Regulatory agencies in india

regulatory agencies in india

1. Regulatory agencies in India By: Tanuja bisht Associate professor Uttarakhand, india

2. bcil Biotech consortium India ltd, New Delhi. Public ltd company established I 1990, under The Companies Act, 1956. Promoted by DBT, GOI Financed by All India Financial Institutions including IDBI, ICICI, UTI, IFCI and some other corporate sectors like Ranbaxy labs, Glaxo India, Cadila lab etc

3. Board of Directors of BCIL: Senior representative of DBT Council of Scientific and Industrial Research Indian Council of Agricultural research All leading Indian Financial Institutions The Biotechnology Industry Different schemes and programs are organized and conducted by BCIL: Biotechnology industry partnership program Biotechnology industrial training program Small business innovation research initiative

4. BCIL’s unique strength Promoted by DBT for facilitating commercialization of biotechnology Extensive experience and expertise in technology evaluation, packaging and transfer CSIR & ICMR and other in-house subject expertise for guidance Valuable resource base of subject specific experts from industry and academia Close linkage with IPR experts Competent and established law firms empaneled to assist BCIL in drafting, filing and prosecution of patent applications

5. Objectives: Spearheading biotechnological commercialization in the areas of vaccines, diagnostics, recombinant therapeutics, bio-fertilizers, biopesticides etc. Efforts in transfer of technology and its commercialization by the licensee and continues to be a link between the technology transferee and the technology recipient.

6. functions Major function include development and transfer of technology for commercialization of biotech products and human resource development Provide necessary linkage among stake holders including industry, R&D institutions, Govt. and business support for facilitating access to technologies by acting as an interface between technology sources and technology seekers both within and outside country. Assist in technology sourcing, marketing tie-ups and identification of joint venture partners. Creates awareness about business opportunities, IPR protection, and biosafety requirements. Has expertise in facilitating IPR protection, regulatory approvals and provides human resources to companies. Other than technology transfer, has been actively involved in project consultancy, fund syndication, information dissemination, manpower training and placement related to biotechnology.

7. Range of services 1. Technology Transfer: Helps in communicating technology by acting as mediator between source and technology developer. To facilitate the transfer of technologies, BCIL undertakes a methodical stepwise approach consisting of-screening for leads, technology evaluation, validation, scale-up, packaging, technology pricing, entrepreneur selection, technology transfer, monitoring, support and consultancy. 11. Project Consultancy: In-depth insights into various issues related to commercialization of different biotech products and processes Experience in executing wide array of consultancy projects and linkages with all key stakeholders enables BCIL to put together the high-quality information cost effectively, in shortest possible time frame. Consultancy services includes: Project feasibility studies and detailed project reports Business plans and design of biotech parks Sectoral studies, market surveys and technical assessment studies Strategic advisory services for new products, diversification plans and investments.

8. 111. Certification services : BCIL has been identified as National Certification System for Tissue Culture Raised Plants (NCS-TCP), implemented by Department of Biotechnology, for assisting in recognition of tissues culture production facilities and accreditation of test laboratories. It will facilitate healthy growth of industry through distribution of quality and certified planting material among the farmers. 1V. Information services: it is engaged in collection, collation, analysis and dissemination of commercially relevant biotech information. Major activities managed are: - Distributed information sub- centre (DISC) of DBT - Biotech club - conducting awareness program -development of informative Biotech weekly update websites.

9. V. Biosafety: BCIL is actively involved in capacity building activities in biosafety, related to genetically modified organisms (GMOs). It includes preparation of research documents and reports and organizing national and international conferences, workshops on key policy issues, state and district level events for various stakeholders and farmers welfare. VI. Project Management: Provide services for technical, administrative and financial management of long-term biotech projects. The projects for which the management services are being offered include National Biodiversity Strategy & Action Plan (NBSAP).

10. Technology Transfer at BCIL Vaccine candidate developed at JNU JNU enters into MoA with BCIL for commercialization of technology BCIL identifies Indian Biotech Company as potential licensee BCIL enters into license agreement with biotech company Licensee approached BCIL with a request to revise the agreement BCIL evaluates the request in consultation with industry experts BCIL mediates between the technology develepor and licensee and agrees to allow contract manufacturing BCIL strikes a deal with revised royalty enabling successful launch of the product in foreign market