National Biopharma Mission

• Towards strengthening the emerging biotechnology enterprise in India, the 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 :

1. Development of products from leads that are at advanced stages in the product development lifecycle and relevant to public health.
2. Strengthening and establishing shared infrastructure facilities for both product discovery validation and manufacturing
3. Developing human capital by providing specific training to address the critical skills gaps in researchers, and nascent biotech companies across the product development value chain, including in business plan development and market penetration.
4. 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, and 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 establishing of technology transfer offices in public and private sectors, and imparting training for technical and non-technical skill development.

Other Features

• The Mission is to support small and medium enterprises so that they can overcome the risks involved in the early stages of product development.
• To promote entrepreneurship, the Mission is to support enhanced industry-academia inter- linkages and provide mentoring and training for academia, innovators and entrepreneurs to translate knowledge into products/technologies.
• 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 to strengthen 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 training 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