What is Supply Chain Management?

Supply Chain Management (SCM) is a combination of science and software that encompasses all operations within the supply chain, including the sourcing, acquisition, and storage of raw materials; the scheduling and management of work-in process; and the warehousing and distribution of finished products. With SCM softwares, businesses can streamline and automate the planning, execution, and control of these key activities.

EXECUTIVE SUMMARY Supply chain management can be simple or complex, but all supply Chains contain similar elements and are managed in a similar way. Logistics is the management of the flow of goods, information and other resources between the point of origin and the point of consumption in order to meet the requirements of consumers. Logistics involves the integration of information, transportation, inventory, warehousing, material-handling, and packaging, and occasionally security. Logistics is a channel of the supply chain which adds the value of time and place utility. Information, communication, cooperation and trust are keys to effective supply chain management. Supply chain business process integration involves collaborative work between buyers and suppliers, joint product development, common systems and shared information. It is said that the ultimate goal of any effective supply chain management system is to reduce inventory. Supply chain management flows can be divided into three main flows: The product flow The information flow The finances flow The product flow includes the movement of goods from a supplier to a customer, as well as any customer returns or service needs. The information flow involves transmitting orders and updating the status of delivery. The financial flow consists of credit terms, payment schedules, and consignment and title ownership arrangements. Increasing numbers of companies are turning to Web sites and Web-based applications as part of the SCM solution. A number of major Web sites offer e-procurement marketplaces where manufacturers can trade and even make auction bids with suppliers.

SCM in DEPTH
Supply Chain Management is one of the leading cost saving and revenue enhancement strategies in use today. Pharma companies are increasingly using this technique to improve the whole functional process. Sushmi Dey takes a look SCM is the management of the entire value-added chain. It involves delivering the right product to the right place, at the right time and at the right price. SCM has also helped companies enhance their efficiency in managing resources and improving relationships. Jiten Sandu, Director-Global Customer Solution Management, i2 says, SCM aims at integrating the companys internal systems to those of its suppliers, customers and partners, so that all inefficiencies can be weeded out and a synergy is created throughout the network. Besides, SCM has proved to be one of the most powerful engines of business transformation. By integrating their supply chain systems with

those of their customers and suppliers, companies stand to create considerable value throughout the entire supply chain. Hence, more revenue is generated with greater cost savings.

The integrating factor SCM basically integrates the companys internal systems to those of its suppliers, partners and customers. It primarily works with five basic components called Plan, Source, Make, Deliver and Return, to achieve three primary goals: Reduce inventory, increase the transaction speed by exchanging data in real time, and increase sales by implementing customer requirements more efficiently. Anupam Sharma, Director, Business Consulting, SSA Global, asserts that SCM helps to fuse the demand chain with the supply chain. It helps manage long product development and approval cycles for new products, handle mergers and acquisitions, meet stringent regulatory requirements and also aid reduction in inventory. With advanced integration capabilities, SCM makes it easy to work with diverse applications with suppliers and customers. An open architecture can provide a common, modern infrastructure that unifies interfaces and standardises connectivity, he explains. New Technologies Latest toolsets and technologies are addressing the three most important aspects of the supply chain optimisation, collaboration and analytic, said Nagaraj Bhargava, Director, Marketing & Special Initiatives, SAP India. SCM is the combination of a co-ordinated set of techniques, to plan and execute all steps in the global network. There is a wide range of developed supply chain and information management services to optimally manage the complex functioning of pharmaceutical companies. The techniques are used to acquire raw materials, transform them into finished products and deliver both products and services to customers. According to Sharma, SCM ensures a companys ability to forecast demand, take an order, give an accurate date, source and manufacture the right goods, position inventory properly, pick, pack and ship efficiently. Interestingly, it includes chain-wide information sharing, planning, resource management and global performance measurements. This, therefore, helps in global procurement and supply chain processes. While many pharmaceutical companies do most of the business using electronic data interchange (EDI), experts say that e-procurement capabilities are an important consideration. According to Sharma, In manufacturing pharmaceu-ticals, there is no room for error in product quality and government compliance. A proven e-procurement solution could provide total confidence in the decisions an organisation is making about its suppliers. According to Bhargava, technology is getting refined to achieve most efficient use of the resources by using optimisation algorithms and radio frequency identification (RFID). Training and deployment While Sharma explains that the deployment time and complexity depends on the solution, almost all professionals agree that training and change management reduces risks and are keys contributors to the success of technology initiatives. We recommend that prior to implementing a solution, the company puts into place a change management plan. It helps ensure that once the solution is live and running within the organisation, there is a plan in place for users to change their organisational behaviour and adapt to using this solution, says Sandu. Competitive Quotient While SCM refers to the entire network of companies that work together to design, produce, deliver, and service products, the field has become increasingly important to companies in an

increasingly competitive global marketplace. Earlier, pharmaceutical companies were focused primarily on manufacturing and quality improvements, but with the efforts extended in the recent times to encompass the entire supply chain, the competition has also spread across the industry. Internet based SCM has made industries more competitive and with that arises an urgent need to access the right data to make informed business decisions, informs Sandu. He further asserts that this is one reason why in the past few years SCM has evolved from a desirable cost-cutting process to an essential survival skill. Pharmaceutical companies that mainly have to deal with distribution networks, bulk purchasers and hospitals, also need to assess current customer supply chain processes against standard and industry benchmarks to identify areas for improvement. Experts say that this is also the most metric-intensive portion of the supply chain. Hence, quality levels, production outputs, and worker produ-ctivity has to be measured. Alternate models are evaluated against identified cost and service objectives with the use of advanced analysis and modelling tools to arrive at the optimal solution. To sustain the competition, there are also emerging novel technologies. Companies are adopting Web-based supplier collaboration solutions, RFID, supply chain optimisation, collaboration over the Internet using ICH, reverse auctions, and collaborative product development. Web-based supplier collaboration solution links manufacturers with major suppliers. Sharma explains, The Web-based supplier collaboration solutions provides suppliers with planned and current demand and gives feedback in the form of supplier acknowledgements to lower your inventory carrying costs and reduce out of stock situations. Through this advanced technology, shipment documents and invoices can be easily created to accelerate shipping. Also, suppliers can gain easy access to current item information, performance details and can also submit and track invoices. This, according to Sharma, results in more accurate orders and efficient delivery schedules. He also asserts that Web-based sales solutions help to manage the sales processes of a business, efficiently and cost effectively. Investments and the ROI According to Sharma, pharmaceutical companies are making investments from few hundred thousand dollars to few million dollars. However, professionals believe that it varies with components of solutions under consideration, company size, number of users, as well as, depth and breadth of the implementation. The investments are in the form of product technology, hardware, services, training and maintenance. Bhargava informs, The ROI is measured in terms of the reduction in the TCO, efficiencies in the supply chain, customer service and retention, better utilisation of capital, reduction in costs and increase in competitiveness. Sandu feels that like other sectors, pharmaceutical industry understands competition, economic pressures, and the changing patient needs that result in fluctuating demand. They must also anticipate sudden changes that can upset carefully made operational plans, he suggests.

Pharma Technology Focus is a new monthly digital magazine offering in-depth and timely coverage of the pharmaceutical industry. Focusing on a special theme within the industry every month, the magazine combines a mix of editorial articles with integrated interactive features and video content in a ground-breaking digital format. In this issue we focus on drug discovery and development. We investigate why open innovation is crucial in the development of ever more complex drugs for the most challenging medical and clinical problems. We also look at new drugs and current research, and explore how IT solutions can help companies achieve clinical trial results quicker and more cost-effective.

Open the Treasure Chest Confronted with increasingly challenging clinical and medical problems, the pharmaceutical industry is facing huge pressure to develop more complex drugs. But no organisation is capable of doing this on its own. Dr Paul Stoffels of Johnson & Johnson tells us why open innovation the collaboration between big pharma, biotech and academic institutions is the way forward.

OBJECTIVES OF THE STUDY

The main objective of the study is to analyze the overall management of logistics in the SynthoChirals Ltd. To examine supply chain management at SynthoChirals Ltd., during the Study period. To develop entrepreniual skills in supply chain management. To implement multiple replenishment techniques, including sequence delivery, supplier managed inventory, and scheduled delivery of the products. To reduce supply chain risks with access to up-to-date performance management information

 To improve data availability and data sharing by integrating functional and departmental business intelligence systems To increase customer service levels with global visibility of material flow throughout the supply chain. To examine documentation for invoices, cargo insurance, letters of credit, ocean bills of lading or air waybills, and inspections To Study the concept of Supply chain& Logistics management in detail To Study the role of Supply chain & Logistics in Pharma, Its Growing importance in Pharma. To understand the problems in handling the Supply chain & Logistics material.

Establish a single, integrated Enterprise Resource Planning (ERP) solution Standardize business proc-esses across the organization Provide a platform for free flow of information and a central data repository Improve visibility PHARMA INDUSTRIES IN INDIA

The Indian pharmaceutical industry is one the of fastest growing sectors in India, and satisfies more than 95 % of domestic market needs. This Industry in India is growing at a CAGR 19.8 and reached US $4.97 billion in 2002 and it is projected to touch US $45 billion. The top 30 players control about 70% of the market share. The total Indian production constitutes about 1.3% of the world market in value terms and 8% in volume terms, and India ranks globally 4th in volume term and 13th in value. More than 60 Indian manufacturing facilities are approved by some of the high standard regulatory agencies such as US FDA, UK MCA, Australian TGA, and WHO etc. And the number of Drug Master Files (DMFs) filed in 2003 with U.S FDA is 126, which is higher than the number filed by Spain, Italy, China and Israel. Complex synthesis capabilities, increasingly good manufacturing practices (GMP) and low-cost production are the core competencies of Indian Industry. However, increasing generic penetration, intense competition and fragmentation of the industry are the key challenges that Indian pharmaceutical industry faces today. (Source: www.indiaoppi.com).

The Pharmaceutical industry in India is the world's third-largest in terms of volume and stands 14th in terms of value.[1] According to Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, the total turnover of India's pharmaceuticals industry between 2008 and September 2009 was US$21.04 billion.[2] While the domestic market was worth US$12.26 billion. Sale of all types of medicines in the country is expected to reach around US$19.22 billion by 2012. Exports of pharmaceuticals products from India increased from US$6.23 billion in 2006-07 to US$8.7 billion in 2008-09 a combined annual growth rate of 21.25%.[2] According to PricewaterhouseCoopers (PWC) in 2010, India joined among the league of top 10 global pharmaceuticals markets in terms of sales by 2020 with value reaching US$50 billion.[3] Some of the major pharmaceutical firms including Sun Pharmaceutical, Cadila Healthcare and Piramal

Healthcare.[2] The government started to encourage the growth of drug manufacturing by Indian companies in the early 1960s, and with the Patents Act in 1970.[4] However, economic liberalization in 90s by the former Prime Minister P.V. Narasimha Rao and the then Finance Minister, Dr. Manmohan Singh enabled the industry to become what it is today. This patent act removed composition patents from food and drugs, and though it kept process patents, these were shortened to a period of five to seven years. The lack of patent protection made the Indian market undesirable to the multinational companies that had dominated the market, and while they streamed out. Indian companies carved a niche in both the Indian and world markets with their expertise in reverse-engineering new processes for manufacturing drugs at low costs. Although some of the larger companies have taken baby steps towards drug innovation, the industry as a whole has been following this business model until the present.[5] India's biopharmaceutical industry clocked a 17 percent growth with revenues of Rs.137 billion ($3 billion) in the 2009-10 financial year over the previous fiscal. Bio-pharma was the biggest contributor generating 60 percent of the industry's growth at Rs.8,829 crore, followed by bio-services at Rs.2,639 crore and bio-agri at Rs.1,936 crore.[6] In the list of top pharmaceutical companies in India it is not the Indian companies but also the MNCs that are becoming the part of the race. Indian pharmaceutical market in 2008 was $7,743m and if compared to year 2007 it was 4% more than that. It is expected that Indian pharmaceutical market will grow more than the global pharmaceutical market and will become $15,490 million in 2014. Today Indian pharmaceutical industry is the second most fastest growing industry displaying the revenue of Rs 25,196.48 crore and growth of 27.32 percent. Top pharmaceutical companies in India are also acquiring the small companies worldwide to further expand the market. Pharmaceutical drugs injections, tablets, capsules, syrups are the products of pharma companies in India along with many more. Looking back into history reveals that it was in 1930 when the first pharmaceutical company in India came into existence in Kolkatta. It is called the "Bengal Chemicals and Pharmaceutical Works". This Indian company is still there and today it is the part of five drug manufacturing companies that are owned by the government. Till the period of 60 years the pharmaceutical industry in India was overshadowed by the foreign drug manufacturing companies but with the Patent Act in 1970, the whole scenario of pharmaceutical companies in India had changed since then. With this the Indian market was more open to Indian pharmaceutical companies than the MNCs. So with this pharmaceutical companies in India started to grow in number At present there is a cut throat competition among top pharmaceutical companies in India with the native as well as MNCs. But there are certain issues that are concerning the growth of pharma companies in India. These are: Mandatory licensing and failure of new paten system. Regular power cuts and inadequate infrastructure. Restricted funding. - Regulatory hindrances that lead to the delays in the launch of new drug or pharma product. Too many small as well as big pharmaceutical companies and excessive competition.

Growth Indicators (Rs. crores) 1965-66 1999-00 Capital Investment 140 Production: Formulations Bulk Drugs Import Export R&D Expenditure 150 18 8.20 3.05 3 2,500 15,960 3,777 3,441 6,631 320

Top 10 Pharmaceutical Companies in India

1. Ranbaxy 2. With a 2007 turnover of Rs 4,198.96 crore (Rs 41.989 billion) by sales, Ranbaxy is the largest pharmaceutical company in India. 3. Dr Reddy's Laboratories 4. With the turnover of Rs 4,162.25 crore (Rs 41.622 billion), Dr Reddy's Laboratories is the second largest pharmaceutical company in India. 5. Cipla 6. With the revenue of Rs 3,763.72 crore (Rs 37.637 billion) Cipla is the third largest pharmaceutical company in India. 7. Sun Pharma Industries 8. Sun Pharma Industries is the fourth largest pharma company in India with the total revenue of Rs 2,463.59 crore (Rs 24.635 billion) and led by Dilip Sanghvi. 9. Lupin Labs 10. Lupin Labs has the total revenue of Rs 2,215.52 crore (Rs 22.155 billion 11. Aurobindo Pharma 12. Sales revenues stood at Rs 2,080.19 crore (Rs 20.801 billion) makes it the sixth largest pharmaceutical company in India. 13. GlaxoSmithKline Pharma (GSK) 14. GSK is the seventh largest pharma company with the total sales revenue of Rs 1,773.41 crore (Rs 17.734 billion) 15. Cadila Healthcare 16. Eight largest company has the total sale revenue at Rs 1,613.00 crore (Rs 16.13 billion) 17. Aventis Pharma 18. Aventis Pharma has the revenue of Rs 983.80 crore (Rs 9.838 billion) and the ninth largest pharmaceutical company in India. 19. Ipca Laboratories 20. Revenue of Rs 980.44 crore (Rs 9.804 billion) makes Ipca India's 10th largest pharma

firm by sales.

Comparison with the U.S.

The Indian biotech sector parallels that of the U.S. in many ways. Both are filled with small start-ups while the majority of the market is controlled by a few powerful companies. Both are dependent upon government grants and venture capitalists for funding because neither will be commercially viable for years. Pharmaceutical companies in both countries have recognized the potential effect that biotechnology could have on their pipelines and have responded by either investing in existing start-ups or venturing into the field themselves.[36] In both India and the U.S., as well as in much of the globe, biotech is seen as a hot field with a lot of growth potential.

GROWTH IN INDIA
Company Total Pharma Market Cipla Ranbaxy Glaxo Smithkline Piramal Healthcare Zydus Cadila Size ($ Billion) 6.9 .36 .34 .29 .27 .24 Market Share (%) 100.0 5.3 5.0 4.3 3.9 3.6 Growth Rate (%) 9.9 13.4 11.5 -1.2 11.7 6.8

Rank 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

Company Cipla Ranbaxy Dr. Reddy's Laboratories Lupin Ltd Aurobindo Pharma Dabur Sun Pharmaceutical Cadila Healthcare Jubilant Lifesciences Piramal Healthcare GlaxoSmithKline Pharmaceuticals Ltd Ipca Laboratories Wockhardt Torrent Pharmaceuticals Sterling Bio Biocon Orchid Chemicals & Pharmaceuticals Limited Alembic Aventis Pharma Glenmark Pharmaceuticals

Revenue 2011 Revenue 2011

(USD millions) (Rs crore)

1348.51 1327.56 1178 929.84 865.19 700.3 673.99 629.45 561.03 480.26 475.8 390 381.23 380.2 358.1 340.38 320.62 270.62 263.75 260.14

Pharma Export In the recent years, despite the slowdown witnessed in the global economy, exports from the pharmaceutical industry in India have shown good buoyancy in growth. Export has become an important driving force for growth in this industry with more than 50 % revenue coming from the overseas markets. For the financial year 2008-09 the export of drugs is estimated to be $8.25 billion as per the Pharmaceutical Export Council of India, which is an organization, set up by the Government of India. A survey undertaken by FICCI, the oldest industry chamber in India has predicted 16% growth in the export of India's pharmaceutical growth during 2009-2010.

Pharmaceutical industry today

The number of purely Indian pharma companies is fairly low. Indian pharma industry is mainly operated as well as controlled by dominant foreign companies having subsidiaries in India due to

availability of cheap labour in India at lowest cost. In 2002, over 20,000 registered drug manufacturers in India sold $9 billion worth of formulations and bulk drugs. 85% of these formulations were sold in India while over 60% of the bulk drugs were exported, mostly to the United States and Russia[25]. Most of the players in the market are small-to-medium enterprises; 250 of the largest companies control 70% of the Indian market.[8] Thanks to the 1970 Patent Act, multinationals represent only 35% of the market, down from 70% thirty years ago[20]. Most pharma companies operating in India, even the multinationals, employ Indians almost exclusively from the lowest ranks to high level management. Mirroring the social structure, firms are very hierarchical. Homegrown pharmaceuticals, like many other businesses in India, are often a mix of public and private enterprise. Although many of these companies are publicly owned, leadership passes from father to son and the founding family holds a majority share. In terms of the global market, India currently holds

Imports - Composition (Rs. crores) Years 1980-81 1981-82 1982-83 1983-84 1984-85 1985-86 1986-87 1987-88 1988-89 1989-90 1990-91 1991-92 1992-93 1993-94 1994-95 1995-96 1996-97 1997-98 1998-99 Bulk Drugs Formulations Intermediates, Chemicals, Solvents & others Total 87.24 105.06 115.55 123.06 178.41 208.13 207.49 234.13 328.35 425.64 322.57 458.51 508.39 612.74 811.43 1,630.00 1,705.00 1,827.00 1,918.00 9.62 1.93 5.41 3.43 10.17 15.82 21.84 21.44 35.43 55.09 84.94 96.12 119.51 138.33 173.02 270.00 345.00 430.00 540.00 15.68 29.34 27.52 36.85 27.05 43.44 58.26 93.87 83.13 171.39 196.49 252.75 509.48 415.46 384.27 505.00 555.50 611.00 670.00 112.54 136.33 148.48 163.34 215.63 267.39 287.59 349.44 446.91 652.12 604.00 807.38 1,137.38 1,166.53 1,368.72 2,405.00 2,605.50 2,868.00 3,128.00

1999-00

2,025.00

680.00

736.00

3,441.00

The pharma industry generally grows at about 1.5-1.6 times the Gross Domestic Product growth Globally, India ranks third in terms of manufacturing pharma products by volume The Indian pharmaceutical industry is expected to grow at a rate of 9.9 % till 2010 and after that 9.5 % till 2015 In 2007-08, India exported drugs worth US$7.2 billion in to the US and Europe followed by Central and Eastern Europe, Africa and Latin America The Indian vaccine market which was worth US$665 million in 2007-08 is growing at a rate of more than 20% The retail pharmaceutical market in India is expected to cross US$ 12-13 billion by 2012 The Indian drug and pharmaceuticals segment received foreign direct investment to the tune of US$ 1.43 billion from April 2000 to December 2008

Contract

Manufacturing in Pharmaceuticals continues to increase

Decreasing profits in pharmaceuticals over the past 5 years has put manufacturing and product costs under greater scrutiny. As a result there has been an increase in the need for a reduction in the size and cost of internal manufacturing and sourcing of cheaper products from external parties. Recent reports indicate that the global pharmaceutical contract manufacturing market will be worth US$40.7 billion by 2015. As the pharmaceutical industry relies on faster drug development and cost containment to maintain growth, there has never been a more important time to develop strategic CMO alliances to facilitate entry into emerging markets, reduce costs and increase product revenue.

Leaner Supply Chains and Effective Pharmaceutical Distribution Channels through Outsourcing

Competition from generics companies from off-patent drugs, Big Pharma is continually searching for new revenue generation models against increasing costs. External factors such as stringent health care reforms worldwide and the pressure to drive drug costs down from developing economies are only exacerbating challenges faced by the industry. The common thread to help alleviate these concerns is a concerted effort by these organizations to structure and tighten their supply chain and distribution capabilities. There is a clear trend in pharmaceutical companies adopting outsourcing as a strategic tool to develop their distribution channels and enhance their customer network footprint. Distribution outsourcing has shown a significant impact on all aspects, including transportation planning, warehouse management, order management and network strategy. Access to market with improved logistics Service providers with a strong global delivery model and an established logistics practice are ideal partners to improve distribution between drug manufacturing centers and consumption sites worldwide. The consumer base is moving slowly towards larger populations in the Asia-Pacific region. The global service provider base has a very strong footprint in these regions and will be able to provide additional support in terms of product security and regulatory compliance requirements for these countries. Connecting all the elements in the distribution chain such as drug distributors, wholesalers, prescribers and patients can be executed effectively through the expertise of service providers rather than investing in building these capabilities in-house. Leaner n meaner supply chains In order to adapt to ever changing customer and market needs, the distribution strategy must have lean and agile aspects. This could mean effective penetration through emerging markets with high potential, improving speed-to-market for new drugs and increasing the flexibility in response time for recalls and

demand spikes. Expertise gained by service providers in dealing with high volatility markets gives outsourcing an edge as they offer proven business models and processes with flexi-resources (people, transportation and assets). This will lead to streamlined product interactions for pharmaceutical companies with their suppliers and end customers. Taking the plunge to outsource The Pharma sector is amongst the most progressive in terms of outsourcing services such as R&D and manufacturing. Over the past 5 years, we have witnessed a slow shift in outsourcing to include partnerships with outsourcing partners for their supply chain and distribution processes. The industry is now moving into a phase which will include a well structured relationship with their service providers. These agreements will encompass features such as clear and open communication, regular feedback and clearly defined service level agreements will show a pronounced impact on the level of satisfaction for the pharmaceutical supply chain and distribution networks. The global pharmaceutical market research has been done by many companies and almost all of the market reports indicate a significant growth of pharma market in 2010-2011. The forecasting indicates pharmaceutical market growth of about 4 - 6% in 2010-2011. The established markets, including the US, UK, and Japan, together account for 30% of the global demand for pharmaceutical excipients.

Pharmaceutical Industry Trends- Global Scenario

If present industry overview is taken into consideration then the global pharmaceutical market in 2010 is projected to grow 4 - 6% exceeding $825 billion. The global pharmaceutical market sales is expected to grow at a 4 - 7% compound annual growth rate (CAGR) through 2013. This industry growth is driven by stronger near-term growth in the US market and is based on the global macroeconomy, the changing combination of innovative and mature products apart from the rising influence of healthcare access and funding on market demand. Global pharmaceutical market value is expected to expand to $975+ billion by 2013. Different regions of the world will influence the pharmaceutical industry trends in different ways.

Asia Pacific Pharmaceutical Market

The pharma market world over will experience significant shifts. Asia-Pacific region will emerge as the fastest growing pharmaceutical market over the recent past. The reason for this positive shift can be attributed to the low costs and favorable regulatory environment. This region has experienced important developments regarding contract manufacturing, especially in generics and APIs. Increased R&D activities in the region has helped Asia-Pacific pharmaceutical industry to achieve an estimated market size of around US$ 187 Billion in 2009. Here, the pharmaceutical industry is expected to grow at a CAGR of around 12.6% during 2010-2012. It can, in fact, become the global API production hub in next few years. pharmaceutical sales are growing at a fast rate in India, China, Malaysia, South Korea and Indonesia due to the rising disposable income, several health insurance schemes (that ensures the sales of branded drugs), and intense competition among top pharmaceutical companies in the region (that has boosted the availability of low cost drugs). Chinas pharmaceutical market will continue to grow at a 20+ % annually, and will contribute 21% of overall global growth through 2013. India - 3rd Largest Producer of Pharmaceuticals Across the World- is already a US$ 8.2 Billion pharmaceutical market. The Indian pharmaceutical industry is further expected to grow by 10% in the year 2010.

Middle East Pharmaceutical Market

The Middle East combined with the African Pharmaceutical market is projected to grow at a CAGR of around 11% during 2010-2012. The development of infrastructure and rapidly changing regulations in this region are being seen as the cause of its growth. Also there is a high prevalence of diseases and huge population base that increases the overall pharmaceutical sales in this part of the world. Presently South Africa, Saudi Arabia and Israel dominate the region's pharmaceutical industry due to their better infrastructure and regulatory environment. However, The Middle East pharma market depends on imported pharmaceutical drugs and therapeutics. The governments of countries in this region are taking measures to raise their domestic production through heavy investments in the pharmaceutical industry. How far they are successful in the attempt of becoming considerable pharma production center remains to be seen.

Pharmaceutical Drugs Trends

Anti-Diabetic Drugs and those for cardiovascular diseases are expected to see the fastest growth in 2011. Cardiovascular patients will increase to 251 million in 2010, with the greatest rate of growth forecast for the US market. This is due to the changes in demographics and lifestyle that will boost the cardiovascular sales. However, the growth rates will be limited by continued patent expiries for major products and due to the lack of of novel therapies. The anti-hypertensives drugs will dominate the global cardiovascular market with a market share of nearly 50%.

Problems Problems Facing the New Pharmaceutical Industry

As the 21st century begins, the pharmaceutical and biotechnology industry has entered an era of explosive growth in innovation, investment and competition. At the same time, both established players and new entrants are facing significant challenges from the weak economy, downward pressure on prices, intense public scrutiny of ethical and business practices, and increasing regulation(1). Some of the problem areas resulting from these challenges include the following: The costs of developing a New Chemical Entity (NCE) have been rising without a corresponding increase in Return On Investment (ROI). At the same time, the downturn in the equity markets has caused investors to focus more on business models and current earnings rather than innovation and the potential for future blockbuster products(2). With a large number of new entrants at the low end of the industry and a trend towards mergers and acquisitions that has led to larger, more integrated firms with broad reach across the industry, there is an increasingly competitive business environment that has created further pressure on companies to quickly build successful product portfolios(3). The need to satisfy the naturally different mindsets and cultural demands that exist between the scientific research and operational areas of a firm results in internal organizational pressure that can hinder the successful adoption of new technologies and development of new products(4). The specific reasons for these problem areas are as many and varied as there are firms in the industry, but there are some common themes that can be seen: Genomics, proteomics and other new information-based biotechnologies have helped make the drug discovery process more efficient, but implementing such technologies can require significant up front and ongoing investment. For example, a large pharma firm might be expected to spend $100M annually on genomics-related technologies(5). Despite the promise of these new technologies, true increases in productivity are often not realized. According to a senior IT director from a large pharmaceutical company recently, one reason for this is that much of the low hanging fruit has already been identified and picked, so tools such as High Throughput Screening (HTS) are not yielding the same results as they did earlier(6). New technologies coupled with intense merger and acquisition activity in the industry has led to structural changes in the competitive environment(7). The seeds planted by genomics and biotechnology has begun yield a new crop of smaller companies that focus on a few instead of tens to hundreds of simultaneous NCE development projects. These companies tend to be more agile than the industry giants and can exploit their core expertise with a particular disease or therapeutic category. This has caused the industry giants to look at ways in which they can gain some of the advantages of the entrepreneurial environment that exists in these new biotech companies. For instance, GlaxoSmithKline has recently announced that it is re-organizing its R&D units to create six Centers of Excellence in Drug Discovery that will allow for more flexibility, better allocation of funding, and improved productivity(8). Finally, the effectiveness of new technologies can be hindered unless the company has put serious effort into developing and implementing change management processes throughout their organizations(9). As a senior IT director we interviewed pointed out, there are essentially three types of people in a pharmaceutical company: the true research scientists, the sales force, and everyone else(10). The first two groups are usually the most demanding in their technology needs, and in fact are often looking for ad hoc solutions that can be quickly built to meet an

immediate need. In the case of research scientists in particular, they typically take an experimental approach to problem solving where they discover a problem, ask a question, conduct an experiment, and once there is an answer, move on to a new question that will perhaps require a new set of tools. This contrasts with the traditional approach to building an information system or business process, where the primary goal is to design something that can be re-used for many different types of problems(11). The bottom line for the industry was summarized by Steven Seget in his report on pharmaceutical innovation: A companys ability to innovate and effectively produce portfolios of innovation assets will determine its ability to generate premium returns in the future(12). That is, a company must be able to use its entire value chain, which might include partnerships and outsourcing arrangements, to carry the innovation process from conception to production in such a way that profitability is maximized.

The US FDA has decided to implement the "Pedigree provisions" of the Prescription Drugs Marketing Act after December 2006, when the current stay on it expires. There is a lot of concern that many pharmaceutical supply chain participants, may not be able to meet this deadline and hence risk non compliance with the provisions of the act. This pharmaceutical article is excerpts from the RFID technology white papers written by Sangeeta of Abhisam Software. The RFID technology white papers attempts to present an RFID Systems solution to ensure timely compliance and get added side benefits in the process.

Problems with the present pharmaceutical supply chain:

There are two major problems with the present pharmaceutical supply chain model of the pharma industry, as it exists today. The first one is not of counterfeiting, but of diversion. More details will be explained in in the background information below and in Sangeeta's RFID technology white papers, but some highlights are below. Drug diversions can be of two types. Drugs meant for Medicare or Medicaid programs, public hospitals or charitable institutions, are diverted to the open market. Unscrupulous persons sell prescription drugs or "controlled" substances to consumers, without proper prescriptions. Counterfeiting (by FDA definition) Dummies/ Placebos, which means that there is no active ingredient at all Products with a lesser quantity of active ingredient than stated Products with the wrong active ingredient Products with a packaging that wrongly suggests that it was made by an FDA approved manufacturer To give you an idea of the scale of the counterfeiting just one of these cases involves $42 million of counterfeit Lipitor. Other high value cases include a case involving a $200 million nationwide drug diversion conspiracy and a $45 million Medicaid fraud involving diversion of blood products.

The FDA's solution to the problem:

The FDA's vision of a safe and secure pharmaceutical supply chain is based on transparency and

accountability by all participants in the (prescription drugs) pharmaceutical supply chain. The FDA had nominated a task force to study whether this system could be implemented with the currently available state of the technology. They came to this conclusion after studying the various technologies currently commercially available, which could meet the pedigree requirements, including RFID or Radio Frequency Identification technology. Amongst all technologies studied including bar coding, RFID seemed to be the most promising and the committee felt that the pedigree requirement could be met by easily leveraging something that is readily available. (More details in the complete RFID technology white paper "RFIDFDA-Regulations.pdf" referenced below)

How the pharma companies can approach this issue:

The million dollar question is "Who can ensure an ROI on this RFID technology, especially after millions have already been spent?" Even if a full scale RFID implementation were done now, how can it be done fast, before the December 2006 deadline? Rather than resist implementation of a pedigree system built on RFID systems , pharmaceutical supply chain participants must realistically estimate the costs of investment in the technology, the real cost of counterfeits and the returns on a foolproof RFID based "track and trace" system. The RFID systems will virtually eliminate the counterfeit pharmaceutical market at one go. Secondly, it can ensure that drug recalls can be done swiftly without any ambiguity. This has been demonstrated many a times. Thirdly, the RFID systems need not cost too much.

How wholesalers and traders can implement track and trace:

Ditto for other pharmaceutical supply chain intermediaries. They can simply join the same global system outlined in the RFID technology white paper that is currently in place and implement the electronic pedigree system easily. The only investment would be in the RFID readers and middleware. Even these can be bought in bulk by their associations at negotiated prices and implemented. This solves the issue of RFID standards too, since all participants would be using similar kinds of RFID readers and RFID software.

Beneficial Side effects of the implementation:

In addition to combating pharmaceutical counterfeiting and diversion, pharmaceutical wholesalers, traders and retailers, get the added benefit of looking into their businesses and track the movement of prescription drugs with full transparency. This will no doubt yield added benefits of inventory optimization, demand forecasting and increasing their knowledge of what is selling and how fast.

RFID Implementation issues:

To implement this system fast, before the deadline of December approaches, it is essential to train all stakeholders (pharmaceutical company personnel, wholesalers, traders, retailers and others) fast but, at a competitive cost. However, the present cost of classroom based training is expensive, besides having other related costs like travel and hotel stay. A better system would be to go for a vendor-neutral elearning program, which can be deployed immediately and across several locations simultaneously. See: http://www.bin95.com/BarCode_RFID.htm This has the effect of bringing up all staff, to a level necessary for them to implement an RFID based pedigree system. The e-learning program should cover all aspects of the RFID technology including the

history, advantages over traditional automatic identification like bar codes, practical RFID systems, RFID standards and middleware as well as other issues like RFID privacy and RFID security. It should ideally also offer a self assessment and a glossary. We believe, that deploying such a program, across many companies is the only option to effectively train hundreds of people, in a cost-effective manner, so that the actual implementation of the system can be done smoothly. It is essential to bring all people on board, make them understand this RFID technology better and only then talk of implementing it.

Conclusion:
RFID track and trace is a technology whose time has come. It not only will meet the FDA requirements for compliance but also prevent pharmaceutical counterfeiting (lost opportunity sales of genuine drugs), prevent diversion, optimize pharmaceutical supply chains as well as fulfill social responsibilities of the pharmaceutical industry fraternity. Training large numbers of people in a short time, is not a problem at all since a vendor-neutral, technology and implementation focused

Pharmaceutical distributors Background :

The Prescription Drug Marketing Act (PDMA) was signed as a law, as far back as 1998 but a number of amendments introduced later, finalized the pedigree requirements only in 1999. The pharmaceutical industry, essentially requesting them to the act "put on hold" , citing several reasons for this, one of them being "the technology required for this system is unproven and not in place." The FDA patience finally wore thin. Therefore it was decided that they will allow the current stay on this act, to expire in December 2006. This may not be a big problem for the pharmaceutical manufacturers, but it could be a really big problem for supply chain intermediaries like distributors, pharmaceutical wholesale suppliers and traders, who may not know much about "electronic track and trace" technology, which is necessary for the compliance. Sangeeta's RFID technology white paper attempts to explain how this RFID track and trace system can be implemented and how it will be beneficial in the long run to all sections of society- pharmaceutical companies as well as intermediaries and ultimately the end users.

Understanding the pharmaceutical supply chain:

The lay reader may assume that it is like any other supply chain, which brings goods from the manufacturers' factories to the retail shelves, but it is not so. The pharmaceutical supply chain is inherently different in its organization. For the pharmaceutical business, the pricing for each end user is different. Therefore a typical hospital gets these drugs at lower rates than does a corner pharmacy. There are programs like Medicare and Medicaid where the procurement prices are different than for someone who buys the same drug at a corner pharmacy. The pharmaceutical distributors diagram to the right shows some of the various flows of prescription drugs through the pharmaceutical supply chain. (More details in Abhisam RFID technology white papers like "RFID-FDA-Regulations.pdf")

IMPORTANCE Role Of Supply Chain Management in Pharmaceutical Industry

Posted by Nelson Jim on April 24th, 2011 [] Pharmaceutical industry is heavily regulated globally and it has many markets, products, processes and intermediaries. The supply chain for the delivery of pharmaceutical services is often fragmented. Changes in one area effect the other area. Pricing, regulatory changes, actions of the competitors impact the whole supply chain. The pharmaceutical industry is ranked fourth in the world in terms of production volume and 13th in domestic consumption value. Supply Chain in the pharmaceutical industry helps the organizations to develop their own blueprint for managing the opportunities and threats to the pharmaceutical supply chain. The pricing in the pharmaceutical industry is different for each customer. For example, the products or services are provided at cheaper rates for hospitals when compared to the individual chemists. The most important factors of supply chain in pharmaceutical industry are inventory reduction and reduction of order cycle time. The logistics also plays very important role in pharmaceutical value chain as they account for 45 to 55 percent of the total costs. The supply chain must be capable of using intellectual property in a right way, provide safe provision for drugs and it should be flexible and cost efficient. The delivery of pharmaceutical products in right quantity, right quality, right price and at right time for the right customer is very important and these products need to be stored at the given temperature and at the right humidity level. The logistics and supply chain management plays an important role in the functioning of the pharmaceutical industry and they help in the enhancement of productivity and in the growth of this industry, With a supply chain management software in place, a business can:

More effectively manage its entire network by overseeing all activities across all suppliers, production plants, and storage and distribution facilities. Streamline and centralize their distribution strategy, to eliminate the logistical errors and lack of coordination that can lead to delays. Increase visibility and enhance collaboration across the entire supply chain by sharing valuable information such as demand trend reports, forecasts, inventory levels, and transportation plans with suppliers. Minimize storage costs and improve cash flow by better managing inventory levels. Improve logistics tracking, to correct break-downs, inefficiencies, or problems in the supply chain management. The Proposed SCM softwares offer a comprehensive suite of modules and features to support end-toend supply chain processes, including: Inventory management to ensure optimum stock levels of components for production plants, finished goods for customers, and spare parts for field service technicians (if applicable), while minimizing related storage costs. Order management that includes automated order entry, dynamic supplier scheduling, and pricing and

product configuration to accelerate the order-to-delivery cycle. Procurement to streamline all sourcing, purchasing, and payables across the entire supplier network. Logistics to enhance the way warehouses are managed and transportation channels are coordinated, so on-time delivery performance can be dramatically improved. Supply chain planning to improve all related operations by enabling accurate demand forecasting, improving order promising, and eliminating manufacturing over-runs. Return management to accelerate the inspection and handling of defected goods, and automate the processing of claims with suppliers and insurance companies. Incentive management to help companies better manage vendor negotiations, discounts, incentive plans, and commissions

Is Supply Chain Analytics The Next Big Thing In Business Intelligence? In my previous post, I noted the importance of the renaissance of RFID across industry verticals and what this means for pharmaceutical supply chains in terms of elevating their current level of performance. In this post, I want to focus on another emerging supply chain trend that seems to be gaining significant traction by allowing companies to increase operational responsiveness and flexibility. This area, known as supply chain analytics, hopes to allow for supply chains to quantitatively segment multiple data points to make fact based predictive decisions as a means become data driven and improve operational performance. Supply chain analytics, a somewhat nascent yet growing business intelligence platform, led by companies such as Teradata, is proving to be a powerful force. While most companies across industry verticals measure supply chain performance based on what has occurred solely in the past through metrics, this approach will no longer be sustainable in the future. By contrast, analytics ties future and predictive performance together by analyzing trends based on millions of data points gathered from operational transactions in real time throughout the globe. The idea of analytics utilized within supply chain management becomes even more important as companies look towards cost containment and freeing up working capital, risk management, sustainability, and increased visibility within their supply chains. Therefore, automating the entire supply chain through advanced modeling and predictive performance is not only here for today, but very well may be the way of the future. The promise of supply chain analytics allows for intelligent systems to learn and adapt to how a particular supply chain is run and then make adjustments accordingly through advanced simulation and complex algorithms. For example, this avant-garde system allows for predictive buying and selling patterns (i.e. what is the supply chain impact of a particular promotional event or seasonal trends) to coincide with the proper level of production, inventory, and distribution to more effectively align costs with revenues. In addition, some companies are even using supply chain analytics software as a competitive advantage, to adjust their supply chains based on market conditions, weather patterns, or customer segments. This ultimately provides the correct level of end to end visibility of the performance of each specific node within the supply chain in order to improve responsiveness, contain costs, and improve customer service. Sophisticated modeling and analytics software may also allow companies to uncover data that may be overlooked within traditional ERP and CRM systems. So what does this mean for pharmaceutical supply chains? For one, it can allow for issues and risks to be predicted earlier, such as seasonal spikes in demand and optimizing inventory accordingly. Perhaps this could allow for these supply chains to finally increase inventory turnover and velocity. Or perhaps

analytics could provide a catalyst for pharmaceutical companies to predict CMO or supplier performance, allowing pharmaceutical companies to work with their suppliers before problems arise. While this is just a theory the basic premise is sound, using analytics to make precise decisions with greater agility and speed while having a full understanding of why certain events may or may not happen. Considering that this is still an emerging trend, we would like to know your thoughts on the future of supply chain analytics in the pharmaceutical industry. Is your company currently utilizing analytics to align supply chain goals with corporate objectives? If so, how is supply chain analytics software being incorporated into your existing technological infrastructure?

Supply Chain Management in Pharmaceutical Industry in India 2008.

the "Supply Chain Management in Pharmaceutical Industry in Poland 2008" report to their offering. Supply chain management in the pharmaceutical industry in Poland 2008 thoroughly examines the most innovative ways of gaining competitive advantage in the pharmaceutical sector. It studies the conditions and the level of advancement of the Supply Chain Management on the Polish market in the context of the best practices employed in Polish enterprises and worldwide. The concept itself is meticulously explained, focusing on drug production in Poland. Key objectives and solutions offered by the SCM in Polish companies are provided on the basis of empirical data gathered specifically for the purpose of this report. Key Points: - Companies are looking for 'non product' solutions to enhance their trade attractiveness. - Logistic operators play an increasingly important role on the pharmaceutical market. - Interorganisational supply control is rare in the Polish pharmaceutical sector. - Functional organizational structures dominate in pharmaceutical companies. The report provides crucial information for anyone involved in supply management in the pharmaceutical sector in Poland and abroad, and particularly for: - top management of pharmaceutical companies in Poland and abroad - logistic operators active on the pharmaceutical market and those planning to enter it - pharmaceutical company managers interested in implementing Supply Chain Management methods - supply chain managers - pharmaceutical distributors - researchers, market analysts and consultants - academic institutions - those wanting to gain a thorough understanding of the Supply Chain Management concept. Executive Summary:

Key sections Section one analyses the ways pharmaceutical manufacturers manage supply chains. It provides details related to supply chain planning and supply and demand synchronisation. It also discusses SCM impact on customer service, the production and distribution of pharmaceuticals, as well as supply and redistribution. Section two investigates SCM integration in Polish companies in the context of the best practices employed abroad. It discusses the SCM strategies employed by Polish companies and internal conditions for SCM implementation. It also analyses the integration of SCM processes and their legal framework, comparing loopholes on Polish and foreign markets. Section three looks into the development of SCM in Polish pharmaceutical companies, focusing on its growth drivers and conditions. It presents SCM as an innovative tool to efficiently improve company competitiveness, and analyses threats and opportunities for SCM growth in Polish pharmaceutical companies. Report overview The report opens with an introduction presenting its objectives and target readership. It then introduces research methods employed in the study and provides a summary and a presentation of its most important conclusions. What follows is a thorough analysis of the supply chains used by pharmaceutical manufacturers, with special attention given to the following aspects: - supply chain planning: - supply and demand synchronization - customer service - distribution - production - supply - redistribution. It then discusses the integration of SCM within Polish pharmaceutical companies, in the context of the best practices employed worldwide. It focuses on the following elements: - SCM strategies of Polish pharmaceutical companies - internal conditions for SCM in Polish pharmaceutical companies - integration of SCM processes - loophole analysis: - Polish companies versus global tendencies. Finally, the report provides information concerning SCM growth drivers in Polish pharmaceutical companies. It examines SCM from the following perspectives: - SCM as a tool to improve competitiveness - threats and opportunities for SCM growth in pharmaceutical companies in Poland. Key Topics Covered: -Report methodology

-Introduction -Executive summary -Model of an excellent supply chain in the pharmaceutical industry -Objective structure of the supply chain -Selected processes in the pharmaceutical supply chain -Summary -Analysis of best practices - selected directions of improving SCM in the Polish pharmaceutical industry

Growth Scenario in 2010

India's pharmaceutical industry is now the third largest in the world in terms of volume. Its rank is 14th in terms of value. Between September 2008 and September 2009, the total turnover of India's pharmaceuticals industry was US$ 21.04 billion. The domestic market was worth US$ 12.26 billion. This was reported by the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers. As per a report by IMS Health India, the Indian pharmaceutical market reached US$ 10.04 billion in size in July 2010. A highly organized sector, the Indian Pharma Industry is estimated to be worth $ 4.5 billion, growing at about 8 to 9 percent annually. Know more out this in our article on Indian Pharmaceutical Industry- Future Trends Also check out Pharmaceutical Market Trends 2010

Future Scenario
With several companies slated to make investments in India, the future scenario of the pharmaceutical industry in looks pretty promising. The country's pharmaceutical industry has tremendous potential of growth considering all the projects that are in the pipeline. Some of the future initiatives are: According to a study by FICCI-Ernst & Young India will open a probable US$ 8 billion market for MNCs selling expensive drugs by 2015 The study also says that the domestic pharma market is likely to reach US$ 20 billion by 2015 The Minister of Commerce estimates that US$ 6.31 billion will be invested in the domestic pharmaceutical sector Public spending on healthcare is likely to raise from 7 per cent of GDP in 2007 to 13 per cent of GDP by 2015 Dr Reddy's Laboratories has tied up with GlaxoSmithKline to develop and market generics and formulations in upcoming markets overseas Lupin, a Mumbai based pharmaceutical company is looking to tap opportunities of about US$ 200 million in the US oral contraceptives market Due to the low cost of R&D, the Indian pharmaceutical off-shoring industry is designated to turn out to be a US$ 2.5 billion opportunity by 2012
Reducing the number of wholesalers helps to reduce internal costs for manufacturers, and by dealing only with a few wholesalers may create more manageable business relationships The European pharmaceutical distribution system is set to change dramatically over the next few years. The adoption of direct-to-pharmacy (DTP) in the UK and its emergence in Poland sets a potential precedent for other European markets.

 To date, pharmaceutical manufacturers have managed to drive the changes to suit their interests. However, the establishment of new relationships with select wholesalers will lead to a new type of distributor, which will expand their portfolio of business interests across Europe. With the underlying structure of the supply chain about to change wholesalers are keen to remain competitive in the market. The Future of Pharmaceutical Distribution in Europe - The impact of DTP on manufacturers and wholesalers from URCH Publishing, is a market report that comprehensively reviews the business of medicines distribution in Europe. This 88 page report is an update of the 2008 report "Pharmaceutical Distribution in Europe".

Future Prospects
The Indian pharmaceuticals market is expected to reach US$ 55 billion in 2020 from US$ 12.6 billion in 2009. This was stated in a report title "India Pharma 2020: Propelling access and acceptance, realising true potential" by McKinsey & Company. In the same report, it was also mentioned that in an aggressive growth scenario, the pharma market has the further potential to reach US$ 70 billion by 2020 Due to increase in the population of high income group, there is every likelihood that they will open a potential US$ 8 billion market for multinational companies selling costly drugs by 2015. This was estimated in a report by Ernst & Young. The domestic pharma market is estimated to touch US$ 20 billion by 2015. The healthcare market in India to reach US$ 31.59 billion by 2020. The sale of all types of pharmaceutical drugs and medicines in the country stands at US$ 9.61 billion, which is expected to reach around US$ 19.22 billion by 2012. Thus India would really become a lucrative destination for clinical trials for global giants. There was another report by RNCOS titled "Booming Pharma Sector in India" in which it was projectedt that the pharmaceutical formulations industry is expected to prosper in the same manner as the pharmaceutical industry. The domestic formulations market will grow at an annual rate of around 17% in 2010-11, owing to increasing middle class population and rapid urbanisation. Read More in Future Prospects of Indian Pharma Industry.

Challenges
All of these changes are ultimately good for the Indian pharmaceutical industry, which suffered in the past from inadequate regulation and large quantities of spurious drugs. They force the industry to reach a level necessary for global competitiveness. However, they have also exposed some of the inadequacies in the industry today. Its main weakness is an underdeveloped new molecule discovery program. Even after the increased investment, market leaders such as Ranbaxy and Dr. Reddys Laboratories spent only 5-10% of their revenues on R&D, lagging behind Western pharmaceuticals like Pfizer, whose research budget last year was greater than the combined revenues of the entire Indian pharmaceutical industry[13, 37]. This disparity is too great to be explained by cost differentials, and it comes when advances in genomics have made research equipment more expensive than ever. The drug discovery process is further hindered by a dearth of qualified molecular biologists. Due to the disconnect between curriculum and industry, pharmas in India also lack the academic collaboration that

is crucial to drug development in the West. Every industry has its own sets of advantages and disadvantages under which they have to work; the pharmaceutical industry is no exception to this. Some of the challenges the industry faces are: Regulatory obstacles Lack of proper infrastructure Lack of qualified professionals Expensive research equipments Lack of academic collaboration Underdeveloped molecular discovery program Divide between the industry and study curriculum

Government Initiatives The government of India has undertaken several including policy initiatives and tax breaks for the growth of the pharmaceutical business in India. Some of the measures adopted are: Pharmaceutical units are eligible for weighted tax reduction at 150% for the research and development expenditure obtained. Two new schemes namely, New Millennium Indian Technology Leadership Initiative and the Drugs and Pharmaceuticals Research Program have been launched by the Government. The Government is contemplating the creation of SRV or special purpose vehicles with an insurance cover to be used for funding new drug research of Pharmaceuticals is mulling the creation of drug research facilities which can be used

Source: FDA, Credit Source: FDA, Credit Suisse/First Boston Suisse/First Boston

The pharmaceutical supply chain like any other industry has a challenge to streamline the flow of products, information and funds from R & D stage to sourcing to ingredients and manufacturing to distribution to final customers. What makes Pharmaceutical supply chain is so different from others is that social responsibility that pharmaceutical industry has got to ensure 100 % product availability at the right time, at the right cost, in good condition (counterfeit issues) to right customers. In order to ensure close to 100% product availability, many industries have taken the strategy of keeping a huge inventory in their supply chain as pharmaceutical products margin is remarkably high but the lifespan of patents is limited. So there is no wonder why logistics cost shares 45 to 55% among other costs in the pharmaceutical value chain, as pharmaceutical industries are willing to keep supply at any cost

The Value Chain Cost Distribution Value Chain Stages Research Cost Primary Manufacturing cost Secondary Mfg/Packaging Marketing / distribution General Administration Profit Total & Development

Cost Distribution

15%

5 10% 15 20 % 30 35% 5% 20% 100 %

The above-mentioned report shows that the pharmaceutical industry has got a huge potential to trap supply chain cost in the value chain as supply chain costs more than R&D costs. Hence company should map their

supply chain process and optimize the same to ensure the product availability at optimal costs. Optimizing supply chain would result in 30% stock reduction, 30% increase in value added time and 7% reduction in supply chain costs, which has been proved by one large drug maker, who reduced supply chain costs up to $30 million with $ 8-16 million p.a.

While many pharmaceutical companies have successfully deployed a plethora of strategies to target the various customer types, recent business and customer trends are creating new challenges and opportunities for increasing profitability. In the pharmaceutical and healthcare industries, a complex web of decision-makers determines the nature of the transaction (prescription) for which direct customer of pharma industry (doctor) is responsible . Essentially, the end-user (patient) consumes a product and pays the cost . Use of medical representatives for marketing products to physicians and to exert some influence over others in the hierarchy of decision makers has been a time-tested tradition. Typically, sales force expense comprises an estimated 15 percent to 20 percent of annual product revenues, the largest line item on the balance sheet. Despite this other expense, the industry is still plagued with some very serious strategic and operational level issues. 2.1 From organizational perspective the most prominent performance related issues are enlisted below: a) .Increased competition and shortened window of opportunity. b). Low level of customer knowledge (Doctors, Retailers, Wholesalers). c). Poor customer acquisition, development and retention strategies d). Varying customer perception. e). The number and the quality of medical representatives d). Very high territory development costs. f). High training and re-training costs of sales personnel. g).. Very high attrition rate of the sales personnel.

h). Busy doctors giving less time for sales calls. i). Poor territory knowledge in terms of business value at medical representative level . j). Unclear value of prescription from each doctor in the list of each sales person. k). Unknown value of revenue from each retailer in the territory l). Virtually no mechanism of sales forecasting from field sales level, leading to huge deviations m). Absence of analysis on the amount of time invested on profitable and not-soprofitable customer and lack of time-share planning towards developing customer base for future markets n). Manual and cumbersome administrative systems and processes designe

Counterfeit Issues in Pharma Supply Chain

The treat of counterfeit drugs entering the marketplace is greater than ever before and so is the risk of pilferage. A recent report in wall street Journal noted that, in several scams, drug companies have had drugs enter the supply chain because new theology make it easy to forget prescription drug labeling and because the high price of drugs in the US has fuelled demand for inexpensive suppliers. For example, Pfizer had a case where its cholesterol drug Lipitor recalled as many as 200, 000 bottles which had a total market value of about US$ 55 million, containing fake pills from outside the US. The number of cases of counterfeiting reported by the FDA has risen from four in 1998 to over 22 in 2002. It clearly emphases the complexity of supply chain design for today environment. Hence, the Supply chain managers should rethink their strategy and process on distribution, warehousing, transportation, and outsourcing activities in order prevent counterfeit in their supply chain. The new technologies such as Radio Frequency Identification (RFID) would help to track and trace the products and prevent any counterfeit activities into the products from the designing stage to consumer stage.

Best Practices for Pharma Supply Chain Excellences

The speed, flexibility, visibility, Responsiveness, costs and safety are the key drivers for the pharmaceutical supply chain excellences. The collaborating planning and forecasting with supply chain partners (contract manufactures and 3rd party service providers), Outsourcing, earlier involvement of vendor in product designing, technology integration and continuous improvements through supply chain metrics are the key strategies for the pharmaceutical supply chain to ensure the product availability at optimal costs in today environment.

Outsourcing Speed, Flexibility and Responsiveness

Outsourcing is the key strategy to reduce time to market and increase the flexibility. Today pharmaceutical Industry is moving toward planning for a range of capabilities instead of for specific product requirements. An outsourcing partner who can reduce product development cycles, eliminate bottle necks and provide immediate access to advanced technologies and expertise would be a valuable assets. Such flexibility would also ensure the responsiveness by responding to customer requests for special packaging or labeling, quickly adopting new production technologies, or getting new products on the market as soon as they receive approval. The time required to establish new capacity is significant: 3 4 years for bulk production and 2-3 years for formulation. Hence company should use outsourcing as a key strategy for competitive advantage rather than reducing companies burden on non-core activities. Companies should also leverage the clinical research outsourcing potential in order to gain the

competitive advantage by reducing product development time. India has a huge opportunity to trap the world outsourcing market, which is estimated at $ 53.2bn in 2003 and growing at CAGR 10.8%. India has the key ingredients, technical skills, and regulatory compliance, cost advantage and global relationships to emerge a powerhouse in this sector. According to Kotak Report, the bulk outsourcing or manufacturing outsourcing currently at $14 billion and slated to grow to $27 billion by 2007(Source: www.pharmaquality.com). It is a segment where Indian companies can best exploit. With India being favorably looked upon by the top pharma companies of the world, the need to match and meet world standards in supply chain is more critical than ever before.

Technology Integration Visibility

Though the security of data appears to be sacrosanct, companies should share necessary data with at least key vendors and customers in order to avoid any lost sales, missed deliveries, obsolete inventory, and poorly planned promotions. Sharing the information with vendors and early involvement of them into product designing would cut the development process time. Though forecasting accuracy has been shown to improve from 30% to 65% over a 12 week forecast in the Pharma industry, there is lots of scope to improve it further. For instance, recent research suggest that the first seven weeks of new product demand data is enough to establish a trend for planning if the companies integrate their vendors and customers along the supply chain by sharing the information at right time by
implementing tools like Collaborating Planning, Forecasting and Replenishment (CPFR) and Vendor Managed Inventory. Hence pharmaceutical players should rethink their strategy on information sharing in order to sense the real demand in the market.

Metrics Continuous improvements

To ensure the continuous improvements in supply chain processes, the pharmaceutical company needs to

put in place clear performance measures. What gets measured gets noticed and improved continuously. The best approach is to assemble a performance scorecard of metrics that are key to the business, and the metrics should be objective, quantifiable and balanced. The SCOR (Supply Chain Operations References) Model and Balanced Score card are the some famous performance measurement models. Responsiveness, Flexibility, Inventory turn over, Cash to Cash Cycle and Asset Turn over are the some key performance indicators in Supply Chain.

Conclusion
The pharmaceutical has got a tremendous opportunity to lower costs, improve asset management and enhance customer service by implementing supply chain best practices such as CPFR, Outsourcing, VMI and Lean thinkings. The companies that adopt these practices will gain a competitive advantage over their rivals, and costs and speed of response will be orders of magnitude lower than traditional methods.
The pharmaceutical industry has a significant presence during residency training, has gained the overall acceptance of trainees, and appears to influence prescribing behavior. Training programs can benefit from policies and curricula that teach residents about industry influence and ways in which to critically evaluate information that they are given. Recommendations for local and national approaches are discussed

This project may leads to conclusion that the Logistics & Supply chain has its own value in Todays competitive World. Whether the problems in Handling the Supply chain & Logistics are overtaken or not. Is there any way to tackle the Problems of Supply chain & Logistics.

Definition of the problem

In Pharmaceutical companies the cost of Supply chain & Logistics is highest as compared to other industries. This Industry also faces the Problem of Handling the Inventory From the study, we may find that, the companies can reduce the Logistics & Supply chain cost or they have to try for some other methods of Supply chain & Logistics to deal with. During my literature review it was found that before some years Logistics & Supply chain was not given greater importance but in Last Few years the Trend is changing rapidly.Because the Logistics & Supply chain department of the Company is now greatly responsible for The Production processes, delivering the Finished & Semi-Finished goods. The Study will be done with an E.O.U (Export Oriented Unit) of Wockhardt Ltd. Waluj, Aurangabad.

RESEARCH METHODOLOGY The instrument will used for the data collection will be questionnaire survey or personal interview to
collect empirical data. The responses have to keep confidential in order to encourage openness and disclosure. The attitude of the Employees towards the very important process of Logistics & Supply chain is noted accordingly by asking them structured questioner. Scaling Rating scale is used for this research. Type of rating scale used: Dichotomous scale Data collection method Sources of data Primary data Primary data First hand information or data was collected on the variables of interest for the purpose of study from the managers, employees and customers of the Pharma industry under study. Secondary data Secondary data was obtained from already existing sources like books, journals, e-books, internet and company records. Data collection methods 1) Questionnaires 2) Interviewing

Sampling technique

Sampling helps in selecting a sufficient number of elements from the population so that a study of the sample and an understanding of its characteristics make it possible for me to generalize characteristics to the population elements. Nonprobability sampling technique was used and the design was Judgment sampling which is a type of purposive sampling. Purposive sampling is one of the broad categories of Nonprobability sampling designs

Nonprobability Sampling technique

This technique is used to obtain some preliminary information in a quick and inexpensive way. As I was in need of specific limited target groups of employees, customers and managers to answer the questionnaires I have used the judgment purposive sampling design so that I can get relevant information

A Literature Review
Process validation has been widely discussed and criticized by the pharmaceutical industry during the past 20-30 years. Regulatory guidelines in the US and Europe have slowly been modernized, and revisions will certainly continue; in autumn 2001 for example, new guidelines for process validation came into force in Europe.(1,2) The unofficial debate regarding process validation has always been quite lively, although ostensibly negative. The advantages and disadvantages of process validation have never been systematically evaluated, and validation is frequently performed without a real understanding of the work involved. The challenge for the pharmaceutical industry is to streamline and/or simplify validation without sacrificing product quality.(3) To successfully fulfil the challenge, those practising validation need to be aware of the best way to perform validations and the real aim of these procedures. This review examines how pharmaceutical process validation has evolved, the attitudes towards it and how it has been accepted by the industry.

Current definitions The three most often referred to definitions of pharmaceutical process validation are those presented by the European Agency for the Evaluation of Medicinal Products (EMEA), the US Food and Drug Administration (FDA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The latest versions of their definitions are described in the sidebar "Current definitions of pharmaceutical process validation." The three definitions are very similar; the only difference is that FDA expresses a minor uncertainty of the concept, despite the efforts of validation, by stating that process validation only provides a high degree of (not absolute) assurance that the process will produce the intended product. This amendment by FDA is, however, essential. Even when approaching process validation as scientifically as possible, by incorporating elements of validation during each stage of product development(68) and evaluating the influence of different process parameters on the final product with statistical principles,(3,9) the possibility of erroneous results still remains.

Confusion The definition and meaning of pharmaceutical process validation has never really been clear.

The expression "pharmaceutical process validation" is said to have first been used approximately 30 years ago by the US authorities,(10) and since then, people have demanded more precise and understandable definitions. But the more the authorities have tried to explain their meanings and provide guidelines, the greater the ensuing confusion and misunderstanding.11-14 John R. Sharp,(14) who at the time was the principal medicines inspector at the Department of Health in the UK, said that such definitions only confused those who already had an idea of what pharmaceutical process validation is and would not enlighten those who did not. He said that process validation is nothing more than common sense - it is simply proving that a process does what it is designed to do.(14,15)

There is also much confusion as to what constitutes process validation and what does not. Pharmaceutical process validation has always been understood in one of two ways - either as the total validation activity in a pharmaceutical manufacturing site from development qualification of the equipment to the final validation of three consequent batches of the final product; or as the final production-scale validation of a pharmaceutical preparation only. This discrepancy is not surprising because interpretations vary between the authorities(1,4) and the textbooks.(10,16)
Historical background Concept. The idea of process validation is not new and is common in many different

fields of life; one can find the need for process validation in almost any kind of process, for example, building a spaceship or treating illnesses. It is important to be sure that these processes do what they are expected to do, otherwise the consequences could be serious. Sharp also interpreted pharmaceutical process validation simply as a step in developing the maintenance of the quality of manufactured medicines.14 Process validation has been included in the first interpretations of good manufacturing practice (GMP) to ensure that medicines are safe and have the identity and strength they are supposed to have.

Table I: Regulatory history of process validation in the US

US regulations. Bernard T. Loftus,(10) a former director of FDA, previously described how and Europe. the principles of process validation evolved in the US from the first current good manufacturing practice (GMP) in 1963 to the first Guideline on General Principles of Process Validation in 1987.4 Prior to 1963, the only way for FDA to prove that a process had not done what it was designed to do was to take samples from the final product, analyse them and show deviations from the specifications. From 1963, the law stated that a pharmaceutical manufacturer had to follow cGMP regulations whilst FDA received authorization to inspect manufacturing facilities. This was a direct consequence of a series of accidents in which people were injured and even killed. These incidents led to the evaluation of manufacturing processes, but it still took a long time before the authorities could point out clear and serious production faults and demand better procedures and processes. Things began to change during the late 1960s and early 1970s when new types of incidents, such as poorly mixed, highly potent tablets and insufficient sterilization procedures for large volume parenterals caused serious patient disorders.(10,15) Many speeches pointing out the need for process validation were made by US authorities and the expression "validated manufacturing process" was finally defined in the Drug Process Inspections Compliance Program in 1978. The more precise definition and adjustment of the concept for process validation was published in the Guideline on General Principles of Process Validation in 1987 and, since then, exhaustive process inspections have been routinely performed by FDA. It took a long time before process validation was directly named in US cGMP regulations. To this day, process validation is not clearly defined, although a new version of the US cGMP rules, including more precise definitions of process validation, has been in preparation for a couple of years.(17) European regulations. At the same time, a similar process was taking place in Europe (Table I), particularly in the UK. In 1968, new guidelines were introduced in the UK governing the sale and distribution of medicinal products, and in 1971 the first edition of Orange Guide, a guide to GMP, was published by the

Pharmaceutical Inspection Convention (PIC). This guide already mentioned validation as being beneficial, but it was only in the 1977 and 1983 editions that validation practices in sterilization, aseptic processing and non-sterile processes were included. In 1989, the first edition of the European Guide to GMP superseded all national guidelines within the European Union (EU).(16) This guide from the European Commission, together with the EMEA guidelines, has served as a model for all European countries regardless of whether or not they belong to the EU. As in the US, European process validation for sterile and aseptic processes was accepted and put into practice soon after the first regulatory guidelines demanded it. Yet, up until recently, process validation for other non-sterile processes has been introduced much more slowly and in limited amounts. More precise guidelines and definitions were also demanded for the European medicinal industry before the systematic validation of all pharmaceutical manufacturing processes was regarded as necessary. The preparation of more detailed instructions went on between 1997-2001,18 and in September 2001, Annex 15 to the EU Guide to GMP came into operation titled Qualification and Validation2 and the Note for Guidance on Process Validation for marketing authorization applicants was introduced.1 It is worth mentioning that these instructions were issued at the same time as the GMP Annex and Note for Guidance on Parametric Release.(19,20) Parametric release is important because it adds more value to process validation.
FDA interpretations At the beginning of the 1980s, US authorities published several guidance speeches

relating to process validation.(12,13,15,21) Additionally, Loftus defined process validation as nothing more than proving that a process works; that is, common sense. He also underlined that FDA emphasized "what to do" and left the "how to do it" to the manufacturer.(15) He stated that the regulatory body should insist on documented validation and was preventing initiatives and progress with meaningless regulatory controls. Ted E. Byers, a consultant and former FDA inspector, explained how to best organize validations and how to maximize their benefits.(21) He introduced the team approach as a model for process validation organization and asked for better co-operation between FDA and the industry when planning individual validation cases. In conjunction with the preparation of the US Guideline on General Principles of Process Validation, Edmund M. Fry, director of the Parenteral Drug Association (PDA), attempted to clarify some points of the draft guideline that had raised questions from the industry.(12,13) His main message was that guidelines are not mandatory, but simply explain one approach to accomplishing the objective of the law. However, FDA comments suggested that it never wanted to define too many details of process validation, but that the industry itself asked for them.
FDA criticized In both the US and Europe, the authorities underlined how beneficial it would be if the

industry made an effort to provide constructive comments on the guidelines before they were published. (12,18) As Loftus from FDA stated: "There is clearly a public policy need that we regulate the industry, but not that we manage it.

ames P. Agalloco was more positive about process validation, highlighting the business aspects and listing the numerous benefits to the manufacturer.(22) However, there was one person who attacked FDA's principles of process validation - John Sharp. He initiated a discussion on process validation just before the US guideline came into operation,(14) although the majority of the discussion took place between 19931995.(23-29) Sharp believed that validation in the US was in danger of becoming a cult-like activity where the original purpose had already been forgotten by spiralling onwards and upwards on a stairway of increasingly demanding standards. Not only did he blame FDA for this, but also found the pharmaceutical industry guilty. Sharp claimed that the need for validation should be inversely proportional to the adequacy of product design, raw material control and other quality control aspects, and directly proportional to the hazard to the consumer that a process failure might present.

Representing European authorities, Sharp found the European method of validating more reasonable than the US approach. He also emphasized the need for an improved level of interpretive consistency among US authorities. According to Sharp, this consistency was an area where the British Medicines Inspectorate had invested a lot of time. Michael H. Anisfeld,(27) who worked at Interpharm Consulting (Buffalo Grove, Illinois, USA), agreed with Sharp and emphasized the importance of the patient perspective. He asked: "How much validation can the patient and the world afford?" and made comparisons of the expenditures on validations and their influence on prices of medicinal products with annual incomes of people in developing countries in need of those medicines. He also highlighted the exaggeration of US regulations and their consequences; some companies were not manufacturing products aimed at the US market in accordance with regulations because they did not want to go through costly FDA validation programmes for new facilities. James Akers28 (Akers, Kennedy & Associates, Cary, North Carolina, USA) agreed with both Sharp and Anisfeld. According to Akers, validation was becoming a negative force within the pharmaceutical industry and the time had come for some fundamental change in the way the industry approached the subject. He wanted to go back to the basics of validation and forget all the bureaucratic exercises with irrelevant definitions and terms. Furthermore, Akers observed that process validation served as an excuse to do nothing new and, therefore, hindered the creativity of scientists and engineers.
Disagreements R.A. Nash, associate professor of St John's University, Jamaica, did not agree with Sharp.

Nash had been working in the field of validation since the early 1980s(23,31) and found Sharp's opinions to be personal attacks; he consequently wrote a heated response.26 However, in 1996,3 Nash also asked for process validation to be streamlined and simplified. Although Gene K. Estes et al.32 had established that process validation emerged primarily from the actions of the pharmaceutical industry, Agalloco suggested the idea first came from a regulatory body,(29,30) and was adopted as a regulatory burden rather than benefit. Agalloco found that validation could be defined as an application of total quality management (TQM), stating that it was the quality of the validation that is important and not the quantity. In 1995, Sharp criticized FDA-type validations and went as far as to suggest the term "validation" be abandoned altogether.(33,34) All that inspectors would then need to ask, he said, would be: "Prove to me that this process works, in that it achieves what it is intended to achieve." During the 1990s, Robert G. Kieffer, a consultant at RGK Consulting (Yonkers, New York, USA), challenged the need for risk-benefit analysis and the need for remembering to take into account the human element when planning process validations,(35,36) suggesting that the steps in a process involving human intervention would present the highest risks. Additionally, the sophisticated technology being used made more demands on people's knowledge and skills. Kieffer also anticipated new trends in pharmaceutical manufacturing - the pressure to do more with less, improve quality with lower costs, the globalization of the pharmaceutical industry and an increase in contract manufacturing. These trends are currently guiding the work of industry and also the work of regulators.(37) Kieffer also suggested that the basic ideas of GMP should be based not on quality control but on total quality, which meant the empowerment of all staff. Another consultant, Keith Powell-Evans, stressed the need to educate individuals involved in the validation process.(38)
European perspective In Europe, the preparation of the new guidelines on process validation began in the

late 1990s. The European authorities explained the new proposals,(18,39,40) consultants and pharmaceutical schools introduced their theories about how to best survive the validation effort41-43 and positive experiences from the field were presented by the industry.(44,45) S. Roman44 (Laboratoire Glaxo Wellcome, France) found validation to be one of the main tools for quality assurance, resulting in reduced production and control costs. M.J. Girault45 (Marion Merrell Bourgoin SA, France) presented calculations showing that the cost of validation compared with the total costs of the plant was approximately 1.2%, and compared with the total costs of the quality department was 7.8%.

D. Caubel from the French Agency for Medicines evaluated the meaning of the guidelines and stated that they should serve mainly as a framework for process validation.39 They should give guidance for reasonable documentation practice but they should only give detailed instructions in particularly sensitive cases, such as cross-contamination prevention and aseptic preparations. Many recent comments go into specific details of validation and/or overall quality assurance, warning regulators of giving too precise instructions in their guidelines.(46,47) A more open approach from the regulatory side is required and a need to aim ultimately for parametric release for all dosage forms is emphasized.(37,48) Interesting additions to the discussion are comments from the less-developed countries where the concept of validation is new.(49)
Discussion The debate regarding pharmaceutical process validation began in the US during the late 1970s

and the first definitions of process validation were introduced at the beginning of the 1980s.(11-15, 21, 31) The discussion continued throughout the 1980s and during the preparation of US guidelines.(12-14, 22) However, the most critical comments were only published after the guidelines had come into operation.(2328) Comments on process validation emerged in European literature later than in the US and most of them were positive and accepting in their nature, apart from those by Sharp. This remained the case between 1997-2001 during the preparation of European guidelines on process validation.(38-45) The authorities, the pharmaceutical industry, consultants and pharmaceutical schools have all contributed to the discussion. Many of them have been critical of some aspects of process validation but none have been totally against it. In fact, many constructive and economic ideas regarding process validation have been suggested.(29,30,33-38) A clear evolution of the discussion can be recognized. The first comments were from US authorities who tried to explain the demands from a regulatory point of view,(11-13,15,21) referring to comments that they had received from the industry.11-13,15 It is important to note that in these early regulatory speeches, the regulators often stressed that they would not like to write too precise instructions about process validation, because they found that the practice varies so much from case to case.12,13,15 But, according to their references, it was the industry that wanted to have these detailed instructions and then started pointing out defects in them. FDA had gone into too much detail in its guidelines and that encouraged misunderstandings, negative attitudes and a substantial amount of unnecessary work in the industry. The European guidelines, although often one step behind, were better accepted. Since the early 1990s, there has been a greater concentration on the risk-benefit analysis, statistical analysis and prioritizing work of process validation.(28,35-37) It appears that the pharmaceutical industry has now accepted that process validation is here to stay and that it is not simply a tool for quality assurance.(50,51) Process validation has become part of strategic quality management and performance improvement;(52) all its benefits (to patients as well as manufacturers) have been recognized and from now on, the challenge is to find the right level of cost-effective validation without any risks to consumers.
Conclusion According to literature published during the last 30 years, pharmaceutical process validation has

evolved. For most people in the industry, it originally appeared as a regulatory requirement and, hence, was often regarded as a burden. Despite originally being criticized, process validation is well accepted and regarded as part of total quality and process management. The US has been more critical of process validation; however, the lack of European literature on the subject does not reveal the true European attitude to process validation.

India India has a well established pharmaceutical industry and produces all the tracer medicines selected in this study. The country however has a complex intra-state and inter-state supply/ distribution chain structure making understanding the functionality of the supply/distribution chain confusing. The distribution set-up in the Indian pharmaceutical industry is a highly fragmented system that has evolved on the basis of a two-tier sales tax structure (the Central Sales tax (CST) and local sales taxes). Most medium and big local pharmaceutical industries avoid the CST by conducting distribution through their own carrying and forwarding agencies that transfer goods across states as interstate stock transfers. While the selected tracer medicines are locally manufactured, their supply/distribution chains can easily be traced, and so clear supply chains can be followed. However, tracing the supply chain between key players is more complex as they include multi-directional relationships between large scale producers, small producers, super-stockists, clearing and forwarding agents, central stores, wholesalers, hospital, retailers or pharmacists, public and NGO agencies, practitioner and the end user/patients.

South Africa South Africa, has a medium-sized pharmaceutical industry. The supply/distribution chain for essential medicines involves both public and private players and often the supply/distribution chains for the selected tracer medicines were not easy to follow. The exact role of the pharmaceutical industry in the supply/distribution of the tracer medicines is unclear. For example, literature describes a context for ARV drug supply chains in South Africas public sector but does not explicitly deal with the key players in the supply/distribution chain for the tracer medicines. The ARV supply chain is not entirely vertical, and there are certain elements which are separate from the overall national distribution systems. For ARVs and anti-TB medicines, the key players (identified through a ministry of health official) include a quality assurance pharmacist from a large local manufacturer, senior management pharmacists within trade associations, the director of the wholesale sector (pharmacist), the national quality assurance mangers from distribution agencies, private retail sector senior representatives from doctors conventions and pharmaceutical societies and public sector pharmacists at managerial level (national and provincial DOH levels). For oxytocin, fluoxetine, metformin and fentanyl, so far there is no literature available for South Africa to identify the key players in the supply/distribution chains of these selected medicines. Uganda Uganda has a pharmaceutical industry that is still in its infancy with only one firm pre-qualified to manufacture ARVs. In Uganda, public sector procurement is limited to medicines on the national essential medicines list (EML), on which the selected tracer medicines are listed. Regulations for public sector procurement of drugs stipulate that 90% of tenders must be national competitive tender and 10% international competitive tender. Of the 90% of nationally competitive tenders, 94% is imported goods, and 6% is produced locally within Uganda. Upstream, the main players are the international and local manufacturers, and the importers. Centrally, the Uganda Ministry of Health procures the medicines which are then stored centrally at the National Medical Stores (NMS). Medicines are also procured by the church funded Joint Medical Stores (JMS) for non-profit organizations, or private sourcing/importer and storage by wholesalers. Downstream, the main players are the public and NGO hospitals, pharmacies, clinics and drugshops. However, the exact relationships and factors affecting the supply/distribution chains are not well documented, and the interaction between international and national players needs further exploration.

Researchers identified 32 articles addressing nursing's relationship to drug companies and those that included the perspectives of the pharmaceutical industry on this issue. Of these, 7 were empirical studies, two were theoretical, and 23 were perspectives, commentaries, opinions, and non-systematic (narrative) reviews. From these 32 articles, they grouped topics and concerns, and positioned them relative to debates in the medical literature about the influence of the pharmaceutical industry upon patient and professional education, gift giving, direct-to-consumer advertising, provision of free drug samples, and other determinants of prescribing practice. The following observations were made: Nursing education fails to prepare graduates to deal with pharmaceutical promotion. Many nurses would appear to accept promotional material uncritically. Many nurses are not trained in critical appraisal, and appear to understand little of the mechanisms by which marketing strategies operate, as well as their own vulnerability, decision-making processes, and conflicts of interest, exacerbated by their relatively meagre training in pharmacology, statistical inference, and critical appraisal.