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Contract Research and Manufacturing Services (CRAMS) in India

Contract Research and Manufacturing Services (CRAMS) in India
The Business, Legal, Regulatory and Tax Environment in the Pharmaceutical and Biotechnology Sectors

by Milind Antani,Gowree Gokhale

  • Publisher : Elsevier
  • Release : 2012-10-31
  • Pages : 248
  • ISBN : 1908818166
  • Language : En, Es, Fr & De
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The field of contract research and manufacturing broadly encompasses those services in the pharmaceutical and biotechnology sectors that require extensive research and development and large-scale manufacturing facilities. The field has great potential for growth in the Indian outsourcing industry, which is world-renowned for its provision of cheap and highly-skilled services. Contract research and manufacturing services (CRAMS) in India provides a detailed account of the current scenario in India and the advantages that the Indian outsourcing industry can offer in the field of CRAMS. Following an overview of the services and their emergence in India, chapters in the book begin by discussing the legal and regulatory scenario and major concerns and issues. In the latter part of the book, topics covered include service agreements, dispute resolution and contract negotiations, followed by a discussion of the outlook for CRAMS in India and some concluding remarks. Several appendices are included, offering a list of major players in the field and various forms for use in licence applications. Simple and accessible presentation using tables, charts and diagrams Practical tips from leading practitioners Inclusion of relevant case laws and other legal considerations

Pharmaceutical Industry and Public Policy in Post-reform India

Pharmaceutical Industry and Public Policy in Post-reform India
A Book

by Reji K. Joseph

  • Publisher : Routledge
  • Release : 2015-07-24
  • Pages : 232
  • ISBN : 1317408837
  • Language : En, Es, Fr & De
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This book examines the impact of economic reforms in India on the pharmaceutical industry and access to medicines. It traces the changing production and trade pattern of the industry, research and development (R&D) preferences and strategies of Indian pharmaceutical firms, patent system alongside pricing policy measures and their shortcomings. It also analyses the public health financing system in India driven largely by out-of-pocket expenditure — about 60 per cent — and characterised by very high share of medicines in total health expenditure. A masterful insight into a topical area, the work will be indispensable to those working on pharmaceutical industry and public policy. It will be of interest to researchers, scholars, students, and policy-makers of economics, industrial policy, public policy, intellectual property rights and health financing.

Innovation in India

Innovation in India
The Future of Offshoring

by Suseela Yesudian

  • Publisher : Springer
  • Release : 2012-11-16
  • Pages : 130
  • ISBN : 1137268557
  • Language : En, Es, Fr & De
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Examines the shift in leading companies in India towards greater 'value added' and innovative work. Is the move towards greater levels of innovation the future of the services off-shoring industry in India?

Winning Strategies for the Indian Market

Winning Strategies for the Indian Market
A Book

by Anuradha Dayal-Gulati,Dipak Jain

  • Publisher : Northwestern University Press
  • Release : 2010-08-31
  • Pages : 238
  • ISBN : 0810126958
  • Language : En, Es, Fr & De
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focuses on India's airline, pharmaceutical, automobile, hospitality, food, and telecommunications industries to create a well-rounded profile of the evolving Indian market. An essay on each business sector describes its market structure, the current state of the industry, the main players, key economic forces, and selected business strategies, analyzing how the sector might develop over the next five to ten years against the backdrop of the deeper economic and demographic transitions that are taking place in India. In sum, this anthology enumerates the challenges and opportunities for companies---both domestic and multinational---doing business in India today.

Growth Strategies Of Indian Pharma Companies

Growth Strategies Of Indian Pharma Companies
A Book

by B Rajesh Kumars M Satish

  • Publisher : ICFAI Books
  • Release : 2007-09-04
  • Pages : 416
  • ISBN : 8131407578
  • Language : En, Es, Fr & De
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The pharmaceutical industry in India is one of the largest and most advanced among the developing countries. During the last three decades, Indian pharmaceutical industry achieved spectacular progress by any standard. India s pharmaceutical industry has b

Strategies for High-Tech Firms

Strategies for High-Tech Firms
Marketing, Economic, and Legal Issues

by P.M. Rao,Joseph A. Klein

  • Publisher : Routledge
  • Release : 2015-01-28
  • Pages : 248
  • ISBN : 1317459296
  • Language : En, Es, Fr & De
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This is the first book to present marketing strategy of high-tech products and services in a legal, economic, and global context. From software to hardware, from pharmaceuticals to digital movies and TV, the authors argue that the understanding of intellectual property rights (IPRs) is essential to devising effective marketing strategies.

Investment Opportunity in Drugs & Pharmaceutical Projects

Investment Opportunity in Drugs & Pharmaceutical Projects
A Book

by NPCS board

  • Publisher : NIIR PROJECT CONSULTANCY SERVICES
  • Release : 2013-10-01
  • Pages : 117
  • ISBN : 9381039216
  • Language : En, Es, Fr & De
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(LIMITED EDITION- ONLY PHOTOSTAT COPY AVAILABLE) Drugs and pharmaceutical industry plays a vital role in the economic development of a nation. It is one of the largest and most advanced sectors in the world, acting as a source for various drugs, medicines and their intermediates as well as other pharmaceutical formulations. The Indian drugs and pharmaceutical industry, over the years, has shown tremendous progress in terms of infrastructure development, technology base creation as well as product usage. The pharmaceutical industry has been one of the fastest growing segments of the Indian manufacturing sector with an average annual growth rate of about 14% and is projected to grow at an average annual rate exceeding 15%. This growth would be fuelled mainly by (i) access to low cost and high volume of generic drugs, (ii) mergers and acquisitions, (iv) industry consolidation, and (v) high growth of contract manufacturing. The pharmaceutical industry has been producing bulk drugs belonging to all major therapeutic groups requiring complicated manufacturing processes as well as a wide range of pharma machinery and equipments. India has carved a niche for itself by being a top generic Pharma player. Indian Pharmaceutical Industry is playing a key role in promoting and sustaining development in the vital field of medicines. This book contains information on L-Ascorbic Acid, Pharmaceutical Unit, Liquid Glucose, Glucose Saline, IV Fluids, Paracetamol, Sorbitol, Aspirin and Ibuprofen along with their manufacturing process, producers, plant economics etc. This book also throws light on Drugs and Pharmaceutical Industries in India. This book will give a thorough knowledge of the contents that it covers and also about the scenario of the Pharmaceutical Industry.

India's Healthcare Industry

India's Healthcare Industry
Innovation in Delivery, Financing, and Manufacturing

by Lawton R. Burns

  • Publisher : Cambridge University Press
  • Release : 2014-01-13
  • Pages : 129
  • ISBN : 1316021211
  • Language : En, Es, Fr & De
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This book analyzes the historical development and current state of India's healthcare industry. It describes three sets of institutions that deliver healthcare services, finance these services, and manufacture products used in these services. These institutions provide healthcare (hospitals, physicians, pharmacies, and diagnostic laboratories), pay for healthcare (individuals who pay out-of-pocket, insurance companies, community insurance schemes, government ministries) and produce the technology used in healthcare delivery (pharmaceuticals, biotechnology, and medical devices). The volume also discusses innovative efforts to raise capital for the development of these sectors. Finally, it includes three interesting case studies of innovative models of healthcare delivery (L. V. Prasad, Aravind, and Vaatsalya), as well as analyses of other innovative organizations like Narayana Hrudaylaya and the hospital chains. The contributors to the volume include Wharton faculty members, graduates of Wharton's healthcare MBA program, and executives and consultants from India.

Clinical Research in Asia

Clinical Research in Asia
Opportunities and Challenges

by U Sahoo

  • Publisher : Elsevier
  • Release : 2012-05-25
  • Pages : 412
  • ISBN : 1908818131
  • Language : En, Es, Fr & De
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Asia is increasingly taking on a leading role in the fields of Good Clinical Practice (GCP) and ethics, two areas that are central to clinical research practices worldwide. Clinical research in Asia examines the evolution of these key sectors in the Asian countries where the greatest developments are taking place, offering valuable perspectives on a wide range of issues affecting clinical research. Following an introduction that provides an overview of the topic and its strengths and weaknesses, each chapter of the book is devoted to clinical research in a specific country, focusing on issues including the history and evolution of clinical research, clinical trials and regulatory aspects. The chapters also offer a perspective on future trends in clinical research in each country. The book concludes with a discussion of the importance of political, economic, socio-cultural, technological, legal and environmental factors (PESTLE analysis). Analysis from a leading and highly respected professional in the sector An overview of country-specific regulatory environments Discussion of challenges and solutions for clinical research

Bioentrepreneurship and Transferring Technology Into Product Development

Bioentrepreneurship and Transferring Technology Into Product Development
A Book

by Agarwal, Swati,Kumari, Sonu,Khan, Suphiya

  • Publisher : IGI Global
  • Release : 2021-06-25
  • Pages : 335
  • ISBN : 1799874133
  • Language : En, Es, Fr & De
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In terms of becoming a successful bioentrepreneur, there is still much more to learn. There are many ways to learn the essential fundamentals of entrepreneurship, including through the mistakes of previous businesses and models. Increased knowledge and a better understanding of what works can be derived from these previous failures and mistakes. Additionally, learning from other bioentrepreneurs can help businesses run successfully. By looking deeper into business models, product development, the fundamental concepts of bioentrepreneurship, and the essential characteristics of bioentrepreneurs, one can become better equipped to understand the role of biological sciences in entrepreneurship, specifically the role of product development. Bioentrepreneurship and Transferring Technology Into Product Development provides a comprehensive understanding of the role of biological sciences, specifically in transforming technology into commercial product. This book compiles the theoretical and practical aspects of bioentrepreneurship and discusses the various factors, including creating business plans, acquiring funding, and successful business models. The chapters also cover areas such as small-scale product development, intellectual property rights, funding schemes for start-ups, and new prospective biotechnology product development. This book is essential for bioentrepreneurs, entrepreneurs, product developers, scientists, practitioners, researchers, academicians, and students interested in product development from a biological science perspective.

The Efficiency and Productivity of Indian Pharmaceutical Companies

The Efficiency and Productivity of Indian Pharmaceutical Companies
A Firm-Level Analysis

by Aas Mohammad

  • Publisher : Cambridge Scholars Publishing
  • Release : 2019-09-24
  • Pages : 224
  • ISBN : 1527540391
  • Language : En, Es, Fr & De
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This book evaluates the performance of the Indian pharmaceutical industry, which plays an important role in economic development. It highlights the role the government has had in facilitating the growth of the industry from non-existence, before the 1970s, to being one of the largest pharmaceutical industries in the world today. The text employs various useful techniques to provide an understanding of productivity and efficiency, such as data envelopment analysis, stochastic frontier analysis, the Malmquist Productivity Index and the Hicks-Moorsteen Productivity Index. The book will be useful to health administrators, students of public policy, and health economists with an interest in the pharmaceutical sector.

Outsourcing Biopharma R&D to India

Outsourcing Biopharma R&D to India
A Book

by P R Chowdhury

  • Publisher : Elsevier
  • Release : 2011-05-05
  • Pages : 130
  • ISBN : 1908818018
  • Language : En, Es, Fr & De
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The trend of outsourcing to India for research and development is catching on fast. Over the last decade, worldwide pharmaceutical and biotechnology companies have made India their choice for a research destination. Initially R&D was inclined more towards developing products for the Indian market within the country. This led to several multinational companies opening up production plants in India, primarily due to the globalization of the Indian economy and offshoring jobs to India. Alongside, several global pharma-biotech majors ascertained large market requirements within the country and capitalized on the advantage of serving Indian customers. Strategies were devised to optimize operational expenses with the setting up of on-site R&D to develop products for local requirements. In view of this, this book seeks to explore various nuances of the outsourcing sector with respect to biopharma in India. Constitutes the first ever comprehensive insight on the Indian biopharma sector Provides a perspective based on practical hands-on legal experience Simply structured, clearly presented and free from excessive legal jargon

Open Source Software in Life Science Research

Open Source Software in Life Science Research
Practical Solutions to Common Challenges in the Pharmaceutical Industry and Beyond

by Lee Harland,Mark Forster

  • Publisher : Elsevier
  • Release : 2012-10-31
  • Pages : 582
  • ISBN : 1908818247
  • Language : En, Es, Fr & De
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The free/open source approach has grown from a minor activity to become a significant producer of robust, task-orientated software for a wide variety of situations and applications. To life science informatics groups, these systems present an appealing proposition - high quality software at a very attractive price. Open source software in life science research considers how industry and applied research groups have embraced these resources, discussing practical implementations that address real-world business problems. The book is divided into four parts. Part one looks at laboratory data management and chemical informatics, covering software such as Bioclipse, OpenTox, ImageJ and KNIME. In part two, the focus turns to genomics and bioinformatics tools, with chapters examining GenomicsTools and EBI Atlas software, as well as the practicalities of setting up an ‘omics’ platform and managing large volumes of data. Chapters in part three examine information and knowledge management, covering a range of topics including software for web-based collaboration, open source search and visualisation technologies for scientific business applications, and specific software such as DesignTracker and Utopia Documents. Part four looks at semantic technologies such as Semantic MediaWiki, TripleMap and Chem2Bio2RDF, before part five examines clinical analytics, and validation and regulatory compliance of free/open source software. Finally, the book concludes by looking at future perspectives and the economics and free/open source software in industry. Discusses a broad range of applications from a variety of sectors Provides a unique perspective on work normally performed behind closed doors Highlights the criteria used to compare and assess different approaches to solving problems

NMR Metabolomics in Cancer Research

NMR Metabolomics in Cancer Research
A Book

by Miroslava Čuperlović-Culf

  • Publisher : Elsevier
  • Release : 2012-12-17
  • Pages : 446
  • ISBN : 1908818263
  • Language : En, Es, Fr & De
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The application of nuclear magnetic resonance (NMR) metabolomics in cancer research requires an understanding of the many possibilities that NMR metabolomics can offer, as well as of the specific characteristics of the cancer metabolic phenotype and the open questions in cancer research. NMR metabolomics in cancer research presents a detailed account of the NMR spectroscopy methods applied to metabolomics mixture analysis along with a discussion of their advantages and disadvantages. Following an overview of the potential use of NMR metabolomics in cancer research, the book begins with an examination of the cancer metabolic phenotype and experimental methodology, before moving on to cover data pre-processing and data analysis. Chapters in the latter part of the book look at dynamic metabolic profiling, biomarker discovery, and the application of NMR metabolomics for different types of cancer, before a concluding chapter discusses future perspectives in the field. Focused description of NMR spectroscopy needed by cancer biologists who are starting to use metabolomics Current overview of knowledge related to the cancer metabolic phenotype from the perspective of metabolomics applications Information about the best practices in NMR metabolomics experimentation and data preprocessing as applied to different sample types

Biomedical Innovation in India

Biomedical Innovation in India
With a Comparison to China and Others

by Parthasarathi Banerjee

  • Publisher : Har-Anand Publications
  • Release : 2007
  • Pages : 276
  • ISBN : 9788124112274
  • Language : En, Es, Fr & De
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Encyclopedia of Pharmacy Practice and Clinical Pharmacy

Encyclopedia of Pharmacy Practice and Clinical Pharmacy
A Book

by Anonim

  • Publisher : Academic Press
  • Release : 2019-06-28
  • Pages : 2358
  • ISBN : 0128127368
  • Language : En, Es, Fr & De
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Encyclopedia of Pharmacy Practice and Clinical Pharmacy covers definitions, concepts, methods, theories and applications of clinical pharmacy and pharmacy practice. It highlights why and how this field has a significant impact on healthcare. The work brings baseline knowledge, along with the latest, most cutting-edge research. In addition, new treatments, algorithms, standard treatment guidelines, and pharmacotherapies regarding diseases and disorders are also covered. The book's main focus lies on the pharmacy practice side, covering pharmacy practice research, pharmacovigilance, pharmacoeconomics, social and administrative pharmacy, public health pharmacy, pharmaceutical systems research, the future of pharmacy, and new interventional models of pharmaceutical care. By providing concise expositions on a broad range of topics, this book is an excellent resource for those seeking information beyond their specific areas of expertise. This outstanding reference is essential for anyone involved in the study of pharmacy practice. Provides a ‘one-stop’ resource for access to information written by world-leading scholars in the field Meticulously organized, with articles split into three clear sections, it is the ideal resource for students, researchers and professionals to find relevant information Contains concise and accessible chapters that are ideal as an authoritative introduction for non-specialists and readers from the undergraduate level upwards Includes multimedia options, such as hyperlinked references and further readings, cross-references and videos

Lean Biomanufacturing

Lean Biomanufacturing
Creating Value through Innovative Bioprocessing Approaches

by Nigel J Smart

  • Publisher : Elsevier
  • Release : 2013-10-31
  • Pages : 384
  • ISBN : 1908818409
  • Language : En, Es, Fr & De
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With decreasing profit margins, increasing cost pressures, growing regulatory compliance concerns, mounting pressure from generic drugs and increasing anxiety about the future of healthcare reimbursement, pharmaceutical manufacturers are now forced to re-examine and re-assess the way they have been doing things. In order to sustain profitability, these companies are looking to reduce waste (of all kinds), improve efficiency and increase productivity. Many of them are taking a closer look at lean manufacturing as a way to achieve these goals. Lean biomanufacturing re-visits lean principles and then applies them sympathetically - in a highly practical approach - to the specific needs of pharmaceutical processes, which present significantly different challenges to more mainstream manufacturing processes. A major goal of the book is to highlight those problems and issues that appear more specific or unique to biopharmaceutical manufacturing situations and to provide some insights into what challenges are the important ones to solve and what techniques, tools and mechanisms to employ to be successful. Following an introduction to lean biomanufacturing, the book goes on to discuss lean technologies and methods applied in biomanufacturing. Later chapters cover the creation and implementation of the Transition Plan, issues facing the biopharmaceutical industry, creating a lean approach towards biopharmaceutical processes and the contribution of simulation models in developing these processes. The final chapter covers examples of new technology innovations which help facilitate lean biomanufacturing. A focus on the issues associated with the application of lean principles to biomanufacturing Practical examples of factors which can affect biopharmaceutical processes Coverage of key factors which require integration to run an efficient biopharmaceutical process

The Funding of Biopharmaceutical Research and Development

The Funding of Biopharmaceutical Research and Development
A Book

by David R Williams

  • Publisher : Elsevier
  • Release : 2013-10-31
  • Pages : 284
  • ISBN : 1908818387
  • Language : En, Es, Fr & De
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The funding of biopharmaceutical research and development provides a comprehensive critical review of the funding of research and development (R&D) in the human biopharmaceutical market sector. It addresses both private and public funding sources available in the US and internationally. The biopharmaceutical market is among the most research-intensive market sectors globally. Clinical researchers face a multitude of public and private funding options with respect to bringing their idea or innovation to market. These funding options are continually changing and complex, and are expected to decrease in the near future. A lack of understanding of the scale, scope, and inner workings of the funding aspects of R&D can, at times, act as a barrier for all involved, and can slow down or even eliminate the R&D process. The book lessens these barriers by describing the theoretical underpinnings, present practice, and trends in R&D funding in this market sector, both in the US and internationally. This includes a review and discussion of public-private partnership activity and their inner-workings, noting the complementary relationship between public and private funding. The book also contains an overview of the inner-workings of strategic alliance activity, including the advantages and disadvantages for each party. It goes on to provide an outline of venture capital activity, detailing the methods by which venture capital firms raise capital and are organized, a description of the venture capital-entrepreneur arrangement, and the effects of this arrangement. The book also presents an overview of the IPO process and the various fates of firms going public. Presents a comprehensive view of the funding issues of R&D in this market sector, adopting a theory-to-practice approach A comprehensive and analytical review of the biopharmaceutical R&D literature and practice An overview of the various and competing/complementary theories of the firm and valuation methods as they apply to biopharmaceutical R&D

Strategic Aspects of Indian Pharmaceutical Industry

Strategic Aspects of Indian Pharmaceutical Industry
A Book

by Dr. Sandeep Tare

  • Publisher : Lulu.com
  • Release : 2021
  • Pages : 129
  • ISBN : 0359085512
  • Language : En, Es, Fr & De
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Competition Law in India

Competition Law in India
A Book

by Srinivasan Parthasarathy

  • Publisher : Kluwer Law International B.V.
  • Release : 2017-02-24
  • Pages : 256
  • ISBN : 904118760X
  • Language : En, Es, Fr & De
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Derived from the renowned multi-volume International Encyclopaedia of Laws, this practical analysis of competition law and its interpretation in India covers every aspect of the subject – the various forms of restrictive agreements and abuse of dominance prohibited by law and the rules on merger control; tests of illegality; filing obligations; administrative investigation and enforcement procedures; civil remedies and criminal penalties; and raising challenges to administrative decisions. Lawyers who handle transnational commercial transactions will appreciate the explanation of fundamental differences in procedure from one legal system to another, as well as the international aspects of competition law. Throughout the book, the treatment emphasizes enforcement, with relevant cases analysed where appropriate. An informative introductory chapter provides detailed information on the economic, legal, and historical background, including national and international sources, scope of application, an overview of substantive provisions and main notions, and a comprehensive description of the enforcement system including private enforcement. The book proceeds to a detailed analysis of substantive prohibitions, including cartels and other horizontal agreements, vertical restraints, the various types of abusive conduct by the dominant firms and the appraisal of concentrations, and then goes on to the administrative enforcement of competition law, with a focus on the antitrust authorities’ powers of investigation and the right of defence of suspected companies. This part also covers voluntary merger notifications and clearance decisions, as well as a description of the judicial review of administrative decisions. Its succinct yet scholarly nature, as well as the practical quality of the information it provides, make this book a valuable time-saving tool for business and legal professionals alike. Lawyers representing parties with interests in India will welcome this very useful guide, and academics and researchers will appreciate its value in the study of international and comparative competition law.