www.ableindia.org

Shrikumar SuryanarayanDirector-General , ABLE

shri@ableindia.org

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.