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Chapter-1
Introduction
The aim of any organization is to improve economically by reducing cost and improving
customer base. To achieve these goals initiatives towards supply chain management has to be
given proper thoughtfulness. The supply chain management of any industry has complex
objectives and numerous intractable constraints. Secondly, supply chain has a continuous
evolving nature and demands. Market, technology and innovation change rapidly and are
temporary. What is right today may not be as right as today in years later. This research tries
to identify evolving determinants of supply chain in current scenario and furthermore to study
their importance and effect on SCs of different type of organisations. From the review of
literature it is also clear that no study has been conducted on the comparison of supply chain
of selected automobile industry and pharmaceutical industry. So, the present study is an
attempt to fill this gap in the literature. Also the study will help the practitioners to take better
decisions regarding understanding of supply chain performance measurement determinants.
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performance measures and metrics that fully integrate a supply chain for the concerned
organizational success (Gunasekaran et al., 2004, Thomas, D.J., 996).
Various forces of SC shown in Fig.1.1 arise from differences in strategic, operational and
tactical levels in a chain due to difference in product, market and production complexity
involved within a chain. Supply chain has to be flexible towards market changes along with
realization of business aim of high product quality at minimum possible cost and maximum
customer service and satisfaction level. Among other approaches, SCM has influenced
strategic, tactical and operational planning and control level to considerably increase an
organization’s productivity and profitability (Sahay, et al., 2006; Fawcett et al., 2008; New,
1997; Cox, 1999; Demirkan, and Cheng, 2008).
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dissimilar as they address different needs. It can be argued that good business performance is
predicated on the formation of an efficient supply chain; that integrates supply chain
management with strategic planning in complete and irreversible way. Today a more
inclusive relationship is achieved between organizations and their upstream suppliers and
downstream customers to minimize ambiguity and enhance control of supply and
distribution. Increased sharing of information have turned both inter and intra firm barriers
into alliances which has increased the financial and operational performance of each channel
member through reductions in total cost and inventories. Alliance with suppliers resulted in
improved service, technological innovation and product design. Supply chain management
objectives could be achieved through proper selection and implementation of SC
performance measure that may help organizations to manage and control the flow of
operating systems, which is associated with inventory control and scheduling of activity
system, across the whole range of resource and within forced time constraints. Both varying
customer needs and supply chain performance require control to meet the broad competitive
and strategic objectives of quality, speed, dependability, flexibility and cost (Slack, et al.,
1991; Gunasekaran et al., 2001; De Toni and Tonchia, 2001). Today performance of an
organization is determined by decisions and actions among global alliances and is no longer
pervasive to the firm. Supply chain (SC) today deals with new forms of organizations, such
as global manufacturing, virtual enterprises and logistics evolution.
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methodologies which could highlight the actions that organizations should follow to
ensure supply chain excellence.
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system, product, production process and flows of information and knowledge to help create
flexibility across supply chain to meet customer demand in cost-effective manner by
providing insights into the topic of intellectual capital (IC) management for redesigning
production process, product and distribution system. Supplier selection and evaluation is
necessary due to supplier’s critical role in a supply chain (Verma, R., 1998). Maintaining
long-term partnerships with fewer but more reliable suppliers is need for firm’s success to
deal with risks regarding their supply due to suppliers’ lead times or defective batches of
parts (Elahi et al., 2011a, Ho et al., 2010). Agility and having systematic, adequate
knowledge to properly implemented programs such as vendor-managed inventory and
knowledge management portals are essential strategies and decisions which are integrated
with their supplier selection and SCM, especially in the automotive industry Liew, C.A.
(2008). He introduced strategic integration concept of customer and knowledge management
as a strong implication for the long-term competitiveness of organizations with relationship
management (CRM) also applicable to SCM as a strategic issue.
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acquisition of raw materials till conversion to the final products being consumed by the end
customers. Business stage decomposition into processes can be followed by process
benchmarking; business stages benchmarking and supply chain ranking to compare SCs at
process and business stage level.
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country in terms of gross national product (GNP) and purchasing power parity (PPP). Indian
organisations have to improve and innovate on competitiveness in product design, quality and
on-time delivery to produce maximum efficiency both within and beyond their operations
(Sahay, 2003; Joshi,D.,et.al,2013, Sahay, B.S, 2003).
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environment lie when these packages could be integrated with supply chain management. A
supply chain involves various stages and sharing access to private data enables monitoring
the progress of products and orders through those various stages or processes (Simatupang
and Sridharan, 2004). Integration across SC network via information sharing between
business partners help in consistent data acquisition, processing, storage, presentation,
retrieval, and broadcasting of demand and forecast data, inventory status and location, order
status, cost-related data, and performance status(G. P. Cachon and M. Fisher,2000; F. Chen,
2003). Supply chain has changed the definition of organizations from ‘traditional’ to
‘networked’ organisation .The use of IT for integration and collaboration, are all depicted as
‘building blocks’ of ‘house of supply chain’ Stadtler (2005). Information systems’ plays an
important role to support supply chain integration and management for the new organization.
Swafford, et al. (2008) reveals role of IT integration in providing SC flexibility, SC agility
and thus result in a competitive business performance. Information sharing enables effective
decision making from processed data and provides improved visibility across entire supply
chain. The effective aspect of information shared is visible only if it is, relevant, accurate,
timely and reliable (Simatupang and Sridharan, 2004; Thatte, 2007). Greater visibility
enables better decisions and actions capability across entire SC (Davenport, et al, 2001;
Thatte, 2007). The first step in supply chain competitiveness is having clear understanding of
supply chain concepts and willingness of supply chain partners to openly share information
(Lummus, and Vokurka 1999; cited in Thatte, 2007).Data are available from many sources
like a typical large and/or multi-centre clinical or electronic data transfers from sites and
central laboratories. Properly available, accessible, current, flexible and understandable data
from many disparate forms and formats, in its usable form help in testing hypotheses, trends
and opportunities identification and derive fruitful conclusions. IT tool are seldom used to
make use of data as most valuable resource for providing information using data mining
techniques in a pharmaceutical environment. Regulating drug testing, prediction of benefit
for a class of patient from a drug and to find desirable activity of a drug are the task that
could be optimized by use of data mining tool. The processed form of ever-increasing
amounts of data into information can be of great competitive advantage for pharmaceutical
environment. Another issue is of managing and use of enormous data existing in
pharmaceutical industry in various forms like warnings, pharmacological properties, multiple
trials going on across many projects for the same compound/drug, contraindications, dosages,
etc. Furthermore processed form of data by increase adoption of technology about the
products in market can be used for increasing revenues by addressing marketing strategies to
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better target and market to certain customer segments by the pharmaceutical organisations.
Data mining application play an increasingly important role in Pharmaceutical industries and
are deployed as decision support tools for strategic decision making to meet Healthcare
decision to support challenges of complex and diverse data and knowledge forms and tasks
(Sheng, and Liu, 2000). Highly informative and intelligent multifaceted views and reports on
key performance indicators of SC at different levels along with providing information on
regulatory compliance reports help in monitoring and tracking R&D. Support is provided for
handling and scaling of large complex data which is spread geographically distributed and
can be analyzed. Data mining can provide intelligence in terms of information regarding
physician prescribing characteristics, preferred drugs, disease-related information, and
regional preferences of prevailing diseases. IT tool such as Data mining in pharmaceutical
industry perform Clinical data analysis during product development and launch to see trends,
irregularity, and risk during development ( Hampshire, and Rosborough ,1993). Inspecting
consumer behaviour on prescription renewal and product purchases for Sales and marketing
analysis of product on basis of profitability. It helps recognize target customer by analyzing
their ability to pay, demographics and historical health trends. It help in operations and
financial analysis by dissecting buying trends to target sale according to geographic region
size or penetration benefiting benefit both the business and the customer. High prescription
rates of a certain drug or treatment by a physician provide information about new drug that
treat complementary symptoms or conditions and help create more drug and product
variations tailored directly towards different age groups and risk factors. Supply chain
analysis from analysis of buying tendencies and treatment outcomes improve production
schedules, efficient inventory management and help to prevent stock-outs at retail and
pharmacy locations. Data mining solutions for the huge data volumes as a result of clinical
trials in the epidemiological domain provide tools to acquire to extract relevant information
from it, provide knowledge which can be used by all persons involved with pharmaceutical
sector (Rada, 2002; Armoni, 2002). Identification and quantification of pharmaceutical
information using Data mining can support(Dutta, A. and Heda, S. (2000)) in the clinical
treatment pathways ,clinicians task and administrative and management tasks, health
organizations patients, insurance companies ,physicians, regulatory agencies, pharmacists,
pharmaceutical manufacturers , drug testing companies , investors etc. Integrating diverse and
geographically spread data can save expensive and time-consuming efforts of pharmaceutical
companies to perform a thorough job of data collection, especially when most of the
information is required by law. The data mining techniques of neural networks to study the
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effectiveness of the drug by feeding the information on a drug can measure how soon the
drug deals with the medical condition for faster restoration of the body’s normal functioning.
It help in statistical analysis of clinical trials to find adverse reactions associated with a
specific drug and aggravates the adverse reaction for example age, sex, and obesity.
Prediction of drugs issues affecting the success of a marketed drug and its impact determine
the future development of the drug. Discovery of new drugs involve finding drug compounds
with desirable characteristics by clustering, classification and neural networks techniques of
data mining and grouping of compound according to the chemical properties of the molecules
via cluster analysis for therapeutic grouping of the new molecule. Measuring the chemical
activity of the molecule for specific disease say tuberculosis help in finding out which part of
the molecule is causing the action and how (De Cooman, 2005; Jayanthi Ranjan, (2009)).
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In recent years, India has emerged as a leading centre for the manufacture of small cars.
Hyundai, the biggest exporter from the country, now ships more than 250,000 cars annually
from India. Apart from shipments to its parent Suzuki, Maruti Suzuki also manufactures
small cars for Nissan which are sold by Nissan in Europe. Nissan will also export small cars
from its new Indian assembly line. The firm is also planning to launch an electric version of
its low-cost car Nano in Europe and the U.S. Mahindra & Mahindra is preparing to introduce
its pickup trucks and small SUV models in the U.S. market.
Bajaj Auto is designing a low-cost car for the Renault Nissan Automotive India, which will
market the product worldwide. Renault Nissan may also join domestic commercial vehicle
manufacturer Ashok Leyland in another small car project. While the possibilities are
impressive there are challenges that could thwart future growth of the Indian automobile
industry. Since the demand for automobiles in recent years is directly linked to overall
economic expansion and rising personal incomes, industry growth would also pickup speed if
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the economy gains gradual strength. The success of an automobile company depends on some
functions carried out effectively and one among them is SCM.
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The automotive industry has upstream suppliers, the Original Equipment Manufacturers
(OEMs), and the downstream dealers and distributors. First tier suppliers provide larger
modules to the OEMs being closet to them in the supply chain. The industry is classified into
a three tier structure:
• Tier – I: Integrated systems to OEMs
• Tier – II: Finished components to tier–I suppliers
• Tier – III: Raw material and basic components to tier–II firms.
First tier suppliers provide larger modules and parts for the final assembly tiers. Other tiers
form the raw material, component and small modules suppliers. The numbers of 2 nd and 3 rd
tier suppliers are often in the thousands, while a manufacturer might only have tens to
hundreds of 1first tier suppliers (Standard & Poor's, 2004). As design is pushed up the supply
chains by the OEMs, the I'st tier suppliers are becoming increasingly important. This requires
that suppliers have to start adapting by gaining new expertise to build whole sections of
vehicles in the form of modules. At the same time they have to handle price reductions
pressure by OEMs on one hand and to deal with rising raw material costs on other end. It
makes situation difficult to improve efficiency and to maintain the margin. The OEMs market
the vehicles, complete the final assembly of modules and components, and usually ship the
cars and trucks to the distributors via rail. In automotive retail the dealers receive the vehicles
by truck either directly from the manufacturing plant, or from a vehicle distribution centre.
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The dealers generate revenue from the sale of new cars, used cars, and service parts. An
important distinction here is that service parts and accessories have different and separate
supply chains, yet are still sold at dealerships front. Parts in the aftermarket may come from
components suppliers as well as the OEMs at the repair, maintenance, or customization
shops. The aftermarket is involved with all purchases that are related to the vehicle coming
for repair, maintenance, or customization after the original sale.
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1.9.1. Overview
The pharmaceutical industry is different from other industries as it preserves universal
entitlement of good health to people (Rossetti and Liu, 2009; Aronsson et al., 2011;Fein,
1998; Danese, et al., 2006).Continuous innovative drugs provide inexpensive and effective
means towards good health. The pharmaceutical industry faces considerable challenges due
to drug counterfeiting, little awareness towards its challenges and due to problems of lack of
R&D etc. Pharmaceutical industries have strategic and operational differences from most
other industries owing to difference in nature of its products and services.
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appropriate measure and actions are needed through the entire product life cycle to stem out
revenue generation and optimization by applying management approach. The solutions
available to the industry is at a stage where significant strategic shifts to remedy the situation
in the corporate policies fall in two categories viz improvement of organisation’s operational
supply chain structure and investing and improving in their R&D productivity.
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and bulk drug, increased capital investment and increased the R & D expenditures with
decrease in the imports growth rate. This symbolizes optimistic sign about the increasing
presence of pharmaceutical industry across the global market. The Indian Pharmaceutical
Industry is also among top five producers of bulk drugs. Firms are either in formulations or
production of bulk drugs or may manufacture both. India is the largest provider of generic
drugs globally. Indian pharmaceutical sector has an important position around the globe
.India supplied about 80 per cent of the antiretroviral drugs to combat AIDS, fulfil generic
demand of 40 per cent in the US, over 50 per cent of various vaccines demand globally, and
25 per cent of all medicine in UK. The pharmaceuticals sector of the country has the potential
to steer the industry ahead to an even higher level. The pharmaceutical industry is a highly
regulated industry. It is a uniquely difficult system with product of life altering nature. It
seems certainly worth investigating supply chain issues of such a multi-billion industry. The
pharmaceutical industry plays an extremely critical role in interests of a nation and makes a
large contribution to the national GDP. The pharmaceutical industry has evolved over time
with mankind by applying latest knowledge to old and new diseases.
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Figure-1.8 Notes: CAGR - Compound Annual Growth Rate, 1 – Import from April 2015-
December 2015.
Source: Department of Commerce India, Department of Pharmaceuticals, India Business
News, BMI
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The characteristics that distinguish Indian pharmaceutical industry globally are given
below:-
• Adaptability for new technology
• Manufacturing competence of International standard
• Abundance of highly skilled , low cost technically sound professionals and other
labour workforce availability
• Scalable process
• Chemistry and synthesis skills
These differentiable characteristics of India make it suitable to produce pharmaceutical
products of high-quality yet of low cost. The Indian pharmaceutical industry is coming up in
various promising fields like contract research, bioinformatics, clinical data management and
clinical Trials and Active Pharmaceutical Ingredients formulations and biotechnology with its
radically developed and technology advanced infrastructure. India export Finished Dosage
Combinations (FDCs), biopharmaceuticals, clinical services, Active Pharmaceutical
Ingredients, vaccines, and other pharmaceutical products at a cost effective basis over the
globe.
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from formulations drugs, bulk drugs and active pharmaceutical ingredients (API).Bulk drug
is used as raw material in manufacturing for formulation and it is an active constituent having
medicinal properties. Specific dosage or an amalgamation of bulk drugs forms Formulation
drug. Formulations can be further classified under different therapeutic groups:
• Pain/Analgesics
• Anti- diabetic
• Anti-infective
• Gastro-intestinal
• Cardiovascular
• Respiratory
• Vitamins/ Neutraceuticals
• Chronic Therapy Segment
• Neurological
• Acute Therapy Segment
• Oncology
• Branded Generics are drugs with non patented molecule and name unlike
innovator name
• Generics drugs are inappropriately regulated with low market share .Generic drug
programme of Indian government is known as Jan Aushadi programme.
• Over-The-Counter Products are drug sold by pharmacist and lacking prescription
from Medical Practitioner and are excluded from prescription only list.
• Patented Products having very small market share due to existence of low-priced
generic produce
The firms having their vision with their ability to implement it for future development are
categorized under the large firms for example firms like Lupin Laboratories, Cipla, Sun
Pharmaceuticals, Dr. Reddy‟s Laboratories, Ranbaxy Ltd etc. The firms having a vision and
are challengers to the large firms are categorized as the Small and medium firms.
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composed of from around 8,000 small to medium enterprises (SME) units and including units
from public sectors. Indian public sector and SMEs working in field of Custom Research
Manufacturing Services (CRAMS) have emerging opportunities in coming years to capture
the substantial global pharmaceutical environment going off patent. Several initiatives have
been taken by the Indian government in various parts of the country as an endeavour
supporting SMEs by speeding the process of licensing, patent reforms and product
reservation and incentivizing participation of local firms in R&D efforts and SMEs cluster
development. Government are trying to promote in-house strengthening to pharmaceutical
industry by providing public health purchases, licensing, and product reservation schemes.
To boost investments, Indian pharmaceutical industry witnessed merger & acquisition
(M&A) and exports and also by reducing approval time for new facilities .Also to make India
a global leader in drug manufacture the Government of India unveiled 'Pharma Vision 2020’,
and introduced the Drug Price Control Order and the National Pharmaceutical Pricing
Authority to deal with the issue of affordability and availability of medicines. To improve the
Indian pharmaceutical sector forward significant policy and reforms were introduced that
increases research development efforts and upcoming emerging strategies by private sector.
One such significance was in direction of patent policy reform. The goal also expected
investment from multinational companies. Furthermore it is expected that these reform will
motivate Indian pharmaceutical firms to become competent in development of new drugs for
diseases prevalent specific in India and other tropical countries and also across the globe.
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issues by either the company or the chemist. If there is any case of overpricing a complaint
could be lodge against such cases with assured action within 48-hours.
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and Jayaraman, 2009; Kazemzadeh, et al., 2012; Smith, et al., 2012). The pharmaceutical
industry is a complex enterprise with highly regulated environment coupled with the life
altering nature of the products characterizes it as a uniquely difficult system. PSC
manufactures and distributes products to millions of people every day. The distribution
process, regulatory and customer requirements in genuine global supply chains differ widely.
It needs to ensure service levels at minimum cost by centralization of master scheduling,
capacity planning (L. B. Davis,et.al, 2011), purchasing and distribution planning for
production in different locations of international markets. PSC Inventory has just been shifted
up the chain by increasing inventory levels at the manufacturer level by inventory reductions
at the wholesale level.PSC continuity require more strategically treatment for inventory. PSC
manufacturing processes will have to engage in collaborative planning to ensure that drugs
reach patients when they need them, even during disasters (Nicholson, et al. (2004)). Further
consolidation and centralization, it may be argued that the PSC is losing flexibility (Gale, and
Sabourian, 2005; Tinham, 2005). For example, the advanced distribution centres currently in
use by large retailers are limited by the number and types of products that they can handle
(Meijboom, and Obel, 2007). With wholesalers, manufacturers, and retailers drift towards
larger centralized distribution centres, the network connecting manufacturers to patients led
to increases in fuel prices or natural/man-made disasters (Elkins, et al., 2005).Wholesaler,
manufacturer, and margins is regulated based on government pricing directive(Scott, A.
(2005); Pennings, and Smidts, 2003). Wholesalers’ activities are currently associated with
risks associated with inventory and customers (Gupta et al.,2002; Xianghua et al., 2005;
Mullin,2003; Reisman, 2002) . PSC channel risk for continuity of medications and their
service levels to consumers is a dependent on effective function of wholesalers. Direct sales,
or product focused channels are emerging alternative channels to wholesalers. Direct sales
alternative entail consolidation of smaller wholesalers, entrance of 3PLs as a new entrant in
the channel, or vertical integration by a manufacturer of a smaller distributor. Another fastest
growing sales channel now is mail order for prescription drugs (Shah, N. ,2004). According
to IMS Health In 2005, mail order drugs grew 18 percent to $33.9 billion. Mail order has an
ability to control pricing in PSC when compared to drug store. Public’s willingness has
limited the greatest potential for market share growth of mail order out of the three alternative
channels (3PL, mail order, and direct shipment).Another important factor is the logistics
infrastructure that is indispensible part of PSC that support service levels, delivery, support,
etc. Effective deliver of new types of drugs to customers in PSC management is another
Product related forces that demand change in PSC. In addition, lower prices of over the
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counter (OTC) and generics drugs categories influence inventory management decisions.
Also a completely different supply chain is the demand for a new human plasma-based and
drugs host of biological drugs. These new family of drugs, known as cold chain, have very
specific shelf-lives and must be kept in controlled environments for temperature and humidity
of their surroundings. The brand name drugs, cold chain and therapeutics controlled by
manufacturer, generic and OTC controlled by retailers are three major product types that
fragment PSC.
The pharmaceutical industry is a complex enterprise with highly regulated environment
coupled with the life altering nature of the products characterizes it as a uniquely difficult
system. PSC manufactures and distributes products to millions of people every day.
• Pipeline stocks account to 25–90% of yearly demand; finished good stocks are of
usually 4–24 weeks’.
• Between 1000 and 8000 h supply chain cycle times between material entering as raw
material and leaving as finished product) value-adding operations of only 0.3–5%.
• The supply chain ending up with low material efficiencies, as only a small proportion
of material entering end up as product pharmaceuticals and fine chemicals.
For patients, caring is a promise that they will do whatever it takes to ensure they have
continued access to the highest quality medicines at affordable prices; whether a disease
affects millions or just a few hundreds. To the medical fraternity, caring means the assurance
of world-class medicines and support across multiple therapeutic areas. For business partners,
caring brings the confidence of always getting world-class quality and competitive prices. For
employees, caring manifests itself in a safe, equal-opportunities’ workplace that fosters
innovation for a healthier world. In India pharma SMEs face global level technical expertise
and financial constraints. An emphasis is on IT tool adoption and applications with capacity
building of Small and Medium Enterprises (SMEs) located in clusters. The limited
manufacturing facilities and dependency high cost of treatment in India. Lack of skilled
manpower and poor access to high end-technology has restricted the growth of domestic
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production in pharma sector to only low technology products. SMEs within the sector in
particular lack Quality related requirements information, less focus on R&D and new product
development is dominated by imports. The disintegrated and scattered SMEs industries in the
country operate with inadequate infrastructure facilities. Inadequate access to information and
Product Knowledge Dissemination de-motivate an entrance of new entrepreneurs. There is
lack of programme on soft activities to create awareness, counselling, motivation and trust
building, exposure visits, market development including exports, participation in seminars,
workshops and training programmes on technology up-gradation, quality control &
Competitiveness, etc. The push-pull boundaries aspects of the supply chain issues
conceptualize the argument of inventory positioning in the supply chain, based on the ability
and quality of the forecast as a practical applications of various options in the context of cost
and service levels. The escalating cost issue in “health care have outpaced inflation in recent
years, with continued double-digit increases expected.” They problem is attributed to many
systemic issues that prevent market forces from operating in this industry. Revenue sharing
between channel partners and distribution between manufacturers and distributors plays a
very important role in functioning of the pharmaceutical supply chain these days due to the
recent developments in the service agreements. Another critically important problem to the
pharmaceutical industry is to deal with shortages. Going back to our issues of complexity, let
us look more closely at how the pharma sector is dealing with it. There are typically two parts
in the overall Supply chain planning and coordination. The first is called Master Planning of
Resources and the second is called Scheduling. Typically the demand forecast comes in 2-3
months prior to the start of the actual manufacturing cycle and this is where master planning
starts. So, considering the forecast and available capacities at each location, the master
planning stage works out material requirements and also projects the capacity shortfall.
Typically, in most companies this is worked out in an ERP package such as SAP or other
software. Inputs can be directly taken from past ERP data such as expected opening inventory
for each input material to arrive at net requirement or can be manually fed in, typically for
capacities available, line wise which can vary from month to month. The output from such a
system is a firm plan and also material requisitions which are forwarded to the procurement
team, along with the expected delivery dates, considering the testing times. The next step is
scheduling, which is active when that particular month is reached. So, based on net of
previous month’s production shortfalls, how much has to be made in next one week say, day
wise, and when, looking at the available material are released. There is a shift in
pharmaceutical supply chain driver, constraints and its set of objectives after the launch of
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drug in market. Availability of drug takeover to agility after launch of drug in market and
subsequently cause a dramatic shift in the models and techniques employed to support this
phase of drug life cycle. The pharmaceutical supply chain phases after a drug launch is
depicted in Figure. In this phase, the very diverse nature of multiply large and independent
stakeholders poses the complexity to the pharmaceutical supply chain. The pharmaceutical
supply chain key stakeholders include multiple drug manufacturers, drug distributors,
government agencies, hospitals, clinics, pharmacy chains, retailers, research organizations,
and the FDA. The complexity increases furthermore due to the fact that the distribution of
prescription drugs, over-the-counter (OTC) medicines, generics branding and its habit
formation(Patel, A., et al., 2009; Lambert, et al., 2003; Steinman, et al., 2007), as well as
biologics compound matters are handled by the same supply chain but with a totally different
operational objectives and handling needs. The management of pharmaceutical supply chain
has very dissimilar behaviour due to numerous other organizations, such as insurance
companies, healthcare management organizations, and GPOs which further increase the
complexity. The pharmaceutical supply networks, due to the regulatory nature of the
industry, have grown in an uncontrolled fashion through numerous merger and acquisitions to
acquire more R&D expertise, rather than being planned for optimal performance.
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meet the demand and supply of patients need and therefore it is very important to make sure
for its availability. Thus the success of drug on trial approval depends on agility, readiness
and flexibility of stakeholders and their responsiveness to respond to any contingency.
Furthermore uncertainty of trial drug cannot be dealt with inventory buffering like solutions
due to cost associated with inventory and limitations of drug’s shelf life.
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obvious reason which mushrooms some small percentage of unsold drug which remain
unsold for a long time hence expires eventually. The industry wide practice to meet uncertain
or unexpected demand by carrying high levels of finished goods inventory intensify drug
expiry issues further. Analysis of the drug expiry and drug recall data can help provide better
insight while evaluating inventory or making inventory related forecasts and policies.
Therapeutic drug therapy brought noteworthy shift with massive investment in R&D and
globalization of pharmaceutical industry.
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There are various key drivers and a set of trends that impact supply chain with varying degree
of intensity and relevance which can be categorized into strategic, tactical and operational
level issues .These issues have varying level of relevance to supply chain performance with
their impact or severity of consequences ranging from negligible effect to a maximum.
Table-1.2: Key Drivers and Their Consequences
Strategic Level Tactical Level Operational level
Competition with generic Failures of product during
drug market development
A faster loss of market Regulatory and Lack of interest
due to increase in towards adopting new technology
revenue from generic
sales
Longer time taken in Lack of IT infrastructure leads to low
outsourcing due to time utilization, high inventories &
taking regulatory issues. regulatory compliance
problems, lower productivity and low
capacity/plant utilization, plant
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The pharmaceutical inventories characterize by all time high inventories and the industry is
realizing of the fact that piling up inventories may not avoid shortages or product
unavailability to met target. The complexity of inventory management in the pharmaceutical
industry is inherently difficult due to the highly fragmented nature of the market, volume
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variability, seasonality, and local attributes or events. The various means of inventory
management related issues are listed as below.
Table 1.3:Inventory Issues
Issue Consequences/Impacts
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