PHARMABy By
Deepak sahuDeepak sahu
The Indian Patent ActThe Indian Patent Act
The Indian Patent Act,1970 Process Patent 5 yrs. for Food, Drugs,
Medicines, etc. & 14 yrs. for other inventions
Indian Market became undesirable to the MPCs
Focus on Generics and Neglect of New Drug Discovery
Development of Expertise in Reverse Engineering
The Patent (Amendment) Act, 2005 Product Patent 20 yrs. for all inventions Reversal of Law in case of
violation of Patent from Plaintiff to Defendant
To recognize all patents filed after 1/1/05
MPCs to enjoy same IPR in India as they enjoyed elsewhere
Shifting of focus from Generics to Innovative Drug Discovery
GROWTH ENABLERSGROWTH ENABLERS
IPR ENFORCEMENT
AcceleratingClinical Trials
Increasing M&A
Off shoring of R&D Activities
Proven ProwessIn Data
Management
Regulatory Reforms
Fiscal Reforms
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 TrialsBridge 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% annuallyProven 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 MarketThe Entry into Market
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, a large German Generic player, & (2) Ranbaxy acquiring Terapia, largest Generic company in Romania
Regulatory Reforms
Strengthening of Legal framework to curb production of spurious drugs
Formation of centralized National Drug Authority (NDA)
Future Outlook & Future Outlook & ChallengesChallenges 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