Advances in Biopharmaceutical Technology in India
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Chapter 9:   Regulatory Landscape for Clinical Trials in India

Abstract:
Global pharmaceutical R&D activity is rising exponentially and is expected to grow by more than 10% during the next five years in conjunction with regulators’ requirements for more detailed and larger patient-based trials and society’s concerns for more accountability and transparency. India’s billion plus population, genetic diversity, highly skilled medical fraternity, several world-class medical institutions, and the cost advantage in labor and infrastructure have fuelled worldwide enthusiasm about clinical research in the country. It is estimated that India could be enrolling 20% of all clinical trial subjects by the year 2010, generating approximately US$1 billion in revenue. While these figures will be validated sometime in future, they clearly reflect the optimism in India amongst various stakeholders about the potential for growth. The surge in clinical trials seen over the past three years is a response to decisions by the government to join the product patents regime and amend clinical trial regulations. This rapid growth has had significant implications for all stake-holders ranging from investigators to Contract Research Organizations (CROs).

About the Authors:

Romi Singh, Ph.D.
Amgen, Inc.
Executive Director Global Regulatory Affairs & Safety
Thousand Oaks, CA 91320 (USA)

Brijesh Regal
Former WHO Consultants & C.E.O.
Apothecaries Ltd.
New Delhi India.


Dr. Romi Singh has over 14 years of extensive scientific and management experience in top-tier pharmaceutical and biotechnology companies such as Burroughs/GlaxoWellcome, Merck, and Amgen. His experience spans across the spectrum of drug development-basic research to regulatory/clinical sciences. He is well published and recognized in field of drug metabolism and is an expert on clinical trials and drug registrations in developing countries. Dr. Singh is currently an Executive Director of Global Regulatory & Safety heading the group that supports expansion into new emerging markets in Latin America, Asia, Central & Eastern Europe. He holds an undergraduate degree from St. Stephen’s College, doctorate from the University of Kansas, and has received postdoctoral training from the University of Washington.

Brijesh Regal is CEO of the Indian pharmaceutical company Apothecaries Ltd and is an expert in the field of clinical trials in India. He previously served as the National Consultant to Drugs Controller General of India for the World Health Organization. He is a member of India’s National Pharmacovigilance Advisory Committee. He has played an active role in shaping India’s drug and pharmaceutical regulatory through initiatives including: Schedule Y (regulations for clinical trials in India), Indian G.C.P. Guidelines, BA-BE study guidelines for India, and the National Pharmacovigilance Programme.

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