India’s union cabinet approved the BioE3 (Biotechnology for Economy, Environment, and Employment) Policy on August 24, 2024. This groundbreaking policy, proposed by the Department of Biotechnology under the Ministry of Science & Technology aims to foster high-performance biomanufacturing. The BioE3 policy supports research and development, entrepreneurship, and innovation across various sectors, focusing on biomanufacturing, bio-artificial intelligence (AI), bio-foundry, green growth, workforce expansion, and job creation. The policy’s focus on regenerative biomanufacturing aligns with India's vision of a cleaner, greener, and more prosperous future.
Biotechnology involves the industrial use of microorganisms and living plant and animal cells to produce beneficial substances through genetic manipulation. In its narrow senses, biotechnology refers to growing microorganisms, such as yeast and bacteria, under controlled conditions. In the broader sense, biotechnology can mean any of the modern technologies that rely on discoveries made in modern science. It includes the manufacture of antibiotics, vitamins, and vaccines, and relies on advancements by modern discoveries in cell biology, biochemistry, and molecular biology.
Biomanufacturing is a specific branch of biotechnology focused on the production of goods using biological systems. It encompasses processes that utilise living cells or their components to manufacture products, often through fermentation or other biological processes.
Need for the Policy
To tackle the complex challenges of the 21st century, a strong policy framework is essential to integrate biotechnology, engineering, and digitalisation, aiming for a more equitable and sustainable future. It is crucial to devise a strategic roadmap that includes incentives to ensure that benefits of the bioeconomy are shared broadly.
Biomanufacturing across various sectors is projected to generate an annual economic impact of US$ 2– 4 trillion (approximately Rs 167–335 trillion) over the next decade. Achieving this requires clear strategies, advanced technology platforms, and thorough risk assessments. The shift to biomanufacturing represents a significant move toward sustainable and efficient production processes, necessitating collaboration among government, academia, industry, and society within a supportive regulatory environment.
The BioE3 Policy is vital for:
- strengthening the science and technology innovation ecosystem through public-private partnerships and international cooperation;
- accelerating technology development and commercialisation via Bio-Enabler Hubs that provide access to necessary technology and infrastructure;
- increasing employment opportunities and fostering entrepreneurship;
- aligning regulatory reforms with global standards;
- establishing an effective and transparent patent system for genetic resources;
- promoting sustainability in various ecosystems by leveraging local community knowledge; and
- supporting a regenerative bioeconomy with ethical and biosafety considerations.
India’s biotechnology industry has grown significantly, from US$ 10 billion in 2014 to over US$ 130 billion in 2024. The BioE3 Policy aims to further accelerate this growth, targeting US$ 300 billion by 2030. This policy will further enhance government initiatives related to ‘Green Growth,’ a ‘Net Zero’ economy, and ‘Lifestyle for the Environment.’
Policy Framework: Vision, Goal, and Objective
The policy’s vision is to position India as a leader in a sustainable future by harnessing biomanufacturing solutions that address global challenges while protecting the environment and mitigating climate impacts.
The policy’s goal is to fast-track sustainable innovation-to-technology by consolidating biomanufacturing activities and incentivising concrete solutions for a greener tomorrow.
The objective of the policy is to establish a framework that would drive to the adoption of advanced technologies, foster innovative research, and transform biomanufacturing processes for greater efficiency, sustainability, and quality, ultimately accelerating the production of high-value bio-based products.
The policy sets an ambitious vision for technology leadership, focusing on addressing major challenges in six key thematic sectors. These six thematic sectors of biomanufacturing include bio-based chemicals and enzymes, functional foods and smart proteins, precision biotherapeutics, climate resilient agriculture, carbon capture and utilisation, and futuristic marine and space research.
The research and translational activities under the thematic sectors of biomanufacturing would be catalysed by accelerating transformation with bio-enablers including bioartificial intelligence hubs, biomanufacturing hubs, skilling human resources, regulatory enablement, and inter-ministerial coordination.
Enabling Mechanisms
The enabling mechanisms for the policy focuses on creating a supportive framework that promotes the integration of biotechnology, engineering, and digitalisation. Key mechanisms include:
Cross-cutting bio-enablers It would augment discovery and translation research to enable biomanufacturing across the six sectoral prioritised verticals.
Bio-AI hubs They would unite biological and computational experts to tackle complex challenges, advancing the understanding of living systems. Integrating AI with biological data, such as genomics and medical imaging, would revolutionise disease diagnosis, treatment, drug discovery, and personalised medicine. Additionally, analysing 'omics' data from microorganisms would enable the design of novel metabolic pathways for producing high-value chemicals and biomaterials. In agriculture, these hubs would leverage data analytics to optimise farming practices, soil conditioning, and productivity, ultimately reducing costs.
A major obstacle in translational research has been the difficulty in converting research into commercial products. Currently, researchers lack access to facilities for scaling up bio-based products from laboratory to market. To address this, biomanufacturing hubs would provide shared pilot and pre-commercial manufacturing facilities for researchers, startups, and SMEs. These hubs would also offer technological support and upscaling expertise to strategic agencies. By sharing infrastructure, innovators could develop, demonstrate, and apply their research, fostering a skilled workforce, job creation, and economic growth. Additionally, the hubs would serve as training centres, ensuring a steady supply of skilled professionals in biomanufacturing through partnerships with educational institutions.
Maintenance of global standards There would be effective regulations and global standards which are crucial for promoting research, innovation, and manufacturing. Strategic reforms would facilitate the production and commercialisation of novel bio-based products while maintaining regulatory stringency. Proactive stakeholder engagement would identify challenges and solutions. The policy would enhance inter-ministerial coordination for a seamless enabling environment, integrating biosafety, biosecurity, and cybersecurity considerations.
Data governance This policy would establish a data governance framework to promote AI-driven discovery, prioritising public benefit over commercial or individual interests. Research findings, inventions, and knowledge generated would be shared openly with the scientific community, while also safeguarding intellectual property rights. Effective data storage, management, and access strategies would be integral to this approach. Equitable data access would be guaranteed, with mechanisms for acknowledging sources and adhering to data usage terms.
Strategies for the Promotion of Biomanufacturing
To foster pioneering biomanufacturing research, cutting-edge technologies would be developed and improved to enhance production of biopharmaceuticals and bio-based products. This would be achieved through six key strategies: integrating biological sciences and AI for advanced biosynthetic platforms; industry-academia collaborations to bridge lab-to-market gaps; co-location to reduce costs and complexity; establishing bio-enabler hubs for discovery and translational research; addressing regulatory roadblocks for genetically modified organism-based processes; and creating a skilled workforce in domestic biomanufacturing. Additionally, bio-AI hub would enable discovery research, while bio-foundries/biomanufacturing hubs would support pilot and pre-commercial scale research.
Partnerships and collaborations Biomanufacturing growth would be driven through collaborative efforts with partners, research institutions, universities, government agencies, startups, and Indian industries.
Public-private co-creation model A public-private model would drive the biomanufacturing initiative, fostering inter-ministerial coordination and private sector partnerships for a sustainable and self-reliant bioeconomy.
International collaborations India would globally collaborate to accelerate green growth through biotransformation, enhancing its biomanufacturing hub status via the BioE3 Policy, with a focus on affordability, accessibility, and economic viability.
Inter-ministerial coordination Mutual collaborations would facilitate a synergistic combination of expertise and services from multiple organisations to address key questions in biomanufacturing's identified sectors. To achieve this, inter-ministerial collaboration would be explored with various concerned ministries and departments, including the Department of Science and Technology, Council of Scientific and Industrial Research, Indian Council of Medical Research, Indian Council of Agricultural Research, Ministry of Earth Sciences, Ministry of Electronics and Information Technology, Indian Space Research Organisation, Ministry of Environment, Forest and Climate Change, Defence Research and Development Organisation, and the Ministry of External Affairs. This collective effort would enable research and establishment of essential enablers in biomanufacturing.
Skilling and human resources The biomanufacturing revolution would transform the traditional biotechnology workforce hierarchy, requiring a diverse set of interdisciplinary and cross-functional skill sets. To drive this change, the focus would be on building human resources with specialised technical skills in upstream biological engineering, manufacturing, and downstream processing. This would enable the efficient development and deployment of innovative biomanufacturing processes, ultimately fostering growth and advancement in the sector.
Potential Impact of the Policy
India is strategically positioned to become a global leader in advanced manufacturing that utilises living systems. Biomanufacturing has the potential to shift the global economy from a consumptive model to one based on regenerative principles. This policy document aims to stimulate research and technological expertise within the country, attract startups and industries, and effectively facilitate the transition to a strong bioeconomy.
The convergence of technologies will drive innovations in medical treatments, tackle agricultural and food-related issues, and encourage the use of bio-based products. Implementing suitable regulatory reforms and attractive incentives will accelerate development and commercialisation timelines. As a result, biomanufacturing will foster more prosperous, equitable, and sustainable development for present and future generations, contributing to the goal of Viksit Bharat by 2047.
Conclusion
The BioE3 Policy is a comprehensive strategy to leverage biotechnology for India's economic growth, environmental sustainability, and employment generation, aligning with the vision of a ‘Viksit Bharat’ (Developed India). As India emerges as a Global Biotech Powerhouse, this policy would revolutionise biomanufacturing, addressing climate change, food security, and health challenges. By investing in biotechnology, India would drive national development, sustainability, and leadership in the 4th industrial revolution.
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