has led to promising outsourcing business opportunities in various related segments including clinical trial data management and statistical analysis. This chapter assesses the status of the data management sector in India, the required human resources and infrastructure and the regulatory requirements of the industry.
About the Authors:
Umakanta Sahoo, MBA, Ph.D.
Chiltern International Private Limited
Faiz Kermani, Ph.D.
Princeton, NJ USA
Dr Umakanta Sahoo, is the Indian Head of Chiltern International, (a Contract Research Organization). He is a Bioscience graduate with an MBA and PhD from India, and has over 14 years of experience in the pharmaceutical industry and CRO sectors. He has worked in various positions in clinical operations, project management, regulatory affairs and data management functions in his assignments with companies such as Core Healthcare, Quintiles, Sterling Synergy (now acquired by PRA international), ClinInvent and at present in Chiltern. He has experience in handling clinical trial projects for US, UK, French and German pharmaceutical companies in different therapeutic areas and their quality assurance / third party audits. He has had a major role in the development of Chilternís Indian business in a global context. He has also been awarded a Diploma in Management and Marketing with special emphasis on the Biopharmaceutical Industry by the Kriger Research Institute, Canada. He is a frequent speaker at industry conferences and academic institutions and has authored a number of publications on the environment for clinical trials in India. In March 2006, he was a delegate on the UK Governmentís Trade & Investment Biotech Scoping Mission to Japan.
Dr Faiz Kermani has several years experience in both academia and the pharmaceutical industry. He has worked in pharmaceutical R&D, clinical trials, pricing and reimbursement, marketing and medical communications. He holds a PhD in Immunopharmacology from St. Thomasí Hospital, London and a First Class Honours degree in Pharmacology with Toxicology from Kingís College, London. He has written extensively on international healthcare issues, and is on the editorial board of several publications. In March 2006, he was a delegate on the UK Governmentís Trade & Investment Biotech Scoping Mission to China and contributed to the subsequent report and official presentation.