Indian Pharmaceutical Industry

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  • Indian Pharmaceutical Industry

    1. 1. A Report Brakes India Limited December 20, 2007 india’s pharmaceutical industry STATUS & ISSUES…
    2. 2. Current Scenario India’s Pharmaceutical Market Size 3.55 4.15 4.39 5.13 5.7 6.41 4.69 9.48 Projected to grow at 13.6%CAGR Source: ASSOCHAM, Cygnus Study In USD Billion
    3. 3. Current Scenario Trend of India’s Pharmaceutical Export 97.5 128.3 152.1 178.6 222.2 Source: Director General of Commerce Intelligence In Rs Billion
    4. 4. Current Scenario Bulk drugs Generics Branded Drugs Copies of off-patent unbranded drugs Formulations
    5. 5. Current Scenario Formulations 79% Bulk Drugs 21% COMPO SITION OF INDIAN PHARMA INDUSTRY
    6. 6. Background <ul><li>Indian Patents Act 1970 recognised only process patents </li></ul><ul><li>Drug Pricing Control Order (DPCO) imposed Price ceilings </li></ul><ul><li>Exodus of global innovator pharma companies from India </li></ul><ul><li>Impetus for import substitution and increased domestic production </li></ul><ul><li>Signing of TRIPS Agreement begins India;s transition to the WTO mandated product patent regime by 2005 </li></ul><ul><li>Increased focus on new drug discovery and development </li></ul><ul><li>Increased export to regulated markets </li></ul><ul><li>Return of global pharma majors </li></ul><ul><li>Indian Pharmaceutical Policy 2002 reduces number of drugs under price control and opens the market further to foreign investment </li></ul><ul><li>MNCs scale up investments, explore new opportunities. </li></ul><ul><li>Outsourcing & alliance trends accelerate </li></ul><ul><li>India becomes product patent compliant from January 1, 2005 </li></ul><ul><li>MNCs ready patented products for India </li></ul><ul><li>Explore IP intensive R&D and Mfg offshoring opportunities </li></ul>1970 1995 2005 Policy Impact Indian Pharma: Up the value chain
    7. 7. Changing Business Models
    8. 8. Issues- Definition of Patentability <ul><li>Pharmaceutical substances that can be patented </li></ul><ul><li>A new entity, the discovery of which has involved one or more “ inventive steps” </li></ul><ul><li>Inventive Steps ? </li></ul><ul><li>Future of an invention that involves </li></ul><ul><ul><li>technological advances as compared to the existing knowledge </li></ul></ul><ul><ul><li>Or having economic significance </li></ul></ul><ul><ul><li>Or both </li></ul></ul><ul><ul><li>and that makes the invention not obvious to a person skilled in the art </li></ul></ul>
    9. 9. Issues- Definition of Patentability <ul><li>Pharmaceutical substances that can be patented </li></ul><ul><li>A new entity, the discovery of which has involved one or more “ inventive steps” </li></ul><ul><li>Inventive Steps ? </li></ul><ul><li>Future of an invention that involves </li></ul><ul><ul><li>technological advances as compared to the existing knowledge </li></ul></ul><ul><ul><li>Or having economic significance </li></ul></ul><ul><ul><li>Or both </li></ul></ul><ul><ul><li>and that makes the invention not obvious to a person skilled in the art </li></ul></ul>
    10. 11. Thank you…

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