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Historical Background and Current Status of Indian Pharmaceutical Industry and Indian Patents Regime

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Abstract

This chapter discusses the historical background and the current status of the Indian pharmaceutical industry and India’s patents regime. First, this chapter presents an analysis of the current global standing of the Indian pharmaceutical industry. Then, it describes some notable features of intellectual property in relation to the pharmaceutical industry, as compared to the Information Technology (IT) industry. Next, it looks at the Indian pharmaceutical industry from the aspects of market share, disease profiles, regulations, and sales profiles. It concludes with a description of the historical background to the Indian regime, including the Indian Patents Act 1970 and the Indian Patents (Amendment) Act 2005.

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References

  1. Kohei Shiino, Basic Data on the Indian Economy: The Current Status and Policies of the New Economic Giant (JETRO, 2009), 8.

    Google Scholar 

  2. World Bank, “Global Economic Prospects, June 2016: Divergences and Risks” (June 2016).

    Google Scholar 

  3. Gulshan Akhtar, “Indian Pharmaceutical Industry: An Overview,” IOSR Journal of Humanities and Social Science 13, no. 3 (Jul.-Aug. 2013): 65.

    Google Scholar 

  4. Takashi Kadokura, “Indian Pharmaceutical Industry Standing on a Turning Point,” Asia Trends (Dai-ichi Life Research Institute, June 2005): 1.

    Google Scholar 

  5. Koji Takeda, “The Indian Pharmaceutical Industry, along with IT, Is Targeting the World Market,” Chap. 74 in The Book of Indian IT (Nihon Keizai Shimbun, 2009).

    Google Scholar 

  6. OECD Health Policy Studies: Pharmaceutical Pricing Policies in a Global Market (OECD Publishing, 2008), 58.

    Google Scholar 

  7. IBEF Website, https://www.ibef.org/industry/pharmaceutical-india.aspx (accessed June 2017).

  8. IBEF Pharmaceuticals (June 2017): 3. https://www.ibef.org/industry/indian-pharmaceuticals-industry-analysis-presentation.

  9. Toshimitsu Kurogi, “Strengths and Weaknesses of Indian Pharmaceutical Companies,” Chap. 14 in The Current Status of Indian Pharmaceutical Industry (Yakuji Nippo, Yakuji Nippo Limited, Sept. 2007).

    Google Scholar 

  10. William Greene, “The Emergence of India’s Pharmaceutical Industry and Implications for the U.S. Generic Drug Market” (Office of Economics working paper, no. 2007-05-A, U.S. International Trade Commission, May 2007): 16.

    Google Scholar 

  11. Office of Pharmaceutical Industry Research (OPIR), “Future Vision of the Pharmaceutical Industry: The Mission and Issues toward 2015” (Japan Pharmaceutical Manufacturers Association [JPMA], 2007): 146.

    Google Scholar 

  12. Japan Generic Medicines Association (news release, Sept. 29, 2016).

    Google Scholar 

  13. IBEF, “Pharmaceuticals” (June. 2017): 11.

    Google Scholar 

  14. Office of Pharmaceutical Industry Research (OPIR), “Current Status of and Issues Surrounding the Pharmaceutical Industry: In Order to Provide Better Medicines” (Japan Pharmaceutical Manufacturers Association [JPMA], 2015): 16.

    Google Scholar 

  15. Office of Pharmaceutical Industry Research (OPIR), “Current Status of and Issues Surrounding the Pharmaceutical Industry: In Order to Provide Better Medicines” (Japan Pharmaceutical Manufacturers Association [JPMA], 2015): 17.

    Google Scholar 

  16. Office of Pharmaceutical Industry Research (OPIR), “Future Vision of the Pharmaceutical Industry: The Mission and Issues toward 2015” (Japan Pharmaceutical Manufacturers Association [JPMA], 2007): 178.

    Google Scholar 

  17. Office of Pharmaceutical Industry Research (OPIR), “Future Vision of the Pharmaceutical Industry: The Mission and Issues toward 2015” (Japan Pharmaceutical Manufacturers Association [JPMA], 2007): 118.

    Google Scholar 

  18. Tata Strategic Management Group, “Asia Business Generator Project: Overview of the Indian Pharmaceutical Industry” (March 2008): 2.

    Google Scholar 

  19. Dr. Reddy’s, “Annual Report,” http://www.drreddys.com/investors/reports-and-filings/annual-reports/.

  20. Lupin, “Annual Report,” http://www.lupinworld.com/archives-annual-report.htm.

  21. Sun Pharma, “Annual Report,” http://www.sunpharma.com/investors/annualreports.

  22. Cipla, “Annual Report,” http://www.cipla.com/en/investor-information/financial-results.html.

  23. “The Current Status of the Indian Pharmaceutical Industry” (research materials, no. 400, The Japan Pharmaceutical Manufacturers Association [JPMA], July 2009): 8.

    Google Scholar 

  24. Kuwashima K. Management of Uncertainty: Solution for Pharmaceutical R&D Management. Nikkei BP. 2006;22

    Google Scholar 

  25. Office of Pharmaceutical Industry Research (OPIR), “Toward Strengthening Competitive Power in the Field of Drug Development: The Current Status and Issues of the Pharmaceutical Industry” (Japan Pharmaceutical Manufacturers Association [JPMA], Nov. 2005): 4.

    Google Scholar 

  26. Hiroyuki Odagiri, Economics of Biotechnology (Toyo Keizai Inc., 2006), 121.

    Google Scholar 

  27. Ministry of Health, Labour and Welfare Website, http://www.mhlw.go.jp/stf/seisakunitsuite/bunya/fukyu1.html.

  28. ClinicalTrials.gov, “A Service of the U.S. National Institutes of Health: Glossary of Common Site Terms,” https://clinicaltrials.gov/ct2/about-studies/glossary#P.

  29. FDA, “FDA Special Consumer Report: Inside Clinical Trials – Testing Medical Products in People,” http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143531.htm.

  30. FDA, “FDA Special Consumer Report: The Beginnings – Laboratory and Animal Studies,” http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143475.htm.

  31. The Japan Pharmaceutical Manufacturers Association (JPMA), Clinical Trial Ruling,http://www.jpma.or.jp/medicine/shinyaku/chiken_02.html.

  32. Hiroshi Akimoto, “R&D Strategy of the Japanese Pharmaceutical Industry and Bio Technology” (presentation material, Path of Bio Innovation and Future Development, Industry-Academy-Govt. Collaboration Workshop, Roppongi Hills, March 10, 2009): 43.

    Google Scholar 

  33. Clinical Trial Navi Website, “Patent Term Extension,” http://www.chikennavi.net/word/tokkyokikan.htm.

  34. Japanese Patent Act [Art. 67 (2)], Ministry of Justice Website, http://www.japaneselawtranslation.go.jp/law/detail/?printID=&ft=1&co=01&x=32&y=19&ky=%E7%89%B9%E8%A8%B1%E6%B3%95&page=10&id=42&lvm=&re=02&vm=02.

  35. IBEF, “Pharmaceuticals” (June. 2017): 13.

    Google Scholar 

  36. IBEF, “Pharmaceuticals” (Jan. 2017): 5.

    Google Scholar 

  37. Indian Stock Online Website, “Indian Pharmaceutical Industry,” http://www.indokeizai.com/industry/medicine.html.

  38. “GMR Data: The Indian Pharmaceutical Market – Leading Domestic Companies” (2015): 46.

    Google Scholar 

  39. Hasit Joshipura (senior vice president, South Asia & Managing Director – India, GSK), interview on July 23, 2009.

    Google Scholar 

  40. Tata Strategic Management Group, “Asia Business Generator Project: Overview of the Indian Pharmaceutical Industry” (March 2008): 1.

    Google Scholar 

  41. Tata Strategic Management Group, “Asia Business Generator Project: Overview of the Indian Pharmaceutical Industry” (March 2008): 4.

    Google Scholar 

  42. Umesh Chandra et al., “Opportunities and Challenges of Indian Pharmaceutical Sector: An Overview,” International Journal of Scientific Research and Management (IJSRM) 4, no. 6 (2016): 4293.

    Google Scholar 

  43. “Diet in an Aging Society, Diabetes,” Global by Nippon Suisan Kaisha, Ltd., no. 57 (Aug. 2007): 1, http://www.nissui.co.jp/news/20070828.html.

  44. Tata Strategic Management Group, “Asia Business Generator Project: Overview of the Indian Pharmaceutical Industry” (March 2008): 4.

    Google Scholar 

  45. The Drugs and Cosmetics Act, 1940, Act No. 23 of 1940 (April 10, 1940), with 2005 amendments., http://www.prsindia.org/uploads/media/1188536330/bill145_20080430145_THE_DRUGS_AND_COSMETICS_ACT_1940_with_2005_amendments.pdf.

  46. Drugs (Prices Control) Order, 2013, Ministry of Chemicals and Fertilizers (May 15, 2013), http://www.nppaindia.nic.in/DPCO2013.pdf.

  47. Ernst & Young/IBEF, “Pharmaceuticals” (2006): 3.

    Google Scholar 

  48. Kazuki Minato, “Indian Pharmaceutical Industry – Structural Background for Development and Changes after TRIPS,” Japanese Generic Medicine Market and Indian & Chinese Pharmaceutical Industries, ed. Kensuke Kubo (Institute of Developing Economies-JETRO, 2007), 24.

    Google Scholar 

  49. PricewaterhouseCoopers, “Global Pharma Looks to India: Prospects for Growth” (2010): 12.

    Google Scholar 

  50. Y. Srihari et al., “Implications of Drug Price Competition and Patent Term Restoration Act (DPCPTRA) on Indian Pharma Industry,” Journal of Intellectual Property Rights 14 (Nov. 2009): 502–503.

    Google Scholar 

  51. Kazuki Minato, “Indian Pharmaceutical Industry – Structural Background for Development and Changes after TRIPS,” Japanese Generic Medicine Market and Indian & Chinese Pharmaceutical Industries, ed. Kensuke Kubo (Institute of Developing Economies-JETRO, 2007), 31.

    Google Scholar 

  52. Atsuko Kamiike et al., “Production Dynamics in Indian Pharmaceutical Industry: Utilizing Individual Data from the Annual Census of Manufacture” (discussion paper, Research Institute of Kobe University, June 21, 2011): 1–37.

    Google Scholar 

  53. Kazuki Minato, “Indian Pharmaceutical Industry – Structural Background for Development and Changes after TRIPS,” Japanese Generic Medicine Market and Indian & Chinese Pharmaceutical Industries, ed. Kensuke Kubo (Institute of Developing Economies-JETRO, 2007), 33.

    Google Scholar 

  54. Kazuki Minato, “Indian Pharmaceutical Industry – Structural Background for Development and Changes after TRIPS,” Japanese Generic Medicine Market and Indian & Chinese Pharmaceutical Industries, ed. Kensuke Kubo (Institute of Developing Economies-JETRO, 2007), 34–35.

    Google Scholar 

  55. Toru Noji, “Current Status of the Indian Pharmaceutical Industry: The Market, Company Trends, Strategies for Dealing with Changes in the Environment,” Mizuho Industry Focus 51 (Industry Research Division, Mizuho Corporate Bank, Nov. 2, 2006): 6.

    Google Scholar 

  56. Kazuhiro Kawabata, “Overseas Penetration by Indian Pharmaceutical Companies,” Chap. 15 in The Current Status of Indian Pharmaceutical Industry (Yakuji Nippo, Yakuji Nippo Limited, Sept. 11, 2007).

    Google Scholar 

  57. R. Joseph, “India’s Trade in Drugs and Pharmaceuticals: Emerging Trends, Opportunities and Challenges” (RIS discussion paper, no. 159, Nov. 2009): 1–45.

    Google Scholar 

  58. Indian Patent Office Website, The Indian Patents and Designs Act, 1911., http://www.theindianlawyer.in/statutesnbareacts/acts/d42.html.

  59. Indian Patent Office Website, IP Act and Rules, http://www.ipindia.nic.in/history-of-indian-patent-system.htm.

  60. WTO Website, “Transitional Arrangements,” http://www.wto.org/english/docs_e/legal_e/27-trips_08_e.htm.

  61. WIPO Website in India, The Patents (Amendment) Act, 1999., http://www.wipo.int/wipolex/en/details.jsp?id=7622.

  62. WTO Website in India, The Patents (Amendment) Act, 2002, http://www.wipo.int/wipolex/en/details.jsp?id=7620.

  63. WIPO Website, Patents (Amendment) Act, 2005 (Act No. 15 of 2005), http://www.wipo.int/edocs/lexdocs/laws/en/in/in065en.pdf.

  64. Keiji Iwata, “The Effect of the Indian Patent Law Amendment,” Patent 61, no. 2 (Feb. 2008): 44.

    Google Scholar 

  65. Mika Yamana, “Pharmaceutical Industry and the Indian Patent Act with Particular Reference to Madras High Court’s Novartis Rulings,” Patent Studies, no. 44 (Sept. 2007): 37.

    Google Scholar 

  66. WIPO Website, Patents (Amendment) Act, 2005 (Act No. 15 of 2005), http://www.wipo.int/edocs/lexdocs/laws/en/in/in065en.pdf.

  67. Madras High Court Judgement, http://www.lawyerscollective.org/files/novartis/IIMadHC/Novartis%20AG%20v%20UoI%20and%20others%20[Mad%20HC%20judgment].pdf.

  68. IPAB Order Dated 26-Jun-2009 in Novartis v. Union of India https://ja.scribd.com/document/133340456/IPAB-Order-Dated-26-Jun-2009-in-Novartis-v-Union-of-India

  69. Data directly obtained by the author during a visit to the Indian Patent Office (2009).

    Google Scholar 

  70. Data directly obtained by the author during a visit to the Indian Patent Office (2009).

    Google Scholar 

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Mitsumori, Y. (2018). Historical Background and Current Status of Indian Pharmaceutical Industry and Indian Patents Regime. In: The Indian Pharmaceutical Industry. SpringerBriefs in Health Care Management and Economics. Springer, Singapore. https://doi.org/10.1007/978-981-10-6790-7_2

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