The Biotechnology for Economy, Environment, and Employment (BioE3) policy follows exciting initiatives including the Anushandhan National Research Fund (ANRF), the Green Hydrogen Mission, the Quantum Mission, and the Artificial Intelligence (AI) Mission, all of which signal a political prioritisation of scientific Research and Development (R&D) in India. Its three focus points — boosting the economy, protecting the environment, and creating employment — align with India’s broader ambitions of maintaining double-digit economic growth and uplifting citizens from poverty, while upholding India’s climate change commitments for sustainable development. 

The BioE3 envisions high-performance biomanufacturing as the central lever to enabling this transformation. It has identified six thematic areas of national interest: high value bio-based chemicals, biopolymers & enzymes; smart proteins & functional foods; precision biotherapeutics; climate resilient agriculture; carbon capture & its utilisation; marine and space research. 

Proposed roadmap of BioE3

While finer details are still awaited, the basic roadmap of BioE3 appears to be to innovate in the six thematic areas. The मूलांकुर Bio-Enabler Hubs are meant to facilitate this research. Where applicable, there will be a use of analytical technologies such as AI on large data sets to identify problem areas and possible solutions. This includes areas in agriculture, health, and climate change, providing insights on farming practices, new therapies, new energy solutions, etc. Interdisciplinary skilling will be an important input to this ambitious and transformative first step, which is likely to yield novel products not already captured by foreign intellectual property. 

Products and services innovated in India would be a key contributor to boosting India’s economy — both directly through their own sales and indirectly, by increasing productivity once applied. For example, a biopesticide will not only increase revenue through its sale, but also boost agricultural productivity and sale of agricultural produce. 

Once a solution is designed and approved, its production has to be scaled-up — this step has been often cited as a key bottleneck by Indian biotechnology companies. The BioE3 focusses on this step, providing governmental support in setting up the infrastructure that can help reduce costs of scaling up for India’s biotechnology industry. Increasing biomanufacturing will generate employment, particularly in Tier2/​3 cities where such facilities are likely to be based. Appropriate skilling of the labour force — including bioprocessing, technical, and administrative jobs- may be required to create the necessary ecosystem for setting up such hubs. 

In 2017, a United States Department of Agriculture (USDA) report had highlighted that for every one bio-based job, 2.79 jobs are created in other sectors. However, setting up such ecosystems will not be easy — biomanufacturing hubs require not only personnel, infrastructure and product licenses, but raw materials, manufacturing grade water, continuous electricity and effective routes for waste management so as to not pollute the surrounding environment. The BioE3 recognises the need to co-locate biomanufacturing hubs with existing research and infrastructure hubs, but the identification of these locations will be a key determinant of the success of this initiative. 

BioE3 will require sustained funding

Another key determinant of the success of BioE3 will be the funding allocated to it. In the follow-up to BioE3, the cabinet also gave its nod to a Biotechnology Research Innovation and Entrepreneurship Development (Bio-RIDE) scheme. This new scheme merges two existing central sector schemes — the Bio-Biotechnology R&D and Industrial & Entrepreneurship Development (I&ED) — and introduces a new component titled ​“Biomanufacturing and Biofoundry”.

The proposed financial outlay for this initiative is INR 9197 crore during the 15^th finance Commission period from 2021 – 22 to 2025 – 26. The two pre-existing schemes had an estimated budget of INR 7119.28 crore for the years 2021 – 22 to 2024 – 25, which does not leave a significant funding space for biomanufacturing. However, these estimated budgets were revised down to INR 4004 crore over the years 2021 – 22 to 2023 – 24, which creates additional space in the proposed budget of INR 3000 crore for new initiatives. The actual allocation of these funds will determine the success of the biomanufacturing and biofoundry initiative. 

A recent study had reported that the annual operational costs of a biomanufacturing hub in Bengaluru is about INR 120 crores, which suggests that the costs of setting up new infrastructure, skilling the labour force and running the hub will run in thousands of crores. The proposed budget may be a good starting point, but has to be supported by further consistent funding and its appropriate utilisation. 

Incentivising market support would facilitate the success of BioE3

Biomanufacturing follows R&D and feeds into the market. The BioE3 policy refers to international collaboration and public private partnerships as enablers for both research and biomanufacturing, but does not elaborate on the market for these products. Creating sustainable markets is going to be important for long-term development of the ecosystem and to enable the growth of biomanufacturing, independent of government support. Current geopolitical conditions have created interesting opportunities for Indian manufacturers to explore international markets. For example, in the US, a new policy that will ban US genomic companies from buying products and services from certain Chinese companies is in advanced stages of development. This Act once passed, will create a window for Indian genomic service providers and product manufacturers to foray into this market space. 

The implementation of BioE3 could focus initial energy on such areas of biotechnology, where an international market is available and could help the domestic Indian biomanufacturing ecosystem while reducing the cost for the Indian government. Preferential purchase agreements or advance purchase agreements between US and Indian companies, facilitated by bilateral governmental interventions, can help build investor confidence and bring in new funding into the Indian biotechnology ecosystem. Other such opportunities either through bilateral cooperation or multilateral fora such as the Quad (US, India, Japan, Australia) or the newly formed​Bio‑5 (US, EU, India, Japan, South Korea) can help prioritise products for biomanufacturing. 

Regulatory coherence will be required to execute BioE3

The BioE3 policy raises the important issue of regulatory reform as a core tenet in need of change. It also notes that this change will require inter-ministerial coordination and cooperation. This is a positive development and much required for promoting biotechnology. For example, the Department of Biotechnology (DBT) has notified a policy that allows research on genetically edited insects for development of agriculture, silk, etc. These areas also fall under the proposed six thematic areas for BioE3 policy. Yet, the actual commercial deployment of such insects would need approval from the Ministry of Environment, Forest and Climate Change.

There is currently no proposed regulation on whether genetically edited insects will be allowed in India or conditions under which such insects may be used. Without this clarity, there is very little incentive for both researchers and investors to put in efforts into this area. Hence, the proposed approach of the BioE3 to get these ministries to coordinate and work on a policy for the development and use of genetically edited insects in India is a welcome move. 

Overall, the BioE3 policy is an excellent signal of governmental intent and a step in the right direction for India’s life science industry. Hopefully this intent will be bolstered by appropriate funding and regulation to facilitate the industry’s growth. This is an exciting time for life science in India and when deployed in its entirety the policy will surely lead India into a top biotechnology destination and fulfil its ambitions of Viksit Bharat 2047.