National Biotech Strategy envisages measures to raise investments

EPP News Bureau - New Delhi

The National Biotech Strategy proposes a series of initiatives to peg up investment in the sector and to strengthen human resources with an objective of achieving a turnover of $5 billion and creation of one billion jobs by 2010.

The Biotech Strategy proposes a 100 per cent FDI through automatic route, National Taskforce on Lifesciences and biotech education, Small Business Innovations Research Initiative, regulatory reforms including setting up of National Biotech Regulatory Authority and support in R&D in high end molecular biology.

Releasing the Strategy and Policy framework here, the Minister of State for Science & Technology, Kapil Sibal said, “Around 30 per cent of the DBT’s R&D budget will be diverted to public-private partnership alone”. “We are also starting an industry promotion cell at DBT,” the minister said. Secretary, DBT, Dr M K Bhan said, “We are proposing 100 per cent FDI in the biotech sector through automatic route”. This is expected to augment foreign investment in the sector especially in the new IPR regime.

Under the HR development plan a Bio-Edu-Grid with public private partnership is proposed aiming at molding industry leaders, which will be a network of universities and industry for pooling resources.

It proposes to introduce short term training course in GLP, GMP, advanced biotech instrumentation, IPR regulation, bio enterprise and clinical trials. There would be specialised e-learning modules, extended attachment to industry for biotech students and dual degree programme with regulation, IPR or biotech enterprise.

In R&D support, the priority areas identified are molecular and cellular biology, neuroscience, molecular genetics, transplantation biology, genomics, proteomics, system biology and RNA interface. In view of supporting SMEs the Biotech Strategy envisages to create a Small Business Innovative Research Scheme (SBIRI) which is to come in 2005-06. The scheme will support pre-proof of concept, early stage innovative research and provide mentorship and problem solving support in addition to grant/soft loan.

Phase I SBIRI will provide financial support up to Rs 50 lakh for early stage pre-proof of concept research of which 50 per cent will be grant-in-aid and the rest interest free loan. In Phase II the scheme will provide soft loan at 2 per cent interest for further product development and commercialisation.

The biotech strategy proposes to set up DNA and Stem cell banking facilities and bio-repositories with industry partnerships, testing facility for GMO/LMO and laboratory support for clinical trials. A virtual network of stem cell centres is also suggested with two core centres and network of sub-centres. Creation of centre for translational research is also on the priority agenda which will deal with technology policy for public health, molecular pathogenesis of disease, technology development, scale up, product evaluation and technology diffusion into programmes. Under the infrastructure development plan, the Strategy envisages at least 10 more biotech parks by 2010.

To ensure a conducive regulatory environment, the Biotech Strategy has suggested the creation of an Interministerial Group chaired by reputed scientist to address the anomalies and issues that arise in regulation from time to time. This recommendation is based on the Dr Mashelkar Committee report on rDNA products which is envisaged to be implemented this year. The Interministerial Group will vet any changes in policies, procedures, protocols for biotech products, resolve issues arising from overlapping of regulatory/legislation, and review guidelines, SOPs or protocols.

Creation of National Biotech Regulatory Authority, centre for in-service training, new guidelines on transgenic research/product/process development and special regulatory cell under DBT in the interim period are some of the key proposals in the Strategy document.

The Biotech Strategy also envisages for strengthening public communication as well as empowering policy makers, judiciary and law enforcement agencies. This includes setting up of dedicated centre for bio-safety, food safety, Codex Alimentarius standards and National Biotech Awareness Fund.