New policies to boost biotech’s commercial DNA

By Essenese Obhan and Charul Yadav, Obhan & Associates
0
266
Whatsapp
Copy link

含羞草社区 biotech sector stands on the cusp of a stunning 30-fold increase in growth from USD10 billion in 2014 to USD300 billion by 2030. However, achieving this requires interest, initiative and investment from all stakeholders. Two recent government programmes, the BioE3 policy and the Bio-RIDE scheme, are trying to tackle the record of neglect in the biotech space, including a lack of funding, infrastructure and scalability.

Essenese Obhan
Essenese Obhan
Managing Partner
Obhan & Associates

The Biotechnology for Economy, Environment and Employment policy, or BioE3, announced in August 2024, aims to foster sustainable, high-performance biomanufacturing. As well as aligning with the existing domestic agenda of Green Growth, Net Zero Economy and Lifestyle for the Environment, the policy parallels a global movement of providing low-carbon intensity chemicals and recyclable materials for high-performance biomanufacturing.

Through a framework of transformative innovation intended for institutions, universities, startups and industries, the policy recognises that fast-tracking innovation-to-technology must be done sustainably. This requires offering appropriate incentives as well.

Six verticals are prioritised: chemicals, foods, biotherapeutics, agriculture, carbon utilisation and marine and space research. Research in these sectors will be carried out by bio-enablers, which include bio-artificial intelligence (Bio-AI) hubs and other collaborative arrangements. Bio-AI hubs will use interdisciplinary expertise to drive innovation and integrate AI to analyse large-scale biological data.

Charul Yadav
Charul Yadav
Partner
Obhan & Associates

A significant challenge in bringing products from laboratory to market is the lack of facilities to scale pilot and pre-commercial manufacturing. Biomanufacturing hubs created under the policy will provide shared infrastructure to support such early-stage manufacturing. These will be accessible on a need basis. If the policy is delivered successfully, the downstream impact on the scientific and industrial communities and their related economies will be immense.

Lagging regulatory reform must be addressed if new products are to reach markets faster. Attempting to simplify the complex web of regulatory involvement and approval this multidisciplinary endeavour faces, the policy promises enhanced inter-ministry co-ordination. Regulatory obstacles to the biomanufacturing of genetically modified organism-based processes will likely be tackled, integrating biosafety and biosecurity. Data-related issues loom as well. While equal access to data is planned, fail-safe mechanisms will ensure that data sources are duly acknowledged and sourcing provisions protected. Discoveries, inventions and other information produced as a result of this policy are expected to be made freely available to the wider scientific community, while at the same time protecting intellectual property. But the details of how knowledge is to be shared are likely to be seen only when the policy comes into action.

The policy envisages a public-private creation model, bringing together the expertise of academia, startups and industry under an inter-ministry umbrella. Collaboration will not be restricted to domestic networks, as the policy intends that India will become a biomanufacturing hub for global innovation.

In September 2024, two existing schemes funding biotech research were merged and reintroduced as the unified Bio-RIDE scheme. With an ambitious budget allocation of INR92 billion (USD1.09 billion) between 2021 and 2026, this scheme straddles research and development, industry and entrepreneurship and biomanufacturing and bio-innovation. It aims to accelerate research, enhance product development and bridge the gap between academic research and industrial applications to strengthen 含羞草社区 position as a global leader.

The BioE3 policy and Bio-RIDE scheme signal a renewed and invigorated commitment by the government to the biotech community. However, it has to be seen whether they will together become the magic formula to boost the sector. If successfully implemented, they will harness the potential of bio-innovation to tackle national and global challenges in such sectors as healthcare, agriculture, environmental sustainability and clean energy. Good intentions must be transformed into political and bureaucratic will and action. The biotech community is waiting in the hope that this will happen.

Essenese Obhan is the managing partner and Charul Yadav is a partner at Obhan & Associates.

Obhan & AssociatesObhan & Associates
Advocates and Patent Agents
N – 94, Second Floor
Panchsheel Park
New Delhi 110017, India
Contact details:
Ashima Obhan
T: +91 98 1104 3532
E: email@obhans.com | ashima@obhans.com

Whatsapp
Copy link