...Clinical Research And It's Scope in India Clinical research is a current booming industry. It provides scientific analysis of the impact, risks, benefits and efficacy of medicines or a medicinal product. The trials are done before initiating the products in the market. The tests are performed at different stages and after-launch, surveys are held to supervise the safety and monitor the side effects if any. The Clinical Research Organisations (CRO) or pharmaceutical companies carry out the tests. It is the best time to become part of this fast evolving industry. So how to enter this field? The prerequisite is an educational qualification in clinical research. The term clinical research refers to the entire record of a drug/device/biologic,...
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...Introduction Clinical trials, for any pharmaceutical company are significant, as they serve as the back bone in Research and development of new medicines and their standardization for the advantage of human population. In developed countries the conduct of clinical trials in more transparent and heavily regulated. However, the conduct of clinical trials in India come with lot of risks, as a lot of people are uneducated, no rules of compliance by the government. India was considered as the economical and feasible place to conduct these clinical trials, as the laws pertaining for the same were not stringent. Clinical Trials: A clinical trial is a scientific investigation to evaluate the effect of new drugs or vaccines other than health interventions, by administering these to human volunteers. They are generally bio medical or health-related research studies in human beings that follow a pre-defined protocol. In 2005 amendments were made on Drugs and Cosmetics Act, 1945, which allowed big companies to start their clinical trials in India. After that, there are number of incidents resulting in death of people participating in such clinical trials, particularly women, aged and even mentally challenged people, across the country. Due to this, the Drugs and Cosmetics Act Amendment Bill 2013 was brought forth in order to strengthen the drug regulatory system and create a central authority for managing drug and medical device approval. The non-conducive climate for clinical trials within...
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...------------------------------------------------- Clinical trial From Wikipedia, the free encyclopedia | This article may be too long to read and navigate comfortably. Please consider splitting content into sub-articles and using this article for a summary of the key points of the subject.(October 2010) | Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place. Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients into small pilot studies initially, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries. Due to the sizable cost a full series of clinical trials may incur, the burden of paying for all the necessary people and services...
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...08-081 November 4, 2008 Biocon India Group Archana Kalegaonkar, Richard Locke, Jonathan Lehrich “Earn as you learn.” For 25 years this unofficial philosophy had served Biocon well. Starting out in the enzyme business in 1978, the Bangalore-based firm had gradually expanded into the pharmaceutical industry. Expertise in manufacturing enzymes led to mass production of generic drugs, which in turn gave Biocon the experience to establish Syngene, a subsidiary contract research organization (CRO) serving the global pharmaceutical market. At each stage Biocon had built on both its recently developed capabilities and the political, biological, intellectual, and financial benefits of the Indian environment to move into new areas of opportunity. By early 2003, Biocon had parlayed earning and learning into a firm that boasted 800 employees and annual revenues of US$75 million. Yet the time had come to consider whether this growth model was reaching its limits. In the eyes of Biocon India Group’s Managing Director, Kiran Mazumdar-Shaw, Biocon’s newest subsidiary, Clinigene, seemed an ideal way to capitalize on the company’s technical strengths by offering services in clinical trials. There was concern, however, that Clinigene could also be an enormous distraction, consuming precious resources in an area in which Biocon had little direct experience. Moreover, if Clinigene did prove profitable, its very success could be a Pyrrhic victory: the subsidiary could rapidly...
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... | | | | | Abstract The paper discusses the evolution and growth of Biocon in recent years. It focuses on the Alternative business models key players in the industry have adopted and highlights the activities and achievements of some of the globally competitive companies across various segments of the market. The paper also chronicles recent developments in the industry with respect to international alliances, product development and investment and expansion. Increasingly, India is being recognized as a country...
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...2012 STRATEGIC MANAGEMENT TERM PAPER ALOK KEJARIWAL 1PI11MBA13 INTRODUCTION Industry Biotechnology Founded 1978 Founder(s) Kiran Mazumdar-Shaw Headquarters Bangalore, India Biocon Limited (BSE: 532523) is a global biopharmaceutical company with products and research services ranging from pre-clinical to clinical development through to commercialization.[ref 1] Within biopharmaceuticals, the Company manufactures generic active pharmaceutical ingredients (APIs) like Statins and Immunosuppressants that are sold in the developed markets of the United States and Europe. It also manufactures biosimilar Insulins, which are sold in India as branded formulations and in both bulk and formulation forms. Located with R & D in Bangalore and API unit in Hyderabad, India, Biocon has two subsidiaries— Syngene, a custom research organization, and Clinigene, a clinical research organization. Biocon’s presence straddles four main therapeutic areas—Diabetology, Cardiology, Nephrology and Oncology. History Biocon is a fully integrated healthcare company that delivers innovative biopharmaceutical solutions. November 29, 1978 Biocon India is incorporated as a joint venture between Biocon Biochemicals Ltd. of Ireland and an Indian entrepreneur, Kiran Mazumdar-Shaw. 1979—Becomes the first Indian company to manufacture and export enzymes to USA and Europe. 1989—Unilever plc. acquires Biocon Biochemicals Ltd. in Ireland and merges it with...
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... Section: B Semester : 3rd Batch : 2011-2013 PES Institute of Technology 2012 1/1/2012 INTRODUCTION Industry Biotechnology Founded 1978 Founder(s) Kiran Mazumdar-Shaw Headquarters Bangalore, India Biocon Limited (BSE: 532523) is a global biopharmaceutical company with products and research services ranging from pre-clinical to clinical development through to commercialization.[ref 1] Within biopharmaceuticals, the Company manufactures generic active pharmaceutical ingredients (APIs) like Statins and Immunosuppressants that are sold in the developed markets of the United States and Europe. It also manufactures biosimilar Insulins, which are sold in India as branded formulations and in both bulk and formulation forms. Located with R & D in Bangalore and API unit in Hyderabad, India, Biocon has two subsidiaries— Syngene, a custom research organization, and Clinigene, a clinical research organization. Biocon’s presence straddles four main therapeutic areas—Diabetology, Cardiology, Nephrology and Oncology. History Biocon is a fully integrated healthcare company that delivers innovative biopharmaceutical solutions. November 29, 1978 Biocon India is incorporated as a joint venture between Biocon Biochemicals Ltd. of Ireland and an Indian entrepreneur, Kiran Mazumdar-Shaw. 1979—Becomes the first Indian company to manufacture and export enzymes to USA and Europe. 1989—Unilever plc. acquires Biocon Biochemicals...
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...Connor Linton and Nicholas Corrado1 Abstract India has charted its own intellectual property (IP) path over the last 35 years, attempting to foster the growth of a domestic pharmaceutical industry and access to medicine while, more recently, also addressing the requirements of the international IP regime. Multinational companies (MNCs) have responded to India’s movement towards compliance with the W TO intellectual property agreement, TRIPS, by increasing the quantity and quality of foreign direct investment (FDI) in the areas of pharmaceutical research and development (R&D) and manufacturing. By contrast, MNCs have adopted a more cautious attitude toward the patenting and commercialization of new pharmaceutical products in India, waiting to see how Indian courts and patent offices interpret the new laws, and awaiting the enactment of longdebated data protection legislation. The ultimate success of the Indian “calibrated approach” to fostering the domestic industry and access to medicine while also addressing international IP requirements remains to be seen. 1 Katherine Connor Linton (katherine.linton@usitc.gov) is the International Trade Analyst for Intellectual Property and Nicholas Corrado was a law student intern in the Office of Industries of the U.S. International Trade Commission (USITC). The views expressed are those of Ms. Linton and responsibility for any errors remains with her; Mr. Corrado provided valuable research assistance. These are not the views of the USITC...
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...Pharmaceuticals and Life Sciences Global pharma looks to India: Prospects for growth Table of contents Introduction 03 Background 04 A fast growing economy An expanding pharmaceutical market Government-provided healthcare improving, but private healthcare dominates Domestic market overview 09 Background Consolidation underway, despite challenges Contract manufacturing Vaccines Over the counter market holds significant potential Reaching the untapped rural market Growing Research & Development 15 Overview Clinical trials Biotech and biosimilars on track for growth Other growth areas Bioinformatics 20 Stem cell research Medical devices Global Pharma’s evolving business models and options in India 23 Background Export-oriented business (Contract Research and Manufacturing Services) Licensing Franchising Joint ventures Wholly-owned subsidiaries Practical concerns 27 Infrastructure Tax environment Counterfeiting Intellectual property Conclusion 30 Related reading: Pharma 2020 31 References 32 Acronyms 38 Introduction The pharmaceutical industry’s main markets are under serious pressure. North America, Europe and Japan jointly account for 82% of audited and unaudited drug sales; total sales reached US$773 billion in 2008, according to IMS Health. Annual growth in the European Union (EU) has slowed to 5.8%, and sales are increasing at an even more sluggish rate...
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...Pharmaceutical Testing of India's People Maira Watts Tarleton State University Abstract This paper looks at the pharmaceutical medical trials and clinical drug testing on the people of India as the ethical perspective conducted from journals and articles provided along with a video that was shown to understand the perspective of what we were to analyze. The journals speak on the process of approval, laws that are in place to advocate for the people, and the overall plight of the subjects that sign up for the clinical trials. The World Health Organization (WHO) and the Drugs Controller of General India (DGCI) are the two main controlling factions in the process to monitor and regulate the companies and sponsors that conduct clinical trials in India. This paper will discuss what happens to the people in the lower caste and what can be done to improve the situation of subjects that are part of the trials. Introduction Clinical medical trials are becoming one of the most prominently profitable industries in the world to come to a country with such a large population spread as India. The country is a largely technically adept workforce that has a great amount of population that demonstrate a variety of medical conditions along with the low cost of introduction into market which makes India hotbed for these medical trials. It comes down the problems of being ethical, is it right for the people, what ill effects will it have on these people, and do they even know...
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...sure his team is will prepared with the history of the countries, the proper contacts with the government and learning the language. Pfizer went from being a building filled with two cousins dream to an international successful, pharmaceutical, agricultural, and chemical company. ("A pioneering spirit," nd.) For the purpose of this assignment, I will chose leading pharmaceuticals company Pfizer that operates in numerous countries across the world. The company has R&D labs as well as manufacturing operations in several countries. The company also sells its drugs in numerous countries across the globe. To further expand on other questions, I will pick Pfizer's operations in India. Pfizer has a state of the art manufacturing facilities in India, as well as invests heavily in research and development in India and employs over 2300 people in the country. The company has partnered with...
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...Ethics of Offshoring: Novo Nordisk and Clinical Trials In Emerging Economies Offshoring is a highly debatable topic throughout the country and the world. Many people base their opinions on different aspects of offshoring. Some people are against offshoring because they feel as if the working conditions in other countries aren’t up to par and are unethical. Some people are against offshoring because they feel it is taking jobs away from people within their own country. Some people are for offshoring because they feel there is greater profit involved or that they can get harder workers in other countries. No matter what side of the debate, everyone can agree on a few things like there needs to be better standards for working conditions, proper safety measures, and high economic and ethical concern. The case Ethics of Offshoring: Novo Nordisk and Clinical Trials in Emerging Economies was a highly informative case on clinical trials and offshoring. There was a reporter who wanted to speak with Anders Dejgaard, chief medical officer of Novo Nordisk, about his take on the offshoring of clinical trials by Danish companies as there had been multiple reports about trials being conducted in developing countries under unethical conditions. When reading the case, it truly made me consider aspects that I had never considered before. There are a few underlying questions that I feel need to be discussed. First of all, when considering both economic and ethical aspects, is it appropriate...
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...M U M B AI SILICON VALLEY BANGA LORE SINGA P ORE MUMBA I BK C NE W DE L HI MUNICH The Indian Medical Device Industry Regulatory, Legal and Tax Overview March 2015 © Copyright 2015 Nishith Desai Associates www.nishithdesai.com The Indian Medical Device Industry Regulatory, Legal and Tax Overview About NDA Nishith Desai Associates (NDA) is a research based international law firm with offices in Mumbai, Bangalore, Silicon Valley, Singapore, New Delhi, Munich. We specialize in strategic legal, regulatory and tax advice coupled with industry expertise in an integrated manner. We focus on niche areas in which we provide significant value and are invariably involved in select highly complex, innovative transactions. Our key clients include marquee repeat Fortune 500 clientele. Core practice areas include International Tax, International Tax Litigation, Litigation & Dispute Resolution, Fund Formation, Fund Investments, Capital Markets, Employment and HR, Intellectual Property, Corporate & Securities Law, Competition Law, Mergers & Acquisitions, JVs & Restructuring, General Commercial Law and Succession and Estate Planning. Our specialized industry niches include financial services, IT and telecom, education, pharma and life sciences, media and entertainment, real estate and infrastructure. Nishith Desai Associates has been ranked as the Most Innovative Indian Law Firm (2014) and the Second Most Innovative Asia - Pacific Law Firm (2014)...
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... | |(Rs. In Crores) | | |2005 |2006 |2007 |2008 |2009 |2010 | |Sales | |Bio Pharmaceuticals |557 |603 |728 |787 |1372 |2036 | |Enzymes |90 |85 |95 |46 |- |- | |Research and Technical Licensing Fees |66 |100 |163 |220 |237 |332 | | | |Total |713 |788 |986 |1054 |1609 |2368 | | | |Other Income |15 |5 |4 |36 |64 |37 | | ...
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...Review Article INTEGRATING DENTAL INFORMATICS IN PLANNING AN EFFECTIVE ORAL HEALTH INFORMATION SYSTEM IN INDIA - NEED OF AN HOUR Eshani Saxena*1, Pankaj Goel2 , Chandrashekar BR3, Sudheer Hongal 4 , 1. P.G Student , Dept of public health dentistry ,Peoples dental academy , Bhopal 2. HOD, dept of Public health dentistry AIIMS Bhopal 3. Dept of Public health dentistry, People’s dental academy , Bhopal 4. Reader, Dept of Public health dentistry, People’s dental academy , Bhopal Corresponding author: Dr. Eshani Saxena , P.G Student , Dept of public health dentistry ,Peoples dental academy , Bhopal . Received on 16 Jan 2014, Published on 2 feb 2014 ABSTRACT Technology in dentistry is a novel science and it will continue to grow in future. The research field that study dentistry from a technical perspective is dental informatics. Dental informatics engrosses every discipline in dentistry. To review the existing literature on dental informatics in public health practice and discuss the feasibility of integrating dental informatics in planning effective oral health information system in India. A thorough search for the literature on dental informatics and oral health information system was made in biomedical data bases using the search engine for two weeks by one investigator. The retrieved literature was then organized into primary and secondary sources, softwares in clinical dentistry, softwares for public health informatics etc. The literature focusing on the applicability of...
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