India’s 2020 Vision

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If India’s biopharmaceutical players are to compete effectively on the global scale and capture 10% of the global biosimilars market by 2020, India’s private sector will have to invest a considerable amount of capital in building the necessary manufacturing capacity and skills base. At the same time, the Government of India (GOI) will also need to provide the necessary enabling environment. India’s biopharma sector consists primarily of vaccines, monoclonal antibodies, recombinant proteins and diagnostics, and the guidelines for biosimilars are already in place. All India needs to take market share is entrepreneurship.

The GOI’s Department of Pharmaceuticals, in partnership with the biotechnology industry body ABLE and PricewaterhouseCoopers have taken up the task of addressing this opportunity and provided recommendations into the following six sections: R&D; manufacturing and commercialization; human capital; the regulatory framework; innovation; and intellectual property.

1 Research and Development

• Build protein characterization laboratories and GLP-certified animal study facilities

• Create a national animal breeding facility

• Expand viral testing facilities

• Provide financial assistance for ensuring compliance with global standards

• Promote the development of pre-clinical service providers

• Provide practical support for clinical trials

• Simplify the procedures for importing and exporting biologics

2 Manufacturing and Commercialization

• Create a single-window system for approvals and clearances

• Introduce flexible pollution controls

• Invest in better transport links and cold-chain facilities

• Provide fiscal incentives

3 Human Capital

• Expand India’s capability in toxicity studies

• Foster a trilateral relationship between industry, academia and government

• Improve and expand the workforce development pipeline

• Establish exchange programmes, “finishing schools” and scholarships

• Increase public awareness about career opportunities in the industry

• Provide more training for existing employees

4 The Regulatory Framework

• Simplify the procedure for approving biologics

• Create an independent inspection facility

• Modify the regulations on process validation

5 Innovation

• Provide seed funding for innovation

• Construct biotechnology clusters

• Promote translational research

6 Intellectual Property

• Protect innovation

• Approve the bill liberalizing the commercialization of intellectual property generated in state-funded institutions

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Viren Konde

Viren Konde

Principal Consultant, iHealthcareAnalyst, Inc.

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