Introduction
In this age of fast-paced routines riddled with stress and anxiety, the increasing and much-needed focus on health and lifestyle has led to the greater consumption of immunity-boosting and lifestyle-enhancing health products. These products are easily accessible and are not medicines or drugs that come with their fair share of risks, fueling a rising attraction towards nutraceutical products.
The term “nutraceutical” consists of the words “nutrient” – a nourishing food component – and “pharmaceutical” – a medical drug. “Nutraceuticals” is a broad term to describe any product derived from food sources with extra health benefits that go beyond the basic nutritional value obtained from foods Considering nutraceuticals provide consumers health benefits and the added relief of not being reliant only on medicines, the emergence and rapid growth of the nutraceutical market do not come as a surprise. The current market size of nutraceuticals in India is approximately USD 7 billion and is expected to double over the next five (5) to six (6) years. The market is estimated to reach USD 18 billion by the end of 2025, compared to the USD 4 billion by end of 2020. It thus becomes imperative to understand the regulatory framework that governs the production, manufacture, and distribution of nutraceuticals considered a “food” category in India.
Brief Overview of Food Regulation in India
‘Food’[1], ‘Food Business’[2], ‘Food Business Operators’[3] and ancillary activities/services are a regulated sector in India. The Food Safety and Standards Act, 2006 (“FSS Act”), read with the Food Safety and Standards Rules, 2011 (“FSS Rules”), in addition to the various regulations thereunder, govern the regulatory regime of food in India. The said legislation and regulations provide for regulatory contours of manufacture, storage, distribution, sale, and import of food to ensure safe and healthy food for human consumption. The Food Safety and Standards Authority of India (“FSSAI”), the statutory body established under the FSS Act and the Ministry of Health and Family Welfare, oversees the regulatory sphere of nutraceuticals in India. The FSSAI, among other things, oversees the manufacture, processing, distribution, sale, and import of food, mainly by setting standards and guidelines for the safety and quality of such products, enforcing quality control, providing scientific/technical advice, and enforcing the licensing and registration requirements under the FSS Act.
Regulation of Nutraceuticals in India
Nutraceuticals in India are regulated by FSSAI under the FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose and Prebiotic and Probiotic Food) Regulations, 2022 (“Nutra Regulations, 2022”), which overhauled the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food, and Novel Food) Regulations, 2016. The Nutra Regulations, 2022, defines “nutraceutical” as “a category of foods which consists of extracts, isolates, and purified chemical compounds having a physiological benefit and help to maintain health”.[4] Such foods can be delivered as powders, granules, tablets, capsules, liquids, semi solids, drops, pills, gummies, jelly, chewable and mouth-dissolving strips, bars, biscuits, and candies intended to be consumed orally in defined quantities and duration. To qualify as nutraceuticals, the products must contain the ingredients and nutrients mentioned in Schedule III of Nutra Regulations, 2022. While the usage levels and limits of ingredients must comply with that specified in Schedule III, the usage levels of nutrients should not exceed the levels that is specified by the Food Authority. In the absence of such specified levels, it should be a minimum 15 percent of the Recommended Dietary Allowance (“RDA”) as specified by Indian Council of Medical Research (“ICMR”), and for a higher nutrient claim, is should not be less than 30 percent of the RDA and not exceed one RDA.
The manufacture, distribution, marketing, import, etc., of nutraceuticals is prohibited unless in compliance with the Nutra Regulations, 2022. While the Nutra Regulations, 2022, have not been notified, the Draft Regulations have been re-operationalised several times vide various FSSAI orders.[5] The said regulation seeks to regulate specially processed food or food formulated for specific nutritional or dietary purpose, namely,
- health supplements;
- nutraceuticals;
- food for special dietary use;
- food for special medical purpose; and
- prebiotic food and probiotic food.
The Nutra Regulations, 2022, specifies distinguishing the aforementioned food categories, because of their special composition, from foods intended for normal consumption and ensuring that these adhere to the characteristics of food provided for in the said regulation. Further, it makes it clear that products under the Nutra Regulations, 2022, should not include a “drug” as understood under the Drugs and Cosmetics Act, 1940, and no products claiming cure or prevention, mitigation of a disease, or disorder, etc., should fall under the regulation.
Brewing of an Interesting Regulatory Tussle?
Nutraceuticals, while a regulated food product, is not as regulated as drugs under the purview of the Central Drugs Standard Control Organisation (“CDSCO”). While evidence from market data may suggest that a comparatively relaxed regulatory regime has paved the way for ease of business in the nutraceutical market, the Ministry of Health and Family Welfare has expressed its concerns over consequent marketing malpractices for nutraceuticals in India.
In this context, the Government of India formed a high-level committee to mull over a shift of the regulatory regime of nutraceuticals from the purview of the FSSAI to that of the CDSCO. The committee has observed multiple regulatory overlaps on dosage provisions between the nutraceutical regulations and the Drugs and Cosmetics Act, 1940, making it difficult to demarcate such products distinctively as either a nutraceutical or a drug. Such overlaps have also led to pharmaceutical companies misusing the ambiguity by shifting their products from the category of drug to nutraceuticals to avail the relaxations provided by a less stricter regulatory regime. For instance, Telangana’s Drugs Control Administration recently seized several pharmaceutical products falsely marketed as nutraceuticals and medicines.[6] Further, nutraceutical products claiming the mitigation and cure of diseases has raised concerns for the drug regulators.
Industry players have voiced their concerns amid the aforementioned deliberations and opposed any potential regulatory shift from the FSSAI to the CDSCO in relation to nutraceuticals. They claim that India’s nutraceutical regulations are compliant with international standards and in line with foreign regulatory regimes and any regulatory shift aiming at stringent compliances would only nip in the bud the growth of the nutraceutical industry.[7] However, with several good reasons to expect a regulatory overhaul, the current nutraceutical regulatory sphere would be interesting to observe.
For further information, please contact:
Biplab Lenin, Partner, Cyril Amarchand Mangaldas
biplab.lenin@cyrilshroff.com
[1] Section 3 (j) , FSS Act defines “food” as “food” means any substance, whether processed, partially processed or unprocessed, which is intended for human consumption and includes primary food to the extent defined in clause (zk), genetically modified or engineered food or food containing such ingredients, infant food, packaged drinking water, alcoholic drink, chewing gum, and any substance, including water used into the food during its manufacture, preparation or treatment but does not include any animal feed, live animals unless they are prepared or processed for placing on the market for human consumption, plants prior to harvesting, drugs and medicinal products, cosmetics, narcotic or psychotropic substances.”
[2] Section 3(n), FSS Act defines “food business” as “any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to any stage of manufacture, processing, packaging, storage, transportation, distribution of food, import and includes food services, catering services, sale of food or food ingredients.”
[3] Section 3(o), FSS Act defines ‘food business operators’ as “in relation to food business means a person by whom the business is carried on or owned and is responsible for ensuring the compliance of this Act, rules and regulations made thereunder.”
[4] Clause 3(g), FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose and Prebiotic and Probiotic Food) Regulations, 2022
[5] https://www.fssai.gov.in/upload/advisories/2022/03/6243ef28079ceDirection_Nutra_30_03_2022.pdf; https://fssai.gov.in/upload/advisories/2023/11/65572d7a4d111Direction_Re-operationalization%20of%20FSS_Nutra_Regulations_17.11.2023.pdf
[6] https://telanganatoday.com/telangana-dca-raid-shops-finds-unlicensed-medicines
[7] Pharma groups criticise plan to shift nutraceuticals under drug authority | Health News – Business Standard (business-standard.com)
