Registration of Nutraceuticals in India with FSSAI: A Complete Guide for Manufacturers

The nutraceutical industry of India is booming exponentially, and thus provides great opportunities for foreign producers wishing to enter the Indian market. Yet compliance with the FSSAI requirements can be difficult without a clear guideline. This detailed guide outlines the step by step registration procedure of OTC nutraceuticals and FSMPs in India in accordance with the most recent regulatory requirements published by FSSAI in 2022.

Understanding India’s Nutraceutical Regulatory Evolution

India's regulations in respect to nutraceuticals are relatively recent when compared to those relating to drugs and cosmetics that are well established. However, in 2006, a regulation framework for food products was set up through the passing of the Food Safety and Standards Act, allowing for the free import of nutraceuticals into the country. In 2008, the FSSAI came up as a regulatory body to handle the food safety scenario in India. The most recent change happened in 2016, when there were set regulations for health supplements, nutraceuticals, foods for dietary use, FSMPs, and pre/probiotics. In 2022, these regulations have been further strengthened by updating the categories of products.

Decoding Product Categories Under FSSAI

Before embarking on the registration process, one must decide on which class his/her product belongs to. Nutraceutical products have been classified into different classes by the FSSAI, with each class carrying different regulations. To begin with, Nutraceuticals are products meant to be taken to offer physiological benefits like inflammation and heart protection and contain components such as curcumin or omega 3. Health Supplements, including multivitamins or protein powder, have been designed to complement the normal food intake. In addition, Foods for Specific Medical Purpose (FSMPs) have been formulated for consumption by individuals suffering from medical conditions; therefore, they are usually taken under the supervision of a medical professional (like ICU formula foods). Other significant classes include Foods for Special Dietary Use (FSDUs), Plant/Botanical Based Foods, and Prebiotics/Probiotics.

The Role Of Ingredient Schedules And Rda Limits

FSSAI uses the Schedule based approval process. The ingredients are categorized in nine schedules ranging from nutrients (vitamins, minerals, amino acids) and botanical/plant based ingredients to food additives, probiotics, and prebiotic compounds.

If the ingredients of your products match these schedules, then it becomes easier to get the approval. But, if there is a new ingredient in the formulation or an ingredient that has been used in a new format like nano formulations and fermented extracts, then your product falls under NSF and a new process has to be adopted for the same. Equally critical is the RDA criteria, which should be based on Indian reference value.

RDA is calculated based on average body weights of Indian adults (60 kg for men and 55 kg for women). It also takes into account different levels of activities and different age groups. If there is excess of RDA limit in the product and if it is meant for any other population than standard population group (for example lactating mother and children), then it is subject to be scrutinized without taking reference of Indian RDA for the respective ingredient values.

Labelling, Claims, And Compliances Under Indian Law

Labeling has been identified as one of the crucial steps in regulatory compliance in FSSAI. As per the Food Safety and Standards (Labeling and Display) Regulations, 2020, the label should indicate the nutritional value of the product, composition of the product, information about the manufacturer/importer, and license number issued by FSSAI. Warnings need to be included in the labeling for example, products containing caffeine should have the warning: "Not recommended for children, pregnant or lactating women."

Moreover, the claims should be in accordance with the FSSAI Advertising & Claims Regulations, 2018. The above are classified into five Schedules:

• Schedule I - Nutrient Content Claims ("low fat", "high fiber");

• Schedule II - Mandatory warning statements for certain substances;

• Schedule III - Permitted disease risk reduction claims ("oats may reduce cholesterol");

• Schedule IV - Fortified food claims; and

• Schedule V - Terms such as natural, pure, etc.

Claims that are misleading and/or not substantiated by facts will result in rejection or penalization after approval; hence, it is crucial to thoroughly analyze the packaging before submitting it.

When Does Your Product Become A Non Specified Food (Nsf)?

Your product will be categorized as Non Specified Food (NSF), if the food includes ingredients that do not fall under the listed schedules, or the process involved in its manufacture involves new technologies and procedures that have not been heard of in India, including nano processing and microbial fermentation.

To pass the NSF application, you need to include:

• Product composition and intended uses of the product,

• Ingredient sources and history of consumption,

• Allergenicity, toxicity and efficacy tests,

• Test reports issued by laboratories accredited by NABL/ILAC, and

• Approval of the food ingredient in other countries.

It generally takes 4-6 months for the NSF to be processed, but in case there are any doubts, FSSAI may call for more evidence. In the absence of adequate proof, your application may hang on indefinitely.

Filing Form B: Standard Registration Pathway

In case the products belong to any approved categories, the Form B form can be considered as the normative way. It is done through the FoSCoS website, and the required documents include the following:

Authorization from the manufacturer or No Objection Certificate (NOC),

• List of ingredients according to Indian laws,

• GMP or ISO certificate of conformity,

• Certificate of Analysis (CoA),

• Labels in accordance with Indian labeling standards.

The whole procedure may take up to 2-3 months and the registration period will last for 1-5 years. The price at the moment is around INR 7,500 (GBP 75).

Import Process And Role Of The Authorized Indian Agent

Customs clearance is the subsequent phase that entails the submission of the shipment documents, inspection, and laboratory testing by port officers. Mismatch of the labels or the formulation may result in rejections and penalties at this phase. It is important for the importers to make sure that all packaging has new Indian compliant labeling and importer's information. This can be done using over sticking, but within pre approved parameters.

Your Independent Authorized Indian Agent (IAA) plays an extremely significant role in your journey. According to the Indian regulations, a foreign manufacturer must appoint an IAA who will liaise on his behalf with the FSSAI and deal with everything from the filing of applications to post market surveillance. This is more than just a regulation – it is a partnership. It is important to choose the right agent in order to facilitate your approval and import process.

Preparing For The Future: FSSAI Vs. CDSCO Jurisdiction

While FSSAI is the regulatory body overseeing the nutraceuticals sector today, the Indian government’s Central Drugs Standard Control Organisation (CDSCO) is beginning to look at products which lie in the grey area of being a food or a medicine. A committee was formed in 2024 to determine whether certain high dosage or medicinal nutraceuticals should come under the CDSCO jurisdiction. If your product makes bold claims about its effectiveness, contains pharmacologically active doses, or is being used in a clinical environment, then keep a close eye on this evolving process.

The registration process for these types of products with CDSCO will take more time (6 to 9 months minimum), be more costly, and involve more rigorous documentation procedures than registering food items.

How Morulaa Healthtech Can Accelerate Your India Entry

Understanding the challenges that you will face in order to meet regulatory requirements, Morulaa HealthTech knows that compliance is much more than a mere formality and helps you to achieve success of your products through the process. With over a decade of experience, having over 5,000+ SKU and presence in over 30 countries, our regulatory team that includes PhDs & MPharm experts will be able to assist you with all aspects of FSSAI, CDSCO, IVD, and Cosmetics compliance.

Our services include but are not limited to:

• Registrations and NSF approvals

• Appointment and management of IAAs

• Alignment of labels and claims

• Coordination with distributors

• Uninterrupted flow of imports into India.

In a bid to make sure that we minimize your costs while entering into the Indian market, we bring in our ground level experience and marketing and regulatory integration.