Efforts of government in promoting biotechnology in the country
DBT and Biotech parks
The remarkable march of India into the world of biosciences and technological advances began in 1986. That year, government of india accepted the vision that unless India created a separate Department for Biotechnology, within the Ministry of Science and Technology, Government of India the country would not progress to the desired extent. This was because many of our macro-economic issues of growth were subsumed within that science’s development.
That decision has made India one of the first countries to have a separate department for this stream of science and technology. However the initiation of deliberations to establish the department started much earlier In 1982, after detailed deliberations with the scientific community, and on the basis of recommendations by the then Scientific Advisory Committee to the Cabinet, a National Biotechnology Board (NBTB) was constituted by the Government to identify priority areas and evolve long term perspective for Biotechnology in India. It was also responsible for fostering programmes and strengthening indigenous capabilities in this newly emerging discipline.
BioPharma Mission
India needs to take firm steps quickly towards achieving its target of $100 billion Biotech Industry by 2025 and capturing 5% of the Global Biopharmaceutical market share if Indian biopharmaceuticals Industry needs to be globally competitive over the next decade. The health standards of India’s population can be transformed only through affordable product development. Therefore, there is an immediate need to consolidate efforts to promote product discovery, translational research and early stage manufacturing in the country to ensure inclusive innovation.
Towards strengthening the emerging biotechnology enterprise in India, Department of Biotechnology (DBT) Ministry of Science & Technology has initiated the Mission Program entitled “Industry-Academia Collaborative Mission for Accelerating Discovery Research to Early Development for Biopharmaceuticals – Innovate in India (i3) Empowering biotech entrepreneurs & accelerating inclusive innovation” (“Program”).Biotechnology Industry Research Assistance Council (BIRAC) setup by DBT is the implementing Agency of i3 Program through a dedicated Program Management Unit (PMU). The National Biopharma Mission has been approved by the Cabinet for implementation in May 2017 with a total cost US$ 250 million which is co-funded World Bank 50%. This Mission is designed in a manner in which it addresses the key components of the Vision outlined in the National Missions like “Make in India” and “Start up India” and also aims to take forward the commitments made by DBT in the National Biotechnology Development Strategy.
Biotech-KISAN scheme
Biotech-KISAN scheme is a farmer centric scheme for farmers, developed by and with farmers. It is a Pan-India program, following a hub-and spoke model and stimulates entrepreneurship and innovation in farmers and empowers women. The Biotech- KISAN Hubs are expected to fulfil the technology requirement to generate agriculture and bio-resource related jobs and better livelihood ensuring biotechnological benefits to small and marginal farmers. Biotech-KISAN also has unique a feature to identify and promote local farm leadership in both genders. Such leadership helps to develop sciencebased farming besides facilitating transfer of knowledge. So far a total of eight Biotech-KISAN Hubs in different Agro-climatic Zones have been supported.
Government Initiatives To Boost Up “Make In India” Campaign In Biotechnology Sector
Patent protection
Apart from Pharmaceutical sectors, biotechnology innovations and research are instrumental in health care systems, agricultural industry, polymers & materials sectors, etc. Research & development in this area is relatively time consuming and involves huge investment with risk involved with the outcome. To promote such results much more importance is affixed with respect to patenting the inventions in said field, and enabling the growing research sector to monetarily sustain itself.
The Indian Patent Office (IPO) has issued draft guidelines on examination of biotechnology patent applications. The guidelines detail illustrative examples on various facets of patentability of biotechnology related inventions, including novelty, inventive step, industrial application, sufficiency of disclosure, clarity of claims and biodiversity related issues. The patentability of biotechnology related inventions particularly genetic engineering has also been discussed. The details of wording of claims, clarity, support and sufficiency of the disclosure are provided. However, for better understanding of the issues related to novelty and inventive step, a preliminary discussion of claims of biotechnology related inventions are covered. These include the polynucleotides or gene sequences, polypeptides or protein sequences, vectors, gene libraries, host cells, micro-organisms and stem cells plants and animals tissue culture, pharmaceutical or vaccine compositions comprising micro-organisms, proteins, polynucleotides and antibodies or antigen binding fragments thereof monoclonal or polyclonal.
In order to help the patent seekers, a Biotechnology Patent Facilitation Cell (BPFC) has been catering to the need of promotion of biotech research by:
- creating awareness and understanding among biologists and biotechnologists, relating to patents and the challenges and opportunities in this area
- providing patenting facilities to biologists and biotechnologists in the country for filing Indian and foreign patents on a sustained basis.
- keeping a watch on development in the area of IPR and make important issues known to policy makers, bio-scientists, biotech industry, etc.
Another government authority working for the same cause is the Council of Scientific and Industrial research (CSIR) which has moved from their earlier mantra of “publish or perish” to “patent or perish”. The Indian Government has under its “Science and Technology Policy” also highlighted that Innovative fiscal measures are planned and strategies for attracting higher levels of investments both public and private in science and technological development and Development of technologies that add value to India’s indigenous resources would be Supported and the Indian share in the global herbal product market would be increased.
Department of Biotechnology (DBT) constituted under the Ministry of Science and Technology is the nodal agency for policy, promotion of R&D, international cooperation and manufacturing activities. Together with DBT, Genetic Engineering and Approval Committee (GEAC) constituted under Ministry of Environment and Forests (MoEF) is the leading regulatory body in the area of Biotechnology in India. Several committees have also been constituted under the said ministries to regulate the activities involving handling, manufacture, storage, testing, and release of genetic modified materials in India. These committees have statutory authority. Most of the committee members are from the scientific community and staff of DBT and MoEF. DBT appoints the members to the committees. The GEAC is supposed to be assisted by the State Biotechnology Coordination Committees (SBCC) and District Level Committees.