The document discusses India's pharmaceutical industry, including its current size and growth rate. It notes that formulations make up 79% of the industry while bulk drugs account for 21%. The background section outlines how India's Patents Act of 1970 only recognized process patents and led to increased domestic production. It also discusses how India transitioned to a product patent regime in 2005 to comply with TRIPS and how this has impacted multinational companies investing in India.

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

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

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

6. 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

7. Changing Business Models

8. 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

9. 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

11. Thank you…