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www.ableindia.org
Shrikumar SuryanarayanDirector-General , ABLE
INDIA – BIOINDUSTRY OVERVIEW
ABLE - Objectives
• Represent the Indian Biotechnology Industry
• Partner with the Government of India in its Biotech
endeavors in formulating policies /regulations specific
to the Biotech Sector
• Promote strengths/competencies of the Indian Biotechnology Industry globally
• Provide a platform for domestic and overseas
companies to explore collaborative partnerships
• Encourage investments into the Biotechnology Sector.
• Forge strong links between industry & academia.
ABLE – Corporate Membership Profile
8%
8%
3%
35%22%
24%
Agri-Biotech
Bio-IT
Bio Suppliers
Pharma Biotech
Research Services
Supporting Ancilliary
ABLE represents the collective face of Biotech in India
5th ABLE – Biospectrum - India Industry survey
5th ABLE - BioSpectrum Industry SurveyIndustry Overview – 2006-07.
• Industry Size USD$ 2.07 Billion
• Export Revenues USD$ 1.19 Billion
• Domestic Sales USD$ 0.87 Billion
• Investments USD $ 0.56 Billion
* BioSuppliers were not included.
An international business focus - strong linkages with US & Europe
Innovation based pharmaceutical companies face increasing realization pressure per molecule
Per Molecule
Realization
Burgeoning R&D and marketingcosts
Increasing development times
Government pressure oncosts
Decreasing patent life
India makes Innovation in R&D and Manufacturing Affordable
• Strong scientific foundation• Innovative and cost effective process engineering
skills• Established regulatory skills • Indian players account for about 25-30% of the
total DMFs filed with the US FDA• India is the largest vaccine producer in the
world . 1 out of 2 children in the world is inoculated with a vaccine produced from India
• India has highest number of US-FDA approved manufacturing facilities outside the USA
Bio-Manufacturing
Development
India - Clinical Development
• Large patient pool – 1.2 billion population• Higher speed of patient enrollment• ICH/GCP guidelines Compliant /Ethics
Committees • Western systems of Medicine & English
language case reporting • Audit friendly.
11
Government and Industry partnership for regulatory issues related to biosafety & biosecurity
Ensuring that governance requirements and an innovation ecosystem can coexist
12
Government of India Government of India
DBTDBTDEPARTMENT OF BIOTECHNOLOGYDEPARTMENT OF BIOTECHNOLOGY
**6500crore rupees ~ $1.7billon
Nov 2007
Conclusions
• India has an innovative & growing Biotech Industry• Increasing Global linkages with companies in
Europe and United States. • Cost effective collaborative research,
development & manufacturing provides benefits to people globally.
• There here is a strong culture of regulation and compliance
• The Industry is aware of evolving international trends in biosafety and biosecurity
• Ease of international audit due to strong English language based systems.
• Partnership with Government.