1. Global Recognition of the Indian Biotech Sector - The Road Ahead Sept 26,2003 Hyderabad

2. Global Scenario - Where is India? Biotech Industry size has reached US $ 43 billion Potential to increase by another 8-10 times in 5 years 17 bio-clusters identified enabling growth with active support from Government Where is India? Can we be the 18th bio-cluster? What do we need to do to get there? What are the challenges? Where are the opportunities?

3. India – The Fact File 6 Industry Competitiveness 4 Regulations 5 Investment climate 10 Natural resources 4 Ease of market entry 7 Domestic market potential 7 Man power Total Biotechnology Market: Attractiveness Score 2001 Overall rating of India on a scale of 100 is 58. Source : Frost & Sullivan 3 Private Sector attitude towards Biotech 4 Infrastructure 8 Manpower Support

4. From a Global Lens - Advantage India Strong scientific, medical and paramedical English speaking manpower base. Strong IT capabilities. Ethnically and Genetically diverse population groups. Presence of national and international accredited research institutions and clinical laboratories. Recognised process development and manufacturing skills. Potential for Phase I - IV clinical trials to be conducted at globally competitive costs.

5. From a Global Lens - Disadvantage India Weak enforcement of IPR and Data Exclusivity - Fear of “Reverse Engineering” Complex Regulatory approval processes - Delays in product approvals leading to cost overruns and uncertainty Accreditation by Indian authorities not on par with global standards. Phase I Clinical Trials for new drugs substances discovered in countries other than India not permitted. - Lack of confidence in studies conducted abroad? or - Lack of confidence in our regulators to verify safety based on pharmacological and toxicity data submitted by a global applicant. ?

6. India - from the Lens of a Biotech Company Lack of active Seed Funding, VC and Government support Multiple regulators and lack of transparent guidelines Concerns about India's image on IPR and Data Exclusivity

7. India Biotechnology - The Common Issues  IPR and Data Exclusivity - The perception challenge  Regulatory Approvals - The uncertain path  Accreditation by Indian authorities - A question mark  Investments in Biotech - Over dependency on VC

8. India - The Road Ahead For Global Recognition Implement WTO/TRIPS with a sense of confidence &determination to build global value through innovation and invention. Build an internationally recognized Regulatory framework that will incorporate high standards of Bioethics & Biosafety Build a high quality educational platform that will provide world class intellectual capital

9. India - The Road Ahead For Global Recognition Allow Phase I Clinical trials without any restrictions and build world class clinical capabilities Focus on generating high value intellectual property that will differentiate through India specific advantage in Genomics and Biodiversity Encourage alternate funding models to catalyze investment in the sector

10. India- Opportunities for Global Recognition Manufacture of generic bio-pharmaceuticals -A number of bio-pharmaceutical compounds will be off patent -Global capacity crunch forecast with revenues from protein based therapeutics expected to grow at 15 %,twice that of Pharma industry - -Potential to be a global base for vaccines production Contract Research -Basic gene sequencing work,cDNA library preparation, genetic research related to medical diagnostics, new crop varieties and early stage drug development.

11. India- Opportunities for Global Recognition Clinical Research /Trials -India's vast and diverse disease patient populations provide an enormous clinical research opportunity -Presence of a large talent pool of medical and paramedical professionals is conducive to building strong clinical development capabilities -Agri-Biotech -India with an agrarian economy has an opportunity to play a leadership role in trasgenic crop research through innovation and execution -Contract research for functional genomics and marker development -Marker based genetic purity testing services.

12. Thank You & Do visit www.ableindia.org www.ableindia.org Biospectrum-ABLE Survey of Indian Biotech Industry Biospectrum-ABLE Survey of Indian Biotech Industry Biospectrum-ABLE Ranking of India’s Top Biotech Companies BioFunding Sources – Government & Venture Capital BioFunding Sources – Government & Venture Capital Biotech Industry News Biotech Industry News