Nearly two years after announcing the National Biotechnology Development Strategy to change the fortunes of biotechnology industry as a sunrise sector, the momentum of transition is yet to pick up as desired, all for the want of a regulatory framework that is pending for years now.
Though the industry on its own is growing fast, still not upto the potential, and the government is taking some steps, the slow pace of the proposed National Biotechnology Regulatory Bill seeking to establish the National Biotechnology Regulatory Authority (NBRA) has denied the sector its much-wanted booster dose.
The formation of the NBRA as an autonomous body to regulate and spur the sector has been one of the key elements of the five-year development strategy announced in November 2007 after two years of deliberations. Though almost two years passed, the bill is yet to reach its logical conclusion. It is still to go to the Cabinet for the approval before going to the Parliament.
The Department of Biotechnology has anyway finalized the draft bill and it has been cleared by the concerned departments. An interdisciplinary and inter-ministerial advisory committee had been constituted to oversee and advise on all matters related to drafting, reviewing the comments of experts and stakeholders as well as preparing final documents. ``The governmental process of inter-ministerial consultation has been completed for obtaining necessary approvals for the NBR Bill by the Cabinet,'' sources said.
The bill seeks to set up the NBRA as an independent, autonomous, statutory agency to safeguard the health and safety of the people and to regulate the safe development and deployment of biotechnology products and processes. Elements of biotechnology regulation are currently spread over multiple acts and some of these would be amended to establish and operationalize the NBRA. The new legislation is expected to provide an opportunity to consolidate and enhance the efficiency and effectiveness of biotechnology regulation, increase collaboration with state governments in this area, promote public confidence in the regulatory system, and facilitate international trade.
Though the strengthening of the regulatory mechanism through legislation is lagging behind the schedule, the department could do some things in promoting the industry and research during the last one year. `` The department is engaged in delivering on the commitments effectively with the help of multiple stakeholders from the public and private space. DBT itself is undergoing rapid evolution as an organization with likely induction of 30 more officers and an expanded institutional framework for delivery of innovation services through the newly created Biotechnology Industry Research Assistance Council and in partnership with Biotech Consortium of India Limited, Association of Biotechnology Led Enterprises, Federation of Indian Chambers of Commerce and Industry & Confederation of Indian Industry,'' an official said.
Research and skills development
The Biotech Strategy emphasized the need to expand the pool of scientists and expand PhD and post-doctoral programmes, making the scientific career more attractive and strengthening education at college level. The expansion of human resources was being addressed through creation of IISERs, new IITs, six new biotech research institutions and globally acknowledged re-entry package such as the DBT-Wellcome Trust Alliance and the Ramalingaswami Fellowship Programme. The DBT-Wellcome Trust partnership is a large investment of US $ 160 million to attract early, intermediate and senior level scientists for career development through flexibility, meetings support and mentorship under this scheme. Similarly, a special research scheme for young scientists in which DBT provides rapid grants within eight to 12 weeks and mentoring support was initiated.
DBT has commenced efforts to help those universities that have potential to become research intensive, to expand the size and depth of the PhD and post doctoral programmes, to strengthen institutional framework and mechanisms for interaction with industry and to make innovation and entrepreneurship a part of the educational process itself. The programmes implemented last year include the UoH-DBT Centre for Research and Education in Biology and Biotechnology at the University of Hyderabad and the Basic Biological Research Unit at the Indian Institute of Science, Bangalore.
To further boost research in the university system and in other institutions, a Centre of Excellence scheme was initiated. The scheme covers basic research as well as translational science and Industrial partnership. Eleven such COEs are under implementation in different areas like genome sciences and predictive medicine, system biology and tuberculosis etc. It is envisaged to fund 50 COEs mostly in universities during the Eleventh Plan.
A concept of technology platforms in public-private partnership has been promoted. Two such platforms established during the year include: Platform for Translational Research on Transgenic Crops-PTTC at ICRISAT, Hyderabad and a Platform for Macromolecular Crystallography to bring focus of Indian investigators on relevant proteins in infectious organisms.
Bioclusters
Works on the four bioclusters are also progressing. They are National Health Technology Biocluster at Faridabad near Delhi, second one at Mohali, Punjab,the third at the University of Agricultural Sciences, Bangalore campus led by National Centre for Biological Sciences and the fourth at the University of Hyderabad who have taken the lead in creating a science bio cluster in their campus.
The first one is dedicated to health science and technology, and will have the Regional Centre for Biotechnology Training & Education partnered with UNESCO, the Translational Health Science Technology Institute (THSTI) partnered with Harvard-MIT Health Science & Technology programme; a Molecular Medicine Centre in partnership with local medical school in the city; technology platform, concept and design application centre, animal services and science centre, nanoscience centre and several mission centres around vaccines, neonatal & children science, chronic disease biology and so on. The Mohali cluster will have the IISER, the Nanoscience institute, a management school, the Agri-Food and Nutrition Biotech Institute with a bioprocessing unit and a biotech park. The NCBS cluster has UAS, Bangalore, the Agricultural University, National Centre for Biological Sciences, the Stem Cell Institute, Centre for Biomolecular Characterization, Silk and Biomaterials Centre, platform technology centre and the innovation society.
Innovation support
Biotech strategy has committed 30 per cent of DBT budget by the end of 11th Five Year Plan for research in which industry is a key participant. This includes start up support for small and medium companies and high innovation R&D support irrespective of the size of the company. Under the Small Business Innovation Research Initiative (SBIRI) scheme meant for this, DBT received nearly 500 proposals spanning health care, agriculture, industrial products and processes, instrumentation, environmental biotechnology, food & nutrition and bioinformatics. Out of these ,48 projects have been funded so far.
Another key element in the strategy --the Biotechnology Industry Partnership Programme (BIPP)-was also launched by the Centre, for promoting drug discovery and late stage late stage development including clinical trials for companies irrespective of size. Upto 100 per cent grant-in-aid support would be provided for phase-I, II and III clinical trials of biotech-based research leads.
In order to facilitate an interface between industry-academia, provide innovation service and help promote start-ups, the Department has established a Biotechnology Industry Research Assistance Council as an autonomous body.
Activities in the current year
The current year has been identified for reforming the competitive grants system and governance. It is aimed to expand capacity for translation research in health, agriculture, industry and environment sectors, advancing standards in manufacturing of biologicals, rapidly responding to new opportunities in newer areas i.e. nano-sciences, stem cell biology, genetics and genomics based healthcare and agriculture, expanding the use of information technology, focusing on young scientists and creating a pipeline of products.
Remodelling of DBT is on the anvil with 40 new positions being filled up. Past decade built infrastructure so far has supported bottom-up research. However with the current strength, mid and high-level inventions may result into bed-to-bench technologies. The department sources claimed that it has a record of making use of 90 per cent of funds allocated every year. The department was allocated an amount of Rs.901.50 crore (Rs. 879.00 crore (Plan) and Rs.22.50 crore (Non-Plan) for the year 2008-09. The budget allocation for 2009-10 is Rs.900.00 crore (Plan) and Rs.24.00 crore (Non-Plan).