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History of Indian Pharma Industry

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CHAPTER: 1 INTRODUCTION History of Indian Pharma Industry The Pharmaceutical industry in India is the world’s third-largest in terms of volume and stands 14th in terms of value. 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$21. 04 billion. While the domestic market was worth US$ 12. 26 billion. Sale of all types of medicines in the country is expected to reach around US$19. 22 billion by 2012.

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Exports of pharmaceuticals products from India increased from US$6. 3 billion in 2006-07 to US$8. 7 billion in 2008-09 a combined annual growth rate of 21. 25%. 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. Some of the major pharmaceutical firms including Sun Pharmaceutical, Cadila Healthcare and Piramal Healthcare. The government started to encourage the growth of drug manufacturing by Indian companies in the early 1960s, and with the Patents Act in 1970. However, economic liberalization in 90s by the former Prime Minister P.

V. Narasimha Rao and the then Finance Minister, Dr. Man Mohan 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. 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. 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 labor 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. Most of the players in the market are small-to-medium enterprises; 250 of the largest companies control 70% of the Indian market.

Thanks to the 1970 Patent Act, multinationals represent only 35% of the market, down from 70% thirty years ago. 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 a modest 1-2% share, but it has been growing at approximately 10% per year. India gained its foothold on the global scene with its innovatively engineered generic drugs and active pharmaceutical ingredients (API), and it is now seeking to become a major player in outsourced clinical research as well as contract manufacturing and research. There are 74 U. S. FDA-approved manufacturing facilities in India, more than in any other country outside the U. S, and in 005, almost 20% of all Abbreviated New Drug Applications (ANDA) to the FDA are expected to be filed by Indian companies. Growths in other fields notwithstanding, generics are still a large part of the picture. London research company Global Insight estimates that India’s share of the global generics market will have risen from 4% to 33%. The Indian pharmaceutical industry has become the third largest producer in the world and is poised to grow into an industry of $ 20 billion in 2015 from the current turnover of $ 12 billion. The Indian pharmaceutical industry is a success story. 00 000 people are employed in this sector, in some 12 000 firms. 2 900 of them are large scale units, following a recent article by Pradeep Aggrawal and P. Saibaba in the renowned Economic and Political Weekly of Mumbai (29 September 2001). In the pre- and post-production sector, a further 2. 5 million jobs are thought to be involved. Compared to the general price index, drug prices have risen much less in the last 15 years and remain far below average. “Worldwide, India is a country of very low drug prices while producing high quality medicines”, Nihchal H.

Israni, president of the Indian Drug Manufacturers’ Association (IDMA), states proudly. Self-sufficiency with regard to pharmaceutics exceeds 90 percent – in spite of the policy of a more open economy pursued by India since 1991. The secret of this success is the Indian Patents Act 1970. India had entered independence with the patent system of the British colonial masters, enacted in 1911. This secured the Indian market for the British industry. Prior to 1970, multinational companies dominated the Indian market with a share of 85%, pharmaceutics were largely imported whereas local production remained minimal.

Section 83 of the Patents Act 1970 states “that patents are granted to encourage inventions and to secure that the inventions are worked in India on a commercial scale and to the fullest extent and not to enable patentees to enjoy a monopoly for the importation”. At the turn of the century, the share of multinationals had declined to a share of 40 percent of India’s market, including a substantial share of local processing by multinationals. 45 of the larger scale production units belong to multinational companies. The “architect” of the patent law of 1970, S.

Vedaraman, then director of the Indian Patent Office, summarizes the spirit of the law as follows: “We are not against patents. And we are prepared to pay decent license fees. But we in India cannot afford monopolies. ” Since then, India has done without product patents for pharmaceutics, with the exception of production processes that may be patented for seven years. In addition, the law allowed for compulsory licenses granted by the state, in the case of a patent holder not granting voluntary licenses on fair conditions. India profited from a large section of well-qualified experts who made good use of the new opportunities.

These moves did not find much favor with the multinational Pharma-industry. It should not be forgotten, though, that in many industrial countries, the protection of inventions through patents was only developed in the last 30 years. The Swiss pharmaceutical industry in particular fought the enactment of a patent law at the end of the 19th century, in order to be able to imitate foreign drugs, such as Aspirin. In the German Reichstag (Parliament) Switzerland was considered a “state of robber barons”, in France a “country of counterfeiters”.

Product patents for medical drugs have only been known in Switzerland since 1978. It is very clear whose interest they serve. Technology exporters profit from patent protection, which shields them from low-cost competition. Technology importers – in other words, most of the developing countries – want access to technical innovations as freely and cheaply as possible, i. e. no patent protection which creates monopolistic barriers. Indeed it was in this way that the economic development of Japan, Korea and Taiwan was able to thrive, due to the beneficial absence of patents.

The Cipla philosophy has for decades been to promote the principle of relying on one’s own strength. “For India, this means striving for a high degree of self-sufficiency in vital areas of health and nutrition, and for our business practice, it means aiming for the fulfillment of the needs of the Indian population, the use of indigenous raw materials and of local personnel”, says Cipla managing director Y. K. Hamied. This philosophy, combined with technical expertise, must have been the reason that the Indian Council for Medical Research suggested to Cipla in 1990 that the AIDS drug Zidovudine be produced locally.

Due to the state investing its limited means in prevention, the market remained small. In India, approximately US$ 2 million is turned over yearly for AIDS drugs. Of this, Cipla has a share of about 80 percent. This is only a small percentage of Cipla’s total turnover of more than US$ 210 million. Indian Pharma industry is very interested in the export of its pharmaceutics. Developing countries are an important market for Indian manufacturers because they produce high quality products at very competitive prices. But free trade is hampered by national and international patent rules.

For a patent does not only constitute the sole right to produce a product but also to import it. Despite these barriers, India’s drug exports exceeded in the year 2000 for the first time US$ 1. 5 billion. The success story of the pharmaceutical sector is part of a wider but less known “economic miracle”: India achieved average rates of economic growth for the last 20 years of six percent annually. Major Pharmaceutical Companies in India: 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. Injections, tablets, capsule; syrups are the products of Pharma companies in India.

Looking back into history reveals that it was in 1930 when the first pharmaceutical company in India came into existence in Kolkata. 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 pattern 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. Top 10 Pharmaceutical Companies in India |Rank |Company Name |Turnover Amount |Remarks | |1. |Ranbaxy |4198. 96 | | |2. |Dr. Reddy Lab. |4162. 25 | | |3. |Cipla |3763. 72 | | |4. |Sun Pharma |2463. 9 | | |5. |Lupin labs |2215. 52 | | |6. |Aurobindo Pharma |2080. 19 | | |7. |Galxo Smithkline |1773. 41 | | |8. |Cadila Healthcare |1613. 00 | | |9. |Aventis |983. 80 | | |10. IPCA Laboratories |980. 84 | | COMPANY PROFILE Medley is a global pharmaceutical company operating since 1969 from Mumbai, India. Since launch, the company consolidated its position with a strong marketing infrastructure. In the year 1976, a formulation plant with modern facility was set up at Aurangabad followed by a couple of units placed at Daman and Jammu. Medley has state of the art facilities maintaining high quality standards at every further stage in manufacturing process with strict adherence to the Good Manufacturing Practices.

Medley Pharmaceuticals Limited is a multidivisional and multi location organization with strong presence in Pharmaceutical formulations. The specialties include Hematinics, Anti ulcerants, Anti bacterial, Pain management, Gynecology & cardiovascular drugs. We specialize in Iron preparations, our mega brand being R. B. Tone Syrup. We also have many 1st time in India brands to our credit like Dompan (Domperidone & Pantoprazole), O2 (Ornidazole & Ofloxacin), Tazocef (Tazobactum & ceftriaxone) & Osmium K2 (1st brand of Vitamin K27 combination in India)

Medley ranks amongst the top 40 pharmaceutical companies in India as per ORG IMS. Medley believes that quality is a continuous process and not an isolated stage in the process. They have an extensive distribution network across the country with 5 Depots, 17 C/Fs & over 1500 Stockiest which caters to the retailers. Research & Development The inbuilt quality of products is assured through scientific way of product development at R&D scale, transfer of technology from lab scale to mass production, analytical method development, stability studies and process validation.

Our current thrust is towards development of innovative dosage forms in the areas of tablets, syrups, aerosols & other types of herbal formulations found in India. We believe that only through integrity one can provide the best medicine to patients whose well being is valued the most as per the company perspective. Medley has established state of the art R&D centers at Daman and Mumbai equipped with the latest ultra modern instruments. These R&D centers have highly experienced team of scientists having post graduate & doctorate degrees in the field of pharmacy & chemistry.

The R&D centre established at Daman has received approval of Department of Science and Technology, Govt. of India in 2006. WORLDWIDE OPERATIONS [pic] Medley has set its eyes on becoming a truly global pharmaceutical company over the next decade. Medley’s products reach 26 countries with significant presence in Asia, Africa, Middle East, Russia and CIS Medley intend to enhance its International presence based on its policy of “Integrity in Medicines” and quality of products. Medley already has setup the office in UK and tied up with partner in USA and SA.

Medley is aggressively working on finalizing its business tie-ups in Brazil. Medley has dynamic team and representative office in Vietnam, Myanmar, Cambodia, Sri Lanka, Kenya, Russia and Kazakhstan. The dynamic field force promotes its specialty formulations. Around 514 formulations are registered in 26 countries. Today International business contributes 12% of Medley sales, but expected to grow substantially in the next three years. We have three manufacturing facilities, two at Daman and one at Jammu which strictly follows WHO GMP guidelines.

All our manufacturing facilities are the state of art manufacturing units for oral and liquid section. The Daman Facility is MHRA-UK approved. One of our facilities at DAMAN is certified for Good Manufacturing Practices (GMP) Conforming to INTERNATIONAL STANDARDS by Competent Regulatory Authorities in Uganda, Sudan, Tanzania, Malawi, Ethiopia, and Yemen. Medley is now preparing for the South Africa. This initiative of Medley would help strive for the growth and to serve the world community. COLLABORATION Collaboration is Key to Our Success:-

Collaboration, cooperation and partnership are the keys to our success. We are committed to working with our corporate partners to offer our research, development, regulatory, manufacturing, marketing and sales expertise. Identifying good partners and managing long-term relationships is part of our company philosophy. Contract Manufacturing Why Medley for Contract Manufacturing? Medley understands the outsourcing requirements of its customers and transforms their needs into solutions. The pharmaceutical industry today is acing challenging business environment due to escalating R and manufacturing costs as well as delays in bringing new drugs to market. Other key factors impacting the industry include: • Ever increasing demands to deliver lower cost of goods & improve customer supply performance • Greater product complexity • Ongoing regulatory compliance demands By using our contract manufacturing services you can access Medley’s comprehensive technology portfolio for pharmaceuticals and the competence we have built up over decades.

Knowledge, modern technology and creativity combined with clear and well-defined communication procedures between our teams of experts and customers & above all consistency, world class quality & delivery ahead of time are the key factors for achieving optimum solutions that will surely exceed your expectations. Complete confidentiality and protection of client intellectual property is the heart of the Medley culture. In-Licensing We look at partnering and collaborating as an important strategic approach that will complement our growth in India and international markets.

We believe in brand building & are leaders in various therapeutic segments with 3 brands featuring in top 300 (IMS-Health). Our extensive distribution network with more than 1500 stockist’s, 6 depots & 16 C&F’s backed by 40 years of marketing experience & strong field force of over 1500 representatives enables us to achieve the leadership position in various therapeutic segments. We use collective experiences and resources that have been proven to work at the highest levels of efficiency to help brands better succeed.

Our core areas of marketing expertise include the gastroenterology, cardiovascular, dialectology, gynecology & Orthopedic therapy areas. We seek to establish a long term, mutually rewarding relationship based on exclusive marketing rights business model, as well as co-marketing or strategic alliances for co-development including clinical trials of products for necessary regulatory approvals. Out-Licensing Our formulation development expertise enables us to develop generic products which are bioequivalent. We seek out-licensing opportunities for our generic formulations for global markets.

Our Global Services • Formulation development • Contract manufacturing of generic formulations for European market • Analytical method development and validation • Extensive QC capabilities (Micro, Chemical, ICH Stability) • Packaging and shipping Company vision [pic] MILESTONES 1. First manufacturing operation in Aurangabad in 1976 for tablets, capsules and liquid orals. 2. Second unit established in 1992 at Daman for liquid orals. 3. Third unit at Daman established in 1998 for tablets and capsules which was later dedicated to Cephalosporin formulations. 4.

Fourth unit established at Daman in 2000 for large volume liquid orals. 5. Fifth unit established at Daman in 2002 for tablets and capsules complying with international regulatory requirements. 6. Medley was accredited as ISO – 9001:2000 companies during the year 2003, by American Quality Assessors (AQA). 7. Largest Brand R. B. Tone is number 2 in haematinic segment as per ORG-IMS. Brand O2 launched in 2005 is number 1 in the anti diarrhoeal segment as per ORG-IMS. 8. A large manufacturing complex in Jammu in 2005 spread over 12. 5 acres of land. 9. State of the art R&D centres established at Daman which has eceived approval of Department of Science and Technology, Govt. of India in 2006. 10. Medley received the well deserved accolade “WHO GMP Certificate”. INFRASTRUCTURE Daman Plant:- The plant is located on plot No. 18 & 19, Zari causeway road, Kachigam, Daman. This facility is located about 5 km away from Vapi railway station & about 179 km from Mumbai. The plot size is 7602 sq. mtrs, and the construction area is 7335 sq. mtrs. It has dedicated and segregated areas meeting current CGMP requirements for manufacturing of oral dosage forms – Tablets, Capsules & Liquid orals.

Adequate areas for storage of Raw materials, Packing materials & finished products has been provided. The manufacturing capacity per annum in single shift is 5100 lac Tablets & capsules and 46 lac litres of liquid orals. The facility is WHO GMP and Schedule M GMP certified by the Indian FDA. The facility is also approved by National Drug Authority of Uganda, MOH Sudan, Tanzania, Malawi and Yemen. The Facility is MHRA-UK approved and scheduled for other highly regulated agencies MCC-SA and WHO-Geneva. Jammu Plant:- The plant is located at Lane-3, Phase I, SIDCO complex, Bari Brahman, Jammu.

This facility is about 20 Kms away from the Jammu Airport. The plot size is 53115 sq. meter and total construction area is 15981 sq. meter. It has dedicated and segregated areas meeting current CGMP requirements for manufacturing of oral dosage forms – Tablets, Capsules & Liquid orals. Adequate areas for storage of Raw materials, Packing materials & finished products has been provided. The manufacturing capacity per annum in single shift is 8040 lac Tablets and capsules and 31. 80 lac liters of liquid orals. COMPANY PRODUCTS SUPRAKARE

Suprakare is the 2nd biggest division of Medley catering mainly to Orthopaedic & Gastroenterology segments. It is also the fastest growing division of Medley & has one of the most innovative and first time launches in the Indian Pharmaceutical Market like DOMPAN (Domperidone plus pantoprazole), Ostium K2 (1st brand of Vitamin K27 combination in India), Tazocef (Tazobactam plus Ceftriaxone), Acenac-N (Aceclofenac plus Pregabalin) to name a few. Today, all of them feature amongst the top 5 brands in their respective segments. Product table: Analgesic & |Analgesic & |Muscle Relaxant |Anti-Osteoporotic |Antibiotics |Digestive enzymes | |Anti-inflammatory |Antipyretic | | | | | |Acenac-P |Nimsaid-P |Colchico 4/8 Mg |Ostium K2 |Cefo L 50/100/200 |Xymex Syrup | |Acenac-SR |Nimsaid-P125/250 |Acenac-MR/Mr8 |Ostium K2 Forte |Cefo L Rediuse |Xymex MPS Tablets | | |Suspension | | | | | |Acenac-N | | | |Cefo LX 100 |Xymex Drops | |Eezflam | | | |Cefo LX 200 | | |Eezflam forte | | | |Tazocef 1. 125 | | NUTRAKARE

NUTRAKARE, A division of Medley Pharmaceutical is thriving since a decade and is by far the largest division of the company. Division is achieving newer heights through unique formulations & innovative ideas. Nutracare is the pioneer in Gynecology and Anti infective Segments and is known for the brands R. B Tone and O2 (First time launched in India) This features among the Top 300 Brands of Pharmaceutical Industry according to IMS ORG. • O2 Tab is ranked 1st in its category in the Ofloxacin and Ornidazole Market • O2 Suspension is ranked 2nd in its category in the Ofloxacin and Ornidazole Market • R. B Tone is ranked 3rd in the Liquid Iron Market. Product table: Haematinics |Antibiotic Anti |Anti-ulcerants |Hepatoprotective |Antibiotics |Anti-Cold | | |diarrhoeal | | | | | |R. B. Tone Syrup |O2 Tablets |Domrab |Trisoliv Syrup |Kefodime 50/100 DT |Oncet-CF Tablets | |R. B. Tone Capsules |O2H Tablets | | |Kefodime 200 |Oncet-CF Syrup | |R. B. Tone Forte |O2 Suspension | | |Kefodime Dry Syrup | | |R. B.

Tone Drops |O2 Infusion | | |Ofoxin 200/400 | | |R. B. Tone Injection | | | |Ofoxin Suspension | | VAZOKARE Vazokare Division is catering into Life Style Segments – Cardiology and Dialectology. The division manufactures and markets the quality brands with the ultimate goal of delivering maximum possible benefits to all its customers. It also strives at its best in offering the premium quality medicines at the most economical price, thus serving the society. Vazokare proves its belief in innovation by launching the India’s first and only Glyceryl Trinitrate Spray in pen form.

Our mission is to give access to the best healthcare products at the most affordable price. Product table: |Anti hypertensive |Anti-Anginal |Lipid Lowering |Anti-Diabetic |Drugs for neuropathy |Multivitamin | | | |Agent | | | | |Betabest XL 25/50 |GTN Pen |Atorin 5/10/20/40 |Gepride M1 |Mecobion P 75/150 |Mecobion OD | |Betabest AM 25 |GTN Spray |Atorin EZ |Gepride M1 |Mecobion OD | | |Encardil 2. /5/10 | |Atorin-F |Glucozid | | | |Telmed AM | | |Glucozid-M | | | |Nevol 2. 5/5 | | |Trizem 1/2 | | | NANOKARE It is the newest addition in the array of SBUs of Medley Pharmaceuticals. The Division is exploring the untapped potential to create newer horizons for the company. Medley’s entry into the rural market is driven by the fact that we have a vast range of products which address disease conditions and health problems widely prevalent in rural areas.

The division covers a realm of products in various therapeutic segments like anti-infective, Hematinics, anti diarrhoeal, anti ulcerants, calcium supplementation, anti cold. The Division currently is operating in Maharashtra & Madhya Pradesh, but soon has vision of spreading its tentacles pan India. Product table: |Haematinics |Analgesic and |Antibiotic |Anti-Ulecerants |Antibiotics |Multivitamin | | |Antipyretic |Antidiarrhoeal | | | | |R. B. Tone Syrup |Nimsaid-P |O2 Tablets |Dompan |Azirite 250/500 |Vistamina Tablets | |R. B.

Tone Capsules |Nimsaid-P125/250 |O2H Tablets |Dompan OD |Azirite Suspension | | | |Suspension | | | | | | | |O2 Suspension | |Ofoxin 200/400 | | | | |O2 Infusion | |Cefo Suspension | | | | | | |Cefo LX 200 | | ZENKARE Within a short span of time division has made a good presence in Generic market. In Zenkare, at present, range of 300 products is available in various therapeutic segments. Introduction of new products will be done timely as per the market demand. COMPETITORS Mankind Pharma Mankind Pharma, the 8th largest Pharmaceutical Company of India, was incepted in 1995 with a meager capital of? ?50 lakhs and 20 employees.

Today, we are amongst the top 5 fastest growing Pharmaceutical companies of India with an employee base of more than 9000 and heading towards a turnover of  [pic] 2500 crores. We aspire to aid the community in leading a healthy life through two parallel objectives: formulating, developing & commercializing medicines and delivering affordable & accessible medication that satisfies urgent medical needs. Mankind is a fully integrated pharmaceutical company, with a comprehensive network of 62 C agents & 6000 Stockiest. With a pan India presence, our offerings span in Antibiotics, Antifungals, Gastrointestinals, NSAIDs, Anthelmintics, Cardiovascular, Dermal and Erectile Dysfunction categories.

Our strong portfolio of businesses, geographies and products ranging from Pharma to popular OTC & FMCG brands – Unwanted72, PregaNews, Kustody, Adiction, Gas-O-Fast, Manforce Condoms and Kaloree1 provide us the strategic benefits of integration that allow us to perform best in an increasingly competitive market. With the thrust of making headway, in 2007 Mankind acquired Magnet Labs Pvt. Ltd. and marked its marketing presence in antipsychotic segment. In January 2010, Mankind acquired Longifene, the former brand of UCB Belgium. We are further expanding the horizon of Serving Life in Vietnam Philippines, Myanmar and other regulated and semi-regulated markets by 2015.

Today, after those tentative first steps, Mankind’s voyage is not only going strong but radiating new standards and that miniscule initial investment has grown by giant strides to crores of rupees in wealth for Mankind’s stakeholders. Having succeeded in garnering the trust of all, Mankind will continue to dream big on its path of novelty and eminence and millions of consumers will relish the results with contentment thereafter. Our Mission “To support a healthy & active lifestyle through our broad portfolio of Pharma, OTC & FMCG products” Our Vision “To be the No. 1 Pharma Company of India by 2015” 1. Mankind Pharma 2. Discovery Mankind 3. Life star Pharma 4. Special Mankind 5. Future Mankind 6.

Magnet Labs Ranbaxy Pharma Ranbaxy Laboratories Limited (Ranbaxy), India’s largest pharmaceutical company, is an integrated, research based, international pharmaceutical company, producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy today has a presence in 23 of the top 25 pharmaceutical markets of the world. The company has a global footprint in 43 countries, world-class manufacturing facilities in 8 countries and serves customers in 125. In June 2008, Ranbaxy entered into an alliance with one of the largest Japanese innovator companies, Daiichi Sankyo Company Ltd. to create an innovator and generic pharmaceutical powerhouse. The combined entity now ranks among the top 20 pharmaceutical companies, globally. The transformational deal will place Ranbaxy in a higher growth trajectory and it will emerge stronger in terms of its global reach and in its capabilities in drug development and manufacturing. Ranbaxy was incorporated in 1961 and went public in 1973. | | | Mission: Ranbaxy’s mission is ‘enriching lives globally, with quality and affordable pharmaceuticals’. Financials: For the year 2011, the company recorded Global Sales of US $ 2. 1 Bn. The Company have a balanced mix of revenues from emerging and developed markets hat contribute 47% and 46% respectively. In 2011, North America, the company’s largest market contributed sales of US $ 791 Mn, Europe contributing US $ 297 Mn and Asia clocking sales. Strategy: Ranbaxy is focused on increasing the momentum in the generics business in its key markets through organic and inorganic growth routes. Growth is well spread across geographies with focus on developed and emerging markets. It is the company’s constant Endeavour to provide a wide basket of generic and innovator products, leveraging the unique Hybrid Business Model with Daiichi Sankyo. In Japan, Daiichi Sankyo Espha Co. , Ltd. (DS Espha) will market generic drugs.

As part of the Hybrid Business Model, Daiichi Sankyo will utilize Ranbaxy’s strong manufacturing capabilities and expertise in developing generic medicines for the Japan and market them. The company will also increasingly focus in high growth potential segments like Vaccines and Biosimilars. These new areas will add significant depth to the existing product pipeline. R: Ranbaxy views its R capabilities as a vital component of its business strategy that will provide a sustainable, long-term competitive advantage. The company has a pool of over 1000 R scientists engaged in path-breaking research. Ranbaxy is among the few Indian pharmaceutical companies in India to have started its research program in the late 70’s, in support of its global ambitions. A first-of-its-kind world class R&D centre was commissioned in 1994.

Today, the company has multi-disciplinary R&D centers at Gurgaon, in India, with dedicated facilities for generics research and innovative research. The R&D environment reflects its commitment to be a leader in the generics space offering value added formulations and development of NDA/ANDAs, based on its Novel Drug Delivery System (NDDS) research capability. Ranbaxy’s first significant international success using the NDDS technology platform came in September 1999, when the company out-licensed its first once-a-day formulation. Ranbaxy has developed the anti-malarial new drug, arterolane maleate + piperaquine phosphate that has been approved by the Indian Drug Regulator, Drug Controller General of India (DCGI) for manufacturing and marketing in India.

In April 2012, the company launched India’s first new drug, Synriam TM, for the treatment of uncomplicated Plasmodium falciparum malaria, in adults. Within Ranbaxy, there is a sharper focus on R&D of Generics, as the company is increasingly working on more complex and specialist areas. People: The Company’s business philosophy based on delivering value to its stakeholders constantly inspires its people to innovate, achieve excellence and set new global benchmarks. Driven by the passion of it’s over 14,000 strong multicultural work force comprising of more than 50 nationalities, Ranbaxy continues to aggressively pursue its mission of ‘Enriching lives globally, with quality and affordable pharmaceuticals’. Piramal Pharma

Piramal Enterprises is the flagship company of the Piramal Group and is a world leader in its various business verticals. It has a global footprint of over 100 countries, manufacturing bases in USA, Great Britain, Sri Lanka, China and Canada and a diversified workforce representing the Piramal Group’s diversified global portfolio. Recently, the UN Conference on Trade and Development’s World Investment Report 2011 ranked Piramal Enterprises CMO (contract manufacturing) business vertical as number five in the top 10 pharmaceutical contract manufacturers worldwide; and was awarded the number one position amongst all Indian CMOs. Drug discovery and research is an important part of the business.

Piramal Enterprises aspires to be the first Indian company to discover, develop and launch its own NCE drug in the global market and has made steady progress towards that goal. The company has more than 115 issued patents and 395 pending patent applications in several countries. The patents and pending applications cover a wide variety of areas across multiple discovery and development programs including compositions of matter (NCEs and natural products), methods of treatment, biomarkers, diagnostics, pharmaceutical compositions, drug delivery systems, etc. Healthcare Information Management: In May 2012, Piramal Enterprises Ltd acquired Decision Resources Group (DRG), a US based company, which is an independent provider of decision support tools, analytics and research for the global healthcare industry.

Considered to offer the “Gold Standard” in analysis according to many of its clients, DRG provides web-enabled insights and predictive analytics via a variety of high value reports, databases, tools and advisory services to the global bio-pharmaceutical, managed care and med-tech industries. DRG is focused on three main market segments: (1) The Bio Pharma business unit provides reports, databases and advisory services on drug utilization trends and forecasting in a variety of therapeutic areas; (2) The Market Access business provides database and analytical services that healthcare companies use to assess the current and future opportunity of their products’ acceptance into a market. (3) The Medical Technology business provides actionable insights and data on the medical device markets.

Headquartered outside of Boston, DRG has a global presence with offices in Belgium, Canada, England and Japan. Indiareit is the real estate equity funding arm. It the largest Reit fund by AUM (assets under management) in India i. e. Rs 3800 crore by June, 2011. It has domestic and offshore funds, and has recently raised funds from UK, Singapore and Dubai. PHL Finance Pvt Ltd. is the non-banking financial company (NBFC) that has recently formed to look into funding of real estate and infrastructure projects. Cipla Pharma Cipla was established in 1935 with the vision of making India self-reliant and self-sufficient in healthcare. Today, we are one of the world’s largest generic pharmaceutical companies with a presence in over 170 countries.

We are renowned for making affordable, world-class medicines that meet the needs of patients across therapies. We also offer services like consulting, commissioning, plant engineering, technical know-how transfer and support. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds. To the medical fraternity, caring means the assurance of world-class medicines and support across multiple therapeutic areas.

For business partners, caring brings the confidence of always getting world-class quality and competitive prices. For employees, caring manifests itself in a safe, equal-opportunities’ workplace that fosters innovation for a healthier world. History: Cipla’s journey began in 1935 when our founder, Dr. K. A. Hamied, set up an enterprise with the vision to make India self-sufficient in healthcare. Over the past 77 years, we have emerged as one of the world’s most respected pharmaceutical names, not just in India but worldwide. We have 34 state-of-the-art manufacturing facilities that make Active Pharmaceutical Ingredients (APIs) and formulations, which have been approved by major international Regulatory Agencies.

We have over 2000 products in 65 therapeutic categories; with over 40 dosage forms, covering a wide spectrum of diseases ranging from communicable, non-communicable, common and emerging diseases to even rare diseases. Our Research and Development (R&D) centre is focused on developing innovative products and drug delivery systems, giving the country and the world many ‘Firsts’. Today, we are one of the world’s largest generic pharmaceutical companies with a strong presence in over 170 countries. We maintain world-class quality across all our products and services. Whether it’s for millions or for just a few hundreds, our journey to care for all humanity continues. Milestones: 1. In 1935, our founder, Dr. K. A. Hamied set up Cipla to make India self-reliant in healthcare. 2.

In 1939, Mahatma Gandhi visited Cipla and inspired our founder to make essential medicines for the country, and strive for self-sufficiency. During World War II, when India was dependent on imported medicines and there was an alarming shortage of life-saving drugs, we manufactured them for the country. 3. In the 1960s, we pioneered API manufacturing in the country and helped lay the foundation for the bulk drug industry in India. 4. In 1970, we spearheaded the New Patent Law by which an Indian pharmaceutical company was allowed to manufacture a patented product as long as the process to manufacture it was changed. This enabled Indian companies for the first time to manufacture any medicines and make them available and ffordable for all Indians. 5. In 1978, we pioneered inhalation therapy in India with the manufacture of Metered-Dose Inhaler (MDI), at a time when the country stopped receiving imported supplies. Today, we have the world’s largest range of inhaled medication and devices. 6. In 1994, we launched Deferiprone, the world’s first oral iron chelator which revolutionized the treatment for thalassemia. For the first time patients with thalassemia had an option that was affordable, painless and convenient. 7. In 1996, we gave the world the first transparent dry powder inhaler which was so simple and easy to use, it changed the face of inhalation therapy in India. 8.

In 2001, we pioneered the access to HIV treatment by making antiretrovirals (ARVs) available at less than a ‘Dollar a Day’. The cost of treatment dramatically fell from $12,000 per patient per year to $300 per patient per year. This caused a revolution where HIV treatment became a reality for the world and millions of lives could be saved. 9. During the 2005 Bird Flu epidemic, we produced an anti-flu drug within a period of 2-3 months, which would have normally taken at least 3 years to develop. 10. In 2012, we made a breakthrough in reducing the prices of cancer drugs, thus making world-class medicines affordable and accessible to cancer patients. THE SEVEN WORST MISTAKES IN PHARMA LAUNCH (AND SECRETS TO AVOID THEM)

In today’s Pharma environment, the product launch period has become critical. To set up a pattern for long-term sales and profits, products must make a big splash upon their introduction. But making this happen is a process that can be filled with uncertainty, confusion and frustration. Mistakes can set back years of effort and millions of dollars in expenses. Understanding the biggest mistakes Pharma marketers can make during launch can help savvy leaders prevent catastrophes, and plot a clear path towards profit. What are the biggest mistakes Pharma marketers make during pre-launch planning, and how can they be avoided? 1. Focusing on Product, Forgetting Everything Else:

Sure, a big part of launching a drug revolves around the drug itself – developing the chemical composition, submitting the drug for approval, ensuring formulary positioning, and more all focus on the physical product. But often lost in the mix is the customer and market. Long before a product is complete and ready for sale, you need a deep understanding of your customers and the market you are targeting. That means understanding, in-depth, some key points: ? The disease you are treating, including standards of care for that therapeutic area ? The people it affects. ? The needs of patients with the disease ? The needs of physicians treating these patients ? Key opinion leaders and professional associations in the therapeutic area ? Trends in patient access, managed care acceptance and reimbursement in the disease area Key regulatory milestones and requirements affecting the disease and the product To further know your market, you must also understand your product in terms of the competition that already exists, and that which is likely to develop before and after launch. Knowing how your product will stack up against other players in the marketplace points toward the true benefits of your drug for customers. Pre-launch planning should include some tough questions: ? How is your product better than the pharmaceuticals and intervention that already exist? ? How can an average customer, payer, physician or pharmacist differentiate between your product and its competition? How will the product provide benefit that is different than other Pharma offerings? ? How will your competitors respond to your market entry? ? How will the competitive landscape change over time? Is this area going to explode with entries? Will generics infiltrate soon? 2. Working with the Wrong Team: A good product is important. But just as, if not more, important is the team guiding that product to market, and pushing it towards success. Instrumental in developing, marketing and selling the Pharma product is a team that boasts knowledge, experience and skills. Choosing this team is a delicate endeavor, and should combine leaders from all pay grades and units.

While product managers, marketing directors and managers are often the go-to team members, chosen for their titles, successful product launches need a team with creativity, problem-solving ability and persistence, skills that can transcend titles. Businesses should therefore build launch teams based on experience and talent for the unique process of launch. 3. Working in Silos: For effective pre-launch planning, company departments must work together. Why is cross-functional work necessary for successful pre-launches? Consider product research and development, which can often take place in a vacuum. With a cross-functional team, R&D can learn the concerns and needs of marketers, incorporating new research points that can be instrumental in later positioning and sales.

Of course, collaboration on this level can be a daunting prospect for Pharma companies, long organized by silos and strict division of tasks. Cross-functional collaboration is the pinnacle of marketing and pharmaceutical hopes, but what often happens in implementation is a crash and burn. Breaking the idea down into tactical steps, however, can ease the process from the very beginning: ? Establish and gather the pre-launch cross-functional team, including R&D, medical and regulatory affairs, and other divisions of importance. For this team of leaders from these departments, the need to differentiate the ultimate product and create value must be explicitly stressed. ? Provide clear objectives for the team, as well as clearly assigned responsibilities.

Everyone must understand his or her role in developing and capturing the product value. ? As key activities take place, particularly market research, review all findings with the team. ? Brainstorm and determine the needs of customers in the target area, including what is meaningful and valuable to physicians, patients and payers. ? Develop options for creating and demonstrating value to the customer base. Together, the team must brainstorm options, anticipating regulatory requirements, clinical development needs and marketing potential. Consider options also in terms of managed care organizations’ perspectives, and how the company can alleviate any concerns. One collaborative partnership that is especially important to launch is that between marketing and sales. Most marketing communications people don’t have a direct relationship with their sellers, and don’t understand the realities that the sellers face in everyday sales situations. Cooperative launch planning can ensure that the sales team has the pre-launch education to get new products off to a big bang, and all the materials and information they need to address target questions. 4. Rushing Launch: Everyone wants the competitive advantages of being first to the market, or first to address a unique need. But rushing product launch can come at the expense of long-term success.

In attempts to speed along launch, many companies give short shrift to critical areas, and don’t try to accelerate more appropriate areas. The most-commonly skipped steps in a time crunch include primary research, business case development and cross-functional coordination, all of them crucial in best serving the market and customers. Companies can also neglect to devote enough time to marketing and sales tactics, brand positioning, pricing, operational support and other key decisions. Due diligence is essential in these areas, and can be tightly project-managed without losing time. An area that can be sped up rather easily, however, is one that many companies don’t think about.

By investing more attention and energy into initial regulatory approval, and obtaining that approval as quickly, efficiently and comprehensively as possible, far greater value can be earned over a products life. Several regulatory means exist through which companies can look to accelerate market arrival. ? Priority Review: It offers an abbreviated priority review process for specific products that can demonstrate a key point: they serve a specific and notable unmet medical need. ? Orphan Drugs: This program offer market exclusivity for the drugs for rare diseases, but this period is offered only to the drug that receives market approval first.

Applications for these orphan drugs are given greater levels of support and feedback from regulators, meaning approvals are accelerated. 5. Failure to Track, Assess and Learn: Launching a new product can be a very educational experience for all those involved. But without the means of measuring success, tracking activities, and learning from mistakes, all the lessons of launch can be forgotten, creating a missed opportunity to improve future launches. Companies should take advantage of credible metrics to measure success during the pre-launch period, and participate in a post-launch review. Companies can strengthen their processes, and set themselves up for future successes. 6. Using a One-Size-Fits-All Approach: Consistency is a critical business practice.

But many companies can take this desire overboard, fitting every new product into the same mold, and eliminating the creativity and uniqueness of each product. One way to resist the cookie-cutter approach, and create a product that can be in it for long haul, is lifecycle management. The key to better, customized product success far into the lifecycle is considering these types of strategies early, even in pre-launch. Product lifecycle management means more than plotting a counter-attack against generics. A true product lifecycle strategy is focused on maximizing the profitability of a product over its life. There are several ways to do this, and they figure prominently in the pre-launch period. Be Proactive. Start early, plan ahead, and prepare for any and all scenarios that will arise during a products life. ? Organize. Set up the cross-functional teams that will enable a comprehensive perspective and approach, whether or not these are official Lifecycle Management teams. Establish clear ownership and accountability for key actions, and defined lines of authority. More than anything, the team must include members that have the actual power and skills to drive action forward and make any necessary changes. ? Franchise Make plans for your specific product, but also consider the possibilities for further expanding into the therapeutic area.

A therapy franchise dominates this area through complementary products, and can be accomplished through solo efforts or licensing partnerships. ? Expand. Plan for current uses of the product, but also never stop thinking about the future uses and areas to expand into. ? Reformulate. Choose the best form of delivery that makes sense in today’s environment, but set the groundwork for new innovations. Scientists are advancing the art of formulation every day, so keep aware and keep focus on newer, patient-friendly methods of administration. Reformulation down the line is an important way of expanding a drugs usefulness and audience. ? Protect. Through the pre-launch period, the focus should be on speeding the product to approval to leverage the amount of patent exclusivity.

During a products lifecycle, the team must study all regulatory trends and methods of maintaining patent protection. Prolonging the time before generic competition is an essential means of protecting the time and energy put into drug production. ? Switch. Think a successful OTC switch will be just the key for protection years down the line? Not without extensive planning that reaches back into the pre-launch period. Some experts contend the switch should be planned while the drug is still in clinical trials, and at a minimum of seven or eight years before action. ? Shut Down. Think you shouldn’t even consider the end of the line when you’re in pre-launch?

Think again. Exit strategies should be planned and plotted. Far too often a product is allowed to limp along in its latter years, consuming valuable organizational and financial resources. Consider the long-term and the potential scenarios for actively managing the end-of-life phase, and pinpoint the cutoff point for when the product no longer delivers value. 7. Missing Out on the Secret Weapon of Analytics: No matter how much you plan ahead, new drug development is inherently risky in today’s environment. Increasingly, Pharma managers and marketers need a way to assess the potential of new products, and the likelihood of success upon launch.

Analytics models can provide insight on what drives your target consumers, and help predict actual launch results. The Eularis Pre-Launch Analytics Systems, for example, have been implemented and worked successfully during both pre-launch and launch of numerous pharmaceutical brands. Due to effective pre-launch analytics and planning that created strong preparation for a successful launch, these products continue to be category leaders. For anyone involved in the pre-launch and lifecycle management of the product, analytics will provide significant assistance through the myriad problems and challenges that comes in this task. SWOT ANALYSIS OF MEDLEY PHARMA Strengths: 1.

Strong growth in emerging market business in Suprakare division. 2. Introduction of Caramel & Zinc salt in Nutracare market that has very limited competition. 3. Co-operative and Experienced Sales team. 4. Price policy as compare to Competitors. 5. Brand value of Medley Pharma. Weakness 1. Limited presence in Indian market. 2. Weak in delivering new products in short time. 3. Lack of motivation factor among MR’s & distribution team. Opportunity 1. Capture the untapped Market 2. Can Increase their share in contract manufacturing. 3. Can improve the commission based dissatisfaction among sales team. 4. Can work on promoting brand in remote areas too. 5.

Can also work on Generic market division too which is yet to launched. Threat 1. Stiff competition from many Indian and other global brands means limited market share growth. 2. Better range of new products by competitors’ at rapid speed. 3. High price & quality sensitivity of consumers. 4. Stringent patent regulations. CHAPTER: 2 RESEARCH METHODLOGY & OBJECTIVES OBJECTIVES OF THE STUDY 1. To study the possible hurdles for launching a new Pharma products. 2. To study the different competitors of Medley Pharma. 3. To study the brand value of Medley Pharma in market. 4. To study the perception and satisfaction level among Doctor’s & Druggists towards Medley Pharma. SIGNIFICANCE OF THE STUDY This research is helpful for the Medley Pharma in understanding the buying preferences of the Distributors with regard to: a) Price b) Quality c) Sales Commission ? This research is helpful for the Medley Pharma in understanding the role of the Advertising in establishing the market of the product. ? This research also helpful for Medley Pharma to improve their Distribution model. RESEARCH METHODOLOGY Research methodology is a way to systematically solve the researcher’s problem or it may be understood as a science of studying how research is done scientifically. It defines various steps that are adopted by a researcher in studying his research problem along with logic behind them. ? Steps to be followed for Research process:- ? SAMPLING AND SAMPLE DESIGN:- SAMPLING:

Sampling can be defined as the selection of some part of an aggregate or totality on the basis of which a judgment or inference about the aggregate or totality is made. In other words it is the process of obtaining information about an entire population by examining only a part of it. The process of sampling is used for various reasons- ? Sampling saves time and money. It is usually less expensive and produces results at faster speed. ? It provides more accurate information. ? It enables to estimate the sampling errors and thus assists in obtaining information concerning characteristics of population. ? It also enables greater speed of collection of data. The ultimate test of sample design is how well it represents the characteristics of the population it purports to represent.

In measurement terms the sample must be valid which depends upon – ? Accuracy – It is the degree to which biasness is absent from the sample. ? Precision – It represents how well the sample represents the population in all respect. SAMPLE DESIGN: A sample design is a definite plan for obtaining a sample from the sampling frame. It refers to the technique or the procedure that is adopted in selecting the sampling units from which inferences about the population is drawn. Sampling design is determined before the collection of the data. Several decisions have to be taken in context to the decision about the appropriate sample selection so that accurate data is obtained and efficient results are drawn.

Following questions have to be considered while sampling design:- ? What is the relevant population? ? What is the sampling frame? ? What is the type of sample? ? What sample size is needed? Sample Size: It indicates the number of individual who would be surveyed. Here the sample size is 102. Respondents: Doctors, Distributors, Retailers & Medical representatives of Medley Pharma. METHODOLOGY We were supposed to operate from Medley Pharmaceuticals Ambala Division. We were made aware about all the products Medley was providing with a more stress on their core product Division i. e. Nutracare. Methodology – (OTJ-On the job) Methodology of the project starts with – In the first phase we are trained and they teach us different things about market. ? They provide the database of Distribution channel. ? Then after that we have to provide details of product & their USP’s. ? Then we have to visit the point to retrieve the information from the respondents. ? Maintaining records of feedback of respondent’s regular basis. Methodology – (OFTJ-Off the job) Exploratory research is a type of research conducted because a problem has not been clearly defined. Exploratory research helps determine the best research design, data collection method and selection of subjects. Given its fundamental nature, exploratory research often concludes that a perceived problem does not actually exist.

Exploratory research often relies on secondary research such as reviewing available literature and/or data, or qualitative approaches such as informal discussions with consumers, employees, management or competitors, and more formal approaches through in-depth interviews, focus groups, projective methods, case studies or pilot studies. The results of exploratory research are not usually useful for decision making by them, but they can provide significant insight into a given situation. Although the results of qualitative research can give some indication as to the “why”, “how” and “when” something occurs, it cannot tell us “how often” or “how many. ” Exploratory research is not typically generalized to the population at large. Exploratory Research Research is exploratory when you use no earlier model as a basis of your study. The most usual reason for using this approach is that you have no other choice.

Normally you would like to take an earlier theory as a support, but there perhaps is none, or all available models come from wrong contexts. Exploratory research means that hardly anything is known about the matter at the outset of the project. You then have to begin with a rather vague impression of what you should study, and it is also impossible to make a detailed work plan in advance. Analysis in exploratory research is essentially Abstraction and Generalization: Abstraction means that you translate the empirical observations, measurements etc. into concepts; generalization means arranging the material so that it disengages from single persons, occurrences etc. and focus on those structures (in variances) that are common to all or most of the cases.

According to Alasuutari, in qualitative analysis of empirical findings, you can distinguish two phases but these two overlap: • Simplification of observations • Interpretation of results (or “solving the enigma”) In the simplification phase, the material is inspected from the theoretical point of view of the study project, and only the points relevant from this angle are noted. Details differing from

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