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