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By Arzi Adbi Kedar Naik
20 yrs. for all inventions Medicines. for Food. Drugs. & 14 yrs. etc.1970 The Patent (Amendment) Act.The Indian Patent Act The Indian Patent Act. for Reversal of Law in case of violation other inventions of Patent from Plaintiff to Indian Market became Defendant undesirable to the MPCs To recognize all patents filed after Focus on Generics and 1/1/05 Neglect of New Drug Discovery MPCs to enjoy same IPR in India as Development of Expertise in they enjoyed elsewhere Reverse Engineering Shifting of focus from Generics to Innovative Drug Discovery . 2005 Process Patent Product Patent 5 yrs.
GROWTH ENABLERS Off shoring of R&D Activities Regulatory Reforms Accelerating Clinical Trials IPR ENFORCEMENT Proven Prowess In Data Management Fiscal Reforms Increasing M&A .
Off shoring of R&D Activities Recognition of R&D as important growth driver by Indian companies Increase in Investment in R&D Activities from 4% in 2004-05 to 7.7% in 2005-06 as a percentage of Sales Low cost of doing R&D in India Fiscal Reforms Conferred Tax Deduction for expenses related to R&D Reduced Interest Rates for Export financing Reduction in Import Duties Favorable economic environment for FDI in R&D .
Accelerating Clinical Trials Bridge between New Drug Discovery and New Drug Approval Alone accounts for over 50% of the overall budget for the new drug development Large Patients pool with genetic diversity Lower per patient cost of conducting trial in India Clinical Research Outsourcing (CRO) Market stands at around Rs. 300 crore and growing at 30% annually Proven Prowess in Chemistry and Data Management Abundance of highly trained and technically skilled clinical research and medical professionals Strong domestic capabilities in Data Management and IT .
The Entry into Market .
& (2) Ranbaxy acquiring Terapia. a large German Generic player. largest Generic company in Romania Regulatory Reforms Strengthening of Legal framework to curb production of spurious drugs Formation of centralized National Drug Authority (NDA) .Increasing Mergers & Acquisitions Rush of International Acquisitions by leading Indian Pharmaceutical Firms Acquisitions intended to give Indian Drug Firms wide geographical footprints Some of the key acquisitions include (1) Dr. Reddy’s acquiring Betapharm.
Future Outlook & Challenges Emergence of India as leading country in Global Pharmaceutical Market Export to be the major thrust of the Industry Evolving of Bio-pharmaceutical Market likely to emerge as one of the largest producer of Vaccines Biotech Market estimated to reach $5 billion by 2010 More Investment required in R&D Fiscal Incentives for R&D should be provided on a long term basis of around 10 years Clear Guidelines required on OTC Drugs Higher Budget Outlay for Healthcare Services required .
Thank You .