Establishing a regulatory framework for a sustainable food future in India: DBT’s leadership and foresight

A large group of people convenes in a decorated conference hall for the Regulatory Conclave on Smart Protein with six panelists prominently featured.

Recognising the potential of smart protein, the Government of India Department of Biotechnology (DBT) has identified it as a thematic sector under the Fostering High Performance Biomanufacturing initiative. To be prioritised as a focus area in a government initiative to promote a circular economy for a green, clean, and prosperous India, is a massive win for the nascent smart protein sector. The road ahead, however, is not without hurdles. The sector continues to need substantial support, particularly in clarifying the regulatory framework for these novel alternative protein products. 

Taking a lead on charting smooth pathways for smart protein in India, DBT, along with Biotechnology Industry Research Assistance Council (BIRAC), organised a closed-door, invite-only Regulatory Conclave on Smart Protein on April 30, 2024. The DBT-BIRAC Conclave was a first-of-its kind pioneering event to convene a dialogue on the regulatory path-to-market for smart protein products by a government department in India. The Conclave brought together key stakeholders across government (including the apex food regulatory body in India – FSSAI and the Ministry of Food Processing Industries), experts from science and academia, Indian and international companies, industry associations, and the international food standards body – Codex Alimentarius. Their collective expertise provided a comprehensive overview of the challenges and opportunities to propel the sector, emphasising that with the right regulatory interventions, India could emerge as a global smart protein leader. GFI India was honoured to be part of the group of expert speakers and observers of the stimulating deliberations.

The discussion spanned all three modalities of smart protein – plant-based, fermentation-derived, and cultivated meat, and the speakers presented a spectrum of factors that would affect the regulatory path-to-market for smart proteins, particularly novel smart proteins in India. The day-long dialogue focused on safety assessment, hazard management, and industry-academia partnerships for data generation for smart proteins. Experts also delved into the technical aspects of smart protein, covering manufacturing processes, inputs, and testing methodologies. Underscoring the need for a clear regulatory framework to advance the sector, there was a consensus on the need for a scientific panel within FSSAI for effective scrutiny of the current regulatory framework and to suggest suitable amendments. 

The Assistant Director, Food Safety and Standards Authority of India (FSSAI), Shri Pankaj Meena, assured of FSSAI’s willingness to work with DBT and BIRAC to establish regulatory frameworks for smart proteins to address regulatory bottlenecks, including data generation, and safety monitoring. He also mentioned that steps can be taken to build internal capacity within FSSAI to create a pool of experts on smart proteins. Diego Varela, Vice-Chairperson of the Codex Alimentarius Commission, shared the discussions at the Codex Alimentarius Commission on the topic and agenda of New Foods and Production Systems (NFPS), which is broadly defined to include cell culture-based food products (meat, fish, dairy), plant-based protein alternatives, and 3-D printed foods, as well as seaweed, microalgae, and insects.

Dr. Rajesh S. Gokhale, Secretary-DBT & Chairman-BIRAC, highlighted the potential of India’s biotechnology ecosystem to contribute to the growth of nascent, sustainable food solutions such as smart protein. He also discussed the economic potential of the smart protein sector and its contribution to economic growth in countries like Singapore and the U.S., while emphasising that a clear, well-thought out regulatory framework was crucial in achieving that. The Conclave concluded with Dr. Jitendra Kumar, Managing Director, BIRAC, and Sonia Gandhi, DGM & Head (Regulatory Affairs & Policy Advocacy), BIRAC, announcing a white paper based on the discussions from the Conclave with the intent to support the regulatory bodies with the path forward.

Is there a regulatory framework for smart proteins in India?

The Food Safety and Standards Authority of India (FSSAI) currently does not have any separate standards for smart protein products. Smart protein products are classified on the basis of ingredients and technologies utilised in the production process and regulated within existing frameworks. Plant-based meat, eggs, and dairy that utilise standardised ingredients in innovative formats are classified as proprietary foods and are not viewed as novel. Fermentation-derived products require pre-market approval from the FSSAI under the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017 (NSF Regulations). Cultivated meat would fall within the purview of the NSF Regulations as well.

Cultivated meat is novel across the globe, and most regulators are either evaluating their existing frameworks and making amendments as required or providing extensive guidance to invite applications from cultivated meat FBOs and make the process as clear as possible. 

The Food Standards Agency (FSA), the regulatory body for the United Kingdom, commissioned a report on the identification of hazards in meat products manufactured from cultured animal cells and issued guidance for businesses on cell-cultivated products and the authorisation process. The FSA is also planning to start conducting safety tests for cultivated meat in 2024 and is working on a pilot ‘sandbox-testing’ project, which will enable it to assess novel proteins for human consumption.

Similarly, South Korea amended its regulatory framework to invite applications from cultivated meat companies and announced regulatory-free zones, to foster cultivated meat R&D. The Brazilian Health Regulatory Agency (Anvisa) also published a Resolution of the Board of Directors RDC 839/2023 which provides for safety proof and authorisation for the use of novel foods and ingredients. The European Food Safety Authority (EFSA) has published Draft guidance on the scientific requirements for an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283 to provide clarity to the applying FBOs. 

Currently, there are over 15 cultivated meat and fermentation-related smart protein companies in India. India is also being viewed as a market for smart protein products by international fermentation companies. So far, FSSAI has granted prior approvals to three novel smart protein ingredients under the NSF Regulations – Perfect Day’s non-animal whey protein (derived from precision fermentation), ACME’s mycoprotein (derived from biomass fermentation of Fusarium venenatum), and Reliance’s phototrophic algal biomass-derived protein powder. 

The FSSAI has previously provided clarity on regulatory frameworks for other food categories by publishing guidance documents, as well as scrutinising and amending the regulatory framework where needed. To provide guidance to the industry and frame science-based regulations (or amendments to the existing framework) for cultivated meat, the FSSAI can institute a working group on cultivated meat. This working group will be able to recommend strategic priorities for cultivated meat (and inputs such as culture media and cell lines) for the FSSAI to consider for regulatory interventions and a strategy for a dynamic regulatory framework. Ultimately, instituting a scientific panel on novel smart proteins would ensure progressive rule-making and risk management.

Key takeaways from the discussion

As per the World Economic Forum, combating climate change and meeting the nutritional needs of a growing population without exhausting our planet’s resources are two of the biggest challenges of our time, and biotechnology holds the solution to both. The use of biotechnology in producing food can address several challenges peculiar to India as well as those shared by the global south, including food insecurity, farmer stress, climate change, and resource degradation. Novel smart proteins that utilise biotechnology—inputs and ingredients derived from fermentation, cultivated meat, and plant-based alternatives—are a sustainable, scalable, and nutritious solution to transform our food systems.

We hope Conclave’s discussions mark the beginning of India’s journey committed to building regulatory frameworks for a streamlined path to market for smart protein products.