Bangalore, July 13, 2010: A ‘Vision 2020’ paper on a bio pharma strategy for India, prepared by PricewaterhouseCoopers and Association of Biotechnology Led Enterprises (ABLE) was released by the Department of Pharmaceuticals, Secretary, Mr. Ashok Kumar at the National Convention on Biopharma, organized by the Department of Pharmaceuticals and Federation of Indian Chambers Of Commerce and Industries (FICCI) in association with the Department of Biotechnology(DBT) and ABLE at New Delhi on July 12, 2010.

He said that the biopharma market in India was growing at 15 per cent annually By 2020, the market is projected to be worth over US$200 billion, driven by a shift in usage from conventional drugs to biopharma products, the relatively high cost of biopharma products, the launch of biosimilars and a new generation of biotherapeutics. This, he said, may be possible because of the remarkable milestones which include a strong local industry which has gone global, world class process chemistry and formulation development, globally competitive manufacturing infrastructure serving global requirements and the high potential for outsourcing and off-shoring requirements, as well as leveraging India’s R&D capabilities leading to strong potential for drug discovery and innovation.

It is worth mentioning that the report has exclusively quoted the Top20 biotech survey by BioSpectrum & ABLE, results of which wre published in the June, 2010 issue of BioSpectrum. The report has used Biospectrum data for providing the information on overall market size, rankings of the companies and other relevant figures.

The ‘Vision 2020’ document spells out the challenges before the biopharma industry and suggests key action areas for the medium term (105) and the long term (2020). For the medium term, it suggests that in the area of Research & Development, India would need to build Protein Characterisation 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 pro-clinical providers; provide practical support for clinical trials and simplify the procedures for importing and exporting biologics.

In manufacturing and commercialization, there would the need to create a single-window system for approvals and clearances; introduce flexible pollution controls; invest in better transport links and cold chain facilities; and provide fiscal incentives. For the development of human capital, the report emphasizes the need to 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 and provide more training for existing employees.

As for the regulatory framework, the report states that it is imperative to simplify the procedure for approving biologics; create an independent inspection facility and modify the regulations on process validation. To give a boost to Innovation, it calls for provision of seed funding for innovation; constructing biotechnology clusters; promotion of translational research and provision of financial support in specific areas of innovation. The report recommends protection of innovation and approval to the Bill for liberalizing the commercialization of intellectual property generated in state-funded institutions.

The report states that if India was to become the world leading provider of affordable biopharmaceutical products by 2020, it cannot simply count on biosimilars and vaccines; it must also become a source of innovation. More specifically, it should aim to have at least 10 original biologics on the local market and at least two on the global market by 2020. It identifies five longer-term (2020) initiatives and recommends that the Government should make an additional $1 billion available over the next 10 years to provide for them. The initiatives that need to be undertaken are: create a framework for intelligent regulation; invoke ‘market pull’; seek opportunities for growth through acquisitions; encourage highly skilled expatriates to come home and leverage India’s expertise in holistic and traditional medicine.