Old wine in a new biotech bottle

CLIMATE change, energy transition, waste management, sustainability, agricultural productivity, the need for new health tools and much more. India can not only address these pressing challenges through the application of biotechnology but can do so while generating jobs and contributing to the national economy. This is what the Biotechnology for Economy, Environment and Employment (BioE3) Policy released by the government on August 31 would have us believe. The only caveat is that the policy is silent on the timeframe, the quantum of investment and human resources required, the possible number or types of jobs that will be generated and the pathway to achieve the goal.

Before embarking upon building a large-scale biotech industry, it would be prudent to develop a robust, autonomous and statutory regulatory system.

The ‘vision’ of the policy is to “set Bharat at the forefront of the future that is more sustainable and responsive to global challenges by accelerating and harnessing biomanufacturing solutions that encompass diverse bioeconomic activities while safeguarding environmental and climate impacts.” The ‘goal’ of the policy is “to fast-track innovation-to-technology” by weaving together fragmented activities under the umbrella of biomanufacturing and to incentivise “concrete options to build a sustainable future”. The overall ‘objective’ is to present a framework to ensure the adoption of cutting-edge technologies and accelerate the development and production of bio-based high-value products.

While presenting the policy, Department of Biotechnology (DBT) Secretary Rajesh Gokhale declared that the goal was the ‘industrialisation of biology’ and making India a global leader in this field. If one cuts the fluff, all that the policy document indicates is the government’s intent to promote biotechnology-based industry and the use of new tools like digitalisation, artificial intelligence and machine learning. If that is so, there is nothing new here because the last policy document the DBT released in 2021 — National Biotechnology Development Strategy (2021-25) — said precisely the same thing but it was backed with timelines, financial targets and clear pathways.

The goal set in 2021 by the DBT was to develop a biotechnology-led ‘knowledge and innovation-driven bioeconomy’ and make India a ‘global biomanufacturing hub’ by 2025. This was to be achieved by building a skilled workforce and enabling infrastructure for industry like bio-foundries, and incentives to the industry for developing and producing affordable products. The thrust areas identified in 2021 were climate change, food security, green energy, waste management, etc. The list has been repeated in the 2024 document, but the DBT has cleverly made no mention of previous policies and strategies to avoid questions being asked about missed goals. The only follow-up action since 2021 is a new scheme to promote bio-foundries announced in the 2024-25 Budget.

In the past four decades, biotechnology has demonstrated its potential in applications ranging from new vaccines and novel crop varieties to environmental cleanup using microbes. Indian policymakers recognised its potential early on, establishing a dedicated government department for its promotion in 1986. The DBT, in its formative years, focused on building research and education capabilities, which has made India a significant player in this field.

However, the biotech-based industry was slow to pick up due to reasons such as a lack of venture capital and an enabling environment. Whatever industry developed was not a result of the DBT’s programmes. The poster boy of the Indian biotech industry, Biocon, predates the formation of the DBT, and other pioneers like Shantha Biotech and Bharat Biotech took root with the help of risk financing by another government body, the Technology Development Board.

In the 2000s, the governments of Karnataka and then undivided Andhra Pradesh rolled out their policies that gave incentives to the biotech industry. The success of the Genome Valley and the IKP Knowledge Park in Hyderabad are shining examples of a state-sponsored technology cluster developing with the active participation of the private sector. It was only in 2012 that the DBT established a commercial arm for industry promotion — the Biotechnology Industry Research Assistance Council.

The government should boost the industrial base in biotechnology by leveraging existing strengths and learning from the experience. However, the new policy does not mention successful models like the Genome Valley or IKP Knowledge Park. Instead, it has rehashed the same concept and given it a new name (Mulankur Bio-Enabler Hub). These hubs, the policy says, will ‘augment discovery and translational research’ and ‘support facilities for pilot scale and pre-commercial scale research’. This is what the functional technology clusters are doing and have successfully incubated firms that have grown to become billion-dollar companies.

While unveiling a grand utopian vision of solving all problems, the policy underplays the key role of regulation (it calls regulation a ‘roadblock’), the need to invest in developing technical manpower and boosting state funding for fundamental research. Regulation is critical as biomanufacturing is all about genetically modified and other organisms. At present, regulation is fragmented and opaque. The Biotechnology Regulatory Authority of India Bill has been in cold storage since 2013. Before embarking upon building a large-scale biotech industry, it would be prudent to develop a robust, autonomous and statutory regulatory system.

The DBT Secretary talks about a ‘new industrial revolution’ fuelled by biotechnology, like the much-celebrated IT Revolution. He should remember that the communication revolution was triggered not by a policy but by the government’s resolve to develop a digital telephone exchange from scratch with a committed investment and a tight deadline. In the same way, it was the state-promoted Software Technology Parks scheme that led to an exponential growth of the software industry and the IT Revolution. Decisive government actions are more important than policy pronouncements.

Public policies are supposed to be guiding documents for responsible governance. They can be forward-looking and aspirational but should have clearly laid out objectives, well-defined timeframes and an understanding of challenges. The DBT, which adhered to this time-tested template in the past, decided to deviate from it while preparing the new policy. Being a scientific department, the least it could have done was to make the policy logical, evidence-based and rational. For a policy with ‘economy’ and ‘employment’ in its title and as prime focus, it is vague, ambiguous and full of rhetoric.