Advances in Biopharmaceutical Technology in India

Advaces i Biopharmaceutical Techology i Idia Jauary 2008 Editor: Eric S. Lager BioPla Associates, Ic. Rockville, MD, USA SOCIETY FOR INDUSTRIAL MICROBIOLOGY Arligto, VA, USA

BioPla Associates, Ic. 15200 Shady Grove Road, Suite 202 Rockville MD 20850 USA 301-921-9074 www.bioplaassociates.com ad Society for Idustrial Microbiology 3929 Old Lee Highway Suite 92A Fairfax, VA 22030-2421 703-691-3357 Copyright 2008 by Eric S. Lager All rights reserved, icludig the right of reproductio i whole or i part i ay form. No part of this publicatio may be reproduced, stored i a retrieval system, or trasmitted i ay form or by ay meas, electroic, mechaical, photocopyig, recordig or otherwise, without the writte permissio of the publisher. For iformatio o special discouts or permissios cotact BioPla Associates, Ic. at 301-921-9074, or ifo@bioplaassociates.com Editor: Project Director, Eterprise: Project Director, Scietific: Productio: Text ad Cover Desig: Eric S. Lager Yibig (Eliza) Zhou Joh Morrow ES Illustratio ad Desig, Ic. Esperace Shatarah Cover photos courtesy of Shatha Biotech ISBN 978-1-934106-07-5 ii

Ackowledgmet This project would ot have bee possible without the exceptioal efforts of the may people ivolved. I particular, we would like to thak: Yibig (Eliza) Zhou, Project Director, Eterprise Joh Morrow, Project Director, Scietific ES Illustratio ad Desig, Ic., Productio Maager, cover graphics. We would also especially like to thak our reviewers, whose expertise esured this volume addressed today s most importat issues: Prof. P.S. Biese, Director, Madhav Istitute of Techology ad Sciece, Idia Prof. Aada Chakrabarty, Uiversity of Illiois, USA Dr. Thomas E. Coloa, Presidet, Biotech Cosultat LLC, USA Dr. Joh Curlig, Presidet, Joh Curlig Cosultig, Swede Dr. Milid Deshpade, Techical Director, Fermetatio ad Processig, Uiversity of Iowa, USA Dr. P.K. Ghosh, Presidet, Biotechology, Cadila Pharmaceuticals Ltd., Idia Dr. Vijai Kumar, Presidet & Chief Medical Officer, Excel Life Scieces, Ic., USA Dr. Yeapu Madhavi, Scietist, Natioal Istitute of Sciece Techology ad Developmet Studies, Idia Dr. Joh Morrow, Presidet, Newport Biotech, USA Dr. Brado Price, Presidet. Falcoridge Associates, Ic., USA Dr. Gayatri Saberwal, Scietist, Istitute of Bioiformatics ad Applied Biotechology (IBAB), Idia Dr. V.K. Sriivas, Geeral Maager R&D, Bharat Biotech, Idia Dr. S. Vsisalakshi, Scietist, Natioal Istitute of Sciece Techology ad developmet Studies, Idia Dr. Scott Wheelwright, Presidet, Strategic Maufacturig Worldwide, Ic., USA We also exted our sicere appreciatio to Shatha Biotech, ad Ms. Sravathi Reddy for her support ad use of cover photos ad graphics. Thak you for your efforts, ad your recogitio of the importace of this study. Eric S. Lager Maagig Editor iii

Preface This study was udertake, maaged ad coordiated by BioPla Associates, Ic., a biopharmaceutical maagemet ad marketig research cosultig firm i Rockville, MD, based o early 20 years experiece ad kowledge of the market segmet. BioPla surveyed the idustry to idetify required cotet, ad the selected subject matter experts to author relevat chapters to this study. The Society for Idustrial Microbiology (SIM), i recogizig the importace of applied scieces i biotechology processes, has let its ame to this edeavor. The Society for Idustrial Microbiology is a oprofit professioal associatio dedicated to the advacemet of microbiological scieces, especially as they apply to idustrial products, biotechology, materials, ad processes. Fouded i 1949, SIM promotes the exchage of scietific iformatio through its meetigs ad publicatios, ad serves as liaiso amog the specialized fields of microbiology. Membership i the Society is exteded to all scietists i the geeral field of microbiology. Idia is oe of the fastest growig ecoomies i the world. The coutry has ivested heavily i advacig its pharmaceutical ad biopharmaceutical techologies to improve its healthcare systems, its populatio s geeral health, ad its overall ecoomy. Both scietists ad etrepreeurs i Idia have made importat cotributios to advacig the field at may levels. This study provides a framework from which both those ew to Idia s rapid advacemets i biotherapeutics ad vaccies, ad those with log histories ca recogize the potetial, ad pla for the future. The fidigs of this study support worldwide public health ad ecoomic policy. Each chapter provides ubiased, peer-reviewed perspectives of the curret state of the sciece ad techology associated with biopharmaceuticals i Idia. While o sigle work ca ecompass all the advaces beig made i the field, this study offers a comprehesive assessmet of the techological ad ecoomic advacemets i Idia. The iteded audieces iclude decisio-makers at biopharmaceutical research orgaizatios, biotherapeutic maufacturers, cotract maufacturig orgaizatios, suppliers to the idustry, policy-makers, ad iteratioal etities evaluatig this market. We pla to keep this study curret by providig regular updates as techologies, ad the idustry advace. iv

Advaces i Biopharmaceutical Techology i Idia Table of Cotets PART 1: Itroductio...vii Chapter 1 Prospects for Moder Biotechology i Idia... 1 Prasata K. Ghosh, Prasejeet Ghosh, Soma Ghosh, ad Kushal Shodha PART 2: State of Idia s Life Scieces Idustry...67 Chapter 2 Chapter 3 A Widow ito Idia s Biopharma Sector...69 Naraya Kulkari Idia Biopharmaceutical System ad Policies...109 Yeapu Madhavi, Ph.D. Chapter 4 Govermet Support for Biotech ad Biopharmaceuticals Idustry...127 Dr. B.M. Gadhi Chapter 5 Chapter 6 Chapter 7 Chapter 8 Chapter 9 Biopharmaceutical Products i Idia...179 Scott M. Wheelwright, Ph.D., ad Hazel Araha, Ph.D. Biogeeric Maufacturig i Idia...203 Ashesh Kumar, Ph.D. Biopharmaceutical Market Situatio...235 Merli H. Goldma, PhD MBA CEg MIChemE The Cotract Research Idustry i Idia...281 Umakata Sahoo, MBA, Ph.D., ad Faiz Kermai, Ph.D. Regulatory Ladscape for Cliical Trials i Idia...313 Romi Sigh, Ph.D. ad Brijesh Regal INDIA BRIEF 1 Pre-Cliical ad Cliical Trial i Idia... 327 V.K.Sriivas, Ph.D Chapter 10 Life Scieces Educatio i Idia...333 Dr Dipti Sawat, Ph.D., MBA, CCRA v

PART 3: Scietific Issues i Idia...383 Chapter 11 Chapter 12 Chapter 13 Vaccie Idustry i Idia...385 Dr. Prasad S. Kulkari, M.D. ad Suresh S. Jadhav, Ph.D. Developmet of Plasma-Derived Biopharmaceuticals i Idia: Challeges ad Opportuities...465 Joh M. Curlig, Christopher P. Bryat, Timothy K. Hayes, Rajeet S. Ajmai Bioprocess Expressio ad Productio Techologies i Idia...519 David M Mousdale INDIA BRIEF 2 Techology Trasfer: Impact ad Importace for Idia Biotechology Growth... 555 Susa Klig Fisto Chapter 14 Chapter 15 Applicatio of Recet Advaces i Immuology for Developig Novel Biotherapeutics i Idia...563 Kumar Shah, MD Early-stage Key R&D Compoets for Successful Developmet of Protei Therapeutics...589 Krisha M. Madduri, Ph.D. Chapter 16 Uderstadig Ayurveda Medicie...605 Dr. Sampada Amol Mahaja PART 4: Biobusiess i Idia...619 Chapter 17 Chapter 18 Chapter 19 Biopharmaceutical Outsourcig: A Comparative Overview of the Ladscape betwee Idia ad Chia...621 Mia A. Damai Biopharmaceutical Research Collaboratios betwee Idia ad the West: A Guide to Prospective Parterships...661 Uri Reichma, Ph.D., M.B.A., Bharat Khuraa, D.V.M., Ph.D., ad Steve M. Ferguso Outsourcig R&D to Idia...723 Probir Roy Chowdhury ad Sajai Sigh INDIA BRIEF 3 Outsourcig Biopharma R&D to Idia... 741 Jim Schabel, Seior Research Associate, BioPla Associates, Ic. Chapter 20 Veture Capital i Idia Today...747 Sajai Sigh ad Probir Roy Chowdhury vi

PART 4: BioBusiess i INDIA

Research Collaboratios betwee 18Biopharmaceutical Idia ad the West: A Guide to Prospective Parterships Uri Reichma, Ph.D., M.B.A. Chief, Ifectious Diseases ad Medical Egieerig Brach Natioal Istitute of Health Office of Techology Trasfer 6011 Executive Boulevard, Suite 325 Rockville, MD 20852 USA Telephoe: 1-301-435 4616 Email: ur7a@ih.gov Bharat Khuraa, D.V.M., Ph.D. Staff Scietist, Departmet of Pathology Uiformed Services Uiversity of the Health Scieces Room # B3121, 4301 Joes Bridge Road Bethesda, MD 20814-4799 USA Telephoe: 1-301-295 3499 Email: bkhuraa@usuhs.mil Steve M. Ferguso Director, Divisio of Techology Developmet ad Trasfer. Natioal Istitute of Health Office of Techology Trasfer 6011 Executive Boulevard, Suite 325 Rockville, MD 20852 USA Telephoe: 1-301-435 5561 Email: sf8h@ih.gov

Advaces i Biopharmaceutical Techology i Idia About the Authors Uri Reichma, Ph.D., M.B.A. -- Dr. Reichma is the chief of the Ifectious Diseases ad Medical Egieerig Brach at the Office of Techology Trasfer, NIH. He joied OTT i December 1999. Prior to joiig the NIH, Dr. Reichma worked for twety years (1980-1999) i the biotechology idustry, specializig i the field of medical diagostics. From 1973 to 1980, Dr. Reichma coducted academic research at Sloa Ketterig Istitute for Cacer Research i New York. Dr. Reichma is a author of 26 scietific papers ad a ivetor o several patets. Dr. Reichma received his Ph.D. i Medicial Chemistry from the Hebrew Uiversity i Jerusalem, Israel, ad obtaied a M.B.A. degree from Ioa College i New York. Bharat Khuraa, D.V.M., Ph.D. -- Dr. Khuraa has over te years of scietific research experiece i the fields of virology, cell ad molecular biology, ad biochemistry. Prior to joiig the Uiformed Services Uiversity of the Health Scieces (USUHS), he was a postdoctoral fellow i the Laboratory of Viral Diseases at Natioal Istitute of Allergy ad Ifectious Diseases, Natioal Istitutes of Health. He received his Ph.D. from Uiversity of Cologe, Germay ad his D.V.M. from Haryaa Agricultural Uiversity, Idia. Dr. Khuraa is also curretly pursuig a part-time dual degree MS-MBA program at the Johs Hopkis Uiversity to expad o his kowledge ad skills i regulatory affairs ad biopharma busiess developmet. Dr. Khuraa has authored or co-authored several research ad review articles i peerreviewed scietific jourals. Additioally, he has reviewed grat proposals for the Advaced Techology Program (ATP) of the Natioal Istitute of Stadards ad Techology (NIST). Steve M. Ferguso curretly serves as the Director of the Divisio of Techology Developmet ad Trasfer. Prior to joiig NIH Office of Techology Trasfer i 1990, Mr. Ferguso served i marketig ad maagemet positios i biomedical firms subsequet to beig a scietist at the Natioal Cacer Istitute. His healthcare experiece has also icluded work as Director of Marketig ad Public Relatios for a rural 70-bed hospital. Registered to practice before the USPTO, Mr. Ferguso also holds Master s Degrees i Busiess Admiistratio (George Washigto Uiversity) ad Chemistry (Uiversity of Ciciati) as well as Bachelor s Degree i Chemistry (Case Wester Reserve Uiversity). Mr. Ferguso has bee a ecoomic reviewer for Marylad Idustrial Parterships (MIPS) as well as the Advaced Techology Program (ATP) grat programs ad is a istructor for both the USDA Graduate School ad the NIH FAES Graduate School where he also the departmet chair for the ew Certificate i Techology Trasfer Program. Mr. Ferguso was also the Susa T. ad Charles E. Harris Visitig Lecturer at the Watso School of Biological Scieces at the Cold Sprig Harbor Laboratory ad has published articles o licesig ad techology trasfer issues. He has received the NIH Director s Award ad seve NIH Merit Awards i recogitio of his activities i the maagemet ad egotiatio of techology licesig agreemets from the Natioal Istitutes of Health. 662

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West ABSTRACT Biopharmaceutical research, ad i particular developmet of iovative drugs ad vaccies require cocetrated efforts o may levels, as well as multiple skills ad expertise. Research collaboratios betwee two or more life sciece orgaizatios are therefore commo i the biopharmaceutical idustry. Icreasigly these collaboratios ca ivolve orgaizatios from differet coutries ad differet cotiets, ad i particular they ow iclude parterships betwee the public ad the private sectors. The recet chages i Idia patet law ad its policies i respose to the requiremets of the Trade- Related Aspects of Itellectual Property (TRIPS), ad the recet shift i Idia to a more iovatio-itese pharmaceutical idustry, as well as the immese progress i Idia s ifrastructure ad capacity for basic research i the biomedical field have all made Idia s life-sciece orgaizatios attractive collaborators to their wester couterparts. These collaboratios have bee further facilitated by the may Idia lifesciece returees who have established liks i the West. This chapter is iteded to serve as a guide to prospective collaborators i both Idia ad the West. Its first half outlies the factors that have made the Idia s biopharmaceutical idustry a attractive collaborator to its wester couterparts, a fact that resulted i Idia s emergece as a hub for iteratioal R&D, maufacturig ad cliical trials. The secod half of the chapter starts with the history ad the chroology of U.S.-Idia collaboratio i sciece, highlightig the areas of health care ad biomedical research, ad goes o to provide iformatio regardig the differet programs for collaborative iitiatives that are available from the U.S. Departmet of Health ad Huma Services (HHS) ad its agecies such as the Natioal Istitutes of Health (NIH), its licesig arm, the Office of Techology Trasfer (OTT), ad the Ceter of Disease Cotrol ad Prevetio (CDC). O the Idia side the chapter highlights the cotributios to such collaboratios of the Idia Departmet of Biotechology (DBT) uder the Miistry of Sciece ad Techology. DBT 663

Advaces i Biopharmaceutical Techology i Idia works i cocert with its U.S. couterparts to cotiually support a large variety of programs, ad to form ew research iitiatives. These joit U.S.-Idia efforts fud research, ad support traiig, bilateral meetigs ad cofereces, as well as facilitate ope exchage of scietific iformatio betwee the two coutries. The chapter provides websites of the differet programs as well as of the istitutios i the U.S. ad i Idia who curretly beefit from the resources ad programs described i the chapter. It is hoped that the iformatio provided i the chapter will be utilized by scietists o both sides of the ocea to establish ew ad iovative parterships for the beefit of global public health. 664

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West Biopharmaceutical Research Collaboratios betwee Idia ad the West: A Guide to Prospective Parterships A. Itroductio to Life Sciece Research i Idia Sice idepedece i 1947, Idia has see a importat role for scietific ad techical collaboratios ad the beefits that they ca provide i the quality of huma life. Ideed Prime Miister Nehru has bee quoted as sayig that the future belogs to sciece ad those who make frieds with sciece. Over the past sixty years this has resulted i policies i the coutry that focused o developig educatio ad ifrastructure resultig today i a strog sciece ad techology capacity. This strog sciece ad Eglish laguage base provide life sciece orgaizatios i Idia with capabilities i biotechology, agriculture, iformatio techology ad pharmaceuticals that are ideal for collaborative projects with wester orgaizatios. Life sciece orgaizatios i Idia with their large ad highly skilled scietific ad techical workforce, less expesive R&D, maufacturig ad iformatio techology skills, access to advatageous govermetal policies backed by a growig etrepreeurial culture have a promisig future that is oly ow begiig to be utilized by outside groups. Iterest by Idia academic ad busiess life sciece orgaizatios to collaborate with their wester couterparts, ad coversely, the iterest of wester life sciece orgaizatios to parter with their Idia couterparts has bee icreasig of the years as both sides start to recogize the emergig opportuities ad syergisms that are possible from workig together. This chapter will provide a overview for wester scietists ad busiess people who are lookig to cooperate with Idia s icreasigly sophisticated biosciece orgaizatios i order to expad their activities i Idia ad to establish R&D, commercializatio, maufacturig operatios ad parterships as well as just for basic research projects. The importace of this caot be uderestimated sice i this curret era of biopharmaceutical developmet compaies must collaborate with public ad academic istitutios wherever i the world where basic research, early discoveries or later developmet are beig made i order to optimize research ad product commercializatio. 665

Advaces i Biopharmaceutical Techology i Idia These U.S.-Idia collaborative efforts fud joit research projects, ad support traiig, bilateral meetigs ad cofereces, as well as facilitate ope exchage of scietific iformatio betwee the two coutries. To set the stage for this, the chapter starts with a descriptio ad discussio of the status of the biopharmaceutical idustry i Idia ad its prospective growth. Existig collaboratios of Idia private eterprises with their wester couterparts are explaied ad how the existig capacities of these Idia firms are beig used for collaboratios for biogeeric ad biopharmaceutical developmet. Followig the examples of idustrial collaboratios, academic collaboratios betwee the Uited States ad Idia will be show ispired by the may bilateral agreemets betwee the two govermets ad implemeted by the appropriate govermet agecies (the Natioal Istitutes of Health (NIH) ad the Ceter for Disease Cotrol ad Prevetio (CDC) i the U.S. ad the Departmet of Biotechology (DBT) i Idia). Because of their log history ad extesive focus i the life scieces area, these bilateral collaboratios are particularly good examples for prospective collaborators both i the U.S. ad Idia of the type ad breadth of iteractios that are possible betwee U.S. ad Idia life sciece orgaizatios. Begiig with the history ad the chroology of U.S.-Idia collaboratio i sciece, this sectio highlights the areas of joit health care ad research, ad goes o to provide iformatio regardig the differet programs for collaborative iitiatives that are available from the U.S. Departmet of Health ad Huma Services (HHS) ad its agecies such as the Natioal Istitutes of Health, its licesig arm, the Office of Techology Trasfer (OTT), ad the Ceter of Disease Cotrol ad Prevetio (CDC). O the Idia side, the chapter illustrates the cotributios to such collaboratios of the Idia Departmet of Biotechology uder the Idia s Miistry of Sciece ad Techology. DBT works i cocert with its U.S. couterparts to cotiually support a large variety of programs, ad to form ew iitiatives related to life scieces ad biopharmaceuticals. These iclude work i such areas as tuberculosis, vaccies, HIV/AIDS, waterbore disease ad ivolve a umber of useful mechaisms relevat for collaboratios such as cotracts, grats, formal ad iformal joit research efforts as well as techology licesig. Of particular ote is a case study relatig to rotavirus vaccie developmet licese by four Idia istitutios from the Natioal Istitutes of Health. These U.S.-Idia collaborative efforts fud joit research projects, ad support traiig, bilateral meetigs ad cofereces, as well as facilitate ope exchage of scietific iformatio betwee the two coutries. Through these various examples ad iformatio refereces provided, it should be possible to improve ad ehace the umber of collaborative research ad developmet efforts betwee wester research orgaizatio ad their couterparts i Idia for the beefit of global public health. 666

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West B. Idia A Emergig Hub for Iteratioal Collaboratios i Biopharmaceutical Techologies With approximately 200 compaies, the biotechology sector i Idia has witessed accelerated growth i recet years that make it ripe for collaboratio ad joit developmet projects. The coutry s biotechology sector grew by 39% to reach a value of $705 millio i 2003-2004, with biopharmaceuticals sector occupyig the largest market share of 76%, followed by bio-agriculture 8.42%, bioservices 7.70%, idustrial products 5.50% ad bioiformatics 2.45%. The Uio Sciece ad Techology Miister, Kapil Sibal, released a draft Natioal Biotechology Developmet Strategy i March 2005 that evisios the biotechology sector to grow still further to reach a value of $5 billio by 2010. With the advet of the ew product patet policy i Jauary 2005, Idia pharmaceutical compaies are udergoig substatial trasformatio. Challeges of globalizatio ad the itroductio of a ew product patet regime have motivated the Idia idustry to gradually shift focus oto more research itesive, iovative bio-pharmaceutical products by expasio of their iteratioal geeric busiess, cotract maufacturig services, cotract research services, ad research ad developmet (R&D) capabilities. Iteratioal pharmaceutical ad biotech compaies, which stayed away from pre-2005 hostile IP regime, are explorig ways to leverage the full beefits of Idia s uique set of skills, resources, capabilities ad opportuities. Idia s rapidly improvig skill set i drug discovery ad developmet research, ad improvig govermet policies supportive of foreig direct ivestmet ad participatio has created substatial strategic opportuities for Wester pharmaceutical compaies. Idia compaies are ow rapidly growig from biotech outsourcig hub for low-ip sesitive discovery, custom sythesis, process sythesis, ad cliical trials to emergig as collaborative R&D parters offerig high-value services. Accordig to a recet survey by Cambridge Healthtech Associates (CHA) etitled Globalizatio of Drug developmet: Idia, Jue 2006, over three-quarters of the top 50 Wester pharmaceutical compaies are coductig drug developmet activities i Idia more tha i ay other emergig coutry. With the advet of the ew product patet policy i Jauary 2005, Idia pharmaceutical compaies are udergoig substatial trasformatio. 1. R & D i Idia Pharma compaies globally are ivestig heavily i research ad developmet (R&D) to develop ew drugs. Accordig to a report by Pharmaceutical Research ad Maufacturers of America (PhRMA), the U.S. biotech ad bio-pharma ivestmet i R&D was $38.8 billio i 2004, a 12.6% icrease from $34.5 billio i 2003. This icrease i pharma R&D ivestmet i 2004 is about five times higher tha that i 1990 ad about twety times higher tha that i 1980. Out of the $38.8 billio that the U.S. pharmaceutical idustry ivested i R&D i 2004, aroud 21% was spet 667

Advaces i Biopharmaceutical Techology i Idia Rabaxy, which boasts of havig the idustry s largest R&D budget, had a R&D spedig level of over 7% of sales i 2005 compared to just 6% i 2004. o outsourcig. With the reported cost of developig a ew drug soarig eormously over the years from $100 millio i the 1980s to more tha $800 millio ow, pharmaceutical compaies i the U.S. ad Europe are uder immese pressure to cut R&D costs. Idia is rapidly emergig as a R&D hotspot that ca offer a attractive destiatio where compaies ca tap ito a existig large pool of iexpesive scietific ad techical workers with good liks to academic research facilities, ad provides a eviromet where iovatio is supported by the itroductio of product patets regime. Accordig to Mr. Utkarsh Palitkar, Director ad Head of Life Scieces Practice, Erst & Youg Idia, the cost of doig R&D ad itroducig a ew molecule i Idia is 30-40% lower tha the cost ivolved i a developed coutry. The ew product patet regime has itroduced a fresh vigor ito the coutry s drug discovery research. Idia pharmaceutical compaies are sigificatly icreasig their R&D spedig. For example, Rabaxy views its R&D capabilities as a vital compoet of its busiess strategy that will provide the compay with a sustaiable, log-term competitive advatage. The compay today has a pool of 1,100 scietists who are egaged i path-breakig research. Rabaxy, which boasts of havig the idustry s largest R&D budget, had a R&D spedig level of over 7% of sales i 2005 compared to just 6% i 2004. The compay plas to progressively icrease its ivestmet i R&D to 9%-10% of sales by 2007. Other examples are Nicholas Piramal spedig 5% share of its total sales o research i 2005-06 compared with 3.5% i 2004-05 ad Su Pharma s R&D spedig of 9% of the compay s total sales i 2005-06, compared to just 8% i 2004-05. 2. Existig or Emergig Focus Areas for Idia Biotech ad Pharmaceutical Compaies Cotract or Collaborative Research Most Idia biotech compaies have opted for cotract or collaborative research as a service model at their start-up stage i order to ear early reveues. Sygee, Aurigee, Geotypic Techology, Chembiotek, Cytogeomics ad Metahelix are some examples of such service based biotech compaies, while compaies like Avesthage ad Bagalore Geei have opted for cotract research services as a secodary busiess to geerate reveues to support existig busiess lies. Accordig to a CHA report (Globalizatio of Drug developmet: Idia, Jue 2006), services compaies such as GVK Bioscieces, Sai Life Scieces, Chembiotek, Sygee, Avra, ad others have thrived with growth ow moderatig to the 50%-70% rage. May of these compaies have to date provided oly a limited rage of services such as low-ip sesitive discovery services, process R&D, ad custom sythesis. These compaies are ow aggressively ivestig i high-value R&D capabilities ad harbor ambitios of origial R&D oce they reach a certai profit level. 668

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West Sygee, a R&D subsidiary of Idia s top biotech compay Bioco, i 2004 etered ito a three-year cotract research agreemet with the Novartis Istitutes for Biomedical Research, Ic. for carryig out research projects to support ew drug discovery ad developmet, primarily i the early stages ad ivolvig small molecules i ocology ad cardiovascular segmets. Avesthage, a healthcare techology group focused o the covergece betwee pharmaceuticals, food ad prevetive persoalized medicie, is based o a collaborative research model. Avesthage s busiess model is to combie IP & product developmet for log term sustaiable reveue geeratio ad value additio, with R&D services ad collaborative research programs for/ with other parties to geerate a early reveue stream ad market focus. I 2005 Avesthage established multiple joit vetures with iteratioal as well as Idia parters. Avesthage formed alliaces with AstraZeeca (geomics ad metabolomics for ifectious diseases), Novartis (molecular biology), BioMérieux (cacers, emergig pathoges ad ifectious diseases diagostics), Nestle ad Itochu (utraceuticals), Uiversity of Miesota (obesity cotrol), Netherlads Orgaizatio for Applied Scietific Research - TNO (utrigeomics), Cetre for Cliical & Basic Research-CCBR (diagostics ad utraceuticals), Cipla (biopharmaceuticals), ad Imperial College Lodo ad Cambridge Uiversity (populatio geetics study ad ifectious diseases programs). Cliical Research Orgaizatios Cliical research is curretly i the ews for its immese busiess potetial i Idia with the focus of cliical research outsourcig to Idia shiftig from cost advatages to quality i coductig cliical trials ad data maagemet services, ad rapid respose (see Table 1). A umber of cotract research orgaizatios (CROs), ecouraged by the recet regulatory reforms, are settig up operatios i Idia. The broadly developed iformatio techology ifrastructure i Idia provides added advatage to esure speedy coduct of studies ad flow of iformatio/ data from the cliical sites to the sposors databases. Experts believe that with the ew patet regime, Idia will soo make a mark for itself i the area of cliical research. The total market value of cliical research performed i Idia i 2001-02 was about $70-80 millio. The Cofederatio of Idia Idustry predicts that it will grow to $200 millio by 2007 ad aywhere betwee $500 millio ad $1 billio by 2010. The pace for drug trials i the coutry is so fast that the Cliical Data Iterchage Stadards Cosortium (CDISC), USA, a o-profit orgaizatio committed to the developmet of cliical research orgaizatios stadards the world over, is plaig to form a Idia-CDISC Coordiatig Committee o the lies of Europe CDISC Coordiatig Committee (ECCC) ad Japa CDISC Coordiatig Committee (JCCC). The Cofederatio of Idia Idustry predicts that it will grow to $200 millio by 2007 ad aywhere betwee $500 millio ad $1 billio by 2010. 669

Advaces i Biopharmaceutical Techology i Idia Table 1. Beefits of coductig cliical trials i Idia Low-operatioal costs, 30-40% lower tha the cost ivolved i a developed coutry. A large pool of treatmet aïve patiets with multiethic ad multiracial backgrouds. Rapid patiet erollmet rate- 0.3 patiets per moth i U.S. as agaist 3 patiets i Idia durig the same period. Vast pool of scietific talet, well-traied ad ethusiastic ivestigators. Wide spectrum of disease profiles. Robust healthcare ifrastructure, such as early 700,000 specialty hospital beds, 221 medical colleges. Robust iformatio techology ifrastructure esures efficiet cliical data maagemet, speedy coduct of studies ad flow of cliical data. Highest umber of U.S. FDA approved plats outside U.S. Established bulk-drug ad formulatio idustry. Well-traied medical commuity to global stadards ad icreasig awareess of Good Cliical Practice. Eglish as the primary busiess ad medical laguage. New laws ecouragig more Foreig Direct Ivestmets i Idia. Govermet commitmet to provide Itellectual Property Protectio. Chages i regulatory policies to facilitate cliical research. With a populatio of more tha 1.1 billio, Idia offers a large pool of treatmet aïve patiets with multiethic ad multiracial backgrouds. This, combied with Idia s highly qualified work force ad umerous world-class medical facilities that meet the global requiremets for cliical testig, offers a strog ifrastructure for huma cliical testig. Idia has a large pool of highly traied physicias, urses, ad techical persoel cosistig of BS, MS, Ph.D.-level workers. I 2005, approximately 600,000 doctors were registered with state medical coucils i Idia, of which about 30% held specialist qualificatios. Additioally, may highly educated Idias that had earlier immigrated to the U.S. ad Europe are ow returig home to participate i the rapid moderizatio of their coutry. Curretly, over 80 govermet ad privately owed hospitals are actively egaged i cliical trials. With more tha 14,000 hospitals i the coutry ad a total bed capacity of early 900,000, hospitals egaged i cliical trials are expected to grow each year. However, may public hospitals will require ifrastructure improvemets before they ca effectively participate i cliical trial programs. The Idia govermet has bee actively cotributig to help capture outsourcig opportuities for cliical trials. The Idia govermet has recetly ameded Schedule-Y of the Drugs ad Cosmetics Rules to allow cliical trials to be carried out i Idia cocurretly with other global trials by removig the phase-lag coditio betwee Idia ad the rest of the world i cliical trials of ew drug substaces. 670

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West Some have raised fears that Idia patiets may be treated like guiea pigs. The low literacy levels of may poor patiets ad voluteers, raises cocers of adequate iformed coset about the cliical trials risks. The Idia govermet has recogized the eed for regulatory policig that esures protectio of huma subjects o cliical trials. The Drugs Cotroller Geeral of Idia (DCGI) the equivalet of the U.S. Food ad Drug Admiistratio (FDA) has streamlied the provisios for coductig cliical trials i the coutry i accordace with the Iteratioal Coferece o Harmoizatio (ICH) good cliical practice (GCP)/good laboratory practice (GLP) guidelies ad FDA stadards. All medical facilities have bee madated to meet the GCP procedures. The Idia Govermet alog with the World Health Orgaizatio (WHO) has udertake a massive campaig to provide traiig support to medical ad regulatory persoel ecessary to achieve this goal. The Idia Govermet is also plaig to itroduce draft guidelies o ethical ad patiet safety issues i differet fields like stem cell research, geetically modified food, geetically modified drugs, biomedical ad behavioral research o HIV/AIDS, assisted reproductive techiques, ad gee therapy. I additio, Idia has provided exemptios for import duties o cliical trials products ad elimiated the procedural hurdles that were prevalet i the past. To provide a fiacial icetive for drug developers to outsource their R&D work to Idia, the Idia govermet has istituted te-year tax holiday cocessios o icome arisig from R&D spedig ad itellectual property aligmet with the World Trade Orgaizatio guidelies. May major pharmaceutical compaies have already successfully used cliical trials data from Idia for US FDA New Drug Applicatio (NDA) submissios. Today global pharma compaies like GlaxoSmithKlie, Johso & Johso, Eli Lilly, AstraZeeca, Novo Nordisk, Avetis, Novartis, Saofi-Avetis, Merck, Wyeth, Bristol-Myers Squibb, Roche ad Pfizer are icluded i the list of compaies coductig cliical research trials across various Idia cities. GlaxoSmithKlie is curretly carryig out the largest umber of cliical trials i Idia. Pfizer has ivested a estimated $13 millio i trials sice 1995 to treat malaria, osteoporosis, breast cacer ad schizophreia. May multiatioal CROs have also outlied plas to tap Idia s large pool of patiets. U.S.-based Quitiles Trasatioal, the first global CRO to establish a presece i Idia, has had tremedous success recruitig patiets quickly ad efficietly. Sice its icorporatio i Idia i 1997 it has coducted more tha 100 cliical studies ivolvig over 700 sites ad early 15,000 patiets i a rage of therapeutic areas icludig ocology, ifectious diseases, gastroeterology, eurology ad cardiovascular disease. SIRO Clipharm, Cliigee (subsidiary of Bioco), Wellquest (cliical trials divisio of the Nicholas Piramal Group) are some of the local compaies that are buildig their reputatio as specialists i cliical research. Idia has provided exemptios for import duties o cliical trials products ad elimiated the procedural hurdles that were prevalet i the past. 671

Advaces i Biopharmaceutical Techology i Idia Cotract Maufacturig Orgaizatios Maufacturig was amog the earliest activities to be outsourced by global pharmaceutical majors to Idia. Over the last decade Idia has emerged as a major source of active pharmaceutical igrediets (APIs) for global pharmaceutical compaies. Today Idia has the maximum umber of U.S. FDA-approved plats outside the U.S. ad Idia compaies are the largest submitters of Drug Master Files (DMFs) outside the U.S. (see Table 2 below). Idia s techical talet i process developmet, cgmp maufacturig drugs ad vaccies to U.S. FDA ad EU stadards ad the itroductio of product patet regime sice 2005 has played a key role i Idia s emergece as a globally preferred destiatio for outsourced maufacturig i pharmaceuticals. Table 2. Active Drug Master Files submitted i 2006 Coutries outside US Type 2* Type 3* Type 4* Type 5* Idia 308 23 8 0 Chia 101 5 0 0 Italy 44 8 0 0 Germay 24 14 6 0 Spai 17 1 6 0 Israel 17 0 0 0 Japa 15 10 13 1 Caada 11 9 1 0 Frace 10 13 1 0 Switzerlad 10 3 0 0 Taiwa 9 0 3 0 Mexico 8 9 0 0 Hugary 6 0 0 0 UK 6 9 1 0 Czech 5 0 0 0 Netherlad 5 2 0 2 Demark 4 1 0 0 Belgium 3 0 0 0 Austria 3 2 0 1 Filad 2 0 0 0 Swede 2 4 0 0 Australia 1 1 0 0 S. Africa 0 0 0 0 Turkey 0 0 2 0 U.S. ad rest of world 91 61 38 6 Total active DMF 702 175 79 10 Idia % 43.9 13.1 10.1 0.0 Note: Type I Maufacturig Site, Facilities, Operatig Procedures, ad Persoel is o loger applicable 672

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West Type II: Drug Substace, Drug Substace Itermediate, ad Material Used i Their Preparatio, or Drug Product Type III: Packagig Material Type IV: Excipiet, Colorat, Flavor, Essece, or Material Used i Their Preparatio Type V: FDA Accepted Referece Iformatio While the larger Idia pharmaceutical compaies started focusig o ew drug discovery ad geeric exports durig mid-1990s to set off the immiet challeges posed by the product patet regime of ot beig able to maufacture ad sell pateted products, cotract maufacturig became a more viable busiess model for several small-medium sized Idia compaies. Compaies offerig cotract-maufacturig services i Idia are fidig opportuities i both o ad off-patet molecules. Several Idia compaies such as Nicholas Piramal, Bioco, Dishma Pharma, Shasu Chemicals & Drugs, Jubilat Orgaosys, Divi s ad Matrix have agreemets with global geeric compaies for off-patet molecules. Cadila Healthcare ad Altaa AG set up a joit veture i 1998 to maufacture ad supply two itermediates for Altaa s blockbuster product Protoix (patoprazole). Protoix is a gastroitestial drug with global sales i excess of $2 billio. The product is uder patet till 2010 i U.S. ad till 2016 i Europe. U.S. bioscieces compay Codexis had established collaboratio with Idia-based Matrix Laboratories i 2005, for the developmet ad commercializatio of a API for a high-value pharmaceutical product. Codexis will use its proprietary pharmaceutical process re-egieerig techology platform to develop a ovel sythetic process for the product. The process will be the trasferred to Matrix for scale-up ad maufacturig. Uder the terms of the agreemet, while Codexis will receive R&D fudig, milestoe paymets ad a royalty o et sales of the product, Matrix will gai exclusive maufacturig ad marketig rights to the ovel process. A large umber of multiatioal compaies icludig Pfizer, Bayer, GSK, Avetis, Merck, ad Novartis are today relyig o productio facilities ad pharmaceutical compaies i Idia to meet their requiremets for APIs ad itermediates. Of the twety global pharmaceutical compaies, fiftee have a active presece i Idia. Several iteratioal pharma compaies, icludig Teva, Sadoz, Pliva ad Ratiopharm, also have acquired or set up their ow maufacturig facilities i Idia. Teva of Israel made a etry ito the Idia market i 2003 by acquirig JK Idustries pharmaceuticals busiess. Teva had sice lauched a fully-owed subsidiary R&D ceter i Idia, Reget Drugs Ltd, focused o process developmet for APIs ad advaced itermediates of APIs. I Jauary 2006, Teva acquired the U.S.-based Ivax to become the world s biggest producer of geeric drugs. Sadoz, Teva s biggest competitor ad the geerics arm of Novartis, has recetly set up its third maufacturig plat i Idia. I August 2006, U.S. geeric drug maker Myla decided to sped aroud $736M to acquire a cotrollig stake i 673

Advaces i Biopharmaceutical Techology i Idia Matrix Laboratories, a Idia maufacturer of APIs i order to expad its maufacturig platform. A ladmark agreemet i 2003 betwee Idia s largest pharmaceutical compay, Rabaxy ad world s secod largest pharma corporatio, GlaxoSmithKlie Plc marks the begiig of a ew phase i the pharmaceutical research i Idia. Fudig by Veture Capitalists Accordig to Erst & Youg global biotech report 2006, the Idia biotech sector is gaiig ivestor cofidece. The sector has ot oly attracted fuds from iteratioal orgaizatios like the World Bak, but ow Idia biotech compaies are successfully tappig ivestors ad hedge fuds for cash. Veture fuds, which util ow have rarely ivested i Idia pharmaceutical compaies, are ow icreasigly participatig i the iovative R&D efforts of Idia firms. GagaGe, Ic., which has operatios i Bagalore, Idia ad Otario, Caada, has raised $3.9 millio primarily from U.S. ivestors, icludig U.S.-based ICF Vetures that specialize i Idia ivestmets. I March 2006, Dr Reddy s Laboratories etered ito a deal with Citigroup Veture ad ICICI Veture Fuds to form a itegrated drug developmet compay called Perleca Pharma Private Limited with a equity capital commitmet of $52.5 millio. I this deal Dr. Reddy s has trasferred to Perleca all rights ad titles for the developmet ad commercializatio of four discovery molecules. Partership Arragemets Partership arragemets, marketig alliaces/licesig deals, joit vetures betwee Idia bio-pharmaceutical compaies ad their iteratioal couterparts are icreasigly developig. The icreasig cofidece due to itroductio of the product patet regime has made such alliaces more attractive. While primary reasos for iteratioal compaies to parter with Idia compaies will be to reduce the cost ad cycle times of product developmet, the parterig model is drive by Idia s eed for a two-way flow of beefits. Foreig compaies ca provide the kowledge that Idia compaies lack such as essetial kow-how about discoverig, obtaiig regulatory approval for, ad marketig ew drugs (BioCetury, The Berstei Report o Biobusiess, 2004, Vol. 12, No. 34). Idia compaies ackowledge that though they have expertise i bioiformatics, lead optimizatio, precliical developmet, scalig up, ad maufacturig, they lack the resources ad expertise i lead geeratio, toxicology studies, regulatory affairs ad patetig. A ladmark agreemet i 2003 betwee Idia s largest pharmaceutical compay, Rabaxy ad world s secod largest pharma corporatio, GlaxoSmithKlie Plc i the area of drug discovery ad cliical developmet marks the begiig of a ew phase i the pharmaceutical research i Idia. The agreemet is a clear ad ope recogitio of research capability of Idia pharmaceutical idustry. The R&D alliace will cover several therapeutic areas icludig urology, ati-fugal, ati-bacterial, diabetes, iflammatio ad asthma. While GSK will mostly provide the leads or potetial molecules to be developed as drugs, Rabaxy will udertake the iitial research, developmet 674

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West ad cliical works. Oce a compoud has bee selected as a developmet cadidate, i most cases, GSK will complete developmet. GSK will have the commercializatio rights worldwide, while Rabaxy will take the lead i Idia. Rabaxy, with the coset of Glaxo may co-promote i EU ad U.S. This collaboratio provides a aveue to Rabaxy to leverage its discovery ad early product developmet stregths ad gai access to large database of drugs of GSK as well as cuttig edge techologies for drug discovery while GSK beefits from Rabaxy s early drug developmet stregth to accelerate its iteral drug discovery programs. Aother outcome of Rabaxy-GSK alliace is the emergece of a ew relatioship betwee Idia s research-based pharmaceutical compaies ad their couterparts i the U.S. ad Europe. I 2005, Dr. Reddy s Laboratories etered ito a co-developmet ad commercializatio agreemet with Demark-based Rheosciece A/S for the joit developmet ad commercializatio of balaglitazoe (DRF 2593) a partial PPAR-gamma agoist, for the treatmet of type 2 diabetes. Uder the terms of the agreemet, Rheosciece will fud all the costs associated with the Phase III cliical trials of DRF 2593 ad Dr. Reddy s will pay Rheosciece a pre-determied amout towards its share of the developmet costs. Rheosciece will retai the marketig rights i Europe ad Chia ad Dr. Reddy s will retai the marketig rights i the U.S. ad the rest of the world. Furthermore, Rheosciece will obtai all ecessary regulatory approvals o behalf of Dr. Reddy s i the Uited States. U.S.-based Nobex Corporatio etered global research collaboratio with Bioco Ltd of Idia to accelerate its project to develop a oral formulatio of isuli, to provide a more patiet-friedly alterative to curret ijectable products for diabetes. I 2005, the two compaies etered aother collaboratio to joitly develop a oral peptide product for the treatmet of cardiovascular disease. Both the collaboratios combie the prove peptide productio capabilities of Bioco with the proprietary oral peptide-delivery techology of Nobex. I March 2006, Bioco acquired for $3.5 millio the itellectual property assets of its parter Nobex, which had filed for bakruptcy i the U.S. I March 2006, Bioco acquired for $3.5 millio the itellectual property assets of its parter Nobex, which had filed for bakruptcy i the U.S. Off-shore Acquisitio Aalysts are observig that Idia pharmaceutical compaies are i a merger & acquisitio spree lately. The mai aim of acquisitios of U.S. or Europea compaies by the Idia compaies have bee to either boost their presece i those coutries markets or to establish a maufacturig or to expedite regulatory processig of their Abbreviated New Drug Applicatios (ANDAs). As the first pharma Idia compay to go overseas, Rabaxy Labs already has a strog presece i Europe. Rabaxy already has a strog presece i UK ad Germay ad acquired Frace s RPG Avetis i 2004. Aimig to expad its presece i the EU market, Rabaxy Labs i 2006 acquired Terapia (Romaia s sixth largest geeric player), Ethimed (Belgium s 10th largest geeric 675

Advaces i Biopharmaceutical Techology i Idia compay), Mudoge (GSK s geeric busiess i Spai) ad Alle S.p.A. (GSK s geeric busiess i Italy). Curretly, Idia compaies lack the resources to carry the ew chemical etities from start-tofiish, forcig them to ofte outlicese molecules after takig them ito either Phase I or II stages. Dr Reddy s Lab, i its first overseas acquisitio i 2002, acquired two small British geeric drug compaies BMS Laboratories ad its subsidiary Meridia Healthcare. With this acquisitio, the pharma major vetured ito the Europea market, which it was eyeig for some time. I 2004, Dr Reddy s Laboratories acquired access to drug delivery techology platforms i the Dermatology segmet through the acquisitio of U.S.-based Trigeesis Therapeutics. I 2005 Dr Reddy s acquired Roche s API Busiess at the stateof-the-art maufacturig site i Mexico with a total ivestmet of $59 millio. Recetly i March 2006, Dr Reddy s Labs acquired a Germa geeric firm Betapharm for 480-millio Euro ($570 millio), i oe of the biggest overseas acquisitios by a Idia pharma compay. Betapharm is the fourth largest player i the Germa market, which is the largest geerics market i the world after the U.S. Some of the other smaller U.S. ad Europea acquisitios by the Idia pharma idustry durig 2005 iclude Matrix Laboratories buyig a cotrollig stake i Belgium s Docpharma ad Switzerlad s Explora Laboratories, Torret Pharmaceuticals Ltd. acquirig Germay s Heuma Pharma, Jubilat Orgaosys acquirig U.S.-based Target Research Associates ad Triity Laboratories. Out-licesig Arragemets Curretly, Idia compaies lack the resources to carry the ew chemical etities from start-to-fiish, forcig them to ofte out-licese molecules after takig them ito either Phase I or II stages. Dr Reddy s Labs, Rabaxy Labs, Torret Pharma, ad Glemark Pharma have out-licesed some of their molecules to global pharma players. Such outlicesig deals, though offer both upfrot ad milestoe-liked paymets to Idia compaies, have its ow iheret risks. Iteratioal pharmaceutical compaies ofte take up 2-3 probable cadidates for further developmet ad Idia compaies ofte have to wait for 3-4 years oly to see it beig dropped for various reasos, accordig to Dr. Aji Reddy, chairma, Dr Reddy Laboratories. Dr Reddy s Laboratories reshaped R&D strategy of out-licesig four of its molecules to Perleca Pharmaceuticals at a early stage of developmet has altered the risk-reward equatio of potetial reveues from its drug pipelie, with Dr Reddy Laboratories iitially holdig a 14% stake ad Citigroup ad ICICI Vetures puttig up the remaiig veture capital fudig. Accordig to Dr. Reddy, oce a commo code o good cliical practices comes ito effect i the coutry, ad the ifrastructure is stadardized for the compaies to coduct their ow trials, Idia pharma compaies focusig o research ca stop out-licesig their molecules to multiatioal compaies. 676

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West I-licesig Arragemets I-licesig agreemets are curretly beig udertake i a big way by may Idia compaies. This will esure that the domestic pharmaceutical idustry will also be beefited by way of ewer molecules. With itellectual property rights i pharmaceuticals secured, Nicholas Piramal Idia Ltd (NPIL) has bee able to iterest overseas pharmaceutical majors to ivest i Idia. It has several i-licesig ad techology trasfer agreemets with leadig multiatioal pharma compaies, icludig Bioge Idec of the U.S. for marketig its ati multiple sclerosis drug Avoex ad Amevive for psoriasis, U.S.-based Gilead Scieces Ic s biotech for marketig drug Ambisome for deep seated fugal ifectios i Idia, marketig of Italia compay s Chiesi s lug surfactat drug Curosurf, Frech Pierre Fabre s dermo-cosmetic drugs Exomega ad Kertyol, Gezyme Corporatio of U.S. for marketig a viscose supplemet Syvisc, Germay s Gruethal for marketig a pai maagemet drug Trimadol, ad a techology trasfer agreemet with Ethypharm of Frace for paracetamol melt tablets drug delivery techology. Several other compaies have sice udertake i-licesig agreemets to acquire ew techologies, icludig Rabaxy ad Zydus Cadilla. A later sectio of this chapter etitled Techology Trasfer Activities betwee the NIH ad Idia is devoted to licesig arragemets betwee Idia s biotech compaies ad public academic istitutios i the Uites States. Prospects for the Future The Idia pharmaceutical compaies are rapidly attaiig critical mass i terms of skills ad capabilities to itegrate fully with the global pharmaceutical sector. Today several Idia pharmaceutical compaies are approved by U.S. FDA ad are listed at NASDAQ. The developmet of several products, such as AIDS diagostic kits, Hepatitis B vaccie, recombiat huma isuli as well as other recombiat therapeutics with high quality but at substatially lower cost, demostrates the potetial of techology iovatio i Idia pharma sector. Several R&D agreemets, icreasig cliical research activities, out-licesig ad i-licesig arragemets, high profile offshore mergers ad acquisitios by Idia compaies, idicate the mometum gaied by the Idia biotechology ad pharmaceutical idustry. From the idustry s perspective much of this is due to the coutry s itroductio, o Jauary 1, 2005, of a system of product patets. The Idia govermet is also movig forward with iitiatives, policies, regulatios ad programs to boost R&D activities i Idia by both iteratioal ad local pharmaceutical compaies. Some of the recet proposals ad iitiatives by Idia govermet, as described i the draft Natioal Biotechology Developmet Strategy for 2005, iclude allowig 100 per cet Foreig Direct Ivestmet, exemptio from the requiremet of compulsory licesig, promotig ad supportig at least te biotech parks by 2010, creatig several techology trasfer cells, With itellectual property rights i pharmaceuticals secured, Nicholas Piramal Idia Ltd (NPIL) has bee able to iterest overseas pharmaceutical majors to ivest i Idia. 677

Advaces i Biopharmaceutical Techology i Idia itroducig ew grats ad loas for promotig small busiess iovatio research, ecouragig collaborative research betwee the public ad private sectors, establishig a ceter for traslatioal research, ad fially establishmet of a Natioal Biotechology Regulatory Authority to provide for a faster ad more efficiet regulatory clearace. With respect to the latter, at the time of the writig of this chapter the Cetral govermet s plas to restructure the regulatory process i Idia have bee disclosed, 78 ad will be detailed i a separate sectio immediately followig this sectio. Though most of the abovemetioed policies ad proposals are yet to be implemeted, they clearly ecourage both iteratioal ad Idia pharma ad biotech compaies to ivest their resources i Idia. The Idia Cetral Govermet is about to itroduce a ew bill that will restructure ad stregthe the drug regulatory process i Idia. Proposed Chages i the Regulatory Process-A positive Measure to Improve the Drug Idustry The Idia Cetral Govermet is about to itroduce a ew bill that will restructure ad stregthe the drug regulatory process i Idia. The ew structure is desiged to cetralize drug approvals ad tighte the still somewhat lax maufacturig practices that have led to a proliferatio of poor ethical practices ad substadard drugs. Accordig to a cabiet ote, a ew idepedet Cetral Drug Authority of Idia (CDAI) will replace the Cetral Drugs Stadard Cotrol Orgaizatio, alog the lies suggested by the former director of the Idia Coucil of Scietific ad Idustrial Research (CSIR), Dr. R.A Mashelkar s expert committee i 2003. The CDAI will be resposible for the developmet ad defiitio of basic stadards, will provide techical visio ad esure that for every activity there is a clear policy framework ad efficiet supervisio to esure a uiform legislatio. Furthermore, the govermet s plas disclose the establishmet of te (10) ew divisios to be headquartered i Delhi ad will take up specific roles, icludig regulatio, eforcemet, legal ad cosumer affairs; biotechology products; pharmacovigilace/drugs safety; medical devices/diagostics; imports; quality cotrol; ad Idia systems of medicie. The States will cotiue to grat drugs sales liceses, but resposibility for the maufacturig liceses is to move over a five-year period to the CDAI. Additioally, the pealty for coductig cliical trials without permissio is to be raised to 10 years imprisomet with a fie of Rs.20 lakh (~US$50,000). The Drugs Cotroller Geeral (DCG) is to become Additioal Secretary, ad two Additioal Drugs Cotrollers will work uder him, oe o Idia systems of medicie ad the other o the remaiig issues. Two ew zoal offices are to be set up i Hyderabad ad Chadigarh, ad 114 posts created o top of the 82 curretly sactioed, of which 29 lie vacat. The extra cost of expasio, estimated at Rs.3 crore, is to be met through ew fees for ispectio ad registratio, ad liceses for maufacturers, ew products ad cliical trials. 678

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West These ew proposals will streamlie licesig ad improve quality cotrol moitorig. Furthermore the proposed chages should brig i more efficiecy ad allow time for more thorough review of applicatios. The ew proposals for cetralizatio of the regulatory process, which are more aliged with the rest of the world will stregthe the pharmaceutical idustry i Idia ad will further improve its stadig with the rest of the world C. History of U.S.- Idia Cooperatio i Sciece ad Techology 1. Backgroud Sciece ad Techology (S&T) cooperatio betwee Idia ad the U.S. has had a log history of more tha fifty years ad is characterized by successful ad productive exchage of scietists ad scietific ideas, joit workshops ad cofereces, joit/collaborative research projects, traiig/fellowship programs ad techology trasfer i virtually all areas of Sciece & Techology - traditioal ad frotier 1. It is oe if the oldest ad most extesive bilateral S&T cooperatio etered ito by Idia. I the late 1950s, Idia ad America scietists bega to collaborate o agricultural research. This activity was expaded i the 1960s ito other fields of sciece ad educatio, ad resulted through the facilitatio of Cosortia of America Uiversities i the establishmet of the Idia Istitute of Techology i Kapur, the Natioal Coucil of Educatioal Research & Traiig i New Delhi, ad the iitiatio of some major projects i health sector o prevetio ad other aspects of parasitic & commuicable diseases, utritio, cacer, etc. Satellite Istructioal Televisio Experimet (SITE) program was udertake i the 1970s i collaboratio betwee the U.S. Natioal Aeroautic ad Space Admiistratio (NASA) ad the Idia Space Research Orgaizatio (ISRO). Furthermore, the year 1974 was marked with the establishmet of the Ido- U.S. Joit Commissio o Ecoomics & Commerce, Sciece & Techology, Educatio & Culture, ad Agriculture. Pursuat to the establishmet of this joit Commissio, a S&T Sub-Commissio was further established i 1975. The S&T Sub-Commissio icludes seve Workig Groups i differet areas: Material & Physical Scieces; Earth Scieces; Atmospheric & Marie Scieces; Eergy; Eviromet & Ecology; Iformatio S&T; Health, ad Medical ad Life Scieces. These Workig Groups geerally met cocurretly with the meetigs of the Sub-Commissio. As a result of the activities of the S&T Sub-Commissio umerous U.S.-Idia joit research programs ad workshops were developed ad implemeted. 679

Advaces i Biopharmaceutical Techology i Idia 2. Specific S&T Programs, Iitiatives ad Agreemets - Chroology The Sciece & Techology Iitiative - STI (1983) 1983 is oted for the establishmet of the Sciece & Techology Iitiative (STI), a ew cooperative fast track program aimed at the ehacemet of S&T collaboratio i five specific areas, i.e. Agriculture, Health, Mosoo Research, Biomass Research ad Egieerig ad Solid State Sciece. The Natioal Sciece Foudatio i the U.S. ad the Departmet of Sciece ad Techology i Idia were joitly charged with the implemetatio of the program, which operated o cost sharig basis for eight (8) years util 1991. The U.S. Idia Fud - USIF (1987) I Jauary 1987, the two govermets siged a agreemet that established the U.S.-Idia Fud (USIF) with the goal of supportig joit activities such as workshops, exchage of scietists ad experts, as well as joit research programs i the field of educatio, culture ad scieces. The USIF was primarily fiaced through the use of U.S.-held rupees provided uder U.S. Public Law 480 (PL 480) fuds ad facilitated through the U.S. Agecy for Iteratioal Developmet (USAID). 2 The USIF operated for eleve years ad resulted i a large umber of productive workshops ad joit scietific projects. The S&T Fellowship Program (1991) S&T Fellowship Program was a parallel activity durig the period 1991-94. Uder this program sevety Idia scietists spet 3-12 moths i the U.S. while te U.S. scietists spedig various time periods i Idia. The Program was supported primarily by the U.S. Agecy for Iteratioal Developmet (USAID). 2 The Departmet of Sciece ad Techology (DST) 15 of Idia played a major role i the success of this fellowship program. Earth/Atmospheric Scieces MOU ad Agriculture MOU (1997, 1998, 1999) A Memoradum of Uderstadig (MOU) for scietific cooperatio i the area of Earth ad Atmospheric Scieces was siged betwee the Departmet of Space (DOS) ad the Departmet of Sciece ad Techology (DST) 15 of the Govermet of Idia, ad the Natioal Aeroautics ad Space Admiistratio (NASA) ad the Natioal Oceaic ad Atmospheric Admiistratio (NOAA) of the Uited States of America o December 16, 1997, i Washigto, DC. The MOU provides for exchage of data ad derived products betwee the two coutries. Similarly, a MOU betwee the Idia Coucil of Agricultural Research (ICAR), New Delhi ad Corell Uiversity, Ithaca, New York for cooperatio i the area of Agricultural Research was siged i November 1998. With 680

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West the sigig of this MOU, both sides agreed to promote research, traiig ad improvemet of productio techiques through exchage of faculty, scietists ad techologists. This MOU called also for a exchage of geetic ad breedig materials, as well as scietific literature, iformatio ad methodology. ICAR had siged a parallel MOU with Iowa State Uiversity durig early 1998, as well a research cooperatio agreemet with the Texas Agricultural Experimet Statio, Texas A&M Uiversity (July, 1997). The DST-NSF Collaborative Research Program (1997) A program for Ido-U.S. collaborative basic research projects was iitiated i 1997. The cooperatig agecies were: Departmet of Sciece & Techology (DST) i Idia ad the Natioal Sciece Foudatio (NSF) i the USA. This program supports workshops ad joit research projects i fudametal areas of sciece ad techology. Proposals uder this arragemet are submitted simultaeously to DST by the Idia collaborators ad to NSF by the U.S. researchers. The Ido-U.S. S&T Forum IUSSTF (2000) A agreemet that established a Ido-U.S. Sciece & Techology Forum (IUSSTF) 58 was siged by Idia s Miister of Sciece & Techology, Dr. M. M. Joshi, ad the U.S. Secretary of State, Ms. M K Albright, durig the visit of Presidet Clito to Idia i March 2000. The Forum was formally lauched by the Miister of Sciece & Techology, Dr. M. M. Joshi, o July 20, 2000. The objective of the Forum is to facilitate ad promote iteractio i Idia ad U.S. betwee govermet, academia ad idustry, i sciece & techology. The Forum promotes research ad developmet, trasfer of techology, ad creatio of comprehesive electroic referece sources for Ido-U.S. S&T operatio as well as electroic exchage ad dissemiatio of iformatio o Ido-U.S. S&T cooperatio. It has bee registered as a Society with the Office of the Registrar of Societies i New Delhi o Jue 23, 2000. The Forum is a grat makig orgaizatios that fuds scietific ad techological projects of mutual iterest to Idia ad the Uited States. It also facilitates collaboratios betwee the U.S. ad Idia through sposored workshops, symposia ad cofereces (for example see the 2006 workshops i Bagalore ad Maesar listed below with NIH Office of Techology Trasfer (OTT) ad Idia techology maagemet professioals), Traiig programs, ad Joit Ceters 4 for research ad developmet. IUSSTF is headquartered i New Delhi ad maaged by the Executive Director uder the leadership of a bilateral Goverig Body cosistig of seve Idia ad seve America researchers ad govermet represetatives ad with the support of Idia Sciece ad Techology Partership (INSTP) 59. Sice its iceptio, IUSSTF has brought together more tha 5,000 Idia ad U.S. scietists ad has helped idetify scores of ew areas for bilateral cooperatio. May of the projects sposored by the Forum are related to biomedical research. The objective of the Forum is to facilitate ad promote iteractio i Idia ad U.S. betwee govermet, academia ad idustry, i sciece & techology. 681

Advaces i Biopharmaceutical Techology i Idia America professioal societies have begu to express a icreasig iterest i Idia ad Idia scietists. Ido-U.S. S&T Roudtables (2000) I cojuctio with Prime Miister Vajpayee s last visit to U.S., represetatives from Idia ad U.S. held the 2 d High Level Roud Table o Sciece ad Techology o September 15, 2000, at Washigto, DC; the 1 st roudtable was held i Hyderabad, durig Presidet Clito s visit to Idia. Distiguished scietists ad admiistrators from both coutries participated i these meetigs. Both meetigs were co-chaired by Idia s Secretary of Sciece & Techology, ad the U.S. Director of the Office of Sciece & Techology Policy ad Assistat to the Presidet. The roud table aimed at discussig the ew directios for the 21 st cetury i Ido-U.S. collaboratio i sciece ad techology. A joit commuiqué issued at the coclusio of the 2 d roudtable was preseted to the visitig Prime Miister. The Roud Tables ad the Ido-U.S. S&T Forum (IUSTF) represet itesified efforts for closer cooperatio ad stroger partership i sciece ad techology. America Professioal Societies Iteractio (2000) America professioal societies have begu to express a icreasig iterest i Idia ad Idia scietists. For the first time i its 80-year history, the America Istitute of Chemists elected a Idia-America Dr. A.K.N. Nadedkar, Professor, Departmet of Biochemistry ad Molecular Biology, Howard Uiversity, ad Director, Geetics, Newbor Screeig Service, Howard Uiversity Hospital, as its Presidet for the year 2000 ad 2001. Oe of the first actios of the ewly elected presidet was to set up a chapter i Idia. Professioal Societies represetig Idia-America scietists maitai strog iteractio with scietists i Idia. The presidets of the U.S. Natioal Academies of Scieces ad Egieerig have also expressed a strog desire for further cooperatio with Idia. Ido-U.S. Sciece ad Techology Agreemet of 2005 - S&T (2005) The Govermets of Idia ad the Uited States siged a umbrella Sciece & Techology (S&T) agreemet i Washigto o October 17, 2005. The purpose of the agreemet is to stregthe the sciece ad techology capabilities of the Uited States ad Idia, to expad relatios betwee the extesive scietific ad techological commuities of both coutries, ad to promote techological ad scietific cooperatio i areas of mutual beefit. The objective of this ew agreemet, which for the first time establishes a itellectual property rights protocol ad other provisios ecessary to coduct active collaborative research, is to accelerate cooperatio betwee Idia ad U.S. scietists i govermet agecies, private sector, ad academia i such areas as basic scieces, space, eergy, aotechology, health, ad iformatio techology that will advace scietific uderstadig ad beefit both atios. The ew sciece ad techology agreemet is also meat to complemet the activity of the Ido-U.S. Sciece ad Techology Forum (see above) by facilitatig follow-o techical collaboratios. 682

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West Next Steps i Strategic Partership - NSSP (2004-2006) The Next Steps i Strategic Partership (NSSP) iitiative lauched i Jauary 2004 allowed opeig a dialogue ad buildig trust o a umber of sesitive areas, icludig high-techology trade, civil uclear cooperatio, space, ad missile defese. The U.S.-Idia strategic partership is rooted i shared values ad is broad i ature ad scope, with the two coutries workig together o global issues, icludig expadig ecoomic freedom ad democracy; esurig pletiful sources of clea, safe, ad reliable eergy; protectig security; supportig iovatio ad techological advaces; ad promotig public health. I March 2005 the U.S. ad Idia agreed to build o this successful partership, movig beyod the Next Steps i Strategic Partership (NSSP) to a Strategic Dialogue. Eergy Dialogue seeks to expad cooperatio i areas such as clea eergy ad civil uclear eergy. Ecoomic Dialogue icludes, for the first time, a forum of chief executive officers (CEOs) from leadig corporatios to advise both govermets o how to accelerate ecoomic cooperatio. The Uited States ad Idia resolved to build a global partership based o areas of cooperatio aouced at the summit betwee the U.S. Presidet ad Idia Prime Miister i Washigto July 18, 2005 White House fact sheet: The Uited States ad Idia Successfully Complete Next Steps i Strategic Partership (NSSP) i July 18, 2005. About fifty scietists from various uiversities ad scietific istitutios i Idia come to U.S. aually for advaced research ad traiig uder the followig three (3) fellowship programs (a) Biotechology Overseas Associates Program of Departmet of Biotechology; (b) Rama Research Fellowship awarded by Coucil of Scietific ad Idustrial Research (CSIR) ad (c) Better Oppor- The areas of cooperatio are: Ecoomic Matters Eergy ad Eviromet Space Democracy ad Developmet Disaster Relief HIV/ AIDS High Techology Cooperatio Group (HTCG) High Techology Cooperatio Group (HTCG) formed betwee Idia ad U.S., which is chaired by Uder Secretary, Departmet of Commerce, U.S. ad Foreig Secretary, Miistry of Exteral Affairs, Govermet of Idia. HTCG focuses towards buildig kowledge ecoomy through public-private participatio i the areas of biotechology, aotechology, defese ad iformatio techology. S&T Fellowship Program 683

Advaces i Biopharmaceutical Techology i Idia tuities for Youg Scietists i Chose Areas of Sciece ad Techology (BOYCAST) fellowship of Departmet of Sciece & Techology. These short ad log-term fellowship programs ot oly provide state-of-the-art research facilities to Idia scietists but also eable them to build log-term relatioship with host istitutios to pursue future cooperative activities The March 2, 2006 statemet also reiterated plas to expad bilateral efforts ad cotiue cooperatio i the area of medical research D. U.S.-Idia Cooperatio i Health ad Biomedical Research 1. Bilateral Agreemets betwee the U.S. ad Idia Govermets Ido-U.S. cooperatio i health ad biomedical research has a log ad productive history of more tha three decades. This collaboratio cotiues to grow, as evideced by a icreasig umber of grats, bilateral agreemets, programs, ad techical assistace iitiatives. Ido-U.S. cotiued collaboratio i biomedical research has resulted i icreasig scietific kowledge, improvig public health, ad cotrollig, prevetig, ad elimiatig diseases. I Jue 2000 the two coutries established a framework for collaboratio o the Prevetio of Sexually Trasmitted Diseases (STDs) ad HIV/AIDS. Followig that, i a joit statemet o July 18, 2005, (see above uder NSSP) Prime Miister Mamoha Sigh ad Presidet George W. Bush committed the two coutries to further stregthe cooperatio i the fight agaist HIV/ AIDS. They agreed to cotiue to expedite U.S. Food ad Drug Admiistratio (FDA) review of geeric Idia ati-retroviral drugs (ARVs), collaborate i basic scieces, product developmet ad cliical trials, establish a corporate fud for HIV/AIDS as detailed below, expad HIV/AIDS workplace programs ad icrease access to safe, effective, quality ati-retroviral drugs. Subsequetly, Prime Miister Mamoha Sigh ad Presidet George Bush issued yet aother joit statemet i New Delhi o March 2, 2006. This later statemet stemmed from a extesive review of the progress made i deepeig the global partership betwee the two coutries sice the earlier statemet of July 2005. I the March 2, 2006 statemet the two leaders expressed satisfactio with the progress i may areas. With regards to cooperatio i the medical frot the joit statemet expressed satisfactio with the expedited U.S. FDA drug approval processes that stregthe the combat agaist HIV/AIDS at the global level ad further ecouraged greater corporate participatio to meet this challege, icludig participatio through the Ido-U.S. Corporate Fud for HIV/AIDS. The March 2, 2006 statemet also reiterated plas to expad bilateral efforts ad cotiue cooperatio i the area of medical research as well as stregthe techical capacity i food ad drug regulatio i Idia ad address the cocer o avia iflueza. The statemet further emphasized the commitmet of both coutries to reachig out to the private sector for developmet of ew medical products. 684

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West Idia further agreed to host a meetig of the Iteratioal Partership o Avia ad Pademic Iflueza i 2007. The U.S. Departmet of Health ad Huma Services (HHS) has bee committed to post public health experts i Idia for collaborative work o avia iflueza ad other emergig ifectious diseases. The joit statemet emphasized the sustaied commitmet by the Uited States Agecy for Iteratioal Developmet (USAID) 2 to provide fiacial ad techical support to WHO for workig with Idia ad stregtheig its capabilities to combat eglected ad emergig diseases (see tuberculosis below). Istitutios i the two coutries are workig together i biomedical research ad HIV/AIDS vaccie developmet. A seior U.S. researcher has bee detailed to joi other U.S. public health scietists workig o HIV/AIDS with the Idia Coucil of Medical Research (ICMR), 11 Departmet of Biotechology (DBT), 14 ad Natioal AIDS Cotrol Orgaizatio (NACO). 60 Joit efforts are uder way to ehace the capacity of Idia istitutios to coduct cliical trials. A Ceter of Excellece i Cliical Research has bee established i Cheai with support from the U.S. Departmet of Health ad Huma Services. A Ido-U.S. Corporate Fud for HIV/AIDS has bee established, maaged by the ICICI Bak ad the GIVE Foudatio i Idia. With cotributios from Idia ad U.S. busiesses, the Fud is iteded to icrease resources to fight HIV/AIDS i Idia. Withi the first moth of the Fud s establishmet, six compaies have pledged a total of $1.2 millio. May more compaies have idicated strog iterest i providig fudig, corporate expertise, or products ad services. Through a expedited review process, the FDA has approved 15 sigle-etity ad co-packaged versios of previously FDA-approved brad ame atiretroviral drug preparatios. Thirtee of the 15 ARVs are maufactured by Idia pharmaceutical compaies. The Govermet of Idia has requested assistace from the FDA i its efforts to raise the capability of the Idia drugapprovig agecy. A team from the U.S. FDA visited Idia to discuss techical cooperatio i this importat area. The U.S. ad Idia are cooperatig i may other importat health areas, such as tuberculosis, malaria, reproductive health, materal ad child health, urba health, evirometal ad occupatioal health, vaccie developmet ad evaluatio, ad disease surveillace. This collaborative work is beig doe uder the auspices of a umber of agecies, through bilateral agreemets ad other iitiatives. I the area of tuberculosis for example, the U.S. Ambassador to Idia David C. Mulford ad the World Health Orgaizatio (WHO) represetative to Idia Salim Habayeb siged a joit agreemet for tuberculosis cotrol i Idia o September 26, 2006 i New Delhi. I this agreemet the Uited States through the Uited States Agecy for Iteratioal Developmet (USAID) 2 has provided $4.17 millio i fuds to WHO for research ad state level imple- Withi the first moth of the Fud s establishmet, six compaies have pledged a total of $1.2 millio. 685

Advaces i Biopharmaceutical Techology i Idia Medical professioals from the U.S. ad Idia have developed plas ad strategies to establish schools of public health i Idia. metatio of the atioal disease cotrol program i Idia. The Uited States has ivested $40 millio i the fight agaist tuberculosis i Idia sice 1998 4. It is importat to ote that tuberculosis is oe of the leadig causes of morbidity ad mortality amog the adult populatio (18-59 years) i Idia. Idia has more cases of tuberculosis tha ay other coutry i the world ad twice as may as Chia, the ext highest. Each day, oe thousad Idias die from tuberculosis, meaig that social ad ecoomic losses due to the disease are eormous, costig about $3 billio per year. USAID 2 ad WHO have achieved sigificat progress through their programs ad collaboratios i the past te years i Idia. I additio to tuberculosis, their parterships have resulted i prevetig ad cotrollig diseases like malaria ad avia iflueza i Idia. USAID ivestmets i Idia i the area of eglected ad emergig diseases have exceeded $56 millio. These ivestmets helped build ad stregthe the capabilities of local istitutios ad have leveraged resources from other developmet parters. Medical professioals from the U.S. ad Idia have developed plas ad strategies to establish schools of public health i Idia. These schools will develop a cadre of public health experts ad policy makers for programs to detect, prevet, ad cotrol diseases. HHS curretly does ad will cotiue i the future to provide techical ad fiacial support for this iitiative. The U.S. Govermet is also Idia s committed parter i the fight agaist polio. The U.S. has bee workig with the Govermet of Idia to esure success i the fial push to elimiate polio from Idia. The U.S. has bee providig techical ad fiacial support to Idia s polio elimiatio efforts by assigig log- ad short-term techical staff, providig vaccie, ad supportig surveillace ad social mobilizatio etworks. The U.S. Govermet will cotiue to support public-private parterships, such as the collaboratio that led to the developmet of a cadidate vaccie agaist rotavirus (Bharat Corp.). The huma rotavirus strai that forms the basis for this vaccie was provided to Bharat through the facilitatio of the Ceter for Disease Cotrol (CDC). 5 Fiacial support for this project has bee provided by the PATH S Childre Vaccie Program 7 at Program for Appropriate Techologies i Health (PATH), 6 a affiliate of the Bill ad Melida Gates Foudatio (Seattle, WA). I this partership, ivestigators from Idia ad U.S. istitutios have developed a promisig cadidate vaccie that is curretly udergoig evaluatio. If successful, this vaccie would prevet a substatial umber of childhood deaths i Idia ad other regios that are due to rotavirus (see more details o this project uder the DBT sectio below). Furthermore, a ew pateted techology related to rotavirus vaccie has bee recetly licesed from the NIH 3 to four Idia vaccie producers. More details about this project will be provided bellow i the sectio describig the collaboratios betwee the NIH 3 or NIH/OTT ad Idia. 686

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West 2. Specific Programs i Health ad Biomedical Research Withi the framework of the U.S.-Idia S&T Cooperatio, collaborative efforts i the health scieces have bee particularly promiet. Special iitiatives have bee udertake over the years i efforts to advace cooperatio more rapidly ad effectively i some areas. Some of the most promiet ad successful programs are described below. The listed programs are fuded by Idia ad U.S. govermet moey, where o the U.S. part, the NIH 3 through its appropriate Istitutes or Ceters is the mai agecy resposible for the distributio ad admiistratio of the fuds. 1,4,61 63, 65 Ido-U.S. Vaccie Actio Program (VAP) Oe of the most importat ad successful of the collaborative programs ad iitiatives has bee the Ido-U.S Vaccie Actio Program (VAP). The VAP had its origi i 1984 whe Dr. Fred Robbis, a U.S. Nobel Laureate i Medicie, visited Idia ad prompted discussios of the possibility of takig advatage of advaces i research techology to address eeds for ew ad better vaccies for diseases of importace to Idia. These discussios, uder the auspices of the Health Medical ad Life Scieces Workig Group of the Ido-U.S. S&T Sub-Commissio, led to a series of actios that ultimately resulted i the sigig of a Govermet-to-Govermet Memoradum of Uderstadig (MOU) for the VAP i July 1987. The cooperatig agecies of the VAP are the Miistry of Health & Family Welfare, ad the Idia Coucil of Medical Research o the Idia side ad the Departmet of Health ad Huma Services (HHS) ad the Uited states Agecy for Iteratioal Developmet (USAID) 2 o the U.S. side. The Natioal Istitute of Health (NIH) 3 ad more specifically the Natioal Istitute of Allergy ad Ifectious Disease (NIAID) 4 withi the NIH are key players i executig ad fudig the VAP program. 61 A similar program was established for cooperatio o cotraceptive ad reproductive health research. The VAP supports a broad spectrum of activities relatig to immuizatio. The program was desiged origially to ecompass laboratory-based research, epidemiological studies, field trials, vaccie quality cotrol, ad delivery of vaccies. Uder the VAP, U.S. ad Idia scietists carry out collaborative research projects directed toward developmet of vaccies ad immuodiagostic reagets, or addressig other issues which are importat for vaccie research. All work is carried out withi areas desigated as VAP priorities by the VAP Joit Workig Group (JWG) that is comprised of scietists ad officials from both coutries. The JWG, co-chaired by oe U.S. ad oe Idia represetative, establishes the policies ad scietific directios for the program, makes decisios o major activities, ad provides scietific oversight ad evaluatio. O the Idia side, the JWG is called the Apex Committee ad is appoited by the Prime Miister. As a committee appoited by the Prime Miister, Oe of the most importat ad successful of the collaborative programs ad iitiatives has bee the Ido-U.S Vaccie Actio Program (VAP). 687

Advaces i Biopharmaceutical Techology i Idia Apex has the power to review ad approve activities o the Idia side. This, coupled with the special authority give to the Idia Departmet of Biotechology (DBT) 14 by the VAP MOU has give this program a extraordiarily workable admiistrative system i Idia i which decisios ca be made rapidly. May projects, for example, have bee reviewed ad approved i a few moths ad scietist exchage visits i as little time as two weeks. The R03 grat provides up to $50,000 direct costs per year for up to two years. Fudig of VAP Fudig for the Vaccie Actio Program is provided by the Departmet of Biotechology (DBT) 14 of the Govermet of Idia ad the Public Health Service (PHS) of the U.S. Departmet of Health ad Huma Services. Research awards are made to U.S. istitutios through the Natioal Istitute of Allergy ad Ifectious Diseases Divisio of Microbiology ad Ifectious Diseases (DMID) 63 at the NIH. Awards to the Idia istitutios are made through the Idia Departmet of Biotechology (DBT). 14 Fiacial support for VAP has bee provided also by the Starr Foudatio, 62 the Iterim Fud, 8 the Childre s Vaccie Program (CVP) 7 of PATH, ad the Bill ad Melida Gates Foudatio through the Malaria Vaccie Iitiative (MVI). NIAID Grats uder the VAP Extramural U.S. ivestigators may be fuded through the NIH R03 mechaism. The R03 grat provides up to $50,000 direct costs per year for up to two years. The R03 awards are ot reewable. Iformatio about R03 grats may be foud uder a ew VAP Program Aoucemet (PA-07-093). 77 Itramural NIH ivestigators ad other Federal scietists may be eligible for research support of comparable duratio ad scope through various iteragecy agreemets. I additio, iformatio about a NIAID Iteratioal Research i Ifectious Diseases (IRID) R03 Program (PAS-04-111), which provides support to istitutios or orgaizatios located i resource- costraied coutries, is also available olie. 76 This mechaism may also provide Idia istitutios workig o VAP projects with additioal fuds to expad their research focus ad collaboratios. Priorities uder the VAP Priorities uder VAP iclude: acute respiratory illesses, rotavirus, cholera, degue, leishmaiasis, rabies, HIV/AIDS, tuberculosis, malaria, ad other emergig ad re-emergig ifectious diseases. Progress related to these priority diseases are give below uder the sectio The Role of the Idia Departmet of Biotechology (DBT) i the U.S.-Idia Collaboratios. Useful iformatioal web liks for the VAP Program: Departmet of Biotechology (Idia) 70 All Idia Istitute of Medical Scieces 71 Natioal Istitute of Immuology (Idia) 72 688

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West Idia Coucil of Medical Research 73 HHS, Office of Global Health 74 Fogarty Iteratioal Ceter at NIH 75 It should be oted that the Natioal Istitutes of Health (NIH) Director Elias A. Zerhoui, M.D., ad Secretary of the Departmet of Biotechology i Idia, Maharaj K. Bha, M.D., reewed the VAP agreemet o May 3, 2007, i Bethesda, for aother five-year period. 64 Iteratioal Ceters for Excellece i Research (ICER) at the Natioal Istitutes of Allergy ad Ifectious Diseases 67 The goal of the ICER program is to develop a sustaied research program of excellece i areas of high ifectious disease burde through parterships with scietists i developig coutries. As a iitial part of this program NIAID through it DMID divisio, is supportig the establishmet of several iteratioal ceters of excellece i research. While focused o cliical research i ifectious disease, each ceter will have the capability to address a rage of research ad traiig eeds. Scietific areas iclude all ifectious diseases except HIV (e.g., TB, malaria, STDs, diarrheal diseases, respiratory diseases, ad vector-bore diseases). I the iitial stages, the goal of this program is to support core ifrastructures cotaiig high quality immuological, microbiological, biostatistical, epidemiological ad cliical research capability. Developmet of i-coutry research capability i areas of high public health importace will be a major emphasis of the ICER Program. The Idia ICER i Cheai, Idia will have a primary affiliatio with the Tuberculosis Research Cetre (TRC), 66 which is a permaet research istitutio of the Idia Coucil of Medical Research (ICMR), 11 a autoomous orgaizatio uder the Miistry of Health ad Family Welfare, Govermet of Idia. I additio, the TRC maitais a umber of academic ad research likages with other Idia istitutios, which may serve as collaboratig ICER sites. The TRC has bee primarily focused o tuberculosis research ad o traiig for tuberculosis research ad cotrol. I additio to well-equipped laboratories for the coduct of bacteriology, immuology, molecular biology, pathology ad biochemistry research, the TRC has ipatiet wards, outpatiet cliics, field sites ad epidemiologic teams. Recet or ogoig activities iclude cliical trials to evaluate priciples of chemotherapy for both pulmoary ad extra-pulmoary tuberculosis, developmet of immuologic ad molecular-based diagostics, mycobacterial geomics, epidemiologic studies o tuberculosis icidece ad prevalece, as well as operatioal research o tuberculosis cotrol. I additio to the support of the Idia Coucil of Medical Research, the TRC has established parterships with a umber of other iteratioal agecies. While focused o cliical research i ifectious disease, each ceter will have the capability to address a rage of research ad traiig eeds. 689

Advaces i Biopharmaceutical Techology i Idia Cheai ad its eviromet also provide opportuities for the study of may other ifectious diseases. The NIAID Laboratory of Parasitic Diseases has had a legthy history of collaboratio with the TRC o pathogeesis of lymphatic filariasis, ad is actively ivolved i ogoig studies o epidemiology, immuology ad chemotherapy of filariasis i the regio. The TRC has also recetly established a HIV laboratory, ad will be ivolved i studies o the iteractio of HIV with TB ad other ifectious diseases. The aim of the DMID program has bee to expad opportuities for research collaboratios o ifectious diseases, ad for research traiig, at the TRC ad its affiliated istitutios. Topics of iterest iclude but are ot limited to tuberculosis, acute respiratory ifectios, parasitic ad other vector-bore diseases. Four additioal projects have bee recommeded for fudig by the eighth CRHR Joit Workig Group meetig held i September 2006. Ido-U.S. Cotraceptive Research Program (CRHR) 68 The Ido-U.S. Cotraceptive Research Program was established i 1997 to promote cotraceptive developmet ad reproductive health research; specific areas addressed withi this program iclude basic cliical ad applied research related to barrier ad immuological methods for cotraceptio ad sexually-trasmitted disease (icludig HIV ifectio) prevetio, microbicide ad spermicide research, epidemiological studies, ad social, behavioral ad itervetio research related to reproductive health - studies of sperm maturatio, motility ad death, edometrial ifertility, ad vagial atimicrobial cotraceptives. Fudig provided by the Departmet of Biotechology 17 of Idia, the Natioal Istitute of Child ad Huma Developmet (NICHD) at the NIH, the Iterim Fud, 11 Office of AIDS Research (OAR) 12 at the NIH, ad the CONRAD Program, 13 a U.S. program dedicated to reproductive health ad HIV prevetio. The DBT Aual report of 2006-2007 details the progress of this importat program. It reports o 11 projects that have bee completed, ad 12 projects that are ogoig. Four additioal projects have bee recommeded for fudig by the eighth CRHR Joit Workig Group meetig held i September 2006. For more details about the various projects the reader may obtai the 2006-2007 aual report by cotactig DBT offices i New Delhi. The Ido-U.S. Disease Surveillace Program The Ido-U.S. Disease Surveillace Program was established i 1997 to assist Ceter/State efforts to stregthe Idia s disease surveillace system. The program objective is to assist the Idia Coucil for Medical Research (ICMR) 11 ad WHO to establish a Field Epidemiology Traiig Program. Fudig for this program comes from ICMR, 11 NICD, 12 CDC, 5 ad the Iterim Fud. 8 The Ido-U.S. Brai Research Program The Ido-U.S. Brai Research Program was established i 1999 to promote eurosciece ad metal health research through targeted workshops to stimulate joit proposals. Fudig for this program is provided by the Natioal 690

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West Istitute of Metal Health (NIMH), the Departmet of Biotechology 14 of the Departmet of Sciece ad Techology 15 i Idia, ad the Natioal Brai Research Ceter of Idia. 13 HIV/AIDS Prevetio Research Program The HIV/AIDS Prevetio Research Program was established i 2000, to promote a rage of HIV/AIDS ad STD prevetio research efforts, icludig behavioral prevetio strategies ad epidemiological ad operatioal research o HIV/AIDS ad STDs, icludig surveillace, STD treatmet, ad reproductive health ad vaccie itervetios. Fudig comes from the NIH 3 (U.S.) ad ICMR 11 (Idia). Materal ad Child Health Research Program 69 The Materal ad Child Health Research Program was established i 2000 to promote research i areas related to materal ad child health ad developmet (MCHDR) of research, icludig but ot limited to idetificatio of ad developmet of itervetio to reduce risk factors for materal morbidity/ mortality, adverse birth outcomes (low birth weight, microutriets), disease prevetio (icludig reproductive tract ifectios, materal-to-child trasmissio of HIV). Basic, cliical ad applied research to addresses the reductio of birth defects, geetic disorders, ad developmetal disabilities, is ecouraged. The MCHDR also covers research o systems/methods of traditioal medicie, reproductive health icludig birth practices, evaluatio of ewer cotraceptives ad social-behavioral factors that impact o the health of mothers ad childre. NIH Visitig Researcher Program At the ed of 2006 there were 276 Idia researchers o the NIH campus (icludes 217 Visitig Fellows, 49 Visitig Scietists, ad 6 Voluteers, 2 Guest Researchers, ad 2 Exchage Scietists). At the ed of 2006 there were 276 Idia researchers o the NIH campus (icludes 217 Visitig Fellows, 49 Visitig Scietists, ad 6 Voluteers, 2 Guest Researchers, ad 2 Exchage Scietists). 3. The Role of NIH i the U.S.- Idia Collaboratios The Natioal Istitutes of Health (NIH), a public health agecy of the Departmet of Health ad Huma Services of the U.S. govermet based i Bethesda Marylad, is supportig medical research programs aroud the globe. The NIH recogizes the importace of improvig public health i developig coutries ad dedicates a large portio of its extramural grats of approximately $28 billio aually to the support of medical research i developig coutries, Idia icluded. The fiacial support for medical research i Idia covers a large rage of diseases ad comes from almost every oe of the 27 Istitutes ad Ceters that costitute the NIH. Research fuds from the NIH may go directly to a Idia research istitutio or to a U.S. istitutio that collaborates with a Idia orgaizatio. Some of the most promiet projects ad collaboratios supported by the NIH i Idia 691

Advaces i Biopharmaceutical Techology i Idia are provided below ad listed accordig to the gratig istitute: NCCAM (Natioal Istitute for Complemetary ad Alterative Medicie) The Christia Medical College (Vellore, Idia), 17 the Ayurvedic Trust, ad Bastyr Uiversity (U.S.) have developed collaboratios to ivestigate the safety ad efficacy of Ayurvedic medicie. 16 It should be oted that Bastyr Uiversity at Seattle, Washigto is oe of the world s leadig academic ceters for advacig kowledge i the atural health scieces. A twetyeight-year pioeer i atural medicie, Bastyr cotiues to be i the forefrot of developig the model for 21st cetury medicie. (FY 05-06) NCI (Natioal Cacer Istitute) SHARE Idia-MediCiti Hospital (Idia) ad Johs Hopkis Uiversity (U.S.) are collaboratig to study markers of progressio to cervical cacer i rural Idia. This project is part of NCI s Specialized Programs of Research Excellece (SPORE) 18 to promote iterdiscipliary research ad to speed the bi-directioal exchage betwee basic ad cliical sciece to move basic research fidig from the laboratory to applied settigs ivolvig patiets ad populatios. (FY 04-08) NHLBI (Natioal Heart, Lug, ad Blood Istitute) The All Idia Istitute of Medical Scieces (AIIMS) 19 i New Delhi has joied Duke Uiversity Medical Ceter i the Surgical Treatmet for Ischemic Heart Failure (STICH) trial. Researchers are ivestigatig the beefits of medical versus surgical itervetio for patiets with obstructive coroary disease ad cogestive heart failure. (FY 05-09) NIA (Natioal Istitute of Agig) TN Medical College/Nair Hospital (Idia) ad Mout Siai School of Medicie i the U.S. have built research capacity for demetia ad agerelated cogitive declie research i Mumbai. (FY 04-06) NIAAA (Natioal Istitute o Alcohol Abuse ad Alcoholism) Ivestigators from the Drug Abuse Iformatio ad Research Ceter i Mumbai ad the Sloa-Ketterig Istitute for Cacer Research i New York have collaborated o the STEP program, a alcohol ad HIV prevetio educatio program. The objective is to develop a program to prevet HIV risk behaviors ad alcohol abuse amog adolescets i Idia resposive to the cultural ad socioecoomic issues that place adolescets there at risk for both alcohol abuse ad HIV trasmissio. (FY 04-06) Researchers from the Sagath Society for Child Developmet ad Family Guidace (Idia) ad the Alcohol Research Group, Public Health Istitute i Berkley, Califoria have studied populatio drikig patters ad HIV risk, i Goa, Idia. (FY 04-06) NIAID (Natioal Istitute of Allergy ad Ifectious Diseases) Collaborators from the Istitute of Molecular Medicie (Idia) ad the 692

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West Research Triagle Istitute (U.S.) 20 are studyig immuity to vaccies ad ifectio i the Populatio Geetics Aalysis Program (FY 05-09). Researchers from the All Idia Istitute of Medical Scieces (AIIMS) 19 ad New York Uiversity are workig towards the desig of broadly eutralizig ati-hiv atibody resposes, a primary goal i the race for a efficiet HIV vaccie. (FY 05-09) Scietists from the Mumbai District AIDS Cotrol Society ad the Uiversity of Califoria have collaborated i efforts to perform a itervetio for male STD patiets i Idia. (FY 00-06) NICHD (Natioal Istitute of Child Health ad Huma Developmet) Researchers from the Natioal Coucil of Applied Ecoomic Research 21 (Idia) ad the Uiversity of Marylad are studyig paretal educatio ad child outcomes. (FY 04-07) Natioal Coucil of Applied Ecoomic Research21 ad College of Behavioral ad Social Scieces (U.S.) researchers have studied the determiats of materal ad child health i Idia. (FY 03-06) NIDA (Natioal Istitute o Drug Abuse) Tata Istitute for Fudametal Research (Idia) ad Uiversity of Arizoa researchers have collaborated o a study of Fos, Ju, ad syaptic plasticity. (FY 04-06) NIDDK (Natioal Istitute of Diabetes ad Digestive ad Kidey Diseases) Researchers from St Joh s Medical College (Idia) 22 ad the Massachusetts Istitute of Techology (U.S.) have bee studyig huma amio acid requiremets. (FY 99-07) Researchers at the LTM Medical College (Mumbai Idia) uder a grat from NIDDK have ivestigated T2*/T2 calibratio ad applicatio to magetic resoace (MR) of heart iro. (FY 03-06) NIMH (Natioal Istitute o Metal Health) Scietists from the Natioal Brai Research Ceter13, a Istitute of the Departmet of Biotechology (DBT) i Idia, ad the Uiversity of Texas Health Sciece Ceter are studyig huma brai CYP p450s ad psychoactive drug metabolism. (FY 04-07) Researchers from the Natioal Istitute of Metal Health ad Neuroscieces (NIMHANS) i Idia ad Johs Hopkis Uiversity have studied cellular tropism ad reservoir i the brai with HIV-Clade C. (FY 04-06) Schizophreia Research Foudatio (SCARF) i Madras, Idia, ad Idiaa Uiversity scietists have studied visual processig i schizophreia ad schizotypal persoality disorder. (FY 04-06) Researchers from the Iteratioal Istitute for Populatio Scieces (Idia) ad the Uiversity of Coecticut Health Ceter have studied male sexual cocers ad prevetio of HIV/STDs i Idia. (FY 02-06) Dr. Ram Maohar Lohia Hospital (Idia) ad the Uiversity of Pittsburgh 693

Advaces i Biopharmaceutical Techology i Idia researchers have studied geetic susceptibility i schizophreia. (FY 02-06) Scietists at the YRG Cetre for AIDS Research ad Educatio i Idia, ad Johs Hopkis Uiversity have performed a collaborative HIV/STD prevetio trial. (FY 99-06) NINDS (Natioal Istitute of Neurological Disorders ad Stroke) Researchers from the Natioal Istitute of Metal Health ad Neuro Scieces (NIMHANS) i Bagalore, Idia, ad the Uiversity of Miami School of Medicie have studied eurological progressio i HIV-1 ad HIV-2 co-ifectio. (FY 02-06) 4. NIH Fogarty Iteratioal Ceter Programs Useful For Collaboratios i Idia The Fogarty Iteratioal Ceter (FIC) 23, the iteratioal compoet of the NIH, addresses global health challeges through iovative ad collaborative research ad traiig programs ad supports ad advaces the NIH missio through iteratioal parterships. I its 35 years history the FIC has grow i a substatial way to havig a budget of $64 millio (2006), all ivested i research, traiig, ad capacity-buildig eterprise extedig to over 100 coutries ad ivolvig some 5,000 scietists i the U.S. ad abroad. Accordig to FIC the total support provided to Idia by the NIH reached more tha $16.5 millio i 2006. The umber of Idia fellows at the NIH at the ed of 2006 approached 300 as metioed above. Followig are some of the iteratioal programs sposored by the NIH/FIC aimed at supportig collaborative research betwee U.S. ad scietists i developig coutries. Support for U.S. - Idia joit research through these programs is emphasized ad detailed below: Fogarty Iteratioal Research Collaboratio Awards (FIRCA) 29 The Fogarty Iteratioal Research Collaboratio Awards (FIRCA) program was iitiated i 1992 by the Fogarty Iteratioal Ceter to foster iteratioal research parterships betwee NIH-supported U.S. scietists ad their collaborators i coutries of the developig world. The program fuds 3- year research parterships betwee practicig scietists ad physicias i the Uited States ad abroad. Geographically, the emphasis is o parterships betwee U.S. scietists ad their colleagues located i developig coutries. The program aims to beefit the research iterests of both the U.S. priciple ivestigator ad the iteratioal research collaborator while icreasig research capacity at the iteratioal site. The program has evolved sice its iceptio with progressively more focus o the capacity developmet aspects of the award. I 1994, a AIDS-specific award, ot restricted to developig or trasitio coutries, was added (AIDS FIRCA). Tata Istitute of Fudametal Research (Idia) ad Yale Uiversity 694

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West researchers have utilized a Fogarty Iteratioal Research Collaboratio Award (FIRCA) to study early eviromet ad the eurobiology of depressio. (FY 04-06) A grat uder AIDS FIRCA was grated to the Tuberculosis Research Cetre (Idia) ad Temple Uiversity to study apoptosis i tuberculosis i Idia. (FY 05-07) FIRCA award was grated to the Uiversity of Califoria, Sa Diego ad Tata Istitute of Fudametal Research i Idia for the study of Geetic Aalysis of Dedritic Targetig. (FY 02-06) FIRCA award was grated to Harvard Uiversity, School of Public Health ad SRI Ramachadra Medical College & Research Istitute of Idia for the study of lead exposure ad outcomes amogst childre i Cheai, Idia. (FY 03-07) FIRCA award was grated to the Uiversity of Virgiia, Charlottesville ad Bose Istitute, Idia, for the ivestigatio of replicatio cotrol i E. histolytica. (FY 05-07) FIRCA award was grated to Staford Uiversity School of Medicie ad Bose Istitute, Idia for the study o idetifyig regulatio of cell cycle gee etworks i E. histolytica. (FY 06-08) The Global Health Research Iitiative Program (GRIP) 30 The GRIP program is iteded to promote productive re-etry of NIHtraied foreig ivestigators ito their home coutries as part of a broader program to ehace the scietific research ifrastructure i developig coutries, to stimulate research o a wide variety of high priority health-related issues i these coutries, ad to advace NIH efforts to address health issues of global import. Researchers from the Cetre for DNA Figerpritig ad Diagostics i Idia, uder a Global Health Research Iitiative Program for New Foreig Ivestigators (GRIP) award, have studied the fuctioig of K-ras i lug type II epithelial cells. (FY 02-06) A additioal GRIP was awarded to researchers at the Cetre for DNA Figerpritig ad Diagostics i Idia to study trascriptio termiatio ad ati-termiatio i E. coli. (FY 02-06) GRIP award was grated to researchers at the Idia Statistical Istitute to study statistical methods for mappig multivariate pheotypes. (FY 03-07) Uder a GRIP award, researchers from the Hyderabad Eye Research Foudatio are performig molecular geetic studies of retiitis pigmetosa i Idia. (FY 03-07) The AIDS Iteratioal Traiig ad Research Program (AITRP) 28 The AIDS Iteratioal Traiig ad Research Program (AITRP) bega i 1988 as oe of the first of a ew geeratio of research traiig programs sposored by the Fogarty Iteratioal Ceter at the Natioal Istitutes of 695

Advaces i Biopharmaceutical Techology i Idia Health. These programs provide traiig for scietists from istitutios i lowad middle-icome coutries to stregthe HIV-related research ad public health capacities at their istitutios. Begiig i 2007, foreig istitutios i low-ad middleicome coutries became eligible to apply for two-year plaig grats. Grats for full research traiig programs are awarded to U.S. istitutios with strog HIV- related research traiig experiece ad with HIV-related research collaboratios with istitutios i low- ad middle- icome coutries. The gratees, i partership with their foreig collaboratig istitutios, idetify foreig health scietists, cliicias, ad allied health workers from the foreig coutries to participate i their joit research traiig programs. Begiig i 2007, foreig istitutios i low-ad middle-icome coutries became eligible to apply for two-year plaig grats. The primary goal of this program is to build multi-discipliary biomedical, behavioral ad social sciece research capacity for the prevetio, care ad treatmet of HIV/ AIDS ad HIV-related coditios for those adults ad childre affected by HIV/AIDS i the collaboratig coutry. AITRP makes provisios for traiig i the Uited States, i other coutries, ad i the home coutries. Support of Idias researchers uder the AIDS Iteratioal Traiig ad Research Program (AITRP) at Johs Hopkis Uiversity, Uiversity of Califoria, Los Ageles, Yeshiva Uiversity, Albert Eistei College of Medicie, Brow Uiversity, Tufts Uiversity, Uiversity of Pittsburgh, Uiversity of Alabama, Birmigham, New York Uiversity, Uiversity of Washigto, ad the Uiversity of Califoria, Berkeley was provided for traiig to icrease the proficiecy ad health professioals to udertake biomedical ad behavioral research related to HIV/AIDS ad to develop their skills i the coduct of cliical trials ad prevetio-related research. Iteratioal Cliical, Operatioal ad Health Services Research ad Traiig Awards (ICOHRTA) 24 The Iteratioal Cliical, Operatioal ad Health Services Research ad Traiig Awards (ICOHRTA) is a iovative program to support itegrated multidiscipliary, cliical, operatioal, ad health services research ad traiig collaboratios betwee U.S. istitutios ad those i developig coutries. The ICOHRTA provides opportuities for health professioals to trai at the Ph.D., masters, ad post-doctoral levels while workig o iteratioal research projects related to a variety of o-commuicable coditios. Iteratioal Cliical, Operatioal ad Health Services Research ad Traiig Awards (ICOHRTA) were grated to Washigto Uiversity ad the Uiversity of Alabama at Birmigham to support Idias researchers at the Natioal Istitute of Metal Health ad Neuroscieces i Bagalore for iteratioal research traiig i cliical scieces ad to researchers the Madras Diabetes Research Foudatio i Cheai for cliical research traiig for studies of CVD i Idia. The awards are iteded to stregthe global capacity to characterize the disease burde of chroic coditios, to ecourage 696

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West iteratioal efforts to apply curret kowledge ad ew discoveries to cliical public health practice, ad to evaluate practical ad affordable therapeutic ad prevetive itervetios ad health service delivery for global health problems i the cotext of local eeds ad coditios. The Iteratioal Traiig ad Research Program i Evirometal ad Occupatioal Health (ITREOH) 25 The Fogarty Iteratioal Ceter, i collaboratio with the Natioal Istitute of Evirometal Health Scieces (NIEHS), NIH, ad the Natioal Istitute for Occupatioal Safety ad Health (NIOSH), Ceters for Disease Cotrol ad Prevetio (CDC), has developed the ITREOH program i order to trai foreig health scietists, cliicias, epidemiologists, toxicologists, egieers, idustrial hygieists, chemists, ad allied health workers from developig coutries ad emergig democracies i both geeral evirometal health ad occupatioal health. Program Desig: Icrease expertise i epidemiology, egieerig, ad other compoets of evirometal ad occupatioal health through short-ad log-term traiig at U.S. istitutios, which may lead to M.S. or Ph.D. degrees i epidemiology, egieerig, toxicology, ad other related areas; Icrease laboratory expertise of techical assistats i foreig coutries who are egaged i epidemiological ad other studies related to evirometal ad occupatioal health through i- coutry, short-term, didactical, ad techical traiig; ad Expad ogoig collaborative traiig ad research i evirometal or occupatioal health betwee U.S. ad foreig scietists. Traiig Types: Traiig i epidemiology cocepts ad methods, evirometal moitorig, idustrial hygiee, field studies ad other research related to evirometal ad occupatioal health that will lead to the M.S. or Ph.D. degree for idividuals with previous field research experiece; Traiig i epidemiology, field studies, evirometal moitorig, idustrial hygiee, ad research related to evirometal ad occupatioal health that will lead to the M.S. degree for idividuals without prior field research experiece; Short-term comprehesive courses i epidemiology, toxicology, chemistry, idustrial hygiee ad evirometal ad safety egieerig, with a emphasis o cotrol of occupatioal ijuries ad illesses, for health ad safety professioals to be give i the U.S.; Traiig i laboratory procedures ad research techiques related to evirometal ad occupatioal health for idividuals with the M.S. or Ph.D. degree to be give i the U.S.; ad Postdoctoral research traiig for foreig scietists who wat to expad their abilities i the epidemiology, diagosis, prevetio ad treatmet of 697

Advaces i Biopharmaceutical Techology i Idia evirometal ad occupatioal disease ad ijury. Postdoctoral traiig ca take place both i the U.S. ad i foreig coutries. I the last several years support of Idias health professioals uder the Iteratioal Traiig ad Research Program i Evirometal ad Occupatioal Health (ITREOH) at the Uiversity of Califoria, Berkley was provided for traiig i areas such as cacer epidemiology, toxicology, occupatioal medicie, ad evirometal epidemiology. Miority Iteratioal Research Traiig Grat (MIRT) 26 The MIRT program, ow amed the Miority Health ad Health Disparities Iteratioal Research Traiig (MHIRT) Grat Program, is ow uder ew maagemet at the Natioal Ceter o Miority Health ad Health Disparities of the NIH. 27 Grats uder the MIRT support iovative programs that offer iteratioal professioal studets who are from health disparities populatios ad/or are uderrepreseted i basic sciece, biomedical, cliical, or behavioral health research career fields. The program is a compoet i the log-term NIH strategy to decrease health disparities betwee miority ad majority groups i the U.S. Uder the Miority Iteratioal Research Traiig Grat (MIRT) support for graduate ad udergraduate U.S. miority studets from the Uiversity of Alabama at Birmigham was awarded to study societal differeces i the treatmet of male ad female childre at the Society for Applied Studies i Kolkata, Idia. Aother MIRT grat was awarded to studets from Alcor State Uiversity i Mississippi to study toxicology, parasitology, immuology, computer modelig, ad ecology i collaboratio with Idia health professioals. Other NIH/FIC Programs to Support Collaborative Research betwee U.S. ad Idia Uder the program of Brai Disorders i the Developig World: Research Across the Lifespa, 33 collaboratio was established betwee Morehouse School of Medicie, Atlata, GA ad Malaria Research Cetre/Regioal Medical Research Cetre (ICMR), Idia to study Cerebral Malaria Neurological Disorders i Idia. (FY 03-07) Iteratioal Research Scietist Developmet Award (IRSDA) 34 was give to the Uiversity of Pittsburgh at Pittsburgh, ad Dayaad Medical College & Hospital i Idia for the study of Ido-U.S. Collaboratio i Geomic Studies o Diabetes. (FY 05-07) Uder the Iteratioal Collaborative Geetics Research Traiig Program, 35 support of Idia scietists at the Wester Psychiatric Istitute ad Cliic at the Uiversity of Pittsburgh has bee provided to study psychiatric geetics i Idia. This program aims to ehace ad promote equitable iteratioal collaboratios betwee ivestigators i the developed world ad those i 698

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West developig coutries where a base level of istitutioal ifrastructure for the advacemet of sustaiable geetic sciece is already established. Support of Idia health professioals uder the Iteratioal Traiig ad Research Program i Populatio Health 36 at the Departmet of Cell Biology at the Uiversity of Virgiia, ad the Uiversity of North Carolia, Chapel Hill was provided to study issues of the reproductive processes, cotraceptive developmet, cotraceptive ad reproductive evaluatio, reproductive epidemiology, ad social ad behavioral factors that ifluece populatio dyamics. Geerally, the Iteratioal Traiig ad Research Program i Populatio Health supports research traiig of low- ad middle-icome coutry scietists with the log-term objective of stregtheig these coutries research programs ad istitutios related to populatio health, icludig the study of demographic ad reproductive processes. The program is iteded to stregthe the ability of scietists from low- ad middle-icome coutries to cotribute to global populatio research efforts ad to commuicate ad dissemiate kowledge i support of populatio policies appropriate for their home coutries ad commesurate with established iteratioal guidelies. Uder the Cetrally Coordiated Bioethics Program for Idia, 37 as part of the FIC Iteratioal Bioethics Educatio ad Career Developmet Award program, support was provided for researchers from the Idia Coucil of Medical Research to work o a two-year plaig project of a cetrally coordiated program i bioethics ad research ethics i Idia. The project has the followig objectives: to pla developmet of a uiform atioal bioethics curriculum for medical studets, health professioals ad researchers with the overall goal of stregtheig the kowledge base i iteratioal bioethics ad research ethics; to develop a cetrally coordiated etwork of faculty to deliver this curriculum; ad to develop a system to modify ad improve this curriculum o a ogoig basis. This program is desiged to support the developmet or expasio of graduate curricula i iteratioal bioethics related to coductig research i low- ad middle-icome coutries. Support was provided to two Fellows uder the a Fogarty Iteratioal Ceter/Elliso Medical Foudatio Award to work i Vellore, Idia uder the metorship of Drs. Keeth Mayer, Brow Uiversity, ad Gagadeep Kag, Christia Medical College, o the molecular epidemiology of cryptosporidial ifectios i HIV ifected idividuals i South Idia. The FIC/Elliso Overseas Fellowships i Global Health ad Cliical Research are a oe year cliical research traiig experiece for graduate level U.S. studets i the health professios. This program presets a opportuity for highly motivated idividuals to experiece metored research traiig at top-raked NIH-fuded research ceters i developig coutries. Each Fellowship is for a oe-year period. The term begis with a itesive orietatio program o the NIH campus i Bethesda, Marylad, followed This program is desiged to support the developmet or expasio of graduate curricula i iteratioal bioethics related to coductig research i low- ad middleicome coutries. 699

Advaces i Biopharmaceutical Techology i Idia by approximately 10+ moths of itese research traiig at the foreig site. Uder the Iteratioal Tobacco ad Health Research ad Capacity Buildig Program, 31 researchers from the Epidemiological Research Ceter i Idia ad the Uiversity of Toroto are collaboratig to stregthe moitorig of Idia tobacco mortality. (FY 04-08) Uder the same program, scietists from the Achutha Meo Cetre for Health Sciece Studies i Idia ad the Uiversity of Miesota are performig cessatio research ad traiig i Idia ad Idoesia. (FY 03-07) Researchers from the Health Related Iformatio Dissemiatio Amogst Youth (HRIDAY) ad the Uiversity of Miesota, uder a Iteratioal Tobacco program award, have collaborated o a study o mobilizig youth for actio agaist tobacco i Idia. (FY 02-06) A goal of aother relevat program, the Stigma ad Global Health Research Program, 32 is to support research that leads to better uderstadig of the role of stigma i health throughout the world. Research i this area is the best hope for developig evidece-based itervetios to prevet or mitigate stigma s egative effects o the health of idividuals, families, ad societies worldwide. Stigma prevets people from seekig diagosis ad care ad from participatig i research that could lead to effective itervetios. Uder the Stigma ad Global Health Research Program, ivestigators from the Tata Istitute of Social Scieces i Idia, ad the Uiversity of Califoria Sa Fracisco are examiig AIDS stigma ad geder discrimiatio i patiets treated i health care systems of Mumbai ad Bagalore. (FY 05-09) 5. The Role of the CDC i the U.S.- Idia Collaboratios The 5 Ceters for Disease Cotrol ad Prevetio (CDC) is oe of the 13 major operatig compoets of the Departmet of Health ad Huma Services (HHS) of the Uited Stated Govermet. Sice it was fouded i 1946 to help cotrol malaria, CDC has remaied at the forefrot of public health efforts to prevet ad cotrol ifectios ad chroic diseases ijuries, workplace hazards, disabilities, ad evirometal health threats throughout the world. The CDC has particular focus o fieldbased epidemiology ad laboratory traiig for i-coutry public health professioals that is especially relevat for health-related collaboratios i Idia. The CDC is composed of differet Ceters, Istitutes ad Offices (CIO) ad a dedicated Office of Global Affairs (OGA). Almost all of the CIO orgaizatios at CDC are active i sposorig ad supportig differet health related programs i Idia ad there are some CDC persoel statioed i Idia to 700

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West assist ad provide expertise i various epidemiological studies. Some of the most active CIOs i Idia are: the Natioal Ceter for Ifectious (NCID), 38 Natioal Ceter for HIV/AIDS, Viral Hepatitis, STD ad TB prevetio (NCHHSTP), 39 Natioal Immuizatio Program (NIP), 40 Natioal Ceter for Evirometal Health (NCEH), 41 Agecy for Toxic Substaces ad Disease Registry (ATSDR), 42 Natioal Ceter for Chroic Diseases Prevetio ad Health Promotio (NCCDPHP), 43 ad Natioal Istitute for Occupatioal Safety ad Health (NIOSH), 44 the Evirometal Protectio Agecy (EPA), 45 ad the Public Health Practice Program Office (PHPPO). 46 Followig is a list of curret activities ad collaboratios betwee the CDC ad Idia govermet ad research istitutios. The list is arraged by alphabetical order, but each of the activities cotais otes regardig the start date of the activity, the status ad the sposorig CIO: Atimicrobial Resistace The WHO Exteral Quality Assessmet Schemes (EQAS) proficiecy ad quality cotrol program is coducted by NCID s Divisio of Healthcare Quality Promotio (DHQP). DHQP staff selects ad package susceptible ad resistat cotrol strais of bacteria for testig ad ships them to participatig iteratioal laboratories i 40 coutries, icludig Idia, who the test the strais ad fax results directly to DHQP for aalysis. DHQP staffs assess laboratory performace ad sed a cumulative summary to each laboratory as well as to WHO. Accuracy of testig has improved i areas where local or regioal assistace is available. CIO: NCID Start Date: Oct, 1996 Status: ogoig Birth Defects As part of a iteratioal quality assurace program, NCEH staff provides dried blood spot quality cotrol ad performace evaluatio materials for screeig tests for a variety of diseases to iteratioal eoatal screeig laboratories, icludig laboratories i Idia. The diseases, which vary by coutry, iclude cogeital hypothyroidism, pheylketouria, galactosemia, cogeital adreal hyperplasia, maple syrup urie disease, ad homocystiuria. CIO: NCEH Start Date: Ja, 1998 Status: ogoig Blood Safety I FY 2003, uder a cooperative agreemet with the America Red Cross (ARC), Global AIDS Program (GAP) Idia idetified traiig priorities for a blood safety program. Natioal leaders, icludig represetatives from the Natioal AIDS Cotrol Program, met with represetatives of the Idia Red Cross to review the assessmet results of 81 blood baks ad review plas for the quality cotrol traiig program. CIO: NCHSTP Start Date: 2001 Status: ogoig 701

Advaces i Biopharmaceutical Techology i Idia [E]ach year DVH sposors a average of 20 iteratioal fellows for traiig i viral hepatitis laboratory research; these fellows sped a average of 2 to 4 years at CDC ad the retur to their home coutries to cotiue their research. Capacity Developmet I FY 2003, Global AIDS Program (GAP) Idia supported data etry of more tha 200,000 patiet records ito the GAP-supported iformatio system (TB/HIV Iformatio System, T/HIS) developed at the Govermet Hospital of Thoracic Medicie (GHTM). Hospital staffs were traied i the use of the iformatio systems ad mothly reports are ow beig geerated. These data have helped both atioal ad state-level officials recogize the critical eed for developig quality care programs for HIV/AIDS ad HIV/ TB throughout souther Idia. CIO: NCHSTP Start Date: 2001 Status: ogoig NCID s Divisio of Viral Hepatitis (DVH) has provided techical assistace to ad coducted workshops ad traiig sessios for public health scietists ad laboratorias from other coutries, icludig Idia. Overseas, DVH persoel have led courses focusig o the epidemiology ad prevetio of viral hepatitis, viral hepatitis surveillace, laboratory aspects ad diagosis of viral hepatitis, ijectio safety, blood safety, ad medical practice safety. Laboratory traiig evets ofte ivolve wet (active) laboratory compoets ad last for several days. I additio, each year DVH sposors a average of 20 iteratioal fellows for traiig i viral hepatitis laboratory research; these fellows sped a average of 2 to 4 years at CDC ad the retur to their home coutries to cotiue their research. CIO: NCID Start Date: 1980 Status: ogoig Cardiovascular Disease I 1984, the curret CDC-Natioal Heart, Lug, ad Blood Istitute (NHLBI) Lipid Stadardizatio Program (LSP) was implemeted to offer combied total cholesterol (TC), triglyceride (TG), ad high desity lipoprotei cholesterol (HDLC) stadardizatio services. Stadardizatio assistace is offered to ay iteratioal laboratory ivolved i cliical trials ad ivestigatios supported by NHLBI, other istitutes of the Natioal Istitutes of Health (NIH), ad WHO icludig laboratories i Idia. The goal of the LSP is to improve the laboratory measuremet of cholesterol ad related lipids so that they are measured with the accuracy ad precisio eeded for detectio, treatmet, ad prevetio of cardiovascular disease. CIO: NCEH Start Date: Ja, 1984 Status: ogoig Evirometal Health I 2002, Idia s Miistry of Health ad Family Welfare ad the U.S. Departmet of Health ad Huma Services siged a Joit Statemet o Ido-U.S. Collaboratio o Evirometal ad Occupatioal Health. The lead agecy for Idia is the Idia Coucil for Medical Research (ICMR). The lead U.S. agecy is CDC/ATSDR. The first meetig of the Joit Workig Group was held i New Delhi i March 2003. The meetig brought together scietists ad govermet represetatives from Idia ad the Uited States. Focus areas 702

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West idetified as priorities for collaborative research ad educatio projects iclude arseic exposure ad toxicity, idoor air pollutio, emergecy respose, peumovoioses, chemical toxicats, childre s evirometal health, ad geeeviromet iteractio. Uder the auspices of the collaboratio, ATSDR has fuded a research project to evaluate the health effects of tremolite asbestos. U.S. members of the Joit Workig Group iclude ATSDR, NCEH, NIOSH, EPA, the Natioal Istitute of Evirometal Health Services, the Armed Forces Istitute of Pathology, ad the U.S. Geological Survey. CIO: ATSDR Start Date: Dec, 1999 Status: ogoig A group of public health scietists i the Uited States ad Idia is participatig i a ogoig collaboratio to foster improved evirometal ad occupatioal health i Idia. The group acts as a catalyst for the establishmet of ew evirometal research collaboratios amog scietists i both coutries. Topics o which NCEH scietists collaborate with Idia colleagues iclude air pollutio, silicosis, ad heavy metal poisoig. CIO: NCEH Start Date: Apr, 2002 Status: ogoig Epidemiology Service ad Traiig I late 1999, the Idia Govermet established a Field Epidemiology Traiig Program (FETP) based i the Natioal Istitute of Epidemiology (NIE) i Cheai (formerly Madras), Tamil Nadu State, Idia. This FETP is similar i desig, methodology, ad outcome to CDC s Epidemic Itelligece Service (EIS) ad is oe of may istitutes of the Idia Coucil for Medical Research (ICMR), which focuses o ifectious disease research. I 2003, CDC selected a experieced field epidemiologist to serve as a residet advisor (RA) ad is workig to place him i Cheai i 2004 through WHO/Idia. The RA will assist i traiig ad metorig FETP traiees as they apply their skills to solve real public health problems i Idia. May strog parterships ad collaboratios helped lauch this program ad will help sustai its growth over time. Curretly, the program hosts traiees from six Idia states whose collective populatio is 200 millio (of the coutry s total populatio of 1 billio). As soo as the Tamil Nadu program is established to the satisfactio of all parters, CDC will ecourage its Idia parters to sed stroger graduates to other states to begi satellite programs atiowide, helpig the Idia govermet realize its goal of improvig the populatio s health while buildig its ow public health ifrastructures. CIO: EPO Start Date: Ja, 2001 Status: ogoig Gastroeteritis NCID s Divisio of Viral ad Rickettsial Diseases hosted a pathologist from the All Idia Istitute of Medical Scieces (AIIMS) i New Delhi. Techical assistace was provided i the examiatio of gastroitestial specimes, which icluded histopathologic evaluatio ad immuohistochemical assays 703

Advaces i Biopharmaceutical Techology i Idia for adeovirus ad rotavirus. CIO: NCID Start Date: Oct, 2002 Ed Date: Nov, 2002 Status: completed Hepatitis I collaboratio with colleagues from the Sajay Gadhi Istitute of Medical Scieces i Luckow, Idia, researchers from NCID s Divisio of Viral Hepatitis (DVH) are studyig the trasmissio of hepatitis E virus (HEV), with particular emphasis o subcliical ifectios as a possible reservoir of the virus i a cyomolgus macaque model of the disease. The data obtaied from these studies will add to curret kowledge about the biology of HEV ifectio ad help to develop strategies aimed at the prevetio ad cotrol of these ifectios. I additio, DVH hosted a guest researcher from the Sajay Gadhi Istitute for a year to work o this project at CDC. CIO: NCID Start Date: May, 1999 Status: ogoig HIV I FY 2003, Global AIDS Program (GAP) Idia siged a cooperative agreemet with the Idia Network of Positive People (INP+) to establish a predischarge family couselig ceter at the Govermet Hospital of Thoracic Medicie (GHTM), which has stregtheed the likages betwee cliical care, the affected commuities, ad HIV prevetio at GHTM. The Govermet of Tamil Nadu has provided space for the couselig ceter o GHTM property ad reovatio plas have bee developed. INP+ members regularly participate i meetigs at GHTM ad are becomig valued members of the HIV/AIDS care ad prevetio team at the hospital. GAP-sposored activities at the GHTM, the largest AIDS care ceter i Idia, have bee i place sice 2001. I 2003, the GHTM averaged 300 HIV-positive outpatiets per day, icludig 30 to 60 ew patiets. Betwee Jauary ad September 2003, the hospital admitted 6,857 patiets ad saw 9,832 ew outpatiets; quarterly reports demostrate that the umber of patiets beig see is substatially higher compared to the previous year. Characterizig these patiets epidemiologically ad cliically will provide valuable iformatio to both the state ad atioal HIV/AIDS program as well as the Natioal Tuberculosis Program. Uder a cooperative agreemet with the Tamil Nadu State AIDS Society (TNSACS), programs at GHTM are beig stregtheed, local owership of the project is growig, ad other key public ad private medical istitutios i the state are beig icluded i the project. CIO: NCHSTP Start Date: 2001 Status: ogoig As part of a iteratioal laboratory quality assurace program, staff from NCEH s Divisio of Laboratory Scieces (DLS) coducts evaluatios for HIV atibody testig o dried blood spots from samples provided by laboratories i fourtee coutries, icludig Idia. DLS also supports CDC s Global AIDS Program o quality assurace issues cocerig cofirmatio of atibody testig i coutry ad use of the ew HIV rapid tests i resource poor coutries. CIO: NCEH Start Date: Ja, 1988 Status: ogoig 704

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West HIV/STD Prevetio I FY 2003, Global AIDS Program (GAP) Idia supported the Natioal Advisory Committee for Quality volutary HIV couselig ad testig (VCT), which made sigificat progress i coductig regioal workshops o VCT, reviewig ad revisig Idia s atioal VCT guidelies, ad creatig opportuities for commuicatig the importace of VCT at atioal ad local forums. Represetatives from the steerig committee commuicate via a desigated Web site ad meet regularly to review progress ad make recommedatios o the implemetatio of the atioal VCT program. GAP Idia also iitiated youth activities i four high prevalece districts i the states of Tamil Nadu ad Adhra Pradesh after cosultatio with state AIDS Directors. CIO: NCHSTP Start Date: 2001 Status: ogoig I FY 2003, Global AIDS Program (GAP) Idia staff established excellet workig relatioships with the Govermet of Idia ad bilateral, multilateral, ad ogovermetal orgaizatio (NGO) couterparts at both the atioal ad local levels, becomig valued techical advisors o HIV/AIDS withi the U.S. Missio, door commuity, ad the Idia govermet. GAP Idia staff actively participated i the Uited Natios Theme Group ad provided techical support to the Idia govermet for the secod ad third rouds of the Global Fud Proposals for HIV/AIDS, Tuberculosis, ad Malaria. The Global Fud applicatios were successful i mobilizig almost $150 millio for HIV/AIDS, TB, ad TB/HIV programs i Idia. GAP Idia worked with a etwork of Idia epidemiologists, biostatisticias, ad behavioral scietists (IdiaCLEN) for techical support of GAP Idia s projects. IdiaCLEN members work closely with GAP Atlata techical staff i order to esure cosistecy of techical support ad to further stregthe local capacity for HIV/AIDS. IdiaCLEN staff has become valued parters at the Govermet Hospital of Thoracic Medicie (GHTM), providig support i the use of the iformatio system for data aalysis. CIO: NCHSTP Start Date: 2001 Status: ogoig I FY 2003, Global AIDS Program (GAP) Idia provided primary health care, HIV couselig, ad referral services to people i slum commuities i Pue, Maharastra through a cooperative agreemet with Project Cocer Iteratioal (PCI). The project was recetly expaded from six to ie urba slum commuities, servig a populatio of 154,000 ad more tha 400 HIV-positive idividuals i their homes. More recetly, after a review of data geerated from the iformatio systems at the Govermet Hospital of Thoracic Medicie (GHTM) ad i cosultatio with GAP Idia ad key officials from Tamil Nadu State, PCI iitiated a secod project i Salem, a high prevalece district i a rural area of Tamil Nadu, coverig a populatio of approximately 170,000. Offices have bee established i Salem ad a memoradum of uderstadig with the district etwork of HIV-positive people was siged. Workig with local leaders, etworks of HIV-positive people, youth, The project was recetly expaded from six to ie urba slum commuities, servig a populatio of 154,000 ad more tha 400 HIV-positive idividuals i their homes. 705

Advaces i Biopharmaceutical Techology i Idia Sice Jauary 2001, NIP has participated o GAVI s Board, Implemetatio Task Force, ad Research ad Developmet Task Force. wome s groups, ad health providers, the project is becomig recogized as a model program for commuity care. Home health aides have bee traied i HIV/AIDS care ad couselors are begiig to carry out pre- ad posttest couselig at the commuity level. I both Maharastra ad Tamil Nadu States, strog likages have bee established with local health care facilities, the atioal Tuberculosis Directly Observed Therapy-Short Course (DOTS) program, ad social support programs. Represetatives from the PCI project regularly participate i traiig programs ad workshops at GHTM i order to facilitate likages betwee hospital-based ad commuity care programs. CIO: NCHSTP Start Date: 2001 Status: ogoig Immuizatio NIP s Global Immuizatio Divisio supports stregtheig global childhood immuizatio programs through direct support to coutries, through parters (such as WHO ad UNICEF), ad through participatio i the Global Alliace for Vaccies ad Immuizatio (GAVI). GAVI was iitiated i 2000 with the primary goals of itroducig ew vaccies (e.g., hepatitis B, Haemophilus ifluezae type b, ad yellow fever), improvig immuizatio coverage, ad improvig ijectio safety (for immuizatio) i the poorest coutries those with per capita GNP of uder $1,000. Fuds exceedig $1.2 billio have bee made available to coutries begiig i 2000 for these purposes, cotiuig for 5 years. CDC is oe of may parters cotributig to this effort, which is led by UNICEF, WHO, the Bill ad Melida Gates Foudatio, the World Bak, ad others. Sice Jauary 2001, NIP has participated o GAVI s Board, Implemetatio Task Force, ad Research ad Developmet Task Force. I Idia, fudig supports routie immuizatio activities i Bihar ad West Begal through UNICEF. CIO: NIP Start Date: JAN, 2000 Status: ogoig Iflueza I September 2003, the WHO Collaboratig Ceter for Surveillace, Epidemiology ad Cotrol of Iflueza i the Iflueza Brach of NCID s Divisio of Viral ad Rickettsial Diseases (DVRD) shipped out 241 kits for global iflueza laboratory surveillace to U.S. state health departmets, foreig atioal iflueza ceters, icludig ceters i Idia, ad other collaboratig istitutios. CDC provides a kit cotaiig reagets for idetificatio of iflueza specimes for global iflueza surveillace. This iformatio is essetial for the idetificatio of variats ad the timely iclusio of ew variats ito the iflueza vaccie. DVRD also distributed kits for the idetificatio of A(H5) ad A(H7) viruses, due to the emergece of these ovel subtypes i humas. CIO: NCID Start Date: Ja, 1991 Status: ogoig Laboratory Diagostics The Model Performace Evaluatio Program for HIV-1 atibody testig is a ogoig exteral assessmet program provided by PHPPO s Divisio of Laboratory Systems (DLS) that is available to laboratories worldwide. Twice a year, 706

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West six refereced survey specimes are shipped to laboratories i Idia for HIV-1 atibody testig. After each site tests the specime pael, its results are set to DLS. DLS staff aalyzes the results ad provide a summary report of the aggregate performace by method type ad reaget maufacturer. The results for idividual laboratories or laboratories by coutry are ot evaluated, but each participatig laboratory ca compare its performace agaist the whole to idetify potetial problems ad make improvemets or chages i its testig process, as eeded. CIO: PHPPO Start Date: Ju, 1986 Status: ogoig Laboratory Methods Developmet PHPPO s Divisio of Laboratory Systems (DLS) provided assistace to Idia for laboratory reovatios i Cheai, icludig fializig equipmet procuremets ad the selectio of laboratory staff. DLS staff coducted a geeral quality cotrol activities workshop i September 2003. CIO: PHPPO Start Date: Sep, 2003 Status: ogoig Laboratory Stadardizatio Esurig the Quality of Iodie Procedures (EQUIP) is a CDC stadardizatio program desiged to provide uriary iodie laboratories with a idepedet assessmet of their aalytical performace. The program, which is operated joitly by NCEH ad NCCDPHP, will help laboratories moitor the degree of variability ad bias i their uriary iodie assays. Iformatio received from the program ca the be used to elimiate bias ad/or precisio problems i the assay system; cofirm the quality of aalysis; ad icrease each laboratory s cofidece level. Curretly, 42 laboratories i 31 coutries, icludig Idia, participate i the EQUIP program. CIO: NCEH Start Date: Jul, 2001 Status: ogoig Malaria NCID s Divisio of Parasitic Diseases is collaboratig with the Malaria Research Cetre o a cohort study o the epidemiologic, immuologic, ad etomologic characteristics of malaria durig pregacy i Idia. CIO: NCID Start Date: Ju, 2002 Status: ogoig Natural Disasters At the request of ad i cosultatio with WHO s Regioal Office for Southeast Asia (SEARO), NCEH s Divisio of Evirometal Hazards ad Health Effects (EHHE) developed ad preseted a 1-week traiig course i Jue 2003 o the epidemiologic respose i disaster settigs to district health officers ad WHO field staff from Gujurat, Idia. Gujurat was the site of a major earthquake that affected a estimated 37.8 millio people ad killed more tha 17,000 i Jauary 2001. CIO: NCEH Start Date: Ju, 2003 Ed Date: Ju, 2003 Status: completed Nocommuicable Disease Prevetio ad Cotrol Through a assigee to WHO, NCCDPHP s Divisio of Adult ad Commuity Health guides the work of the Mega Coutry Health Promotio Network. 707

Advaces i Biopharmaceutical Techology i Idia I Alaska, out of 648 work-related deaths takig place i 1990-1999, oe-third (217 cases, or 33% of the total) occurred amog fisherme. The Network was established to mobilize the world s most populous coutries, icludig Idia, to address the trasitio of the global burde of disease from commuicable to ocommuicable coditios ad to promote health i a collaborative effort. Priority areas to be addressed through the Network have bee idetified by Mega coutry represetatives. These iclude: school health as a key settig for primary disease prevetio; key risk factors of chroic diseases (icludig tobacco, diet ad utritio, ad physical activity) as a itegrated approach to the field of chroic diseases; ad behavioral risk factor surveillace as a tool for stregtheig the evidece base for chroic diseases. Data collectio o key behavioral risk factors bega i 2003 by the Idia Coucil of Medical Research (ICMR) i New Delhi amog a sample of 5,000 persos aged 15 to 64 i the urba areas of East Delhi, coverig both slum ad o-slum areas. This work liks the data collectio efforts i five other ceters curretly collectig behavioral risk factor data. I 2003, work also bega o a data actio report amog the Mega coutries to documet how data collected o three key risk factors, tobacco use, diet/utritio, ad physical activity, are beig used i the most populous coutries to implemet health policies ad programs. CIO: NCCDPHP Start Date: Mar, 1998 Status: ogoig Occupatioal Safety ad Health Throughout the world, commercial fisherme labor i deadly eviromets. They edure isolated fishig grouds, high wids, seasoal darkess, extremely cold water ad icig, ad short fishig seasos, where very log workdays are the orm. These hazardous work coditios have a strog impact o fisherme s safety. I Alaska, out of 648 work-related deaths takig place i 1990-1999, oe-third (217 cases, or 33% of the total) occurred amog fisherme. This is equivalet to a aual fatality rate of 124/100,000 workers/ year 28 times that of the overall U.S. work-related fatality rate. NIOSH has a strog iterest i improvig safety ad health outcomes for commercial fisherme ad has a ogoig commitmet to dissemiate curret kowledge o best safety practices ad policies for these workers. I 2003, the Secod Iteratioal Fishig Idustry Safety ad Health Coferece, IFISH II, was coveed i September 2003 i Sitka, Alaska. The coferece served as a primary meas by which NIOSH fostered collaboratio amog fishig coutries to address the global hazards of commercial fishig. The Alaska Marie Safety Educatio Associatio assisted with coveig the coferece. The U.S. Coast Guard supported the coferece by assistig with program plaig ad providig fishig safety equipmet ad demostratios durig the evet. Local support for program plaig ad speaker recruitmet came from the Alaska Vocatioal Techical School i Seward, Alaska. The Food ad Agriculture Orgaizatio provided scholarships for seve idividuals from developig atios to atted the coferece, icludig Idia, Pakista, Sri Laka, Chile, Toga, ad Seegal. Maritime Safety Agecies or other regulatory bodies set 708

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West represetatives from New Zealad, Australia, Namibia, Swede, the Faroe Islads, ad Caada. Nogovermetal orgaizatio (NGO) represetatives were set by Idoesia, Norway, ad Australia. Publicatio of the proceedigs from IFISH II (scheduled for 2004) will result i at least 30 ew papers that will add sigificatly to the body of kowledge o this topic. CIO: NIOSH Start Date: Oct, 2000 Status: ogoig Parasitic Diseases Scietists from NCID s Divisio of Parasitic Diseases have collaborated with researchers from the Cysticercosis Workig Group at the Christia Medical College (CMC) i Vellore to compete a referece diagostic study. The study showed that although mior variace occurs i the diagostic atiges from Idia parasites as compared to those from Lati America, the predictive values of tests based o these atiges remai uchaged. This is a importat issue because of the extet of global travel. Aother collaborative study o the systematic, defiitive classificatio of sigle lesio (SL) eurocysticercosis cases ad edemic prevalece is ogoig with participatio from Idia (CMC), the Peruvia Cysticercosis Workig Group, ad NCID. The results of this study will provide a stadardized, global defiitio of SL cases i eurocysticercosis as well as defiitive prevalece data for SL i Idia ad Peru. CIO: NCID Start Date: 2001 Status: ogoig Researchers from NCID s Divisio of Parasitic Diseases (DPD) are ivolved i molecular epidemiologic studies of cryptosporidiosis ad microsporidiosis, usig cliical specimes from hospitals, case cotrol or cohort studies, ad aimals ad the eviromet. Goals of the study iclude determiig the ifectio/cotamiatio sources ad the distributio of athropootic ad zoootic parasites, as well as idetifyig risk factors ad trasmissio dyamics. CIO: NCID Start Date: Ja, 2002 Status: ogoig Refugee Health By law, NCID s Divisio of Global Migratio ad Quaratie (DGMQ) is resposible for overseeig the medical screeig ad health assessmet of immigrats ad refugees boud for the Uited States. This oversight resposibility ivolves assessmets of the physicias (kow as pael physicias) who perform the examiatios overseas as well as assessig the laboratories ad x-ray facilities used by these physicias. DGMQ staff assessed the activities of pael physicias i Idia i order to correct ay deficiecies i screeig for certai commuicable diseases, icludig TB ad HIV. CIO: NCID Start Date: Nov, 2000 Status: ogoig Rotavirus NCID s Divisio of Viral ad Rickettsial Diseases is collaboratig with two U.S. istitutios (NIH ad Staford Uiversity) ad two Idia istitutios (the All Idia Istitute of Medical Scieces i New Delhi ad the Idia Istitute of Sciece i Bagalore) to develop, test, ad produce a live, oral rotavirus 709

Advaces i Biopharmaceutical Techology i Idia Work to develop pilot lots of the two cadidate vaccies i Idia has begu i collaboratio with Bharat Biotech Iteratioal Limited. vaccie i Idia to prevet severe rotavirus diarrhea i childre. The two cadidate eoatal rotavirus vaccies beig proposed represet the products of two idepedet research teams that have worked i parallel for more tha a decade uder the auspices of the Ido-U.S. Vaccie Actio Program (VAP) ad are ow combiig their efforts. The project ivolves three goals: vaccie productio, vaccie testig, ad surveillace. A Idia commercial parter with experiece i vaccie developmet, Bharat Biotech Iteratioal Limited, has bee elisted to help first with the preparatio of a test lot of vaccie for cliical trials ad the to prepare the vaccie for widespread use. The goal of this work is the productio of a quality rotavirus vaccie i Idia that would be fully tested accordig to the best iteratioal stadards for safety, immuogeicity, ad efficacy ad would become available for iclusio i the uiversal program for childhood immuizatio. The project is beig supported by the Childre s Vaccie Program at the Program for Appropriate Techology i Health (PATH), the Idia Govermet s Departmet of Biotechology (DBT), WHO, ad the Natioal Vaccie Program Office. Durig FY 2003, Phase I studies of the NIH-maufactured cadidate rotavirus vaccies i adults were completed. The trials demostrated that the cadidate vaccies were safe amog Idia adults. The team the proceeded with developig protocols for testig of the NIH-maufactured vaccie i childre 2 to 12 years of age ad i ifats 6 to 12 weeks of age. Work to develop pilot lots of the two cadidate vaccies i Idia has begu i collaboratio with Bharat Biotech Iteratioal Limited. Multi-ceter surveillace for rotavirus disease amog hospitalized childre is beig established at five sites i Idia i preparatio for vaccie testig i FY 04. The project is ow i Phase IIa cliical trials. CIO: NCID Start Date: Ja, 1998 Status: ogoig School Health Through WHO, NCCDPHP s Divisio of Adolescet ad School Health (DASH) provides techical support ad recommedatios for improvig coordiated school health ad HIV prevetio programs to atioal school groups i the world s 11 most populous coutries (kow as the Mega coutries) ad i ie Global AIDS Program (GAP) coutries. CIO: NCCDPHP Start Date: Nov, 1998 Status: ogoig Surveillace I FY 2003, Global AIDS Program (GAP) Idia supported the Natioal Associatio for State ad Territorial AIDS Directors (NASTAD) i cotiuig its collaboratio with the Adhra Pradesh State AIDS Society (APSACS) to develop a epidemiologic profile of oe of state s high prevalece districts (populatio 3.8 millio). Workig closely with staff from APSACS ad a local medical college i order to build local capacity, the team reviewed existig data ad used Epi Ifo for data etry ad aalysis. A prelimiary draft of the District Epidemiologic Profile was preseted to the Project Director of APSACS i September ad plas are uderway to expad the project to other 710

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West districts of Adhra Pradesh State. Other State AIDS Directors are requestig similar support from GAP Idia. CIO: NCHSTP Start Date: 2001 Status: ogoig I September 2003, scietists from NCID s Divisio of Viral ad Rickettsial Diseases (DVRD) traveled to Idia to meet with represetatives of the Idia Coucil for Medical Research (ICMR) ad the Natioal Istitute of Commuicable Disease to discuss ogoig ad future collaboratio o emergig ad reemergig ifectious diseases ad disease surveillace. Discussios focused o expadig existig collaborative etworks for public health edeavors, icludig iteragecy ad iteratioal parterships, which would be beeficial to ivestigatig ad cotrollig outbreaks ad to achievig overall public health goals. DVRD ad ICMR agreed o developig mechaisms for scietific exchage ad traiig i applied epidemiology, field ivestigatios of disease outbreaks, virological diagostics, ad cotaimet ad hadlig of emergig disease viruses. DVRD staff will cotiue efforts to place a residet advisor with Idia s Field Epidemiology Traiig Program. CIO: NCID Start Date: Sep, 2003 Status: ogoig Syphilis Scietists i the Syphilis Serology Referece Laboratory i NCHSTP s Divisio of STD Prevetio provided syphilis serology proficiecy testig samples for 76 laboratories i 57 coutries, icludig Idia. CDC admiisters the program, with WHO erollig participats. CDC is resposible for preparig samples, sedig them to the erolled laboratories, gradig results, ad providig summary reports for three shipmets per year. This program has bee i place sice 1988 ad is a fuctio of the WHO Collaboratig Ceter for Referece ad Research i Syphilis Serology. CIO: NCHSTP Start Date: Ja, 1991 Status: ogoig Tobacco Cotrol I 1998, NCCDPHP s Office o Smokig ad Health (OSH) ad WHO s Tobacco Free Iitiative (TFI) lauched a Global Youth Tobacco Survey (GYTS) as part of a WHO/UNICEF-supported project o youth ad tobacco. The GYTS is a school-based, tobacco-specific survey that focuses o adolescets aged 13 to 15 years, providig a i-depth assessmet of studets kowledge, attitudes, ad behaviors related to tobacco. The GYTS has bee completed i 116 coutries ad is i process i 34 coutries. Traiig is plaed for 26 additioal coutries, icludig Idia. The GYTS also has bee repeated i 12 coutries, with aother 22 coutries plaig to repeat the survey durig 2004. For each coutry coductig the GYTS, OSH staff assist i the developmet ad review of the fial questioaires; provide data collectio aswer sheets; process, edit ad weigh all data; produce detailed tables; ad provide a data diskette for idividual aalysis. OSH staff provides ogoig techical assistace regardig further aalysis, iterpretatio of results, ad report writig. Recet fidigs of the GYTS Collaboratig Scietists i the Syphilis Serology Referece Laboratory i NCHSTP s Divisio of STD Prevetio provided syphilis serology proficiecy testig samples for 76 laboratories i 57 coutries, icludig Idia. 711

Advaces i Biopharmaceutical Techology i Idia Group, etitled Geder Differeces i Global Youth Tobacco Use, were published i the August 2003 issue of the Joural of School Health (Vol. 73, No. 6). CIO: NCCDPHP Start Date: Dec, 1998 Status: ogoig I early 2000, NCCDPHP s Office o Smokig ad Health (OSH) ad WHO s Tobacco Free Iitiative (TFI) bega the developmet ad implemetatio of a Global School Persoel Survey (GSPS) as part of a WHO/ UNICEF-supported project o youth ad tobacco. The GSPS is a tobaccospecific survey of school persoel that provides i-depth assessmet of behaviors, kowledge, attitudes, school curricula ad policies regardig tobacco. For each coutry coductig the GSPS, icludig Idia, OSH Staff assist i the developmet ad review of the fial questioaires; provide data collectio aswer sheets; process, edit ad weigh all data; produce detailed tables; ad provide a data diskette for further aalysis. OSH staffs also provide ogoig techical assistace regardig further aalysis, iterpretatio of results, ad report writig. CIO: NCCDPHP Start Date: Ja, 2000 Status: ogoig Staff from NCCDPHP s Office o Smokig ad Health are workig with WHO s Tobacco Free Iitiative (TFI) to collect iformatio o tobacco-related kowledge, attitudes, ad behavior of atioally represetative samples of medical doctors i WHO member atios. The Global Medical Doctor s Survey (GMDS) was piloted i 2003 i three sites i Idia ad Myamar. The GMDS focuses o doctors persoal smokig histories as well as the treatmet approaches they use with patiets. The ext steps ivolve aalyzig the pilot data ad fializig materials to be used durig the survey s global implemetatio. CIO: NCCDPHP Start Date: Apr, 2000 Status: ogoig The Idia Miistry of Health (MOH), i partership with the Idia Coucil of Medical Research (ICMR) ad NCCDPHP s Office o Smokig ad Health (OSH), is preparig a joit report o Collaborative Approaches for Comprehesive Tobacco Cotrol i Idia. The objective is to collate the evidece-based iformatio o tobacco use i Idia, complemeted with a aalysis of the curret situatio ad recommeded proposals for future strategies to implemet effective tobacco cotrol. The report will be modeled after the U.S. Surgeo Geeral Reports, published aually sice 1964, which have become the evidece-based resource for tobacco use prevetio ad cotrol i the Uited States. OSH is providig techical expertise for the developmet of the report. Two successful Idia ad U.S. team workig group meetigs were held i October 2002 ad Jue 2003. A joit Idia-U.S. release of the report is expected. CIO: NCCDPHP Start Date: Oct, 2001 Status: ogoig Traiig I FY 2003, Global AIDS Program (GAP) Idia traied hospital persoel at the Govermet Hospital of Thoracic Medicie (GHTM) i laboratory quality assurace. GAP Idia also helped establish a curriculum committee at GHTM. Uder a cooperative agreemet with the U.S. Health Resources ad 712

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West Services Admiistratio (HRSA) ad the Uiversity of Washigto, timelies for the developmet of traiig modules have bee developed i cosultatio with the hospital staff ad Tamil Nadu State AIDS Society (TNSACS). Traiig modules o the treatmet of opportuistic ifectios ad ifectio cotrol were idetified as the highest priorities. Roudtable discussios with key leaders i public health ad HIV/AIDS i Tamil Nadu have bee held to discuss traiig eeds i the state, moitorig ad evaluatio, laboratory quality cotrol, ad other key topics. CIO: NCHSTP Start Date: 2001 Status: ogoig Led by a Steerig Committee cosistig of WHO, CDC, the Daish Istitute for Food ad Veteriary Research, Istitute Pasteur Iteratioal Network, Health Caada, ad the Netherlads' Aimal Scieces Group, WHO Global Salm-Surv is a iteratioal etwork of over 800 idividuals ivolved i foodbore diseases. The etwork's log-term missio is to reduce foodbore disease globally by ehacig laboratory-based surveillace ad outbreak detectio ad respose techiques. WHO Global Salm-Surv coducted eight traiig courses i FY 03 to help stregthe the skills of microbiologists ad epidemiologists i laboratory-based surveillace ad outbreak detectio ad respose techiques. The courses promoted iteractio with regioal Field Epidemiology Traiig Programs. Each course had approximately 20 to 30 participats, with a total of approximately 200 people traied from 75 atios, icludig Idia. CIO: NCID Start Date: 2000 Status: ogoig Tuberculosis I respose to a techical assistace request from the WHO Regioal Office for South-East Asia (SEARO), NCHSTP s Divisio of Tuberculosis Elimiatio (DTBE) has assiged a Medical Officer ad recogized techical expert i TB prevetio ad cotrol to SEARO. The assigee is providig techical assistace to assist i the implemetatio of improved TB cotrol programs i Idia ad the surroudig regio; advise WHO, the World Bak, the Govermet of Idia, ad other govermets i the regio o TB cotrol strategies; ad develop mechaisms to stregthe existig iteratioal parterships ad to forge ew relatioships that will optimize fudig, iteratioal activities, ad impact by WHO, Stop TB, CDC, ad various atios, particularly i assessig ad addressig priority eeds i TB cotrol. I additio to the field assigee at SEARO for TB support for Idia, DTBE has provided a umber of short-term cosultacies for specific evaluatio exercises ad epidemiologic studies. These have icluded a aalysis of seasoal treds of TB diagosis to determie correctio factors for TB drug procuremet processes ad a evaluatio of a public-private sector collaborative project lookig at stregtheig TB diagosis ad maagemet i the private sector, where 50% of Idia s TB cases are diagosed ad maaged. CIO: NCHSTP Start Date: Dec, 2002 Status: ogoig WHO Global Salm- Surv coducted eight traiig courses i FY 03 to help stregthe the skills of microbiologists ad epidemiologists i laboratorybased surveillace ad outbreak detectio ad respose techiques. 713

Advaces i Biopharmaceutical Techology i Idia I FY 2000, the U.S. Govermet lauched the Leadership ad Ivestmet i Fightig a Epidemic (LIFE) Iitiative, which has evolved ito the Global AIDS Program (GAP) ad is maaged by NCHSTP. GAP s objectives iclude the reductio of HIV trasmissio through primary prevetio of sexual, mother-to-child, ad blood-bore HIV trasmissio; developmet of programs to improve commuity-ad home-based care ad treatmet of HIV/AIDS/STI ad opportuistic ifectios; ad stregtheig the capacity of coutries to collect ad use surveillace data ad to maage atioal HIV/ AIDS programs. Improvig TB prevetio ad cotrol efforts is a importat compoet of the project. DTBE staff members have bee actively ivolved i supportig TB cotrol efforts i several GAP coutries, icludig Idia. Additioally, DTBE will be providig icreased support to GAP for TB prevetio, treatmet, ad care issues i GAP coutries idetified as part of the Emergecy Pla for AIDS Relief (EPAR). CIO: NCHSTP Start Date: Ja, 1998 Status: ogoig Vaccie Prevetable Diseases Scietists from NCID s Divisio of Viral Hepatitis (DVH) have worked with WHO, WHO Regioal Offices, ad Miistries of Health of umerous coutries o several short-term cosultacies related to the itroductio of hepatitis B vaccie. Ogoig techical support ad assistace are beig provided to coutries to develop routie ifat hepatitis B immuizatio plas, assess hepatitis disease burde, ad apply for the Global Alliace for Vaccies ad Immuizatio (GAVI) ad Vaccie Fud support. I FY 2003, DVH provided techical assistace to Idia. CIO: NCID Start Date: 2000 Status: ogoig Waterbore Disease Rural areas i South Asia still lack safe water supplies ad saitary facilities, leadig to sigificat opportuity costs of time spet gatherig water ad high morbidity from waterbore pathoges. The World Bak fuds umerous ifrastructure projects to relieve the situatio ad also is developig state-ofthe-art hygiee promotio campaigs to improve health. NCEH s liaiso to the World Bak helps develop feasible ad useful health moitorig systems that ca be itegrated ito project maagemet. Projects fuded by the Bak iclude rural water supply ad saitatio projects i Idia ad Nepal. The NCEH staff member serves as a member of the preparatio teams for these projects ad is ivolved i several demostratio projects i these coutries to promote better health outcomes through improved hygiee. CIO: NCEH Start Date: Ja, 2001 Status: ogoig 714

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West 6. Techology Trasfer Activities betwee the NIH ad Idia Parterships Icludig Techology Licesig Techology trasfer, icludig licesig, has bee part of the biomedical research efforts at the NIH. It is the vehicle through which the outputs of the NIH ad the FDA itramural research (i the case of NIH about 10% of its total budget) are trasferred to idustry to be ultimately developed ito medical products to advace huma health. The office resposible for maagig both the NIH ad FDA ivetio portfolios ad to carry out the madate give by the Cogress through its legislative Acts is the Office of Techology Trasfer (OTT), located at 6011 Executive Boulevard, Suite 325, Rockville, MD 20852 (www.ott.ih.gov). OTT has bee makig cotiuous efforts to expad its activities to coutries outside of the Uited States ad i particular to areas of the world where vaccies ad therapeutics for devastatig ifectious diseases are sorely eeded. Due to Idia s tremedous advaces i buildig strog ifrastructure ad capacity i biomedical research ad a biopharmaceutical idustry i geeral, as well as the sigificat chages i Idia s IP system ad compliace with iteratioal stadards as a result of Idia access to the World Trade Orgaizatio (WTO) ad its commitmet to the Agreemet o Trade-Related Aspects of Itellectual Property (TRIPS) that support such a idustry, OTT has bee makig ew efforts to utilize IP i Idia to facilitate ew parterships with Idia s biopharmaceutical compaies. OTT has curretly fifty-three issued or pedig patets i Idia. Additioally, i the last several years OTT trasferred umerous techologies (IP ad biological materials) to some of the major vaccie ad drug compaies i Idia. Recipiets of NIH techologies iclude compaies such as: Serum Istitute of Idia Laboratories (SIIL) Idia Immuologicals Paacea Biological E Bharat Biotech Iteratioal Shatha Biotechics Rabaxy.Pharmaceuticals Biomed (P) Ltd Nicholas Priamal Idia Limited Sahajaad Medical Techology The techologies licesed to these compaies iclude the followig: Recombiat proteis (called repa ad rtt) for productio of cojugate vaccies agaist bacterial-caused diseases. Novel cojugatio method also useful for the efficiet preparatio of cojugate vaccie (efficiet cojugatio of carrier protei to bacterial polysaccharide) Efficiet ad high yield process for productio of acellular pertussis vaccie Rotavirus vaccie based o huma bovie reassortat rotavirus strais 715

Advaces i Biopharmaceutical Techology i Idia At the third quarter of 2007 the vaccie etered Phase III cliical trials with the hope that will become a successful vaccie that will be provided to the Africa atios. Degue vaccie based o recombiat atteuated Degue strais Vaccie for Varicella-Zoster vaccie based o atteuated virus Reagets ad vectors useful for the developmet of HPV vaccie DDI HIV therapeutics Methods ad compositios for treatig alopecia Huma cell lie expressig luciferase reporter gee Evaluatio of cardiovascular therapy Oe partership through the mechaism of techology trasfer is particularly worth otig i this sectio. I 2005 PATH (Program for Appropriate Techology i Health), a promiet global No-Govermetal Orgaizatio (NGO) supported maily by the Bill ad Melida Gates Foudatio, siged a licese agreemet with OTT (represetig the FDA i this case) related to a ovel efficiet cojugatio method for the productio of meigitis A vaccie to be used i efforts to combat the devastatig epidemic i sub-sahara Africa. The Meigitis Vaccie Project (MVP), 47 which was established as a partership betwee PATH ad the World Health Orgaizatio (WHO) is uder which this vaccie has bee developed. Serum Istitute of Idia Laboratories (SIIL) was selected by PATH with the approval of the NIH to joi the MVP project as the sole producer of the vaccie i recogitio for the capabilities of this compay i vaccie research ad maufacturig. The chemical method ecompassed i the licese agreemet was developed at the laboratories of the Food ad Drug Admiistratio (FDA) ad cotiues to be improved through a Collaborative Research ad Developmet Agreemet (CRADA) betwee PATH-SIIL ad the FDA. The MVP project, with all the complexities of vaccie developmet, cotiues to meet the expectatios set by the partership at the iitiatio of the project. At the third quarter of 2007 the vaccie etered Phase III cliical trials with the hope that will become a successful vaccie that will be provided to the Africa atios. Aother partership worth otig is the rotavirus vaccie project. The rotavirus vaccie was developed at Dr. Albert Kapikia s laboratory at the Natioal Istitute of Allergy ad Ifectious Diseases (NIAID) at the NIH ad is based o bovie-huma reassortat strais. It icludes 6 strais of rotavirus ad thus has a broad rage of reactivity. I 2005 four Idia vaccie maufactures obtaied the rights to develop the vaccie for Idia ad for some coutries outside of Idia. The licesees received all the biological materials required for the vaccie developmet ad are workig closely with NIAID scietists at all stages of the commercial developmet. Most oteworthy is the support of PATH 6, 7 to this project. PATH has bee providig some fiacial support to the project, but is primarily committed to support scale-up procedures ad maufacturig of platform reagets through outsourcig. 716

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West Iteractios betwee Idia techology maagemet professioals ad OTT The icrease i techology trasfer activities betwee the NIH ad Idia i the last several years has led to the creatio of special relatioship betwee the NIH Office of Techology Trasfer ad Idia techology maagemet professioals. Joit workshops betwee OTT ad Idia techology trasfer staff o the topic of IP Maagemet i Public Private Partership took place i the Natioal Cetre for Biological Scieces (NCBS) i Bagalore (February 8-10, 2006) ad i the Heritage Village, Maesar (February 13-15, 2006). The workshops were orgaized by NIH/OTT, Ido-U.S. Sciece ad Techology Forum, New Delhi (see above sectio about the Forum), ad the Patet Facilitatig Cetre (PFC), Techology Iformatio, Forecastig ad Assessmet Coucil (TIFAC), Departmet of Sciece &Techology (DST), 15 New Delhi. The goal of the workshops was to exchage iformatio ad share experieces betwee the two parties related to techology iovatio, maagemet of Itellectual Property ad patetig ad licesig policies, so as to stregthe the ties betwee Idia ad the U.S. i the area of techology trasfer. Idia participatio i each of the workshops icluded early 70 techology maagers, scietists, lawyers, ad policy officers from the public ad private sectors, as well as members from academic istitutios. The U.S. delegatio icluded four techology maagers from OTT, Dr. Luis Salicrup, Seior Advisor for Iteratioal Techology Trasfer, Dr. Uri Reichma, Chief, Ifectious Diseases ad Medical Egieerig Brach, OTT, Mr. Peter Soukas, a Techology Licesig Specialist at OTT, ad Ms. Fatima Sayyid, also a Techology Licesig Specialist at OTT. The workshops were followed with a oe day symposium i hotel i New Delhi o February 17, 2006. Followig the workshops ad the symposium OTT hosted a umber of techology trasfer persoel from Idia uder OTT s iteratioal fellowship program. OTT visitig fellows icluded Dr. Padma Satish, Chief Techical Officer from Idia Istitutes of Techology (IIT) i Bombay, Dr. Sadhaa Srivastava, a seior research officer, Itellectual Property Rights Uit of Idia Coucil of Medical Research (ICMR), 11 New Delhi, Mr. Yashawat Dev Pawar from the Patet Facilitatig Ceter (PFC) at TIFAC, Dr. S. Balram from Sree Chitra Tirual Istitute for Medical Scieces ad Techology i Kerala State, south Idia, ad Dr. Sukdeb Siah from the Departmet of Biotechology (DBT), Miistry of Sciece ad Techology, New Delhi. These visits ad traiig of the Idia fellows further stregthe the relatioship betwee the two coutries i the area of techology trasfer. Idia participatio i each of the workshops icluded early 70 techology maagers, scietists, lawyers, ad policy officers from the public ad private sectors, as well as members from academic istitutios. 717

Advaces i Biopharmaceutical Techology i Idia 7. The Role of the Idia Departmet of Biotechology 14 i U.S.-Idia Collaboratios The Departmet of Biotechology (DBT), uder the Miistry of Sciece ad Techology i Idia was established i 1986 i order to give a ew impetus to the developmet of the field of moder biology ad biotechology i Idia. I additio to its large variety of activities withi Idia, DBT has recogized the importace of iteratioal collaboratios. Through the auspices of DBT, collaboratios i biomedical research were established with Demark, Filad, Norway, Korea ad Ukraie Germay, UK, Australia, Caada, but by far the most extesive collaboratios efforts sposored by DBT have bee with the U.S. Some of the projects supported by DBT have bee metioed i previous sectios of this chapter, i particular the Ido-U.S. Vaccie Actio Program (VAP), which is partially fuded by DBT o the Idia side. At preset the projects uder implemetatio uder the VAP fudig are of rotavirus, hepatitis-c, tuberculosis, RSV ad leishmaiasis. The iformatio provided below describig the progress of various joit projects was for the most part derived from DBT Aual Report 2006-2007. Vaccies Collaboratios (uder VAP) Rotavirus: The iteratioal partership for the developmet of rotavirus vaccie based o the rotaviral diarrhea eoatal vaccie strais 116E ad 1321 was metioed already before, uder Bilateral Agreemets betwee the U.S. ad Idia Govermet ad uder the CDC activities i Idia. The project is makig satisfactory progress ad is ow i phase IIa cliical studies. Malaria: Uder the project implemeted at Iteratioal Cetre for Geetic Egieerig (ICEB) 48 ad the U.S. Naval Medical Research Ceter (NMRC) 49, both through their operatio offices i New Delhi, expressio of recombiat PvRII (oe of the P.vivax Duffy bidig proteis) ecodig for 38 kd product has bee studied. Methods for productio of PvRII have bee scaled up at the Bharat Biotech Iteratioal Ltd. i Hyderabad uder cgmp coditios. Immuogeicity studies i mice with this malaria cadidate vaccie have bee successful. Phase-I cliical trials i huma have bee iitiated. Hepatitis-C: The joit project implemeted at Deca College of Medical Scieces & Allied Hospital, Hyderabad ad Uiversity of Teessee Health Scieces Ceter, Memphis, Teessee focuses o molecular epidemiology of geetic variatio i the hyper variable regio-1 (HVR-1) sequeces of Idia patiets ad respose to iterfero therapy. Tuberculosis: The collaborative study o High Throughput PCR Assays for Diagosig Tuberculosis Caused by Mycobacterium Tuberculosis ad Mycobacterium Bovis Usig Molecular Beacos at the All Idia Istitute for Medical Scieces (AIIMS), New Delhi, CJILMD, Agra ad Public Health Research Istitute (PHRI) 50 Newark, New Jersey supported with a objective to develop reliable devr ad hupb-based PCR assays i visual format usig 718

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West molecular beacos. The beacos were obtaied from the U.S. collaborator. This project is curretly goig through optimizatio procedures ad the studies with cliical samples so far shows promise with respect to specificity ad sesitivity of the test. Leishmaia: Studies were coducted at the Istitute of Pathology, New Delhim ad CBER, FDA, U.S.A o discovery of virulece-related gees i Leishamaia doovai usig geomic microarray. The study has idetified the full legth ORF of 3 cloes ad foud them to be calpai, NAD/FAD depedet dehydrogease ad a trypaosomatid specific hypothetical protei. Further studies with trascripts of each of these gees implicated their role i disease pathoogeisis. Cloig, expressio ad fuctioal characterizatio of these gees are uderway. Respiratory Sycytial Virus (RSV) ad huma Metapeumovirus (hmpv): The first commuity-based viral Acute Lower Respiratory Tract Ifectio (ALRI) i Idia i the past three decades has bee coducted at AIIMS, New Delhi ad Uiversity of Alabama Birmigham School of Medicie, Birmigham, Alabama. The data geerated from this joit study will be useful for plaig the study of future respiratory virus vaccie for other itervetios to reduce the disease due to viral Acute Respiratory Ifectios (ARIs). Molecular characterizatio of RSV strais from New Delhi revealed variatio i proportio of ifectios by differet RSV geotypes. This is the first study of RSV molecular epidemiology from Idia, ad the first descriptio of the circulatio patter of RSV geotypes i both rural ad urba Idia settig. Molecular characterizatio of RSV strais from New Delhi revealed variatio i proportio of ifectios by differet RSV geotypes. Group A Streptococcus (GAS): Epidemiological surveillace studies were coducted at Post Graduate Istitute of Medical Educatio ad Research (PGIMER) 51 Chadigarth, Christia Medical College (CMC), 52 Vellore, ad NIAID, NIH. At PGIMER, out of a total of 178 group A positive samples of pharygitis ad impetigo, 53 emm typig of 111 has bee doe, emm typig of the rest will be completed i the ear future. Ati Steptolysi O ad Ati Dase B will also be cotiued. Joit Workshops for Collaborative Projects I order to have traied persoel to carry out cliical trials ad coduct cliical research, DBT, ICMR, 11 DCGI (Drug Cotroller Geeral of Idia), ad U.S. Departmet of Health ad Huma Services have orgaized a series of workshops o cliical trials ad cliical research. The goal is to provide stateof-the-art traiig o cliical research with particular emphasis o cliical trials ad the complex requiremets ecessary for the testig ad licesure of drugs, vaccies, diagostics, ad devices for therapeutic ad prevetative use. The first workshop took place i April 4-6, 2006 at G.S. Medical College & KEM Hospital, Mumbai with the participatio of 140 scietists/cliicias. The secod workshop o Bioethics i Cliical Research was orgaized i Jue 20-22, 2006 i New Delhi, with the participatio of more tha 100 persos. 719

Advaces i Biopharmaceutical Techology i Idia This workshop focused o a specific aspect of cliical research related to ethical priciples ad practices. Traiig of Idia Scietists I 2006-2007 about 300 Idia scietists have bee traied i leadig istitutios i the U.S. for vaccie developmet ad other related techologies. Cosiderable ifrastructure ad other facilities have bee established uder the program i the collaboratig Idia istitutios, for advaced R&D. Joit Workig Group (JWG) The twetieth meetig of Joit Workig Group of Ido-U.S. Vaccie Actio Program was orgaized i September 26-27, 2006, to review the progress made uder ogoig ad completed projects ad also to cosider ew joit projects. A joit Ido-U.S. workshop o Traslatioal Research was also orgaized with this JWG meetig. Collaboratio with the Iteratioal AIDS Vaccie Iitiative (IAVI) 55 DBT ad IAVI, a U.S.- based iteratioal orgaizatio etered ito discussios regardig collaboratio i maily two areas of HIV/AIDS research. The two areas for which proposals were developed ad approved are eutralizig atibodies ad ew atige desig for potetial ew vaccie cadidates. New iitiative: Staford Idia Biodesig Iteratioal Fellowship i Biomedical Techology Iovatio Staford Uiversity ad DBT very recetly aouced the lauch of Staford-Idia Biodesig (SIB) fellowship. 54, 56 The goal of the fellowship is to trai the ext geeratio of biomedical techology iovators i Idia. For applicatio to these fellowships the reader is referred to the provided website. The fellowships will start i Jauary 2008. Each fellowship will last two years. Approximately half of the fellows time will be spet i New Delhi ad the other half at Staford Uiversity. These fellowships will be team based. Fellows will work i a multidiscipliary team joiig other iovators with a combiatio of egieerig, medical, ad busiess backgrouds. The team will examie cliical eeds withi the Idia settig, idetifyig opportuities for biomedical techology iovatio. Workig closely with Staford, AIIMS 19 ad Idia Istitute of Techology Delhi (IITD) 57 faculty, the teams will ivet, prototype, develop ad patet oe or more ew techologies. Priority will be give to iovatios for the medically uderserved. I additio to the cliical, busiess, ad egieerig faculty at Staford, AIIMS ad IITD, real-world experts from the medical techology, legal ad veture capital sectors i the U.S. ad Idia will advise ad metor the fellows. Idia citizes with graduate degrees ad work experiece i egieerig, medicie or busiess will be eligible to compete for the fellowship grats. 720

Chapter 18 Biopharmaceutical Research Collaboratios betwee Idia ad the West E. Coclusio Collaboratios i sciece ad techology have bee a edurig feature of the Uited States-Idia relatioship for more tha five decades, ad cooperatio i the health scieces has bee most promiet. Collaboratios i the health scieces have itesified sice Idia has committed itself to the stadards of TRIPS ad thus overhauled its patet law to iclude product patets (Jauary 2005). This measure ad with it, the trasitio of the Idia biopharmaceutical idustry from a geeric idustry to a more iovative i ature, created icetives for additioal orgaizatios from the West to ivest i Idia, ad furthermore to collaborate with Idia i biomedical research. Over the years the U.S. Departmet of Health ad Huma Services has played a pivotal role i supportig these collaboratios, primarily through its public health agecies such as the NIH ad CDC. These collaborative relatios itesified i the last few years through the techology trasfer activities of the Office of Techology Trasfer (OTT) at the NIH. OTT s activities have led i the past few years to the creatio of umerous parterships betwee the NIH ad Idia biotech eterprises, i particular i the area of critical vaccies vital for the developig world. O the Idia side, the Departmet of Biotechology uder the Miistry of Sciece ad Techology, ad i cocert with its U.S. couterparts, has take the lead i supportig ad creatig such joit collaboratios. This chapter was primarily writte to describe the may differet opportuities ad existig programs available for Ido-U.S. collaboratios. The iformatio provided i the chapter regardig the differet research fudig opportuities, traiig ad scietific exchage opportuities iclude the relevat websites of specific programs ad leadig participatig istitutios. It is hoped this iformatio will be utilized by biomedical scietists both i Idia ad the U.S. I particular it is hoped that U.S.-traied Idia returees will cotiue their relatioships with their metorig labs ad establish collaboratios that will lead to ew vaccies, therapeutics ad diagostics for the beefit of public health. 721

Advaces i Biopharmaceutical Techology i Idia Web Liks 1. http://www.idiaembassy.org/ewsite/idosci.asp 2. http://www.usaid.gov/ 3. http://www.ih.gov/ 4. http://www3.iaid.ih.gov/ 5. http://www.cdc.gov/ 6. http://www.path.org/ 7. http://www.path.org/vaccieresources/ 8. http://wpgfd.org/dowloads/agecyit_sample.pdf 9. http://www.oar.ih.gov/about/about_oar.htm 10. http://www.corad.org/press/may042005.htm 11. http://www.icmr.ic.i/ 12. http://www.icd.us/ 13. http://www.brc.ac.i/ 14. http://dbtidia.ic.i/publicatio/publicmai.html 15. http://dst.gov.i/ 16. http://www.allayurveda.com/discover.htm 17. http://www.cmch-vellore.edu/departmets/home.asp?did=19 18. http://spores.ci.ih.gov/ 19. http://www.aiims.edu/ 20. http://www.rti.org/ 21. http://www.caer.org/ 22. http://www.idiaeducatio.eret.i/isitutios/profile. ASP?o=U01305 23. http://www.fic.ih.gov/ 24. http://www.fic.ih.gov/programs/traiig_grats/icohrta/ idex.htm 25. http://www.fic.ih.gov/programs/traiig_grats/itreoh/ idex.htm 26. http://www.fic.ih.gov/programs/traiig_grats/mirt/ idex.htm 27. http://cmhd.ih.gov/ 28. http://www.fic.ih.gov/programs/traiig_grats/aitrp/ idex.htm 29. http://www.fic.ih.gov/programs/research_grats/firca/ idex.htm 30. http://www.fic.ih.gov/programs/research_grats/grip/ idex.htm 31. http://www.fic.ih.gov/programs/research_grats/tobacco/ idex.htm 32. http://www.ih.gov/ews/pr/aug2002/fic-28.htm 33. http://www.fic.ih.gov/programs/research_grats/brai_ disorder/idex.htm 34. http://www.fic.ih.gov/programs/traiig_grats/irsda.htm 35. http://www.fic.ih.gov/programs/traiig_grats/geetics. htm 36. http://www.fic.ih.gov/programs/traiig_grats/itrph/ idex.htm 37. http://www.fic.ih.gov/programs/traiig_grats/bioethics/ idex.htm 38. http://www.cdc.gov/cidod/diseases/ 39. www.cdc.gov/chstp/od/chtp.html 40. http://www.cdc.gov/vaccies/ 41. http://www.cdc.gov/nceh/ 42. http://www.atsdr.cdc.gov/ 43. http://www.cdc.gov/ccdphp/ 44. http://www.cdc.gov/iosh/ 45. http://www.epa.gov/ 46. http://www.phppo.cdc.gov/ 47. http://www.meigvax.org/ 48. http://www.icgeb.trieste.it/ 49. http://www.mrc.avy.mil/idex.htm 50. http://www.phri.org/ 51. http://pgimer.ic.i/ 52. http://www.cmch-vellore.edu/ 53. http://www.mayocliic.com/health/impetigo/ds00464 54. http://dbtidia.ic.i/misc/pdfdoc1.pdf 55. http://www.iavi.org/ 56. http://biodesig.staford.edu/idia 57. http://www.iitd.eret.i/ 58. http://www.idousstf.org/ 59. http://www.istp.org/ 60. http://www.acoolie.org/ 61. http://grats.ih.gov/grats/guide/pa-files/pa-07-093.html 62. http://grats.ih.gov/grats/guide/otice-files/ot99-097. html 63. http://www3.iaid.ih.gov/about/orgaizatio/dmid/ido 64. http://ewdelhi.usembassy.gov/pr051507a.html 65. http://www.grats.gov/search/search. do?mode=view&oppid=11633 66. http://www.trc-cheai.org/ 67. http://grats.ih.gov/grats/guide/rfa-files/rfa-tw-03-002.html 68. http://grats.ih.gov/grats/guide/otice-files/not-hd-03-009.html 69. http://grats.ih.gov/grats/guide/otice-files/not-hd-03-010.html 70. http://dbtidia.ic.i/ 71. http://www.aiims.ac.i/ 72. http://www.ii.res.i/ 73. http://www.icmr.ic.i/ 74. http://www.globalhealth.gov/ 75. http://www.fic.ih.gov/ 76. http://grats.ih.gov/grats/guide/pa-files/pas-04-111.html 77. http://grats1.ih.gov/grats/guide/pa-files/pa-07-093.html 78. http://www.thehidu.com/2007/09/07/ stories/2007090761731500.htm 722

About Advaces Biopharmaceutical Techology i Idia The biopharmaceutical idustry i Idia has grow dramatically over the past few years, ad sales have exceeded US$1.5 billio. This study describes the Idia biopharmaceutical idustry, its history, its advatages ad opportuities, as well as its challeges ad risks. Today, the biopharmaceutical idustry i Idia has brought several protei drugs to market ad is developig may more. The ext several years will be iterestig as Idia takes its place o the global stage. Biopharmaceutical products have a log history i Idia, ad trace their roots back several thousad years through schools of healig practice. The Idia govermet is curretly workig towards developig that experiece ito a soud biotech idustry. The coutry s objective is to help miimize foreig depedece, especially i high-tech areas. This study describes the idustry s history, ad the Idia govermet policies that have helped eable the maufacture of moder biotech products at affordable prices. We discuss the patet factors ad history that have shaped the Idia idustry, icludig the idustry s reliace o productio of outside-of-patet products. As the Idia govermet cotiues its efforts to create alliaces betwee private idustry ad research istitutes, the ext decade should show a sigificat growth i the Idia biotech idustry, ad ovel biotech drugs may ultimately domiate. Idia is expected to emerge as a strog player i the productio ad sale of biotech products i the comig years, as local cosumptio rises, ad as its local biotech idustry takes steps to develop a globally competitive local idustry that stads o a foudatio of basic research. Authors from: M J Biopharm Pvt. Ltd. Bharat Biotech Iteratioal Ltd. Neo BioMed Services beòcarta Ltd. Chilter Iteratioal Pvt. Ltd. Jim Schabel, BioPla Associates, Ic. Joh Curlig Cosultig AB ProMetic BioTherapeutics, Ic. Celestial Biologicals Ltd Dow AgroScieces LLC Edocrie Techology, LLC Magetical CaBiotech Biospectrum Asia Serum Istitute of Idia Ltd. Cadila Pharmaceuticals Ltd. J. Sagar Associates Amge, Ic. Apothecaries Ltd. Chilter Iteratioal Private Limited Strategic Maufacturig Worldwide, Ic. GAEA Resources Ic. Fisto Cosultig, LLC Chilter Iteratioal Private Ltd. Health Iteractios Natioal Istitute of Health Uiformed Services Uiversity of the Health Scieces Natioal Istitute of Sciece Techology ad Developmet Studies ISBN 978-1-934106-07-5 9 781934 106075