Advances in Biopharmaceutical Technology in India

Editor: Eric S. Langer
Project Director, Enterprise: Yibing (Eliza) Zhou
Project Director, Scientific: John Morrow
Production: ES Illustration and Design, Inc.
Text and Cover Design: Esperance Shatarah
Cover photos courtesy of Shantha Biotech
ISBN 978-1-934106-07-5

Acknowledgment
This project would not have been possible without the exceptional efforts of the many people involved. In particular, we would like to thank:
Yibing (Eliza) Zhou, Project Director, Enterprise
John Morrow, Project Director, Scientific
ES Illustration and Design, Inc., Production Manager, cover graphics.
We would also especially like to thank our reviewers, whose expertise ensured this volume addressed today’s most important issues:
Prof. P.S. Biesen, Director, Madhav Institute of Technology and Science, India
Prof. Ananda Chakrabarty, University of Illinois, USA
Dr. Thomas E. Colonna, President, Biotech Consultant LLC, USA
Dr. John Curling, President, John Curling Consulting, Sweden
Dr. Milind Deshpande, Technical Director, Fermentation and Processing, University of Iowa, USA
Dr. P.K. Ghosh, President, Biotechnology, Cadila Pharmaceuticals Ltd., India
Dr. Vijai Kumar, President & Chief Medical Officer, Excel Life Sciences, Inc., USA
Dr. Yennapu Madhavi, Scientist, National Institute of Science Technology and Development Studies, India
Dr. John Morrow, President, Newport Biotech, USA
Dr. Brandon Price, President. Falconridge Associates, Inc., USA
Dr. Gayatri Saberwal, Scientist, Institute of Bioinformatics and Applied Biotechnology (IBAB), India
Dr. V.K. Srinivas, General Manager R&D, Bharat Biotech, India
Dr. S. Vsisalakshi, Scientist, National Institute of Science Technology and development Studies, India
Dr. Scott Wheelwright, President, Strategic Manufacturing Worldwide, Inc., USA
We also extend our sincere appreciation to Shantha Biotech, and Ms. Sravanthi Reddy for her support and use of cover photos and graphics.
Thank you for your efforts, and your recognition of the importance of this study.
Eric S. Langer
Managing Editor

Preface
This study was undertaken, managed and coordinated by BioPlan Associates, Inc., a biopharmaceutical management and marketing research consulting firm in Rockville, MD, based on nearly 20 years experience and knowledge of the market segment. BioPlan surveyed the industry to identify required content, and then selected subject matter experts to author relevant chapters to this study.
The Society for Industrial Microbiology (SIM), in recognizing the importance of applied sciences in biotechnology processes, has lent its name to this endeavor. The Society for Industrial Microbiology is a nonprofit professional association dedicated to the advancement of microbiological sciences, especially as they apply to industrial products, biotechnology, materials, and processes. Founded in 1949, SIM promotes the exchange of scientific information through its meetings and publications, and serves as liaison among the specialized fields of microbiology. Membership in the Society is extended to all scientists in the general field of microbiology.
India is one of the fastest growing economies in the world. The country has invested heavily in advancing its pharmaceutical and biopharmaceutical technologies to improve its healthcare systems, its population’s general health, and its overall economy.
Both scientists and entrepreneurs in India have made important contributions to advancing the field at many levels. This study provides a framework from which both those new to India’s rapid advancements in biotherapeutics and vaccines, and those with long histories can recognize the potential, and plan for the future. The findings of this study support worldwide public health and economic policy.
Each chapter provides unbiased, peer-reviewed perspectives of the current state of the science and technology associated with biopharmaceuticals in India. While no single work can encompass all the advances being made in the field, this study offers a comprehensive assessment of the technological and economic advancements in India.
The intended audiences include decision-makers at biopharmaceutical research organizations, biotherapeutic manufacturers, contract manufacturing organizations, suppliers to the industry, policy-makers, and international entities evaluating this market. We plan to keep this study current by providing regular updates as technologies, and the industry advance.

Table of Contents
PART 1: Introduction......................................vii

Chapter 1 Prospects for Modern Biotechnology in India................ 1
Prasanta K. Ghosh, Prasenjeet Ghosh, Soma Ghosh, and Kushal Shodhan

PART 2: State of India’s Life Sciences Industry..................67
Chapter 2 A Window into India’s Biopharma Sector....................69
Narayan Kulkarni

Chapter 3 Indian Biopharmaceutical System and Policies..........109
Yennapu Madhavi, Ph.D.

Chapter 4 Government Support for Biotech and Biopharmaceuticals Industry ...........127
Dr. B.M. Gandhi

Chapter 5 Biopharmaceutical Products in India....................179
Scott M. Wheelwright, Ph.D., and Hazel Aranha, Ph.D.

Chapter 6 Biogeneric Manufacturing in India.........203
Ashesh Kumar, Ph.D.

Chapter 7 Biopharmaceutical Market Situation...........235
Merlin H. Goldman, PhD MBA CEng MIChemE

Chapter 8 The Contract Research Industry in India ..........281
Umakanta Sahoo, MBA, Ph.D., and Faiz Kermani, Ph.D.

Chapter 9 Regulatory Landscape for Clinical Trials in India.....313
Romi Singh, Ph.D. and Brijesh Regal

INDIA BRIEF 1 Pre-Clinical and Clinical Trial in India............ 327
V.K.Srinivas, Ph.D

Chapter 10 Life Sciences Education in India..........333
Dr Dipti Sawant, Ph.D., MBA, CCRA

PART 3: Scientific Issues in India......383
Chapter 11 Vaccine Industry in India..........385
Dr. Prasad S. Kulkarni, M.D. and Suresh S. Jadhav, Ph.D.

Chapter 12 Development of Plasma-Derived Biopharmaceuticals in India: Challenges and Opportunities....................465
John M. Curling, Christopher P. Bryant, Timothy K. Hayes, Ranjeet S. Ajmani

Chapter 13 Bioprocess Expression and Production Technologies in India.............519
David M Mousdale

INDIA BRIEF 2 Technology Transfer: Impact and Importance for Indian Biotechnology Growth......... 555
Susan Kling Finston

Chapter 14 Application of Recent Advances in Immunology for Developing Novel Biotherapeutics in India...........563
Kumar Shah, MD

Chapter 15 Early-stage Key R&D Components for Successful Development of Protein Therapeutics...............589
Krishna M. Madduri, Ph.D.

Chapter 16 Understanding Ayuveda Medicine...........605
Dr. Sampada Amol Mahajan

PART 4: Biobusiness in India......619
Chapter 17 Biopharmaceutical Outsourcing: A Comparative Overview of the Landscape between India and China...........621
Minna A. Damani

Chapter 18 Biopharmaceutical Research Collaborations between India and the West: A Guide to Prospective Partnerships........661
Uri Reichman, Ph.D., M.B.A., Bharat Khurana, D.V.M., Ph.D., and Steven M. Ferguson

Chapter 19 Outsourcing R&D to India................723
Probir Roy Chowdhury and Sajai Singh

INDIA BRIEF 3 Outsourcing Biopharma R&D to India................... 741
Jim Schnabel, Senior Research Associate, BioPlan Associates, Inc.

Chapter 20 Venture Capital in India Today...............747
Sajai Singh and Probir Roy Chowdhury