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Navigating the food regulatory maze in India

Process improvement framework for food businesses

Introduction  - the changing regulatory landscape 

With more than ten years of existence, FSSAI (Indian FDA) is a familiar name within the food fraternity. Moreover, the recent content management and campaigns of central department helped penetrate the subject of food safety to the large public. Besides support from Government of India, new leadership tried numerous strategies to change the perception of the department. With limited resources, I feel they have done some exceptional work in the last four years. Of which, expanding the product standards was stupendous because it eases out the business problems as well as the workload of the department. Of course, a lot of grandfathering and global regulatory framework adaption is evident in this exercise. However, the million-dollar question “is compliance hassle-free for food businesses?” remains static. 

In this article, I would like to mention one of the critical regulatory requirement that food businesses find it challenging to cascade into their organisation processes. That said, typically, large entities will have a piece of first-hand information about the developments due to economic policy reasons and start implementing to mitigate the risk factors. However, the SME businesses lack such opportunity and will have to bank on the transition time provided by the regulator. Although, this write up is helpful across all food business, it directs largely towards SME players. 

Classification of Standard product, Proprietary Food, Nutraceutical, supplements or a novel

In this series of blogs on regulatory maze, I start with“Are your ingredients approved?” which resumes with the compliance process “Classification of your food recipe.”

Recipe is the core of any food business, and it forms a major distinction between brands. That said, I see brand owners, including importers, often find it very difficult in categorising the recipes when compared against the rules. This complexity is even true for standard products (like chocolates, beverages, etc.) because the reviewer has to match the additives (preservatives, emulsifiers), which are exhaustive. 

For proprietary foods lack standards resulting in verification of ingredients. The subtle difference in classification between proprietary and standard products is the review outlook, i.e., for proprietary one look at standards horizontally, and for standard product, it is vertical. For instance, take the biscuit as this product have standards; the manufacturer has to comply with prescribed ingredients, quality and safety parameters. Now consider premix for biscuit, since there is no definition for this product; the brand has to comply with the ingredients, i.e., performing a check for ingredients across regulations. The same applies to instant breakfast mixes, herbal beverages, infusions entering into the market.

Similarly, there are separate regulations given for nutraceuticals and supplements. Comparing the recipe with schedules provided would give a fair understanding of the category. It is important to note that, whenever there is an overlap of herbs in this category, the definition plays an important role in ascertaining the classification. 

Take a look at the illustration which demonstrate the navigation of food recipe through the approved food ingredient databases of food regulator. By closely reviewing the flow, one can determine the category of recipes that are in the pipeline or the R&D phase. 

FSSAI classification of food products 

With regards to novel, products are those with ingredients out of FSSAI approved database, and hence such ingredients require an approval from the scientific panel. Even, this approval mechanism also covers novel processes in manufacturing foods. Such products require prior approval before launching into the market. 

Lastly, standardisation of this classification process may be a bit challenging due to frequent changes in the regulatory system. However, if the business understands the framework, they can work with agility and implement these incremental steps in the existing process. Simple things like visiting the FDA website, assessing the impact of new changes, sharing feedback on draft regulations and planning improvement would bring great efficiency. Because streamlining classification process is very pertinent as this forms the genesis for aligning with other rules like licensing, advertisements, labelling and packaging, which we delve in the coming blogs. 

Sai Hari is a consulting professional who primarily practices in the area of strategic planning, sales growth, process improvement, IT Project and risk management. Besides associating with the verticles like E-Governance, Food, beverages, retail, and E-Commerce, he also helps startup entities to get off the ground. He can be reached at for any productive discussions


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