23-Mar-2021: DBT has initiated the National Biopharma Mission entitled: “Industry-Academia Collaborative Mission for Accelerating Discovery Research to Early Development for Biopharmaceuticals – Innovate in India Empowering biotech entrepreneurs & accelerating inclusive innovation”
Towards strengthening the emerging biotechnology enterprise in India, Department of Biotechnology (DBT), has initiated the Cabinet approved National Biopharma Mission entitled: “Industry-Academia Collaborative Mission for Accelerating Discovery Research to Early Development for Biopharmaceuticals – Innovate in India Empowering biotech entrepreneurs & accelerating inclusive innovation”.
The approved objectives of the Mission are enlisted below :
- Development of products from leads that are at advanced stages in the product development lifecycle and relevant to the public health.
- Strengthening and establishing shared infrastructure facilities for both product discovery validation and manufacturing
- Developing human capital by providing specific training to address the critical skills gaps in researchers, nascent biotech companies across the product development value chain, including in business plan development and market penetration.
- Creating and enhancing technology transfer and intellectual property management capacities and capabilities in public and private sector.
In alignment with the approved objectives the specific targets for the Mission, over a period of five years, include: development of 5 biopharma products – Vaccines, biotherapeutics, medical devices and diagnostics; establishment of shared infrastructure and facilities such as GLP Validation and Reference Lab, CMC facilities; Med-Tech validation facility; Consortia for translational and interdisciplinary research, process development, development of cell lines and expression systems; Clinical trial networks; Setting up and establishment of technology transfer offices in public and private sector; and imparting trainings for technical and non-technical skill development.
The Mission is supporting small and medium enterprises so that they can overcome the risks involved in early stages of product development. To promote entrepreneurship, the Mission is supporting enhanced industry-academia inter- linkages and providing mentoring and training for academia, innovators and entrepreneurs to translate knowledge into products/technologies. The domestic manufacturing is being promoted through the supported shared national facilities such as GLP Analytical Facilities; CMC facilities for Clinical Trial Lot Manufacturing; Cell Line Repositories; Setting up of Clinical Trial Networks and supporting translational research consortia.
To promote innovation for inclusiveness, the Mission is strengthening the ecosystem for affordable product development through the following: Development of vaccine candidates for Cholera, Influenza, Dengue, Chikungunya and Pneumococcal disease, Rabies and COVID-19; Biosimilar products for Diabetes, Psoriasis, Cancer; Diagnostic kits; Med Tech Devices for Imaging, Pumps for dialysis and MRI scanners; Supporting shared facilities for Biopharmaceutical development (10), Med Tech device development (9) and Vaccine Development (2); Establishment of hospital based and field site based Clinical Trial Networks for clinical trials of vaccines and bio-therapeutics; Supporting Translational Research Consortia (TRC) for infectious diseases to accelerate vaccine development efforts; Support for 7 Technology Transfer Offices for promoting entrepreneurship; Imparting trainings to address the critical skill gaps among the nascent biotech companies in areas such as Product development, intellectual property registration, technology transfer and regulatory standards
The Mission is being implemented in a PAN-India manner and the grantees are selected through an open competitive Request For Applications (RFA). Currently, no projects from the state of Rajasthan have been funded under the Mission.
24-Sep-2020: National Biopharma Mission is supporting small and medium enterprises for biopharmaceutical product development
The National Biopharma Mission was approved by the Cabinet in 2017 with an aim to transform the health standards of the country through affordable product development and bring 5-7 biopharmaceutical products closer to market.
Objectives and goals of the Mission are:
- Specific Product development under vaccines, biosimilars and medical devices
- Building shared infrastructure for product testing, characterization and manufacturing
- Promoting scientific research through establishment of translational research consortia and development of novel biopharmaceuticals and devices
- Skill development though trainings
- Creating and enhancing technology transfer and intellectual property management.
The Mission is supporting small and medium enterprises for biopharmaceutical product development, enhancing industry academia interlinkages and providing opportunities to translate knowledge into products/technologies for vaccines, biotherapeutics, devices and diagnostics. The indigenous manufacturing is promoted through the supported shared facilities for process optimization, clinical grade manufacturing of Biologics, Analytical testing labs, cell line repository, prototyping facilities, large animal testing facilities and medTech zone for manufacturing devices and diagnostics at large scale. These high capital facilities provide easy access to equipment and infrastructure thus encouraging indigenous manufacturing. Technology transfer offices have been established to support technology transfer and support entrepreneurship.
Financial and mentorship support has been provided to industry and academia for indigenous product development. This includes projects on development of components of upstream and downstream biologics manufacturing, such as engineered cell lines, media, resins and bioreactors which are currently in-licensed, requiring huge capital. To boost innovation, Mission is also supporting development of novel biologics, novel vaccines and medical devices like MRI, ventilators, diagnostic probes and Medical grade camera.
Five projects are being supported in Haryana, 3 projects in Faridabad district (for Medical Device and Translational Research Consortia) and 2 in Gurgaon district (for Medical device and Clinical Trial network).
This information was given in a written reply by the Minister of Science and Technology, Earth Sciences, and Health & Family Welfare, Dr Harsh Vardhan in Lok Sabha on September 23, 2020.
13-Mar-2020: NBM - an industry-Academia Collaborative Mission for accelerating biopharmaceutical development
The National Biopharma Mission (NBM) is an industry-Academia Collaborative Mission for accelerating biopharmaceutical development in the country. Under this Mission the Government has launched Innovate in India (i3) programme to create an enabling ecosystem to promote entrepreneurship and indigenous manufacturing in the sector. The mission will be implemented by Biotechnology Industry Research Assistance Council (BIRAC). The mission was approved in 2017 at a total cost of Rs 1500 crore and is 50% co-funded by World Bank loan. It is managed through a dedicated Program Management Unit (PMU) at BIRAC. Together with National and International experts, the most promising projects are selected in response to open Request for Applications issued by the PMU. The oversight to the mission activities is provided by the inter-ministerial Steering Committee chaired by the Secretary-DBT. The Technical Advisory Group (TAG) provides approval and reviews scientific progress of its components. Further downstream, domain specific Scientific Advisory Groups (SAG), each for the activities/ product development partnerships, are responsible for providing scientific decision making and knowledge and oversight necessary for TAG.
The program is promoting entrepreneurship by supporting small and medium enterprises for indigenous product development (Novel Cell lines, indigenously developed Biologics, devices and Raw materials for Biologics manufacturing) and through establishment of shared facilities and Technology Transfer Offices.
Innovation is being promoted in India for inclusiveness. This scientifically driven enterprise aims at developing an ecosystem for affordable product development and is focused on the following 4 verticals:
- Development of product leads for Vaccines , Biosimilars and Medical Devices that are relevant to the public health need by focusing on managed partnerships. Presently the mission is supporting the development of candidate vaccines for Cholera, Influenza, Dengue, Chikungunya and Pneumococcal disease; Biosimilar products for Diabetes, Psoriasis, emergency situations & Oncology and 08 products for development of MedTech Devices for Imaging, Pumps for dialysis, MRI and Molecular Biology devices.
- Upgradation of shared infrastructure facilities and establishing them as centres of product discovery/discovery validations and manufacturing. Support is being extended by the Mission for establishing shared facilities. 15 facilities have been funded for - Biopharmaceuticals development (7), MedTech device development (6) and Vaccine Development (2).
- Develop human capital by providing specific trainings to address the critical skills gap among the nascent biotech companies across the product development value chain in areas such as Product development, intellectual property registration, technology transfer and regulatory standards.
- Technology Transfer Offices: To help enhance industry academia inter-linkages and provide increased opportunities for academia, innovators and entrepreneurs to translate knowledge into products and technologies, 5 Technology Transfer Offices are being considered for funding under NBM.
25-Apr-2018: Signing of Legal Agreements between Govt. of India and World Bank on National Biopharma Mission
Towards strengthening the emerging biotechnology enterprise in India, Department of Biotechnology (DBT), Ministry of Science & Technology has initiated the Mission programme entitled: Industry-Academia Collaborative Mission for Accelerating Discovery Research to Early Development for Biopharmaceuticals – “Innovate in India (i3) Empowering biotech entrepreneurs & accelerating inclusive innovation”. The National Biopharma Mission is being implemented by Biotechnology Industry Research Assistance Council (BIRAC) - a Public Sector Undertaking of Department of Biotechnology (DBT). This Mission of the Department was approved by the Cabinet in May 2017 and formally launched by Hon’ble Minister for Science & Technology on 30th June, 2017.
The Mission has been approved at a total cost of US$250 million for five years with 50% funding through World Bank Loan, with an aim to make India a hub for design and development of novel, affordable and effective biopharmaceutical products such as vaccines, biologics and medical devices for combating public health concerns. This Programme of DBT would strengthen translational capability of academic researchers; empower bio-entrepreneurs and SMEs by decreasing the cost and risk during early stages of product development and also elevate the innovation quotient of the industry. The global experience of World Bank would be instrumental in building sustained global linkages, technical assistance and knowledge flow between public private partners for business promotion in biotech sector.
The Legal Agreement with World Bank for flexible financing arrangements for this Mission of DBT was executed on April 24, 2018 between the project implementing agency – BIRAC a PSU of DBT, Department of Economic Affairs, Ministry of Finance, Govt. of India and International Bank for Reconstruction and Development (on behalf of World Bank). This mission will mark the beginning of a new partnership between DBT and World Bank. It is envisaged that this programme will revolutionize the Biotech market. It will help deliver 6-10 new products in the next five years, create several dedicated facilities for next-generation skills, and hundreds of jobs in the process. It is anticipated that in the long term it would benefit the Indian population at large due to availability of affordable solutions and products relevant to Indian health needs.