Research Study I: PG Diploma in Pharmacy
Research Study I: PG Diploma in Pharmacy
PG Diploma in Pharmacy
Submitted by:
Nidhi Upreti ENROLMENT NO. Bioinformation Institute of India C-56A/28, Sector-62, Noida
CONTENTS
Abbreviations Chapter I Name Introduction Of Ranbaxy Laboratories Chapter II Name Existing Status Of Ranbaxy Laboratories Chapter III Name Approaches By Renowned Scientist Chapter IV Name Prevailing Status Of the Process Involved Chapter V Name Related/Applied Matter Chapter VI Name Conclusion/ Suggestions
References
ACKNOWLEDGEMENT
A project can blossom and be a success if it is guided, assisted and inspired at various quarters and spheres of its formation. My project was given its present shape by assistance of many people whom I am greatly indebted to. I take this opportunity to express my deep gratitude to the BIOINFORMATION INSTITUTE OF INDIA,NOIDA for providing me the opportunity to get an exposure and to complete my project report on Pharma Quality Assurance and Quality Control. At last I am thankful all those persons, who directly or indirectly involved in this project.
NIDHI UPRETI
DECLARATION
Certified that this Research Study is my original work and that I have not taken or borrowed any material from others work nor have I presented this partly or fully to any other Institution/ College/ University. I have complied with all the formalities prescribed in this regard.
RESEARCH
Research as systematic and scientific search for pertinent information on a specific topic. It is a systematic effort to gain knowledge. It redefines problem, formulating hypothesis or suggested solutions, collecting organizing and evaluating data, making deductions and reaching conclusions.
RESEARCH METHODOLOGY
Research Methodology is a way to systematically solve the research problem. In it we study the various steps that are generally adopted by a researcher in the logic behind them. The purpose of the methodology is describing the process involved in the research sampling procedure.
RESEARCH DESIGN
Research design refers to the pattern or outline of a research project working. It comprises a series of prior decision that taken together provide a master plan for exceeding a report. Research design used in this study is exploratory type. This method used in the study is survey feedback. This method is suggested for better study of reviewing problem through organization development perspectives
MEANING OF RESEARCH
Research in common parlance refers to a search for knowledge. Once can also define research as a scientific and systematic search for pertinent information on a specific topic. In fact, research is an art of scientific investigation. The Advanced Learners Dictionary of Current English lays down the meaning of research as a careful investigation or inquiry specially through search for new facts in any branch of knowledge.1 Redman and Mory define research as a systematized effort to gain new knowledge.2 Some people consider research as a movement, a movement from the known to the unknown. It is actually a voyage of discovery. We all possess the vital instinct of inquisitiveness for, when the unknown confronts us, we wonder and our inquisitiveness makes us probe and attain full and fuller understanding of the unknown. This inquisitiveness is the mother of all knowledge and the method, which man employs for obtaining the knowledge of whatever the unknown, can be termed as research. Research is an academic activity and as such the term should be used in a technical sense. According to Clifford Woody research comprises defining and redefining problems, formulating hypothesis or suggested solutions; collecting, organising and evaluating data; making deductions and reaching conclusions; and at last carefully testing the conclusions to determine whether they fit the formulating hypothesis. D. Slesinger and M. Stephenson in the Encyclopaedia of Social Sciences define research as the manipulation of things, concepts or symbols for the purpose of generalising to extend, correct or verify knowledge, whether that knowledge aids in construction of theory or in the practice of an art.3 Research is, thus, an original contribution to the existing stock of knowledge making for its advancement. It is the persuit of truth with the help of study, observation, comparison and experiment. In short, the search for knowledge through objective and systematic method of finding solution to a problem is research. The systematic approach concerning generalisation and the formulation of aconsisting of enunciating the problem, formulating a hypothesis, collecting the facts or data, analyzing the facts and reaching certain conclusions either in the form of solutions(s) towards the concerned problem or in certain generalisations for some theoretical formulation.
OBJECTIVES OF RESEARCH
The purpose of research is to discover answers to questions through the application of scientific procedures. The main aim of research is to find out the truth which is hidden and which has not been discovered as yet. Though each research study has its own specific purpose, we may think of research objectives as falling into a number of following broad groupings: 1. To gain familiarity with a phenomenon or to achieve new insights into it (studies with this object in view are termed as exploratory or formulative research studies); 2. To portray accurately the characteristics of a particular individual, situation or a group (studies with this object in view are known as descriptive research studies); 3. To determine the frequency with which something occurs or with which it is associated with something else (studies with this object in view are known as diagnostic research studies); 4. To test a hypothesis of a causal relationship between variables (such studies are known as hypothesis-testing research studies.
TYPES OF RESEARCH
The basic types of research are as follows: Descriptive vs. Analytical: Descriptive research includes surveys and fact-finding enquiries of different kinds. The major purpose of descriptive research is description of the state of affairs as it exists at present. In social science and business research we quite often use. The term Ex post facto research for descriptive research studies. The main characteristic of this method is that the researcher has no control over the variables; he can only report what has happened or what is happening. Most ex post facto research projects are used for descriptive studies in which the researcher seeks to measure such items as, for example, frequency of shopping, preferences of people, or similar data. Ex post facto studies also include attempts by researchers to discover causes even when they cannot control the variables. The methods of research utilized in descriptive research are survey methods of all kinds, including comparative and correlational methods. In analytical research, on the other hand, the researcher has to use facts or information already available, and analyze these to make a critical evaluation of the material. Applied vs. Fundamental: Research can either be applied (or action) research or fundamental (to basic or pure) research. Applied research aims at finding a solution for an immediate problem facing a society or an industrial/business organisation, whereas fundamental research is mainly concerned with generalisations and with the formulation of a theory. Gathering knowledge for knowledges sake is termed pure or basic research.4 Research concerning some natural phenomenon or relating to pure mathematics are examples of fundamental research. Similarly, research studies, concerning human behaviour carried on with a view to make generalisations about human behaviour, are also examples of fundamental research, but research aimed at certain conclusions (say, a solution) facing a concrete social or business problem is an example of applied research. Research to identify social, economic or political trends that may affect a particular institution or the copy research (research to find out whether certain communications will be read and understood) or the marketing research or evaluation research are examples of applied research. Thus, the central aim of applied research is to discover a solution for some pressing practical problem, whereas basic research is directed towards finding information that has a broad base of applications and thus, adds to the already existing organized body of scientific knowledge. Quantitative vs. Qualitative: Quantitative research is based on the measurement of quantity or amount. It is applicable to phenomena that can be expressed in terms of quantity. Qualitative research, on the other hand, is concerned with qualitative phenomenon, i.e., phenomena relating to or involving quality or kind. For instance, when we are interested in investigating the reasons for human behaviour (i.e., why people think or do certain things), we quite often talk of Motivation Research, an important type of qualitative research. This type of research aims at discovering the underlying motives and desires, using in depth interviews for the purpose. Other techniques of such research are word association tests, sentence completion tests, story completion tests and similar other projective techniques. (iii) (ii) (i)
Attitude or opinion research i.e., research designed to find out how people feel or what they think about a particular subject or institution is also qualitative research. Qualitative research is specially important in the behavioural sciences where the aim is to discover the underlying motives of human behaviour. Through such research we can analyse the various factors which motivate people to behave in a particular manner or which make people like or dislike a particular thing. It may be stated, however, that to apply qualitative research in practice is relatively a difficult job and therefore, while doing such research, one should seek guidance from experimental psychologists. (iv) Conceptual vs. Empirical:
Conceptual research is that related to some abstract idea(s) or theory. It is generally used by philosophers and thinkers to develop new concepts or to reinterpret existing ones. On the other hand, empirical research relies on experience or observation alone, often without due regard for system and theory. It is data-based research, coming up with conclusions which are capable of being verified by observation or experiment. We can also call it as experimental type of research. In such a research it is necessary to get at facts firsthand, at their source, and actively to go about doing certain things to stimulate the production of desired information. In such a research, the researcher must first provide himself with a working hypothesis or guess as to the probable results. He then works to get enough facts (data) to prove or disprove his hypothesis. He then sets up experimental designs which he thinks will manipulate the persons or the materials concerned so as to bring forth the desired information. Such research is thus characterised by the experimenters control over the variables under study and his deliberate manipulation of one of them to study its effects. Empirical research is appropriate when proof is sought that certain variables affect other variables in some way. Evidence gathered through experiments or empirical studies is today considered to be the most powerful support possible for a given hypothesis. (v) Some Other Types of Research: All other types of research are variations of one or more of the above stated approaches, based on either the purpose of research, or the time required to accomplish research, on the environment in which research is done, or on the basis of some other similar factor. Form the point of view of time, we can think of research either as one-time research or longitudinal research. In the former case the research is confined to a single time-period, whereas in the latter case the research is carried on over several time-periods. Research can be field-setting research or laboratory research or simulation research, depending upon the environment in which it is to be carried out. Research can as well be understood as clinical or diagnostic research. Such research follow case-study methods or indepth approaches to reach the basic causal relations. Such studies usually go deep into the causes of things or events that interest us, using very small samples and very deep probing data gathering devices. The research may be exploratory or it may be formalized. The objective of exploratory research is the development of hypotheses rather than their testing, whereas formalized research studies are those with substantial structure and with specific hypotheses to be tested. Historical research is that which utilizes historical sources like documents, remains, etc. to study events or ideas of
the past, including the philosophy of persons and groups at any remote point of time. Research can also be classified as conclusion-oriented and decision-oriented. While doing conclusionoriented research, a researcher is free to pick up a problem, redesign the enquiry as he proceeds and is prepared to conceptualize as he wishes. Decision-oriented research is always for the need of a decision maker and the researcher in this case is not free to embark upon research according to his own inclination. Operations research is an example of decision oriented research since it is a scientific method of providing executive departments with a quantitative basis for decisions regarding operations under their control. theory is also research. As such the term research refers to the systematic methodof providing executive departments with a quantitative basis for decisions regarding operations under their control.
Research methodology is a way to systematically solve the research problem. It may be understood as a science of studying how research is done scientifically. In it we study the various steps that are generally adopted by a researcher in studying his research problem along with the logic behind them. It is necessary for the researcher to know not only the research methods/techniques but also the methodology. Researchers not only need to know how to develop certain indices or tests, how to calculate the mean, the mode, the median or the standard deviation or chi-square, how to apply particular research techniques, but they also need to know which of these methods or techniques, are relevant and which are not, and what would they mean and indicate and why. Researchers also need to understand the assumptions underlying various techniques and they need to know the criteria by which they can decide that certain techniques and procedures will be applicable to certain problems and others will not. All this means that it is necessary for the researcher to design his methodology for his problem as the same may differ from problem to problem. For example, an architect, who designs a building, has to consciously evaluate the basis of his decisions, i.e., he has to evaluate why and on what basis he selects particular size, number and location of doors, windows and ventilators, uses particular materials and not others and the like. Similarly, in research the scientist has to expose the research decisions to evaluation before they are implemented. He has to specify very clearly and precisely what decisions he selects and why he selects them so that they can be evaluated by others also. From what has been stated above, we can say that research methodology has many dimensions and research methods do constitute a part of the research methodology. The scope of research methodology is wider than that of research methods. Thus, when we talk of research methodology we not only talk of the research methods but also consider the logic behind the methods we use in the context of our research study and explain why we are using a particular method or technique and why we are not using others so that research results are capable of being evaluated either by the researcher himself or by others. Why a research study has been undertaken, how the research problem has been defined, in what way and why the hypothesis has been formulated, what data have been collected and what particular method has been adopted, why particular technique of analysing data has been used and a host of similar other questions are usually answered when we talk of research methodology concerning a research problem or study.
the time and energy of researchers are spent in tracing out the books, journals, reports, etc., rather than in tracing out relevant material from them. 8. There is also the problem that many of our libraries are not able to get copies of old and new Acts/Rules, reports and other government publications in time. This problem is felt more in libraries which are away in places from Delhi and/or the state capitals. Thus, efforts should be made for the regular and speedy supply of all governmental publications to reach our libraries. 9. There is also the difficulty of timely availability of published data from various government and other agencies doing this job in our country. Researcher also faces the problem on account of the fact that the published data vary quite significantly because of differences in coverage by the concerning agencies. 10. There may, at times, take place the problem of conceptualization and also problems relating to the process of data collection and related things.
PRIMARY DATA
Primary data are those which are collected a fresh and for the first time and thus happens original in character we collect primary data during the course of doing experiments is an experimental research or through direct communication with respondence in one form or another or through personal interviews. 1) Most of the data is collected with the help of questionnaire and direct observation. 2) Another type of primary data are: Direct Survey Personal Interview Telephone Interview Questionaire Analysis
SECONDARY DATA
Secondary data on the other hand are those which have already been collected by someone else and which have passed through the statistical process the nature of secondary data collection is only that of complication.
1) Published Data 2) Unpublished Data 3) Books, Magazines and Manuals 4) Internet 5) Performance record of the last employees.
The objective
recommendation as per the requirement of the study. In the undertaking is to gather information regarding Quality Control and Assurance Research.
provide a sustainable, long-term competitive advantage. The company has a pool of over 1,200 R&D personnel engaged in path-breaking research. Ranbaxy is among the few Indian pharmaceutical companies in India to have started its research program in the late 70's, in support of its global ambitions. A first-of-its-kind world class R&D centre was commissioned in 1994. Today, the company has multi-disciplinary R&D centers at Gurgaon, in India, with dedicated facilities for generics research and innovative research. The R&D environment reflects its commitment to be a leader in the generics space offering value added formulations and development of NDA/ANDAs, based on its Novel Drug Delivery System (NDDS) research capability. The NDDS research at Ranbaxy focuses on maximizing the overall therapeutic and commercial value of commonly prescribed pharmaceutical formulations by enhancing their performance and reducing their adverse event profile. Such innovation also helps to improve the overall patient convenience and compliance The company's NDDS focus is mainly on the development of New Drug Applications (NDA) / Abbreviated New Drug Applications (ANDAs) of oral controlled- release products for the regulated markets. The Company's first significant international success using the NDDS technology platform came in September 1999, when Ranbaxy licensed its once-a-day Ciprofloxacin formulation on a worldwide basis to a multinational Company. Ranbaxy's in-house NDDS programs are primarily focused on the oral segment. Inhalation (patented devices) and trans-dermal (patented adhesive polymers) programs are also being pursued through collaborations. In the oral NDDS space, Ranbaxy has already developed four platform technologies namely Gastro Retentive, Modified Matrix, Multiparticulate and AeroGel. Several products leveraging these technologies have been successfully developed. In July 2010, Ranbaxys New Drug Discovery Research (NDDR) was transferred to Daiichi Sankyo India Pharma Private Limited as part of the strategy to strengthen the global Research and Development structure of the Daiichi Sankyo Group. While NDDR has become an integral part of Daiichi Sankyo Life Science Research Center in India, based in Gurgaon, Ranbaxy continued to independently develop the anti-malarial new drug, Arterolanemaleate + Piperaquine phosphate. In 2011, Ranbaxy received permission from the Indian Drug Regulator, Drug Controller General of India (DCGI), to manufacture and market this drug in India. Ranbaxy will also explore the further development of late stage programs developed by NDDR in the last few years, including the development programs in the GSK collaboration. Within Ranbaxy, R&D of Generics will now get a sharper focus, as the company is increasingly working on more complex and specialist areas.
RANBAXY
History:
Ranbaxy was founded in Amritsar in 1937 by Ranjit Singh and Dr Gurbax Singh, who distributed vitamins and anti-tuberculosis drugs for a Japanese pharmaceutical company. After the Second World War, Ranbaxy continued as a distributor. Bhai Mohan Singh bought the company from his cousins Ranjit Singh and Gurbax Singh. Ranbaxy's name is a fusion of Ranjit and Gurbax's names. The company started in 1937 as a distributor for Japanese vitamins and anti-tuberculosis drugs. The companys manufacturing history was triggered by an alliance in 1951 with the Italian company Lapetit under which Ranbaxy distributed Lapetits products in India. In 1961, Lapetit assisted Ranbaxy to set up some limited local manufacture. This was the first example of Ranbaxys use of alliances to gain technical expertise. The association with Lapetit ended in 1966, due to Ranbaxys determination to formulate more products locally. Faced with an ensuing product shortage, Ranbaxy reverse-engineered Lapetits products by 1969. At the same time, it also expanded its product range by developing Calmpose, its own version of Valium. At that stage, there was nothing to prevent Ranbaxy copying others products, but Ranbaxy was very small compared to the foreign multinationals (MNCs) and Indian public sector firms, such as Hindustan Antibiotics ltd and IDPL, which dominated the local market. The Indian government introduced patent legislation in 1970; however, this only protected processes. Competitors were free to imitate products as long as they used a different process. This created a disadvantage for MNCs compared to local imitators, and they were further discouraged by the introduction of price controls on drugs and later (in 1973) by restrictions on the amount of equity they could hold in local companies. This clearly provided a spur for the development of local pharmaceutical companies such as Ranbaxy, which established its bulk drugs facility at Mohali, Punjab, in 1971 and went public in 1973. Over subsequent years, it has continued to invest in its Indian manufacturing operations, which still form the core of its operations. Initially the company concentrated on the local market; however, given the low-cost Indian labour, the low capital cost of setting up a pharmaceutical plant in India (onethird the cost of Europe or United States), and the highvalue density of pharmaceuticals, exporting either generic products, which were out of patent, or copies of patented drugs to countries which were prepared to accept them was an obvious strategy for Ranbaxy, and indeed this is what it started in 1975. From 1980, the company transformed from a local to an international company. The driving forces were Parvinder Singhs vision, the extension of price controls in the Indian market, and some encouragement from the government to companies to invest abroad. In 1993, reflecting the growing importance of its overseas operations, Ranbaxy restructured into four regions India and Middle East; Europe CIS and Africa; Asia Pacific; and North and South America setting up regional headquarters in the US and UK in the following year. In 1992, Ranbaxy expanded it operations via a joint venture with Eli Lilly to manufacture Lilly products in India and market them throughout South Asia; in 1994, when it looked as if the US
healthcare reforms would trigger an explosion in the generic drug market, Lilly also contracted Ranbaxy to make generics for it. By 1997 the Indian economy was beginning to slow down and drugs exporters, facing competition by the Chinese, began to increase focus on generics, and in the same year Ranbaxy engaged in a spate of alliances and acquisitions to gain scale domestically. Although Parvinder Singh died in 1999, the company continued along the same course, but after 2004 its international activities seem to have accelerated slightly anticipating the acceleration of outward FDI from the country as a whole. It is interesting to note that M&A increasingly appears to have become the dominant expansion mode, perhaps driven by increasing levels of inward FDI, the growth in the Indian economy, and relaxation of the constraints on Indian companies, which wanted to expand overseas.
Company Profile
Ranbaxy Laboratories Limited (Ranbaxy), India's largest pharmaceutical company, is an integrated, research based, international pharmaceutical company, producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy today has a presence in 23 of the top 25 pharmaceutical markets of the world. The Company has a global footprint in 43 countries, world-class manufacturing facilities in 8 countries and serves customers in over 125 countries. In June 2008, Ranbaxy entered into an alliance with one of the largest Japanese innovator companies, Daiichi Sankyo Company Ltd., to create an innovator and generic pharmaceutical powerhouse. The combined entity now ranks among the top 20 pharmaceutical companies, globally. The transformational deal will place Ranbaxy in a higher growth trajectory and it will emerge stronger in terms of its global reach and in its capabilities in drug development and manufacturing.
Mission
Ranbaxy's mission is 'Enriching lives globally, with quality and affordable pharmaceuticals'.
Financials
Ranbaxy was incorporated in 1961 and went public in 1973. For the year 2011, the Company recorded Global Sales of US $ 2.1 Bn. The Company has a balanced mix of revenues from emerging and developed markets that contribute 47% and 46% respectively. In 2011, North
America, the Company's largest market contributed sales of US $ 791 Mn, Europe contributing US $ 297 Mn and Asia clocking sales of US $ 503 Mn.
Strategy
Ranbaxy is focused on increasing the momentum in the generics business in its key markets through organic and inorganic growth routes. Growth is well spread across geographies with focus on developed and emerging markets. It is the Company's constant endeavour to provide a wide basket of generic and innovator products, leveraging the unique Hybrid Business Model with Daiichi Sankyo.
R&D
Ranbaxy views its R&D capabilities as a vital component of its business strategy that will provide a sustainable, long-term competitive advantage. The Company has a pool of over 1,200 R&D personnel engaged in path-breaking research. Ranbaxy is among the few Indian pharmaceutical companies in India to have started its research program in the late 70's, in support of its global ambitions. A first-of-its-kind world class R&D centre was commissioned in 1994. Today, the Company has multi-disciplinary R&D centers at Gurgaon, in India, with dedicated facilities for generics research and innovative research. The R&D environment reflects its commitment to be a leader in the generics space offering value added formulations and development of NDA/ANDAs, based on its Novel Drug Delivery System (NDDS) research capability. Ranbaxy's first significant international success using the NDDS technology platform came in September 1999, when the Company out-licensed its first once-a-day formulation to a multinational company. In July 2010, Ranbaxy's New Drug Discovery Research (NDDR) was transferred to Daiichi Sankyo India Pharma Private Limited as part of the strategy to strengthen the global Research and Development structure of the Daiichi Sankyo Group. While NDDR will now become an integral part of Daiichi Sankyo Life Science Research Center in India, based in Gurgaon. However, Ranbaxy continued to independently develop the anti-malarial new drug, Arterolane maleate + Piperaquine phosphate that has been approved by the Indian Drug Regulator, Drug Controller General of India (DCGI) for marketing in India. Ranbaxy will be launching the drug soon. The company will also explore the further development of late stage programs developed by NDDR in the last few years, including the development programs in the GSK collaboration. Within Ranbaxy, R&D of Generics will now get a sharper focus, as the Company is increasingly working on more complex and specialist areas.
Products
Using the finest R&D and Manufacturing facilities, Ranbaxy Laboratories Limited manufacture and markets generic pharmaceuticals, value added generic pharmaceuticals, branded generics, active Pharmaceuticals (API) and intermediates. The Company remains focused on ascending the value chain in the marketing of pharmaceutical substances and is determined to bring in increased revenues from dosage forms sales. Ranbaxy's diverse product basket of over 5,000 SKUs available in over 125 countries worldwide, encompasses a wide therapeutic mix covering a majority of the chronic and acute segments. Healthcare trends project that the chronic treatment segments will outpace the acute treatment segments, primarily driven by a growing aging population and dominance of lifestyle diseases. Our robust performance in Cardiovasculars, Central Nervous System, Respiratory, Dermatology, Orthopedics, Nutritionals and Urology segments, clearly indicates that the Company has strengthened its presence in the fast-growing chronic and lifestyle disease segments.
Top 10 Molecules (2010) Valacyclovir Simvastatin Donepezil Atorvastatin & Combinations Co-amoxyclav & Combinations Ciprofloxacin & Combinations Ketorolac Tromethamine Imipenem+Cilastatin Ginseng+Vitamins Loratadine & Combinations
People
The Company's business philosophy based on delivering value to its stakeholders constantly inspires its people to innovate, achieve excellence and set new global benchmarks. Driven by the passion of it's over 14,000 strong multicultural workforce comprising of more than 50 nationalities, Ranbaxy continues to aggressively pursue its mission of 'Enriching lives globally, with quality and affordable pharmaceuticals'.
Quality itself has been defined as fundamentally relational: 'Quality is the ongoing process of building and sustaining relationships by assessing, anticipating, and fulfilling stated and implied needs.' "Even those quality definitions which are not expressly relational have an implicit relational character. Why do we try to do the right thing right, on time, every time? To build and sustain relationships. Why do we seek zero defects and conformance to requirements (or their modern counterpart, six sigma)? To build and sustain relationships. Why do we seek to structure features or characteristics of a product or service that bear on their ability to satisfy stated and implied needs? (ANSI/ASQC.) To build and sustain relationships. The focus of continuous improvement is, likewise, the building and sustaining of relationships. It would be difficult to find a realistic definition of quality that did not have, implicit within the definition, a fundamental express or implied focus of building and sustaining relationships." Quality assurance (QA) In developing products and services, quality assurance is any systematic process of checking to see whether a product or service being developed is meeting specified requirements. Many companies have a separate department devoted to quality assurance. A quality assurance system is said to increase customer confidence and a company's credibility, to improve work processes and efficiency, and to enable a company to better compete with others. Quality assurance was initially introduced in World War II when munitions were inspected and tested for defects after they were made. Today's quality assurance systems emphasize catching defects before they get into the final product. ISO 9000 is an international standard that many companies use to ensure that their quality assurance system is in place and effective. Conformance to ISO 9000 is said to guarantee that a company delivers quality products and services. To follow ISO 9000, a company's management team decides quality assurance policies and objectives. Next, the company or an external consultant formally writes down the company's policies and requirements and how the staff can implement the quality assurance system. Once this guideline is in place and the quality assurance procedures are implemented, an outside assessor examines the company's quality assurance system to make sure it complies with ISO 9000. A detailed report describes the parts of the standard the company missed, and the company agrees to correct any problems within a specific time. Once the problems are corrected, the company is certified as in conformance with the standard.
requirements of the client or customer. QC is similar to, but not identical with, quality assurance (QA). QA is defined as a procedure or set of procedures intended to ensure that a product or service under development (before work is complete, as opposed to afterwards) meets specified requirements. QA is sometimes expressed together with QC as a single expression, quality assurance and control (QA/QC). In order to implement an effective QC program, an enterprise must first decide which specific standards the product or service must meet.
While the initial years in the career of a Ranbaxy manager is used in developing the professional skills, the focus changes as a person moves to the middle management level. Here leadership potential becomes critical. We have a robust process of identifying potential in individuals. Each of our middle level managers goes through a process that clearly identifies their strengths, development areas and aspirations for the future. This is supported by a structured process of development, which includes movement within the organisation.
2011 has been a year of challenge and stellar achievements. In the face of adversity, Ranbaxy has shown resilience and capitalised on opportunities. In November 2011, we received approval from the US Food & Drug Administration (FDA) to launch Atorvastatin in the US, the generic version of the world's largest selling cholesterol reducing drug. This is a giant leap towards bringing trusted, high quality, affordable medicines, within easy reach of all. Ranbaxy also took the significant step forward in resolving pending matters with the US FDA. While restoring normalcy, this brings greater certainty and clarity to our business in the US. Over the last three years, we have made significant investments in improving quality systems and processes in R&D and manufacturing operations. Ranbaxy also crossed the landmark figure of US $ 2 Bn, in sales, in 2011, becoming the first pharmaceutical company of Indian origin, to do so. Yet another significant achievement in the year has been the approval in India for our new Anti-Malaria Drug. We are the first pharmaceutical company from India to have developed a New Drug. This places Ranbaxy
in the illustrious league of innovator pharmaceutical companies, in service of mankind. Ranbaxy is now ready to move with confidence into a new era of vigorous growth and expansion. The way forward will be to Consolidate, Strengthen and Grow business with a firm commitment to the defined mission of 'Enriching lives globally, with quality and affordable pharmaceuticals'.
This year 'The Golden Jubilee' is the theme for the Annual Report. It aptly reflects two distinct time zones the past and the future. Leveraging our glorious history of expansion, consolidation and resilience over the last 50 Years, Ranbaxy is now at the cusp of an exciting opportunity. The future holds great promise with the realisation of the true potential of our unique Hybrid Business Model with Daiichi Sankyo. The Best is yet to come.
The true hallmark of leadership is the ability to overcome challenge and emerge stronger from the experience. The year gone by has been difficult for global economies. But rather than deter us, it has inspired us to look within and seek beyond; to discover ways of making our Hybrid Business Model more robust and generate synergies across the value chain. We have set in motion synergies, aimed at tapping opportunities beyond new boundaries. The scope is now wide - across geographies and functions. From being arguably India's most global company, we are now amongst the world's top 20 pharmaceutical players, globally. Already, there is visible progress in our thrust markets. A key priority now is strengthening our leadership position in the domestic market. Due emphasis is being given to effective crossfunctional teamwork, with a view to inculcate a vibrant, enabling and empowering work culture, so vital for continued growth. The accruing benefits of synergized expertise are beginning to appear, both at the front and back ends; and this is just the start an apt entry point for achieving our ambitious 3-year strategy plan.
The coming together of Ranbaxy and Daiichi Sankyo is a pathbreaking confluence that, in one sweep, catapults the new, empowered entity to the status of the world's 15th largest pharmaceutical Company. Individually, the two pharmaceutical giants are formidable - one, India's largest generics Company and the other, among the largest innovator companies in Japan. And now, this synchronisation of proven, individual competencies in a unified, complementary platform has catalysed a highoctane thrust into a farreaching transformational trajectory. This synergy of tested success mantras energises the combined business model manifold. It ushers in an expanded global footprint, a wider product portfolio, added revenue streams and better costcompetitiveness, while allowing both companies to optimise research & manufacturing capabilities and much more.
Abstract The caselet talks about the global marketing strategy followed by Ranbaxy that helped the company to become an Indian MNC. It examines the company's focus on generic drug markets that involves identifying off-patent drugs and capturing the market for these drugs. The caselet discusses the company's strategy towards prescription drug market. Finally, it highlights the challenges that Ranbaxy might face in pursuing its global marketing strategy successfully. Issues: Global marketing strategy and Indian companies Product strategy in global markets Role of environmental analysis in designing global marketing strategy Global pharmaceutical market Introduction Ranbaxy is a leading pharmaceutical company in India. It is also one of the few Indian multinational companies whose operations spread across 60 countries. Nearly 70% of its total revenues come from its global operations. The business model of the company is quite different from other Indian multinationals. Companies like Reliance, Sundaram Fasteners, Hero cycles, and Amara Raja Batteries use the 'economies of scale' advantage achieved in the domestic market to export goods manufactured at their Indian plants. However, Ranbaxy has plants and operations in the countries where it has a presence, representing a true multinational company...
RANBAXYS MANAGEMENT
Executive Team
The Executive Committee is an apex body at Ranbaxy, that oversees Company's global functioning. The group deliberates on important Company issues steering it in the right direction. The Committee ensures that all decisions are taken in the best interest of the organisation. This forum brings in different perspectives on a subject. Issues are discussed, analysed and concluded through exchange of ideas, reflecting the Company's philosophy of participative management. It also facilitates the Company's compliance with the best standards of Corporate Governance.
Mr. Dale Adkisson Executive Vice President and Head - Global Quality
Mr. Ashwani Malhotra Executive Vice PresidentGlobal Pharma Manufacturing & Supply Chain
Personnel
The number of persons employed by the Company decreased from 29 to 28 during the year (as of 31 December 2010).
RESULTS OF OPERATIONS
In the year 2010, we could achieve an increase in sales by EUR 2.0million (In INR 120.5 Million ) (9%) to EUR 24.5 million (In INR 1475.9). This development is attributable to the rise in the number of rebate contracts awarded
by health insurance companies. A slight increase was registered in the supply business. The gross profit (sales less cost of materials) went up by EUR 1.4 million [ IN INR 84.3 million], representing an improvement of the gross profit margin from 22% to 26%. The increase in amortisation by EUR 0.2 million (In INR 12.00 million] is caused by an unscheduled writedown on product licenses which cannot be used and by a writedown on a product licence acquired in the 3rd quarter of the year 2009 and recognised for the first time for a 12 month period. Other operating expenses sank by 9% compared to prior year. Cost reductions were realised particularly in the area of administration. Furthermore, donations to charitable organisations nearly halved compared to prior year. On the other side, sales and marketing expenses rose by 19%, as a result of an intensification of marketing activities and the higher logistics costs incurred in connection with the increase in the volume realised under rebate contracts. With an operating result of EUR 1.1 million (In INR 66.3 million) {prior year: -EUR 0.2 million(In INR 12.5 Million )} and a net income of EUR 0.8 Million (In INR 48.2 million] for the financial year {prior year: -EUR 0.2 Million ( In INR 12 million] , the earnings situation again shows a clearly positive trend. FINANCIAL POSITION AND NET ASSETS Long term assets decreased by EUR 0.9 million (In Rs. 53.9 Million) due to the depreciation charged on fixed assets. Short and medium term assets exceed by EUR 10.7 Million (In INR 640.7) million prior years level. The main reasons for this situation are (1) the increase in cash which occurred as a result of the delay in the offset of rebates by the health insurance funds and (2) the rise in receivables.
2.P/L ACCOUNT(STANDALONE)
B/S(CONSOLIDATED)
2007
-Ranbaxy Laboratories Ltd and GlaxosmithKline (GSK) on February 06, 2007 have signed a new multiyear R&D agreement that modifies and expands the terms of their strategic alliance established in 2003 to provide the Company expanded drug-development responsibilities and further financial opportunities. - Ranbaxy unveils asthma inhalation capsules. - Ranbaxy Laboratories Ltd has received final approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Amlodipine Besylate Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base). - Ranbaxy Laboratories Ltd on August 22, 2007 has the launch of Roliflo OD (combination of Tamsulosin and Tolterodine) brand in the Indian market for the management of "bladder outlet obstruction with concomitant overactive bladder", a chronic urological disorder. This is a Novel Drug Delivery System (NDDS) product which is being introduced for the first time in India.
2008
-Ranbaxy Laboratories on July 28 said it has launched the generic version of Omeprazole capsules, used in the treatment of acid related diseases in the US healthcare system.
2010
- Ranbaxy Laboratories Limited (Ranbaxy) has launched a New Chemical Entity (NCE), Lulifin (Luliconazole), in the Indian Dermatology market. This follows a strategic in-licensing agreement with Summit Pharmaceuticals International Corporation, Japan (SPI) allowing Ranbaxy, exclusive marketing rights, for India, 7'he introduction of this NCE, significantly strengthens Ranbaxy's presence in the Dermatological segment, - Ranbaxy Laboratories has entered into an agreement with US-based Pfenex Inc for developing biosimilars. Biosimilars are drugs which are manufactured with the use of biotechnology.
2011
On December 1, 2011, Ranbaxy got the much-awaited approval from the US Food and Drug Administration to launch the generic version of drug lipitor in the United States of America after its patent expired.[8] [9] On February 8, 2012, three batches of the gastric acid secretion inhibitor Pantoprazole were recalled in The Netherlands due to the presence of impurities
Dr Lalit Kumar, Professor of Medical Oncology, Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi for his outstanding contributions in the application of stem cell transplantation in oncology and other medical disorders Pharmaceutical Sciences Dr. Anil Gulati, Professor and Associate Dean for Research, Midwestern University Chicago College of Pharmacy, USA for his contributions in advancing the field of endothelin (ET) and its possible applications Dr. Arabinda Chaudhuri, Scientist E-II and Project Leader, Indian Institute of Chemical Technology, Hyderabad for his contributions in advancing the knowledge of efficient non-viral transfection vectors towards ensuring the clinical success of gene therapy Ranbaxy Science Scholars-2008 Ms. Mridula Nambiar, Senior Research Fellow, Department of Biochemistry, Indian Institute of Science, Bangalore for her research work Characterization of the Molecular Mechanism of Chromosomal Translocations in Lymphoma and Leukemia. Ms. Sagarika Haldar, PhD Student, Department of Biotechnology, All India Institute of Medical Sciences, New Delhi for her research work Development and validation of improved assays for the rapid diagnosis of tuberculosis. Dr. Tulika Prasad, Assistant Professor, Jawaharlal Nehru University, New Delhi for her research work Finding Novel Strategies to combat drug resistance in Candida Mr. Umesh Gupta, Senior Research Fellow (ICMR), Department of Pharmaceutical Sciences, Dr. Hari Singh Gour University, Sagar (M. P.) for his research work Polypropylene imine dendrimer mediated solubility enhancement: effect of pH and functional groups of hydrophobes. Ranbaxy Research Awards and Ranbaxy Science Scholar Awards The Ranbaxy Research Awards aim to encourage, recognize and reward excellence in original research work in the fields of Medical and Pharmaceutical sciences by Indian scientists. The efforts of the Foundation have contributed significantly towards driving superior quality of research in India and motivating the scientific community to continue to perform for excellence in science and research. Each Research Award carries a citation, trophy and a cash incentive of Rs. 1 lac. Beginning 2007, the Foundation also instituted Ranbaxy Science Scholar Awards with an aim to recognize and reward the brilliant and young science scholars in order to stimulate their interest in research. Each Science Scholar Award carries a certificate and a scholarship of Rs. 50,000/-.
The Foundation also organized its XV Annual Symposium on the topic Hormonal Receptors and Womens Health on this occasion. Eminent scientists from across the world deliberated on various issues related to various aspects of womens health like reproduction, contraception and malignancies including other medical conditions. Ranbaxy Science Foundation, presently chaired by Dr. Nitya Anand, is a non-profit organization, promoted by Indias largest pharmaceutical company, Ranbaxy Laboratories Limited. RSF aims to encourage scientific endeavour in the country by rewarding excellence in medical and pharmaceutical research and channeling national and international knowledge and expertise. Among the prime activities it undertakes every year are presenting Ranbaxy Research Awards to the Indian scientists for outstanding research work and Ranbaxy Science Scholarship Awards to the young and brilliant science scholars, presenting special award for outstanding work in the field of public health, holding of Scientific Symposia in front line areas of research, inviting Foreign Scientists as Visiting Professors, holding Round Table Conferences on topics of public health concern and publishing the proceedings of symposia and Round Table Conferences.
PREVAILING STATUS OF THE PROCESS INVOLVED WITH THE RANBAXY LABORATORIES A) RECEIVES FROST & SULLIVAN MALAYSIA EXCELLENCE AWARD, FOR GENERIC DRUGS
Gurgaon, India April 13, 2012 Ranbaxy Malaysia Sdn. Bhd., Malaysia, today received the 2012 Frost & Sullivan Malaysia Excellence Award for being adjudged the Malaysian Pharmaceutical Company of the Year in the Generics Drug Category. The methodology and selection process involved a rigorous independent market research by Frost & Sullivian and evaluation by a distinguished panel of independent judges. The 2012 Frost & Sullivan Malaysia Excellence Award was conferred to Ranbaxy Malaysia at a ceremony held in Kuala Lumpur on April 12, 2012. Mr. Jeyabalan Thangarajah, Managing Director of Ranbaxy Malaysia Sdn Bhd and Area Director ASEAN, received the award on behalf of Ranbaxy. Commenting on the occasion Mr. Jeyabalan said, The award is recognition of Ranbaxys commitment and ability to deliver quality medicines at affordable prices. Ranbaxy has been a leader in Branded Generic Products, in Malaysia, since 1996. We have to our credit, First to Launch products such as Histac Tablets (Ranitidine), Lestric Tablets (Lovastatin), Invoril Tablets (Enalapril) and more recently Storvas Tablets (atorvastatin), with major supplies to Government Hospitals and GP Clinics. The availability of these branded generic medicines has resulted in significant savings in healthcare costs incurred by the government. We remain committed to offering quality affordable medicines in Malaysia. Ranbaxy Malaysia Sdn Bhd(RMSB) is a joint venture company of Ranbaxy Laboratories Limited, India and Malaysian shareholders. Established in 1984, RMSB is today one of the major generic companiesin this market providing medicines in the Cardiovascular, CNS, Anti-infective, Gastroenterology and Anti-viral therapeutic segments. RMSB manufacturing facility in Sungai Petani, Kedah, Malaysia, was commissioned in 1987. RMSB employs over 300 employees in Malaysia.
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