Astha Gaur• Senior Policy Specialist - Regulatory • July 01 2024

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

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 May 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

  • Regulatory Framework and Global Competitiveness: To position India as a global leader in smart protein production, it is essential to develop a clear and supportive regulatory framework. This includes addressing the regulatory challenges of cultivated meat and ensuring that safety assessments for novel smart proteins are as thorough and efficient as for any other food category in India. Building on India’s foundation of a strong pharmaceutical industry, young entrepreneurs, and technical talent, with adequate regulatory support, the country is well-placed to lead technological development and manufacturing in this sector.                                                                                                                                                                       
  • Pre-application consultation process and early engagement with the companies: There is a need for different regulatory approaches for various modalities of smart protein. While plant-based smart proteins are categorised as proprietary food, that use standardised ingredients and do not require extraordinary safety data, novel smart proteins like cultivated meat need to establish safety before approval. Given that this category is new to India, companies require guidance in the form of a pre-application consultation process from FSSAI. This approach for early engagement with companies making novel food approval applications followed in geographies like Singapore and the US, will ensure reduced timelines, robust data collection/submission, and less burden on the regulator and the scientific committee.                                                                                                                                                                                             
  • Promoting ease of doing business through sector specific regulatory compliances: To achieve price parity, low-cost manufacturing models of novel smart protein products will need to be developed that support manufacturers in optimising the production process. Regulatory compliances for the life sciences industry with an emphasis on high sterility and stringent cGMP are over-engineered and overly expensive for food production purposes. Therefore, it is essential that a unique set of compliances be designed for manufacturing cultivated meat and fermentation-derived inputs for food.                                                                                                                                     
  • Publishing clear guidance under the FSSAI’s Non-Specified Foods Regulations to support smart protein companies: The novel smart protein companies, particularly those manufacturing fermentation-derived inputs, require guidance from the FSSAI on dossier preparation and submission under the NSF Regulations. A guidance document from the FSSAI with clear guidelines to conduct and submit safety assessment data for such novel smart protein companies would provide clarity to companies on regulatory processes and requirements. This would effectively reduce timelines, encourage companies to apply in India, and increase compliance.                                                                                                                                                                                            
  • Establishing partnerships for regulatory data collection: Data to establish risk assessment, toxicity, allergenicity, acceptable residue limits of inputs (in the case of cultivated meat), and human studies including dietary exposure are still not widely available for cultivated meat and fermentation-derived inputs. While product-specific safety assessments would have to be carried out by individual companies, collating process-specific and product-agnostic data would require wider partnerships and collaborations between industry, academia, and the food regulator.                                                                                                                                                                                       
  • Informative labelling and consumer trust:  A crucial aspect of effective communication is the labelling of products. Allowing progressive and informative labelling to communicate accurate sensory information (of what the product tastes like) will help consumers understand how to cook, eat, and incorporate smart protein into their diets. While there can be various approaches to labelling, they all need to be transparent (through the use of qualifiers like plant-based) and provide consumer-centric information.                                                                                 
  • International collaboration and best practices: To accelerate the go-to-market for novel smart proteins, international collaboration and learning from global best practices are of paramount importance. Different regulatory processes from other countries can be studied and adapted to the Indian context. This includes early engagement with companies, data sharing, publishing safety assessments and findings of novel food products, and a regulatory sandbox approach to foster innovation while ensuring safety (as mentioned by the FSA).

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. 

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