New Public Initiatives in promoting Biotechnology

 

 

Kavita Mehra

 

The National Biotechnology Development Strategy, an outcome of Department of Biotechnology’s two year long efforts was approved by the Government during November 2007. The strategy, while enabling the full utilization of existing available opportunities in manufacturing and services, aims to lay a strong foundation for discovery and innovation, effectively utilizing novel technology platforms with potential to contribute to long term benefits in agriculture, animal productivity, human health, environmental security and sustainable industrial growth. The strategy seeks to address a number of challenges relating to the biotech sector in terms of R&D, creation of investment capital, technology transfer, absorption and diffusion, IPR, regulatory issues and tailor made human capital for all these aspects.

 

One of the key elements of the strategy is promoting biotech industry in Industry. To do so, as a major departure from normal funding mechanisms, it has been decided to invest up to 30 per cent of DBT’s budget through various public-private partnership schemes by the end of 11th five year plan. This is to promote innovation, pre-proof-of-concept research; accelerated technology and product development .Following are the new initiatives towards joining hands with industry and reaching out to nurture industry R&D.

 

A) Biotechnology Industry Partnership Programme (BIPP)

 

Biotechnology Industry Partnership Programme for advanced technologies is being launched for achieving global competitiveness, addressing major national unmet technological needs and generating intellectual property in frontier biotechnology areas(for details www.biotechnews.in/PPP.html). In November 2008, DBT launched BIPP, a highly industry-friendly initiative with an approved budget of Rs 350 crore ($ 70 million).

 

BIPP will run as a pilot project for two years and will be scaled up with additional resources after a thorough evaluation. A special feature of BIPP is that the scheme will be handled by an industry veteran who will be assisted by a senior technocrat from DBT. The funds will be available to companies to take up really innovative research programs and the government, for the first time, will assume all the risks associated with it. The rewards will mainly belong to the innovator/entrepreneur with a small part of royalty going back to the government to shore up the finances for further extension of the scheme.

 

http://biospectrumindia.ciol.com/content/editorial/10812051.asp (DBT’s Industry Handshake 5 December 2008).

 

As a principle, BIPP would strictly promote high risk, transformational technology/process development. No incremental development will be supported. On a broad basis, it is directed at path-breaking research in frontier futuristic technology areas having major economic potential and making Indian industry globally competitive and focused on IP creation with ownerships by Indian industry and where relevant, collaborating scientists. In this program, the project has to be innovative which otherwise cannot be done through a usual kind of a partnership. It has to be something that a company won't go easily into because of its high complexity.

[http://biospectrumindia.ciol.com/content/policy/10812053.asp]

 

Idea generation

It has been proposed that there would be wide ranging consultation to generate ideas for cutting edge technologies of national and social relevance and possible solutions, with senior experts, academia and industry. The industry partnership platform established by DBT in partnership with FICCI will be used as a knowledge circle for idea generation in partnership with industry. A Technical Screening Committee (TSC), which would be area specific, will then work on the concept development based on priority areas identified. This concept would then be advertised or if there is limited capacity in the country, the most appropriate company which meets the required criteria would be asked to submit a proposal, along with an academic partner whenever felt necessary. The specific priority areas identified would be widely published and proposals invited. The priority areas could change with advancing technologies and these would be considered and approved by the apex committee.

Funding, cost sharing, IP and royalties

This scheme provides for grant-in-aid by government to biotech industries ranging from 30-50 percent for the R&D component i.e. Category I and II and 100 percent for the product evaluation and validation. The Intellectual Property, technology transfer and licensing arrangements proposed would vary with the model of partnership and cost sharing. The contribution of the government and percentage of royalty would be as per the apex committee recommendations based on the technical committee's evaluation. Some of the points of considerations will be: level of innovation, an advanced technology of great promise, a technology of tremendous value for national security and public health, level of risk and potential commercial value.

Following are the likely models of operation and investment & cost sharing mechanisms etc:

Model

Investment, cost sharing and sharing of benefits

Government supported-private managed, facility will be located in a national laboratory and managed by a consortium of industries or a single Industry, which has no conflict of interest.
  1. 100 % grant-in-aid
  2. User charge basis
  3. Ownership with Government
  4. Differential fee for public and private user

 

Public supported in a public institution in partnership with a private investor who has no conflict of interest.
  1. Cost sharing with the industry
  2. Up to 50 % grant-to-aid
  3. Shared Profits
  4. Ownership will depend on contribution
  5. Differential fee for public and private user

Specialised facility for discovery and innovation to be established, operated and managed by a single private industry
  1. Soft loan as per approval SBIRI norms
  2. User charge basis
  3. Differential fee for public and private
  4. Should devote time for education and training of DBT identified trainees for capacity building

 

B) Expanding Small Business Innovation Research Industry (SIBRI)

Small Business Innovation Research Industry SIBRI is an ongoing scheme to promote innovation in SMEs and has been successful. Based on the urgent need to support innovation in small and medium botech enterprises and recognition of the effort received from the industry, it has been decided for expansion of the SIBRI scheme efforts during 11th plan.

 

Regarding relationship of and BIPP, SBIRI is in its early stage. The projects require small initial resource. In BIPP, projects that succeed in SBIRI could apply and also those which don't fit into the budget of SBIRI. BIPP covers the whole value chain from early stage to late development right through to commercialization. It will look at those projects that require larger resources and demand more in terms of originality, novelty and potential value. SBIRI encourages a wide variety of people to try out a number of things. BIPP is focusing on grand challenges.

 

C) Biotechnology Industry Research & Development Assistance Council (BIRAC)

Biotechnology Industry Research & Development Assistance Council (BIRAC) is being established by the Department of Biotechnology (DBT) to  i) act as an interface between academic and private sector , particularly SMEs and start-ups, ii) nurture and catalyze R&D and innovation in biotechnology in private sector and iii) promote public-private partnerships. BIRAC is structured to offer a range of services specially designed to help SME's access key resources, new technologies, testing and validation facilities and financial assistance at the right time. BIRAC would facilitate and promote industrial research through technology transfer and IP Management, technology acquisition and technology forecasting. In addition, there would also be a special cell to address training and capacity building needs.

The idea behind setting up of BIRAC is to have an instrument of R&D and innovation within the companies, particularly SMEs . Create a new organization, which has DBT, ABLE, BCIL as core partners. Their role in BIRAC is independent of their role as an organization. This organization (BIRAC) is distinct from all organizations and it has its own entity and own purpose, which is unique to it.

The reorganised structure has DBT, which is the national funding agency.It funds all kinds of life sciences research and BIRAC is an agency, which will become the innovation management agency of the government in biotechnology. So BIRAC will not only operate industry R&D schemes, it will provide innovation link service, technology  transfer, IP, service support and advice to new companies. It will also provide regulatory advice, clinical trials support and field trials thus covering the whole value chain. DBT will manage the science function and BIRAC, the innovation management. 30 percent of DBT's budget in future will be spent through BIRAC and 70 percent through DBT.

 

 

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