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Indian Pharmaceutical Industry

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Information about Indian Pharmaceutical Industry

Published on June 17, 2008

Author: inside_out

Source: slideshare.net

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A Report Brakes India Limited December 20, 2007 india’s pharmaceutical industry STATUS & ISSUES…

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

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

Current Scenario Bulk drugs Generics Branded Drugs Copies of off-patent unbranded drugs Formulations

Current Scenario Formulations 79% Bulk Drugs 21% COMPO SITION OF INDIAN PHARMA INDUSTRY

Background Indian Patents Act 1970 recognised only process patents Drug Pricing Control Order (DPCO) imposed Price ceilings Exodus of global innovator pharma companies from India Impetus for import substitution and increased domestic production Signing of TRIPS Agreement begins India;s transition to the WTO mandated product patent regime by 2005 Increased focus on new drug discovery and development Increased export to regulated markets Return of global pharma majors Indian Pharmaceutical Policy 2002 reduces number of drugs under price control and opens the market further to foreign investment MNCs scale up investments, explore new opportunities. Outsourcing & alliance trends accelerate India becomes product patent compliant from January 1, 2005 MNCs ready patented products for India Explore IP intensive R&D and Mfg offshoring opportunities 1970 1995 2005 Policy Impact Indian Pharma: Up the value chain

Indian Patents Act 1970 recognised only process patents

Drug Pricing Control Order (DPCO) imposed Price ceilings

Exodus of global innovator pharma companies from India

Impetus for import substitution and increased domestic production

Signing of TRIPS Agreement begins India;s transition to the WTO mandated product patent regime by 2005

Increased focus on new drug discovery and development

Increased export to regulated markets

Return of global pharma majors

Indian Pharmaceutical Policy 2002 reduces number of drugs under price control and opens the market further to foreign investment

MNCs scale up investments, explore new opportunities.

Outsourcing & alliance trends accelerate

India becomes product patent compliant from January 1, 2005

MNCs ready patented products for India

Explore IP intensive R&D and Mfg offshoring opportunities

Changing Business Models

Issues- Definition of Patentability Pharmaceutical substances that can be patented A new entity, the discovery of which has involved one or more “ inventive steps” Inventive Steps ? Future of an invention that involves technological advances as compared to the existing knowledge Or having economic significance Or both and that makes the invention not obvious to a person skilled in the art

Pharmaceutical substances that can be patented

A new entity, the discovery of which has involved one or more “ inventive steps”

Inventive Steps ?

Future of an invention that involves

technological advances as compared to the existing knowledge

Or having economic significance

Or both

and that makes the invention not obvious to a person skilled in the art

Issues- Definition of Patentability Pharmaceutical substances that can be patented A new entity, the discovery of which has involved one or more “ inventive steps” Inventive Steps ? Future of an invention that involves technological advances as compared to the existing knowledge Or having economic significance Or both and that makes the invention not obvious to a person skilled in the art

Pharmaceutical substances that can be patented

A new entity, the discovery of which has involved one or more “ inventive steps”

Inventive Steps ?

Future of an invention that involves

technological advances as compared to the existing knowledge

Or having economic significance

Or both

and that makes the invention not obvious to a person skilled in the art

 

Thank you…

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