Bioeconomy in India: Policy, Prospects and Perspective

ABSTRACT

India is at a stage where the economy is rapidly expanding with bioeconomy emerging as a significant contributor to national growth and is being supported by the government through targeted missions and strategic policy interventions. Landmark initiatives such as Make in India, Startup India and establishment of Biotechnology Industry Research Assistance Council (BIRAC) have laid a robust foundation for nurturing innovation and entrepreneurship. Having created the necessary innovation ecosystem, recent policy frameworks such as the BioE3 policy and Research Development and Innovation Fund (RDIF) will further strengthen the technology‐driven development. All these efforts are enabling India to move towards a competitive bioeconomy that balances economic growth with environmental sustainability. With an increasing emphasis on biomanufacturing and circular bio‐based solutions, India is progressing towards a resilient, future‐ready bioeconomy.

The current manuscript focuses on India's transition towards a bio‐based economy by highlighting the policy frameworks, innovation financing and growth in biomanufacturing. With expanding start‐up ecosystem, synthetic biology capabilities and research transition, the country is focusing on building a competitive and future‐ready bioeconomy aligned with low‐carbon development goals.

1. Introduction

India is among the world's largest economies, with a nominal Gross Domestic product (GDP) of approximately ∼US $ 3.7–3.8 trillion and is projected to become the third largest in the world with an estimated GDP of $7.3 trillion by 2030 [1]. As India's economy grows, the country is focusing more on sustainability and innovation, with the bioeconomy emerging as a critical pillar for development. Bioeconomy is defined as the production, utilisation and conservation of biological resources, knowledge and technologies to provide products and services across all economic sectors [2]. It encompasses a wide range of sectors including biofuel, agriculture, forestry, food and beverages, climate change mitigation and adaptation.

Building a globally competitive bioeconomy is both feasible and strategic for India, given its unique strengths. The country is already ranked among the top 12 destinations worldwide in biotechnology with an approximate 3% share in the global biotech industry [3]. It hosts the 3rd largest start‐up ecosystem globally and is recognised as the largest vaccine manufacturer [4]. These advantages are further complemented by India's extensive coastline stretching over 7500 km and availability of more than 140 million hectares of agricultural land. India's natural resources, along with its strong pharmaceutical industry [5] and growing innovation system, creates a good opportunity for building a diverse and resource‐rich bioeconomy that is environment friendly and sustainable.

With this context, this review provides an overview of the current status of the bioeconomy and synthetic biology in India. It examines structural shifts within the sector and highlights the role of the BioE3 policy, along with the contributions of the Department of Biotechnology (DBT) and the Biotechnology Industry Research Assistance Council (BIRAC) in shaping the ecosystem. The review also examines how these elements collectively support innovation and translation within the country.

2. Bioeconomy Development: India and the Global Context

Reflecting this progress, India's bioeconomy was valued at $165.7 billion in 2024 (Figure 1a) contributing approximately 4.2% to the national GDP [6, 7]. This represents a near doubling of its value of $86 billion in the year 2020 [8] underscoring the sector's rapid expansion. This concerted growth can be attributed to the country's effort to position biotechnology‐based innovations as a key driver for sustainable and inclusive development.

FIGURE 1.

(a) Growth of Indian Bioeconomy over the years (b) Segmentation of the sectors of Bioeconomy over the last few years (data from [6, 8, 73, 74]).

Indian bioeconomy comprises four key sectors namely biopharma, bio‐industrial, bio‐agri and bio‐services, and its structure has undergone significant transformation over the years. According to India Bioeconomy Report [6], in the year 2024–25, the bio‐industrial sector comprising of biofuels, enzymes, bioplastics and chemicals, was valued at $78.2 billion, which accounted for 47.2% share of the total bioeconomy. This was closely followed by the biopharma sector valued at $58.4 billion (35.2% share), bio‐IT/research services (9.4% share) and the bio‐agri sector (8.1% share). This was in stark contrast with the values in the year 2020 when biopharma was the dominant sector (58%), followed by the bio‐agri sector (19%) (Figure 1b). The bio‐industrial sector contributed only 8% share [9]. This rapid expansion was probably a result of a sustained policy push over the years, supported by initiatives such as the Production‐Linked Incentive Scheme, National Biofuel Policy and Green Hydrogen Mission, among others. These initiatives helped the industrial biotechnology sector, which was previously relatively peripheral, in moving to the mainstream in alignment with global priorities of circular economy and decarbonisation. The rise of the bio‐IT/research sector also suggests a gradual strengthening of bioinformatics and computational biology research in the country. Overall, this 5 year trajectory indicates a shift from a biopharma‐driven phase towards a more balanced multi‐pillar structure across biotechnology sectors. Though biopharma continued to remain as the major contributor towards the bioeconomy, a greater diversification could be seen in the ecosystem, which involved increased participation from other sectors as well.

Supportive government initiatives and enabling policies have played a major role in the expansion of bioeconomy. In 2012, Department of Biotechnology (DBT) set up Biotechnology Industry Research Assistance Council (BIRAC) as a central enabling agency to promote an ecosystem of innovation in biotechnology. In 2014, Government of India launched the ‘Make In India’ programme. The mandate was to transform India into a global innovation and manufacturing hub. DBT recognised the necessity for entrepreneurship development among the youth in the country and established a Make in India Facilitation Cell for Biotechnology Sector (at BIRAC) in 2016. The Cell was mandated with responsibilities such as facilitating investments, fostering innovations and promote the ease of doing business. The launch of the ‘Start‐up India’ initiative in 2016 further catalysed the start‐up culture and helped to build a strong and inclusive ecosystem for innovation and entrepreneurship in India. Eligible companies could get recognised as start‐ups by Department for Promotion of Industry and Internal Trade, Government of India in order to access facilities such as tax benefits, easier compliance, IPR fast‐tracking, etc. The Union Budget 2023–2024 identified ‘Green Growth’ as a national priority, emphasising sustainable development across energy, transportation and agriculture. Targeted investments were proposed in renewable energy, climate‐resilient infrastructure and bioresource‐based industries to accelerate India's low‐carbon economic transition [10].

The supportive initiatives contributed to a surge in the start‐ups and advances in research and innovation. The number of start‐ups in the country has crossed a major milestone to reach 10,075 in 2024, a significant rise from just a few hundred a decade ago [8]. These start‐ups are fostering a vibrant innovation landscape across healthcare, agriculture and industrial biotechnology. In addition, academic and research institutions have also played a pivotal role by driving cutting‐edge research, technology development and skill‐building that support industry requirements and start‐up growth.

Recently, in November 2025, the Government of India launched a new flagship initiative called the Research, Development and Innovation Fund (RDIF). With a landmark corpus approximately USD 12 billion to be deployed over a period of 6 years, RDIF aims to catalyse private‐sector‐led research and development and promote deep‐tech innovation in strategic sectors like AI, biotechnology, energy security, quantum computing and more. The financing structure, encompassing long‐term loans at low or nil interest rates, equity infusions and contributions to Deep Tech Fund of Funds, is designed to stimulate innovations while de‐risking early‐stage technologies. When blended with the existing grant in aid mechanisms and private investment, RDIF can help bridge the critical ‘valley of death’ between lab research and market deployment. The programme also seeks to facilitate the acquisition of technologies that are of high strategic importance. Overall, RDIF is expected to boost research‐driven entrepreneurship and advance sustainable and inclusive economic growth.

Together, these efforts are gradually supporting to position the bioeconomy as a foundational pillar in India's transition towards a low‐carbon, self‐reliant and innovation‐led economic future, and accordingly, the country has set up an ambitious target to grow its bioeconomy to $300 billion by 2030 [11].

Globally, the development of bioeconomy has been shaped by diverse policy approaches and governance frameworks. Several studies have compared and analysed the bioeconomy strategies across countries [12, 13, 14, 15, 16], compared and summarised 41 countries worldwide and highlighted that the fossil fuel–based economy has shaped the current systems so strongly that shifting to a bioeconomy would need smart governance framework that is capable of overcoming the various path‐dependency problems. They further highlighted that development of a modern bioeconomy is being regarded as a central strategy to ensure sustainable development. However, to achieve these goals, national bioeconomies need an effective and globally coordinated governance framework backed up by operating guidelines and documenting implementing processes [13]. Comparative analysis of G20 and OECD member states also suggests that sustainability and environmental regeneration will be a major goal of governance for the future bioeconomies [17].

At the same time, it was noted in the Global bioeconomy report, 2020 [16] that bioeconomy is seen as an important driver of economic growth and job creation as well as a new strategy for reindustrialisation. Having said that, the report also observed that although many countries acknowledge that bioeconomy can make a significant contribution to jobs and sustainability, the governance aspect is weak [16, 18]. Concrete action plans and legal acts (such as mandates or tax incentives) needed to make the strategy, a reality, are often lacking.

The bioeconomy strategies have been categorised into three visions namely biotechnology, bioresource and bioecology [19]. Existing literature indicates that national strategies are dominated by the bioresource vision, emphasising biomass utilisation and economic growth, with limited prioritisation of environmental objectives. While the biotechnology vision appears in several documents, it is often framed around industrial applications and job creation rather than transformative ecological outcomes. Notably, the bioecology vision, which focuses on sustainability, biodiversity, and socio‐environmental resilience, remains under‐represented in policy implementation. Similarly, a systematic global analysis of 78 bioeconomy policies from 50 countries indicated that goals and visions prioritise economic growth, while environmental considerations are less salient [14]. The bioresource vision emerges as the globally dominant perspective, while the bioecology and biotechnology visions have lower salience.

Together, these findings indicate that economic, technological, ecological and sustainability considerations need to be addressed in an integrated manner to promote bioeconomy.

In this context, the Indian case reflects a setting where bioeconomic growth is shaped through a combination of public investment and institutional mechanisms, similar to global trends.

3. Institutional Drivers for Bioeconomy in the Country

3.1. Department of Biotechnology

The Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India is the main driver for biotechnology‐based academic research in India. Established in the year 1986, DBT was created with the mandate to enhance India's global competitiveness in biotechnology research, innovation, human resource development and fostering industry—academia interaction [20]. DBT played a central role in shaping the institutional R&D ecosystem in biotechnology through establishing centres of excellences, developing infrastructure and formulating of biotechnology policy and guidelines. The programs and partnerships created by DBT are broadly aligned with the national missions of the Indian Government such as Aatmanirbhar Bharat (Self‐Reliant India), Swasth Bharat (Healthy India), Swachh Bharat (Clean India), Startup India and Make in India.

Proposals are regularly supported in cutting‐edge research areas such as human genetics and genomics, cancer therapeutics, diagnostics and biology, dementia science, genome editing/engineering applications in healthcare, energy biosciences, waste to value, environment and forest biotechnology, and agricultural and animal biotechnology, among others. As a part of its translational mandate, DBT was instrumental in supporting 12 Biotechnology Parks in partnership with State Governments. These were created for accelerating the translation of research leads into commercial products or technologies through mechanisms such as technology incubation, technology demonstration and pilot plant studies, thereby contributing to bioeconomy outcomes.

DBT has also supported multi‐institutional whole genome sequencing under the Genome India Project. This became a major highlight of the Department's activities with the release of the data of whole genome sequences of 10,000 individuals from 99 different populations of India through the Indian Biological Data Centre [21]. In agricultural biotechnology, DBT has been instrumental in supporting research that resulted in the release of improved crop varieties, development of genotyping arrays, genomic selection and speed breeding facilities. In another programme called the Biotech‐Krishi Innovation Science Application Network (Biotech‐KISAN) programme, farmers (especially women), were empowered by providing knowledge about the solutions related to water, soil, seed and markets. Biotech‐KISAN hubs have contributed to promotion of rural agri‐entrepreneurship in several regions. As a future endeavour DBT has signed a Memorandum of Understanding with Indian Space Research Organization (ISRO) for Cooperation in ‘Space Biotechnology and Biomanufacturing’. Under this initiative, DBT in collaboration with ISRO supported food and nutrition‐related experiments that were conducted onboard the International Space Station (ISS) as part of the Axiom Mission 4 (Ax‐4). DBT has also supported the establishment of several microbial repositories for preservation of indigenous and improved strains. In parallel, it has expanded scientific partnerships globally through bilateral and multilateral programmes with the EU, UK, Japan and the US. Additionally, it has played an important role in the development of biosafety frameworks and guidelines including those related to genome editing, genetically modified crops, etc.

3.2. Biotechnology Industry Research Assistance Council (BIRAC)

Recognising the need to complement these public sector efforts with a strong industry interface, it became imperative to have a dedicated organisation, which could foster translation and encourage industry–academia partnerships.

Under the National Biotechnology Development Strategy (especially the 2007–2010), the Department of Biotechnology made a policy decision to establish a dedicated organisation that could promote public–private partnership, bridge the gap between industry and academia and support creation of affordable products. This was followed by the approval of the Union Cabinet [22] for the formation of the Biotechnology Industry Research Assistance Council (BIRAC), which was set up in the year 2012 as a public sector enterprise under the Department of Biotechnology, Ministry of Science and Technology, Government of India. BIRAC was given a clear mandate to support start‐ups, entrepreneurs, and medium and large companies to undertake high‐risk innovations and to facilitate and mentor the translation of ideas into biotech products and technologies.

Operating primarily through a public private partnership model, BIRAC has been instrumental in promoting the biotechnology‐based innovation ecosystem in the country. Activities range from supporting high‐risk translational research, early‐stage innovative ideas and developing shared infrastructure.

BIRAC has played a pivotal role in promoting biotechnology‐based innovation in the country due to its alignment with other Government of India initiatives like Make in India and Startup India. Its commitment to stay at the forefront of technological advancements and fund innovative solutions for the creation of affordable products has helped address the needs of the largest section of the society.

BIRAC's programs and schemes are designed to support different stages of the innovation life cycle, spanning ideation, proof of concept, product development, scale‐up and commercialisation. BIRAC plays a pivotal role in supporting the journey from the lab to the market by facilitating translational research, funding early‐stage innovations and enabling product commercialisation.

Recognising the importance to promote a culture of innovation at the grassroots level, especially to individual innovators, early‐stage start‐ups and academic entrepreneurs, the Biotechnology Ignition Grant (BIG) scheme was conceptualised. The intent was to support high‐risk innovative ideas at the ideation or the proof‐of‐concept stage. Simultaneously, the need for access to state‐of‐the‐art laboratories, infrastructure and incubation support led to the launch of the Bioincubators Nurturing Entrepreneurship for Scaling Technologies (BioNEST) programme, which aimed at establishing a network of biotech incubators across the country. Over the years, both BIG and BioNEST have emerged as cornerstones of India's biotech innovation landscape. The BIG scheme has supported over 1000 innovators and start‐ups, many of whom have successfully secured follow‐on funding and advanced their concepts to develop market‐ready products. Under the BioNEST mandate, more than 75 incubators (including centres for Empowering Youth for Undertaking Value Added Innovative Translational Research (EYUVA)) have been established across academic and research institutions in the country (Figure 2). These bioincubators not only provide wet lab and instrumentation facilities but also provide a nurturing environment to the start‐ups through access to mentorship programs, networking platforms and investor connect. Together, they have significantly strengthened the pipeline of biotech enterprises in the country.

FIGURE 2.

Location of different bio‐incubation centres across the country.

Prior to the launch of the BIG programme, BIRAC was already implementing two flagship schemes—Biotechnology Industry Partnership Programme (BIPP) and Small Business Innovation Research Initiative (SBIRI). Both these programs were mandated to support innovation in small and medium enterprises and industry‐led R&D and laid the foundation for India's biotech‐based product development through public private partnership mode. These schemes supported high‐risk, discovery‐led research and product development fostering early collaboration between industry and academia. Over the years, both these programs have continued to play a complementary role to newer initiatives, by providing the necessary follow‐on support for scale‐up, validation and pre‐commercialisation. These efforts are further complemented by the product commercialisation programme (PCP), which offers additional financial support for market launch, test validation in targeted markets and large scale commercialisation. Simultaneously, the Promoting Academic Research Conversion to Enterprise (PACE) programme helps to bridge the gap between academic research and enterprise creation, facilitating translation of academic leads. Taken together, these schemes act as a ladder that supports across the innovation life cycle from ideation and validation to scale‐up and commercialisation.

The effectiveness of such enabling mechanisms is further demonstrated through mission‐mode initiatives such as the National Biopharma Mission, implemented by DBT with support from the World Bank. The Mission is implemented through a dedicated Programme Management Unit (PMU) established at BIRAC. The mission has significantly accelerated the development and commercialisation of biopharmaceutical products by supporting vaccines, biologics and diagnostics.

Alongside its funding support, BIRAC also serves as an enabler by providing access to specialised services such as IP (intellectual property) facilitation and regulatory support. These dedicated mechanisms help to transcend the critical barriers to market entry, by providing essential guidance on IP facilitation and regulatory pathways, ensuring that promising technologies are better positioned for successful commercialisation. To further facilitate translation of research outputs, BIRAC has also supported the establishment of regional technology transfer offices (RTTOs) across the country. These RTTOs played a key role in intellectual property management, licencing and industry matchmaking, thereby helping to bridge the divide between laboratory research and industrial application.

In the 14 years since its inception, BIRAC has been able to create a robust innovation ecosystem in the country and has emerged as a key enabler of the bioeconomy (Table 1).

TABLE 1.

A snapshot of BIRAC's achievements in last 14 years.

BIRAC's achievement	Status
Total proposals accessed	More than 28,000
Number of beneficiaries supported from academic institutes	∼400
Number of beneficiaries supported from start‐ups/companies	∼4800
Investment made by BIRAC	Rs. 4000 crore ($480 million to $500 million USD)
Co‐funding by industry and others	Rs. 2600 crore (∼$313 million)
National and international partnerships	∼100
Incubation centres created	More than 75
High skilled jobs created	More than 35,000
Students/entrepreneurs engaged	More than 15 lakhs (∼1.5 million)
Products in market	More than 800
Mentor pool available	More than 10,000
Follow on funding raised by startups	∼Rs. 5500 crore (∼$650 million)

4. Focusing on Sustainable Development—India's BioE3 Policy

As India's bioeconomy continued to expand with increasing contributions from start‐ups, industries and academic institutes, there was need to shift the focus from scattered innovations to a unified approach that fosters convergence among biotechnology, engineering and digitalisation. At the same time, the need for a policy framework that promotes sustainability while enabling the efficient use of biological resources had become imperative for continued growth.

In the year 2024, the Department of Biotechnology announced the BioE3 (Biotechnology for Economy, Environment, and Employment) policy to support the advancement of sustainable biomanufacturing in India. The policy seeks to accelerate the growth of Indian bioeconomy by technology‐driven innovation to address the challenges such as climate change, environmental degradation and resource utilisation while embedding biotechnology deeply into India's developmental agenda. The policy is being jointly implemented by DBT and BIRAC aiming to accelerate the translation of research into commercial products.

4.1. Thematic Areas and Bioenabler Infrastructure

The BioE3 policy identifies six thematic sectors to achieve technology leadership and tackle major challenges. These include biobased chemicals and enzymes, functional foods and smart proteins, precision biotherapeutics, climate‐resilient agriculture, carbon capture and utilisation and futuristic marine and space research.

Within each of these thematic areas, the policy envisages setting up of Moolankur (English translation as radicle referring to the first part of a seedling to emerge from the seed) bioenablers. The bioenablers would consist of a network of biofoundries, biomanufacturing hubs and bio‐AI hubs for catalysing research and translational activities under these verticals. These foundries and hubs would serve as centralised platforms for pilot‐scale production, technology validation and pre‐commercial units within the six thematic sectors and are expected to address the current bottleneck of limited scale‐up infrastructure for the research efforts to move from lab towards commercialisation. Simultaneously, bio‐AI hubs will help to integrate the biological data with computational capabilities giving impetus to innovation and commercialisation.

4.2. Strategic Relevance of Thematic Areas

The thematic areas have been very thoughtfully selected to address national challenges while building on the existing strength of the country.

1. Climate resilient agriculture: As a country with over 50% of its population engaged in agriculture, prioritising innovations in climate‐smart farming, superior crop phenotypes and soil microbiome engineering is strategic and necessary.

2. Functional foods and smart proteins: With the population of the country crossing the 1.4 billion mark, there is a growing demand for nutritious and sustainable food sources. Hence, protein from alternative sources with an additional benefit of lower environmental impact align with the country's goals of food security

3. Futuristic marine and space research: The country's 7500+ km coastline offers significant potential for exploring the marine biotechnology for energy and bio‐based products. The Government of India already has a mandate for developing the blue bioeconomy and enabling exploration of marine resources for bioactives, enzymes and sustainable food production [23]. The inclusion of marine resources in the BioE3 policy will enable integration of the biotechnological approaches for exploring the marine resources thereby giving further impetus to the growth of bioeconomy and contributing to the overall development of economy.

4. Precision therapeutics: Rising disease specificity, personalised medicine and population dynamics make precision biotherapeutics highly relevant in today's world [24]. India, with its vast population and immense genetic diversity, offers an ideal setting to advance precision medicine. However, its application is in the early stages and specific research is going on in a few areas like oncology, cardiology, psychiatry and diabetology with limited translation to patient care [25]. Given the fact that the Western nations are significantly advanced, it is important to accelerate the efforts. Inclusion of precision therapeutics, specifically focussing on cell and gene therapy and mRNA‐based research, the BioE3 policy indicates alignment with the mandate of leveraging biotechnology for improved healthcare.

5. Carbon capture and utilisation: India is the 3rd largest emitter of CO₂ in the world after China and the USA. As of 2019, India's CO₂ emission per capita was 2.68 metric tonnes, and it is constantly increasing [26]. It is extremely important to decarbonise the industrial sector to ensure sustainable development and economic growth. Recognising this, NITI Aayog (the premier public policy think tank of the Government of India) has brought out a policy paper on abatement of emissions and technologies that can be embraced to help reduce the dependence on fossil sources [27]. The inclusion of innovation pertaining to carbon capture and its utilization in the BioE3 policy can result in the development of next‐generation solutions ranging from bio‐based carbon capture systems to innovative bio‐industrial processes. Such solutions, if developed with high efficiencies and lower cost, could support India's transition towards low‐carbon economy.

6. Bio‐based chemicals and enzymes: Polymers, chemicals, active pharmaceutical ingredients, etc. are being made by the fossil route for the past many years. However, growing concerns over environmental pollution and climate change is driving a shift towards the use of agricultural biomass and waste gases for development of these products. India produces 990 metric tonne biomass [28], a substantial quantity of which is decomposed or burnt [29]. Harnessing of this resource through the biorefinery approach can help in the production of a number of bio‐based products. With its inclusion in the BioE3 policy, it is hoped that research efforts will be scaled substantially to find cost‐effective processes to be adopted at industrial scales.

With its focus on diverse thematic sectors, the BioE3 Policy is broadly aligned with India's commitment to green growth, the Government's vision of achieving net‐zero emissions by 2070 [30] and the Lifestyle for Environment (LiFE) initiative. The focus is also on harnessing the economic potential of biotechnology, using it as a tool for environmental sustainability and as a driver for employment generation in the country. Together, these factors have set the stage for India to move towards the path of sustainability and economic growth. It is anticipated that with all the supportive government policies, research may increasingly move beyond isolated academic and start‐up labs towards integrated and collaborative efforts.

4.3. Enabling the Role of Regulations in the BioE3 Policy

4.3.1. Regulatory Framework for GMOs in India

India has established a comprehensive and multi‐tiered regulatory framework to oversee the safe development, handling and environmental release of genetically modified organisms (GMOs).

GMOs and the products thereof are regulated under the ‘Rules for the manufacture, use, import, export & storage of hazardous microorganisms, genetically engineered organisms or cells, 1989’ (referred to as Rules, 1989) notified under the Environment (Protection) Act, 1986 [31]. The regulatory system for GMOs is anchored by three key bodies namely Institutional Biosafety Committee (IBSC), Review Committee on Genetic Manipulation (RCGM) and Genetic Engineering Appraisal Committee (GEAC). These agencies are responsible to provide oversight from laboratory research to environmental release.

IBSC is an oversight committee and is established at the institutional level. It reviews and approves research involving GMOs within laboratories and ensures compliance with biosafety guidelines. The IBSCs comprise the head of the organisation, scientists engaged in the recombinant work, an expert from the medical side and a nominee of the DBT [31].

RCGM functions under the Department of Biotechnology and supervises ongoing research involving GMOs and small scale trials. The Committee has members from different departments of the government and scientific organisations in the country. The RCGM is also responsible for issuing guidelines for the use and research associated with GMOs, import/export, storage and handling, manufacturing, and disposal and facility certification. These guidelines are generally developed after detailed consultations with relevant stakeholders and inter‐ministerial deliberations and classifies the organisms into risk groups and corresponding biosafety level requirement. The guidelines also specify the physical containment and work practices suitable to conduct experiments with genetically engineered (GE) plants, plants associated with GE microorganisms, small animals or arthropods.

GEAC is the body responsible for approving large‐scale use, environmental release and commercialisation of GMOs. It functions under the Ministry of Environment, Forest and Climate Change. The Committee is also responsible for undertaking comprehensive environmental and biosafety assessments before granting approvals.

In addition to these, the Central Drugs Standard Control Organisation (CDSCO) regulates GMOs when they are developed as drugs, vaccines, biologics or diagnostics, overseeing clinical trials, safety evaluation and product approval for human use. Food Safety and Standards Authority of India (FSSAI) is responsible for regulating food and food ingredients derived from biotechnology. This multi‐tiered regulatory system incorporates internationally accepted principles of risk assessment, environmental release and containment while formalising the regulations. This is further reinforced by India's participation in major international frameworks like to the Convention to Biological Diversity and the Cartagena Protocol on Biosafety. India is also a signatory to the Nagoya Protocol and a state party to the Biological Weapons Convention.

4.3.2. Implementation Considerations and Emerging Needs

The well defined regulatory ecosystem provides a structured foundation for the effective implementation of the BioE3 policy and may enable translation of innovations from the lab scale to commercialisation. The existing framework offers mechanisms that can provide guidance for maintaining biosafety and environmental safeguards. However, certain implementation challenges may influence overall efficiency. The involvement of multiple agencies across different stages of approval can, at times, lead to procedural complexity and coordination issues. Variations in interpretation and differing timelines may also affect overall approval timelines. This may lead to sequential clearances, which can extend timelines and create uncertainty for innovators. Additionally, applications that span multiple sectors may require parallel regulatory pathways, making navigation more complex. Addressing these aspects through improved coordination, clearer delineation of roles and single window approaches can help to achieve faster decision‐making. Simultaneously, strengthening of institutional capacities may help support a more cohesive and responsive regulatory environment.

Having said that, it is important to be aware that the rapidly evolving landscape of gene editing technologies introduces new dimensions that may require further regulatory refinement. The BioE3 policy places strong emphasis on synthetic biology, precision therapeutics, cell and gene therapy, bio‐based chemicals, etc. which often involve complex and novel functionalities that may not align seamlessly with the existing regulatory classifications. For the policy to be successful and translate into tangible outcomes, a more streamlined and adaptive regulatory pathway might be needed. Strategic consultation have been convened with global experts and stakeholders to deliberate on strengthening India's clinical trial regulatory ecosystem, including approaches for early‐phase studies and regulatory sandboxes for emerging therapies [32].

The regulatory bodies will have a very key role in enabling innovations while ensuring that biosafety and environmental aspects are appropriately safeguarded. Greater clarity for emerging technologies such as those involving complex genetic circuits, synthetic chassis, gene drives, etc. would be needed. Often synthetic biology–based research enables creation of an organism with novel or augmented traits; further strengthening of the environmental risk assessment framework might be helpful. It may also be worthwhile to align these regulations with the international best practices to strengthen India's ability to operationalise the policy.

4.4. Positioning India in the Global Bioeconomy Landscape

The launch of the BioE3 policy places India among a growing group of nations that recognise bioeconomy as a transformative force for the 21st century.

In March 2024, Food and Agricultural Organisation of the United Nations launched the world's first Global Bioeconomy Dashboard. This is an interactive monitoring tool, launched by a UN body, to display the latest information on national and regional bioeconomy strategies and guide policymakers, researchers and stakeholders to understand how different countries are approaching the bioeconomy transition [33]. For India, this tool can provide a very valuable data source to compare the progress of the BioE3 policy with those of the global peers and align with international best practices.

Several countries have already announced bioeconomy policies, which are quite varied in priorities and outlook. According to the Global Bioeconomy Report, as of 2020, almost 60 countries around the world were pursuing bioeconomy‐related policies. There are 19 dedicated national and macro‐regional bioeconomy policy strategies worldwide, including Austria, Costa Rica, EU, Finland, France, Germany, Ireland, Italy, Japan, Latvia, Malaysia, Nordic Countries, Norway, South Africa, Spain, Thailand, UK, USA and East Africa [16]. Rest of the countries had some form of bioeconomy policy in place, although they may not be proper strategy documents. The common focus of all these policies and related documents was to reduce the reliance on fossil carbon, promote technology‐based innovations, circular economy principles and sustainable resource management to facilitate a transition towards bio‐based sustainable options.

The BioE3 policy is a strong mix of bioresource and biotechnology. It focuses on sustainable use of biomass, algae and marine resources while integrating AI, synthetic biology and genome editing to accelerate innovation. The BioE3 policy largely aligns with the global trends and puts emphasis on biotechnology and AI integration making them as the drivers for India's bioeconomic growth.

The BioE3 policy reflects India's unique strengths and priorities, and it also aligns with the broader international mandate of prioritising innovation, reducing consumption of nonrenewable resources and resonates with the broader global shift towards technology‐driven, sustainable growth. For the BioE3 policy to be successful, it will be very important to ensure that there is an amalgamation of bioecology, biotechnology and bioresource visions. The BioE3 policy makes mention of creating an enabling environment with seamless integration of biosafety and biosecurity considerations, supportive regulations, and putting progress indicators in place will ensure the success in the implementation of the policy. There has to be more stress on collaborative efforts and developing shared platforms and effective knowledge exchange.

The BioE3 framework also envisages the establishment of BioE3 centres as integrated biomanufacturing and translational hubs to bridge the gap between laboratory‐scale innovation and industrial deployment. These centres are expected to provide shared pilot‐scale infrastructure, support scale‐up and validation, and facilitate regulatory readiness, particularly for start‐ups and MSMEs [34].

Another critical factor is the availability of adequately trained manpower not only in strain engineering but also for bioprocess development and scale‐up. Having created the infrastructure as a part of the BioE3, it will be critical to ensure that these facilities operate at optimal capacity so that the long‐term sustainability and operational expenses do not become a limiting factor once the government funding terminates. At the same time, it also needs to be ensured that the facilities are accessible and affordable to all researchers, start‐ups and industries. There will be a need to create a strong market pull as bio‐based products may face the challenge of limited market update, and hence, there will be a need for creating incentives for using replacement of petrochemical products. Seamless operation will also require strengthening the associated supply chain ecosystem for specialised consumables, plastic ware, glassware, etc. In parallel, the regulatory systems will have to be made agile, ensuring efficient approvals.

5. Synthetic Biology—As the Backbone of BioE3 Policy

The BioE3 policy places advanced biotechnology tools as the backbone of India's transition towards a bio‐based economy. Within this framework, synthetic biology emerges as cornerstone technology, with the potential to help India achieve the targets of the policy and also promote itself on the path of a technology‐driven bioeconomy.

Synthetic biology is the design and construction of new biological parts, devices and systems, and the redesign of existing, natural biological systems for useful purposes. With growing understanding of cell metabolism, synthetic biology is helping to build systems and pathways that can enhance flux, metabolise faster, improve yields and overproduce the metabolites paving the way for cost‐effective production of high‐value chemicals, fuels and therapeutics. By integrating systems biology, metabolic engineering and AI tools, researchers can now develop robust microbial cell factories tailored for industrial applications. These advances have resulted in enhanced production of metabolites such as surfactants [35], pharmaceuticals [36, 37], biofuels [38, 39], food and flavour additives [40, 41, 42], colour [43, 44] and platform chemicals [45].

5.1. Global Ecosystems and Enabling Mechanisms

Globally, synthetic biology has matured through coordinated missions, national strategies and large‐scale investments. Countries such as the USA, UK and EU members are at a very advanced stage in synthetic biology and have established structured programs focusing on research and development of technology platforms. These countries have established strong translation ecosystems through biofoundries, innovation clusters and industry partnerships [46, 47]. The UK and Singapore have coordinated regulatory systems, enabling faster approval cycles for emerging technologies. Internationally, numerous associations/forums interact regularly to facilitate collaborations, technology transfer and policy dialogues. Engineering Biology Leadership Council in the UK interacts with the industry, academic institutes, regulators, nongovernment organisations, etc. to provide strategic leadership for the UK's synthetic biology development [48]. Advanced economies deploy mission‐driven models, which link research, funding and commercialisation. For example, in the United States, the Advanced Research Project Agency (ARPA) model, National Science foundation, Department of Agriculture, etc. supports high‐risk and high‐impact projects that accelerate transition from the lab to the market [49, 50]. The European Union integrates synthetic biology via large‐scale, coordinated funding and public–private partnerships through Horizon Europe and initiatives such as Strategic Technologies for Europe Platform [51]. These countries have also invested in shared, standardised infrastructure, which reduces entry barriers and accelerates design–build–test cycles. A global alliance of biofoundries was established in 2019 to promote open‐access for the development of biological engineering through shared software, hardware, protocols and standards, enabling rapid and reliable prototyping of engineered biological systems [52]. Today, nearly 40 biofoundries are members of this alliance and operate worldwide, with Asia emerging as a key hub led by China, South Korea, Japan and Singapore [53]. Leading facilities such as those in London and Singapore provide cost‐effective, high‐throughput design–build–test capabilities, expanding access to advanced infrastructure for academia and industry. Paris biofoundry (launched in 2024) is driving synthetic biology research in the France. It brings together research institutions across Île‐de‐France, offering dedicated platforms for mammalian and microbial systems, cell‐free systems and industrial scale‐up. Synthetic biology in Germany is mostly centred in academic labs with dedicated focus on areas such as synthetic microbiology, signalling, optogenetics, plant synthetic biology or metabolic engineering [54]. Singapore also has a well‐developed synthetic biology framework spanning across academia and industry. SynCTI and SYNERGY are taking the lead in driving the synthetic biology sector, fostering collaborations and innovations. Australia has charted out a detailed road map for synthetic biology till 2040. The road map is phased into 3 sections—with the first focusing on capacity building and demonstrating commercial feasibility, the second section on early commercial success and finally to achieve growth through market determined applications by 2040.

5.2. Status and Emerging Opportunities in India

Synthetic biology is in a nascent stage in India—the adoption of the technology is still limited and commercialisation is yet to be realised. The ecosystem is gradually strengthening through increasing funding opportunities, targeted academic research, international research collaborations and a rising wave of entrepreneurial involvement. The Government of India is trying to ease the regulatory pathway. Certain genome editing categories (SDN‐1 & SDN‐2) have been exempted from biosafety regulations under Rule 20 of the Environment Protection Act (EPA), 1989—clearing regulatory hurdles for gene‐editing projects [55]. Meanwhile, the advancement in DNA synthesis technology has provided scientists with a precision tool for construction of biological systems, which has been a major driver for research expansion in this area.

Market assessments also reflect this steady progress. According to the Grand View market report, the synthetic biology market in India generated a revenue of USD 513.2 million in 2024 and is expected to reach USD 1599.9 million by 2030 [56] implying a CAGR of approximately 21.1% from 2025 to 2030 (Figure 3). In terms of revenue, India accounted for 3.2% of the global synthetic biology market in 2024. The technologies that were considered for this report were PCR, NGS, genome editing and bioprocess technologies focussing on healthcare, biofuels, speciality chemicals, crops, clinical and nonclinical applications.

FIGURE 3.

Estimated size of India's synthetic biology market growth (2018–2030). Values approximated and adapted from Grand View Research [56].

A second analysis by the IMARC group provides projections based on the consumption of the enabling products such as oligonucleotide/oligo pools and synthetic DNA, enzymes, cloning technologies kits, xenonucleic acids and chassis organisms [57]. However, these estimates largely reflect the consumption of enabling products used in synthetic biology–based research rather than revenue from the commercialised synthetic biology–based products. Although commercialisation of products is still a distant prospect, the increasing consumption of products for research use is significantly enhanced over the years and suggests a rise in the synthetic biology research activity across the country.

This trend is also reflected in the scientific output across the country. Researchers are working on different technologies using synthetic biology–based platforms such as the gene delivery platform for different crops using the CRISPR/Cas9 system [58], yield enhancement in plants [59, 60], CRISPR‐Cas9–based diagnostic kits for rapid detection pathogenic organisms [61, 62, 63, 64], production of biofuels [38, 65], high‐value chemicals [66] and microbial chassis [67, 68, 69]. A noteworthy example of indigenous innovation is the development of a COVID‐19 diagnostic test named ‘FELUDA’. Developed by the Council of Scientific and Industrial Research of CSIR Institute of Genomics and Integrative Biology (CSIR‐IGIB), New Delhi, the kit was approved for human use from the Drug Controller General of India (DCGI).

Research teams from academic institutes like the Indian Institute of Technology, Indian Institute of Science, Indian Institutes of Science Education and Research, Institute of Bioinformatics and Applied Biotechnology, International Centre for Genetic Engineering and Biotechnology, Jawaharlal Nehru University, Institute of Chemical technology, Saha Institute of Nuclear Physics, etc. are actively engaged in areas like advanced research in genome engineering, microbial chassis development, synthetic regulatory circuits and metabolic pathway development.

Despite these advancements, several systemic gaps still exist, which constrain the growth and possible commercialisation of synthetic biology in India. While early‐stage research is well supported through government grants, there is a significant gap in financing for scale‐up studies and demonstration facilities. Ragharhia et al. have critically reviewed the genome engineering technologies and CRISPR‐based projects supported by different funding agencies across academic institutes in India. They have provided a comprehensive list of extramural research projects executed and funding received between 2012 and 2019. Challenges such as a lack of funding to support for large‐scale research, limited trained manpower and weak industry–academia interaction continue to persist. The absence of adequate infrastructure and limited access to shared facilities further restrict the transition of research from laboratory. In this context, the establishment of biofoundries could help mitigate some of these constraints by enabling high‐throughput design–build–test cycles. In addition, dependence on imported reagents, enzymes and specialised equipment increases costs and exposes the ecosystem to global supply chain disruptions.

There is a shortage of trained manpower with interdisciplinary expertise spanning biology, engineering and computational sciences, which are essential for synthetic biology. In addition, limited exposure to hands‐on training and industrial‐scale processes constrains the development of a job‐ready workforce.

5.3. Role of Institutions and Private Players

Synthetic biology requires sustained high capital investment over long gestation periods, specifically for developing microbial strains, optimising bioprocesses and validating production at industrial scales. In this regard, BIRAC has played an important role for bridging the early‐stage funding gaps and promoting this area within the country. Focused calls launched in 2018 and 2019 supported joint research and development activities and also helped to advance the application of synthetic biology for promoting bio‐based economy in India. The proposals, which were supported focused on the development of rose oxide, riboregulators, nisin production, sandalwood sesquiterpenes, homo‐butanol production, etc. The proposals completed after achieving proof of concept for the development of different molecules at lab level and are being followed up for further development. In parallel, BIRAC has also contributed to capacity building through residential hands‐on trainings and workshops at premier academic institutes enabling skill development on different aspects of strain development and biomolecule production involving synthetic biology tools.

The BioE3 policy has catalysed the creation of a National Biofoundry Network, consisting of 21 shared ‘bio‐enabler’ facilities providing infrastructure for scale‐up, testing and commercialisation [71]. These facilities are being established under a public private partnership model, enabling a shared financial responsibility. The facilities would focus on providing access to design–build–test–learn platforms and support the translation of laboratory research into commercial applications thereby providing infrastructure for start‐ups in sectors like bio‐based chemicals, precision therapeutics, and smart protein. Biofoundries can significantly accelerate the engineering of biological systems by providing higher reproducibility, throughput and ease of sharing of standardised protocols [53]. The biofoundry at the International Centre for Genetic Engineering and Biotechnology, New Delhi is the country's first publicly funded facility and integrates automation, artificial intelligence and synthetic biology to rapidly design and test engineered organisms across food, agriculture, chemicals, pharmaceuticals and energy [72]. Although still developing compared to global leaders, India is transitioning from isolated capabilities to a coordinated, distributed ecosystem to align with global players and strengthen its position in the synthetic biology landscape.

Despite these developments, the proportion of projects involving synthetic biology, submitted by companies or start‐ups remains smaller. This may be due to long gestation period for product development, an uncertain market path, the need for specialised expertise or significant regulatory uncertainties for products developed through this route. Other sectors of biotechnology such as biopharma, diagnostics or agri‐biotech, where the market is more accommodating and regulatory pathway is streamlined, the investor confidence has been established and funds for scale‐up and validation are more easily available. As a result, synthetic biology research is perhaps still perceived as a high‐capital intensive and high‐risk domain in India.

In recent years, many private players are also incorporating synthetic biology in their research and innovation mandate, signalling a shift towards industrial integration. India's industry landscape has seen a rise in synthetic biology‐driven start‐ups and private R&D centers. Few notable examples are as follows:

• String Bio Pvt Ltd—utilises synthetic biology to convert methane into value‐added products (https://www.stringbio.com/).

• Reliance Industries—Extensive research is ongoing at Reliance innovation Leadership Centre on sustainable and eco‐friendly materials and ingredients. The company is investing in algal technology and synthetic biology for developing sustainable biomaterials, bio‐polymers and chemicals (https://www.ril.com/about/innovation)

• Jananom Private Limited—A start‐up company focused on synthetic biology and metabolic engineering targeting novel compounds, specifically small molecules and peptides (https://jananom.com/#about_section)

• Fermbox Bio Pvt Ltd—A Synthetic Biology Research & Manufacturing start‐up developing and delivering sustainable Synbio products and solutions leveraging microbial fermentation and synthetic biology (https://fermbox.bio/about‐us/).

• E2E Biotech—The start‐up is involved in developing technologies, process and products through intensive R&D by deploying cutting‐edge biotechnology and synthetic biology strategies (http://www.e2ebiotech.com/)

• CRISPR BITS—The company is using CRISPR to develop pervasive diagnostics and surveillance tests. They are enabling the application of CRISPR editing to areas addressing critical healthcare needs, such as building the next‐generation CAR‐T cells and disease tissue models from edited induced pluripotent stem cells (https://crisprbits.com/).

• Alstonia Bio Private Limited—An emerging start‐up focused on creating a synthetic biology platform to develop new drugs, food products and sustainable biomaterials using AI (https://alstonia.bio/)

• Amogen Pharma—focussing on synthetic biology and fermentation for developing plant‐based ingredients (https://www.amogenpharma.com/)

• Tojovikas Biotech Private Limited—focussing on biotechnological production of flavours and fragrances.

Achieving a reasonable balance between environmental sustainability, economic growth and social resilience can enable tangible impact and support India's movement towards a globally competitive, innovation‐driven bioeconomy. With focused investments in infrastructure, skill development, and translational research, India can bridge the gap between laboratory research and commercialisation.

6. Conclusion

Significant progress is underway in India with multiple centres of excellences, strong academic and research institutions and steadily expanding start‐up ecosystem. India is at a stage where the government policies are becoming progressively aligned to support innovation and entrepreneurship. On the front of entrepreneurship and funding, India is at a very strong position, and the stage has been set for taking research to the next level of commercialisation. The BioE3 policy has further strengthened this trajectory by laying out an ambitious vision of setting up biofoundries, biomanufacturing hubs and bio‐AI hubs across strategically identified thematic areas. The six thematic areas have been very strategically chosen to strengthen the bioeconomy and ultimately contribute to India's economy. Synthetic biology is emerging as a key enabling technology to support sustainable bio‐based industrial development in the country. DBT and BIRAC are at the forefront of promoting this growth. Strengthening interdisciplinary collaboration, enhancing industry participation and deepening international partnerships will be critical to ensure that the momentum generated is converted into sustainable, large‐scale outcomes.

Author Contributions

Shilpi Gupta: conceptualization, data curation, visualization, writing – original draft. Jitendra Kumar: conceptualization, writing – review and editing.

Funding

The authors have nothing to report.

Conflicts of Interest

The authors declare no conflicts of interest.

Data Availability Statement

The authors have nothing to report.