Awesum paper on INDIAN PHARMACEUTICAL COMPANIES, POLICIES AND GOVERNANCE.pdf

Awesum paper on INDIAN PHARMACEUTICAL COMPANIES, POLICIES AND GOVERNANCE.pdf

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Opening Up to the World: India’s Pharmaceutical Companies Prepare for 2005 Sean Eric Smith May 2000
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Asia/Pacific Research Center Institute for International Studies Stanford University Encina Hall E301 Stanford, CA 94305-6055 (650) 723-9741 fax (650) 723-6530
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3 Table of Contents ABSTRACT ........................................................................................................................ 5 PREFACE ............................................................................................................................. 7 1. INTRODUCTION ...................................................................................................... 11 1.1 S TRUCTURE OF PAPER ............................................................................................... 11 1.2 S UMMARY OF FINDINGS ............................................................................................ 11 2. OVERVIEW ............................................................................................................ 13 2.1 A B RIEF H ISTORY (1900–1999) .............................................................................. 13 2.2 T HE P HARMACEUTICAL P RODUCTION C YCLE ............................................................... 14 2.2.1 Discovery ..................................................................................................... 14 2.2.2 Clinical Trials ............................................................................................... 15 2.2.3 Production and Manufacturing .................................................................... 16 2.2.4 Marketing and Distribution ......................................................................... 16 2.3 R EGULATORY E NVIRONMENT .................................................................................... 17 2.3.1 Approval Process ......................................................................................... 17 2.3.2 Price Controls .............................................................................................. 17 2.3.3 Intellectual Property (IP) Protection ............................................................ 18 2.3.4 Other Regulatory Issues ............................................................................... 19 2.4 T HE I NDIAN M ARKET .............................................................................................. 19 3 IMPACT OF 2005 ON FIRM STRATEGIES .......................................................... 20 3.1 E XPECTATIONS ........................................................................................................ 20 3.1.1 New Delhi’s will to affect change ................................................................. 20 3.1.2 New Delhi’s ability to affect change ............................................................. 21 3.1.3 Firms’ views ................................................................................................. 22 3.2 C APABILITIES ........................................................................................................... 22 3.3.1 Size ............................................................................................................... 23
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4 3.2.2 Markets ........................................................................................................ 24 3.2.3 Present Technological Capabilities ............................................................... 25 3.3 S TRATEGIES ............................................................................................................ 25 3.3.1 Technological strengthening ......................................................................... 25 3.3.2 Redefining New Drug Discovery .................................................................. 25 3.3.3 Public research ............................................................................................. 26 3.3.4 Leveraging Nontechnical Strengths .............................................................. 26 3.3.5 Growing Larger ........................................................................................... 27 3.3.6 Help from Parent Companies ....................................................................... 28 3.3.7 Export Focus ................................................................................................ 28 3.3.8 Localization of Operations for MNCs ......................................................... 29 4. APPENDIX: COMPANY PROFILES ...................................................................... 30 4.1 D ABUR R ESEARCH F OUNDATION ................................................................................ 30 4.2 D R . R EDDY S L ABORATORIES (DRL) ......................................................................... 31 4.3 G LAXO I NDIA L TD . ................................................................................................. 32 4.4 H INDUSTAN A NTIBIOTICS L TD ................................................................................... 32 4.5 H OECHST M ARION R OUSSEL L TD . (HMR) ................................................................ 33 4.6 K NOLL P HARMACEUTICALS L TD . (BASF P HARMA ) ...................................................... 33 4.7 L UPIN L ABORATORIES L TD . ....................................................................................... 34 4.8 N ICHOLAS P IRAMAL I NDIA L TD . (NPIL) . ................................................................... 35 4.9 N OVARTIS I NDIA L TD . ............................................................................................. 35 4.10 R ANBAXY L ABORATORIES ..................................................................................... 36 4.11 S UN P HARMACEUTICALS I NDUSTRIES L TD . ............................................................... 37 4.12 W OCKHARDT L TD . .............................................................................................. 38 5. BIBLIOGRAPHY .................................................................................................... 41 5.1 P RINTED S OURCES ................................................................................................... 41 5.2 I NTERVIEWS ............................................................................................................ 42
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5 Abstract In 2005, India will implement new intellectual property (IP) laws that recognize product patents on pharmaceuticals. Because India’s 1970 Patent Act only recognizes process patents, Indian drug companies have been free to copy molecules from multinational companies (MNCs), to sell within India and other nonpatent conforming markets. New laws, such as the Exclusive Marketing Rights amendment to the 1970 Patent Act (ratified on April 19, 1999), will substantially alter this practice. This paper discusses what companies are doing to prepare for 2005 and beyond. As is the case today, Indian and MNCs alike will figure prominently in the future of the pharmaceutical sector, albeit in somewhat altered form. Although the new patent regime has the potential to reward MNCs at the expense of Indian firms, local companies will likely benefit from stricter laws. In fact, it is plausible that the 2005 laws will vault some Indian pharmaceutical companies into globally prominent positions.
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7 Preface Until 1991, India’s industrial policy regime was among the most inward-looking anywhere.
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